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Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars
Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars
Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars
Doug Long VP, Industry Relations IMS HEALTH Vincent Andolina Vice President Regulatory Affairs AUROMEDICS PHARMA LLC Heather Boussios Intellectual Property Counsel EMERGENT BIOSOLUTIONS Head of Regulatory Affairs MOMENTA PHARMACEUTICALS Brian Malkin Partner FROMMER LAWRENCE & HAUG LLP Bruce Pokras Senior Corporate Counsel PFIZER E. David Murray, Jr., Ph.D. Associate Director Regulatory Affairs QUALITEST Kalpesh Shroff Associate Director of Regulatory Affairs SAGENT PHARMACEUTICALS
*Pending Confirmation
Jeff Wasserstein Senior Vice President of Business Development and Strategy FOUGERA Hayden Rhudy Senior Health Policy Advisor THE OFFICE OF SENATOR ORRIN G. HATCH Christopher-Paul Milne, DVM, MPH, JD Associate Director of Regulatory Affairs TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT Kevin Noonan, Ph.D. Partner MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP Valerie Gallagher Director Regulatory Affairs, US Consumer Healthcare PERRIGO
CHICAGO, IL 60654 (P) 312.822.8100
Candis Edwards Senior Vice President of Regulatory and Clinical Affairs AMNEAL PHARMACEUTICALS Len Smith Principal IP Counsel MEDICIS Thomas Hoffman Patent Counsel and Consultant SANDOZ, INC Sunni Churchill Associate Director of Regulatory Affairs, CMC TEVA PHARMACEUTICALS
(F) 312.602.3834
www.q1productions.com
ATTENDEE PROFILE:
Executives that will find this program of greatest applicability will be those within the generic drug and biosimilars market that are concerned with or responsible for the regulatory clearance and market access of new and existing generic and biosimilar products. Those executives from branded drug companies that are also concerned about the generic drug market and the impact on the overall healthcare environment are also encouraged to participate. Job titles of executives joining the Q1 Regulatory Clearance & Commercialization of Generic Drug and Biosimilars Conference from industry companies will include: VPs, Directors and Managers of Regulatory Affairs VPs, Directors and Managers of Intellectual Property General Counsel and Assistant General Counsel Chief Executive Officers VPs, Directors, and Managers of Business Development
SPONSORSHIP OPPORTUNITIES:
At this time, there are a variety of sponsorship and exhibition opportunities available for companies wishing to increase their visibility and participation in the program, ranging from keynote speaking opportunities through to exhibitor and documentation sponsors. Organizations most suitable for this type of exposure provide services and solutions including: Clinical Research Organizations Regulatory Clearance Consultants Contract Manufacturers Active Pharmaceutical Ingredient Manufacturers Law Firms Specialized in Patent or Life Science Law Market Research Organizations
CHICAGO, IL 60654
TRACK 2: BIOSIMILARS
2:00 OUTLINING THE FDA BIOSIMILAR GUIDELINES The highly anticipated guidelines related to biosimilar clearance pathways were released as a draft by the FDA describing the necessary steps for approval of a biosimilar product. However, the guidelines are strategically filled with vague language leaving the industry with questions, especially about the amount of testing necessary to prove bioequivalence. A thorough understanding of the guidelines can help ensure a high quality application, which will bring a product to market as quickly and with as few complications as possible. Understand what is and is not included in the guidelines Detailing the impact of the guidelines on the industry Assessing time saved through the abbreviated pathway Head of Regulatory Affairs MOMENTA PHARMACEUTICALS 2:45 BIOSIMILARS: UNTANGLING THE MYSTERIES OF BIOEQUIVALENCY The large molecules that make up biosimilars are significantly more complex than small molecule-generics causing them to be more difficult to replicate and regulate. Due to their complex nature, a biosimilar will not be interchangeable with the branded version without further and extensive testing, which is of great concern to both industry and regulators. The biosimilar guidelines, released