Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars

ALEXANDRIA, VAJULY 12-13, 2012

REGULATORY CLEARANCE & COMMERCIALIZATION OF GENERIC DRUGS & BIOSIMILARS

Addressing Continued Challenges in Working to Streamline FDA Clearance Timelines, and Changes in Fee Structures and Biosimilar Pathways, all while Exploring the

Future of the Global Generic Drug and Biosimilar Marketplace

500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

As healthcare professionals, payers and con-sumers continue to call for reduced prices of pharmaceutical and biotechnology products, the generic drug and biosimilars market will continue their steady integration of new prod-ucts and continued growth. With 2012 poised to be a bumper year for the industry, with a very large number of high-profile products facing patent expiration in the branded drug industry, it would seem that the generic drug industry is in an enviable position. Unfortunately, this increased growth has also caused increased scrutiny, especially from the FDA, who are con-tinually concerned with the quality and safety of medicines on the US and global market. Poten-tial user-fees from the FDA, ever growing time-lines for approval, and continued push back from branded drug companies all present con-siderable challenges for this exciting industry.

Through a two-track program, attendees partici-pating in the Q1 Regulatory Clearance & Com-mercialization of Generic Drugs and Biosimilars conference will have an unrivaled opportunity to discuss and debate the challenges faced in bringing new products to the market. Traditional generic drug companies will have sessions fo-cused on forecasting the years ahead, FDA us-er-fees, and the continued changes presented by equivalence standards from the FDA. Those organizations investigating or already produc-ing biosimilar products will focus their attention on new FDA policies and pathways for biosimi-lars, and the challenges that the industry faces in producing safe and effective biosimilar prod-ucts, while still maintaining profitability. Each of these industries face specific and unique challenges, and through specific case studies focusing on market leaders and innovators, panel discussions involving the audience, and FDA OGD perspectives, this program will be the must attend event of the calendar year.

PROGRAM OVERVIEW:

Russell WesdykScientific CoordinatorFOOD AND DRUG ADMINISTRATION

Peter C. BeckermanSenior Policy AdvisorFOOD AND DRUG ADMINISTRATION

Marcie McClintic CoatesChief of StaffMYLAN

Elizabeth JexAttorney AdvisorFEDERAL TRADE COMMISSION

Karen Goldman, Ph.D.AttorneyFEDERAL TRADE COMMISSION

Brett Wendling, Ph.D.EconomistFEDERAL TRADE COMMISSION*Pending Confirmation

Jeff WassersteinSenior Vice President of Business Development and StrategyFOUGERA

Hayden RhudySenior Health Policy AdvisorTHE OFFICE OF SENATOR ORRIN G. HATCH

Christopher-Paul Milne, DVM, MPH, JDAssociate Director of Regulatory AffairsTUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

Kevin Noonan, Ph.D.PartnerMCDONNELL BOEHNEN HULBERT & BERGHOFF LLP

Valerie GallagherDirector Regulatory Affairs, US Consumer HealthcarePERRIGO

Doug LongVP, Industry RelationsIMS HEALTH

Vincent AndolinaVice President Regulatory AffairsAUROMEDICS PHARMA LLC

Heather BoussiosIntellectual Property CounselEMERGENT BIOSOLUTIONS

Head of Regulatory AffairsMOMENTA PHARMACEUTICALS

Brian MalkinPartnerFROMMER LAWRENCE & HAUG LLP

Bruce PokrasSenior Corporate CounselPFIZER

E. David Murray, Jr., Ph.D.Associate Director Regulatory AffairsQUALITEST

Kalpesh Shroff Associate Director of Regulatory AffairsSAGENT PHARMACEUTICALS*Pending Confirmation

Candis EdwardsSenior Vice President of Regulatory and Clinical AffairsAMNEAL PHARMACEUTICALS

