Adaptive Pharmacogenomics, LLC
Clinical development for personalized medicine
Webinars
FDA and Industry Perspectives on Clinical Development with Predictive Biomarkers
February 14, 16, 21 and 23
Program
1. Transitioning Biomarkers to Companion Diagnostics: Strategic Considerations – Scott D. Patterson, PhD, Executive Director, Medical Sciences, Amgen Inc.
2. Implementing Biomarker Assessments in Preclinical and Clinical Studies – Frank C Richardson DVM, PhD, DABT, President, FC Richardson Consulting LTD
3. Translational Medicine-Driven Methods for the Prospective Identification of Multi-Component Predictive Biomarkers – Jonathan R. Smith, Ph.D., Vice President, Research & Development, Adaptive Plus, LLC
4. Diagnostic Devices for Predictive Biomarkers: Regulatory and Statistical Perspectives on Development and Validation – Gene Pennello, PhD, Team Leader and Mathematical Statistician, Division of Biostatistics, FDA
Already indispensable in clinical development, predictive biomarkers are personalizing the practice of medicine. On February 14, 16, 21 and 23, join our panel of distinguished experts from the FDA and industry as they share lessons learned from past experience, assess frontier areas for predictive biomarkers and companion diagnostics, and look at the promise and pitfalls of translating pre-clinical and clinical experience into FDA-approved products successful in the marketplace.
Past
Translating Science Step by Step in Drug Development
October 11, 17, and 18
Program
1. Planning for a Biomarker Strategy in All Phases of Drug Development: Advantages of a Translational Approach – Brandon Higgs, Ph.D., Senior Scientist, Pharmacogenomics Group, Translational Sciences, MedImmune
2. A Viral Dynamic Model to Optimize Treatment Regimens with Direct Antivirals for Chronic Hepatitis C– Bambang S. Adiwijaya, Ph.D., Pharmacometrician Fellow, Department of Clinical Pharmacology, Vertex Pharmaceuticals Incorporated.
3. Modeling and Simulation: A Tool-Box to Improve Drug Development – Pravin R Jadhav, Ph.D., Team Leader and Expert Regulatory Scientist, Division of Pharmacometrics, Office of Clinical Pharmacology, FDA
Discovery, translation, development, market--step by step a product moves from concept to life saver. Successful companies know how to foresee boundary issues and to efficiently get compounds across the boundaries and into the marketplace. Join us on October 11, 17, and 18 to hear three distinguished experts from industry and the FDA share insights and experiences on the use of pre-clinical and clinical information to inform the successive stages in the advancement of a compound from concept to market.
Biomarkers and the Crisis in Early Stage Drug Development with Focus on CNS Drugs
June 1, 2, and 6
Program
1. Impact of Drug Development Biomarkers on Registration and Marketing: the Arrival of Personalized Medicine – Gail M. Farfel, Ph.D., President, G Meredith Consulting, LLC
2. Possibilities for New CNS Drugs Open Up Using Biomarkers and Animal Models – Jack Gorman, M.D., Consultant, Comprehensive Clinical Development
3. The Role and Interpretation of Pilot Studies: Implications for Personalized Treatments for Psychiatric Disorders – Andrew C. Leon, Ph.D., Professor of Biostatistics in Psychiatry, Professor of Public Health, Weill Cornell Medical College
When asked "What have you done for me lately?" by corporate bosses, R&D presidents have recently had to answer "Not much, I guess..." And, R&D spending has felt the resulting pain. Industry and regulators agree that there is a crisis in converting R&D effort into market success and public health success. We, the R&D community, need to fix this and biomarkers are one of the most promising tools that we have, if properly used. Learn about proper use of biomarkers in drug development, with the focus on CNS, from three recognized experts.
Modeling and Simulation for Optimizing Clinical Development
March 30, 31, April 5, 6
Program
1. Uses of Modeling and Simulation to Optimize Clinical Trials, Conventional or Adaptive – Tom Parke, Head of Clinical Trial Solutions, Tessella PLC
2. Using Systems Biology to Accelerate Oncology Drug Development – Matthew Onsum, Ph.D., Principal Scientist in Computational Biology, Merrimack Pharmaceuticals
3. Value-Based Drug Development – Zoran Antonijevic, Senior Director, Center for Statistics in Drug Development, Quintiles
4. Modeling and Optimizing Drug Development Programs – Carl-Fredrik Burman, Ph.D., Senior Principal Scientist, AstraZeneca and Assoc. Professor in Biostatistics, Chalmers Univ. Tech
These four live webinars will show how modeling and simulation support better understanding, better communication, and the optimization of clinical trial design. Join our expert speakers to see how they've combined efficacy, safety, regulatory needs, ethical demands, and commercial necessity into models and advanced their drug development programs into the modern age. The prerequisite to benefit from these webinars is knowledge of drug development for regulatory approval. Mathematical knowledge is not a prerequisite!
