Lori Abrams, Director, Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb (BMS)
Lori Abrams is the Director of Diversity & Patient Engagement in Global Clinical Operations at Bristol-Myers Squibb (BMS). Over the past four years she has built a Team that develops innovative and unique advocacy approaches that bring BMS clinical trial awareness and accessibility to patients, physicians, and caregivers. During this time the Group has developed many relationships with minority-focused health, community, and faith-based organizations, in order to increase diversity in BMS clinical trial populations. Lori’s Team has implemented Programs to gain patient and caregiver insights to promote an emphasis on improving the patient experience while participating in BMS clinical trials. Lori came to Bristol-Myers Squibb in 1998 as a Sr. Clinical Scientist in the Virology Group. During her first six years she was the Clinical Working Group Lead on both Videx EC and Reyataz. She joined the Drug Development Learning & Collaboration Team in 2003 managing a team of learning professionals. Lori’s career in drug development began at the National Institute of Allergy & Infectious Diseases, and US Military’s HIV Program. Lori completed her undergraduate studies at the University of Maryland, and received a Graduate Certificate in Organization Development from the NTL Institute for Applied Behavioral Sciences.
Murray Abramson, M.D., M.P.H., Vice President, Global Clinical Operations, Biogen
Dr. Murray Abramson received his B.S. degree in Chemistry with honors from Duke University and his M.D. from Duke University Medical School. He completed his internship and residency with AOA honors in internal medicine at Duke University Medical Center, followed by a clinical fellowship in infectious disease. He then was appointed to a one-year assignment as the Chief Resident within the Department of Medicine. After formal training, Murray joined the Duke University Medical School faculty as Director of the Infectious Diseases Research Consortium of the Duke Clinical Research Institute (DCRI). Murray spent 13 years at Merck where he held positions of increasing clinical, operational, and leadership responsibilities in the divisions of Merck Research Laboratories and U.S./Worldwide Human Health & Medicine Clinical Development Programs. In 2011, he joined Biogen as VP, Global Clinical Operations (GCO) where he was responsible for leading the Clinical Operations/Trial Management group including strategic planning and operational execution of all clinical trials across all indications and phases. Since 2013, Murray has been leading an expanded GCO organization, which includes Clinical Country Management and Field Operations, Quality Operational Capabilities, Performance Operational Capabilities, and Clinical Partnership. In his expanded role, Murray and his team have been leading many corporate initiatives beyond time, cost, and compliance. These initiatives include a focus on patient needs, scientific quality, and the growing relationship with their CRO Partnership, Quintiles. Over the course of his career, Murray has also participated on a number of regulatory submissions and authored several original, peer-reviewed publications including articles published in The Lancet and The New England Journal of Medicine.
Gareth Adams, Founder and Strategic Innovations Consultant, Syniad Consulting
Gareth Adams is an International Freelance Consultant specialising in innovative solutions for technology and process implementation within the life sciences sector. In his 20 years of professional experience he has held a number of senior management positions within top 5 CROs and has been involved in process design and optimisation, strategic visioning, talent management and change leadership. He graduated with honours in Biological Sciences from the University of Plymouth before starting his career with a top 10 global CRO, working as a Data Analyst in a predominantly paper based environment. Since then, Gareth has strived to champion progressive thinking, alternative approaches and innovative technology solutions to solving many of the issues faced in the clinical research industry."
Bardia Akbari, Pharm.D., Vice President, Product Global Development, Oncology Genentech, Inc.
Bardia joined Roche in 1996 and has held positions of increasing responsibility working in Medical Affairs, Clinical Operations, Alliance Management and Pharma Partnering. This included the roles of Director of Clinical Operations in the autoimmune, Global Alliance Director, and Global Head Business Development for Inflammation, Respiratory, and Ophthalmology Therapeutic areas. In 2012, he joined the Global Clinical Operations group in Pharma Development at Genentech. In his current role as Vice President of Product Global Development, Oncology, Bardia and his leadership team are accountable for the operational planning and conduct of over 150 studies with approximately 270 individuals in 4 groups: Operations Project Leadership (OPLs), Study Management, Sample Management, and TA Business Operations. The newly formed Business Operations group is accountable for providing focused analytical and tactical support to PDG’s two therapeutic areas; Oncology and I2ON. Bardia’s professional passion is to embed data-driven decision making in the clinical operations discipline. As a member of the PDG leadership team, Bardia has contributed to many efforts towards efficiency and effectiveness. These include the Therapeutic Area Portal, the PDG Book of Business, predictive feasibility modeling, and the PDG innovation goals. In 2013, Bardia initiated the drive to create an Operational Plan to complement the Clinical, Statistical and Regulatory strategies within a development plan. In collaboration with his colleagues in the other Therapeutic Areas, a data driven approach to the planning of global studies has been included in Development Review Committee (DRC) presentations. This provided visibility and focused attention to the critical operational aspects of designing and implementing clinical trials. Bardia’s passion goes beyond Roche. In his senior leadership role, he continues to champion the Roche-Rutgers PharmD Fellowship Program that recruits talented PharmD graduates to Roche from over 100 US and Canadian pharmacy schools. Bardia has been in the clinical research field since 1994. He received his Bachelor of Science in Pharmacy from the University of Colorado and his Doctorate of Pharmacy degree from the State University of New York.
Débora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim
Débora S. Araujo has over 10 years of experience within clinical trial operations with a special focus in the areas of global clinical contracting and clinical financial management. Her previous roles include both large and small pharmaceutical and biotech sponsors as well as the investigative site side of clinical trials. Having worked within organizations such as Novartis Pharmaceuticals, Eisai, Inc., Merck & CO., and Schering-Plough Research Institute, among others, has given Débora unique insight into the systemic blind spots sponsors have regarding clinical contracting and clinical financial management, particularly investigative site payments. In her current role as Associate Director, Clinical Contracting Services within Boehringer Ingelheim, Débora manages from both a strategic and tactical level, driving global harmonized processes for clinical contracting and clinical financial management with a strong customer focus.
Munther Baara, Senior Director, Development Business Technology, Pfizer
Munther has over 20 years of experience in the pharmaceutical industry. He is currently Sr. Director of Development Business technology at Pfizer, a worldwide pharmaceutical company. Munther is currently the head of Clinical Paradigm within the WRD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies. Munther Led the Clinical Aggregation Layer (CAL) implementation of a high-profile, large-scale clinical private cloud of clinical and operational data. In addition, he has extensive experience in application and system strategies, best practices, and standards that work for clinical and enterprise architecture, information management, workflow/process automation and integration of both home-grown and commercial applications across mixed platforms.
Jean Baumann, Change Management Specialist, JMB Consulting, LLC
Jean Baumann is a change management expert, with 30 years of experience being both an internal change manager and an external coach and consultant. Jean has helped leaders, teams, and organizations envision and implement major change initiatives and business transformations in government and private sectors, as well as highly regulated industries such as energy and healthcare. Jean is known for assisting individuals and groups attend to the people-side of change along with the business process and technical aspects so that they achieve their desired results easier and faster."
Elizabeth Beatty, Head, Digital Clinical Trials, Bristol-Myers Squibb
Liz Beatty leads the Digital Clinical Trials team in Clinical Trial Planning & Operations at Bristol-Myers Squibb. Liz started her career at Bristol-Myers Squibb in 2001 and has held various clinical operations positions supporting neuroscience, virology and oncology studies. More recently, she managed a global team of Recruitment Leads, and designed and launched the Bristol-Myers Squibb Study Connect website for patients and caregivers. In her current role, Liz is responsible for the digital strategy for clinical studies across Global Clinical Operations including digital protocol and program level strategies, enhancements to the Bristol-Myers Squibb Study Connect website, and innovations in mobile, health IT, and social media as the Chair of the Digital Acorn working group. Liz’s team focuses on creating a connected customer experience for patients, caregivers, sites, and HCPs by using digital solutions in clinical trials.
Michael Bem, IT Manager, Medicines Development, Eli Lilly and Company
Mike graduated from the University of Pittsburgh in 1993 with Chemistry and a minor in computer science. He Joined Lilly in May of 1993 as an IT Analyst supporting the library and computational chemistry organization in research IT. For 21 years, Mike worked in Research IT as programmer, business analyst, project leader, and manager driving business/IT solutions from Target Identification to Candidate Selection. In February of 2014, Mike joined the Medical Development Unit IT organization as manager leading efforts to implement solutions for risk based monitoring, patient centric engagement, and quality in design efforts. HIs current focus is managing a group to support and implement risk base monitoring.
Karina L. Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx) ,Translational Medicine, Merck Research
Karina Bienfait, Ph.D, is a Principal Scientist in Genetics and Pharmacogenomics within Translational Medicine at Merck Research Laboratories, and the head of Global Genomic Policy, Process and Compliance (GPPC). As head of GPPC, Dr. Bienfait helped to implement routine genotyping of patients participating in Merck’s clinical trials to identify genetic predictors of drug response. She is responsible for evaluating the impact of global genomic policies and regulations on Merck’s research programs; developing Merck policies, processes and consent related to genomics and biobanking; and ensuring the compliant use of biospecimens. In this capacity, Dr. Bienfait works closely with Merck’s global subsidiaries to develop strategies to address countries recalcitrant to genomic research and with global health authorities and ethical boards to negotiate approvals for genomic research in the context of Merck’s clinical trials. Dr. Bienfait completed an internship in Clinical Psychology at Nassau University Medical Center and a postdoctoral fellowship in Clinical Psychopharmacology in the Department of Psychiatry at Rutgers University - Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a B.A. in Psychology and French from New York University.
Dex Bilkic, MBA, Leader, Business Support Group, Boehringer Ingelheim
Dex Bilkic is a Leader of the Business Support Group at Boehringer Ingelheim Canada. He began his career at the Centre of Forensic Sciences as a Technologist. Previous to his current position he worked as an Associate Project Manager at AstraZeneca and a Scientist at GlaxoSmithKline. Dex has more than 20 years of experience in the Pharmaceutical industry where he has held various positions from working in research on the lab bench to managing clinical trials. Dex holds an HBSc from University of Toronto and an MBA from Queen’s University. He is an accomplished leader in the pharmaceutical Industry with a progressive experience in drug/product development from preclinical to post marketing. Dex has proven capabilities in providing strategic direction, managing diverse functional groups, eliciting peak team performance and employee engagement.
Kimberly R Bojczuk, Investigator, Discovery Supply, Global Biological Assets, GlaxoSmithKline
Kimberly Bojczuk joined SmithKline Beecham in 2000 after receiving her B.S. Biochemistry from Temple University and has worked in various roles to continuously improve and develop the capabilities of the Biological Archiving efforts at GlaxoSmithKline. She is currently in the Biological Assets group, which is developing a central platform for the provision, processing, quality control, storage and distribution of biological materials for drug discovery and development . Kimberly obtained her Project Management Certificate from Lehigh University and worked closely with an IT Development team to implement a biological registration and inventory application that supports GSK’s global biobanking efforts. She has also focused efforts on implementation of a sample storage strategy, coordinating off site long term storage of clinical and nonclinical samples globally. She is currently an Investigator in the Discovery Supply group of which maintains and develops innovative platforms and services to enhance and deliver small molecule and biological samples and leverage expertise in automation, IT, compliance and QA for the benefit of the GSK enterprise.
Loni Branon, Director, Sitetrove/Chinatrove, Pharma Intelligence
Loni is the Director of Sitetrove and Chinatrove solutions at Pharma Intelligence. Loni has expertise in optimizing country and site selection through analysis of clinical trial and drug landscapes, disease prevalence, and clinical investigator and trial site experience, as well as extensive knowledge of requirements to conduct clinical trials in China. Based on these data, she has created numerous visualizations for client presentations, sales and marketing.
Karen Brooks, Ph.D., Senior Director, Clinical Operations, Adare Pharmaceuticals
Karen Brooks has 24 years of clinical research experience. Karen is currently Senior Director of Clinical Operations at Adare Pharmaceuticals. Dr. Brooks is providing strategy and innovation to organizations on the importance of diversity inclusion in clinical trials. Previously she was a Sr. Director/TA Lead for Oncology and Rinat Clinical Operations, in Pfizer’s Development Operations Group. She also co-chaired the Pfizer Initiative of Increasing Clinical Trial Diversity. Her prior roles included the Director of Clinical Projects at sanofi-aventis where she was responsible for ensuring overall implementation and study conduct of clinical trials in North America across all therapeutic areas. Dr. Brooks also initiated diversity in clinical trials at sanofi working with the project management and regional team. Her extensive years of experience have afforded her the opportunity to work with many investigators, study teams, and sponsor companies with the initiative to improve the inclusion of minorities and women in clinical trials. Dr. Brooks holds a BS in Biology from East Carolina University, Masters in Health Administration from Central Michigan University, and a PhD in International HealthCare Research from Trident University.
