Mid-Atlantic Bio Conference Panels To Address Pressing Health Care Policy Issues
From healthcare reform and PDUFA to changes in intellectual property protections and Small Business Innovation Research regulations, it can be difficult to keep up with policy changes. Through a wide-ranging program, the 2012 Mid-Atlantic Bio Conference will help attendees understand the latest developments on Capitol Hill and at the FDA.
“With an FDA workshop, sessions focused on the changes to the America Invents Act as well as the future of health policy, the latest SBIR changes and developing medicines for orphan diseases, we have a comprehensive public policy program that can’t be beat,” said Art Jacoby, Chief Executive officer, Tech Council of Maryland. “Our attendees will be able to learn about these policies and how they affect their companies straight from the experts here in Washington, DC.”
“One of the greatest draws for our constituents,” Steve Casey, Vice President of Statewide Operations for NCBiotech, added, “is the fact that Washington, DC is the epicenter for health care policy in our country. This conference offers participants a unique opportunity to engage with government officials who directly influence policy and funding decisions, as well as sessions that allow researchers, business executives and government officials to collaborate on ways to improve access to life-changing therapies and foster a competitive research and development environment.”
This year’s conference takes place September 27-28 in Bethesda, MD.
Plenary Panel: Seeing a Bright Future: What’s ahead for an ever-changing Life Sciences Industry
Thought leaders from industry, investment and public policy share observations and insights on developments, trends and opportunities.
Panelists
N. James Barrett, Ph.D., General Partner, New Enterprise Associates (NEA)
Vicki Seyfert-Margolis, Senior Advisor to Chief Scientist, FDA
Ron Cohen, M.D. President and CEO Acorda Therapeutics, Inc.
Reassessing intellectual property strategies in response to the America Invents Act
Over the coming year several significant changes to IP will be phased into law: a modified first-to-file system for awarding patents; a post grant review procedure on petition by a third party; an expanded definition of prior art; an expanded prior use defense against infringement; and a new administrative derivative proceeding, among others. Intellectual property experts from corporate, university, and private practice who are daily studying and responding to these changes in the law will offer insights.
Panelists
Bruce Artim, Director, Federal Affairs, Eli Lilly and Company
Wes Blakeslee, Executive Director, Johns Hopkins Tech Transfer
Best Practices for Working with the FDA, Parts I & II
During this two-part workshop, panelists drawn from the FDA, regulatory consultants, and other companies will discuss opportunities, challenges and the best practices in key areas for early stage companies as well as the recent reauthorization of PDUFA. The presenters will also discuss – in detail – the elements of a good FDA submission.
Moderator: Peter A. Patriarca, Senior Clinical Consultant, Biologics Consulting Group
Panelists
Joelle P. Blakaitis, MS, RAC, Director, Global Regulatory Affairs, MedImmune
Shannon Williams, Chief Scientific Officer, ADial Pharmaceuticals
Lynn Whipkey Mehler, Partner, Hogan Lovells
FDA staff
SBIR/STTR Workshop: Current Opportunities and understanding program changes
The SBIR (Small Business Innovation Research) and STTR (Small Business Technology Transfer) Grants provide one of the largest sources of early stage technology funding (over $2 billion per year). In the first of this special two-hour session, experts will describe the changes in rules proposed to implement recent reauthorization, and a discussion of strategic role of SBIR/STTR and non-dilutive funding in the financial strategy of a startup. In the second hour, program representatives from leading NIH Institutes will describe current open funding opportunities and will be available for one-on-one breakout discussions with attendees.
Panelists
Matt Portnoy, NIH SBIR/STTR Program Coordinator, Director, Division of Special Programs, OEP, OER, NIH, DHHS
Christy Shaffer, PhD Venture Partner and Managing Director Hatteras Venture Partners
Kurt Marek, Program Director SBIR coordinator, National Heart Lung Blood Institute (NHLBI)
Stephanie Fertig, Research project manager SBIR Program, National Institute of Neurological Disorders and Stroke (NINDS)
Jennifer Shieh, AAAS Science & Technology Policy Fellow, SBIR Development Center, National Cancer Institute (NCI)
Succeeding in Rare Diseases: A Collaborative Approach
Orphan products can often deliver life-saving therapies where no other option previously existed. Panelists will discuss recent regulatory changes, combined with the ever-increasing environment in which reimbursement will be limited to the most innovative products, creating both traps and opportunities. Our experts will also examine successful orphan products, which require expertise, new relationships and novel strategies allowing the potential to generate significant financial returns.
Panelists:
Tim Cote, CMO, NORD, and former Director OOPD
Ros Cheetham, MD, Vice president, Medicine Development Leader, Rare Diseases, GSK
Anne Pariser, M.D. Associate Director for Rare Diseases, Rare Disease Program, Office of New Drugs, Center for Drug Evaluation and Research, FDA
