Dimitris Agrafiotis, Ph.D., Vice President, Informatics & Enterprise Architecture, Covance; former, Vice President, Informatics, Johnson & Johnson Pharmaceutical Research & Development
Dimitris Agrafiotis, PhD, FRSC, is Vice President of Informatics & Enterprise Architecture at Covance, where he is responsible for the architecture, design, implementation, operation, and support of information technology services, and for establishing an encompassing informatics vision to infuse innovation and strategic differentiation into the company’s product offerings. Prior to joining Covance in 2013, he spent 10 years at Johnson & Johnson Pharmaceutical Research & Development where he served as Vice President of Informatics and Research IT. Dr. Agrafiotis received his Ph.D. in Theoretical Organic Chemistry from Imperial College, London (1988, Henry Rzepa advisor), and held postdoctoral fellowships with Andrew Streitwieser at the University of California, Berkeley, and Nobel Laureate E. J. Corey at Harvard. In 1991, he joined Parke-Davis (now Pfizer) as a Senior Scientist in the Computer-Aided Drug Design group, and in 1994 he moved to 3-Dimensional Pharmaceuticals (3DP) as a founding member of its scientific staff, where he built the company’s informatics and computational drug design capabilities. Following a successful IPO and the acquisition of 3DP by Johnson & Johnson in 2003, he was appointed Senior Research Fellow and Team Leader of the Molecular Design & Informatics group at the East Coast site, a position he held until 2006 when he was appointed VP and global head of Informatics and Research IT. His work spans many areas of computational life sciences and informatics, and is documented in >90 peer-reviewed publications and book chapters, and 18 issued US patents.
Barbara Isquith Arone, MS, Senior Director, Service Operation, Real-World Late Phase, Quintiles
Ms. Arone is Senior Director, Service Operations, Real-World, Late Phase Research for Quintiles. She has managed or overseen more than 50 registries or post-approval projects, representing the full spectrum of post-approval research, including pregnancy registries, orphan disease registries, product and drug safety registries, as well as quality improvement programs. She has operational excellence in both prospective and retrospective data collection methods in North America and globally, including the EU, Central and South America as well as Asia. Currently Ms. Arone oversees a group of departments responsible for registry study design, database development, EDC deployment, data management, analysis, reporting, and medical writing. Ms. Arone is a 1994 graduate of Brown University. She holds a Masters of Sciences in Human Genetics from Sarah Lawrence College, and is a board certified Genetic Counselor. Ms. Arone has additional previous clinical and research experience from her 6 years of clinical genetics at Columbia Presbyterian Medical Center in New York and New England Medical Center in Boston.
Munther Baara, Senior Director, Development Business Technology at Pfizer
Lori Ball, COO, BioStorage Technologies
Lori Ball leads global operations for BioStorage Technologies which include: operations, logistics, sample handling and processing, information technology, sales, and domestic and international marketing. Ball was formerly at Covance, Inc., where she served as global head of sales/business development and global head of supply chain management and logistics. Ball has earned MBA and Bachelor of Arts degrees. In addition, she holds Six Sigma Green Belt credentials and has completed Six Sigma Executive and Champion training.
Charles Barr, M.D., Head, Evidence Science & Innovation, Group Medical Director, US Medical Affairs, Genentech, Inc.
Charlie Barr, MD, MPH is currently Group Medical Director and Head of Evidence Science and Innovation in US Medical Affairs at Genentech, where he was previously Head of Patient Registries from 2009-2013. From 2003-2009 he held a number of positions in both US and Global Medical Affairs at Roche Pharmaceuticals, including International Medical Leader for Metabolism in Global Medical Affairs, Clinical Team Leader for Clinical Development, US Medical Director, and Therapeutic Area Director for Health Outcomes. His responsibilities have included leadership of registrational and phase IV clinical trial programs, pharmaco-economics and outcomes research programs. At Roche his most recent focus was osteoporosis, but responsibilities have included oncology, cardio-metabolism, diabetes, hyperlipidemia, rheumatoid arthritis, Alzheimer’s disease, hepatitis, influenza and HIV.
Rhonda Benotti, Business Manager, Strategic Outsourcing, Genentech, Inc.
Rhonda Benotti has worked at Genentech for nine years as a Business Manager in the Strategic Outsourcing Group. In this role she develops, negotiates and executes clinical trial agreements as well as manages the relationships and performance of all outsourced companies. Prior to Genentech she worked at University of California San Francisco and San Francisco Veterans Affairs Medical Center managing clinical trials in oncology and cardiology. Rhonda has a BA in Psychology from the University of Massachusetts, Amherst and has done post-graduate work in nursing and business at Brigham and Women's Hospital, San Francisco State University and University of California, Berkeley.
Nadia Bracken, Clinical Program Manager, Clinical Operations, Biotie Therapies
Nadia Bracken has 8 years of Phase I-IV clinical operations experience in a variety of therapeutic areas for trials in the US, Canada, South America, and Europe. Ms. Bracken has expertise as a Clinical Research Associate and Clinical Data Manager for pharmaceutical companies and CROs. Ms. Bracken is the author of “The ClinOps Toolkit” and "The Lead CRA" blogs and finalist and Bronze recipient of the Pharmatimes 2010 US Clinical Researcher of The Year New CRA/Site Manager award. Ms. Bracken received her BS from North Carolina State University.
Bonnie Brescia, Founding Principal, BBK Worldwide
As one of BBK’s two founding principals, Bonnie guides BBK’s continual evolution as a leader in marketing consultation for the patient recruitment industry. She manages and develops BBK's worldwide alliance of companies, ensuring a multinational foundation for initiatives like our global investigator network and Web-based recruitment portal. Bonnie co-authored the book “Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success,” and regularly contributes to key industry publications. She is highly sought after as a guest speaker at patient recruitment and healthcare communications forums, and was selected as one of PharmaVOICE's 100 most inspiring people in patient recruitment in 2005. She is a member of the Drug Information Association and a past president of the New England Council of the American Association of Advertising Agencies.
Kyle Brown, CEO, PatientCrossroads
Kyle is the founder and CEO of PatientCrossroads, a provider of patient registry solutions to the rare and neglected disease community. PatientCrossroads collects patient provided medical history and testing results in order to gain insight into disease progression and to recruit patients for inclusion in clinical studies and trials. Kyle is a respected authority on rare disease patient registries and is a frequent speaker at research conferences educating the non-profit and research community on the need for universally accessible, de-identified patient information. Kyle's passion is to change the economics of patient provided information from closed, proprietary access, to universally available self-funding programs that accelerate disease research.
Jeri Burtchell, Patient Advocate Blogger, Gilenya and Me
Jeri Burtchell is a patient advocate, MS Blogger and freelance writer for www.Healthline.com. She has spoken at several pharmaceutical conferences around the country to address the topic of clinical trials from a patient perspective and the emerging role that social media plays in research. Jeri is currently developing a website at www.PartnersInResearch.org with the vision of being a patient-to-patient resource for those interested in learning about clinical trials. She blogged her own experience in the TRANSFORMS trial at www.GilenyaAndMe.com.
Zhaohui (John) Cai, M.D., Ph.D., Director, Biomedical Informatics, Clinical Medicines Development, AstraZeneca Pharmaceuticals, Inc.
Zhaohui (John) Cai, MD, PhD, is a Biomedical Informatics Director supporting Payer and Real World Evidence (PRWE) in AstraZeneca. He received his MD from China Medical University, PhD from Albany Medical College, and Medical Informatics Fellowship training from Harvard Medical School. Dr. Cai leads a Medical Informatics group providing RWE data and analytics services to early and late stage drug projects, as well as supporting other strategic programs in AstraZeneca, including Personalized Health Care, Clinical Trial Design and Interpretation, and Predictive Safety. With unique combination of medical informatics experience and drug development expertise, Dr. Cai is leading multiple initiatives of applying real world data and analytics to clinical trials design and operations.
Hui Cao, M.D., Ph.D., Senior Director, Personalized Healthcare, R&D Information, AstraZeneca
Katherine Cartwright Norris, Director, Compliance & Integrity Programs, Becker & Associates Consulting; former Director, Corporate Compliance, The Spectranetics Corporation
Katherine Norris has significant CIA and Aggregate Spend experience in both the pharmaceutical and medical device manufacturing industries. Ms. Norris is the previous Director of Corporate Compliance at The Spectranetics Corporation, a small publicly traded medical device firm specializing in vascular intervention and cardiac lead removal technologies. At Spectranetics, Ms. Norris assumed significant responsibility for all aspects of the company’s compliance program, including compliance support for clinical investigations and management of aggregate spend initiatives. Ms. Norris spearheaded the cross-functional implementation of systems and technologies to support compliance with the transparency requirements of PPACA as well as led the auditing and monitoring activities associated with transparency reporting.
Chris Chan, Director, R&D Financial Planning and Analysis, Onyx Pharmaceuticals
Chris Chan is Director and Head of R&D FP&A at Onyx Pharmaceuticals and has over 20 years industry experience, including 16 managing R&D finances for biopharmaceutical companies of various sizes. He holds an MBA from UC Berkeley’s Haas School of Business and is a Certified Management Accountant (CMA) & Certified Financial Manager (CFM).
Adam Chasse, COO, RxTrials
Adam Chasse has had a long and distinguished career in clinical research since entering the industry in 1995. Since 2011 he has led the corporate development of RxTrials, a management/training/consulting firm that helps research sites optimize operational performance. Prior to that he pioneered the concept of strategic alliances between research sites and industry while with Quintiles, where his many management roles included leading the global program for strategic alliances with large health systems. Adam represents RxTrials on the Metrics Champion Consortium's clinical operations steering committee. He has served on the Multi-Regional Clinical Trials (MRCT) project steering committee, ACRP’s membership committee, and the Site Solutions Summit advisory board. Adam holds a Master of Healthcare Administration degree from the Gillings School of Global Public Health at the University of North Carolina-Chapel Hill, and is a member of the Delta Omega public health honorary society.
Shailesh Chavan, M.D., Senior Director, Clinical Research, Medical Affairs & Drug Safety, Biotest Pharmaceuticals Corporation
Janet Christoff, Clinical Trial Manager, Sanofi Pasteur
Janet Christoff is a senior Clinical Trial Manager at Sanofi Pasteur with over 25 years in the health care industry including the past 17 years in clinical research. She received her BA from Leicester University, England and her RN from The Nightingale School of Nursing at St. Thomas' Hospital, London, England. Her research experience includes Phase I-IV trials at the site, CRO and sponsor level. She currently manages a 17,500 subject trial within the flu franchise of Sanofi Pasteur and in addition, is responsible for territory development and QC oversight.
Larissa Comis-Tis, Director, Clinical Strategy, Thomson Reuters
Larissa has worked for more than a decade in the healthcare industry developing and implementing strategies and launching products focused on the needs of all industry stakeholders – biopharmaceutical companies, payers, providers, and patients. Her work has primarily been focused on clinical trials informatics and technology, with a concentration in oncology. She led one of the nation’s leading cancer clinical trials matching services and databases, and has developed and launched clinical informatics products for the pharmaceutical and biotechnology industries.
Brenda Conger, Founder and President, CFC International
Brenda Conger incorporated the CFC Family Network back in 1999 after three years of endless trips out of state with her husband and child to find out what rare syndrome their son was born with. In 2003 the organization revised their name to reflect their outreach to all areas of the world. Today, CFC International has grown from the original listing of 21 USA cases to now close to 350 International families. Under Brenda’s leadership the group established their own BioBank of DNA and clinical data. This valuable collection was instrumental in the 2006 CFC gene discoveries. Brenda has established publication of a quarterly newsletter, produced a syndrome brochure, Parent’s Guide, web site, computer list serve, and hosted seven International Conferences and medical consult programs. The organization has organized a prestigious medical advisory team. Brenda serves on the CFC International Board and The Foundation for Improving the Lives of Developmentally Challenged Individuals in Binghamton, NY. She is actively involved with the Genetic Alliance and National Organization for Rare Disorders. Brenda has a master’s degree in special education from Binghamton University. She had been employed by the Binghamton, NY School District as a special education teacher for the past 34 years and retired from her position as Coordinator of Work-Study, Transition Services, and the School Based Intervention Team in 2012.
Patricia Cornet, Associate Director, Advocacy, Global Recruitment & Analytics, Bristol-Myers Squibb
Patricia has over 15 years of experience in the pharmaceutical industry, working in both pharmaceutical companies and CROs. Patricia began her career in the industry as a clinical site monitor having worked at the CROs Bio-Pharm and Covance. Patricia has worked in clinical project management for over 10 years covering the therapeutic areas of Immunology, Respiratory, Endocrinology and HIV at Schering-Plough. She has also developed a multi-faceted experience base by working on Phase IV clinical trials, in Outsource Management and in Data Management. Patricia joined BMS in June 2004 as a Protocol Manager with oversight of clinical trials in immunology for global development operations. In October 2006, Patricia joined the Global Recruitment & Analytic Department for a newly-created position of Senior Recruitment Manager based in Shanghai, China. In the new role, she supported the overall goal of building the clinical trial business in the geographic region by focusing on patient recruitment, investigator recruitment/training, and strategic alliances with head quarter key stakeholders. She returned to the U.S. in 2009 to oversee a global team of recruitment managers and country specialist. As Associate Director, Patricia was responsible for driving the strategic direction of the recruitment team and department initiatives with a focus on optimization of study start up and acceleration of recruitment for early phase and late phase studies focusing in Immunology, CV, Metabolics for later stage studies. In 2013 Patricia transitioned in advocacy role within GR&A supporting Immunology, CV, Metabolics and digital expansion. Patricia has had a personal and professional interest in advocacy supporting efforts within and external to BMS over the last several years.