Michael Brown, Executive Vice President, Business Development, Ancillare, LP
Michael Brown is the EVP of Business Development at Ancillare, LP. Mike has 23 years of experiences in global business development, client relationship and clinical trial management innovations within the pharmaceutical and CRO industries. He has contributed to the growth of Ancillare by bringing innovative ideas and implementing processes to increase value and deliver success to all customer programs. Michael holds a Bachelor of Business Administration from The Wharton School of the University of Pennsylvania.
Leigh Burgess, Chief Research Operations Officer, Duke Cancer Institute, Duke Cancer Institute
Leigh Burgess, MHA, MEd, MA is the Chief Research Operations Officer of the Duke Cancer Institute (DCI). In her role, she and her colleagues at the DCI work together to effectively lead and forward the mission of Duke Medicine by developing and implementing strategic initiatives within basic, translational and clinical research. Leigh is a member of the senior team responsible for providing guidance, support and assistance to the multi-disciplinary administration and leadership cross-institutionally at Duke. She currently supports a team of over 180 clinical research operations and administration staff and directs the administrative and operational functions of the CCSG P-30 nine Research Programs and thirteen shared resources, four developing shared resources and other research centric associated cores.As a current example of a key area that Leigh supports and leads, she is focused on supporting and planning for the development, implementation and improvement of clinical trials management, scientific and feasibility review and quality data capture. This work includes tracking protocol throughput, reviewing and projecting clinical trial accruals with a specialized effort to understand how to utilize organizational and human systems theory to impact and improve clinical trial activation and overall efficiency. She oversees the work of key areas of clinical research operations for oncology, included but not limited to data, safety and monitoring, cancer protocol committee, scientific review, regulatory, compliance, informatics, reporting, biobanking, biostatistics, accrual tracking/metrics, activation cycle time and strategic growth opportunities. In concert with DCI Senior Leaders, she develops and implements plans for financial, operational and administrative priority setting and strategy deployment outlining needs, improvements, opportunities and relationship building. She identifies/addresses/strategizes and directs the improvement of operational areas of opportunity at the organizational level based on metrics data, internal audit reports, and input from faculty, functional group leaders, project leaders, research partners, NCI and the NIH.Her past leadership experiences include graduate medical education, oncology quality, patient centered care, patient education and clinical research. She is currently a doctoral candidate completing her PhD in Human & Organizational Systems.
Chris Caldron, Director, Radiant Research
Chris Caldron is the Marketing Director at Radiant Research. He develops marketing strategies for clinical research studies, new site development, and company brand. As the Director of Marketing, he identifies the current and future needs of the company and align the marketing strategy to aid in accomplishing those goals. His job functions include, but are not limited to developing marketing plans, overseeing daily study advertising, measuring success and correcting issues, managing budgets, designing graphic collateral, identifying ways to target new sites, managing online presence, and planning for a cohesive corporate culture.
Jerome Chiaro, Vice President, Clinical Operations, StudyKIK
Jerome Chiaro is VP of Clinical Operations of StudyKIK, a Clinical Trial search and social media engine. Volunteer work is a big part of his life. He is currently a mentor and workshop presenter for SCORE Orange County, helping small businesses grow. He also volunteers at ""Purpose with Friends,"" a community project dedicated to helping Veteran's hospitals, women's shelters, and homeless initiatives. Growing up in the restaurant industry he has a passion for food, wine and travel. Visit his Restaurant Blog, Restaurant-Forms.com, for the latest Free Social Media & Restaurant Management Videos. Specialties: Clinical Trial Patient Recruitment, Social Media Marketing, Search Engine Optimization, Restaurant Consulting, Small Business Mentor.
Stephanie Clark, Associate Director, Risk Management-Central Monitoring, Janssen Research & Development, LLC
Stephanie Clark has over 15 years of experience in clinical research and drug development in the pharmaceutical and CRO arenas, as well as in basic academic research. At present, she is an Associate Director in the Risk Management-Central Monitoring Group at Janssen R&D. In this role, Stephanie has assisted in the creation and management of infrastructure and resources to support an analytical and risk-based model of clinical trial management and central monitoring. Prior to her RBM-focused work, Stephanie worked in clinical trial and site management at Janssen R&D and Centocor R&D, at RPS, Inc and at ICON in a variety of therapeutic areas and in basic immunological research at Children’s Hospital of Philadelphia. Stephanie is also a member of the Transcelerate BioPharma Risk-Based Monitoring Initiative.
Steven Coca, M.D., Associate Professor of Medicine, Internal Medicine, Icahn School of Medicine, Mount Sinai
Dr Steven Coca is an Associate Professor of Medicine at Icahn School of Medicine at Mount Sinai and serves as the Director for Clinical Research in the Division of Nephrology. He has been an active investigator in three large NIH-funded consortiums. His major research areas include using newer biomarkers to aide risk-stratification for outcomes in acute kidney injury and chronic kidney disease, as well as using biomarkers and other tools to aide in enrollment for conduct of efficient clinical trials.
Michelle Collins, Ph.D., Director, Patient and Investigator Relations, Clinical Field Operations, AbbVie
Michelle is a graduate from Northwestern University, where she received her PhD from Northwestern’s Institute for Neuroscience. Michelle has a 17-year pharmaceutical research career at Abbott Laboratories, now AbbVie where she has served in a variety of roles in Clinical Development and Medical Affairs. Michelle is currently the Director of Patient and Investigator Relations where she leads AbbVie’s Clinical Operations efforts to establish robust patient and investigator engagement strategies, and develop robust recruitment and retention programs.
Christopher Conklin, Director, Feasibility Center of Excellence, Pfizer
Chris is a Director in the Feasibility Center of Excellence at Pfizer where he is responsible for all aspects of protocol feasibility including program country strategy, protocol optimization, enrollment modeling, investigator strategy and assessment of competitive landscape. Chris has nearly 15 years of experience in the clinical research industry coming to Pfizer from Merck’s Global Trial Optimization organization where he spent 7 years in positions of increasing responsibility. Chris has also led projects designed to increase the use of Social Media in clinical trials and served as Project manager for the launch of a clinical trials website designed to education and inform the public about clinical trials opportunities. Chris’s prior experience includes roles in project management and study coordination at Johnson & Johnson PRD, Acurian and the Fox Chase Cancer Center.
Melva T. Covington, M.P.H., M.B.A., Ph.D., Senior Director, Field Medical Strategy Lead, Diabetes Cardiovascular Disease Business Unit, Sanofi
Dr. Covington is currently a Senior Director, Field Medical Strategy Lead in the Diabetes Cardiovascular Disease Business Unit at Sanofi. She has held various leadership roles within the Global R&D and Medical Affairs organizations at Sanofi since 2010. Her leadership skills, expertise and collaborations in public health, patient access, clinical research and operations have spanned over 20 years, covering the range of lifecycle development and therapeutic areas. She has a background in public health, early intervention, pharmacoeconomics, strategic thinking and business management. Her goal is to apply these skills strategically and innovatively to address complex issues within healthcare systems, organizations and communities. Much of her work focuses on population-based disparities in health outcomes, operations management and cultural competency.Prior to joining Sanofi, Melva led both Global and US-based teams in Health Outcomes and Pharmacoeconomics across a number of therapeutic areas at Lilly and Roche Labs. She is passionate about assessing integrated data and perceptions contextually and then applying that knowledge for targeted solutions to improve outcomes across diverse patient populations.She has an A.B. in Politics/Economics from The Catholic University of America, Masters of Public Health in Maternal and Child Health and Ph.D. from the University of North Carolina at Chapel Hill and MBA from Cornell University. Melva has authored numerous publications and is an impassioned public speaker.
Cathy W. Critchlow, Ph.D.,Vice President and Head, Center for Observational Research, Amgen, Inc
Dr. Critchlow joined Amgen in 2004 and assumed leadership of the Center for Observational Research in 2012. The Center for Observational Research provides operational and strategic leadership for the design and conduct of observational research in support of drug development and commercialization. In addition to her work at Amgen, Dr. Critchlow is an Affiliate Professor of Epidemiology at the University of Washington.Prior to joining Amgen, Dr Critchlow was a faculty member in Epidemiology in the School of Public Health and Community Medicine at the University of Washington. Dr. Critchlow received her BA from Stanford University, and her master’s degree in biomathematics and doctorate degree in epidemiology both from the University of Washington
Michelle Crouthamel, Lead, Clinical Innovation & Digital Platforms Unit, GlaxoSmithKline
Michelle Crouthamel is the managing director of the Clinical Innovation & Digital Platforms Unit at GlaxoSmithKline. The CIDP team focuses on harnessing digital technologies and platforms to transform the way clinical trials are conducted in Pharma R&D. Michelle is currently leading the strategy and development of e-patient recruitment and mHealth platforms within CIDP. She is also involved in the TransCelerate eSource work stream. Her previous roles in discovery and development have included leadership of pre-clinical and clinical development projects from target selection to market at both Merck and GSK. Michelle is an inventor who holds multiple patents. She also published extensively in the areas of Neuroscience, Oncology and mHealth. Michelle has a Master degree from the Neuroscience Institute of National Yang-Ming University in Taiwan and is currently pursuing a Doctoral degree at Temple University, Fox school of business.
Kym Denny, CEO, hVIVO
Kym Denny is the CEO of the innovative drug discovery and development company, hVIVO Plc, headquartered in London, England. Kym is a leading pioneer in site management, having founded one of the first of its kind, InSite Clinical Trials, in 1993 in Atlanta, Georgia. Since then, she has gone on to manage global clinical studies in a wide range of therapeutic areas, leveraging her knowledge of recruitment and site operations to achieve an enviable career project completion track record. Kym served as Managing Director of Harrison Clinical Research and was Vice President of Clinical Research at Constella/SRA prior to becoming CEO of hVIVO in 2010. At hVIVO, she has pioneered the human challenge model in flu, RSV and asthma exacerbation, leading the company through one of the most successful IPO’s on the UK’s AIM stock exchange in 2012. She has raised nearly £100m to mine hVIVO’s ‘disease in motion’ samples for biological insights, which led to the first mapping of the pathways underpinning the human host response to influenza infection. She has also led the creation of two joint ventures, with novel and ground breaking products in flu & cold prevention, a universal flu vaccine, and a mosquito borne disease vaccine platform currently being tested for Zika in collaboration with the National Institute of Health. In 2016 Kym was awarded the Ernst Young Entrepreneur of the Year award for life sciences in London and the South East.
Navreet Dhindsa, Director Clinical Operations, Clinical Operations, Merrimack Pharmaceuticals Inc.
Presently working at Merrimack Pharmaceuticals, Inc. in Cambridge MA, as Director - Clinical Operations, and leading the clinical perations group for the Development Business Unit. Recent achievements include FDA approval of Onivyde®, the first drug to receive FDA approval for treatment of advanced pancreatic cancer patients who have failed prior gemcitabine based treatment. I am an inventor on 2 patents that have been issued in the U.S., and have an additional ~ 50 patents filed globally.
Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Rob DiCicco is currently the Vice President of the Clinical Innovation and Digital Platforms Group at GlaxoSmithKline. He is also the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate BioPharma and one of the Team Leaders for CTTI's Novel Endpoints Work Stream as part of the mHealth in Clinical Trials Initiative. Rob has more than 25 years of experience in clinical development in a variety of leadership positions in CRO, mid-sized and large pharmaceutical companies. He received his Doctorate of Pharmacy degree at the University of the Sciences of Philadelphia. Over the course of his career he has had a key role in the development of a number of successful new medicines. Rob’s area of expertise includes clinical pharmacology and experimental medicine, innovative clinical trial design, project management and ethics in human research.
Riad Dirani, Ph.D., Vice President, Global Health Economics and Outcomes Research (GHEOR), Teva Pharmaceuticals
Riad Dirani, PhD, is currently the VP of Global Health Economic and Outcomes Research at Teva Pharmaceuticals. His responsibilities include overseeing the establishment of this function within Medical Affairs, and developing the strategic capabilities for HEOR to optimize the development and commercialization of Teva’s portfolio of products and offerings globally.Riad has worked in the pharmaceutical industry since 2000, including positions of increasing responsibility at Aventis, GlaxoSmithKline, Pfizer, and Johnson & Johnson in multiple therapeutic areas. Riad joined Teva in 2014 to build the HEOR group and establish it operating model. Riad received his Ph.D. in Health Services Research/Health Economics from The Pennsylvania State University. He has published over 25 journal articles and made numerous presentations to professional organizations, including the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and therapeutic-specific conferences.
Pam Duffy, IT Lead, Core Clinical Solutions & Services, Pfizer
Pam Duffy has 25 years of experience in IT enablement with the last 12 in the pharmaceutical industry. She is currently responsible for the IT strategy and enablement of Clinical Trial Solutions Information Management, Clinical Pharmacology and Clinical Statistics at Pfizer. Pam led the successful delivery of the Accenture Life Sciences Cloud within Pfizer to enable the aggregation, analytics and reporting of clinical data, both operational and patient data, across more than 40 sources and multiple CRO partners. Pam has a passion for redefining clinical trials to enable speed to market and is currently partnering across industry through the Accenture Life Sciences Consortium and the Alliance for Clinical Research to facilitate meaningful change in the clinical trial paradigm.
