MONDAY, NOVEMBER 5
7:30-8:20 am Conference Registration
8:20-8:30am Chairperson’s Introduction
Russell Linderman, Ph.D., Executive Director, Pfizer
KEYNOTE SESSION
8:30-9:00 Precision Medicine in PoC
Kavita Patel, M.D., M.S., Fellow, The Brookings Institute
9:00-9:30 Paradox or Oxymoron: Stratified PoC?
 Mark Trusheim, M.S., Executive in Residence, Visiting Scientist, Massachusetts Institute of Technology
Stratified or personalized medicine requires parallel development of a therapeutic and a companion diagnostic. For most first in class therapies is it absolutely required or absolutely impossible to have both the Rx and the CDx proven in Phase II? As experience grows and the hype fades, what is possible, what is not and how can a development team weigh its choices? Drawing on recently published simulations and recent product experiences, the session will suggest possible paths to success.
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9:30-10:00 Cancer Biomarkers: Selecting the Right Drug for the Right Patient
Gary Kelloff, M.D., Advisor to Associate Director, Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute
Biomarker-related clinical trials are either designed for drug evaluation using the biomarker or for evaluating the ability of the biomarker to select personalized therapy or therapy regimens. Measurement of biomarkers is and will be performed by a diverse set of platforms and assays requiring different standards and developmental pathways. The data required for development, use, and commercialization is complicated by the alternative oversight by CLIA and FDA regulations, single vs. pathway targets, discrete vs. multiplex measurements, and specific contexts of use. Financial disincentives deriving from unpredictable insurance coverage has slowed assay development and commercialization.
10:00-10:40 Coffee Break in the Exhibit Hall
10:40-11:10 Development of Patient Stratification Markers to Maximize the Opportunities toward Achieving Success in Oncology Drug Development
Yaping Shou, M.D., Ph.D., Medical Director, Oncology Clinical Research, Millennium: The Takeda Oncology Company
11:10-11:40 The Early Candidate Medical Director: Shepherding Pre-Clinical Assets through Clinical Development
Matthew R. Yudt, Ph.D., Early Candidate Medical Director, Specialty Care Business Unit, Pfizer
The Early Candidate Medical Director (ECMD) is a unique role within Pfizer’s Specialty Care Business Unit. In partnering with research units, clinicians, marketers, and numerous other functions, we provide a strategic foundation that promotes a seamless transition from early to late stage development. The role requires both a solid scientific understanding of numerous disease areas along with a commercial acumen to effectively build both medical and commercial teams necessary for success. Among the subjects to be discussed include the tools used to make early assessments; the various roles involved in transitioning projects through development; and an insight on how decisions to invest are made.
11:40-12:10pm Tools and Approaches Available for Early Development Decision-Making
Jeffrey Paul, Ph.D., Executive Director, Global Head Clinical Pharmacology & Exploratory Development Science (GCPED), Astellas Pharma Global Development, Inc.
The talk will include approaches for writing into the early clinical plan a set of knowledge questions that would lead to early decision making. Some of the tools are simple, such as one for systemic exposure or certain safety events. Teams are encouraged to fully employ all technical platforms available to them, including pharmacogenomics, physiological testing, imaging, etc. Emphasis will be made on setting up criteria that is consistent with the target product profile and applying quantitative decision making where possible.
12:10-1:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:30-2:00 Using a ‘Pseudo N-of-1’ Conceptual Framework to Impact PoC Design and Outcomes
Gary J. Keil II, Ph.D., R.Ph., former Strategic Intelligence Analyst, Strategy Portfolio and Performance, AstraZeneca
Preclinical and clinical studies designed to identify health, disease and therapeutic response factors at the single animal/patient level are generally known as “N of 1 studies.” While these studies may be informative, they lack the translative power necessary to help define large-scale populations. Thus, the links between personalized medicine on individual and larger levels are lacking. Philosophical and practical limitations of traditional (i.e., one size fits all) and “N of 1 studies” can be discussed to help create “pseudo-N of 1” study design concepts that use data from individual and grossly defined populations in order to help redirect individualized treatments.
2:00-2:30 Where do PoC Studies Come From? - A Framework for Strategic, Scientific, and Operational Excellence in Early Development
Ted Grasela, Ph.D., President & CEO, Cognigen
The design of effective Proof-of-Concept studies is a critical function of Pharma research and development teams. An interdisciplinary synthesis of data from
in vitro and in vivo research is critical to an understanding of the determinants of efficacy and safety outcomes and plays a critical role in the design of Proof of Concept studies. This presentation will provide a framework for performing the interdisciplinary synthesis while ensuring alignment of the strategic, operational, and technical aspects of study design, planning, execution, analysis and interpretation of results.
2:30-3:00 Proof-of-Concept (PoC) in Optimal Drug Development (ODD)
Alan Xiao, Ph.D., Director, Clinical Pharmacology & DMPK, AstraZeneca
This talk will cover understanding the Target Product Profile (TPP) and PoC, as well as pre-PoC data collection and knowledge accumulation, optimizing PoC strategy implementation, decision-making criteria and risk/uncertainty in optimized drug discovery.
3:00-3:45 Refreshment Break in the Exhibit Hall
3:45-4:45 Interactive Roundtable Discussions:
Concurrent roundtables to discuss some of the broader questions facing the industry today; discussions will be led by one moderator and limited to 10-12 participants.
Topics include:
- PoC Study Designs Beyond Adaptive Trials: What’s Next?
- PoC for Trial Design- What Works?
- Methods & Platforms to Improve PoC Study Real-Time Data Tracking & Sharing
- Evaluating Overseas Trials: Top 10 Questions You Need to Ask
- Co-Studies for PoC for Both Drug and Diagnostic
4:45-5:45Welcome Reception in the Exhibit Hall