by the FDA in early February, promise to help push the biosimilar industry forward but do not clearly address the issues related to determining interchangeability. The definition of bioequivalence and interchangeable Steps for demonstrating bioequivalence in biosimilars Identifying key data needed to prove interchangeability Kevin Noonan, Ph.D., Partner MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP 3:30 NETWORKING BREAK 3:45 PATENT PROTECTION AND REGULATORY EXCLUSIVITY OF BIOSIMILARS UNDER BPCIA The release of the BPCIA guidelines provides numerous opportunities to bring biosimilars to the market, but also presents a complex framework for patent litigation which diverts from the traditional Hatch-Waxman approach. As a result, many companies are hesitant to make this transition into biosimilars, preferring to wait until there is more guidance or clarity regarding the approval pathways. The uniqueness of the 351k pathway provides a considerable set of challenges that must be fully understood in order for the biosimilar market to truly reach its full potential. Summary of exclusivity and litigation provisions How to go about the legal process Implications of 7 versus 12 year exclusivity period Heather Boussios, Intellectual Property Counsel EMERGENT BIOSOLUTIONS 4:30 BIOBETTERS AND EXTENDING INTO THE MARKETPLACE BEYOND PATENT EXPIRATION Biobetters represent an opportunity to innovate and it has been predicted that they will have bigger market opportunities than biosimilars. Improving on an approved biologic creates strong marketing opportunities for the product but requires extensive testing to be approved under a full application. Understanding the challenges and benefits of biobetters can establish a company in the market instead of waiting for patent expirations. Identifying opportunities to expend into the marketplace Resources necessary for production of biobetters Assessing the risks and benefits of producing a biobetters Brian Malkin, Partner FROMMER LAWRENCE & HAUG LLP
12:30 LUNCHEON FOR ALL PARTICIPANTS 1:45 OUTLINING LIFE CYCLE MANAGEMENT STRATEGIES Through a series of four, 30-minute presentations, the following sessions will highlight many of the life cycle management strategies that branded drug companies employ to further lengthen their market share. Ensuring a firm understanding of these strategies is critical for generic drug and biosimilar manufacturers, as they work towards releasing new products into the market, as well as plan for future offerings. Insights on how to work within these strategies is crucial and will be the overall goal of the presentations; following which a panel discussion will encourage audience interaction and input into these branded drug company strategies. 1:45 ANTICIPATING AND MANAGING EXTENSIONS OF EXCLUSIVITY Recognizing possibilities for extending exclusivity Examples of branded company strategies for extending exclusivity Strategies used in facing and dealing with extended exclusivity strategies Len Smith, Principal IP Counsel MEDICIS 2:15 EXTENDING PATENTS Overcoming the challenge of unanticipated extensions Recognizing modifications to product that extend patents Real-time examples of branded company modifications Thomas Hoffman, Patent Counsel and Consultant SANDOZ, INC 2:45 ORANGE BOOK USE CODES Understanding coding in the Orange Book and its impacts on labeling How the Orange Book is important for decision making about the drugs going to market Impact of the Federal Circuit decision in Sun Pharmaceuticals v. Eli Lilly Bruce Pokras, Senior Corporate Counsel PFIZER 3:15 CITIZEN PETITIONS Overview of citizen petitions and their impact on generic drugs Abuse of citizen petitions by branded companies Managing delays caused by a citizen petition Vincent Andolina, Vice President Regulatory Affairs AUROMEDICS PHARMA LLC 3:45 CLOSING REMARKS & PROGRAM CONCLUSION
CONTACT Q1 PRODUCTIONS:
CHICAGO 500 N. Dearborn, Suite 500 Chicago, IL 60654 Phone: 312.822.8100 Fax: 312.602.3834 LONDON London House 271-273 King Street London, W6 9LZ Phone: +44 (0) 208 233 2833 Fax: +44 (0) 207 504 3792 MONTPELLIER, FRANCE BAT Latecoere, 34134 Montpellier, France Phone: +33 9889 99860 Fax: +1 312 602 3834
CHICAGO, IL 60654
(P) 312.822.8100
(F) 312.602.3834
www.q1productions.com