Chris Edwards, Chief Marketing Officer, Validic
Chris is the Chief Marketing Officer at Validic, the industry’s leading digital health platform. Chris leads the global strategy, marketing, and business development across Validic, which has a patient population reach of over 223 million across 47 countries. A frequent speaker for Validic, Chris has been running global marketing and strategy for healthcare technology B2B and B2C companies for over 20 years. Chris was recently awarded the Chief Marketing Officer Growth Award, among over 800 global CMOs, for demonstrating leadership in new strategies and programs resulting in significant company growth. Validic was named to Gartner's "Cool Vendors" list and received Frost & Sullivan's "Best Practices and Best Value in Healthcare Information Interoperability" and "Top 10 Healthcare Disruptor" awards. Chris has a passion to put the “health” back into “healthcare,” and can be followed on twitter @chrissedwards.
Rachel Edwards Ph.D, Executive Director, Global Clinical Program Management, Amgen
Rachel Edwards, BSc, PhD, with nearly 20 years of experience in Clinical Operations, is currently Executive Director for Global Clinical Program Management at Amgen, where she has worked for the last nine years. Rachel has previously worked in study management & medical affairs roles at AstraZeneca and Eli Lilly and before this studying for her PhD at Nottingham Medical School, UK. During her time at Amgen she previously managed study delivery within EU, Emerging Europe, Middle East Africa, Canada and the US and led the implementation of the FSP model for the sourcing of CRAs and CTAs across 11 CRO providers in 53 countries which has been continuously delivering both in terms of quality and performance. Rachel also lead the development and implementation of Amgen’s risk based centralized monitoring model. She can be reached at firstname.lastname@example.org.
G. Paul Evans, Ph.D., Corporate Vice President, Global Site Solutions, PAREXEL International
Paul Evans focuses on study strategy incorporating feasibility, site intelligence, patient recruitment and site alliances. He leads a global team of 160 experts to identify the right countries, sites and patients for clinical studies. Paul has more than 25 years of industry experience in global CROs and site management organizations, during which he has established successful trial execution strategies in Phase 1-4. He earned his PhD in Biomedical Engineering from the University of London.
Yechiel Engelhard, Senior Director, Patient Technologies, Teva Pharmaceuticals
Dr. Yechiel Engelhard was the founder and former CEO of Gecko Health Innovations, a Cambridge, MA, software and connected devices company which Teva Pharmaceuticals acquired in Summer 2015. The company develops mobile apps and sensors, based on behavioral incentive tools, to help patients take control of their COPD or asthma. The system is designed to support payers and providers with clinical and costs efficiencies. Gecko was named one of the best gadgets for asthmatic patients by Frost & Sullivan, TEDMED, and leading publications such as the Huffington Post, Wall Street Journal, Boston Business Journal, Wired, and the Boston Globe. After spending 16 years as a healthcare entrepreneur, a practicing physician, a researcher, and a medical officer in the Israeli Air Force Special Operations, Yechiel is now leading new technology products development at Teva Pharmaceuticals. He has co-founded and worked with several medical and healthcare IT companies in Israel and the US, and he is a frequent speaker at industry events about mobile and connected devices in healthcare. Yechiel spends time mentoring teams at MIT, Harvard, and other global healthcare accelerators. Yechiel received an MD and MHA from Ben-Gurion University in Israel and an MBA from MIT Sloan School of Management.
Liam Eves, Executive Vice President, Humatics, hVIVO
Liam Eves is Executive Vice President, Humatics at hVIVO (formerly Retroscreen Virology), a London-based specialty biopharma company focused on respiratory diseases. hVIVO’s clinical trials unit is discovering and developing its own drugs in respiratory medicine in addition to conducting clinical trials on behalf of key biopharma customers- a service they have been providing for over 25 years. As leader of ‘Humatics’, the group responsible for attracting and processing clinical trial patients and their data. Liam has pioneered his ground-breaking philosophy of taking volunteers and patients on a positive clinical trial journey. This approach has enabled his team to successfully recruit, screen and enrol over 1,353 clinical trial patients in under 5 years. He has also overseen the development of the recruitment brand ‘Flucamp’ which has registered over 260,000 individuals since its inception, with over 45,000 people passing through the Flucamp screening clinics, and has overseen the operational delivery of healthy patients with a “Recruit on Time” success rate of ~93% for more than 4 years. Prior to joining hVIVO in 2011, Liam primarily worked within the Pharma industry specialising in site management, across a range of therapeutic areas. Liam has a degree in Neuropsychology from University of Central Lancashire.
Jane Fang, M.D., Head, R&D Information and Analytics for Clinical Biologics, AstraZeneca/MedImmune
Jane is the head of MedImmune R&D IS for Clinical Biologics. She is a trained physician with Master’s degree in healthcare management and informatics. She has 20 years of broad professional experience, from medical practice and clinical research to eClinical strategy and information analytics in healthcare and biopharmaceutical industries. Jane has provided leadership roles in building eClinical ecosystems as well as capabilities to enable better clinical research and clinical trial delivery.
Louis Fiore, M.D., MPH, Executive Director, Department of Veterans Affairs, MAVERIC
Louis Fiore MD MPH is the Executive Director of the Massachusetts Veterans Epidemiology Research and Information Center at the VA Boston healthcare System. He has 25 years of experience in clinical research in the areas of clinical trials, biobanking, epidemiology and informatics. His current primary focus is on embedding clinical research into the clinical care ecosystem through both the Point of Care Clinical Trials Program and the Precision Oncology Program, both sponsored by the VA Office of Research and Development. He is a proponent of data sharing and strives to reduce silos that isolate researchers from each other and from the clinical care world that they ultimately serve.
Brigid Flanagan, Senior Director, Clinical Development, Frenova Renal Research
Brigid Flanagan, MS, RN, CCRC is a certified Clinical Research Coordinator who joined Fresenius Medical Care as the National Research Coordinator in 2003. In that role, Brigid oversaw the research approval process for clinical trials in all Fresenius facilities and developed SOPs to ensure compliance with ICH guidelines and the Code of Federal Regulations. Since 2010, Brigid has been a Director in the Clinical Studies Department and expanded the services offered by Fresenius Medical Care NA to include select CRO services to Sponsors conducting research in the nephrology arena. In 2015, the Clinical Studies Department was re-branded Frenova Renal Research, and Brigid is now Senior Director of Clinical Development. Brigid has a Master’s degree in Bioethics and serves on the ethics committee at ACRP.
Aaron Fleishman, Product Innovation and Engagement Strategist, Market Expansion and Product Innovation, BBK Worldwide
Aaron Fleishman leads BBK’s Product Innovation and Engagement Team and works directly with pharmaceutical sponsors, advocacy organizations and patient thought leaders to create award-winning, innovative strategies that generate awareness and engagement surrounding clinical research. A well-regarded speaker and forward-thinking strategist, Aaron has been recognized by PharmaVOICE (PharmaVOICE 100) and others for his commitment to patients, study engagement, social media and technology innovation.
Balazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Meyers Squibb
Balazs is a key R&D contributor to the company’s efforts to integrate analytics, strategy and insights capabilities to drive key decisions that generate greater outcomes for patients. His team provides predictive analytics, clinical trial feasibility and forecasting capabilities together with tracking, benchmarking and metrics generation for the R&D organization.
Graduated as a physician, explored medicine from the academic perspective before he joined BMS in 2005. Balazs held roles of different functions in R&D before taking over the leadership of the Clinical Trial Analytics group in the newly formed Business Insights and Analytics organization in February 2016. His main goal in this new integrated analytics organization is to establish common consciousness in R&D and to connect strategy and execution through data and insights.
Jeff Frazier, CEO, THREAD Research
Jeff Frazier is the CEO and founder of THREAD Research, a pioneering mHealth medical research company that has launched 3 of the first 8 apps that leveraged Apple’s ResearchKit. Most recently, THREAD Research partnered with Apple and Johns Hopkins University to launch EpiWatch®, the first mobile seizure tracker for patients with epilepsy with a synced Apple Watch® app. THREAD is also developing the first two Apple CareKit apps featured at Apple’s recent World Wide Developer Conference. Jeff’s aspirations in mobile research are lofty; he has challenged his team to collaborate with the world to answer every human biological question by 2030. Jeff and his team are hard at work developing the fastest technologies and methods possible in order to surface those human biological truths. Often, Jeff can be found ranting about the need for more collaboration in research, claiming, “This work is too important to humanity for us to not share what’s working with one another!”
Bruno Gagnon, Executive Consultant in Clinical Operations, Xenon Clinical Consulting, Inc.
Bruno Gagnon, B.Pharm, MSc. is co-author and the former Vice President of Clinical Operations at BioMarin. As a 25-year industry veteran, Bruno now spends most of his time as an Executive Consultant leading emerging life sciences companies and teaching at San Francisco State University in the Clinical Trial Design and Management Certificate Program.
Jamie L. Geier, Ph.D, Senior Director, Epidemiology, Pfizer, Inc.
Jamie Geier received her MPH and PhD in Epidemiology at Columbia University with a concentration in Psychiatric Epidemiology. Over the past 10 years at Pfizer, Jamie has been responsible for the Epidemiological Strategy of several products in Neuroscience and Inflammation.
Melinda Geurts, Vice President, Operations, DAC Patient Recruitment Services
Melynda is a veteran healthcare industry executive with more than 20 years of experience. As the Vice President of Operations for DAC, Melynda is responsible for the strategic growth of the organization and is integral to ensuring DAC remains a leader within the patient recruitment and retention niche. An in-demand speaker and presenter, Melynda is invited often to present and train worldwide at industry conferences and client events. She has contributed many articles to the patient recruitment industry body of knowledge and is extremely passionate when it comes to educating the public about participation in global clinical research opportunities. Melynda is a 2008 inductee into the PharmaVoice 100 Most Inspiring People in the Life-Sciences."
Jacqueline Gough, Advisor, Clinical Risk Management, Eli Lilly and Company
Jackie Gough is currently an Advisor in Clinical Risk Management at Eli Lilly and Company including responsibility for Risk Assessment as well as Risk-based Monitoring groups. Jackie spent the past three years with the RBM team, initially as a Central Monitor and then as the leader of the group. Jackie spent almost 20 years as a Statistician, followed by five years as a Data Scientist in the pharmaceutical industry. Her last 13 years have been with Eli Lilly and Company. Jackie leads the Central Monitoring subteam in the RBM workstream for TransCelerate and is the author of two papers on Central Monitoring with that group.
Christian Gossens, Ph.D., MBA, Global Head Early Development Workflows, Research & Early Development Informatics, F. Hoffmann-La Roche Ltd
Christian is leading an informatics team supporting the global early development function in Roche’s Research and Early Development (pRED) organization. A computational biochemist PhD and MBA by training, he started his career in a leading management consultancy before joining Roche as a director in the Emerging Technology team in the Group Research department - identifying strategic, game changing trends in the pharma information/informatics space and developing strategies to act on those.
Benjamin Greenberg, Senior Manager, Lead, Clinical Outsourcing & Operational Analysis, Curis
Benjamin Greenberg is currently the head of Clinical Outsourcing & Operational Analysis at Curis, Inc, bringing more than 12 years of experience in Clinical Outsourcing, Vendor Management, Relationship Management, Contracts Management/Negotiation, and Project Analytics. He has worked previously at Sunovion, where he was responsible for Strategic Sourcing & Analytics for two late stage PhII/III compounds, as well as, four early stage PhI/IIA compounds, all comprising of more than 30 different trials in Oncology, Neurology, and Pulmonary diseases. Ben has also worked at Shire, UMass Medical School (MassBiologics), and Beth Israel Deaconess Medical Center, giving him a broad range and understanding of drug development and the pharmaceutical industry. Ben earned a Business Leadership degree from Northeastern, with a focus in Biotechnology.
Thomas Haag, B.A. Hartwick College , Learning and Process Lead, Digital Development, Novartis Pharmaceuticals
Tom has been working at Novartis for 14 years in the areas of Clinical Data Management, Systems Validation, and Quality Assurance. He has spent the last 4 years focused on the adoption of eSource and Mobile Patient Data as part of the Novartis Digital Development group in order to modernize clinical trials. He is an experienced project manager and quality assurance engineer with a focus on Computerized System Validation and Data Integrity.
Lynne Hamm, Senior Director, Clinical & Medical Services, RTI Health Solutions
Lynne Hamm is Senior Director of Clinical and Medical Services at RTI HS. She has extensive experience in the pharmaceutical industry designing, implementing, and managing phase 2-4 clinical studies. Ms. Hamm has been involved with multiple clinical and observational studies in the United States, Canada, and Europe. Ms. Hamm also has interacted with key opinion leaders in various disciplines, presented at sponsor advisory boards, and has broad experience in operationalizing complex multicenter studies, in addition to possessing an in depth knowledge and oversight of clinical monitoring and safety reporting. While working in the pharmaceutical industry, Ms. Hamm has been involved in protocol design, study report writing, preparations for Food and Drug Administration (FDA) Advisory Committees, and New Drug Application (NDA) submissions.