Len SmithPrincipal IP CounselMEDICIS

Thomas HoffmanPatent Counsel and ConsultantSANDOZ, INC

Sunni ChurchillAssociate Director of Regulatory Affairs, CMCTEVA PHARMACEUTICALS

DISTINGUISHED PRESENTERS INCLUDE:

DAY ONE / THURSDAY, JULY 12


7:30 REGISTRATION & CONTINENTAL BREAKFAST

8:30 PANEL: PREPARING FOR THE EVOLUTION OF THE GENERIC DRUG AND BIOSIMILAR INDUSTRYWith the recently released FDA guidelines on biosimilars and large numbers of blockbuster drugs coming off patent, the generic drug and biosimilar indus-try is preparing for increased opportunities to bring products to market. This exciting and significant change in its landscape is being propelled forward by new healthcare legislation and hopes to bring lower cost drugs to consumers. But with this shift comes some uncertainties that the industry must plan for.• Transitioning through the patent cliff• Predicting the biosimilars market• Identifying opportunities for innovative productsBrian Malkin, Partner, FROMMER LAWRENCE & HAUG LLPHayden Rhudy, Senior Health Policy AdvisorTHE OFFICE OF SENATOR ORRIN G. HATCHMarcie McClintic Coates, Chief of Staff, MYLAN

9:15 HIGHLIGHTING THE IMPACT OF THE GENERIC DRUG USER FEE ACT (GDUFA)The backlog of ANDA applications within the FDA has widely affected com-panies’ abilities to bring generic drugs to market, but GDUFA brings hope of alleviating these issues. GDUFA is anticipated to bring resources to the FDA to help decrease approval time while improving the safety and consistency of the drug supply. The upcoming fees stand to change the generic drug land-scape but it is yet to be determined what these fees will amount to and their actual impact on the overall industry.• Identify the positives and negatives of user fees• Examining differences of affect to large versus small companies• Understanding how fees will effect filing and profitability • Applying GDUFA to biosimilarsPeter C. Beckerman, Senior Policy Advisor, FDARussell Wesdyk, Scientific Coordinator, FDAMarcie McClintic Coates, Chief of Staff, MYLAN

10:15 HEALTHCARE REFORM’S IMPACT ON GENERIC DRUGS AND BIOSIMILARSThe Patient Protection and Affordable Care Act (PPACA) strives to manage the increasing costs of healthcare, with one of the largest cost contributors being prescription drugs. As the government tries to save money without impacting the quality of care, they are encouraging generic drug substitution, which cost, on average, 80% less than brand name drugs. PPACA also includes the Biolog-ics Price Competition and Innovation Act that developed an approval pathway for biosimilars and encourages innovation and competition. Healthcare reform promises to aid in the continual growth of the generic drug and biosimilar industry. • Status of PPACA and what it means for generics and biosimilars• Adapting to the changing healthcare environment• Forecasting healthcare changes in an election yearHayden Rhudy, Senior Health Policy AdvisorTHE OFFICE OF SENATOR ORRIN G. HATCH

11:00 NETWORKING BREAK

11:30 LOOKING AHEAD: THE BIOSIMILAR MARKET IN THE US The Biologics Price Competition and Innovation Act of 2009 (BPCIA) has result-ed in many manufacturers considering the possibility of entering the biosimi-lar market. With current estimates indicating that the market could potentially reach $8 billion by 2020, it seems as though the time has come for this exciting market. Further fueling interest in biosimilars is the release of draft guidance from FDA which will ultimately provide a regulatory framework for these types of products and will further clarify the potential market for biosimilars.• How to best align organizations to enter biosimilar production and sales• Understanding what the competitive market for biosimilars will look like• Reviewing the difficulties in projecting profitability of biosimilarsElizabeth Jex, Attorney Advisor, FEDERAL TRADE COMMISSION

