Day 1 - Thursday, July 24, 2014

7:15
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks
8:30
Unearthing Changes at the Office of Generic Drugs and Understanding Their Impact on the Future Growth and Evolution of the Generic Drug Industry
9:15
Keynote Address
10:15
Morning Coffee Break
10:30
Deciphering GDUFA and Its Impact on ANDA Approvals, Profit Margins, and Performance Metrics
11:30
Demystifying the FDA’s Rulemaking Authority: Exploring How FDA’s Proposed Labeling Rule and Other Proposed Rules and Guidances Will Affect the Dynamics of the Generic Pharmaceutical Industry
12:30
Networking Luncheon
1:45
The Changing Paradigm of the Generic Drug Market Entry: Assessing Brand Name Drug Vulnerabilities and New Targets for Generic Drug Manufacturers
2:45
Afternoon Refreshment Break
3:00
Operating in the Post-Bartlett Landscape in Light of New Decisions and FDA Rulemaking
4:00
The Case for Generic Drug Quality: Understanding How Quality Initiatives in Congress and FDA, and DOJ Enforcement Activity Have Impacted the Generic Drug Industry
5:00
Mitigating the Effects of New Stability Data Requirements to Ensure the Integrity of Generic Drugs
6:00
Conference Adjourns to Day 2

Day 2 - Friday, July 25, 2014

7:15
Continental Breakfast
8:15
Co-Chairs’ Opening Remarks
8:30
Exploring Strategies for Biosimilar Development in the United States: Regulatory, IP & Commercial Considerations Gleaned From the Global Framework
9:45
Exploring New Developments and Related Tactics in Hatch-Waxman Litigation Which Are Impacting the Strategies of Generic Drug Manufacturers
10:45
Morning Coffee Break
11:00
Developing Settlement and Negotiation Methods Post- Actavis to Minimize Chances of Costly Government Enforcement Actions
12:15
Networking Luncheon
1:30
View from the Bench: The Judges Speak on Major Developments Affecting the Generic Drug Industry
2:30
Afternoon Refreshment Break
2:45
Comprehending How Mergers and Acquisition Activity and Collaborative Partnerships Are Impacting and Changing the Dynamics of the Generic Pharmaceutical Industry
4:00
Examining Provisions of the Affordable Care Act Impacting Generic Drug Pricing and Reimbursement
5:00
Conference Adjourns

Day 1 - Thursday, July 24, 2014

7:15
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks

Stephen R. Auten
Partner
Taft Stettinius & Hollister LLP

Carmen M. Shepard
Senior Vice President, Global Policy and Regulatory Counsel
Mylan Inc. (Washington, DC)

8:30
Unearthing Changes at the Office of Generic Drugs and Understanding Their Impact on the Future Growth and Evolution of the Generic Drug Industry

Gary J. Buehler R.Ph.
VP, Global Regulatory Intelligence and Policy
Teva Pharmaceuticals Industries Ltd. (North Wales, PA)

Recent developments at the Office of Generic Drugs (“OGD”) at the FDA have impacted the generic pharmaceutical industry at unprecedented levels. From the musical chairs-like changes in leadership positions, to the hiring of hundreds of new staff members, and the OGD’s designation as a “super office,” the Office of Generic Drugs has experienced growing pains which have significantly affected the generic drug industry. OGD has ultimate jurisdiction on how generic drug companies conduct their business activities and over GDUFA and its continuing implementation. This session will examine how generic drug companies can adapt and adjust their practices accordingly.

  • Examining changes at the FDA which have impacted the evolving structure and powers of the OGD
    • Defining OGD’s status as a super office
    • Monitoring comprehensive personnel reorganizations within the office and understanding their significance
    • Exploring circumstances which are contributing to administrative and substantive delays of significant decision-making at the OGD
  • Working around and with the FDA’s new procedures for an effective flow of information
    • Mastering the MaPP for better communications
  • Identifying sources of funding and addressing how funding at the Office of Generic Drugs affects its operations
  • 9:15
    Keynote Address

    Speakers

    Keith Flanagan
    Transition Lead for Policy, OGD/CDER/FDA, Office of Generic Drugs
    United States Food and Drug Administration (Rockville, MD)