Amir Handzel, Ph.D., Statistical Science Director Astrazeneca
Dr. Handzel is a Statistical Science Director at Astrazeneca, member of its Personalized Healthcare & Biomarkers Extended Leadership Team and member of the team leading multi-drug, multi-party clinical trials. He serves in additional roles, including Global Product Statistician for several drug development programs and ad hoc contributor to due diligence analysis for licensing. Previously, he was the head of the bioinformatics and biostatistics group at OSI Pharmaceuticals, a former subsidiary of Astellas Pharma, where he led the development of multivariate predictive biomarkers of drug efficacy for the oncology portfolio. He had also worked at Merck & Co. in the Biometrics Research department and at Beyond Genomics, a biotechnology start-up that specialized in broad profiling of high dimensional “omics” biomarkers. Dr. Handzel obtained his M.Sc. in Physics and Ph.D. in Applied Mathematics from the Weizmann Institute of Science and he conducted post-doctoral research at the Institute for Systems Research at the University of Maryland
Matt Hendricks, Partner, PHARMICA Consulting
Matt Hendricks is a Partner at PHARMICA Consulting. Matt has worked in life sciences for 20 years, splitting his time between IT / Informatics and R&D Portfolio planning. Matt specializes in collaboration, decision facilitation, and architecture with experience as varied as leading an internal usability service, to implementing sophisticated mathematical modeling for clinical trial patient recruitment, to building iOS games. Matt is six sigma certified and has his Masters of Science in Information Science from Penn State. He enjoys road biking and has a basement full of boardgames he has collected from around the world.
Jaime Houde, Manager, Clinical Trial Transparency, EMD Serono, Inc.
As Manager of Clinical Trial Transparency at EMD Serono, Inc., Jaime Houde leads the development and implementation process of Lay Patient Summaries, partnering with various Global Research & Development units and their leadership teams. Jaime’s held roles within increasing responsibility in Global Clinical Trial Management. Prior to joining EMD Serono, Inc., Jaime worked as a Clinical Trial Manager at Vertex Pharmaceuticals and held various positions within Clinical Operations at Millenium Pharmaceuticals, Inc.She earned her Bachelor of Science, Social Work from a CSWE accredit program and Bachelor of Science, Sociology from Castleton State University.
Michelle Hylan, Founder and CEO, Innov8tive Research; Clinical Operations Consultant, Rhythm Pharmaceuticals
Ms. Hylan is an internationally experienced clinical research professional with demonstrated success partnering with clients to optimize clinical program outcomes through systematic alignment of business strategy, processes and organizational composition. She is the founder and CEO of Innov8tive Research Consulting where she combines her 20 years in the clinical research industry with 16 years of management to identify gaps in a company's clinical operations and develops and implements plans for programs, teams, or individuals. Michelle has broad experience with leveraging the unique talents of diverse groups into high value, strategically focused teams. Michelle has worked with large, small and virtual companies in all phases of the development life cycle, with targeted activities in quality system development, training and mentoring, risk mitigation, and vendor oversight.
Michael Jay, Vice President, Society for Clinical Research Sites (SCRS)
Michael Jay is Vice President of Special Projects for SCRS. Prior to this position, he was the VP of Budgets & Contracts for RxTrials. Since 2001, Michael had successfully negotiated and executed hundreds of clinical trial contracts and is recognized in the industry for his comprehensive understanding of the financial aspects of conducting clinical trials. In that role, Michael also advised hospitals, private practices and research sites on financial and contractual operational activities. Michael is a frequent speaker at both the national and local clinical research conferences around the United States and Canada on the topic of clinical research budgeting and on all aspects of clinical trial management at the site level. He has spoken for organizations such as SCRS, FDA News, ACRP, DIA, and the Society of Research Administrators.
Daniel Joelsson, Director, Global Business Planning & Operations, MedImmune
Dan is currently Director in the R&D Strategy organization at MedImmune where he leads strategic planning and strategy execution for the Clinical organization. Prior to this position he spent 15 years in various roles in pharma R&D including leading laboratory teams and operational excellence efforts at Merck & Co.
Hassan Kadhim, Business Consultant, IT RDM, Boehringer Ingelheim
Hassan Kadhim is a pharmaceutical industry executive having spent the past 10 years in the industry. Hassan is currently employed with Boehringer-Ingelheim and has extensive experience in consulting with Drug Discovery Research and Clinical Ops teams. He has a degree in bioinformatics and a graduate degree in pharmaceutical sciences, both from the University of Montreal in Canada, and is passionate about transforming the clinical research / clinical operations arena to improve their processes through the use of technologies and benefit patients with more patient-centric protocols.
Francis Kalush, Ph.D., Health Programs Coordinator, Professional Affairs and Stakeholder Engagement (PASE), CDER, FDA
Dr. Francis Kalush is the Health Programs Coordinator in the Professional Affairs and Stakeholder Engagement (PASE) at the Office of the Center Director, Center for Drug Evaluation and Research (CDER )at the Food and Drug Administration(FDA). She. provides a focal point for advocacy, to enhance two-way communication and collaboration with healthcare professionals, patients, patient groups, and others on CDER issues concerning drug development, drug review, and drug safety. Dr. Kalush provides leadership and strategic planning direction for educating, developing, communicating, implementing, and assessing an advocacy and stakeholder relations strategy for CDER. She is CDER’s Network of Experts Coordinator. Before joining CDER, Dr. Kalush was a Senior Science Health Advisor at the Office Center Director at the Center for Devices and Radiological Health (CDRH) at FDA. She directed and managed center wide initiatives, led the development of a FDA National Medical Device Curriculum Program, enhanced communication and transparency by leading outreaching activities to patient advocates consumers and professional associations. As the Diagnostics and Personalized Medicine Network Leader at CDRH, she planned, managed and coordinated the activities for the Network, encompassing premarket, post market, compliance, science, personalized medicine collaborations and communications to enhance safety of medical devices within the total product life cycle. Since 2008 she is the Healthy People 2020 Medical Product Safety Interagency Workgroup Coordinator. Dr. Kalush was the representative to the Global Harmonization Task Force (GHTF) In Vitro Diagnostics working group. Playing an important role in the international regulatory arena, she assessed COFEPRIS, Ministry of Health, Mexico on setting up their new regulatory reform for medical devices and over the counter medicines. Francis was essential on setting up Pharmacogenomics guidances and roundtable meetings with industry organizations and FDA to address the regulatory, scientific and co-development concerns of drug-diagnostics targeted therapies in Personalized Medicine. Before Joining FDA, Dr. Kalush was the Director, Pharmacogenomics at Celera Genomics. She was responsible for the development of Celera SNP Databases, online support for Applera Projects. Oversaw input from academic and commercial markets and public health programs for the development of Pharmacogenomics, Toxicogenomics and Genetics products. She is the author of multiple publications including “The Sequence of the Human Genome “and she is a well-known international speaker. Dr. Kalush holds a Ph.D in Chemical Immunology from the Weizmann Institute of Science, MSc. in Human Microbiology from Sackler Schoold of Medicine, Tel Aviv University and BSc. in Chemistry and Biology from the Hebrew University, Jerusalem.
Matt Kibby, MBA, President and Chief Innovation Officer, BBK Worldwide
Matt Kibby leads BBK's technology and innovation group, integrating the company's experience with its ever-evolving recruitment data systems to produce effective forecasting, assessment and tracking of results and improve the clinical research experience for patients around the world. He oversees the ongoing development of TrialCentralNetSM, and the company's suite of patient and site engagement solutions. Matt was recognized by PharmaVOICE as one of the 100 most inspiring people in the life sciences industry.
Kenneth Koury, Ph.D., Executive Director, Clinical Biostatistics, Merck Research Laboratories
Ken Koury is Executive Director, Biostatistics at Merck Research Laboratories, and Franchise Lead within Late Development Statistics for Infectious Diseases. His group is responsible for the design, analysis, interpretation, and reporting of clinical studies for investigational and marketed products in the Infectious Diseases therapeutic area, including HCV and HIV products, as well as anti-bacterial, anti-fungal and other novel infectious diseases products.Ken has served as Co-chair of the FDA/Industry/Academia Safety Graphics Working Group, on PhRMA’s Biostatistics and Data Management Technical Group, as Program Chair and Chair of the ASA Biopharmaceutical Section, and on the Steering Committee for several FDA/Industry Workshops.
Jim Kremidas, Executive Director, Association of Clinical Research Professionals
Jim Kremidas is currently the Executive Director for ACRP, a not-for profit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two different large CROs for over 6 years where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers including CRO’s, scientific staffing firms and Patient Recruitment Suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as, implement standardized processes for the development and implementation of marketing materials. He is on the advisory board of CISCRP (a non-profit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the NIH. He is a frequent presenter at Industry Conferences and his articles/papers have been published in a wide variety of trade journals.
Sheri Kuss, Associate Director, Clinical Process Development, Teva Pharmaceuticals
Ms. Sheri Kuss has over 20 years of clinical research experience in the industry working at pharmaceutical, medical device, CRO and biotechnology companies. Sheri's vast range of expertise has developed from her roles within clinical trial monitoring, clinical trial management and operations, clinical quality assurance and compliance, training and continuous improvement. Sheri has a proven track record of establishing and delivering inspection readiness and regulatory compliance training tools and programs as a direct result of her experiences hosting and preparing for more than 15 pre-approval regulatory agency inspections. In the area of operational excellence, she demonstrated success in leading business process teams and improving upon existing quality management systems through continuous improvement initiatives. Sheri's Sponsor and CRO experiences give her a unique quality insight and a practical approach to the risks and operational compliance issues related to the conduct of clinical trials and quality management systems.
Megan Laker, CoLAB Consultant, CDIO, Eli Lilly and Company
With her strong vision that partnering with Sites and Patients will transform the study experience, Megan Laker is leading the CoLAB initiative at Eli Lilly & Co. For the past three years, she has been working in CoLAB helping study teams incorporate the site and patient perspective into the development of Lilly clinical research studies. This work spans across protocols from Phase 1 to 4, as well as all therapeutic areas of interest for Lilly, and includes regional perspectives from around the globe. In Megan’s 16 years at Lilly, she has held various roles in Bioproduct Research & Development, Clinical Project Management, and Clinical Development Information and Optimization.
David Leventhal, Director, Clinical Innovation, Worldwide R&D, Pfizer, Inc.
As a member of the Clinical Innovation team David is committed to defining the desired future of clinical trials for Pfizer, Inc. and our stakeholders, by working across Business and Research Units to ensure that the investments and initiatives to achieve that future are fully realized. David's current role at Pfizer, Inc. is to influence the Drug Development landscape and incubate innovation opportunities in Research and Development. In particular, he is focused on the use of healthcare data and technologies that offer novel approaches to Clinical Trial design, recruitment, and execution.
Bennett Levitan, M.D., Senior Director, Benefit-Risk Assessment, Janssen Research & Development
Dr. Levitan introduced state-of-the-art patient-focused benefit-risk assessment to Janssen and has led numerous teams in preparation of benefit-risk assessments for regulatory submissions and health authority advisory meetings. He has co-led cross-disciplinary teams to implement processes to support growing regulatory requirements for development and post-approval benefit-risk assessment. Dr. Levitan has published widely on both theoretical and pragmatic aspects of patient-focused benefit-risk and is a frequent speaker on the topic. He co-led development of the PhRMA Benefit Risk Action Team (BRAT) Framework for drug benefit-risk assessment. He serves on several PhRMA committees that influence policy in this field and on numerous international groups that focus on benefit-risk methods and policy including the ISPE Benefit Risk Assessment, Communication and Evaluation (BRACE) team and the DIA Benefit-Risk Group, and he is on the steering committee for the Medical Device Innovation Consortium (MDIC) Patient-Centered Benefit-Risk Project. He received his BSc in electrical engineering from Columbia University in New York and his MD-PhD in bioengineering from the University of Pennsylvania.
Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer Inc.
Craig 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.
Elizabeth MacLean, PharmD, Ph.D., Director, Regional Outcomes Research , Oncology, U.S., Pfizer Global Health & Value Outcomes and Evidence
As Director, Regional Outcomes Research, Elizabeth MacLean, PharmD, PhD is a member of Pfizer Global Health & Value / Outcomes & Evidence group. In this role, Dr. MacLean works with U.S. based payers, specialty pharmacies and other large organizations to provide clinical and health outcomes information regarding Pfizer’s oncology portfolio. In this role, MacLean also leads development of non-interventional studies to address questions related to “real world” experience in Pfizer oncology disease areas and/or use of Pfizer oncology compounds. Additional responsibilities include generation of deliverables to support formulary review of Pfizer oncology compounds such as AMCP dossiers and budget impact models as well as healthcare economic information that meets the FDAMA 114 standard of competent and reliable evidence.Prior to joining Outcomes & Evidence and supporting Pfizer Oncology in the U.S. in 2011, MacLean was a Medical Outcomes Specialist with Pfizer in Boston, MA. In this role, she collaborated with the healthcare community (payers, medical groups, health systems, employers) regarding the design, implementation and evaluation of quality improvement initiatives and outcomes assessment. Related responsibilities included education of the healthcare community regarding the role of observational research and use of this real world data to inform decision making. This role with Pfizer also involved educating clinicians and healthcare decision makers regarding clinical and pharmacoeconomic data related to Pfizer primary care products and related disease states.MacLean joined Pfizer in June 2001 from the Memorial Hospital of Rhode Island where she served as Clinical Coordinator of Pharmacy Services and managed the clinical practice of pharmacists and related patient care delivery in acute medical-surgical care, obstetrics, and oncology. MacLean has several publications in peer reviewed journals and has presented numerous posters at scientific congresses. Dr. MacLean earned her undergraduate degree in pharmacy from Northeastern University and Doctor of Pharmacy degree and PhD in Pharmaceutical Sciences with specialization in Pharmacoepidemiology from the University of Rhode Island.