12:15 UNDERSTANDING THE EUROPEAN BIOSIMILAR MARKET In Europe, there have already been 14 biosimilar products approved, while the US market is starting to blossom with the release of the FDA biosimilar draft guidelines. As a result, European companies have already encountered and addressed challenges unique to the regulation and marketing of biosimi-lars. Companies can benefit from examining the progress that has already been made in Europe to prepare for the emerging market and competition. • Comparing FDA and EMA’s guidelines • Similarities between US and key EU markets• Key lessons learned from the European marketDoug Long, VP, Industry Relations, IMS HEALTH

1:00 LUNCHEON FOR ALL PARTICIPANTS

ATTENDEE PROFILE:

SPONSORSHIP OPPORTUNITIES:

KEY CONFERENCE SPEAKERS:

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 indus-try 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

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 ex-hibitor 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

Marcie McClintic Coates, Chief of StaffMYLAN

Bruce Pokras, Senior Corporate CounselPFIZER

Elizabeth Jex, Attorney AdvisorFEDERAL TRADE COMMISSION

DAY ONE / THURSDAY, JULY 12 / TRACKED SESSIONS

500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com Q1 Productions. Quality First.

TRACK 1: GENERIC DRUGS

2:00 GENERIC DRUGS: DEMONSTRATING EQUIVALENCY IN A SHIFTING FDA LANDSCAPEGeneric companies have the benefit of filing an abbreviated new drug ap-plication (ANDA) with the FDA allowing them to prove that their formulation is the same as the reference product without costly and timely clinical trials. However, the FDA is continually changing their requirements for what they consider 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 as quickly as possible. • Overview of changing requirements• Understanding how to best document equivalency• Preparing for future changes in standardsSunni Churchill, Associate Director of Regulatory Affairs, CMCTEVA PHARMACEUTICALS

2:45 UNDERSTANDING 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; a move that is causing considerable concern for the industry. These new stan-dards will require organizations to rethink their approach to applications and manufacturing, as QbD involves designing the manufacturing processes in a streamlined 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 AffairsQUALITEST


3:45 LOOKING AHEAD: PREPARING FOR STABILITY GUIDELINESGeneric drug companies are feeling increased pressure as the FDA tighten their bioequivalency requirements, implement QbD and soon adopt modified ICH stability requirements. In the future, 12 months of stability data will be required for an ANDA, as opposed to four months, which could increase the time for approval and the cost to bring a drug to market. The industry is still waiting for further guidance on stability from the FDA, but by gaining an early understanding of the new standards a company can ready themselves for a successful adoption of the stability guidance. • Outlining ICH stability expectations• Revising scheduling to include extended stability testing• Predicting effects of increased testing on profitabilityCandis Edwards, Senior Vice President of Regulatory and Clinical AffairsAMNEAL PHARMACEUTICALSValerie Gallagher, Director Regulatory Affairs, US Consumer HealthcarePERRIGO

4:30 ASSESSING INCREASED COMPETITION AMONG GENERIC COMPANIESIn the past decade, a number of innovator and smaller generic drug compa-nies have entered into the generic drug market, causing a dramatic shift in the overall landscape. This increased competition has resulted in the need for generic drug companies to undertake far more planning when determin-ing which products to manufacture and bring to the market. As additional branded products come off patent in the coming years and the growth of the market continues, assessing the competitive market and ensuring appropri-ate planning and forecasting is done, will be essential to remain an active member of this exciting market.• Identify how the increased diversity in the field is changing the market• Strategies to differentiate a product or company• Preparing for the long term effects of international competitionJeff Wasserstein, Senior VP of Business Development and StrategyFOUGERA

5:15 DAY ONE CONFERENCE CONCLUDES

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 ap-proval 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 under-standing 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 pathwayHead of Regulatory AffairsMOMENTA 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 interchange-able 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., PartnerMCDONNELL BOEHNEN HULBERT & BERGHOFF LLP


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 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 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 CounselEMERGENT BIOSOLUTIONS

4:30 BIOBETTERS AND EXTENDING INTO THE MARKETPLACE BEYOND PATENT EXPIRATIONBiobetters 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. Under-standing 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 biobettersBrian Malkin, PartnerFROMMER LAWRENCE & HAUG LLP