    10:15
    Morning Coffee Break
    10:30
    Deciphering GDUFA and Its Impact on ANDA Approvals, Profit Margins, and Performance Metrics

    Michael H. Hinckle
    Partner
    K&L Gates LLP (Research Triangle Park, NC)

    The Generic Drug User Fee Amendment of 2012 (“GDUFA”) further solidified the legitimacy of the generic drug industry and enhanced its status. By all estimates, it has been calculated that GDUFA will bring in approximately $1.5 billion dollars in additional revenue for the FDA. In its second year, the generic drug industry is still grappling with the complex language, while the OGD is preparing to meet its third year performance metrics on October 1, 2014. In this session, conference participants will benefit from listening to the panelists’ exploration of best practices for avoiding ANDA delays and obtaining the coveted 180-day exclusivity in a more expeditious manner. Points of discussion will include:

    • Exploring GDUFA Milestones: Discovering where OGD is in meeting its performance metrics for October
    • Surveying the backlogs of ANDA submissions
    • Strengthening the quality of ANDAs to minimize delays
      • Federal Register (Jan. 23, 2014) on improving the quality of ANDAs
    • Mastering GDUFA requirements to obtain exclusivity
    • Predicting how the FDA and OGD will strategize to eliminate the backlog and increase efficiency

    11:30
    Demystifying the FDA’s Rulemaking Authority: Exploring How FDA’s Proposed Labeling Rule and Other Proposed Rules and Guidances Will Affect the Dynamics of the Generic Pharmaceutical Industry

    Marc J. Scheineson
    Partner
    Alston & Bird LLP (Washington, DC)

    Carmen M. Shepard
    Senior Vice President, Global Policy and Regulatory Counsel
    Mylan Inc. (Washington, DC)

    Christine Simmon
    Senior Vice President, Policy & Strategic Alliances
    Generic Pharmaceutical Association (GPhA) (Washington, DC)

    The FDA and the OGD announced that it will publish several rules and guidances which will have a considerable impact on the landscape of the generic drug industry. The FDA is currently considering comments to its proposed rule on generic drug labeling, which would effectively undermine the Supreme Court’s ruling in Mutual Pharmaceutical Co. v. Bartlett (2013) and expose the generic drug industry to substantial new tort liability. The generic drug industry can also expect more clarity on biosimilars, exclusivity guidance for certain combination drugs, and guidance on REMS-controlled drugs. These rules and guidances will extensively govern how generic drug companies will operate certain aspects of their business to comply with new requirements.

    • Deciphering the FDA’s Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
      • Understanding how the imposition of liability for matters relevant to the labeling requirements will impact the generic pharmaceutical industry
      • Exploring the Rule’s potential effect on the branded pharmaceutical industry
      • Examining the FDA’s logic in this proposed rulemaking
        • reactive vs. passive
    • Monitoring other proposed rules and guidances that will have a tremendous impact on the generic drug industry
      • Pending guidance for biosimilars
      • Draft exclusivity guidance for certain combination drugs
      • Forthcoming guidance on REMS-controlled drugs

    12:30
    Networking Luncheon
    1:45
    The Changing Paradigm of the Generic Drug Market Entry: Assessing Brand Name Drug Vulnerabilities and New Targets for Generic Drug Manufacturers

    David Abramowitz
    Partner
    Locke Lord LLP

    Richard DiCicco
    Chairman
    Harvest Moon Pharmaceuticals USA, Inc. (Falls Chuch, VA)

    John L. Dauer Jr.
    Chief Patent Counsel
    Sun Pharmaceutical Industries, Inc.