Beth Mahon, Associate Director, Global Clinical Operations - US, Janssen Research and Development
As Associate Director within Global Clinical Operations at Janssen Research & Development, Beth and her team of US Trial Managers and Site Managers are responsible for protocol feasibility, site selection, study conduct, and monitoring of Phase II/III oncology trials. Beth has over 15 years of clinical operations experience and has been with Janssen since 2007. Beth earned her JD from Seton Hall University School of Law with a concentration in Intellectual Property and is admitted to the Bar in New York and New Jersey. She holds a BS in Biomaterials from the University of North Carolina at Chapel Hill.
Marina Malikova, Ph.D., Executive Director, Surgical Translational Research: Operations and Compliance, Surgery, Boston University Medical Center
Dr. Malikova has eleven years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Vascular Surgery, Neurosurgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova has a PhD in Biochemistry and a Master’s degree in Clinical Investigation and Project Management Certification from Boston University. In her current role as Executive Director, Dr. Malikova manages research efforts in 11 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, compliance and risk management, financial management, quality assurance, strategic planning, and macro-management of research programs. She provides assistance to investigators with protocol and informed consent writing, regulatory submissions, clinical trial agreements and budget development.
Mark Mann, Head, Clinical Outsourcing and Contracts, Upsher-Smith Laboratories
Mark Mann is the Clinical Outsourcing and Contracts head at Upsher-Smith Laboratories, a mid-size pharma company located in Minneapolis, MN. Mark has 31 years in the pharmaceutical industry, holding a variety of positions in Clinical Development. He began his tenue at Upsher-Smith 8 years ago in Clinical Operations developing and implementing the processes and infrastructure necessary for Clinical Development to transition from ANDA drug development to NDA drug development. His responsibilities evolved to focus more on the outsourcing strategy, contract and vendor management functions for both the ANDA and NDA sides of the business. He is now in the process of expanding the best practices that have been developed for clinical to the other functional areas within R&D so that Upsher-Smith can harmonize its approaches to outsourcing and vendor management.
Edward Mannello, Feasibility & Recruitment Director, Clinical Operations, AstraZeneca
Mr. Mannello has over 20 years of experience in the pharmaceutical industry with the majority of them focused on patient recruitment and leading teams for the successful delivery of clinical trials. As the Feasibility & Recruitment Director within AstraZeneca, Ed is responsible for leading the development, execution and measurement of both strategic and tactical feasibility and patient recruitment efforts. Prior to joining AstraZeneca in 2006, Ed was part of Covance’s Clinical Development group in the Philadelphia, PA area and Princeton, NJ. He graduated magna cum laude from the University of Pittsburgh with a Bachelor of Science degree in Pharmacy and he earned a Masters of Business Administration focused on Pharmaceutical Marketing from Saint Joseph’s University.
William Martin, Ph.D., Senior Director, Clinical Development, Alkermes
Bill Martin is Senior Director, Clinical Development at Alkermes where is he responsible for the delivery of multiple late-stage CNS programs. Over the past two decades, Bill has worked in a variety of roles including clinical research coordinator, monitor, sub-investigator and clinical development team lead. All throughout Bill has maintained a passion for deploying innovative techniques to enhance patient enrollment.
Jerry Matczak, Consultant, Clinical Innovation, Eli Lilly and Company
I'm a member of Lilly's Clinical Innovation group, focused on bringing clinical trials as on option for people who may benefit from them in the digital age. Engaging with patients and other stakeholders to improve our ability to develop new, valued treatments for disease. Jerry Matczak is the Community Manager for the Lilly Clinical Innovation Team, focused on bringing together people and ideas to improve clinical trials. He has a BA in English & Philosophy fromAllegheny College and a MS degree in Information Science from the University of Pittsburgh. His IT experience at Eli Lilly combined with a variety of sales, marketing and technology roles in startup and consulting environments provide a diverse set of experiences that help him join people & technology. In his current role, he manages the Clinical Innovation Twitter (@Lilly_COI ) and blog (www.lillycoi.com) social media. Jerry is equal part translator, sense-maker, community-builder and networker, with a common-sense understanding of technology and people.
Richard Mayewski, Associate Director, Clinical Trial Intelligence, Global Clinical Trial Leadership, Novartis
Rich Mayewski is a Clinical Trial Intelligence manager within Novartis. He has been there since December 2012. Rich joined the pharma industry in November of 1999 and has been exposed to multiple therapeutic areas while serving as a CRA, informatics/analytics, site feasibility, study feasibility, and patient recruitment and retention. He currently holds a bachelors of science in Kinesiology from Penn State and will be pursuing his masters in the Fall.
Karen McCarthy Schau, Principal Consultant, Clinical Optimization Practice, Paragon Solutions
Karen McCarthy Schau has over 15 years of experience working for CROs as a data manger, monitor, trial manager, and director of clinical operations. During this time, she helped implement numerous new technology and process solutions. For the past two years, she has worked at Paragon Solutions helping clients improve their operations by implementing new solutions.
Kelly McKee, Advisor, Clinical Innovation, Eli Lilly and Co.
Kelly McKee is a patient recruitment and retention subject matter expert responsible for the design and successful deployment of innovative strategies and tactics world-wide. She currently serves as an Advisor in the Clinical Innovation group at Lilly, with previous positions at Merck and sanofi-aventis and is a member of the CTTI patient recruitment project team. She has an in-depth understanding and application of novel tactics and technology in protocol feasibility, site selection and patient recruitment and was named PharmaTimes US Clinical Researcher of the Year in 2012 in the clinical research team category.
Jason Methia, Vice President, Vault Study Startup, Veeva
Jason leads the Vault Study Startup initiative for Veeva, overseeing the product vision, implementation, and marketing. Prior to joining Veeva in 2013, Jason held a variety of roles within clinical development operations at the Dana Farber Cancer Institute, Wyeth Research, and Vertex Pharmaceuticals. Jason has created strategies and solutions in business areas across clinical development including trial master file management, inspection readiness, and study startup.
Matt Miller, Vice President, Global Patient Recruitment & Feasibility, StudyKIK
Matt Miller is the VP of Global Patient Recruitment & Feasibility at StudyKIK, a website that builds social media patient communities and links them to clinical trials at reseach sites around the world. Matt has managed many digital lead generation camapigns ourside the pharmaceutical industry as well as worked for a Mid Sized CRO and managed many patient recruitment campaigns for early and late phase development. He has more than 6 years’ experience with developing, creating, and implementing digital and social campaigns designed for lead generation and conversion. He has designed more than 300 patient recruitment campaigns for early and late phase clinical trials using digital and social media.
Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono, Inc.
Paulo Moreira, Vice President, Global Clinical Operations – External Innovation at EMD Serono, Inc., has 24 years of experience in clinical research. He has been with EMD Serono for the last 16 years in positions of increasing responsibility within Clinical Development & Operations. Paulo is also a Visiting Scholar at Boston College where he teaches for the Pathways in Clinical Research Program. He is very active in several industry-wide organizations and serves on the Steering Committee of the Clinical Trial Transformation Initiative (CTTI), in addition to his role on TransCelerate’s Oversight Committee, representing EMD Serono.
Rick Morrison, CEO, Comprehend
Rick is responsible for the overall direction and management of Comprehend Systems.Prior to Comprehend Systems, Rick spent nearly a decade developing clinical analytics tools, including tools used by the FDA and top pharmaceutical companies, at companies including Integrated Clinical Systems, where he led the design and implementation of several major new features. Rick holds a bachelor’s degree in Computer Science from Carnegie Mellon University in Pittsburgh, Pennsylvania.
Mary Murray, Associate Director, Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb
As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary Murray develops initiatives through collaboration with Advocacy groups, community organizations and internal functions to help engage patients in our clinical research. With a background in training development, Mary joined Bristol-Myers Squibb’s R&D training organization in 2009. Before joining BMS, Mary was the principal in a consulting firm, servicing Fortune 500 companies and small businesses on a range of intercultural approaches to reach diverse audiences. Mary has published in trade journals and presented at pharmaceutical industry conferences on the topic of establishing cultural competence in multinational clinical trials and global drug development. Mary completed her undergraduate studies in Russian at Bryn Mawr College, and received a graduate degree in international management from Thunderbird School of Global Management.
Nariman Nasser, Digital Strategist, Genentech
Nariman Nasser is a Digital Strategist at Genentech. She previously was the Senior Director of Participant Recruitment at the University of California, San Francisco’s Clinical & Translational Science Institute. This campus-wide service assists researchers in recruiting study participants while improving communication and outreach about clinical research opportunities to the general public. Previously at the Immune Tolerance Network she was responsible for the development and implementation of clinical trials that define new tolerance biomarkers. Ms. Nasser’s previous experience also includes molecular immunology and stem cell biology bench research as well as industry-sponsored clinical research project and portfolio management, marketing, and technology.
Virginia Nido, Global Head, Industry Collaborations, Genentech, Roche Group
Virginia Nido is the Global Head of Industry Collaborations Management for Roche Product Development. In this role, Virginia is accountable for strategic oversight of industry collaboration initiatives. Virginia serves on the Oversight Committee of TransCelerate Biopharma and the Executive and Steering Committees for Clinical Trials Transformation Initiative. Prior to joining Roche in 2002, Virginia was Head of West Coast Data Management for Quintiles. Virginia sits on the board of the Women's Cancer Resource Center in Oakland, CA. Virginia has a Bachelors degree from Barnard College and a Master of Science degree from the University of Pennsylvania.
Christine Pierre, Founder and President, Society for Clinical Research Sites (SCRS)
Christine Pierre is the 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 is also the Founder of RxTrials, a network of investigator sites. 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) and is on the Board of Advisors for both the Center for Information & Study on Clinical Research (CISCRP) and Hands Across the Americas. In 2016 PharmaVOICE honored Christine with the Red Jacket Award 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.
JoAnn Pfeiffer, Ph.D., Associate Director, Clinical Research Management, Arizona State University
JoAnn Pfeiffer is currently the Associate Director, Clinical Research Management Graduate Program at Arizona State University. She completed her Doctorate of Regulatory Science at the University of Southern California where she conducted a research survey of U.S. Principal Investigators and their role in the management of clinical trial agreements. The results of her study have been published in professional journals and presented at scientific meetings. She holds Masters’ Degrees in Regulatory Science and Public Health. Her clinical research experience includes managing clinical trial operations, contract negotiations and management, budget development and management, site audits, IND research, regulatory compliance, IRB submissions, GCPs, regulatory reporting, protocol and consent development, staff development and management. She is certified by the Regulatory Affairs Professional Society and the Association of Clinical Research Professionals.
Audrey Plough, RN, MS, CCRC Executive Director, Operations, Immune Tolerance Network, UCSF
Audrey Plough, RN, MS, CCRC currently serves as the Executive Director of Operations for the Immune Tolerance Network. She possesses over 20 years’ experience in healthcare and clinical research environments, including critical and acute care nursing, clinical research coordination, and clinical research operations in academic, community, and industry settings. Her clinical research experience encompasses over 12 different therapeutic areas and the management of more than 40 clinical trials (preclinical to phase IV) covering all phases of the clinical research project lifecycle. Her experience imparts a unique understanding of the operational challenges required to efficiently and effectively conduct multi-centered clinical trials at leading academic institutions in the U.S. and internationally. This includes the development and utilization of various systems to support clinical trial management, biobanking, data management and reporting.
Rich Polgar, Director, Global Procurement, Bristol-Myers Squibb, Co.
Rich works for BMS as global category strategist for R&D’s Business Partnering and Strategy division in Global Procurement in Princeton, NJ office. In this position, Rich leads a global team that evaluates capabilities of services providers to promote synergies and value enhancement across the company. His team sets category strategies, negotiates MSAs, develops sourcing tools and enhances strategic vendor relationships by driving innovation internally and externally within the clinical trial space. Rich has set strategy for CROs, Clinical Labs, Core technology and optimized logistics globally. Prior to joining BMS 7 years ago, Rich worked at Schering-Plough (now part of Merck) for 6 years and with two CROs. Rich received his Masters of Science in Neuroscience from Syracuse University and has been involved in drug development and testing for the last 16 years.