Andre Daniels, Ph.D., Executive Medical Director, Global Safety, Amgen
Nick Darwall-Smith, Vice President, CRS Technology, PAREXEL
Nancie Deckard, Biomarker CRA, Clinical Operations, Duke Clinical Research Institute (DCRI)
Nancie Deckard, CCRA, BSN, MS serves as a Clinical Research Associate in the Duke Clinical Research Institute (DCRI) Advanced Biomarker Group. Ms. Deckard has six years of experience in direct patient care as a registered nurse and six years of clinical trial operations experience working with protocols in a variety of therapeutic areas including post-operative pain management and infection control, cardiovascular surgery, and biomarker discovery. Ms. Deckard holds a Bachelor’s of Science in Nursing from the University of North Carolina Chapel Hill, and Bachelor and Master of Science degrees in Chemistry from North Carolina State University and the University of Georgia, Athens respectively. The DCRI Advanced Biomarkers Group provides scientific expertise and operational support for the incorporation of biospecimen collection, routine laboratory and biomarker testing, and advanced molecular biomarker research, into clinical trials. In her role with the DCRI Advanced Biomarkers Group,Ms.Deckard overseesthe administrative aspects of several trial and network biorepositories. Ms.Deckard’s contributions provide a subject matter expert in the responsible sharing of specimens and biospecimen collection best practicesto DCRI trial teams and investigators.
Carla DeMuro, Head, Patient Reported Outcomes, RTI Health Solutions
Ms. DeMuro has extensive experience in the rigorous development and validation of patient-reported outcome measures for use in clinical trials, as well as large scale epidemiologic and population-based studies. Ms. DeMuro has worked on multiple types of patient-reported outcomes, including health-related quality of life, treatment satisfaction, symptom severity, daily event logs, patient diaries, utility measures, and other PROs across a broad spectrum of therapeutic areas.
Elizabeth Desrosiers, Director, Global Trial Management, Merck & Co., Inc.
Elizabeth Desrosiers has been employed by Merck Research Laboratories in North Wales, PA for the past 20 years, where she currently holds the position of Director and Head, Global Trial Optimization. In this role, she has responsibility for the feasibility assessment and execution of clinical trials across the Merck portfolio. She has worked in both the clinical and operational team settings with experience in multiple therapeutic areas. Prior to Joining Merck, Elizabeth worked at a lab specializing in pre-clinical trials. She received her degree in Biology from Ursinus College and MS in Zoology from Miami University. She completed her PMP certification in 2009.
Reinerio Deza, M.D., Head Global Pharmacovigilance, CDMA Management, Cubist Pharmaceuticals, Inc.
Dr. Deza is currently Head of Global Pharmacovigilance at Cubist Pharmaceuticals. He has over 20 years of experience as a pharmaceutical physician supporting primarily functions in Medical Affairs and Drug Safety. Prior to Cubist, Rene led the Medical Services and Clinical Risk Management group for Merck’s (Schering-Plough) strategic products in 5 therapeutic areas. Rene’s prior work experience has been with GlaxoSmithKline (Director of Medical Affairs and Drug Safety for N. America, Consumer HealthCare Division), Bristol-Myers Squibb (Squibb Diagnostics), Bracco Diagnostics, and Gilead Sciences with the latter two companies as Head of the Global Drug Safety Departments. He has led PV activities in support of many NDAs and MAAs including several blockbuster drugs, the integration of the safety departments with several mergers and acquisitions, PV lead for FDA and EMA inspections, and directed implementation of several safety databases. Prior to joining the industry, Dr. Deza was a research scientist in the epidemiology department at the Division of AIDS, NJ Department of Health under a CDC grant. Dr. Deza has an MD from the University of Santo Tomas, Philippines with training and clinical practice in Occupational and Industrial Medicine and was Head of the Department of Microbiology and Parasitology at the College of Medicine, WVSU Philippines.
Christopher Dowd, Clinical Research Program Manager, Medical, The Cystic Fibrosis Foundation
Christopher Dowd is the Clinical Research Program Manager for Cystic Fibrosis Foundation Therapeutics where he manages the CF Foundation’s involvement in the Phase IV post-approval space. He oversees the unit that works with Pharmaceutical Sponsors in the design of Phase IV observational trials using the CF Foundation’s robust patient registry. Prior to coming to the CF Foundation, Chris spent 6 years working for a clinical research company in North Carolina conducting trials as a clinical research coordinator and later managing one of the subsidiary research facilities. He received his Bachelor of Science in Biology from New Mexico Tech in 2005 and subsequently earned his MBA from Lenoir-Rhyne University in 2010.
Robert Dracker, M.D., Medical Director, Summerwood Pediatrics; Member, Pediatric Advisory Committee, FDA
Robert A. Dracker, MD, MHA, MBA, CPI Dr. Dracker received his B.A in Biology from NYU, graduating Phi Beta Kappa and subsequently attended medical school at the SUNY Health Science Center at Syracuse, where he also graduated Alpha Omega Alpha with honors. He completed a residency in Pediatrics and fellowships in Pediatric Hematology/Oncology and in Blood Banking/Transfusion Medicine, all at University Hospital in Syracuse. Dr. Dracker later obtained a Master’s degree in Health Services Management (MHA) from the New School for Social Research and most recently an MBA from Columbia College in 2007. He is board certified in Pediatrics, Transfusion Medicine, and as a Certified Physician Investigator. Dr. Dracker is also certified in Managed Care Medicine and in Quality Assurance and Utilization Review, with sub board certification in managed care review. Dr. Dracker was the President of the Onondaga County Medical Society from November, 2009 through November 2010. He is also the Chief of Pediatrics at Community General Hospital in Syracuse. Dr. Dracker served as Medical Director of the Transfusion Medicine Service at University Hospital for five years prior to his current position as founder and Medical Director of Summerwood Pediatrics (previously known as North Area Pediatrics) since 1993, having offices in Liverpool and Camillus. He also founded Infusacare Medical Services, which provides adult and pediatric patients with currently standard and emerging outpatient intravenous therapies. Dr. Dracker has been actively involved in the area of cord blood banking and stem cell transplant. He was the medical director of The Biocyte Corporation which facilitated the first cord blood transplant in the United States and was the Medical Director of ViaCord in Cambridge, Massachusetts up until May of 2007. He is currently the Executive Medical Director of Americord, based in New York City.
Halleluya Dunn, Clinical Recruitment Manager, Patient & Physician Services, United BioSource Corporation
Mrs. Dunn is an Operations Manager with extensive experience in the clinical research field. At UBC, she oversees the execution of patient recruitment and retention programs for both clinical and post-marketing programs across a wide array of therapeutic areas, including neurology, gastroenterology, and oncology. Mrs. Dunn comes to UBC with 8 years of clinical research experience as a trial manager for domestic and international Phase I-IV studies with Intercell USA Inc., Technical Resources International and CONRAD. In her previous roles she managed aspects of recruitment, regulatory submissions, and the general logistics of conducting clinical trials in the U.S and the rest of the world.
Barbara Elashoff, CEO, Patient Profiles, LLC
Barbara Elashoff is a former FDA statistical reviewer and currently the CEO of Patient Profiles, which makes a software program that produces individual patient reports for clinical trials integrating medical history, efficacy variables, adverse events, concomitant medications & labs. Barbara received a master’s degree in Biostatistics from Harvard University.
Silke Ewald, M.D., Head, Trial Feasibility Assessment, Bayer HealthCare AG
Silke has more than 20 years of clinical research experience in CRO and in the pharmaceutical industry. She joined BayerHealthCare in 2007 as Global Clinical Leader and was responsible for clinical development of pharmaceutical products in Primary Care. She directed the completion of multiple clinical studies (Phases I-III). She is currently the Head of Study Feasibility Assessment for all global studies within BayerHealthCare. In her role she has set up a new feasibility process focusing on early strategic feasibility assessment of projects.
Jane Fang, Ph.D., R&D IS Lead, Clinical Business Management & Analytics, MedImmune
Jane is R&D IS Lead for Clinical Business Management and Analytics with MedImmune (Biologics business unit of AZ). Jane has successfully built the eClinical Trial Management Systems and Analytics function from scratch to support biologics trial delivery and cross clinical functions. She has provided leadership roles in various eClinical projects and has promoted and guided use of eClinical ecosystems, environment and analytics to enable better clinical research and better clinical trial delivery. Jane is a trained physician with Master’s degree in healthcare management and informatics. She has about 20 years of broad experiences cross from medical practice, clinical and biomedical research, program/project management, system management to information analytics in healthcare and biopharmaceutical industries. Jane started as a physician with clinical research experience focusing on trial protocol design, clinical data analysis and GCP implementation at a prestigious and the largest medical center in China. She then did research in the molecular immunology and pathology area and moved to healthcare management and medical informatics field.
Erin Fassett, Clinical Transplant Research Nurse, Baylor Research Institute
Erin Fassett received her BSN degree in 2000 from the University of Texas at Arlington. She began her career in health care in the 12th grade of high school by working as a certified nursing assistant at Arlington Memorial Hospital. Since that time, she has accumulated 13 years of nursing experience in Surgery, Transplant, Oncology, and Research. In addition to her clinical experience, Erin also has an outstanding academic background that includes a Master of Science in Nursing and a Master of Business Administration from the University of Texas at Arlington. Her long term career plans are to continue her education and work on a PhD in nursing.
Nikki Fink, Director, Patient Access and Retention Services, PRA International
Nikki Fink has thirteen years of clinical research experience with a special focus on patient recruitment and retention, and site relationship management. She has held senior patient recruitment roles at Quintiles and PPD, worked as a pharmaceutical consultant for Arthur Andersen LLP, and led N. America patient recruitment operations for GSK for 5+ years. Nikki worked as a senior strategist for a global patient recruitment supplier, and is currently Director of Patient Access & Retention Services with PRA International. Bringing a unique mix of CRO, sponsor and supplier experience, Nikki has worked on more than 300 recruitment and retention campaigns in all therapeutic areas. She proudly graduated from the University of Florida with a BS in Communications.
Mary Flack, M.D., Vice President, Clinical Research, Nanobio
Dr. Flack has nearly 20 years of clinical research experience at the NIH and in the pharmaceutical industry. Before joining NanoBio in 2002, Dr. Flack was Clinical Director of Endocrinology and Women’s Health Care at Pfizer (formerly Parke-Davis/Warner Lambert) where she was responsible for clinical development of pharmaceutical products for osteoporosis, hormone replacement therapy, fertility and contraception. She directed the completion of multiple clinical studies (Phases I-IV), leading to four approved NDA submissions, and has extensive experience with three different divisions of the FDA, including dermatology, endocrinology and reproductive health. She is currently Vice President of Clinical Research at NanoBio Corporation.
Bruno Gagnon, Vice President, Clinical Operations, BioMarin Pharmaceutical, Inc.
Bruno Gagnon is an opinion leader in the field of Clinical Operations. He has over twenty years of drug development experience. He has held positions in big pharma, CRO, biotech and diagnostics companies. Prior to his current position, Bruno headed the Clinical Operations group at Roche Molecular Systems, Inc. Functional areas under his responsibility have included: Clinical Trial Management, Medical Writing, Outsourcing and Contracts, Supply Chain Management, Clinical Data Management, Clinical Systems, Document Management and Training. Bruno has taken several teaching assignments and speaking engagements at professional meetings throughout his career. He has a Bachelors degree from the School of Pharmacy, Laval University and a Masters in Pharmaceutical Sciences from University of Montreal, both in Quebec, Canada.
Heidi Gambino, Chief Administrative Director, Surgery, Boston University Medical Center
Rose Gerber, Director, Communications and Patient Advocacy, Community Oncology Alliance
Rose Gerber,a 10-year breast cancer survivor,is the Director of Communications and Patient Advocacy for the Community Oncology Alliance in Washington, DC. Her experience as a patient, survivor, clinical trial participant and advocacy program director provides audiences with unique and multiple insights. Rose speaks to national live and media audiences and was recently a guest on MSNBC’s “All In” program speaking on national oncology issues. Additionally, Rose is skilled in advocacy program development and management and hasserved as a consumer reviewer on three Department of Defense Breast Cancer research panels.
Jayne Gershkowitz, Vice President, Patient Advocacy & Public Policy, Amicus Therapeutics, Inc.
Jayne Gershkowitz, is a long-time patient advocacy professional with expertise in the rare disease community, who has been extending her perspective to the broader biotech arena. She is a member of the Steering Committee of the Healthcare Institute of New Jersey, the Government Relations Committee of BIO, a co-founder of the Patient Advocacy Committee of BioNJ, which she co-chairs, and serves as Vice President of Education of the Board of Directors of National Tay-Sachs & Allied Diseases Association, a member of the Patient Advocacy and Access and Reimbursement Committees of the Corporate Alliance of the Global Genes RARE Project and participates on the Policy Committee of NORD-National Organization for Rare Disorders. Ms. Gershkowitz often speaks on issues affecting the patient community and about the partnership between patients and industry in orphan drug development. She joined Amicus in June 2006. She is responsible for developing relationship management strategy with US and international patient organizations, directing the company’s educational grants and charitable contributions program, determining all aspects of patient outreach and education related to clinical trial awareness and working collaboratively on cross-functional program teams to implement these strategies. She gives voice to patient concerns, such as access, reimbursement and disease management on cross-functional teams, including alliance teams, and founded Amicus’ Patient Advisory Boards program.
Kenneth Getz, Director, Sponsored Programs, Tufts CSDD; Chairman, CISCRP
Ken Getz is the director of sponsored research programs and an associate professor at the Center for the Study of Drug Development, Tufts University School of Medicine where he studies R&D management and operating models, investigative site, outsourcing, and study volunteer trends and policies. Ken is also the founder and owner of CenterWatch. A well-known speaker at conferences, symposia, universities and corporations, Ken has published more than 200 articles and chapters in peer-review journals, books, and in the trade press. He is the author of two nationally recognized books for patients and their advocates titled, Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation, and the recipient of several awards for innovation and scholarship. Ken has held a number of board appointments in the private and public sectors, including serving on the Institute of Medicine's Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative.
Melynda Geurts, Vice President Operations, DAC Patient Recruitment Services
During her 14 years of tenure with DAC, Melynda Geurts’ has emerged as a driving force in the company’s approach to project operations, site management, contract negotiations, and business development. She is credited with leading the project operations team in procuring and managing contracts spanning 100,000 patients at 16,000 clinical trials sites in 100+ countries. A recognized authority in the clinical trials industry, Geurts has presented at numerous conferences and seminars worldwide. She is widely published and was a contributing writer for “Global Issues in Patient Recruitment and Retention” and “A Guide to Patient Recruitment and Retention,” both published by CenterWatch in 2012 and 2004, respectively. In 2008 PharmaVoice named her among the 100 Most Inspiring People in the Life-Sciences.