    As nearly every major blockbuster drug is set to go off patent by 2017, the generic drug industry must now make product assessments outside of the blockbuster model. The industry is becoming ever more creative and resourceful in isolating key drug products to minimize investment risks. In choosing these new targets, the generic drug industry is encountering difficulties with matters such as REMScontrolled drugs. This panel shall explore strategies that generic drug companies can employ in choosing new branded targets and obtaining the prize of 180-day exclusivity. Points of discussion will include:

    • Maximizing profit margins by crafting smart legal and business strategies for identifying targeted pharmaceutical patents ripe for an ANDA or biosimilar challenge
    • Exploring questions of valuation: economic and monetary considerations for determining which products on brand name drugs are worth targeting
      • Identifying niche drugs in a crowded marketplace
    • How do generic drug companies differentiate their strategies from those of their competitors in target assessment?
    • Fine-tuning approaches to obtaining samples for REMScontrolled drugs
      • Analyzing the advantages and disadvantages of pursuing a citizens petition in a REMS matter
      • Exploring antitrust implications with REMS-controlled drugs
    • Determining how to pursue products under REMS or restricted distribution/access and when to ignore or pursue such products
      • Reviewing the time frame to obtain samples
      • Orange Book patents covering REMS or restricted distribution/access processes

    2:45
    Afternoon Refreshment Break


    3:00
    Operating in the Post-Bartlett Landscape in Light of New Decisions and FDA Rulemaking

    Delphine W. Knight Brown
    Partner
    Axinn, Veltrop & Harkrider LLP (New York, NY)

    Jay Lefkowitz
    Partner
    Kirkland & Ellis LLP (New York, NY)

    The Supreme Court in Mutual Pharmaceutical Co. v. Bartlett (2013) ruled that generic drug manufacturers were shielded from tort liability because they were prohibited from changing a generic drug’s label from that of the brand name drug counterpart. However, generic drug manufacturers must continue to remain vigilant as emerging case law and FDA’s rulemaking authority may expose them to new tort liabilities.

    • Analysis of Bartlett and its reaffirmation of PLIVA, Inc. v. Mensing (2011) and Wyeth v. Levine (2009)
    • Exploring the theory of federal preemption from the generic drug industry’s perspective
    • New trends in products liability theories affecting generic drugs
      • Ramifications of failure to update labels theories
    • Responding to new products liability theories made by plaintiffs
      • Implications of Wyeth, Inc. v. Weeks
    • Understanding FDA’s proposed rule which may impose liability on generic drug manufacturers despite the Supreme Court’s ruling in Bartlett and avenues for generic drug manufacturers to potentially challenge the rule
    • Repositioning products liability defenses to counter FDA’s proposed rule on labeling

    4:00
    The Case for Generic Drug Quality: Understanding How Quality Initiatives in Congress and FDA, and DOJ Enforcement Activity Have Impacted the Generic Drug Industry

    Shashank Upadhye
    Partner
    Amin Talati & Upadhye, LLC

    Douglas Farquhar
    Director
    Hyman, Phelps & McNamara, P.C. (Washington, DC)

    W. Warren Hamel
    Partner and Chair, Investigations and White Collar Defense Practice
    Venable LLP

    In the course of the last several years, FDA has scrutinized the quality of generic drugs and as a result, there have been several high profile actions for violations of current good manufacturing practices (“cGMPs”) by generic drug manufacturers. There has also been DOJ activity against generic drug manufacturers for cGMP violations which based on statements by DOJ officials, will not stop anytime soon. In tandem with the activities of these federal agencies, last year’s implementation of the Drug Quality and Security Act (the “track and trace program”) — which seeks to drastically minimize instances of contamination in the manufacturing and distribution process — has also had extensive ramifications for the generic drug industry. This session will discuss new cGMP definitions and increased enforcement activity, along with the repercussions from the Drug Quality and Security Act on the generic drug industry.

    • Decoding FDASIA provisions applicable to cGMPs
      • Interpreting changes to the definition of cGMPs
      • Identifying risk-based cGMP concepts and applicability to risk-based inspections
      • Exploring risk-based concepts under the FDA’s initiative, Pharmaceutical cGMP’s for the 21st Century: A Risk-Based Approach
    • Examining the FDA’s Quality Agreements Draft Guidance
      • Determining how third party suppliers and contract manufacturers must follow cGMP protocols
      • Safeguarding the integrity of imported products and ingredients for generic drugs
    • Preparing for CDER’s inspections at manufacturing facilities
    • Recognizing the consequences of CDER’s international inspections and how they affect the generic drug industry in the United States
    • Analyzing the Ranbaxy cGMP enforcement action and its impact on the generic drug industry
    • Dissecting the Drug Quality and Security Act: understanding the consequences of the track and trace program
      • Simplifying the timeline under the ‘track and trace’ program
      • Complying with the requirements on electronic tracking of generic drugs