Mark A. Price, MA, Med, Senior Director, Surveys and Observational Studies
Mark Price is a Senior Director of Surveys and Observational Studies where he works on both qualitative and quantitative tasks associated with prospective observational and survey studies. Mr. Price has designed, led, or supported numerous burden-of-illness studies centered on collecting patient-reported outcomes, functional assessment, and medical record data to support the development of economic models, outcomes research, and market access initiatives for industry clients. These studies have entailed leadership and coordination with multidisciplinary teams of key opinion leaders, health economists, epidemiologists, patient-reported outcomes experts, clinical research associates, survey development experts, and biostatisticians. Mr. Price has more than 15 years of experience in the design, collection, analysis, interpretation, and reporting of health data.
Debbie Profit, Ph.D., Director, Corporate Projects, Otsuka Pharmaceuticals Development and Commercialization
Deborah Profit has worked in pharmaceutical research and development for over two decades and is currently the Leader, Otsuka Information Technology (OIT) at Otsuka Pharmaceuticals. In this role, Dr. Profit is responsible for both the commercial and the research and development IT arms of the Otsuka organization. Dr. Profit has been employed by Otsuka for fifteen years and is responsible for facilitating creative solutions across clinical development and commercial teams, coordinating engagements with external innovation companies/consultancies, promoting and further strengthen relationships with health care providers and clinical investigators, and actively lead cross-functional pilots and prototypes. She also plays a key role in transitioning pilots and prototypes to full-scale projects to leverage solutions that complement the business portfolio to include digital medicine, digital health and big data platforms. Preceding 2001, Dr. Profit was the Director, Project Management at a top tier global Clinical Research Organization. In advance of joining industry, she worked in the community mental health setting as the Director of Research supporting the administration of clinical drug studies, and federal and state grants, in accordance with various regulatory agency requirements.
Marisa Rackley, Director, Clinical Research, Global Trial Optimization, Merck
Marisa joined Merck in January 2001 and has held positions of increasing responsibility within both the Clinical Research Operations and Clinical Sciences organizations. She supported a number of late stage development programs in the Bone, Endocrine, Diabetes, Cardiovascular, and Oncology therapeutic areas. She served as the operational program lead for Fosamax, Januvia, and Odanacatib. During her time in operations she was appointed lead change agent for the Global Clinical Development Organization. In 2008, Marisa joined the Global Trial Coordination group as therapeutic area lead for BRIE (Bone, Respiratory, Immunology, Endocrine). In 2010, Marisa shifted into the Clinical Scientist Organization to take an assignment as a project manager tasked with coordinating the department’s Merck / Schering Plough integration. Marisa then moved into the Cardiovascular clinical group where she was the lead CS on REVEAL which is a 30K patient study in collaboration with Oxford. In late 2013, Marisa assumed responsibility for co-leading the design team for the CDEO organization and worked as a member of the implementation core team. Prior to Merck, Marisa was employed at Theradex, a global oncology CRO, and Blue Cross Blue Shield insurance company. Marisa graduated with a B.S. from the University of Scranton and holds a Master’s Degree in Healthcare Administration from Seton Hall University. In her personal time, she volunteers as Board of Trustee member and Treasurer for a non profit organization.
Ratan Ratnesh, Director and Head, Clinical Outsourcing, Otsuka
Ratan Ratnesh is a director and head of clinical outsourcing at Otsuka. Prior to joining Otsuka, Ratan worked at Wyeth and Novartis where he managed different categories related to clinical outsourcing. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply chain across different industries and moved to clinical outsourcing in early 2000. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana.
Scott Rauscher, Associate Director, Global Procurement R&D, Bristol-Myers Squibb
Scott has a bachelor’s degree in Civil Engineering and a Masters degree in Finance. He has spent the past 17 years in the in the pharmaceutical industry working in both clinical operations and outsourcing. Prior to joining BMS in 2014, Scott ran a small CRO that provided operational support to the Biotech industry. In his current role at BMS, Scott is the category lead for CRO services from phase 2b-phase IV as well as HEOR and patient recruitment vendors.
John Reites, Head, Digital Health Acceleration, Quintiles
From entry level to executive leader, John’s career includes 14 years as an intrapreneur at Quintiles, the global leader for healthcare research and commercialization. He has led two internal startups from formation thru product development to global growth and execution scale. John is currently leading a third startup focused on Digital Health Acceleration. Named one of the Top 100 Influencers in Digital Health, he provides expertise and execution experience in digital health strategy, virtual clinical research, Phase I - IV clinical research, patient reported outcomes, Apple ResearchKit/CareKit, mobile health, omni-channel experience and virtual reality. His experience spans more than 150 clinical research programs in 52 countries supporting the majority of top biopharmaceutical companies and providers. John is also a keynote speaker and published author featured in various conferences, journals, articles and media outlets.
Todd Reul, Associate Director, Global Strategic Sourcing, BioMarin
Todd has over twenty three years of experience in the pharmaceutical industry including seventeen years in clinical research. During this time he successfully held positions in scientific research, clinical development, operations and management within the industry. This experience includes positions within sponsor and service provider companies resulting in a well-rounded perspective and understanding of drug development and sponsor/service provider relationships. On the personal side, Todd grew up in upstate New York and earned a BS in Chemistry from the University of New Hampshire. After a few years working on the East Coast, he moved out west and has been living/working in the Bay Area Biotech industry ever since. Currently, Todd lives in beautiful Sonoma County with his wife and dogs
Jonathan Reuter, Associate Director Global Procurement R&D, Clinical Labs, Bristol Meyers-Squibb
Jonathan is the Associate Director of R&D Global Procurement responsible for Clinical Laboratory services at Bristol-Myers Squibb including Central and Specialty Laboratories, Biorepository and Tissue Procurement. He previously supported Vendor Strategy & Management at Schering Plough and Merck, before joining BMS in 2010, to support the Central Lab space. In 2011, he took on the additional responsibility of Specialty Labs and partnered with BMS scientific teams to put in place robust biomarker category strategies throughout each technology area. In 2011 and 2014, respectively, he added the additional responsibilities in Biorepository and Tissue Procurement, and has recently put in place a category strategy that will integrate these two book-ends of R&D to put forth an integrated category strategy to enable and enhance Translational R&D in all phases at BMS. Jonathan earned his BS in Business and Finance from Monmouth University.
John Rodermund, Global Head of Clinical Research Data Management and Centralized Monitoring, AstraZeneca
John is currently the Global Head of Clinical Research Data Management and Centralized Monitoring for AstraZeneca, with Data Managers in China, Sweden, Poland, Canada, the US, the UK and India, and has a wealth of experience spanning 25+ years within Clinical Research, including Sr. Leadership Positions in Statistical Programming, IT, and Product Development. John has a Master of Science in Public Health in Epidemiology and Biostatistics, and a Masters of Sciences in Information Systems.
Andrew Roddam, VP & Head Real World Evidence and Epidemiology, R&D Projects, Clinical Platforms & Sciences GSK
Andrew is currently Vice President and Head of Real World Evidence at GSK and is a renowned expert in epidemiological research with specific interest in the utilisation of routine data for research purposes. He acts as an advisor to a number of projects surrounding the development and use of electronic health data and serves on a number of advisory and grant boards as well as serving on the HL7 advisory council. Andrew obtained his DPhil in Statistics at the University of Oxford working with Sir David Cox, where he also completed a post-doc in Infectious Disease Epidemiology. He was a Senior Researcher at the Cancer Research UK Cancer Epidemiology Unit at the University of Oxford before taking up an appointment at Amgen where he was most recently Regional Head (EU, EEMEA) in the Center for Observational Research.
Stewart Rosen, M.D., Vice President of Medical Affairs, Quintiles Health Management Solutions, Quintiles
As Vice President of Medical Affairs, Health Management Solutions, Dr. Rosen focuses on developing strategic alternatives to traditional commercial models. This encompasses medical educational models to aid patient health management through the management, training and deployment of Medical Science Liaisons, Clinical Educators, and Clinical Trial Educators. These teams help prescribers and practice sites to facilitate diagnoses, improve treatment regimens, support clinical research implementation, enhance patient adherence and improve outcomes. Dr Rosen is also a member of Quintiles Global Regulatory Affairs Network (GRAN) and Counsel on Research Ethics (CORE), providing support and review of policies as it relates to corporate compliance and ethics. Dr. Rosen earned his medical degree from the Universidad Autonoma de Guadalajara, Mexico and completed his clerkship at Jamaica Hospital in Queens, New York. He regularly presents at national industry meetings and lectures and is a member of the Medical Science Liaison Society.
Julie Ross, President, Advanced Clinical
Julie Ross is President at Advanced Clinical, a full service, global outsourcing solutions provider of CRO, Staffing, FSP and Consulting Services. She is a tenured executive leader who has been instrumental in leading the growth, profitability and overall success of multiple companies. Ms. Ross has over 30+ years of clinical research experience, has participated in fund-raising, mergers, and acquisitions, authored many clinical research articles, and is a well-known industry speaker. She is a change management expert who has successfully led multiple company integrations, implemented a variety of cutting edge technologies and platforms, currently services as a Director at Large on the Board of HBA, and served 6 years as Board President for a non-profit community group where she navigated a headquarter change twice and raised money through angel investors. Personally, Julie is a wife, a mom to four grown children, and practices servant leadership. She is a graduate of the University of Wisconsin, La Crosse with a bachelor's degree in Nuclear Medicine Technology.
Jonathan Rowe Ph.D., MS, MA, Executive Director, Head of Quality Performance and Risk Management, Clinical Development Quality, Clinical Sciences & Operations, Pfizer
Since 1996, Jonathan Rowe has been working within and supporting large and small pharmaceutical companies to develop medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles of increasing responsibility including Clinical Director, Cardiovascular Risk Factors Group with responsibility for the phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director Pharmaceutical Sciences Process and Performance. Jonathan spent a number of years in supporting the growth of small pharmaceutical companies. From 2009-2014 he was the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences, and was a member of the team that managed the Phase III clinical program and eventual approval of Vascepa. Jonathan earned his PhD and MS from the Department of Biochemistry at the Albert Einstein College of Medicine and his MA in reproductive endocrinology from the State University of New York at Binghamton. He has authored articles in peer-reviewed journals across the basic and clinical sciences, is an inventor on a number of patents and has served as a consultant on the topics of Innovation and Strategy Implementation.
Janelle Sabo, Pharm.D., MBA, Sr. Group Director, Product Delivery, Medicines Development Unit, Eli Lilly and Company
Janelle Sabo, PharmD, is an award-winning drug development expert specializing in global bench-to-patient management processes. After graduating from the University of Missouri-Kansas City (UMKC), Dr. Sabo began her career at Eli Lilly and Company. Her leadership in managing Cialis led to promotion as that groups Chief Operating Officer. She then served in leadership roles in Early and Late Phase R&D Development and Portfolio Management, including establishing operating systems such as critical chain project management, leading to significant cost and time savings. She is currently Senior Group Director, Product Delivery, responsible for clinical trial drug product manufacturing, clinical trial material and CMC project leadership for the worldwide Lilly Development portfolio. In this role, Dr. Sabo has led the group to achieve industry leading delivery of CT material, including a significant focus on patient centered design.
David Sall, President & CEO, Patient Enrollment Advisors
David Sall is a marketing and engagement specialist with a focus on the healthcare industry. He was graduated with honors from The George Washington University with a Bachelor of Arts in Communications and a concentration in Business Marketing.
David started his career in national broadcasting sales by representing hundreds of the nation’s top radio properties. As the media industry hit the technology revolution, David continued his career by building and managing the New York office of Hiwire, one of the original pioneers in digital streaming technology. With the opportunity to bring this knowledge to the traditional media space, David joined CBS Broadcasting’s management team and handled the flagship terrestrial radio news properties as well as the many digital assets of the Tiffany network.
David is now the CEO and President of Patient Enrollment Advisors, which focuses on the recruitment and retention of qualified participants in medical clinical trials. This venture was born out of a clear need for the industry to approach the business of clinical trials with a unique set of eyes.
“Our company takes a patient-focused strategy to help the healthcare industry quickly and safely bring products to market for those in need. Patient Enrollment Advisors not only finds qualified patients, but we also listen to them.” This humanistic approach makes the clinical trial process a better experience than ever before - for everyone involved - which ultimately helps pharmaceutical companies meet their research goals. Patient Enrollment Advisors reaches qualified trial candidates, retains them, and ensures they fulfill all requirements to bring a clinical trial to a successful, complete end.
David is very excited to be a partner with SCOPE for the Participant Engagement Awards, and especially excited to highlight the innovation of engagement with study participants. He lives and works in New York City with his wife and two children.