Alicia Gilsenan, Ph.D., Senior Director, Epidemiology, RTI Health Solutions
Alicia Gilsenan, PhD, is a Senior Director of Epidemiology within RTI HS and a licensed pharmacist. Dr. Gilsenan's primary area of expertise is pharmacoepidemiology and therapeutic risk management. Since joining RTI in 1997, she has directed multidisciplinary international teams for large primary data collection studies in the United States and Europe, including rare disease and drug registries.
Abraham Gitterman, Associate, Arnold & Porter, LLP
Abraham Gitterman, JD, is a recent graduate of the University of Maryland Francis King Carey School of Law, (magna cum laude) where he received a Health Law Certificate. Mr. Gitterman is also a Research Associate for Rockpointe, Inc., a medical education company based in Columbia Maryland, and regularly contributes to the blog, Policy & Medicine (www.policymed.com). Mr. Gitterman has held internships at FDA’s Office of Policy, Office of Counsel to the Inspector General for HHS, the Department of Justice Consumer Protection Branch, and the Department of Justice Fraud Section, Health Unit. Mr. Gitterman will be an associate at Arnold & Porter, LLP beginning in November 2013.
Gretchen Goller, Senior Director, Therapeutic Expertise, Patient Access and Retention Services, PRA International
Gretchen Goller is the Senior Director of Therapeutic Expertise - Patient Access and Retention Services, PRA International. Prior to that role, she was the Patient Recruitment/Compliance Strategist at sanofi-aventis since 2007. She went to sanofi-aventis after spending time at Wyeth as a Clinical Trial Manager and AstraZeneca as a Clinical Research Scientist. Prior to pharma operations, Gretchen was with the University of Pennsylvania for 9 years as Project Manager and Clinical Research Coordinator in cardiology, ophthalmology, and women’s health. She has an MSW from the University of Pennsylvania with experience in HIV risk reduction, drug/alcohol abuse and victim crisis support. She has 15 years of experience in clinical research. Gretchen supports the US CRU at sanofi-aventis for recruitment and compliance strategy and works with their therapeutic teams to improve overall enrollment, retention, and site management.
Kathleen Greenough, Senior Manager, Clinical Systems & Technology, Biogen Idec
Kathleen has spent 14 years in the life sciences industry, 12 of which at Biogen Idec. Her career has spanned IT, Finance and Clinical Operations with a focus on systems implementations, including CTMS and management reporting systems. Prior to her current role in Clinical Systems & Technology she was a leader in Biogen Idec's Clinical Business Planning group for 5 years and spent much of that time working on various solutions to gain greater visibility into the investigator grant payment process.
Bill Gwinn, MBA, Vice President, Clinical Informatics Solutions, Optum
Bill supports the clinical trials of new drugs with medical statistics and other information. The metrics offer better planning for faster trials. Previously, Bill held positions as VP of New Product Development and VP of Product Marketing for Inclinix, a contract research organization specializing in patient enrollment. Bill’s expertise lies in quantitative analysis for site selection and finding patients, and he provides the direction of technology and market research. Earlier, he was with Thomson Reuters, Healthcare Division, Medstat Group, where he was Director of Clinical Trial Solutions. He is a speaker at industry conferences and writer in trade journals. Bill holds an MBA from the University of Chicago and has held roles of leadership with Procter & Gamble, Schering-Plough, and IMS Health.
Jamie Heywood, Co-Founder and Chairman, PatientsLikeMe
An MIT engineer, James Heywood entered the field of translational research and medicine when his brother Stephen was diagnosed with ALS in 1998 at the age of 29. With experience in design, information technology, systems modeling, neuroscience and industrial engineering, Heywood brings a unique perspective to drug discovery and medicine. In 1999, shortly after Stephen was diagnosed, Heywood founded the ALS Therapy Development Institute (ALS TDI), the world’s first non-profit biotechnology company, where he served as CEO until 2007. Today, Heywood is the chairman of PatientsLikeMe, where he provides the scientific vision and architecture for its patient-centered medical platform. He co-founded the company in 2004 with his youngest brother, Benjamin, and friend, Jeff Cole. Named one of “15 companies that will change the world” by CNN Money, PatientsLikeMe is a personalized research and peer care platform that allows patients to share in-depth information on treatments, symptoms and outcomes. A published author, frequent speaker, media pundit and active investment advisor, Heywood speaks at business, government and academic conferences around the world. Heywood’s work has been profiled in the The New Yorker, The New York Times Magazine, Businessweek, 60 Minutes, CBS Evening News, NPR, Science, and Nature. In 2009, he was chosen for WIRED magazine’s “Smart List” and Fast Company’s “10 Most Creative People in Healthcare.” Heywood and his brother Stephen were the subjects of Pulitzer Prize winner Jonathan Wiener’s biography, His Brother’s Keeper, and the Sundance award-winning documentary, “So Much So Fast.”
Bill Hirokawa, Pharm.D., Coordinator, Investigational Drug Section, Pharmaceutical Services, Ronald Reagan UCLA Medical Center
Bill Hirokawa’s career has spanned over 33 years at Ronald Reagan UCLA Medical Center, working in various capacities in the Pharmaceutical Services Department as well as the Jonsson Comprehensive Cancer Center with the UCLA School of Medicine. Currently, he is the Manager of the Investigational Drug Section, overseeing all of the Investigational Drug trials that are accruing subjects in the UCLA HealthCare System. The Ronald Reagan UCLA Pharmaceutical Services Department is involved with approximately 500 clinical trials that are being conducted locally as well as in other clinics throughout California as well as multiple clinics that are located in areas throughout the United States. Prior, to that Bill also worked in the Clinical Trials Quality Assurance Office of the UCLA Jonsson Comprehensive Cancer working as the QA Director as well as Compliance Officer for all of the Hematology-Oncology clinical trials being conducted at the Medical Center.
Toby Ann Holetz, Global Head, Global Aggregate Spend Reporting Team, Quintiles
Toby Ann Holetz graduated with a degree in Business Management and is currently employed by Quintiles Inc. based in the Research Triangle Park, North Carolina. Toby has been with Quintiles for more than 14 years and has experience in CRM system implementation, balanced scorecards, strategy map creation and communications. Toby is currently the Sarbanes-Oxley Control owner for all global Clinical Revenue and is the Global Head of Quintiles’ Payment Transparency Program. Within her role as the head of the transparency program Toby is responsible for working directly with customers to deliver on requirements, managing internal resources, developing processes to accurately document and capture data for reporting, and managing the communication and training plans.
Kelly Hollis, MBA, Global Head, Surveys and Observational Studies, RTI Health Solutions
Kelly Hollis, MBA, is Global Head of Surveys and Observational Studies at RTI Health Solutions. Her background in survey research has led to the successful design, implementation, and leadership of global research studies. She has particular expertise in planning and managing large-scale prospective observational studies, including health economic and epidemiologic studies, patient outcomes research, risk management programmes, and patient registries.
Kirstin Holzapfel, Deputy Director, Global Clinical Data Center, Bayer / Global Clinical Operations
In 2008, Kirstin joined Global Data Managementas Deputy Director Clinical Data Center Berlin at Bayer Pharma AG. This includes support of Study Teams with respect to process tools, applications and reports for all kinds of data handling for internal as well as external studies. In that function, she supported various internal as well as external projects and initiatives, e.g. EU sponsored IMI EHR4CR project till March 2012. At that point in time, Kirstin became Business Lead for Clinical Information Environment component as part of Bayer internal project FECD: Future Environment for Clinical Data targeting to implement end-to-end information integration, streamlined processes and future-proof systems and tools.From 2002-2007 she lead a group coordinating Schering/Bayer Pharma R&D IT needs wrt/ innovation, implementation and maintenance with the Corporate IT department and relevant business functions.In 1991 Kirstin joined Schering AG with a Computer Science degree as system analyst. She lead as project manager various global projects supporting R&D departments in strengthening global processes and IT systems.
Ty Hoover, M.D., J.D., FCLM, FCAP, Director, Biorepository Regulatory Support, University of Texas MD Anderson Cancer Center A native south Texan, Dr. Hoover attended Southern Methodist University and then graduated from the University of Texas Southwestern Medical School. He completed a general surgery internship in Dallas before completing a residency in pathology at Baylor University Medical Center. Having developed an interest in the legal and ethical aspects of medicine as a resident, he completed law school at SMU’s Dedman School of law in Dallas. A former trial lawyer in Florida, he served as the Medical Director of the Total Cancer Care project and the Tissue Core Facility at the H. Lee Moffitt Cancer Center in Tampa, where he was involved in the startup of a large-scale and multi-institutional translational biobanking effort. While in Tampa he co-directed the University of South Florida College of Medicine’s Scholarly Concentration in Law & Medicine. Most recently he started de novo a translational cancer biobank for a contract research organization in Tennessee. A licensed physician in both Florida and Texas, he is a member of the Florida Bar, the American Association for Justice, and is board certified in Anatomic and Clinical Pathology. He is a member of the College of American Pathologists’ Texas House of Delegates and is active in other professional medicolegal and biobanking organizations, including the American College of Legal Medicine and the International Society of Biological and Environmental Repositories, where he serves on the ISBER Strategic Planning Committee and co-chairs a workgroup focused on the rights to and control of human tissue intended for research. His current role includes facilitating the continued excellence of all aspects of biorepository efforts at MD Anderson in the Office of Clinical Research. In his spare time he drinks Dr. Pepper, eats Whataburgers, and enjoys the company of his wife and their Akita.
Denise Hopkins, Pharm.D., Senior Director, Late Phase Research, Optum
Dr. Hopkins utilizes her long standing experience in late phase research to provide oversight, guidance and support for OptumInsight’s North American late phase business. Located in Ohio, Dr. Hopkins joined OptumInsight in 2008. Prior to assuming this position with OptumInsight, Dr. Hopkins headed global late phase studies for another CRO. Dr. Hopkins joined the pharmaceutical industry over 15 years ago with Procter and Gamble Pharmaceuticals (P&GP) Medical Affairs and held a variety of positions of increasing responsibility, including providing global medical affairs oversight across the P&GP gastrointestinal product portfolio. In addition to the gastrointestinal field, Dr. Hopkins also worked in the Endocrine & Women’s Health fields while at P&GP. She has had additional therapeutic experience overseeing programs in the rheumatology, hematology, pain (cancer pain and chronic pain), infectious disease, neurology, respiratory, ophthalmology, and endocrine therapeutic areas. Her academic training includes a Bachelor of Science in Pharmacy from the University of Cincinnati and a Doctor of Pharmacy degree, also from the University of Cincinnati.
Keith Howells, Senior Vice President, Development, OmniComm Systems, Inc
Keith Howells is an executive with 20 years’ experience in the application of Information Technology to the drug development process. As Senior Vice President of Development at OmniComm, he is responsible for product innovation for the TrialMaster and eClinical suites. Previously, as Senior VP of Development for Medidata Solutions, he helped launch Medidata Rave from relative obscurity to being one of the most widely adopted EDC systems in the industry. Prior to that, he played a major role in establishing Oracle’s pharmaceutical application business, initially as director of consulting for Oracle Clinical and then as VP of Development.
Michael Howley, Ph.D., Clinical Associate Professor, Business, LeBow College of Business, Drexel University
Mike Howley PA-C, PhD is an Associate Clinical Professor of Marketing at the LeBow College of Business at Drexel University, with research focused on provider productivity in healthcare and measuring performance in clinical research. He is a fellow in the Center for Teaching Excellence. He is also a founding partner at CRO Analytics and serves as Chief Science Officer.
Chris Hoyle, Executive Director, Elite Research Network
Mr. Hoyle entered clinical research in 2001 after obtaining his MBA. While working at a dedicated research site, he was involved in all aspects of investigator site management, including patient recruitment, budgets and contracts, and business development. He founded the Elite Research Network in 2004. Since then, Mr. Hoyle has been responsible for leading the company from a network of four sites to its current size of twenty-one sites based in the U.S., with one additional site in Latin America. He earned his BS in Zoology from NC State University and his MBA from UNC – Wilmington.
Adwoa Hughes-Morley, NIHR Doctoral Research Fellow, MRC North West Hub for Trials Methodology Research, Centre for Primary Care, Institute of Population, The University of Manchester
Adwoa is a Doctoral Research Fellow, funded by the UK National Institute of Health Research (NIHR). The Fellowship is based at the University of Manchester and has been awarded to undertake her PhD on the project titled: “What are effective methods to recruit research participants into clinical trials in mental health?” The project is linked with the UK MRC START (Systematic Techniques for Assisting Recruitment to Trials) project
Lisa Ingellis, Global Transparency Reporting Consultant, Eli Lilly and Co.
Lisa Ingellis has undergraduate degrees in Journalism and Biology from Indiana University. She has been active for 25 years in a variety of service-related roles in the pharmaceutical industry. The majority of her experience has centered on the support of clinical development and operations personnel by leading key change initiatives. The last three years, Lisa has been the expert at Eli Lilly and Company for Research and Development personnel working to comply with ever-changing HCP payment reporting requirements. Lisa also has experience in learning and development, clinical data management, medical information, pharmacovigilence, and medical communications. Lisa is Six Sigma Green Belt certified and is known for her focus leading process improvement initiatives, which include the adoption of new technology.
Donna Jarlenski, Vice President, Clinical Development Execution, Global Medicines Development & Affairs, Vertex
After an academic research career in bacteriology and a decade spent as a physical therapist, Donna joined the biotech/pharma industry in 1991. First as a CRA, she has held positions of Manager, Director, and Vice President in Clinical Operations, Clinical Development, or Program Alliance throughout these years at Merck, Medco Research, PPD, Sepracor, Purdue Pharma, Tolerx, Momenta Pharmaceuticals, and now Vertex. Her specialty in the clinical realm is program and alliance management, clinical quality by design, and metrics application.
