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8:00 am Registration and Morning Coffee

8:45 Chairperson’s Opening Remarks

Daniel FoltzDaniel Foltz, Director, Health Informatics, Computer Sciences Corporation


8:50 Special Co-Presentation on Integrating Drug Safety Knowledge across a Compound’s Lifecycle and across a Portfolio

Part 1: Corporate Risk Management

Michael ForstnerMichael Forstner, M.Sc., Ph.D., Integrated Safety Risk Manager, F. Hoffmann-La Roche, Basel, Switzerland

Integrated Safety Risk Management planning involves the coherent and consistent identification, assessment, and improvement of the management of drug safety risks throughout the lifecycle of a product and across the product portfolio to improve knowledge of products, communicate that knowledge, and to protect patients. The Integrated Safety Management Plan (ISMP) is a tool for the prospective strategic assessment of safety risks as well as the retrospective collection, handling and archiving of safety assessments, including the documentation of the benefit risk assessment of a drug. As such, the ISMP is the single repository of key safety information, serving as a basis for post-approval risk management planning.

Part 2: Data Mining

Colette SaccomannoColette F. Saccomanno, Ph.D., MSLIS, Integrated Safety Risk Manager, Hoffmann-La Roche, Nutley, NJ

Data Mining spans the complete product lifecycle. One role of the Integrated Safety Risk Managers is to assist Safety Teams with accurate and appropriate data mining via the use of integrated business processes that link the various and often disparate data sets that exist across the product lifecycle. An illustration of how Roche is implementing this
function will be presented.

Part 3: Comparative Benefit Risk Assessment

James Cross, MS, Ph.D., Integrated Safety Risk Manager, Genentech, San Francisco, CA

The purpose of Comparative Benefit-Risk Assessment (CBR) is to improve company practices in comparative benefit-risk assessment to ensure that the products we move forward in development and commercialization ultimately have benefit-risk tradeoffs acceptable to patients and clinicians. This shall be achieved by improving consistency and transparency in decisions regarding tradeoffs by developing and implementing structured approaches to CBR assessment. Illustrations of an cross-functional approach being developed will be highlighted.

10:15 Networking Refreshment Break



10:45 Qualitative Strategies towards Benefits Optimization, Risk Minimization and Uncertainties Management:
A Regulator’s Perspective

Robyn LimRobyn Lim, Ph.D., Scientific Advisor, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada

A benefit-risk-uncertainty management approach, which is holistic and more explicit, is suggested to enhance federal regulatory and downstream decisions by: 1) placing potential benefits in context with risks so that deciders can confront inherent trade-offs and examine their risk tolerance; and 2) recognizing associated uncertainties in benefit and risk estimates that can modulate the value assigned to each by health community deciders.

11:15 Using Benefit-Risk Assessment as a Guidepost for
Developing Risk Management Plans and REMS

Paul CoplanPaul Coplan, D.Sc., MBA, Executive Director, Risk Management and Epidemiology, Purdue Pharma L.P.


11:45 Sponsored by
The Role of Social Media in Drug Safety and How this Technology can Promote Transparency and Health Literacy

Elizabeth Garrard Elizabeth Garrard, Pharm.D, R.Ph, Chief Safety Officer, Drug Safety Alliance, Inc.

Patients and healthcare professionals are exponentially seeking information and having conversations on the Internet to gather health information in unparalleled numbers. They are using social networks, blogs, chat rooms and other social media to take control of their health decision making and share their experiences with other users. This presentation will explore the use of social media by pharma and examine how this technology can promote transparency and health literacy.

12:15 pm Sponsored Luncheon Presentation (Opportunity Available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com) or Lunch on your Own



Shared Session with CHI’s
Mitigating Safety Risks in Early Clinical Development

1:25 Chairperson’s Opening Remarks

Stephen Furlong, Ph.D., Safety Science Lead, US Patient Safety, AstraZeneca

1:30 Bridging the Gap between Preclinical Data, Clinical
Studies and Post-Approval Drug Safety

Philip SagerPhil Sager, M.D., Vice President, Clinical Research, Head, CV/Metabolic Clinical Development, Gilead

This session explores how preclinical testing results can be used to guide the early clinical development program with respect to the intensity and approaches to early CV safety data collection and analysis. Using the paradigm presented, the early human testing approach can be modulated to most efficiently determine the presence or absence of a safety signal in a manner that maximizes efficiency and is mindful to resource utilization. Furthermore, the preclinical data and the clinical database will significantly impact the post-approval safety database and strategies to further define and mitigate potential safety issues will be discussed.