Shruthi Sampath, Biomarker Operations Program Leader, Genentech
Shruthi is highly experienced in Personalized Healthcare Technologies. Shruthi works as a Program Leader at Genentech, spearheading the execution of biomarker and companion diagnostics strategies for multiple drug molecules in late stage oncology product development (PDL1, Her2). She has successfully implemented several best practices to improve process and workflow. She's played key roles in clinical trial management, investigative toxicology and early drug development at Novartis, Schering-Plough, Johnson & Johnson and Astrazeneca. She managed biomarker projects in multiple clinical trials for cardiovascular programs. She led projects to develop in-vitro tissue, explant and cell culture models to assess the safety of new compounds, and assess new targets for various indications impacting programs in the drug development pipeline. Shruthi loves the outdoors; she is an advanced scuba diver; part of a whaleboat rowing team and loves to spend time hiking and biking.
Fabian Sandoval, M.D., CEO & Medical Director, Emerson Clinical Research Institute (ECRI)
Dr. Fabian Sandoval, CEO & Medical Director, has over 18 years of bench to bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount University, and his Doctorate of Medicine from the Autonomous University of Guadalajara, School of Medicine. Before opening the doors to Emerson Clinical Research Institute (ECRI) Dr. Sandoval’s research activities have included bench research at the National Institutes of Neurological Disorders and Stroke (NINDS) where he focused his work on Early Onset Alzheimer’s Disease, and Cretzfelt-Jakob Disease. At the NIHs’ Clinical Center conducting research in the outpatient Oncology unit, followed by his successful support of an NIH RO1 grant on preventing epilepsy in post-traumatic brain injury patients in adults and children, simultaneously run at the Washington Hospital Center, and Children’s National Medical Center. Dr. Sandoval served as the Supervisory Research Integrity & Compliance Officer in the Army Human Research Protections Office in the Office of the Army Surgeon General. Responsibilities included establishment, and oversight of Human Research Protection Programs across Army commands. His input has been instrumental in the review, development, and selection of protocols, in addition to education and training for resident and hospital faculty.
Maryanne Santilli, Associate Director, Clinical Trial Management Finance & Operations, Novo Nordisk
Maryanne Santilli is an innovative and results-oriented accountant with strong analytical and financial modeling skills linked with the ability to quickly identify problems and provide cost effective solutions. At Novo Nordisk, she supports successful clinical trials by providing leadership in financial analysis, management, accountability, and control. She ensures the accuracy and transparency of budgets, oversees the operations of clinical trial investigator and supplier management. She also identifies and drives cost savings initiatives while ensuring clinical trial operational delivery as well as leads multiple cross functional relationships and initiatives to ensure the effective delivery of all department milestones.
Peggy Schrammel, Vice President, APAC and Scientific Affairs, PAREXEL ACCESS, PAREXEL
Peggy Schrammel has served as the VP, Asia Pacific and Scientific Affairs for PAREXEL ACCESS since July 2015. In that role, Peggy has corporate oversight of PAREXEL’s Managed Access Programs (MAP) service line, and coordinates all business development and marketing tasks associated with the its growth. Prior to her current position, Peggy was VP, Portfolio Management and Project Leadership within the former PACE group at PAREXEL and had operational oversight for a global team of over 12 Portfolio Directors and nearly 100 Project Leaders. She is a well-known late-phase thought leader and has had various business development, operational and executive positions in several global CROs of increasing seniority over the past 20+ years, all focusing in the peri- and post-approval arena. 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.
Jessica Scott, Director, North America Medical Policy and Advocacy, Global Medical, GlaxoSmithKline
Jessica received her M.D. from Tufts University School of Medicine in Boston, Massachusetts (1993), completing her residency in Family Medicine with the University of Virginia. She practiced Family Medicine in North Carolina for more than a decade, leaving her medical practice in 2012 to join GlaxoSmithKline. Jessica also attended Campbell University School of Law, graduating with honors with admittance to the NC Bar in 2010, where she is currently licensed to practice law and medicine. Jessica serves on the NC Bar Association Health Law Section Council and the Ethics Committee. She is a certified mediator with advanced certification having mediated over 60 cases. She has instructed both mediation and collaborative law training courses and has worked in law firms on issues related to health care and medical errors. Jessica pioneered the development and implementation of an innovative program for improving patient outcomes through early dispute resolution in her role as Director, Healthcare ADR Innovation at Carolina Dispute Settlement Services. Entitled the Integrated Accountability & Collaborative Transparency (IACT) Program, this initiative is well underway in NC and is currently before the NC General Assembly for consideration as a state-wide pilot program with strong stakeholder support as it couples increased disclosure, dispute resolution and the patient safety movement. In her role at GSK, Jessica leads efforts related to clinical trial.
Dan Serretti, Director, MRL IT, Merck
Dan is a Director in Merck Research Labs, Global Development IT with over 18 years experience in life sciences IT system development. Dan supports the Global Clinical Trial Organization, Global Operations and Monitoring Excellence groups and is currently leading various internal and external initiatives improving overall investigator collaboration.
Rebecca Simamora, Senior Director, Clinical Operations Head, MedImmune
Rebecca is currently the Sr. Director, Clinical Operations Head (COH) of CVMD at MedImmune where she has built the clinical operations team since the therapeutic area was initiated in 2014. Prior to her role as the COH, she has had roles of increasing responsibility within MedImmune, including 20 years of experience within clinical both operationally and scientifically at various pharmaceutical organizations including Wyeth and Shire. Rebecca has been involved in initiatives to improve clinical trial execution within MedImmune.
Gregory Skalicky, Chief Commercial Officer, inVentiv Health Clinical
Gregory Skalicky, Chief Commercial Officer at inVentiv Health Clinical Division, is responsible for enhancing the company's global market position. As the senior executive leading the global sales strategy across the Early Stage, Phases II-IV and Strategic Resourcing businesses, Greg assists clients in identifying the specific therapeutic expertise and skills needed to achieve success in clinical development and post-market research. Greg has worked in the pharmaceutical industry for nearly 20 years in both clinical operations and business development. He began his career at inVentiv Health in 1997, with responsibility for developing strategic relationships. Greg is an active member of the clinical roundtable network, Linking Leaders and was recently selected as a PharmaVoice Top 100 most inspirational and innovative life-science industry professionals of 2016.
Mark Sloan, M.D., Hematology & Medical Oncology, Boston Medical Center
Mark Sloan, MD, has been appointed attending physician, in the section of hematology and oncology at Boston Medical Center (BMC), and assistant professor of medicine at Boston University School of Medicine (BUSM). Dr. Sloan received his medical degree from Yale University School of Medicine and completed his residency at Yale New Haven Hospital. His clinical interests include leukemia, lymphoma and peripheral blood stem cell transplantation. Prior to his appointment at BMC, Dr. Sloan was a senior fellow in hematology and medical oncology at Dana-Farber Cancer Institute and Massachusetts General Hospital. He is board certified in internal medicine, hematology and oncology.
Lucia Soares, Vice President, Healthcare Technology Strategy, Johnson & Johnson
Lúcia Soares is VP, Healthcare Technology Strategy at Johnson & Johnson. In this role, Lúcia is responsible for the strategy of Healthcare Technology Innovation efforts across the enterprise, connecting these efforts to critical business and R&D goals that will accelerate growth for Johnson & Johnson. She manages the portfolio of enterprise Healthcare Technology work, and relationships with key external strategic partners. Lúcia began her career with Johnson & Johnson in 2002, where she led programs for LifeScan’s institutional business products in the Informatics/R&D space. Over the last 14 years, she held positions of increasing responsibility, including serving as the CIO for J&J’s Diabetes Care Franchise and J&J’s Cardiovascular and Specialty Surgery companies. Lúcia came to J&J from SBI (formerly marchFIRST and USWeb), an interactive marketing consulting firm in San Francisco. At SBI, Lúcia worked as Director of the Project Management Office and the User Experience practice. She led engagements with a variety of clients and launched a User Experience Center of Excellence, focused on user/market research, usability testing for web products and launched a variety of technology solutions to address clients’ brand strategy needs. Lúcia lives in San Jose, California – the heart of Silicon Valley with her husband and two daughters. She holds a Master’s Degree in Business Administration from San José State University in California, a Master’s Degree in Literature from the University of California at Santa Cruz, and a Bachelor’s Degree in Foreign Languages from San José State University. She is passionate about the intersection of health and tech and is inspired by literature, languages, community and good wine. She recently edited a book written by her husband for a centennial Portuguese-American church.
Jeremy Sohn, Vice President, Head of Digital Business Development & Licensing, Novartis
Jeremy joined Novartis, in November 2015, as VP, Head of Digital Business Development & Licensing supporting Novartis’ Digital Medicines program cross-divisionally. Since February 2016, Jeremy has also served as ad interim Global Head of Digital Development, Novartis Pharma. Jeremy is a serial software entrepreneur with more than 15 years of experience founding, managing and advising both healthcare and technology companies. Prior to Novartis, Jeremy was Managing Director & Operating Partner at MPM Capital where he led the firm's digital health investment strategy and partnership with Novartis. At MPM, Jeremy founded two companies, CentrosHealth (a mobile, patient-engagement platform designed to improve the patient experience during clinical trials, acquired by Clinical Ink) and TriNetX (a federated network of clinical data warehouses that optimizes clinical trial protocol design and patient recruitment). In 2011, Jeremy co-founded GrapeVine, a transformative software company that uses data aggregation, predictive analytics and targeted marketing, and business intelligence tools to improve how organizations connect with the individuals based on their interests, needs, and friends’ networks. From 2007-2011, Jeremy was the Chief Operating Officer and Vice President of Strategy & Corporate Development for North Plains Systems, where he helped lead the company's growth and eventual sale to Accel-KKR. In 2000, he co-founded an operating system and software-storage company, Wasabi Systems, and led the company's worldwide Business Development activities. Jeremy graduated from Princeton University's Woodrow Wilson School of Public and International Affairs, with a focus on biotechnology and medical policy.
William Spalding, Ph.D., Director and Epidemiology Lead in Global Health Economics and Outcomes Research and Epidemiology, Shire
Director and Epidemiology lead in Global Health Economics and Outcomes Research and Epidemiology at Shire. Previously have worked in HEOR at Ironwood Pharmaceuticals and Sunovion, and within HEOR and Biostatistics at Pfizer.
Ginger Spitz, Executive Director, Foundation of Sarcoidosis Research
Ginger Spitzer joined the Foundation of Sarcoidosis Research in September 2012. As Executive Director, she leads the implementation of a new strategic plan to support the Foundation’s mission and to raise vital funds in a cost-effective and time-efficient manner. Building on the Foundation’s previous successes, Ginger leads a comprehensive plan that both highlights and unifies the FSR’s multiple research and education initiatives with the goal of bringing accelerated changes for sarcoidosis patients.With nearly 25 years of experience in managing non-profit organizational operations, Ginger provides expertise in organizational growth, best practices operations, and funder relations. Her professional endeavors encompass executive management positions for nonprofits with both a service and advocacy mission throughout nationally and globally. She also has held numerous adjunct university teaching positions. She currently is a member of the American Thoracic Society PAR committee, as well as the PAR Awards Committee and the PAR Health Disparities Committee. In addition, she is a member of DIA, a 2015 Fellow of DIA-PEC, and associate editor of the DIA-PEC Newsletter, as well as a member of the Pfizer Rare Disease Advocacy Board, and numerous other professional organizations. Currently she is a PhD candidate at the University of Chicago.
Abbe Steel, MSc, Founder & CEO, HealthiVibe, LLC
Ms. Steel is the Founder and CEO of HealthiVibe, a company that enables patients to contribute to the design of clinical trials, resulting in faster, more effective and less expensive research & development. She founded HealthiVibe out of her passion for patient engagement and firmly believes there are opportunities to improve clinical development programs by leveraging the patient voice. Ms. Steel has 25 years experience in the life sciences industry, leading clinical development and post-marketing programs. She is an advisor to pharma sponsors in the design and implementation of patient-directed global programs that leverage data, insights and mobile/digital technology to satisfy patient/caregiver, provider, payer and regulator needs. She has extensive experience designing and managing large-scale clinical development programs as well as successful patient adherence, clinical trial patient recruitment & retention and drug safety initiatives. Ms. Steel previously worked as Vice President of Patient & Physician Services at UBC-Express Scripts; worked at Sanofi on global marketing programs; was Senior Director, Patient Programs at PAREXEL; and was Vice President at a health IT start up. Ms. Steel received her Masters of Science in Health Communications from Boston University and her BA from George Washington University.
Stella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Development, Tufts University
Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol complexity. She has also been a speaker at conferences and has published articles in trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a B.A. from Brandeis University.
Jim Stolzenbach, President, Jim Stolzenbach Consulting, LLC (former Vice President for Abbvie Renal and Immunology Therapeutic Development)
Jim Stolzenbach has extensive Research and Development experience in the pharmaceutical industry where currently he is a consultant with Jim Stolzenbach Consulting, LLC. Jim is the former Vice President for Abbvie Renal and Immunology Therapeutic Development. Previously, he held several senior leadership roles with Monsanto and Pharmacia including Vice President for Cardiovascular and Metabolic Product Development. Jim has led global projects for both small molecule and biologic programs ranging from proof of concept trials to large Phase 3 trials designed for regulatory approval. During the course of his career he has co-authored over 30 publications in refereed journals with numerous abstracts for presentation. Jim has a Bachelor’s degree in Science from the University of Connecticut, a Master’s degree from the University of Georgia and obtained his Ph.D. at Oregon State University. Jim belongs to several professional organizations including Sigma Xi, American Association of Pharmaceutical Sciences, Drug Information Association, and the American Heart Association.