Michael Jasper, Ph.D., Director, Clinical Documentation, Genzyme, a Sanofi Company
Michael received his BS in Electrical Engineering from Cornell University. After a few years in the industry, he developed an interest in physiology, and returned to school, obtaining an M.S. in Exercise Physiology and Anatomy from Boston University’s Sargent College. He continued his studies, receiving his Ph.D. in Neurobiology, Physiology and Biophysics from Brown University, where he did his graduate work studying control of hormonal rhythms. Michael did his post-doctoral fellowship at Massachusetts General Hospital in Boston, studying neuroendocrine control of body weight and metabolism. Although the prospect of endless postdoctoral fellowships was attractive, he perversely decided to get a real job, and started his career in Medical Writing at Parexel, later moving to Genetics Institute in Cambridge. In 2001, he founded the Medical Writing Department at Millennium Pharmaceuticals. He moved to Genzyme Corporation (now a Sanofi Company) in 2004 to direct Medical Writing for Regulatory Submissions and Publications for the Rare Disease programs, adding MS, Renal and Endocrine programs to his portfolio over time. Michael has been involved in a number of initiatives aimed at automating the process of writing, review and approval, and in the beginning of 2013, became the Clinical Documentation Program Manager for the CRUISE Content Reuse program at Sanofi.
Les Jebson, Executive Director, Diabetes Center of Excellence, University of Florida Academic Health Center
Les Jebson currently serves as an administrator and faculty member with The University of Florida Health System. He has held professional roles in clinical, financial, operational and research roles in both private and academic healthcare organizational settings. Les has published and presented extensively for an array of healthcare organizations, predominantly focusing on healthcare decision intelligence and process improvement. He holds degrees in economics, communications, healthcare management and is also a licensed healthcare risk manager.
Otis Johnson, Executive Director, Clinical Informatics & Feasibility, inVentiv Health, Inc.
Michael Jones, Senior Director, Global Site Development, Clinical Operations, Eli Lillly & Co.
Since joining Eli Lilly and Company in 1982 as a molecular geneticist, Mr. Jones has held a variety of leadership positions throughout Lilly Research Laboratories supporting global clinical development of pharmaceutical products including Clinical Operations, Regulatory Affairs, Information Systems, Quality and Product Development team leadership. Presently, he is Senior Director of Global Clinical Operations, responsible for planning and implementation of Lilly-sponsored clinical trials worldwide. Mr. Jones is engaged in a number of current industry initiatives including membership in the Clinical Trial Transformation Initiative Steering Committee, TransCelerate BioPharma, Inc. Risk-Based Monitoring team, and the Society for Clinical Research Sites Leadership Council.
Janet Jones, Vice President, Access to Patients, Synexus Ltd.
Elke Jordan, Ph.D., Manager, Clinical Development, Bavarian-Nordic GmbH
Elke has worked since 2005 as Clinical Development Manager. Over the past 18 years, Elke has worked in different positions in clinical research and medical science in CROs and in different international pharmaceutical companies. Elke has received a Diploma in Pharmaceutical Medicine ECPM at University Hospital Basel, Switzerland PhD in Physiology at the Albert Ludwigs University in Freiburg, Germany.
Aaron Kamauu, M.D., President & CEO, Anolinx, LLC
Dr Aaron Kamauu (MD, MS Biomedical Informatics, MPH – University of Utah School of Medicine) is the President & CEO of Anolinx LLC where he leads innovation in leveraging healthcare data to support a variety of clinical research,, informatics, clinical trials and drug development activities, including pharmacoepidemiology, outcomes research, systems analysis, protocol design, site identification and patient recruitment. Prior to Anolinx, Dr Kamauu was the Head of Healthcare Data Strategy at Roche Pharmaceuticals & Genentech Inc, and prior to that he worked for a software development company managing the underlying coding schemes for an outpatient electronic health record (EHR) system. Dr. Kamauu brings a unique combination of clinical, biomedical informatics, drug development and public health training and experience, resulting in the application of innovative biomedical informatics methodology to support projects based on individual patient care as well as population-based observations.
Suresh Kannan, Vice President Products, Clinical Trial Optimization Solutions, IMS Health
Suresh Kannan brings over 20 years of leadership delivering business analytics and performance optimization solutions for the Life Sciences industry. As Vice President (Products) at IMS Health, Suresh is responsible for product strategy and development of the company's clinical trial optimization solutions. Prior to IMS, he oversaw the development of DecisionView's cloud-based clinical trial solutions, and at Oracle he spearheaded development of Oracle's business analytics software for over a decade. Suresh has a B.S. in Computer Science & Engineering from the National Institute of Technology in India, and an MBA from the University of California at Berkeley.
Jeffrey Kasher, Ph.D., Vice President, Global Clinical Trial: Materials, Implementation and Transformation, Eli Lilly & Co.; TransCelerate Operations Committee Member
Jeffrey Kasher, Ph.D., was named vice president, global clinical trial: materials, implementation and transformation in September 2012. He received a bachelor of science degree in chemistry from Franklin & Marshall College (Lancaster, Pa), a doctorate in pharmacology from the State University of New York (Syracuse) and a postdoctoral fellowship in physiology at Yale University School of Medicine. Kasher joined Lilly in 1986 as a senior pharmacologist in the department of drug metabolism and disposition where he made numerous contributions to the discovery and development of projects in the infectious disease therapeutic area. In 1992, he was named manager of pharmaceutical project management. Kasher had operational responsibility for the Zyprexa (olanzapine) heavyweight team from 1995 to 1998, successfully leading the late phase development, global submissions, and launches of the product. In 1998, he was named director of pharmaceutical products, where he helped establish Lilly’s product team organization. Kasher moved to Belgium in 2000 as the managing director for the research and development site in Mont Saint-Guibert. Upon his return to Indianapolis in 2003, he served as operations director and then executive director for discovery biology in Lilly Research Labs, leading the transformation of the division into therapeutically-focused drug hunting teams. Kasher served as the executive director of the osteoarthritis/rheumatoid arthritis platform team, leading the development of an integrated strategy for a portfolio of novel drug candidates. Kasher was named vice president and chief operating officer, global clinical development for Eli Lilly and Company in February 2007. He established and was accountable for the Lilly Clinical Development Organization which included Clinical Project Management, Regional Clinical Operations, Global Clinical Pharmacology & Diagnostics, Statistics, Scientific Communication, Data Science & Solutions, and 6 Sigma/Business Process Management/Critical Chain Project Management. In his current role he is responsible for the delivery of clinical studies and information in support of Lilly molecules. The primary responsibility is to patients and healthcare professionals who depend on our products and services today and in the future. Kasher has responsibility for Regional Clinical Operations, Global Clinical Pharmacology & Diagnostics, Clinical Trial Manufacturing & Material Services, 6 Sigma/Business Process Management/Critical Chain Project Management, and Clinical Development Innovation.
Vanessa Kemp, Manager, Project Controls; Master Capital Planning, Engineering, Novartis
Vanessa graduated from University of Denver with a Biochemistry degree and built and ran her own for a number of years out of college before moving into Project Management in Pharmaceutical companies. Due to the high level of controls that she maintained in her projects, she was quickly promoted into a newly created position in the Engineering department at Sandoz, as their Project Controls Manager / Master capital planning.
Francis Kendall, Global Head, Statistical Programming and Analysis, GLIDE Future Investigation Team Lead, Genentech
Jackie Kent, Director, Clinical Development Information & Optimization (CDIO), Eli Lilly & Co.
Jackie joined Eli Lilly and Company in 1990, within the IT organization. Jackie held a variety of positions within IT both technical and leadership before moving into Lilly Research Labs, supporting global clinical development in 2001. Presently, Jackie is responsible for the organization that provides services to study team to support Clinical Trial planning, protocol optimization, feasibility and enrollment planning across all therapeutic areas. Jackie is also the lead for the TransCelerate Investigator Portal.
Lee King, Vice President, Late Phase Research, ICON plc
Mr. King is responsible for executive oversight of projects within project operations for the Americas including both interventional, non-interventional research and risk management. In the role, Mr. King ensures the development of appropriate executional strategies for late phase projects. He provides consulting and staff development to clients in the areas of observational study design, risk based monitoring, centralized operational methodologies and adaptive source document verification. Additionally, Mr. King is responsible for the overall integration of processes and procedures internally within the late phase group and externally through his seat of the Global SOP steering committee. Mr. King brings over 17 years of management, global clinical research and strategic development experience to ICON. Prior to joining ICON, Mr. King served as the Region Head for the Americas in the Late Stage Research Group at Pharmaceutical Product Development (PPD). In this role, Mr. King provided senior oversight to all late stage studies and Risk Evaluation Mitigation Strategies (REMS) projects led out of the Americas and direct oversight to the Research Coordination Centers in North and South America. Additionally, Mr. King was a member of the Scientific and Strategic Advisory Team. Prior to joining the late stage research group, Mr. King served as the Senior Director of Hematology and Oncology. In this role, Mr. King coordinated all development activities within the therapeutic area and was responsible for proposal response and resourcing. Mr. King received his undergraduate degree from the University of North Carolina at Wilmington and his master’s in education from East Carolina University. He is an affiliate member of American Society of Clinical Oncology, Oncology Nurses Society, The International Society for Pharmacoepidemiology and The International Society of Pharmacoeconomics and Outcomes Research.
Joe Kim, MBA, Director, Clinical Operations, Shire Pharmaceuticals
Joseph Kim serves as the Clinical Operations Director at Shire, focusing on developing and implementing innovative trial optimization solutions in an outsourced model. He has spent over 14 years in the Pharma industry utilizing a unique approach that integrates his experiences working for Sponsors, CROs, and niche vendors. He has the rare combination of experience that includes early and late phase clinical research, and a command of IT related solutions and development models. Joseph was also recognized as one of “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova.
Andrea Kirby, Director, Enterprise Integration and Customer Collaboration, Merck & Co, Inc.
Andrea Kirby is leading the overall External Partner Program at Merck as well as leading IT Account Management for World Wide Licensing, Scientific Knowledge Discovery, Global Competitive Intelligence and Alliance Management. She has been at Merck for 12 years. Prior to her current position, Andrea held positions in MRL IT supporting Business Development, Regulatory Affairs, Animal Health as well as Consumer Care. Andrea's interests lay primarily in driving operational efficiencies within MRL IT as well as cross divisional across Merck. Global externalization and collaboration and data exchange is a key aspect in preparation and maintenance of professional relationships and engagements. She is driving adoption of a more collaborative work environment and processes including future strategy to position Merck as a global partner of choice. She is very interested in innovation and new technologies supporting Merck’s preparation for the future by remaining objective, agile and open minded.
Cathy Koepper, Director, Global Registry Operations, Genzyme, a Sanofi Company
Debi Koltenuk, Vice President, Products and Services, sampleminded
Debi Koltenuk has over 25 years experience with clinical and biological research data management issues, beginning when she left nursing to join GenBank®, just before the one millionth base pair celebration. After working on database design issues for genomics and genetics data at both GenBank and the Human Genome Information Resource, Debi spent seven years at the bench at the University of Utah conducting a DNA sequence-based evolutionary-developmental research project. Since 1998, Debi has provided domain expertise for numerous software development projects that span the genomics and proteomics laboratory data-management and clinical research data management domains.
Paul Konstant, Manager, Translational Informatics, Janssen Pharmaceutical Co.
Greg Koski, Ph.D., M.D., Co-Founder & President, ACRES; former Director, Office for Human Research Protections, U.S. Department of Health and Human Services
Greg Koski, PhD, MD, is an internationally recognized leader in human research and subject protection and co-founder of the Alliance for Clinical Research Excellence and Safety (ACRES). As the first director of the Office for Human Research Protections at the U.S. Department of Health and Human Services, he established its Office for International Activities. While serving as director of OHRP, he chaired the inter-agency Human Subjects Research Subcommittee of the Committee on Science at the White House and served as Executive Secretary of the national Human Research Protections Advisory Committee. He is past President of the Academy of Pharmaceutical Physicians and Investigators, and formerly a member of the Board of Trustees of the Association of Clinical Research Professionals, international not-for-profit organizations promoting professionalism and excellence in human research. He continues to work to enhance capacity for quality human research and ethical review in developing countries around the world, chairing the advisory board for the Strategic Initiative for Developing Capacity for Ethical Review (SIDCER). He is also a member of the Executive Committee of the Multi-Regional Clinical Trials (MRCT) Center at Harvard and serves on the Executive committee of the International Federation of Associations of Pharmaceutical Physicians. He is Associate Editor of the Journal for Empirical Research in Human Research Ethics (JERHRE), and Associate Professor of Anesthesia at the Harvard Medical School where he practices and teaches anesthesia for cardiovascular and thoracic surgery at the Massachusetts General Hospital, and Senior Scientist at the Mongan Institute for Health Policy.
Anna Kravets, Director, User Experience Strategy & Realization, Merck & Co., Inc.
Subha Krishnan, CCDM Principal Data Manager, Optum
Since 1999, Subha has assumed increasing roles of responsibility within clinical data management, supporting various phases of clinical development from both a sponsor and vendor perspective. She hastherapeutic experience in respiratory, oncology, cardiovascular, neuroscience, and medical device products. She has extensive experience in providing investigator meeting training, managing third party vendors, and articulating process development, and managing people and studies. She remains an active member of the Society for Clinical Data Management, and is a Certified Clinical Data Manager (CCDM).
Lisa La Luna, Senior Vice President, Corporate Development & Implementation, ePharmaSolutions
Lisa has more than 15 years' experience in the pharmaceutical and clinical trials industry starting her career with Boehringer Ingelheim, Genentech, and MedImmune. Lisa then moved into the clinical services sector helping start Acurian and ePharmaSolutions.
Andrew Lee, Senior Vice President & Head, Global Clinical Operations, Genzyme Corp., a Sanofi Co.
Andy Lee is the Deputy Head of Clinical Sciences and Operations at Sanofi. He is responsible for the execution of clinical trials, across diverse phases and therapeutic areas, around the world to deliver clinical trials to high-quality international GCP and regulatory standards in a timely and cost effective manner. Andy has ~20 years industry experience conducting clinical studies ranging from pre-clinical to phase IV drug development, across multiple platforms such as devices, small molecules, biologics and gene-therapies. Andy is interested in Human Subject Protection, Multiregional Studies, Quality and Compliance, Operational Excellence and finding more efficient ways to run clinical trials. At Sanofi he Sponsors the Innovation team in Clinical Operations.