    5:00
    Mitigating the Effects of New Stability Data Requirements to Ensure the Integrity of Generic Drugs

    Candis Edwards
    Senior Vice President, Regulatory/Clinical Affairs
    Amneal Pharmaceuticals LLC (Hauppauge, NY)

    Chandra Vattikonda M.Pharm., Ph.D.
    Executive Director, Biopharmaceuticals
    Par Pharmaceuticals, Inc. (Spring Valley, NY)

    Over eighty percent of prescriptions in the United States are filled with generic drugs. In order to ensure the integrity and quality of generic drug products, as of this past June 20, several drug companies were required to submit more stability data to obtain ANDA approvals. With approvals getting more costly and harder to obtain, generic drug companies must determine how to meet FDA’s expectations and decrease costly errors.

    • Implementing strategies for complying with new stability data requirements
    • Overcoming hurdles associated with providing more stability data
      • Alleviating the effects of barriers to entry
      • Appraising the increased costs in producing generic drugs
    • What impact will providing additional stability data have on the timeline for generic drug companies?
    • Reinforcing the idea that generic drug products are as safe as the reference products

    6:00
    Conference Adjourns to Day 2

    Day 2 - Friday, July 25, 2014

    7:15
    Continental Breakfast
    8:15
    Co-Chairs’ Opening Remarks

    Stephen R. Auten
    Partner
    Taft Stettinius & Hollister LLP

    Carmen M. Shepard
    Senior Vice President, Global Policy and Regulatory Counsel
    Mylan Inc. (Washington, DC)

    8:30
    Exploring Strategies for Biosimilar Development in the United States: Regulatory, IP & Commercial Considerations Gleaned From the Global Framework

    Timothy H. Kratz
    Partner
    McGuireWoods LLP

    Gregory J. Glover MD
    Principal
    Pharmaceutical Law Group PC (Washington, DC)

    • Battling legal challenges to developing biosimilars in the United States
    • Anticipating the release of FDA’s guidance on biosimilars
      • When can we expect that the draft guidance will be released?
      • What can we learn from the FDA’s draft guidance?
    • Smart ways to combat REMS obstacles in biosimilar development
    • Clarifying the status of state and federal regulatory frameworks for biosimilars
      • Examining interchangeability requirements at the state and federal levels
      • Reviewing interchangeability requirements under the Biologics Price Competition and Innovation Act of 2009
      • Surveying a pharmacist’s authority for automatic substitution of biosimilars in the states and at the federal level
      • What are the hurdles to overcome with respect to naming issues in the state and federal frameworks?
      • Clarifying exclusivity provisions for biosimilars
    • Observing global pathways for lessons on biosimilar regulatory approval

    9:45
    Exploring New Developments and Related Tactics in Hatch-Waxman Litigation Which Are Impacting the Strategies of Generic Drug Manufacturers

    Moderator: Teresa “Terry” Stanek Rea
    Partner
    Crowell & Moring LLP (Washington, DC)

    Huong Nguyen
    Senior Director, Intellectual Property
    Impax Laboratories, Inc. (Hayward, CA)

    Rekha Hanu Ph.D., Esq.
    Counsel - Intellectual Property
    Akorn, Inc.

    Stephen R. Auten
    Partner
    Taft Stettinius & Hollister LLP

    • Understanding the implications of inter partes review (“IPR”) and post-grant review (“PGR”) for the generic drug industry relative to Hatch-Waxman litigation
      • When is the best time to invoke AIA post-grant review and inter partes review procedures?
      • Gathering valuable lessons on generic drug IPR cases: Apotex v. Alcon, Ranbaxy v. Vertex, and Amneal v. Supernus
    • Analyzing new obviousness considerations in the district courts and the PTO
      • Comprehending the potential impact of the Goodlatte bill
    • Untangling Hatch-Waxman safe harbor provisions
      • Consequences of the Supreme Court denying certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, Inc.
      • What constitutes a safe harbor?
      • Tackling the circuit splits and reviewing key decisions
    • Exploring standards and controversies for claim construction
      • Lighting Ballast Control v. Philips Electronics