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
Linda B. Sullivan is Co-Founder & President of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings. Ms Sullivan received a B.S. in Biology from Trinity College and a M.B.A. from Dartmouth College where she was named a Tuck Scholar.
Mark Summers, President & CEO, ThreeWire, Inc.
With over thirty years of experience in the pharmaceutical and medical device industries, Mark is widely recognized as a veteran entrepreneur and thought leader in the area of accelerating clinical trial patient enrollment. As the founder and CEO of ThreeWire, Inc., he has led the company through the development and patenting of its proprietary model for maximizing clinical trial patient enrollment. His clinical trial experience in the industry and at ThreeWire covers a wide range of therapeutic areas and includes patient recruitment for more than 100 study protocols that have screened in excess of 250,000 patients in partnership with over 500 sites in more than 10 countries. Prior to founding ThreeWire, Mark held executive positions at two early stage medical device firms where he drove more than $100 million in global growth following completion of extensive clinical trials. Mark is a graduate of the University of Michigan and is also a United States Navy veteran where he spent 7 years flying F-14s from various aircraft carriers and at Topgun.
Michael Tanen, Director, Clinical BMx Specimen Management, Merck
Michael Tanen is the director of the Clinical Biomarker Specimen Management group at Merck Research Laboratories. Michael leads a group that is responsible for collection, tracking, and storage of clinical biomarker specimens collected in clinical trials. During his 19 years at Merck he has been involved in the utilization of clinical biomarker specimens from the prospective of discovery research through the usage for diagnostic development. His team has established an industry leading specimen management solution that supports data integration between clinical data and specimens, improving how we make utilization decisions in the complex area of biomarker research.
Jaydev Thakkar, Clinical Trial Design and Management – Global IS Service Owner, Director Information Systems, Amgen
Jaydev leads IS group at Amgen supporting Clinical Trial Design and Global Development Operations. Currently, he is IS lead for a strategic cross functional program (driven by CEO staff), working in close partnership with business executives for streamlining Clinical Trials, delivering a suite of IS solutions that enable significant cost efficiency, cut down cycle time and enable Amgen to be a sponsor of choice for Clinical Sites and Patients. His responsibilities include defining Amgen's Clinical IT vision, managing execution of IS portfolio with a multi-year roadmap, and identifying innovations in health care industry that Amgen can leverage in Clinical Development such as Digital Health, Mobile Apps, wearables & sensors, Virtual/Remote trials, Real World Data etc. Over 25 years experience developing and applying technology for finance, telecom, manufacturing and Life sciences industry.
Gary Thompson, Senior Director, Data Sciences and Solutions and Biometrics Sourcing, Eli Lilly
Gary Thompson, MS, is the Senior Director of Lilly’s Data Sciences & Solutions organization, which includes leadership of Lilly’s global clinical data management, real-world data and central monitoring capabilities. Gary has over 21 years of experience in the clinical research field in a variety of CRO and sponsor settings. Gary joined Lilly in 1999 in the Global Clinical Data Management organization and has held a number of leadership roles related to data management, clinical capabilities development, and statistics operations. His experiences have focused on data management portfolio delivery, strategic sourcing, process and technology development and implementation, and operational delivery. Prior to joining Lilly, Gary held positions at Clintrials Research and Insite Clinical Trials. Gary holds a Master of Science degree in Biomedical Engineering
Hilde Vanaken, Ph.D., Director, Clinical Trial Innovation, Janssen Research & Development
Hilde is a Director of the R&D Operations Innovation department at Janssen. She has more than 16 years of experience in pharmaceutical companies and clinical research organizations, where she held various leading positions in clinical operations, data management, safety management, professional affairs, quality management, strategic business improvement and clinical trial innovation. Prior to clinical research, Hilde worked as a research scientist for 6 years. Hilde has a passion for complex or so called mission impossible projects and has a track record to transform them into success stories. In her current role, she is leading several transformational projects such as eConsent, eLabel/eMeds, eSource, iSTEP (Integrated Smart Trial and Engagement Platform) to modernize Janssen’s clinical trials and improve the experience of patients and investigators. As Transcelerate eConsent lead, Hilde also drives cross-industry the eConsent project with the patient as key stakeholder. Hilde holds a degree in Engineering in Chemical and Agricultural Sciences, a Master in Environmental Sciences and a PhD in Medical Sciences, all from the Catholic University of Leuven in Belgium.
Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company
Katherine (Kathy) Vandebelt believes patients are the most important constituent in clinical development. She is collaborating with various companies to deliver a new and better clinical development model that makes clinical trials more accessible to patients and provide them with responsive and considerate care. Kathy has experience in setting up a network of strategic partnerships to increase flexibility, capacity and capabilities to meet the ever changing needs of drug development. Being part of an international company, Kathy is well aware of the challenges of working with a distant work force. She believes there is tremendous value in developing a diverse work force and is always trying to discover ways to ensure the talents of the people can be leveraged to bring innovative health care solutions to patients. Kathy received her Bachelor of Science specializing in Pharmacology with a minor in Physiology from Trinity College at the University of Toronto. She started her career at Lilly in Toronto, Canada as a Clinical Research Associate and led clinical development programs across various therapeutic areas. In 1999, Kathy moved to Sydney, Australia to build and lead the Clinical Outcomes and Research Institute. Over a four year period, the research investment tripled, the scope of responsibility expanded to support a larger geographical area, and the scientific and technologic advancements were externally recognized as being innovative and world class. In 2003, Kathy moved to Indianapolis, Indiana (Lilly headquarters) and has held senior leadership roles in Data Sciences / Solutions and Statistics accountable for ensuring clinical data integrity and quality for worldwide medical research conducted for human pharmacology, therapeutic exploratory, therapeutic confirmatory and therapeutic use.
David Vulcano, AVP & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)
David is a well-known expert and leader in the clinical research industry. He was born and raised in New Orleans, Louisiana. He has a Masters degree in both Social Work and Business Administration and holds the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC). He is the Responsible Executive for Clinical Research for Hospital Corporation of America (HCA). He is and has been in many other industry leader roles both in the United States and globally, including Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP). He is also the President of the Nashville Angel Capital Group. He is married with 2 children and lives south of Nashville, Tennessee where he involves himself in work, family life as well as other charitable and entrepreneurial opportunities. David was recently honored with the “Outstanding Speaker” award, presented at the 2015 MAGI West conference.
Keith Wharton, MD PhD, Molecular Pathologist in Preclinical Safety / Translational Medicine, Novartis Institutes for Biomedical Research
Keith is a board-certified pathologist who directs tissue biomarker activities for early stage clinical trials across multiple therapeutic areas at Novartis in Cambridge, MA, USA. As part of a preclinical safety organization he is also a study pathologist, program investigative lead and toxicologist, and human tissue consultant. Prior to joining biopharma in 2009, at the University of Texas Southwestern Medical Center he served as Associate Dean of medical education, pathology course director, attending pathologist, and principal investigator of an NIH-funded laboratory studying intercellular communication in development and cancer. He was raised in Arizona and earned a BS in Chemical Engineering from the University of Arizona, followed by an MD/PhD in Molecular Biology from the University of California, Los Angeles as part of the Medical Scientist Training Program. His postdoctoral training at Stanford included pathology residency and a fellowship in developmental biology funded by the Howard Hughes Medical Institute. He has >30 peer-reviewed publications and numerous honors and awards. In 2015 he coedited and contributed chapters on outsourcing pathology in clinical trials, next generation sequencing in anatomic pathology, and fundamentals of disease to the book, “Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development” (http://www.springer.com/us/book/9781493926800). He is broadly interested in the molecular control of health and disease, technologies that advance understanding of disease, and drug and diagnostics development. He has a passion for communicating biomedical science to diverse audiences and enjoys mentoring trainees and colleagues at all career stages.
Kenneth Wilson, Director, Business Operations, Clinical Outsourcing Lead, Pfizer
Ken has 27 years of experience in clinical research with varying levels of responsibilities at several CROs as well as 4 years in Outsourcing at Pfizer. Ken began his career at Quintiles in 1987 as a Statistical Programmer and then moved into Statistical Programming line management. He was appointed and served as the Director of Biometrics for Quintiles CNS division until 2000. Following Quintiles, Ken served as Site Director for I3 Statprobe’s San Diego office for a few years with overall business and operational management responsibility. Ken has also worked in Business Development at Clinimetrics/Omnicare selling full-service CRO services in various therapeutic areas as well as helping initiate FSP models with different clients in the industry. Ken has managed many projects from full-service to single service-contracts in many different indications. Ken is currently a Director in Business Operations at Pfizer, Inc. where he is responsible for Clinical Outsourcing of five of Pfizer’s key development programs.
Brenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer
Brenda is Director, Clinical Innovation at Pfizer. In this role she advises senior executives regarding opportunities to innovate the clinical development space, whether it’s identification of new policy gaps, process needs, or technology infrastructure or tools. Brenda has held leadership roles in science, operations, and IT at Merck and Pfizer, and also acted as a management consultant at IBM. She recently led an effort to operationalize Precision Medicine through building the infrastructure to support Pfizer’s Human Tissue and Biospecimens Policy.
Kate Zarish, Director, Strategic Study Start Up, Development Operations, Clinical Field Operations, AbbVie
Kate Zarish holds a MPH from Tulane University School of Public Health & Tropical Medicine and is a Certified Clinical Research Associate. She has over 20 years of experience in the industry and has worked in many different roles specifically in Clinical Operations and Medical Affairs. Kate is passionate about helping to facilitate discussions around data driven decisions to ensure decisions are made with the best information available.
Roni Zeiger, M.D., Co-founder, Smart Patients
Roni Zeiger is the former Chief Health Strategist at Google. In 2012, he co-founded Smart Patients, an online community where patients and families learn from each other in safe and high quality online communities. Roni serves as CEO of Smart Patients and continues to see urgent care patients part time at Santa Clara Valley Medical Center, where he is a Community Staff Physician.
Sean Zhao, M.D., Head, US Patient Safety Surveillance, AstraZeneca
Dr. Sean Zhao is a senior pharmaceutical executive with over 15 years of diverse working experience and proven ability in pharmacovigilance, pharmacoepidemiology, risk evaluation, management and mitigation, post marketing safety studies, safety process development and refinement, and outcomes research. He successfully led global safety department, safety surveillance teams, and pharmacoepidemiology teams in various mid- and large-size biotech and pharmaceutical companies. He has deep knowledge in safety regulations and guidance enforced by regulatory agencies worldwide. Dr. Zhao currently serves as head of US Patient Safety Surveillance at AstraZeneca Pharmaceuticals LP.
Heather Zigmund, Pharm.D., Senior Director and Head of Clinical Services, MedImmune
Heather Zigmund, Pharm.D., is Senior Director & Head of Clinical Services at MedImmune, the biologics science unit of AstraZeneca. In this role, she de-constructed the existing vendor oversight model and re-built a fit for purpose governance model focused on maximizing the direct and indirect benefits of successful partnerships. Prior to MedImmune, Heather spent 14 years at PRA Health Sciences where she held several leadership roles including the Head of Clinical Vendor Management where she successfully established the department, defined PRA's outsourcing strategy and policies in accordance with GCP and managed a team who provided oversight of over 350 vendors. In her spare time, she enjoys spending time with her husband Bill and three daughters Cate, Ella, and Harper.
Kelly H. Zou, Ph.D., PStat®, Senior Director and Analytic Science Lead, Real World Data & Analytics (RWDnA), Global Health & Value (GH&V), Pfizer, Inc.
Kelly H. Zou, PhD, PStat, ASA Fellow, is Senior Director and Analytic Science Lead, Real-World Data & Analytics at Pfizer Inc. Dr. Zou is an elected Fellow of the American Statistical Association and an Accredited Professional Statistician. Previously, she was Senior Director and Statistics Lead, Statistical Center for Outcomes, Real World & Aggregate Data at Pfizer. She was Associate Professor of Radiology and Lecturer in Health Care Policy at Harvard Medical School, as well as Director of Biostatistics at its affiliated teaching hospitals. She was Associate Director of Rates at Barclays Capital. She received both MA and PhD degrees in Statistics from the University of Rochester, following a BA in Mathematics (summa cum laude), with a Minor in Physics. She completed her Postdoctoral Fellowship at Harvard. Her research interests include healthcare policy, big data, and outcomes research, with over 130 professional articles and 4 books. She has played several leadership roles: Incoming Chair-Elect and Secretary, Health Care Policy Statistics Section; Chair and Vice Chair, Statistical Partnerships among Academe, Industry, and Government Committee; Chair, Committee of Presidents of Statistical Societies Awards; Vice Chair, Committee on Applied Statisticians; Member, Publications Committee, International Chinese Statistical Association. She has been on several editorial boards