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Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars

Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars

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ALEXANDRIA, VA
JULY 12-13, 2012
REGULATORY CLEARANCE & COMMERCIALIZATION OFGENERIC DRUGS & BIOSIMILARS
Addressing Continued Challenges in Working to Streamline FDA Clearance Timelines,and Changes in Fee Structures and Biosimilar Pathways, all while Exploring theFuture 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 willcontinue their steady integration of new prod-ucts and continued growth. With 2012 poisedto be a bumper year for the industry, with a very
large number of high-prole products facing 
patent expiration in the branded drug industry,it would seem that the generic drug industryis in an enviable position. Unfortunately, thisincreased growth has also caused increasedscrutiny, 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 backfrom 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 Biosimilarsconference will have an unrivaled opportunityto discuss and debate the challenges faced inbringing new products to the market. Traditionalgeneric drug companies will have sessions fo-cused on forecasting the years ahead, FDA us-er-fees, and the continued changes presentedby equivalence standards from the FDA. Thoseorganizations investigating or already produc-ing biosimilar products will focus their attentionon new FDA policies and pathways for biosimi-lars, and the challenges that the industry facesin producing safe and effective biosimilar prod-
ucts, while still maintaining protability. Eachof these industries face specic and uniquechallenges, and through specic case studies
focusing on market leaders and innovators,panel discussions involving the audience, andFDA OGD perspectives, this program will be themust attend event of the calendar year.
PROGRAM OVERVIEW:
Russell Wesdyk
Scientic Coordinator 
FOOD AND DRUG ADMINISTRATIONPeter C. Beckerman
Senior Policy Advisor 
FOOD AND DRUG ADMINISTRATIONMarcie McClintic Coates
Chief of Staff 
MYLANElizabeth Jex
 Attorney Advisor 
FEDERAL TRADE COMMISSIONKaren Goldman, Ph.D.
 Attorney 
FEDERAL TRADE COMMISSIONBrett Wendling, Ph.D.
Economist
FEDERAL TRADE COMMISSION
*Pending Conrmation
Jeff Wasserstein
Senior Vice President of BusinessDevelopment and Strategy 
FOUGERAHayden Rhudy
Senior Health Policy Advisor 
THE OFFICE OF SENATORORRIN G. HATCHChristopher-Paul Milne, DVM, MPH, JD
 Associate Director of Regulatory Affairs
TUFTS CENTER FOR THE STUDY OFDRUG DEVELOPMENTKevin Noonan, Ph.D.
Partner 
MCDONNELL BOEHNENHULBERT & BERGHOFF LLPValerie Gallagher
Director Regulatory Affairs, US Consumer Healthcare
PERRIGODoug Long
VP, Industry Relations
IMS HEALTHVincent Andolina
Vice President Regulatory Affairs
AUROMEDICS PHARMA LLCHeather Boussios
Intellectual Property Counsel
EMERGENT BIOSOLUTIONSHead of Regulatory AffairsMOMENTA PHARMACEUTICALSBrian Malkin
Partner 
FROMMER LAWRENCE & HAUG LLPBruce Pokras
Senior Corporate Counsel
PFIZERE. David Murray, Jr., Ph.D.
 Associate Director Regulatory Affairs
QUALITESTKalpesh Shroff 
 Associate Director of Regulatory Affairs
SAGENT PHARMACEUTICALS
*Pending Conrmation
Candis Edwards
Senior Vice President of Regulatory and Clinical Affairs
AMNEAL PHARMACEUTICALSLen Smith
Principal IP Counsel
MEDICISThomas Hoffman
Patent Counsel and Consultant
SANDOZ, INCSunni Churchill
 Associate Director of Regulatory Affairs, CM
TEVA PHARMACEUTICALS
DISTINGUISHED PRESENTERS INCLUDE:
 