Wei Li, Functional Manager, Strategic Outsourcing, Genentech, Inc.
Wei has been with Genentech for the past 17 years, and has been in the industry for more than 20 years. Currently she is a Sr. Manager for Contract and Outsourcing (C&O) group, and SPoC to Genentech Early Development (gRED). As the SPoC, she helped to establish and maintain strong working relationship, and build governance model with gRED. Prior to joining Clinical Outsourcing, Wei was a manager of Statistical Programming Analysts in Genentech. Before joining Genentech, Wei has worked for a private cancer research company, and Indiana University School of Medicine as a statistician. She has a MS in Statistics from Virginia Tech, and BS from Hollins University.
Craig Lipset, Head, Clinical Innovation, Worldwide Research & Development, Pfizer
Mr. Lipset is Head of Clinical Innovation within Worldwide Research & Development at Pfizer. Craig’s team is managing initiatives and investments that impact development of the Pfizer portfolio today while collectively redefining the future of clinical research. Craig previously served as Venture Partner in Pfizer Venture Investments (Pfizer’s VC arm), where he focused on diversifying the company’s $50M annual budget for private investments in the areas of diagnostics and health technology. Craig was also Senior Director in Molecular Medicine, where he spearheaded initiatives driving innovation in clinical research and personalized medicine by drawing upon tools from health information technology, telemedicine, and eHealth. Craig brings over 15 years of leadership and innovation in the field of drug development. He previously served as Associate Vice President of Program Management at Adnexus Therapeutics (acquired by Bristol-Myers Squibb), and on the founding management team for Perceptive Informatics (now part of PAREXEL International). Listed among the 2010 PharmaVOICE most inspiring people in the life sciences and among Pharmaceutical Executive’s 2011 Emerging Leaders, Craig was recently named program chair for the 2012 Annual Meeting of the Drug Information Association. Outside of Pfizer, Craig serves on the Board of Directors for the Foundation for Sarcoidosis Research and as a Mentor at health tech accelerator Blueprint Health.
Charles Love, Vice President, Clinical Affairs, Endologix, Inc.
Mr. Love is currently the Vice President of Clinical Affairs for Endologix, Inc. Prior to joining Endologix, Mr. Love served as Vice President of Clinical and Regulatory Compliance at CircuLite, Inc., a privately held medical device company developing disruptive solutions for the treatment of chronic heart failure. He has also served as a consultant and held management level Clinical Affairs, Regulatory and Strategic Development positions for a variety of medical device companies, including Medtronic, CoreValve, nContact Surgical, Inc., Ventracor Limited, and Converge Medical, Inc. His experience also includes senior management positions at Ramus Medical Technologies and Autogenics. He serves on the Board of Directors for Loma Vista Medical and is on the Technical Advisory Board for Dexteritie Surgical. Mr. Love received a B.A. in Biology from Westmont College. He also completed undergraduate work in Engineering at Gonzaga University and completed management programs at the University of California and Stanford University.
Sarah Luijpers, Director, Global Recruitment Operations, Forest Research Institute, Inc.
Jamie MacDonald, CEO, INC
Jamie Macdonald serves as the Chief Executive Officer at INC Research. He has more than 15 years of senior management experience in operational and financial roles in the CRO and biopharmaceutical industries. In the CRO sector, he joined INC Research in 2011 as COO when the Company acquired Kendle, where he was also COO. Prior to Kendle, he served as Senior Vice President and Head of Global Project Management at Quintiles with direct responsibility for a team that delivered approximately $2 billion in annual service revenue. Mr. Macdonald began his career in the pharmaceutical sector as part of Syntex/Roche. He earned a Bachelor of Arts in Economics from Heriot-Watt University in Edinburgh, Scotland and is a UK qualified Chartered Management Accountant (ACMA).
Rick Malcolm, Ph.D., CEO, Acurian
Rick brings more than 27 years of experience in healthcare management to his role as CEO. Prior to joining Acurian, Rick was Vice President, Business Development for ICON Clinical Research, one of the world's largest Contract Research Organizations. Rick started his career in healthcare at SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline) where he had product marketing responsibility for several cardiovascular, gastrointestinal, depression and anti-arthritic products. In addition to serving as the worldwide head for SBCL's Clinical Trials Center (now Quest's central laboratory), he has served in senior management and consulting roles at start-up pharmaceutical companies including The Medicines Company and Neutris Pharmaceuticals. Rick received his B.S. in Microbiology at the University of Michigan and his Ph.D. in Pharmacology at the University of Southern California.
Marina Malikova, Ph.D., Executive Director, Surgical Translational Research: Operations and Compliance, Surgery, Boston University Medical Center
Marina has over seven years of experience in clinical research, including managing all phases of investigational drugs, devices and biologics (gene therapy, stem cells, growth factors) of both sponsored and Investigator initiated trials in the fields of Vascular Surgery, Neurosurgery Surgery, Cancer Diagnostics and Interventional Radiology. She has served as a co-investigator on multiple industry sponsored and Investigator initiated clinical trials involving, breast cancer diagnostics, gene therapy for peripheral arterial disease and critical limb ischemia, stem cell therapy for venous stasis ulcers, tissue regenerative medicine and limb preservation, vascular devices for bleeding prevention, hypertension and varicose veins. She has a MS in Biological Sciences, majoring in Biochemistry and Physiology, from Voronezh State University, Voronezh, Russia and a Ph.D. in Biochemistry from the Institute of Biochemistry, Russian Academy of Science, Moscow. Marina also holds a Certificate in Clinical Research a Masters of Art in Clinical Investigation, both from Boston University School of Medicine.
Kathleen Mandziuk, MPH, RN, Senior Scientific Affairs Director, PRA Late Phase Services
Ms. Mandziuk has dedicated the last 15 years of her career on the science and operations of global post-approval and minimal risk research. Her background includes data management, project management and scientific affairs. In addition, she has a Master’s in Public Health from Drexel University, which allows her to design protocols and execution strategies with both scientific and operational objectives in mind.
Deborah Manzo, Senior Director, Clinical Business Operations & Transformation, Clinical Operations, AbbVie
Sylvia Marecki, Ph.D., Senior Director, Product Management & Strategy, Product Management, Citeline
Sylvia Marecki, Ph.D. is Product Manager for Sitetrove at Citeline. Prior to assuming this role, she was Senior Director, Autoimmune/Inflammation & Process/Product Improvement, where she was responsible for overseeing and optimizing editorial operations in Sitetrove and the Autoimmune/Inflammation therapeutic area within Trialtrove. She received her doctorate in Pathology and Immunology from Boston University School of Medicine and has over 10 years of experience in pharmaceutical business/competitive intelligence and market research.
Elizabeth Mascherino, Associate Director, Clinical Operations, Shire Pharmaceuticals
Elizabeth Mascherino is the Associate Director of Clinical Operations at Shire where her primary responsibility is to implement and sustain a trial optimization discipline for Shire’s Clinical Programs Department. Prior to joining Shire, Liz spent 3 years at Merck in the Global Trial Optimization department, developing end to end optimization strategies for 20+ protocols across a number of indications. Liz has also worked at Acurian, a patient recruitment firm and Bracket’s Rater Training Group. Before entering the Pharmaceutical industry, Liz lived in the in Prague and Spain teaching English as a foreign language. Liz holds a BS in Healthcare Communications from James Madison University in Virginia.
Jomol Mathew, Ph.D, Director, Clinical and Translational Informatics, IS, Dana-Farber Cancer Institute
Richard Mayewski, Associate Director, Clinical Trial Intelligence, Novartis
Rich brings more than 13years of experience within pharma to his role at Novartis. Prior to his current role, he has been involved with working at the site levels, worked as a CRA (both in the field and in-house), and finally, began to settle in to the arena of study feasibility and patient recruitment & retention. The latter experience has been moving forward since 2005, where he began working with the GTO group within Merck. From this time to present, he has been part of EMR/EHR protocol feasibility and recruitment initiatives, social media platforms to better inform patients in support of clinical trials and even recently has lead an effort for the global roll-out of patient modeling and simulation within Novartis through the use of system tools. Rich has a degree in Kinesiology which he received from Penn State University and will return to school in the fall of 2014 where he will begin working on his MBA from Temple University.
Juliet McBride, Associate, King & Spalding
Juliet McBride is an associate in King & Spalding’s Houston Healthcare Practice Group whose principal area of practice is focused on providing legal services to the healthcare industry. Mrs. McBride received a Bachelor of Arts degree from Southern Methodist University in 2003 and received her Juris Doctor degree, summa cum laude, from Thurgood Marshall School of Law at Texas Southern University in 2008. While in law school, Mrs. McBride served as a judicial intern for the Honorable Kenneth Hoyt in the U.S. District Court for the Southern District of Texas and as a judicial intern for Justice George C. Hanks, Jr. in the First District Court of Appeals of Texas.
Kelly McKee, Associate Director, Clinical Research, Global Trial Optimization, Merck & Co., Inc.
Kelly McKee is an Associate Director in the Global Trial Optimization group at Merck, overseeing patient recruitment and retention activities in the infectious disease and vaccine therapeutic areas. Prior to joining Merck, she was responsible for launching the first patient recruitment program utilizing a national network of chain and independent pharmacies to prescreen and refer patients into clinical studies. She has an in-depth understanding and application of electronic healthcare data in protocol feasibility, site selection, and patient recruitment activities.
Kevin McNulty, Director, Product Marketing, Life Sciences, Intralinks, Inc.
Kevin McNulty is the Director of Product Marketing for Life Sciences at Intralinks. He is responsible for the go to market strategy for all life sciences solutions at Intralinks. Kevin has a deep understanding of drug development processes and related applications from Phase 1 through post marketing, including EDC, CTMS, and pharmacovigilance systems. He also has experience with healthcare software solutions, with a particular focus on translational research, HIE, and healthcare analytics. Previous to Intralinks, Kevin worked for Oracle Health Sciences and Phase Forward in both product marketing and marketing communications roles.
Brenda Medina, former Director, Global Head, Clinical Business Operations, Eisai, Inc.
Brenda Medina has 12 years of direct experience. Currently, she holds the position of Global Head of Clinical Business Operations responsible for the functions of Study Budget Management, R&D Aggregate Spend tracking and reporting, Investigators Fair Market Value Assessment & Benchmarking, Strategic Meeting Management, Clinical Insurance and Quickbase Implementation and Analysis all of these functions are focused on the Clinical/R&D business units of Eisai. She has been at Eisai six plus years and has fully developed the process and tools for study budget management process, including Investigator Benchmarking, Budget Negotiations, Reconciliation, and Aggregate Spend Reporting for Sunshine and State reporting. Previous to Eisai Brenda has a well balance mix of experience in Clinical Arena from Biotech and the Finance Arena from several auditing and private firms. Brenda’s earned her degree in Accounting and Computer Information Systems from Dowling College and through her experience and education has been able to become a well-established Translator of the Clinical Development process for the Finance teams and a Financial Liaison to the Clinical Teams; a role and department (Business Operations) she has established at Eisai.
Sean Melville, Senior Director, Business Development, BioPharm Clinical
Sean Melville joined Infinata in 2007 to further develop Infinata’s flagship product, BioPharm Insight. In 2009, Sean changed roles to lead the business development efforts for the company’s new product, BioPharm Clinical. Since joining, Sean has become an expert in the clinical operations field, providing insight through innovative product development and becoming a key opinion leader to fellow industry peers.
Mark Mills, Director, Clinical Scientific Data Warehouse, Pfizer
Kim Mooney, Manager, Patient Advocacy, Clinical Operations, BioMarin Pharmaceutical, Inc.
Kim Hart Mooney, MS, CGC, is the Manager of Patient Advocacy at BioMarin. Kim has been in the industry for over nine years and has worked on a number of clinical trials during that time, as well as the development of the clinical trials section of the corporate website, and the coordination of programs to increase patient education and enrollment in clinical trials. Kim is a Certified Genetic Counselor and worked as a Study Coordinator prior to her current industry experience.
Helen Moore, Ph.D., Program Director, Biorepositories & Biospecimen Research Branch Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute
Dr. Helen Moore directs the National Cancer Institute (NCI) Biospecimen Research Network (BRN) which is part of the Biorepositories and Biospecimen Research Branch (BBRB, formerly known as OBBR). Under her leadership, the BRN has grown from concept stage to an internationally known, multidimensional program. The BRN encompasses extramural research programs, a Web-based biospecimen literature database, and community outreach activities including the BRN Symposium, “Advancing Cancer Research Through Biospecimen Science.” Dr. Moore is a Molecular Biologist with a broad background in research and development. She came to the NCI in 2006 from Celera Genomics, where she contributed to the assembly and annotation of the human genome; led and managed cross-functional teams to develop bioinformatics products focused on Comparative Genomics and data visualization; and developed new drug targets for complex diseases using multiple approaches including genetic analysis of disease association study data, biological pathways analysis, literature mining, and genomic analysis. Dr. Moore earned her doctorate at Cornell University and her B.A. at Wellesley College. Dr. Moore is a member of the Science Policy Committee of the International Society for Biological and Environmental Repositories (ISBER) and is the Biospecimen Science section editor for the journal Biopreservation and Biobanking. Dr. Moore gives numerous invited presentations about the BRN and BBRB across the U.S. and internationally.
Eric Morfin, Senior Director, Project Management, Allergan
Eric Morfin is a partner with Critical Skills Inc. and the Clinical Excellence Research Institute and has over 27 years of leadership and managerial experience in Life Sciences. Mr. Morfin has led many departments, such as Project Management, QA/QC, Data Management, Operations, Clinical Trials and others for companies such as Merck, Novartis, Pfizer, GSK, Roche, Aventis, BMS, Amylin, the National Cancer Institute, Astrazeneca, Quintiles and many others. He has worked with large pharmaceuticals, small biotech, medical devices companies and CROs around the world. Over the past 10 years, Mr. Morfin has spent more than 50% of his time in Asia (Singapore, China, Taiwan, Malaysia, India, South Korea and Japan mostly) and has consulted with many companies such as Roche Shanghai, Pfizer Asia Pacific, Novo Nordisk China, Hangzhou MSD, Kanghong Pharmaceutical, Quintiles, Malaysia Biotech Corp, SFDA, CK Life Sciences, Otsuka, etc… He has also partnered with UC Berkeley, several American universities and IBC Asia for selected engagements. Mr. Morfin and Critical Skills Inc deliver customized training workshops and consulting engagements in many areas including CRO Best Practices, Clinical Operations, GCP Auditing, Project Management, CRA Excellence, Global Trials, and many more. Eric Morfin also founded the non-profit global organization BioPharmaPM.org who is dedicated to enhancing the skills and knowledge of project professionals in the Pharmaceutical, Medical Devices and Health Care industries. He dedicates a significant amount of his time to this organization and its members.
