Regulatory

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Track 2
Friday, March 9, 2012

Session 1
Regulatory Risk: How Do We Manage?
9:45AM – 11:00AM

The generic/pharmaceutical/biotech industry is being faced with a constantly changing landscape with growing pressures from the regulatory agencies on delivering better clinical outcomes. As a result, companies are dedicating a higher R&D budget to improve the success rate of drug approvals. However, in recent years, there is a poor correlation between high R&D budgets and high drug approval rates.

What are the main reasons why drugs do not get approved?
What are the reasons why drug approvals get delayed?
What are the areas of drug discovery research that need better support (in order to catch “failed drugs” faster)
What regulatory decisions are being made by companies in order to reduce risk and improve profits in current times?
An overall summary of the strategic avenues companies are taking to compete in the current landscape will be discussed as well as a guide on how we can improve the value of each R&D dollar that is spent.

Moderator

Manisha Deshmukh
Regulatory Affairs
BioMarin Pharmaceutical, Inc.

Panel Speakers

Flavia Borellini, Ph.D.
Lifecycle Leader, Zelboraf
GPS Oncology
Genentech (a member of the Roche group)

Steven B. Engle
CEO, Averigon Consulting

Pooja Jain
Sales Development Manager, PharmaBioTech
Elsevier, Inc.

David Sahner, M.D.
Senior Director, Clinical Translation
SRI International

Session 2
Coverage and Reimbursement Risks: The Influence of Deficit Reduction and Other Pressures
11:30AM – 12:45PM

The panel of legal, government relations, and industry experts will decipher the deficit-reduction measure proposals that may be implemented and will have a profound impact on the Life Science community, in both the near term and the longer term. The discussion will highlight legal, government relations, and business risk for Life Science companies to consider as health care reform implementation continues, and coverage and reimbursement is increasingly threatened. The panelists have significant experience coordinating patient and disease groups and providers and other stakeholders to lay the groundwork for success in securing appropriate coverage and adequate reimbursement. The panel will cover the following questions, among others:

What coverage and reimbursement changes are Congress, the Administration, and others considering right now and which ones are the most likely to be implemented?
How will election year politics at both the federal and state levels affect coverage and reimbursement issues?What impact may deficit-reduction have on biosimilars?
How will orphan drug development programs be impacted by these developments? Will they receive any special protections?
How will the issues regarding drug shortage affect the potential for coverage and reimbursement cuts?

Moderator

William A. Sarraille
Healthcare Partner, Sidley Austin LLP

Panel Speakers

Peter G. Milner, M.D., FACC
Founder, Optivia Biotechnology, CV Therapeutics, Inc. and ARYx Therapeutics, Inc.
Former Assistant Professor of Medicine at Washington University

Perry Goldman
Vice President, Deputy General Counsel, Onyx Pharmaceuticals, Inc.

Esme Smith
Vice President, Deputy General Counsel and Assistant Secretary, Dendreon Corporation

Jason Brandwene
Corporate Counsel, Gilead Sciences, Inc.

Session 3
Regulating Diagnostics: Anticipating the Path Forward
2:30PM – 3:45PM

In a time when advanced technologies and the proliferation of new genomic information are transforming healthcare, diagnostics companies are compelled to develop the next big thing that will enhance how we predict, diagnose and treat disease. Currently, our ability to develop companion diagnostics and cheaper and faster genetic sequencing tools for clinical use surpasses the guidelines that stand to regulate them. But governing bodies may shake things up with proposed changes that could rewrite the playbook for lab-developed and direct-to-consumer tests and modify reimbursement procedures that could dramatically alter the commercial diagnostics landscape. This has left diagnostics companies, as well as labs, without clear guidance as they build their pipelines and expand their test menus. In addition, the uncertainty has sent investors to the bench, unwilling to play and subsequently restraining innovation. Featured on this panel are industry decision-makers with extensive regulatory experience who will discuss how they navigate the U.S. regulatory pathway for in vitro diagnostics and anticipate the possible changes ahead.