Agenda
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Day 1
June 20, 2024
Registration and Breakfast
The Politics of Innovation and Cost: The Impact of the Biden Administration’s Cadence on Manufacturer Pipelines, Product Launches and Pricing Strategies
Deirdre ParsonsHead & Senior Director, Public Policy & Government RelationsAlnylam Pharmaceuticals
Hans SauerDeputy General Counsel, VP of IPBiotechnology Innovation Organization
Maureen A. BresnahanAssistant General CounselEisai Inc.
Christine BaederPresidentApotex Corp. US
Eva TemkinPartner | Chair of FDA PracticePaul Hastings LLP
This opening session will examine how the Biden Administration’s efforts to improve access to medication are reshaping the landscape for research institutions and manufacturers, influencing their portfolios, product launch timelines, pricing strategies, and ultimately, market access. Topics of discussion will include:
- Exploring recent and proposed legislation designed to improve access to therapies and lower drug prices:
- The price control provisions of Inflation Reduction Act (IRA)
- Ensuring Pathways to Innovative Cures (EPIC) Act
- Preserve Access to Affordable Generics and Biosimilars Act 2023
- Proposed march-in rights expansion under Bay Doyle Act
- Biosimilar Red Tape Elimination Act
- Reading the tea leaves of the lawsuits challenging the price control provisions of the Inflation Reduction Act
- Reviewing the drugs currently selected for price negotiation with CMS
- Revisiting the COVID-19 vaccine waivers and lawsuit
Morning Networking Break
Biosimilar Market Retrospective
Unpacking the Humira and Non-Humira Biosimilar Launches and Lawsuits: Lessons Learned and Insights for the Future
Craig BurtonExecutive Director | Senior Vice President, Policy and Strategic AlliancesBiosimilars Council | Association for Accessible Medicines
Paul Walden, Ph.DVice-President, Medical AffairsCelltrion Healthcare Co., Ltd.
Robert CerwinskiManaging PartnerGemini Law LLP
Anita VarmaPartnerWhite & Case LLP
14 years have passed since the Biologics Price Competition and Innovation Act was signed into law, and more than a year since Amgen’s Amjevita launched, the first in a string of nine Humira biosimilars. In this retrospective, industry stakeholders will assess the trends, market uptake, and lessons learned from both the Humira and non-Humira biosimilar launches and lawsuits, offering strategies for designing forward-thinking portfolio strategies. Topics of discussion include:
- Exploring which biosimilars have seen “successful” market uptake across product class, applications, and geography
- Reviewing the Adalimumab BPCIA biosimilars and identifying market dynamics, pricing strategies, and other factors influencing uptake disparities
- Assessing why the higher-priced Amjevita saw higher uptake than the lower-priced Amjevita
- Assessing the impact of interchangeable status on biosimilar uptake
- Reflecting on approved and marketed biosimilars while looking ahead and considering clinical insights, manufacturing needs, pricing and dosages for pipeline development
Implications for Product Launch and Market Exclusivity: Decoding In Re Cellect, USPTO Guidance on Patent Term Adjustments and OTDP
James T. Evans, Ph.D.Senior Director, Assistant General Counsel, Dispute ResolutionRegeneron Pharmaceuticals
Matthew A. PearsonPartnerAkin Gump Strauss Hauer & Feld LLP
Mark A. PerryPartner | Co-Head Appeals & Strategic CounsellingWeil, Gotshal & Mangers LLP
John Christopher RozendaalPartner | Director | Chair of Trial & Appellate Practice Group Sterne Kessler Goldstein & Fox LLP
Alicia A. RussoPartnerVenable LLP
- Understanding how product launches are influenced by PTE and OTDP
- Unpacking the In Re Cellect federal circuit arguments and decision
- Reading the tea leaves on what this case will mean for the future of patent term adjustment strategy
- Appreciating the interplay between obviousness type double patenting and In re Cellect
- Emphasizing strategies in drafting claims for first filed and subsequent continuation applications to avoid OTDP concerns
- Maintaining safe harbor of a divisional all the way through versus filing all at once and re-dividing down the line?