Nancy Mulligan, Senior Director, Operations, Patient & Physician Services, UBC
Ms. Mulligan has over 22 years of experience in medical and pharmaceutical communications. In her current position at Patient & Physician Services for UBC, she manages an in-house team of medical writers, designers, production and communications professionals all focused on designing and executing aggressive, multi-media initiatives and site-based programs for various stakeholders. Ms. Mulligan is responsible for program operations of all TES strategies and vehicles that support physicians and patients, including recruitment and retention programs for research studies. Prior to joining UBC, Ms. Mulligan was a consultant with Booz Allen Hamilton and served as Vice President at Matthews Media Group. She holds a B.S. in Communications from University of Massachusetts.
Meredith Nahm, Ph.D., Associate Director, Clinical Research Informatics, Biomedical Informatics Core, Duke Translational Medicine Institute
Dr. Meredith Nahm has dedicated her career to studying issues in data quality. She has a National Library of Medicine funded grant in Health Information Quality, and two FDA grants for data standards development. She co-leads the Phenotypes, Data Standards and Data Quality core on the NIH funded Healthcare Systems Research Collaboratory. At Duke, she is an instructor in the Clinical Research Management and Health Informatics programs, and serves as an Associate Director for the Duke Center for Health Informatics.
Ramzi Najm, Vice President, R&D Information and Technology Management, Allergan
Ramzi Najm is the Vice President of R&D Info and Technology Management at Allergan Inc. where he oversees Global R&D information technology strategy and implementation as well as the optimization of business processes leveraging technology solutions. Prior to joining Allergan in 2001, Ramzi held different positions in business operations and information systems at various Pharmaceutical, Biotech and Contract Research Organizations. He brings over 25 years of experience in the Pharmaceutical IT environment. Ramzi earned degrees in Biological Sciences and Information Computer Sciences as well as an MBA in General Business.
Nariman Nasser, Senior Director, Participant Recruitment & Study Management Services, Clinical & Translational Science Institute, University of California, San Francisco
Derenda Nichols, Vice President, Operations Americas, Mapi
Ms. Nichols brings more than 23 years clinical research experience to the Vice President, Operations position with Mapi Real World Evidence. In this role, she provides leadership and direction to the Project Management, Monitoring and Site Management, Biometrics and Records Management groups covering North and Latin America. Her industry experience covers diverse clinical research disciplines including monitoring, project management and quality assurance as well as previous CRO corporate operations responsibility for Phase I-IV clinical monitoring, investigator services, patient recruitment and a studies support center in the Americas. For the last five years, Ms. Nichols has been solely dedicated to operational excellence in post-marketing and registry studies.
Daniel O’ Connor, InnovoCommerce
Daniel O’Connor brings extensive software company development and commercialization expertise. Mr. O’Connor is President & Chief Business Officer at InnovoCommerce. Prior to co-founding InnovoCommerce, he was Technology Director for Computer Science Corporation’s (CSC) emerging SharePoint practice. Prior to CSC, Daniel was the co-founder of Zorch Software, which designed and developed enterprise project management and document management solutions. Before launching Zorch Software, Daniel was the Vice President of Business Development at Workshare, a leading document collaboration and change management software company. At Workshare, Daniel headed business development and technical integration efforts with leading document management and compliance vendors Daniel earned his undergraduate degree from San Francisco State University, and graduate degree from University of California, Los Angeles, as well as a Juris Doctor from University of California, Hastings College of Law.
Al O. Pacino II, President, HealthCarePoint.com
Al O. Pacino, II is a U.S. veteran and a senior executive with over 25 years experience in healthcare and clinical research. He has held multiple positions with well established CRO and technology companies within our industry. He is the co-founder and president of HealthCarePoint Transnational Collaborative Networks, which serves over 500,000 professionals growing at 6,000+ per month. HealthCarePoint is a global collaborative environment which empowers healthcare and research professionals to properly maintain and exchange verifiable compliance records information with requesting organizations on demand. He has previously introduced the phenomenon and coined the phrase “trialdrift” and, along with other experts in the field has been able to bring to the forefront the issues, causes, consequences and solutions associated with this clinical research phenomenon. He has extensive experience with standardization, collaborative networks creation and is working alongside industry leaders to eliminate redundancies, minimize and ultimately eliminate fraud and abuse within healthcare and clinical research. Al is a military veteran and a 90-month cancer survivor.
Krista Payne, Executive Director, Value Demonstration within Peri- and Post-Approval Services; Senior Research Scientist, United BioSource Corporation
Ms. Payne, BA (Hons), MEd, is responsible for the conceptualization, design, and implementation of observational studies and registries including burden of illness evaluations and disease, national and multi-national direct-to-patient surveys, retrospective chart reviews, as well as product and safety registries. Ms. Payne has almost 20 years of pharmacoeconomic and research experience ranging from oncology, cardiology, and neurology, to pulmonology and gastrointestinal indications. Ms. Payne has designed and executed various multi-national observational studies and registries, including prospective and retrospective data collection projects in more than 14 countries around the world.
Nye Pelton, Clinical Operations Portfolio Manager, Clinical Research, Eli Lilly & Co.
Nye is currently a Clinical Operations Portfolio Manager with Eli Lilly. His responsibilities include managing site selection for Neuroscience and Auto-Immune Trials in North America, predicting enrollment timelines, managing early and late feasibility, and managing enrollment risk plans. He has 25 years Industry experience, the last 13 years with Eli Lilly clinical trials.
Gerson Peltz, M.D., Medical Director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb
Gerson Peltz MD, MPH is Medical Director of Global Pharmacovigilance and Epidemiology at Bristol-Myers Squibb. Prior to join BMS, he was Senior Medical Advisor of Eli Lilly and Co, Associate Professor (tenure) of University of Texas at Brownsville, and Chair of the Department of Internal Medicine from the Brazilian National Institute of Cancer. He has a fellowship in Health Disparities from NIH-sponsored program offered by University of North Texas.
Jane Perlmutter, Ph.D., MBA, President and Founder, Gemini Group; Steering Committee Member, Clinical Trials Transformation Initiative (CTTI)
Jane was first diagnosed with breast cancer in 1985 at the age of 36 and with no family history. Three years later, breast cancer was diagnosed in her other breast. Since these experiences, Jane has been involved in a number of organizations committed to educating the public about breast cancer, supporting people affected by it, and eradicating the disease. Jane has a Ph.D. in Cognitive Psychology and Masters Degrees in Educational Psychology, Computer and Information Science as well as an MBA. She started her career as an experimental cognitive psychologist at the University of Texas in Austin, spent most of her career at Bell Labs, and currently runs her own consulting company—Gemini Group. In regard to clinical trials, Jane is the lead advocate on the I-SPY 2 clinical trial. She has also been an advocate member of the Clinical Trials Transformation Initiative (CTTI), Clinical Trials Summit’s Informed Consent Steering Committee, Alliance (previously CALBG) Cancer Cooperative Group, and the Translational Breast Cancer Research Consortium (TBCRC). She is also a coach for a National Cancer Clinical Trials Pilot Breakthrough Collaborative run by the Education Network to Advance Cancer Clinical Trials (ENAACT). She has also worked on a number of NCI groups--Advocate Research Working Group (ARWG) Cancer Hub (CaHub) Ethics, Legal and Societal Issues (ELSI) Working Group, Return of Research Results Workshop, the Community Clinical Oncology Program (CCOP) Strategic Planning Group, the Concise NCI Informed Consent Template Project, the Breast Cancer Steering Committee (BCSC) and Local Regional Task Force (BOLD)--ASCO committees--ER/PR Guidelines, REMs recommendations, HER2+ Treatment Guidelines—and been a stakeholder reviewer for the American Cancer Society (ACS), the US Department of Defense’s external research program, the California Breast Cancer Research Program, Patient Centered Outcomes Research Institute (PCORI), and a member of the ACS’s External Research Council.
Christine Pierre, President, The Society for Clinical Research Sites (SCRS)
Christine Pierre is the CEO and Founder of RxTrials, Inc. and the Founder and President of the Society for Clinical Research Sites (SCRS). She is internationally known for her experience and expertise in clinical research site management and patient recruitment and retention for the clinical trials industry. In addition to being a frequent guest speaker at industry conferences, she has also addressed audiences around the world on issues pertaining to human subject protection, site operations, and subject recruitment and retention. Her global reach has included presentations and consulting in Australia, Canada, Africa, Israel, and the United States. Christine has served as Chairman of the Board of the Association of Clinical Research Professionals (ACRP) and has served on numerous editorial boards of industry publications. She is currently a member of the Steering Committee of the Clinical Trials Transformation Initiative (CTTI), a board member of the Metric Champion Consortium (MCC) and is on the Board of Advisors for both the Center for Information & Study on Clinical Research (CISCRP) and Hands Across the Americas. In 2009, PharmaVOICE named Christine one of the “100 Most Inspiring People” in the life sciences industry and she has been nominated as one of the top female business professionals in Maryland. In 2011, the National Association of Professional Women (NAPW) named her “Professional Woman of the Year.” Christine co-authored the book Responsible Research: A Coordinators Guide, and has contributed to several recognized publications related to patient recruitment. She holds a degree in Nursing and is an avid philanthropist for many organizations. She has developed her expertise in human subject protection and clinical site operations for more than 25 years and is a sought-after advisor to clinical research organizations around the world.
Joe Popowicz, Principal Consultant, Emergent Clinical Consulting; former Director, Clinical Operations, Stryker Orthobiologics
Joe Popowicz was the Director of Clinical Operations at Stryker Orthobiologics (formerly Orthovita). In this position, Joe was responsible for the study development and execution of the clinical development programs. Prior to Stryker, Joe held various positions in the areas of trial operations, enrollment planning, patient recruitment, and data management. Joe earned a Bachelor of Science degree in Psychology and a Master of Science degree in Experimental Psychology from Saint Joseph’s University.
Gary Puckrein, Ph.D., President and Chief Executive Officer, National Minority Quality Forum
Gary A. Puckrein, PhD, is President and Chief Executive Officer of the National Minority Quality Forum (formerly the National Minority Health Month Foundation), a not-for-profit organization that he founded in 1998. The Forum addresses the critical need for strengthening national and local efforts to use evidence-based, data-driven initiatives to guide programs to eliminate the disproportionate burden of premature death and preventable illness for racial and ethnic minorities and other special populations. The goal of the Forum is to strengthen the capacity of local communities to eliminate the disproportionate burden of premature death and preventable illness in minority populations through prevention, early detection, and control of disease complications. Dr. Puckrein also serves as the Executive Director of the Alliance of Minority Medical Associations (a collaborative effort of the Asian and Pacific Physicians’ Association, the Association of American Indian Physicians, the Interamerican College of Physicians and Surgeons, and the National Medical Association), which was formed on the basis of evidence-based data that highlight significant disparities in health-care treatment plans and outcomes among many underserved populations within the United States. In April 2001, the National Minority Health Month Foundation launched National Minority Health Month in response to Healthy People 2010, the national health-promotion and disease-prevention initiative.
Teresa Raich, Ph.D., Vice President, Nanosphere
Andrea Renninger, Head, BioBank Operations; Senior Manager, Clinical Coordination, Eisai, Inc. Andrea Renninger is the Head of Eisai BioBank Operations at Eisai Inc and Senior Manager of Clinical Coordination for the BioMarkers and Personalized Medicine Cross Functional Unit. Since joining Eisai in 2009, Andrea has standardized and implemented the processes for the collection, tracking, and management of biosamples from global clinical trials for Pharmacogenomic, biomarker and biobanking purposes. Recently, Andrea also lead the effort to establish an in-house biobank. Andrea has extensive experience in the clinical trial arena working in clinical operations for both medical devices and pharmaceuticals. Her experience at Beckton Dickinson enhanced her expertise on biosample handling and pre-analytical variables, which has been essential to educate internal and external collaborators on best practices for the collection of high quality biosamples for biomarker and biobanking purposes. Andrea has a successful track record in advocating for the clinical trial sample collection for biobanking purposes globally with IRB's and health Authorities. In Andrea’s talk she will highlight the current barriers in mandatory sample collection with the intention of banking.
Terry Robins, Consultant; former, Global Director, Scientific Affairs, Quest Diagnostics Terry Robins is currently an independent consultant to several drug and diagnostic companies that are working in the area of companion diagnostics. He has previously held positions at Quest Diagnostics Clinical Trials, Focus Diagnostics, Specialty Laboratories and Abbott laboratories all involving clinical trials and has a broad background in clinical trial design, laboratory operations and molecular assay R&D.
Jorge Rodriguez-Larrain, M.D., Head, Global Site Management, Global Clinical Operations, Alcon
Jorge Rodriguez-Larrain received his Medical Degree in 1986 from the Universidad Nacional Mayor de San Marcos, Lima - Peru. He is a member of the American College of Physicians and Fellow of the American College of Cardiology, as well as a member of several other international medical societies. In 1994 he was named member of the Alpha Omega Alpha Honor Medical Society. He joined Merck Sharp & Dohme (MSD) – Peru, subsidiary of Merck & Co., Inc., in 1998 as Clinical Research Manager and was promoted to Associate Director in year 2000. In 2002 he was transferred to MSD - Brazil as Director Clinical Research. In December 2004 he was transferred to MSD - Mexico as Medical Director, performing this role until September 2007, when he was promoted to the position of Regional Operations Director for the Latin America Region, he is currently based in Rahway, New Jersey.