2:00 Better Integrating Clinical and Preclinical Safety to Achieve Translational Safety

James MilliganJames Milligan, M.D., Safety Science Expert/Safety Physician, Clinical Safety, AstraZeneca

Steve FurlongCo-developed by Stephen Furlong, Ph.D., Safety Science Lead, US Patient Safety, AstraZeneca

Integration of clinical and preclinical safety strategy will be discussed from a strategic and operational perspective. Why an organization must re-evaluate its strategy and organizational structure and how to implement the change (sounds obvious, but easier said than done) are the key points of the discussion

Sponsored by
Pega Systems 
2:30 Breaking Down Pre- & Post-Approval Safety Silos with BPM  
Ed Chase, Director Life Sciences Framework Solutions, Pegasystems Inc.
Presentation abstract:  In many organizations, clinical trial safety reporting and post market surveillance are managed separately, with challenges arising whenever they cross paths.  While many barriers arise from where the safety data originates (i.e. EDC/CRFs vs. contact centers), the downstream requirements are often the same – how to quickly and accurately acquire, analyze and report on safety data in the context of a given product or study?  BPM can improve safety practices by harmonizing the management of processes and business rules across your organization while preserving and improving the flow and transparency of both safety and process data. 

3:00 Networking Coffee Break

3:30 Lessons Unlearned: Determining Risks from Clinical Trials

Mike Kleppe Michael J. Klepper, M.D., former Founder and President of Integrated Safety Systems, Inc.; co-author of “Drug Safety Data”

The ability to determine risk from clinical trials is limited in a number of ways including limited numbers of subjects exposed and limited duration of exposures. Nevertheless preemptive measures can and should be taken to maximize the detection of risk. Unfortunately, these steps are often not taken resulting in greater and unnecessary risks to subjects; increased time, costs and expenditure of resources to the company; and potential delays in approval or non-approval of drugs. These issues are universally relevant but remain inadequately addressed. The audience will gain an understanding of the pitfalls in determining risk and a pragmatic approach of how to avoid these pitfalls and maximize risk detection during clinical development.

4:00 Translational Toxicology as Part of Risk Management throughout the Life Cycle of a Product

Anja SlikkerveerAnja Slikkerveer, M.D., Scientific Director Translational Science, Drug Safety Research Laboratories, Astellas Pharma

From the moment of the first study in humans, risk management is implemented in drug development. At that time there is only non-clinical data. Gradually, during the development these data become complimented with clinical safety data. It is essential that throughout this period, there is an adequate integration of the data sets. More importantly, a greater awareness and understanding needs to be created between non-clinical and clinical safety specialists to make the process work. At Astellas, it is the role of the translational toxicolgist to build the bridges between non-clinical and clinical.


4:30 Break-Out Discussion Groups and Afternoon Session Wrap-Up:

Concurrent roundtables are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of issues presented in the afternoon session. Delegates will join a roundtable of interest to them and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE 1: Improving Pre-Clinical Models

Moderators: Peter Hoffmann, M.D., Ph.D., Executive Director, Preclinical Safety, Novartis Institutes for BioMedical Research

Pierre Lainee, Ph.D., Principal Scientist, Preclinical Safety, AstraZeneca

  • Use of disease models in preclinical safety (e.g., diabetes models)?
  • Which models should be introduced for better prediction of late stage human cardiovascular toxicity?
  • How to select, establish and validate new models?
  • Decision making based on data obtained in exploratory preclinical studies

TABLE 2: Improving Signal Detection and Validation: How do you Maximize your Ability to Detect Important Safety Signals Early in Clinical Development? 

Moderator: Michael J. Klepper, M.D., former Founder and President of Integrated Safety Systems, Inc.; co-author of “Drug Safety Data”

  • What are the pitfalls in early identification of important safety signals in early clinical development?
  • How do you maximize identification of safety signals in early clinical development?
  • What are “best drug safety/pharmacovigilance practices” in early clinical development?

