Biotech Policy: 100 Days with a Democratic Congress
9:45am – 11:00am

BayBio2007 will mark the first 100 days under a Democratic Congress since 1994. Already, we are seing legislation on Medicare Part D price negotiations, drug safety initiatives, and renewed stem cell legislation. Where is all this going? What will happen with FDA and such issues as drug safety and reauthorization of prescription drug (and medical device) user fees? This session will explore the initial developments under the new Congress and how they are likely to affect the biotech industry; how the “new” Congress made its mark so far in impacting the nation’s healthcare agenda in general and the biotech industry specifically; how oversight “Democratic style” is likely to influence FDA regulations.

Panel Moderator:

Michael A. Swit, Esq.
Vice President, The Weinberg Group, Inc.

Panel Speakers:

Dan Bernal
District Director for Congresswoman and Speaker of the House Nancy Pelosi

Peter Muller
Director, Government Affairs, Genentech, Inc.

Peter Pitts
Senior Vice President, Global Health Affairs, Manning Selvage & Lee
Co-Founder, Center for Medicine in the Public Interest
Former Associate Commissioner for External Relations, FDA

Jeffrey L. Taylor
Federal Relations Group, Barnes & Thornburg LLP
Washington D.C. Representative, BayBioCONNECT

Evolving Regulatory Environment: Challenges and Opportunities
11:15am – 12:30pm

2007 represents the cusp of unprecedented legislative, legal, and regulatory changes affecting the Food & Drug Administration and the companies it regulates, and these looming changes will significantly impact the strategic and financial plans of life sciences companies. Key issues that will be addressed by Congress, FDA, and the Courts in 2007 and beyond include congressional reauthorization and potential expansion of the Prescription Drug User Fee Act (PDUFA), new drug safety legislation, potential limitations on drug marketing and promotion, and Medicare drug reimbursement policy changes; FDA implementation of new rules for expanded access to, and charging for, experimental therapies, and an increasingly enforcement-minded attitude at FDA; Evolving judicial interpretations of intellectual property rights and product liability law for FDA-regulated products; and continued scrutiny of company disclosures by the SEC, FDA, and private securities litigants in the context of public offerings and company announcements regarding clinical trials and regulatory milestones. This panel will provide both an overview of the momentous changes that are already underway, as well as practical real-life advice on how companies should prepare for the challenges and opportunities under the evolving regulatory environment.

Panel Moderator:

James Czaban
Partner, FDA Department, WilmerHale

Panel Speakers:

Ginny Beakes-Read
Regulatory Liaison and Special Projects, Genentech, Inc.
Formerly of FDA’s Center for Drug Evaluation and Research

Brian C. Cunningham
Chief Executive Officer, Trellis Bioscience

Sailing to FDA Product Approval: Innovations in the Clinical Trial Paradigm
2:00pm – 3:15pm

As biotechnology related to the study and diagnosis of disease has progressed, there is increasing concern that the number of products that gain approval by FDA has decreased, due to failures in the clinical trial phase. It has been estimated that clinical testing for a new biotech product candidate takes on average approximately eight years at a cost of $626 million. This session will provide an overview of current regulatory and legal issues for clinical development of biopharmaceuticals, with an emphasis on innovations intended to streamline clinical testing. The panel specifically will explore issues including FDA’s Critical Path Initiatives and resultant guidelines on adaptive trial design, revisions to traditional data analysis methods, such as the use of Bayesian Statistics, exploratory Investigational New Drug studies, and the debate on appropriate trial endpoints. Topics addressed will include litigation by patients and advocacy groups to gain increased access to investigational products, and efforts by FDA to expand patient access and allow reimbursement for investigational products. The panel also will discuss recent issues confronting sponsors in clinical trial agreements with investigators and investigational sites, and in subject informed consent forms, and the impact of the clinical trial process on shareholder value.

Panel Moderator:

Judith Hoglind, PhD
Senior Director, Global Regulatory Affairs and Medical Writing, Quintiles Inc.

Panel Speakers:

Josh L. Distler, Esq.
Chief Operating Officer, Attenuon LLC

Dr. Phoebe Mounts, Esq.
Morgan, Lewis & Bockius LLP

Eugene C. Poggio, PhD
President, Biostatistical Consulting, Inc.

Personalized Medicine: Development, Delivery and Regulation
3:30pm – 4:45pm

This session introduces the scientific, policy, and business concepts impacting new business models of linking genomics, bioinformatics, imaging, systems networking, and partnering with unique healthcare stakeholders to create the necessary infrastructure for personalized medicine (PM) to take shape and succeed in the US healthcare marketplace. Examples of innovative PM products (as models) that integrate molecular, bioinformatics, miniaturization, robotics, and RX/DX concerns, as well as the clinical realities of a specific disease state will be highlighted that can more efficiently provide insight into the dilemmas and opportunities for PM solutions. A high level review of an academic study that qualitatively and quantitatively captures what the broad stakeholder community believes about the promise of personalized medicine and what they plan to do within their own enterprises over the next 5 years with that current understanding. A review of the current legislative, regulatory, and public policy activities will also be presented. And finally, the discussion will encompass the critical issues, strategies, and challenges related to the delivery of these products and likely factors that will drive these advances in the near future.

Panel Moderator:

Patrick Terry
Co-Founder, Director of Consumer Advocacy, Genomic Health, Inc.

Panel Speakers:

Pierre Cassigneul
President and CEO, XDx Inc.

Patricia Deverka, MD
Fellow in the Center for Genome Ethics, Law and Policy, Duke University

Matthew K. Hudes
National Managing Principal, Biotechnology, Life Sciences & Health Care, Deloitte Consulting LLP