Stewart Rosen, M.D., Vice President, Medical Affairs, Health Management Solutions, Quintiles
As Vice President of Medical Affairs, Health Management Solutions, Dr. Stewart H. Rosen focuses on developing strategic alternatives to traditional pharmaceutical commercial models. He supports the management, training and deployment of Clinical Educators, Clinical Trail Educators and Medical Science Liaisons who help prescribers and practice sites facilitate diagnoses, improve treatment regimens, support clinical research implementation, enhance patient compliance and improve outcomes. Prior to joining Quintiles in 2000, Dr. Rosen’s industry experience included management positions at Knoll Pharmaceutical Company with responsibilities in the areas of medical marketing, managed care, government affairs and retail distribution. Dr. Rosen also has experience as a practicing clinician, in the area of Physical Medicine and Rehabilitation.
Alesci Salvatore, M.D., Ph.D., Vice President, Scientific Affairs, PhRMA
Salvatore (“Salvo”) Alesci, M.D., Ph.D. joined PhRMA in December 2011 as Vice President, Scientific Affairs. In this role, Dr. Alesci serves as the primary expert for PhRMA on scientific and medical issues. He carries overall responsibility for establishing PhRMA as a “go to” source for input on policies and legislation related to innovative approaches to biopharmaceutical discovery and development. Dr. Alesci brings to PhRMA over ten years of combined academia/government/industry research experience and multi-disciplinary expertise in Translational Medicine. Prior to joining PhRMA, Dr. Alesci served as Vice President and Franchise Integrator, Women’s Health and Endocrine at Merck, where he was responsible for overseeing all activities to optimize the output of drug candidates to achieve “proof-of-concept” in early development, and enter late stage development in a time- and resource-efficient manner. Before his tenure at Merck, Dr. Alesci served in a number of Translational Medicine leadership roles at Wyeth and Pfizer. In addition to his experience in the pharmaceutical industry, Dr. Alesci spent eight years in research at the National Institutes of Health (NIH), where he completed his post-doctoral training and held a number of positions. Dr. Alesci has authored over fifty scientific publications, chaired and presented at prestigious national and international meetings, and is the recipient of two Special Acts of Service Awards by the US Department of Health and Human Services, and a NIH Fellow Award for Research Excellence (FARE).
Jessica Saucier, Clinical Transplant Research Nurse, Baylor Research Institute
Jessica Saucier currently holds a Bachelor of Science in Nursing from the University of Texas at Arlington. She began her nursing career in 2007 on the transplant unit at Baylor All Saints Medical Center in Fort Worth, and is a Certified Clinical Transplant Nurse (CCTN). Jessica transitioned to the Clinical Transplant Research Nurse role in 2011, where she blends her knowledge of transplant and research for optimal study outcomes. She also serves on the American Board of Transplant Certification Board of Governors as CCTN At-Large, and often gives oral presentations on nursing and transplant-related topics. Jessica is currently enrolled in the Master of Science in Nursing program at the University of Texas at Arlington.
Peggy Schrammel, Vice President & Global Head, Portfolio Management, PACE PAREXEL
Peggy Schrammel serves as the Global Head of Portfolio Management within PACE. She is a well-known late-phase thought leader and most recently headed the Registries and Post-Approval Development business at a niche CRO specialized in observational research. Peggy has spent more than 15 years in the late phase research space and brings a strong track record in late-phase leadership within global CROs. Peggy received both her undergraduate degree in political science and her Master of Public Administration (MPA) from the University of Pittsburgh. Throughout her career Peggy has published in peer-reviewed journals and has been a regular speaker on various late phase topics.
Colin Scott, M.D., Senior Director, Respiratory Development, Clinical Development, Forest Research Institute, Inc.
Colin Scott, MD is senior pharmaceutical industry executive with over 30-years of experience in international strategic pre-clinical, clinical and regulatory development. He has an established track record in the development and management of pre-clinical, medical and regulatory departments in both big pharma and biotech and has worked as an independent consultant. He is currently tasked with evaluation of early stage development compounds and is championing expanded approaches to patient recruitment for Forest Research Institute.
Gary Secrest, CTO and Vice Chairman, SAFE-BioPharma Association
Lisa Sergas, Manager, Clinical Outsourcing, Medivation
Lisa has over ten years of Outsourcing and Contracts leadership experience in the area of Clinical Development primarily at small to mid-size biotech organizations. She has extensive experience establishing and managing processes for vendor selection and oversight for globally outsourced clinical trial services in various therapeutic indications and phases of development. She has held previous roles in both CRO and Sponsor organizations which give her valuable perspective from both sides of the industry. Lisa has lead the Clinical Outsourcing function at various small to mid-sized biotech companies including BioMarin Pharmaceutical, Inc. and Santen, Inc., and is currently working to establish the Clinical Outsourcing role and strategy at Medivation, Inc. in San Francisco.
Nigam Shah, Ph.D., Assistant Professor, Medicine & Biomedical, Informatics, Stanford Center for Biomedical Informatics Research
Dr. Nigam H. Shah is an Assistant Professor of Medicine (Biomedical Informatics) at the Stanford School of Medicine. Dr. Shah's research is focused on combining machine learning and text-mining with knowledge encoded in medical ontologies to learn practice-based evidence from unstructured clinical data. He teaches a graduate class on data-driven medicine. Dr. Shah holds an MBBS from Baroda Medical College, India, a PhD from Penn State University, USA and completed post-doctoral training at the Stanford Medical School.
Mollie Shields-Uehling, President and CEO, SAFE-BioPharma Association
Mollie Shields-Uehling is president and CEO, SAFE-BioPharma Association, the non-profit consortium of biopharmaceutical and related companies that developed and manages the SAFE-BioPharma digital identity and digital signature standard for the biopharmaceutical and healthcare sectors. She has 20+ years experience in international trade and in the biopharmaceutical industry, including leadership positions with Bristol-Myers Squibb, Wyeth, the International AIDS Vaccine Initiative and the White House Office of the U.S. Trade Representative and the U.S. Foreign Commercial Service.
Eric Silberstein, Co-founder & CEO, TrialNetworks
Eric passionately believes that technology can and must radically enhance clinical trial operations to ensure a steady stream of innovations addressing major health challenges. His work on over 15 trials and his background in technology and online collaboration have fueled the vision behind TrialNetworks. Prior to TrialNetworks, Eric was founder and Chairman of Idiom Technologies (acquired by SDL). Idiom’s technology, used by Fortune 500 companies including five of the top ten web companies, enables global teams to efficiently collaborate on multilingual translation. Eric holds a BA in computer science from Harvard University and is one of the original winners of the MIT TR100 prize. Eric lives in Newton, Massachusetts with his wife Frances and their two children.
Ellie Smith, Global Clinical Site Developer, Alcon
Ellie is a strategic, energetic, and knowledgeable pharmaceutical and device professional with over 15 years’ experience in clinical research. She earned a Masters of Science in Health Sciences – Clinical Research from the George Washington University.
Tina Soares, Senior Director, Trial Coordination Site Management, GCO, Johnson & Johnson
Tina has been with Johnson & Johnson for 15 years. During her tenure at J&J she has worked in early development and late development as well as post-marketing. She is currently the Head of Trial Coordination and Site Management for the United States and is responsible for the execution of Janssen R&D clinical trials within the United states across 5 different therapeutic areas.
Simon Sparkes, Senior Vice President, Clinical, ArisGlobal
Simon Sparkes joined ArisGlobal in 1990. During his time with ArisGlobal, he was responsible for the product development strategy of ArisGlobal's safety, clinical and MI suite including ARISg, the market-leading PV system and other bespoke clinical systems. In 2010, Simon took over ArisGlobal's clinical software product unit with full responsibility for ArisGlobal'seClinical product strategy that includes CTMS, eTMF, EDC and IWRS systems, with a specific focus on the smart integration of systems using latest technology and industry standards.
Manfred Stapff, M.D., Executive Director, Global Medical Operations, Forest Laboratories
Manfred Stapff MD PhD is a physician with clinical training in Internal Medicine and a board certified Clinical Pharmacologist. He has 20+ years of industry experience in clinical research and in the drug lifecycle management process. He acquired his extensive expertise in a range of positions, as a practicing physician, investigator, field monitor, medical director and worked in clinical development, medical and regulatory affairs in increasing global responsibilities in research oriented pharmaceutical companies like Merck & Co and Forest Laboratories, Inc. His publication list includes abstracts, articles, and books in cardiovascular medicine, clinical trials, and scientific project management.
Abbe Steel, Vice President, Patient & Physician Services, United BioSource Corporation
Ms. Steel has over 22 years of experience working in the pharmaceutical industry in the fields of patient education and compliance, risk management, clinical trial management, and clinical trial patient recruitment and retention. Her responsibilities at UBC include managing a team of medical communication professionals that design and execute physician and patient communication programs to support clinical trials and post-marketing programs.
Daniel Steenblik, Vice President, Technology and Operations, sampleminded
Daniel Steenblik began his career engineering astrophysics educational software while working as an undergraduate for the Cosmic Ray Research program at the University of Utah. Since then, he has been in the biotechnology arena, architecting modular and configurable software for laboratory sample tracking and PCR instrumentation.
Thomas Sullivan, President, Rockpointe Corporation
Thomas Sullivan is the President and founder of Rockpointe Corporation, a leading medical education company headquartered in Columbia, MD. Rockpointe and its ACCME accredited subsidiary, PCME, are recognized for the scientific content of its programs, compliance with CME guidelines and practices, and creative approaches to instructional design. Tom is a graduate of the University of Florida in Economics and a hard core Gator fan. He has 15 years of experience in medical education and program development working with clients such as the American Heart Association, American College of Cardiology, American College of Chest Physicians, American College of Physicians, The Endocrine Society, American Diabetes Association, National Multiple Sclerosis Society, American Society of Clinical Oncology, as well as most of the major pharmaceutical companies. Tom is a recognized authority in the changing medical education environment and economy. He has parlayed his passion for the political process to inform the medical education community and other stakeholders of emerging trends, threats and changing practices. Recently, Tom launched www.policymed.com a website devoted to news and information about political events which effect CME providers and the pharmaceutical and device industries. Tom’s leadership has helped to keep Rockpointe ahead of the curve in the changing regulatory environment.
Ramita Tandon, Senior Vice President & General Manager, Patient Outcomes, inVentiv Health, Inc.
Sameer Tandon, Global Supplier Performance & Innovation (SP&I) Manager, R&D, Outsourcing, Novartis
Sameer has been with Novartis for 10 years working in roles supporting data management, clinical sourcing, and currently as the Global Supplier Performance & Innovation (SP&I) Manager for R&D. In this role, Sameer’s focus is on the unique capabilities and technologies in Novartis’s supply base across all cross-divisional R&D functions. He also works with key suppliers and business stakeholders in order to fairly measure mutual performance against specific deliverables or business challenges.
Kristin Tatum, Senior Project Manager, Mapi
Ms. Tatum graduated from Rutgers University with a Bachelor of Science in Biotechnology and a minor in Biochemistry. She has provided oversight and direction for all contracted functional services for each of the projects she has managed. Ms. Tatum is a certified Project Management Professional and is an active member of the Association Project Management Institute.
Judith Teall, Director, Clinical Excellence, Operations, Exco InTouch
Judith Teall is Director of Clinical Excellence at Exco InTouch. She has 20yrs of experience in clinical research from major pharmaceuticals, culminating in a patient recruitment and engagement focus, but originally graduated as an RGN nurse. Judith brings this multi-faceted background into her keen interest in patient-centric clinical research approaches.
Piet Theisohn, Director, Resource Management & Business Support, Global Clinical Development, Bayer Healthcare Pharmaceuticals
Since 2007, Piet built and led a dedicated team in Global Clinical Development (Bayer Pharmaceuticals) supporting the clinical teams in planning and tracking clinical trials timelines, recruitment, and cost. In parallel, he consolidated clinical trial and project planning information together with time recording data used to support the clinical functions with their Resource Management. From 2001-2006 he led a group coordinating Bayer Pharma Development's IT needs with strategy, implementation, maintenance and support with the Corporate IT department. In 1997 he joined Bayer with a Computer Science degree as a project manager for various projects supporting Bayer's R&D departments with innovative solutions.
Kate Trainor, Vice President & Global Head, Project Management &Technology, PACE PAREXEL
Kate joined PAREXEL in September, 2004 and is currently Vice President, Global Head of Project Leadership and Technology, Peri Approval Clinical Excellence (PACE). She is responsible for the Project Manager Operations team worldwide, and for creating vision and leading the operational model for technology innovations in the late phase arena. Areas of focus include developing, delivering and measuring excellence in operations; innovative implementations in eClinical technologies, providing options facing sites, sponsors, and subject users for better decision making. Previously, she has served as Vice President, Operations for PACE North America, and Vice President, Integration Services Group (ISG), Perceptive Informatics. She was responsible for the delivering services around the Perceptive product portfolio, including Business Intelligence Portals, eClinical Consulting Services and Customer Care. Business models incorporate both direct customers, and partnering with our parent company, PAREXEL. Kate's previous experience includes functioning as Director Clinical Data Operations for Phase Forward, where she managed trial hosting, quality assurance and compliance, and other services for all global clinical trials. She also has experience as Services Manager for Nugenesis Technologies Corporation. Nugenesis provides scientific data management solutions for pre-clinical research including electronic lab notebook solutions. Kate has a significant understanding of technology, clinical research industry, late phase clinical research, project and quality management, and regulatory compliance issues. Kate has a BS in Electrical Engineering from Northeastern University and has taken graduate level courses at Worcester Polytechnic Institute. She has also achieved Executive Certification from Massachusetts Institute of Technology, in Management and Leadership.
Lisa Vaughan, Head, US Clinical Site Management, Alcon
Lisa has over 25 years of experience in clinical research holding a variety of US and global positions. She currently leads an innovative global function at Alcon expanding their global footprint throughout the world in the areas of pharmaceutical, device and vision care products.
Rita Viegas, Clinical Operations Lead, Biogen Idec
As a Clinical Operations Lead at Biogen Idec, Rita partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. She leverages Phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan and program level strategy. Rita has also independently overseen multiple trials by establishing the operational strategy and securing excellence in execution through the CRO partner. Prior to joining Biogen Idec, she was a Project Manager and Field Manager at Lantheus Medical Imaging. Rita has also worked as a “GCP”, and “Design and Conduct of Clinical Trials” instructor at Boston University and is a member of the Association of Clinical Research Professionals (ACRP) and Drug Information Association (DIA). She obtained my BSc at Kingston University, in UK, and my Masters in Clinical Investigations at Boston University.