Modern Clinical Trials Design and Improved R&D Productivity
January 25, 26, and February 1, 2011
Program
1. Modern Clinical Trials Design and Improved R&D Productivity – Navjot Singh, Ph.D. Partner, McKinsey and Company and Joga Gobburu, Ph.D., Director, Division of Pharmacometrics, Office of Clinical Pharmacology, FDA
2. The use of Efficient Trial Design in Phase II – Alun Bedding, Ph.D., Early Phase Consultant, Biostatistics Development Partners, GlaxoSmithKline
3. Modeling and Improving R&D Productivity – Daniel S. Mytelka, Ph.D., Research Advisor, Global Health Outcomes, Eli Lilly & Company
Program chair – Michael Palmer, President, Adaptive Pharmacogenomics, LLC
These live webinars will show how modern clinical trials techniques and strategies promise to substantially increase the number and quality of innovative, cost-effective new medicines, without incurring unsustainable R&D costs. Join our expert speakers from industry and the FDA to learn how improved R&D productivity can be attained and sustained Moving from the traditional clinical development approach based on sequential, distinct phases towards a more integrated view that uses adaptive design tools to increase flexibility and maximize the use of accumulated knowledge could have an important role in increasing development productivity. Understanding and modeling the R&D process including key drivers of productivity is essential to succeeding.
Modeling Clinical Development Strategies with Biomarkers at the FDA
August 24 and 25, 2010
Program
1. History, Motivation, and Use of the FDA-APG Software Tool - Federico Goodsaid, Ph.D., Associate Director for Operations in Genomics and Biomarker Qualification Coordinator, FDA and Michael Palmer, President, Adaptive Pharmacogenomics, LLC
2. Methodology for using the FDA-APG software tool for assessing clinical program complexity and cost Michael Palmer, President, Adaptive Pharmacogenomics, LLC
The two webinars showed the FDA-Adaptive Pharmacogenomics (APG) software tool for modeling clinical development strategies that include predictive biomarkers and they related experiences with the tool in the FDA's Genomics Group.
Multi-Discipline Model-Based Drug Development to Improve “Accelerate/Go/No Go" Decisions for New Products
April 26, 27, May 4, May 5, 2010
Program
1. Modeling disease mechanisms – Matthew Onsum, Ph.D., Principal Scientist, Merrimack Pharmaceuticals
2. Modeling for statistical study design and assessment – Alun Bedding, Ph.D., Early Phase Consultant, Biostatistics Development Partners, GlaxoSmithKline
3. Modeling for PK/PD and clinical trials simulation – Kenneth G. Kowalski, President & CEO, A2PG - Ann Arbor Pharmacometrics Group, Inc.
4. Modeling product economic value – Sean Hu, MBA, Ph.D., Leader, Personalized Medicine Strategy, IMS Health
Program chair – Michael Palmer, President, Adaptive Pharmacogenomics, LLC
These live webinars showed how modern modeling techniques can be used to avoid incorrect drug development decisions, tackle costs, and assess value. The expert speakers will survey the uses of model-based drug development, particularly its role in improving decisions about accelerating, continuing or canceling a drug's development. Modeling is sometimes broken down into biological modeling (mechanisms), statistical modeling (assessment), pharmacometric modeling (PK/PD and clinical trial simulation), and economic modeling (value) and expert speakers in each area will conduct the web-based instruction. The webinars will be conducted during the weeks of April 26 and May 3. Each webinar will be 90 minutes in duration with about 70 minutes of presentation and 20 minutes for Q&A.
Consulting
Biomarkers in your clinical development programs--will the benefits outweigh the costs? Our longstanding relationship with the FDA and industry puts us in a unique position to address this question. Our consulting practice uses unique modeling and visualization techniques developed during six years of working with the FDA on biomarkers in clinical development.
The Platform
Put your modeling and simulation tools into the state-of-the-art software platform that we developed with the FDA. Scientifically capable, computationally able, web-based, and scalable, the APG software platform will support your modeling and simulation needs today, into the future, locally and globally.
Webinars
APG produces webinars that examine modern clinical trials design and improved R&D productivity from an analytical perspective. Our customers tells us that APG webinars foster intelligent discussions in their companies that span disciplines and encourage innovative thinking.
Partners and Customers