TABLE 3: Leveraging Informatics and IT to Improve Safety Prediction

Moderators: Sandeep Modi, Ph.D., Cheminformatician, Safety & Environmental Assurance Centre, Unilever; former Research Associate, GlaxoSmithKline; Aris Persidis, Ph.D., President, Biovista, Inc.

  • How can we better analyze safety data and manage knowledge across an organization?
  • What are the true costs and benefits?
  • Where is the greatest ROI for small and large companies when considering tools, technology and human resources to dedicate?

TABLE 4: How to Minimize the Risk of Drug-Induced Liver Injury

Moderators: Paul Watkins, M.D., Verne S. Caviness Distinguished Professor of Medicine, Professor of Pharmacotherapy, University of North Carolina Chapel Hill

James Dykens, Ph.D., Group Leader, Investigative Cell Toxicity, Drug Safety R&D, Pfizer, Inc.

  • Will recent genetic insights change no go decisions in clinical development?
  • What are appropriateuse of investigational biomarkers?
  • Do you consider off-target mitochondrial impairment important for the etiology of DILI? If so, how are you addressing it?

TABLE 5: QT Analysis during Clinical Development and Post-Approval Safety Assessment

Moderator: Phil Sager, M.D., former Vice President, Clinical Research, Head, CV/Metabolic Clinical Development, Gilead

  • The role of careful QT assessment during SAD and MAD studies
  • Automatic QT analysis- is this a viable approach?  Does it add value?
  • What are the best approaches to Phase III when there is a QT signal

TABLE 6: Overcoming Challenges in Cardiovascular Risk Assessment

Moderator: Ihor Gussak, M.D., Ph.D., FACC, Chief Medical Officer and Vice President, NewCardio, Inc.

  • Automated versus semi-automated ECG evaluation in early cardiac safety assessment
  • New markers for cardiac (pro-arrhythmic) toxicity and their clinical validation

TABLE 7: Challenges and Opportunities for Outsourcing and Off-shoring Post Approval-Drug Safety

Moderator: Gretchen Dieck, Ph.D., Vice President, Safety, Epidemiology and Risk Management, United BioSource Corporation (UBC)

  • Outsourcing vs Off-shoring - pros and cons from a cost, quality, and regulatory perspective
  • Do low cost centers remain low cost over the long term?  Are they low cost in the short term?
  • Building corporate historical memory re safety - should this be a consideration?

TOPIC 8: How to Evaluate the Effectiveness of Your Risk Minimization Strategies

Moderator: Michael Forstner, M.Sc., Ph.D., Integrated Safety Risk Manager, F. Hoffmann-La Roche, Basel, Switzerland

  • How can we measure what we may have caused not to happen?
  • Subjective assessments, objective measures, evaluation models
  • What can we learn from other industries?

TOPIC 9: DSMBs as a Part of a Pro-Active Risk Communication Strategy

Moderator: Barton Cobert MD, FACP, FACG, FFPM, President, BLCMD Associates LLC

  • Is there ever a role for a DSMB in phase I studies for highly toxic or controversial drugs
  • For DSMBs covering multiple studies, what operational tools are available to help the committee monitor large amounts of data?
  • Should the statistician be from outside the sponsor in all DSMBs?
  • Should the DSMB ever interact with the sponsor's drug safety group and/or the investigators?
  • How should the DSMB respond if it feels the sponsors' drug safety group is not adequately handling safety data or picking up signals?
  • Should the DSMB meet routinely in its closed sessions without any sponsor representatives present?

TABLE 10: The Role of Social Media in Drug Safety and How this Technology May Improve or Hurt Communication

Moderator: Elizabeth E. Garrard, PharmD, RPh., Chief Safety Officer, Drug Safety Alliance, Inc.

  • What forms of social media are being used by your company where you work?  If the media is interactive and under the control of the pharma company you work for, do you actively look for mention of AE’s?
  • What challenges face pharma in the use of social media and AE detection?
  • Do the benefits of increased communication outweigh the risks with the use of social media?


5:30 Networking Cocktail Reception

6:30 Close of Day

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