DAY ONE /THURSDAY, JULY 12 / TRACKED SESSIONS
TRACK 1: GENERIC DRUGS
GENERIC DRUGS: DEMONSTRATING EQUIVALENCY IN A SHIFTINGFDA LANDSCAPE
Generic companies have the benet of ling an abbreviated new drug ap
-plication (ANDA) with the FDA allowing them to prove that their formulationis the same as the reference product without costly and timely clinical trials.However, the FDA is continually changing their requirements for what theyconsider equivalent, which can further delay approvals and time to market.Understanding the increased regulatory demands during a time of applica-tion backlogs and drug shortages can help bring a product to market asquickly as possible.
• Overview of changing requirements• Understanding how to best document equivalency• Preparing for future changes in standards
Associate Director o Regulatory Aairs, CMC
2:45UNDERSTANDING AND IMPLIMENTING QUALITY BY DESIGN(QBD) FOR GENERIC DRUGS
From 2013, the FDA will require that all generic drug manufacturers incor-porate quality by design, or QbD measures into their ANDA applications; amove that is causing considerable concern for the industry. These new stan-dards will require organizations to rethink their approach to applications andmanufacturing, as QbD involves designing the manufacturing processes in astreamlined fashion to help ensure the quality and consistency of the prod-
uct. A review of FDA’s expectations and projected timelines will help organiza
-tions transition more smoothly into QbD implementations.
• Overview of expectations and required data• Reviewing application of standards across drug type• Meeting requirement with limited resources
E. David Murray, Jr., Ph.D.,
Associate Director Regulatory Aairs
3:30NETWORKING BREAK3:45LOOKING AHEAD: PREPARING FOR STABILITY GUIDELINES
Generic drug companies are feeling increased pressure as the FDA tighten
their bioequivalency requirements, implement QbD and soon adopt modied
ICH stability requirements. In the future, 12 months of stability data will berequired for an ANDA, as opposed to four months, which could increase thetime for approval and the cost to bring a drug to market. The industry is stillwaiting for further guidance on stability from the FDA, but by gaining an earlyunderstanding of the new standards a company can ready themselves for asuccessful adoption of the stability guidance.
• Outlining ICH stability expectations• Revising scheduling to include extended stability testing • Predicting effects of increased testing on protability
Senior Vice President o Regulatory and Clinical Aairs
AMNEAL PHARMACEUTICALSValerie Gallagher,
Director Regulatory Aairs, US Consumer Healthcare
4:30ASSESSING INCREASED COMPETITION AMONG GENERICCOMPANIES
In the past decade, a number of innovator and smaller generic drug compa-nies have entered into the generic drug market, causing a dramatic shift inthe overall landscape. This increased competition has resulted in the needfor generic drug companies to undertake far more planning when determin-ing which products to manufacture and bring to the market. As additionalbranded products come off patent in the coming years and the growth of themarket continues, assessing the competitive market and ensuring appropri-ate planning and forecasting is done, will be essential to remain an activemember of this exciting market.
• Identify how the increased diversity in the eld is changing the market• Strategies to differentiate a product or company• Preparing for the long term effects of international competition
Senior VP o Business Development and Strategy
DAY ONE CONFERENCE CONCLUDES
TRACK 2: BIOSIMILARS
2:00OUTLINING THE FDA BIOSIMILAR GUIDELINES
The highly anticipated guidelines related to biosimilar clearance pathwayswere released as a draft by the FDA describing the necessary steps for ap-
proval of a biosimilar product. However, the guidelines are strategically lled
with vague language leaving the industry with questions, especially aboutthe amount of testing necessary to prove bioequivalence. A thorough under-standing of the guidelines can help ensure a high quality application, whichwill bring a product to market as quickly and with as few complications aspossible.
• 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 AffairsMOMENTA PHARMACEUTICALS
2:45BIOSIMILARS: UNTANGLING THE MYSTERIES OFBIOEQUIVALENCY
The large molecules that make up biosimilars are signicantly more complexthan small molecule-generics causing them to be more difcult to replicate
and regulate. Due to their complex nature, a biosimilar will not be interchange-able with the branded version without further and extensive testing, which isof great concern to both industry and regulators. The biosimilar guidelines,released by the FDA in early February, promise to help push the biosimilarindustry forward but do not clearly address the issues related to determining interchangeability.
• The denition of bioequivalence and interchangeable• Steps for demonstrating bioequivalence in biosimilars• Identifying key data needed to prove interchangeability
Kevin Noonan, Ph.D.,
MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP
NETWORKING BREAK3:45PATENT PROTECTION AND REGULATORY EXCLUSIVITY OFBIOSIMILARS UNDER BPCIA
The release of the BPCIA guidelines provides numerous opportunities to bring biosimilars to the market, but also presents a complex framework for patentlitigation which diverts from the traditional Hatch-Waxman approach. As aresult, many companies are hesitant to make this transition into biosimilars,preferring to wait until there is more guidance or clarity regarding the ap-proval pathways. The uniqueness of the 351k pathway provides a consider-able set of challenges that must be fully understood in order for the biosimilarmarket 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
Intellectual Property Counsel
4:30BIOBETTERS AND EXTENDING INTO THE MARKETPLACE BEYONDPATENT EXPIRATION
Biobetters represent an opportunity to innovate and it has been predictedthat they will have bigger market opportunities than biosimilars. Improving onan approved biologic creates strong marketing opportunities for the productbut requires extensive testing to be approved under a full application. Under-
standing the challenges and benets 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 benets of producing a biobetters
FROMMER LAWRENCE & HAUG LLP