BIO’s IP & Diagnostics Symposium (BIO IPDX) will review the current patent law landscape and evaluate the impact on both the genetic diagnostics and biopharmaceutical sectors. The program will review IP issues for both diagnostics generally and companion diagnostics. The program will also explore some of the potential regulatory dimensions. BIO aims to use this event to inform industry and government alike on how to move the science forward in the current climate.
Where & When
Monday, July 22, 2013
Hilton Alexandria Old Town Hotel │ 1767 King Street, Alexandria, VA 22314
Schedule of Events
*subject to change
Keynote Breakfast 8:00 am – 9:30 am
Jeffrey N. Peterson, Chief Executive Officer, Target Discovery, Inc.
Session One: Obtaining Patent Protection 9:30 am – 11:00 am
Sponsored by: McDonnell Boehnen Hulbert & Berghoff LLP
The first panel will discuss strategies for obtaining patent protection for diagnostic reagents and methods in light of recent decisions from the Supreme Court and Federal Circuit. The panel will provide views from in-house patent counsel, outside counsel and a representative from the US Patent and Trademark Office.
Moderator: Don Zuhn, McDonnell Boehnen Hulbert & Berghoff LLP
Kevin Noonan, McDonnell Boehnen Hulbert & Berghoff LLP
Duane Marks, Patent Counsel, Roche Diagnostics Operations, Inc.
Mary Till, Legal Advisor, Office of Patent Legal Administration, U.S. Patent & Trademark Office
Networking Break 11:00 am – 11:15 am
Session Two: Regulatory & Reimbursement 11:15 am – 12:30 pm
Sponsored by: Brinks Hofer Gilson & Lione
The panel will present an overview of the FDA review process for investigational drugs being developed with companion diagnostics, and tips for regulatory submissions specialists in preparing pre-IND packages, participating in meetings with the FDA, and preparing IND and NDA filings. The panel will also address reimbursement strategies and potential issues for companies developing diagnostics.
Moderator: Jennifer L. Fox, Counsel, Brinks Hofer Gilson & Lione
Sheila D. Walcoff, Founding Principal, Goldbug Strategies LLC
Jeffrey N. Gibbs, Hyman, Phelps & McNamara, P.C.
Working Luncheon & Session Three: 12:30 pm – 2:15 pm
Business Development & Strategic Deals
Sponsored by: Sterne Kessler Goldstein & Fox LLP
The panel will discuss best practices in structuring commercial collaborations and transactions in the personalized medicine and companion diagnostics space and the impact of recent case law on patents in this industry.
Moderator: Eric Steffe, Director, Sterne Kessler Goldstein & Fox LLP
Tim Shea, Director, Sterne Kessler Goldstein & Fox LLP
Pia Maria Gargiulo, PhD, Managing Director, Companion Diagnostics, Precision for Medicine
Mollie Roth, Managing Partner, PGx Consulting
Zoran Zdraveski, Senior Director of Intellectual Property, Epizyme, Inc.
Closing Remarks 2:15 pm –2:45 pm
Although there is no fee to register, space is limited and you must reserve your seat. To promote a diverse audience, BIO asks that each company/organization register no more than two (2) people. Exceptions will be made for government attendees. To register, please contact Caroline Arrington at [email protected] or (202) 962-9228.