Christina Villar, MPH, Director, Clinical Affairs, Johnson & Johnson Vision Care, Inc.
Christina Villar joined Johnson and Johnson Vision Care, Inc., Jacksonville, FL in December 2010. As the Director, Clinical Affairs, Global Clinical Operations, Christina oversees the implementation of company sponsored clinical research conducted globally by Vision Care, Inc. including more than 250 clinical studies to date. Christina has 20 years of experience overseeing preclinical and clinical research conducted by industry, contract research organizations, academia, and non-governmental organizations. Christina has led the conduct and oversight of ophthalmology, cardiovascular, anti-infective, immunology, and oncology device, drug, and combination product studies both nationally and internationally. Christina was formerly with Stealth Peptides, Inc. where she conducted preclinical and clinical research in cardiovascular and ophthalmology indications for new chemical entities manufactured in China. Christina has expertise in Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs) as it applies to research and manufacturing of drug and biological products in Asia, Europe, Latin America and the United States. Prior to her role with Stealth Peptides, Inc. Christina was Director, Clinical Research with IOMAI Corporation (currently Intercell Vaccines) where she was instrumental in the development, evaluation and submission of a novel vaccine delivery system combining a biologic with a device. Christina has also held senior management roles at various Contract Research Organizations specializing in anti-infective, cardiovascular, and immunology research. While at the World Health Organization in Geneva, Switzerland, Christina partnered with international regulatory authorities, such as the US FDA, the UK DFID, and the Netherlands RIVM in the development and implementation of training initiatives for industry in the areas of GMP, GLP, vaccine manufacturing, product release and testing, and GCPs. Christina received a Master in Public Health degree from George Washington University, Washington DC and a Bachelor of Arts degree from the American University, Washington DC.
Lee Walke, Senior Director, Biometrics, Mapi Real World Evidence
Mr. Walke is responsible for both operational and administrative functions for the Biometrics group, which includes Data Management, Statistics, Medical Writing and the Programming that supports those functions. Mr. Walke possess over 21 years of experience in clinical research, and has implemented new technologies that have since become industry standards. Mr. Walke’s innovations include pioneering the use of standard data integration practices to support regulatory submissions, implementing electronic regulatory submissions processes and technologies and working directly with the FDA on several eNDA’s, introducing EDC, implementing CDISC-based Standards throughout Clinical Data Management.
John Walker, Director, NIBR IT, Novartis Institutes for BioMedical Research, Inc.
John Walker is a Director in IT at the Novartis Institutes for BioMedical Research (NIBR) where he is responsible for leading a global team who provides IT systems to support pre-clinical safety, DMPK and early phase clinical development. Prior to joining NIBR in 2010, John worked at Infinity Pharmaceuticals for 8 years where he lead the development of Infinity's clinical IT systems and was responsible for data management. In addition to 10+ years of drug discovery and development experience, John also worked at Bowstreet, an enterprise software company, that was acquired by IBM. John holds a B.A in Biochemistry from Bowdoin College.
Amelia Wall Warner, President, Board of Directors, Gentris Corporation; former, Head Clinical Pharmacogenomics and Clinical Specimen Management, Merck
In 2013, Amelia joined Gentris Corporation as President and Member of the Board of Directors. Gentris is a pioneer in genomic biomarker strategy, testing, operations, ethics, consulting, and global regulation and law. The company is also a global leader in biobanking operations, procedures, policy, consulting, and storage. Amelia will lead the Executive Management team for US-based science, operations, and business development. Amelia is the Founder and CEO of Global Specimen Solutions, Inc.- an innovative company offering pharmacogenomics operation services and consultancy to the pharmaceutical industry. Global Specimen Solutions, Inc provides expert ability to write pharmacogenomic and biomarker protocols, informed consent, negotiate consents, annotate specimen permissions, manage and clean key files, create blinded data sets, manage biorepository activities, design and plan of pharmacogenomic and biomarker corporate strategy and development design. Amelia has over 15 years experience building and incorporating clinical pharmacogenomic research into comprehensive, cohesive, integrated prospective strategy. Amelia conceptualized and built biorepository programs from the ground up at Children's Hospital of Philadelphia, Schering-Plough, and Merck. Customizing programmatic needs from academic programs to pharmaceutical company needs, Amelia has developed optimized approaches for pharmacogenomics, human specimen research, and biobanking that are compliant, maximize return-on-investment, and yield important understanding of human variation in response to drug therapy. She leads international teams focused on optimizing genetic sample collection, data generation, and data transfer globally and continues to work on international policy for both genetic specimens and human specimen research. She was a PhRMA representative to ICH E16 for Genomic Biomarker Data Submissions and is Past Chair of the Industry Pharmacogenomics Working Group.
Neal Weinreb, M.D., Director, Gaucher Disease - Fabry Disease Treatment Center; University Research Foundation for Lysosomal Storage Diseases
Neal J. Weinreb, M.D., FACP is a graduate of the Jewish Theological Seminary (Bachelor of Hebrew Literature), and Downstate Medical Center ( MD, summa cum laude). After a residency in Internal Medicine at Albert Einstein College of Medicine and a fellowship and faculty position at Mt. Sinai School of Medicine, N.Y., he practiced Hematology and Medical Oncology in South Florida. Dr. Weinreb, the director of the University Research Foundation for Lysosomal Storage Diseases in Coral Springs Florida, now devotes his entire professional attention to clinical research and management of patients with LSDs, especially Gaucher disease and Fabry disease. Dr Weinreb is a Voluntary Associate Professor of Medicine at the University of Miami Miller School of Medicine and a Clinical Professor of Medicine (Hematology) at the NOVA Southeastern College of Osteopathic Medicine. He is an active participant in Gaucher and Fabry Disease registries and co-Chair of the International Collaborative Gaucher Group Board of Scientific Advisors. He also serves as a member of the Medical Advisory Board for the National Gaucher Foundation.
Chunhua Weng, Ph.D., Florence Irving Assistant Professor of Biomedical Informatics, Columbia University
Dr. Chunhua Weng is the Florence Irving Assistant Professor of Biomedical Informatics at Columbia University, where she has been a faculty member since 2007. Before arriving at Columbia, she obtained an undergraduate degree in computer science with a focus on software engineering from Nankai University, P. R. China, a master’s degree in Information and Computer Science from University of California at Irvine, and a Ph.D. in Biomedical and Health Informatics from University of Washington at Seattle. Her research theme is developing human-computer collaborative approaches to help clinical researchers make the best use of health information technology. Her current research is focused on interactive query formulation to help clinical researchers develop a good understanding of the patient population and apply this understanding in informed clinical trial designs.
Dan White, Vice President, Global Clinical Operations, Quintiles
Dan White currently is a VP of Global Operations for Quintiles’ centralized monitoring group (PCC) as well as our endpoint adjudication group (CEVA). In this position, Dan leads over 26 PCC locations around the world including centers in Latin America, Eastern/Western Europe, Australia, South Africa, India, and the US (largest center). Dan is Quintiles’ subject matter expert on risk based monitoring working with customers on the implementation of risk based monitoring across Quintiles’ organization. Dan has been with Quintiles over 13 years and is based in NC out of the RTP office.
Seth Whitelaw, S.J.D., Director, Health Sciences Compliance, Deloitte & Touche LLP
Seth Whitelaw is a Director in Deloitte & Touche’s Enterprise Risk Services Group focusing on Health Sciences. He has more than 20 years of experience in the Life Sciences and Healthcare industries in the areas of food and drug law, and transparency as well as corporate governance and compliance for medical devices, pharmaceutical sales and marketing, and pharmaceutical R&D. A licensed attorney, most recently Seth served as Compliance Officer for GlaxoSmithKline R&D. Previously he was Legal Compliance Officer, Pharmaceuticals NA for SmithKline Beecham Pharmaceuticals and before that, Senior Attorney and Compliance Coordinator for C. R. Bard, Inc. where he was responsible for implementing and managing Bard’s Global Compliance Program in addition to providing advice on various food and drug matters. Seth also was a former Food and Drug Law Institute Fellow (FDLI) and Intern with the FDA’s Office of Chief Counsel. A frequent speaker and writer, Seth recently authored, “How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?”, for the FDLI Policy Forum in June 2011, and “Practicing Avoidance: Navigating Qui Tam and Consent Decrees,” for Pharmaceutical Compliance Monitor in January 2012.
Adam Wilcox, Ph.D., Director, Medical Informatics, Intermountain Healthcare
Adam Wilcox, PhD, is a Director of Medical Informatics at Intermountain Healthcare in Salt Lake City, Utah. He is nationally known for his work with the analysis and use of clinical databases for research, the architecture and design of health information technology (health IT), and supporting innovative care transformation through health IT. He has led the design of system-wide and departmental information systems, and has directed development teams for electronic health records, data warehousing, and health information exchange. He has worked most recently as an Associate Professor of Biomedical Informatics at Columbia University and the Director of Clinical Databases at NewYork Presbyterian Hospital (NYP). There he led many health information technology, exchange, and research efforts in New York City. This included leading the WICER project, a $10M award from AHRQ and New York State to build an informatics infrastructure for comparative effectiveness research. He is a fellow of the American College of Medical Informatics.
Kevin Williams, Vice President, Corporate Development & Marketing, CFS Clinical (CFS)
In his current position, Mr. Williams is responsible for driving the continued growth of the company through marketing and strategic enhancement of the CFS solutions. Prior to his current role at CFS, Kevin has been a leader from both a Business Development and Operations perspective, responsible for the development, delivery, and growth of the investigator contract and grant payment services. He is focused on developing innovative, customer-focused solutions and efficient processes to address the needs of this critical area of clinical research. Kevin joined CFS in 2006 from Merck and has more than 15 years of experience in the Pharmaceutical and Healthcare Industries. Mr. Williams holds a B.S. in Health Science from Lock Haven University and an MBA/MS from Temple University (Fox School of Business) in Philadelphia, PA with a focus in Health Care Administration and Finance.
Patty Wood, President, NBIA Disorders Association
Patricia Wood, of El Cajon, California, is president and founder of the NBIA Disorders Association. Neurodegeneration with Brain Iron Accumulation (NBIA) is a group of rare, inherited, neurological disorders. Since 1996, the association has been providing emotional support to families affected by NBIA, educating the public about these rare disorders and supporting research. The organization has awarded over $850,000 to researchers to study NBIA, were founding members of the Genetic Alliance BioBank and now are participating in an International Patient Registry for NBIA disorders. They are one of 13 partners from 8 countries in a research consortium titled Treat Iron-Related Childhood-Onset Neurodegeneration (TIRCON). The goals of TIRCON are: set up an international NBIA patient registry; establish a biobank; develop biomarkers for the disease; conduct a randomized clinical trial of the iron-chelating drug deferiprone in PKAN; and develop pantethine derivatives for treating PKAN. Patricia has a 27-year old daughter, Kimberly, who was diagnosed with NBIA in 1989. Ms. Wood has undergraduate degrees in Community Services and Distribution & Transportation Management. She has also studied for an MBA at San Diego State University. Before devoting herself to the organization, she was a business owner for 11 years.
Barbara Wuebbels, Associate Director, Patient Advocacy, BioMarin Pharmaceutical, Inc.
Barbara Wuebbels is Associate Director for the Global Patient Advocacy program at BioMarin Pharmaceutical Inc. in that capacity she over sees patient recruitment, patient education for clinical trials, and patient advocacy. Prior to assuming her present position she was Manager of Medical Affairs Investigator Relations at BioMarin. Barbara has spent thirteen years in the orphan drug area. Prior to joining BioMarin she was the Director of Ucyclyd Pharma. She serves on the boards of ICORD and the RARE Project. She has a Master’s degree in nursing.
Fei Xue, M.D., Observational Research Director, Center for Observational Research (CfOR), Amgen, Inc.
Fei Xue, MD, ScD, is an epidemiologist (Global Observational Research Director) in the Center for Observational Research (CfOR) at Amgen Inc. She received her medical degree from the Nanjing Medical University in China and doctoral degree in reproductive and cancer epidemiology from the Harvard University School of Public Health. Over the past 7 years, her research interest has been in designing and implementing pharmacovigilance studies to evaluate long-term drug safety in the post-marketing settings. She has published over 20 papers and book chapters based on her research in chronic disease epidemiology and pharmacoepidemiology.
Brenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer
Brenda Yanak is the Precision Medicine Lead for the Clinical Innovation group within the Worldwide Research and Development organization at Pfizer. She is responsible for advising senior scientific, technology, and operations executives on various ways to innovate the clinical development space. Prior to this role, Brenda was IT Site Head for three of Merck’s sites and lead for the Exploratory and Translational Sciences IT department, a group that provided technology strategy for an organization of 1,200 scientists that performed all molecular biomarker, pharmacogenomic, imaging, RNA therapeutic, translational model, and high-throughput screening research at the company. Prior to Merck, Brenda was a management consultant at IBM and also acted as Pfizer’s Biobank Lead, where she managed multiple biorepositories (Pfizer and Pharmacia) and built Pfizer’s internal Biobank.
Alan Zanich, Ph.D., Clinical Trial Supply Manager, EMD Serono
Alan Zanich is a Clinical Trial Supply Manager at EMD Serono. Dr. Zanich received his Ph.D. in biology from the University of Cambridge, UK. He transitioned to clinical trial coordination working at two London Hospitals, where he was involved in biopsy and blood sample collection and patient consent in to genetic studies.
Dr. Zanich has managed aspects of clinical trial research for Merck Serono (EMD Serono in the US) for over five years. He initially joined, and later led, the Biomarker Logistics Team. This team managed sample collection and accrual surveillance for biomarker research and pharmacokinetic analyses in phase I-III studies, globally, across multiple indications. Most recently, Alan is working as a Clinical Trial Supply Manager at EMD Serono, providing support for drug supply for global and regional studies.
Sean Zhao, M.D., Ph.D., former Pharmaceutical Executive in Global Safety Organization
Anita Zubak, Director, Business Systems Integration, Merck & Co, Inc.