8:00 REGISTRATION & CONTINENTAL BREAKFAST

9:00 REVIEWING THE HATCH-WAXMAN AMENDMENT & THE ONGOING IMPACT ON THE GENERIC INDUSTRYThe creation of the Hatch-Waxman Amendment in 1984 helped to establish today’s generic drug system, providing regulatory and commercialization guidance to both generic and branded drug companies. The act allows for originator companies to extend patent terms and generic companies to bring patents to litigation and file with the FDA via an abbreviated approval path-way. While Hatch-Waxman provides numerous opportunities, it also adds an additional level of complexity with changes that have occurred to it and re-quires frequent review by all organizations guided by the regulation. • Reviewing adjustments and extensions made to the Act• Discussing current controversies involving Hatch-Waxman• How branded and generic deals can change Hatch-Waxman litigationsBruce Pokras, Senior Corporate CounselPFIZER

9:45 BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS): A CASE OF REGULATORY SCIENCE HITTING THE ROAD… OR ROADBLOCKS?Christopher-Paul Milne, DVM, MPH, JDAssociate Director of Regulatory AffairsTUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT


11:00 OPTIMIZING OUTSOURCING FOR GENERIC AND BIOSIMILAR DEVELOPMENT Outsourcing to companies such as contract research organizations (CRO) and active pharmaceutical ingredient (API) manufacturers can help to accelerate development timelines, which often result in substantial gains in time and thus profitability for a generic drug company. The right CRO, which provides essential expertise and technology, and API suppliers aide in successful ge-neric drug development but poor selection can at the same time be detrimen-tal and hold up approval of an application with the FDA. Insight into proper outsourcing is critical for a smooth application process that can quickly bring a drug to market.• Selection criteria of API suppliers and CROs• Ensuring quality by monitoring CROs• How outsourcing impacts ANDA applicationsKalpesh Shroff, Associate Director of Regulatory AffairsSAGENT PHARMACEUTICALS *Pending Confirmation

11:45 AUTHORIZED GENERICS: SHORT-TERM EFFECTS AND LONG-TERM IMPACTIn recent years, authorized generic drugs (AGs), which are approved as brand-name drugs but are distributed as generics, have become common. Although AGs are often launched when no competing ANDA-generic has 180-day ex-clusivity, their distribution during a competitor’s 180-day exclusivity period has been controversial. This session presents perspectives from the FTC’s industry-wide study of AGs’ effects on competition in the prescription drug marketplace.• AG marketing and its relationship to the 180-day exclusivity system• Price and revenue effects of AGs• Objectives, strategies, & decision-making of brand-name and generic firms• AGs: Assessment of impact on patent challenges; use in settlementsKaren A. Goldman, Ph.D., Attorney, FEDERAL TRADE COMMISSIONBrett Wendling, Ph.D., Economist, FEDERAL TRADE COMMISSION*Pending Confirmation

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 strategiesLen Smith, Principal IP CounselMEDICIS

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 ConsultantSANDOZ, 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 CounselPFIZER

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 petitionVincent Andolina, Vice President Regulatory AffairsAUROMEDICS PHARMA LLC

3:45 CLOSING REMARKS & PROGRAM CONCLUSION


ABOUT THE ORGANIZERS:

Q1 Productions designs and develops webinars, training courses, con-ference programs and forums aimed at specifically targeted audiences in order to provide strategic and timely information. Through a rigid production process focused on end-user research and design, our team is able to understand the immediate business concerns of today’s lead-ing executives. Whether focusing on new or pending legislative issues, enhanced business processes or technologies that will drive efficiency and customer service, our programs provide solutions to the urgent needs of our attendees.

DAY TWO / FRIDAY, JULY 13

CONTACT Q1 PRODUCTIONS:CHICAGO500 N. Dearborn, Suite 500Chicago, IL 60654Phone: 312.822.8100Fax: 312.602.3834

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Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars

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