    10:45
    Morning Coffee Break
    11:00
    Developing Settlement and Negotiation Methods Post- Actavis to Minimize Chances of Costly Government Enforcement Actions

    Seth C. Silber
    Partner
    Wilson Sonsini Goodrich & Rosati

    James Peterka
    Partner
    Locke Lord LLP

    The Supreme Court issued its decision in FTC v. Actavis in June 2013 to address reverse payment matters in Hatch-Waxman cases. Although the Supreme Court held that “rule of reason” would be the standard by which reverse payment matters were decided, the widespread effects of Actavis are still not yet clear as states and the FTC continue to challenge settlement agreements.

    • Understanding the antitrust law and related principles affecting the generic pharmaceutical industry
    • Evaluating the Supreme Court’s ruling in FTC v. Actavis
      • Reviewing the “rule of reason” standard and its application in branded-generic agreements
    • Anticipating new developments in reverse settlement cases
    • Formulating effective review procedures to negotiate settlements
    • Predicting FTC action in negotiating settlements
    • Assessing settlement strategies in light of the Actavis ruling

    12:15
    Networking Luncheon
    1:30
    View from the Bench: The Judges Speak on Major Developments Affecting the Generic Drug Industry

    Hon. Joseph A. Dickson
    U.S.M.J.
    United States Federal District Court, District of New Jersey

    Hon. Ruben Castillo

    U.S. Dist. Ct., N.D. Ill.

    In this session, distinguished judges from the federal courts and the Patent Trial Appeal Board will answer questions on major cases impacting generic drug manufacturers. Judges will analyze cases from various courts to forecast how key decisions will affect generic drug companies’ business activities.

    2:30
    Afternoon Refreshment Break
    2:45
    Comprehending How Mergers and Acquisition Activity and Collaborative Partnerships Are Impacting and Changing the Dynamics of the Generic Pharmaceutical Industry

    Mr. Sean Moriarty
    Vice President, Legal Affairs
    Lupin Pharmaceuticals, Inc. (Baltimore, MD)

    Ildiko Mehes
    Vice President & General Counsel, North America Generics Leader, U.S. Generics Products & Portfolio
    Teva Pharmaceutical Industries Ltd.

    The environment that generic drug manufacturers are operating in is transforming rapidly as the industry continues to see a number of signifi cant mergers and acquisitions and other collaborative partnerships. The lines between generic and branded drug companies are being blurred as alliances increase, shaping the future for the generic drug industry. This session will include performing due diligence with respect to pharmaceutical companies and lessons to extract from past merger and acquisition activity.

    • Analyzing the reasoning and goals fueling M&As and other collaborative partnerships in the generic drug industry
    • Working within the dynamic world of collaborative partnerships to determine the effect on the generic drug industry
    • Investigating a company’s key practices and qualities making it a crucial target for partnership
    • Exhausting due diligence research specifi c to generic drug manufacturers
    • What can we learn from past mergers and acquisitions in the industry?
      • Generic-generic acquisitions (Sandoz Inc.’s acquisition of Fougera Pharmaceuticals, Inc.)
      • Generic-branded acquisitions (Actavis PLC’s acquisition of Forest Laboratories)

    4:00
    Examining Provisions of the Affordable Care Act Impacting Generic Drug Pricing and Reimbursement

    Romit Kamdar
    Partner
    Akara Group LLC (Morristown, NJ)

    • Exploring the impacts of the Affordable Care Act and the CMS AMP Rule to generics pricing and reimbursement
    • Understanding impacts of legislation to Authorized Generic arrangements for manufacturers
    • Cascading impacts of regulatory changes to generic trade and incentive contracting

    5:00
    Conference Adjourns

    Romit Kamdar
    Partner
    Akara Group LLC (Morristown, NJ)

    • Exploring the impacts of the Affordable Care Act and the CMS AMP Rule to generics pricing and reimbursement
    • Understanding impacts of legislation to Authorized Generic arrangements for manufacturers
    • Cascading impacts of regulatory changes to generic trade and incentive contracting