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Tuesday, May 4
8:00-9:00 am Registration for Pre-Conference Events
8:30-12:00 Pre-Conference Short Course*
(*Separate Registration Required)
Course Instructors:
John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON Development Solutions
Viswanath Devanarayan, Ph.D., Director, Global Exploratory Statistics, Abbott Laboratories
This tutorial will provide recommendations on the “fit-for-purpose” best practices in the development and validation of biomarker assays for the intended exploratory or advanced biomarker applications. Strategies for different applications at various phases of biomarker development will be described. Key elements in method development and validation will be illustrated with examples, including references to standard material, sample stability and collection integrity, validation and QC samples, validity of reference standards, calibration curve fitting methods, method optimization and method feasibility studies. The special challenges in protein biomarker assays will be discussed, including strategies for moving from biomarker panels in the exploratory phase to the few markers chosen to support clinical trials.
Outline:
- Introduction: Nomenclature, types of biomarker methods/assays, biomarker method development & validation road map, fundamental validity, similarity and differences from PK assays & diagnostic application
- Pre-analytical and bioanalytical elements: Target range, standards, validation & QC samples, stability, matrix effect, specificity, and relative selectivity
- Calibration curve model selection, evaluation, and weighting
- Method feasibility and optimization with precision profiles
- Evaluation of some pre-study validation characteristics such as precision, bias, sensitivity and quantification limits
- Use of sample controls for in-study performance monitoring and conformance testing among laboratories
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9:00-12:00 Executive ThinkTank*
(*Separate Registration Required. Access is limited to delegates who are Management-level at pharmaceutical, diagnostic or biotechnology companies.)
Discussion Facilitator:
Geert J.C.M. Kolvenbag, M.D., Ph.D., Global Product Vice President, Oncology, AstraZeneca Pharmaceuticals, Inc.
The Executive ThinkTank roundtable provides a facilitated discussion on key issues in biomarker implementation, allowing senior managers to share experience and brainstorm actionable solutions.
Discussion Topics Include:
- Which types of biomarkers should be developed at various stages in the drug pipeline?
- What strategies help translate biomarkers from preclinical to clinical development?
- What are the current obstacles in clinical implementation of biomarkers?
- How should pharma address drug-diagnostic co-development?
- What type of biomarker data should lead to terminating a target or a compound? What type of data should lead to increased investment in a compound?
- How should biomarker data be weighed against “traditional” safety and efficacy data? Can “general” toxicity biomarkers be re-used across programs?
- What level of validation is required for which types of decisions?
- What are the current biomarker “best practices” in place at big pharma?
- How to estimate and measure ROI on biomarkers?
- Which biomarkers should big pharma develop independently and which can be co-developed in a cost-sharing model as pre-competitive information?
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12:00-1:00 pm Main Conference Registration
1:00-1:15 Welcoming Remarks from Conference Director
Julia Boguslavsky, Executive Director, Conferences, Cambridge Healthtech Institute
Chairperson's Opening Remarks
Geert J.C.M. Kolvenbag, M.D., Ph.D., Global Product Vice President, Oncology, AstraZeneca Pharmaceuticals, Inc.
1:15-1:45 A New Era with Targeted Drugs: New Development Approaches are Needed to Achieve Success
Geert J.C.M. Kolvenbag, M.D., Ph.D., Global Product Vice President, Oncology, AstraZeneca Pharmaceuticals, Inc.
Innovative development approaches are needed to assess a growing number of candidate drugs and a related increase in the number of clinical trials. Unfortunately, patient participation in clinical trials remains low, and hurdles for regulatory approval and reimbursement have not decreased. Additionally, the success rate for oncology drug development remains low. With the wealth of new targeted agents and a growing understanding of the underlying biology, is it possible to make better decisions in a timely fashion, to pick the winners and eliminate the losers? Getting the right therapy to the right patient demands early investment to explore the potential development of a companion diagnostic. This is an opportunity as well as an increased risk. This presentation will address three questions using real life examples. How far has personalized health care come for cancer patients? How smart can we be in combining two or more new targeted agents? And lastly, are there tools available to enhance decision making in the drug development process?
1:45-2:15 Evolutionary Genetics of Alzheimer’s Disease
Allen D. Roses, M.D., Jefferson-Pilot Professor of Neurobiology and Neurology, Director, Deane Drug Discovery Institute, Duke University
We sequenced the linkage disequilibrium region containing TOMM40 and APOE in multiple AD patients, and analyzed with phylogenetic mapping technologies. We found a variable TOMM40 polyT polymorphism [rs10524523] inherited on each allele, with different copy number mutations occurring over evolutionary time. Larger variants were associated with earlier age of onset of AD. APOE4 was virtually always on the same strand as a long variant and APOE3 containing strands could be inherited either a long or short variant. The predictive genetics supports a prospective validation and delay of onset therapeutic trial.
2:15-2:45 Applied Biomarkers: The Role of Benefit Management in Translating Personalized Medicine from Research to Practice
Felix W. Frueh, Ph.D., Vice President, Research & Development, Personalized Medicine, Medco Health Solutions, Inc.
2:45-3:15 Biomarkers and the Development of Personalized Medicine: A Regulatory Perspective
Francis Kalush, Ph.D., Network Leader, Diagnostics & Personalized Medicine, CDRH, U.S. Food and Drug Administration
3:15-4:00 Networking Refreshment Break
Chairperson's Opening Remarks
Geert J.C.M. Kolvenbag, M.D., Ph.D., Global Product Vice President, Oncology, AstraZeneca Pharmaceuticals, Inc.
4:00-4:30 Translational Medicine: The “Do or Die” for the Pharmaceutical Industry
Giora Feuerstein, M.D., President, FARMACON, LLC, Translational Medicine Drug Discovery and Developmentn Consulting; formerly Assistant Vice President and Head, Discovery Translational Medicine, Wyeth Research
The continued high attrition rate of New Medical Entities (NMEs) registration and innovative, high medical impact of drug delivery for patients care sent a ‘call to arms’ in all pharmaceutical industries to reshape and revolutionize the centuries old drug discovery and development processes. To this end, translational medicine entities have sprung up in numerous shapes and formats in all ‘Pharma,” with the objective to improve the scientific quality of the dossiers via enhanced, more rigorous scientific processes. In the present talk, we will review a new model in translational medicine that encompasses target validation, compound-target interaction, Pharmacokinetics and Pharmacodynamics, new disease biomarkers and patients selection. Specific case studies that illustrate these issues will be provided.
4:30-5:00 Identification of a Transcriptional Biomarker of Target Engagement and Use in Oncology Early Clinical Development
Samuel C. Blackman, M.D., Ph.D., Associate Director, Experimental Medicine/Oncology, Merck Research Laboratories
In this talk I will present a case study on the identification of a novel transcriptional biomarker of target engagement in an easily accessible human surrogate tissue. I will discuss the role of healthy subject studies in oncology biomarker development and early clinical development, as well as the use of novel surrogate tissues for PK/PD studies. This presentation will also demonstrate the potential for discovery efforts that can result from biomarker studies.
5:00-6:00 Opening Reception with Exhibit and Poster Viewing
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