DAY ONE /THURSDAY, JULY 12
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
7:30REGISTRATION & CONTINENTAL BREAKFAST8:30PANEL: PREPARING FOR THE EVOLUTION OF THE GENERIC DRUGAND BIOSIMILAR INDUSTRY
With the recently released FDA guidelines on biosimilars and large numbersof 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 signicant 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 products
Brian Malkin,
Partner,
FROMMER LAWRENCE & HAUG LLPHayden Rhudy,
Senior Health Policy Advisor 
THE OFFICE OF SENATOR ORRIN G. HATCHMarcie McClintic Coates,
Chie o Sta,
MYLAN
9:15
 
HIGHLIGHTING THE IMPACT OF THE GENERIC DRUG USER FEEACT (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 FDAto 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 theiractual 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 ling and protability• Applying GDUFA to biosimilars
Peter C. Beckerman,
Senior Policy Advisor,
FDARussell Wesdyk,
Scientifc Coordinator,
FDAMarcie McClintic Coates,
 
Chie o Sta,
MYLAN
10:15
 
HEALTHCARE REFORM’S IMPACT ON GENERIC DRUGS ANDBIOSIMILARS
The Patient Protection and Affordable Care Act (PPACA) strives to manage theincreasing 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 pathwayfor biosimilars and encourages innovation and competition. Healthcare reformpromises 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 year
Hayden Rhudy,
Senior Health Policy Advisor 
THE OFFICE OF SENATOR ORRIN G. HATCH
11:00
 
NETWORKING BREAK11:30LOOKING 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 potentiallyreach $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 guidancefrom 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 difculties in projecting protability of biosimilars
Elizabeth Jex,
Attorney Advisor,
FEDERAL TRADE COMMISSION
12:15UNDERSTANDING THE EUROPEAN BIOSIMILAR MARKET
In Europe, there have already been 14 biosimilar products approved, whilethe US market is starting to blossom with the release of the FDA biosimilardraft guidelines. As a result, European companies have already encounteredand addressed challenges unique to the regulation and marketing of biosimi-
lars. Companies can benet 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 market
Doug Long,
VP, Industry Relations,
IMS HEALTH
1:00
 
LUNCHEON FOR ALL PARTICIPANTS
ATTENDEE PROFILE:SPONSORSHIP OPPORTUNITIES:KEY CONFERENCE SPEAKERS:
Executives that will nd this program of greatest applicability will be those
within the generic drug and biosimilars market that are concerned with orresponsible for the regulatory clearance and market access of new andexisting generic and biosimilar products. Those executives from brandeddrug companies that are also concerned about the generic drug market andthe 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 Ofcers• VPs, Directors, and Managers of Business Development
At this time, there are a variety of sponsorship and exhibition opportunitiesavailable for companies wishing to increase their visibility and participationin the program, ranging from keynote speaking opportunities through to ex-hibitor and documentation sponsors. Organizations most suitable for thistype 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 Staff 
MYLAN
Bruce Pokras,
Senior Corporate Counsel
PFIZER
Elizabeth Jex,
 Attorney Advisor 
FEDERAL TRADE COMMISSION
 
DAY ONE /THURSDAY, JULY 12 / TRACKED SESSIONS
Q1 Productions.
Quality 
 
First.
TRACK 1: GENERIC DRUGS
2:00
 
GENERIC DRUGS: DEMONSTRATING EQUIVALENCY IN A SHIFTINGFDA LANDSCAPE
Generic companies have the benet 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
Sunni Churchill,
Associate Director o Regulatory Aairs, CMC 
TEVA PHARMACEUTICALS
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 Aairs
QUALITEST
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 modied
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 protability
Candis Edwards,
Senior Vice President o Regulatory and Clinical Aairs
AMNEAL PHARMACEUTICALSValerie Gallagher,
Director Regulatory Aairs, US Consumer Healthcare 
PERRIGO
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
Jeff Wasserstein,
 
Senior VP o Business Development and Strategy 
FOUGERA
5:15
 
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 signicantly more complexthan small molecule-generics causing them to be more difcult 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 denition 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 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
Heather Boussios,
Intellectual Property Counsel 
EMERGENT BIOSOLUTIONS
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 benets 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 benets of producing a biobetters
Brian Malkin,
Partner 
FROMMER LAWRENCE & HAUG LLP

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