- Unpacking the USPTO’s Guidance on obviousness rejections
- Updating patent adjustment forecasts to biologic or biosimilar launch timelines
Networking Lunch
Adapting to Regulatory Shifts in Approval Pathways, Labelling, and Staying Ahead of Induced Infringement
Jeremiah J. KellyPartnerVenable LLP
Adapting to a changing and dynamic regulatory landscape is paramount for success in the biosimilars and innovator biologics markets. In this comprehensive session, industry leaders will demonstrate how proactive adaptation and strategic foresight are essential for a competitive advantage. Topics of discussion include:
- Crafting successful BLAs
- Reviewing FDA’s draft guidance on diversity in clinical trials
- Proactively evaluating manufacturing for compliance with applicable laws and regulations towards passing the FDA’s pre-approval inspection
- Strategies for effective manufacturing monitoring and compliance outside of the U.S.
- Navigating the FDA’s attempts to streamline data requirements for biosimilarily and interchangeable status
- Identifying the data required by FDA to approve biosimilars for use in specific indications or populations without direct clinical trials
- Considering the role switching studies currently play in the approval process and evaluating their necessity
- Evaluating the impact that interchangeable status has on market uptake
- Comparing conflicting state laws on interchangeability
- Unpacking the updated FDA labelling recommendations
- Understanding when information can put you at risk for infringement claims regardless of labeling revisions have been approved by FDA as part of a skinny label
- Analyzing the evolving jurisprudence for induced infringement of follow-on biologics
Afternoon Networking Break
Investor’s Roundtable: Valuation, Biosimilar and Innovator Biologic Market Trends, and Strategic Insights for Portfolio Planning
Edric EngertVenture Partner | EVP, Commercialization and Business Development Social Impact Capital | RxGuardian Inc.
Cody PowersPrincipal, Portfolio and Business DevelopmentZS Associates
Ali AhmedSenior Vice President, BiosimilarsFresenius Kabi USA
In this special roundtable, life sciences investors will identify market trends, assess the impact of regulatory shifts and political cadence, and derive the strategic insights critical for informed portfolio planning and investment decisions.
- Identifying areas of significant M&A activity and emerging investment opportunities in life sciences IP
- Demystifying investor risk assessment, preferences and their target areas for investment or acquisition
- What financial valuation methods do investors use?
- Considering strategic alliances and royalty monetization
- Appreciating how investors are considering the impact of the price control provisions on IP under Inflation Reduction Act and the potential of march-in rights under the Bayh-Dole Act in today’s deal-making
- How are price controls, federal funding and patents linked?
- Outlining what investors wish inventors knew before coming to the table
- What do investors want to see in patents and IP strategy?
- When is the strength of the patent the bottom line and when do other factors (such as regulatory exclusivity or clinical trial results) prevail?
- How can IP counsel best present their FTO findings?
Conference Cocktail
Conference Adjourns
Day 2
June 21, 2024
Registration and Breakfast
Reviewing Cases and Distilling Trends: The Key Federal and District Court Lawsuits Shaping the BPCIA Landscape
Larry CouryVice-President, Associate General CounselRegeneron Pharmaceuticals
Aziz BurgyPartnerAxinn, Veltron & Harkrider LLP
Hassen A. SayeedPartnerO’Melveny & Myers LLP
Alison HansteadPartnerWhite & Case LLP
- Diving deep into Regeneron’s BPCIA litigation against Celltrion, Samsung Bioepis, Formycon, and Mylan for each of their proposed biosimilars of EYLEA
- Exploring Regeneron’s motion to establish multi-district litigation encompassing the aflibercept BPCIA cases
- Learning the latest biologic patent litigation strategies:
- Timing the lawsuit and seeking preliminary injunctions to block accused infringer’s at risk launch
- Learning the latest biosimilar patent litigation strategies:
- Appreciating when and how courts find permanent injunctions appropriate before receiving FDA approval
- Analyzing the decision to argue against a PI versus not launching at the end of the market exclusivity period
Balancing Innovation and Competition in BioPharma: Best Practices for Avoiding the FTC’s Crosshairs Within and Outside the BPCIA
Vishal C. GuptaPartner | Co-Chair Life Sciences Practice Steptoe LLP
Kevin E. Noonan, Ph.D.Partner | Co-Chair Biotechnology and Pharmaceuticals Practice GroupMcDonnell Boehnen Hulbert & Berghoff LLP
Sarah WohlSenior Counsel Specialist | Assistant General Counsel, AntitrustGenentechFormer Deputy Assistant Director, FTC
Navigating the intricacies of biosimilar settlements and launches pursuant to the BPCIA requires a consideration of the Federal Trade Commission and legal concepts such as reasonable damages. Even outside of the BPCIA, the FTC and, to a lesser extent, the ITC, are keeping a close eye on mergers within biopharma and alleged antitrust and anticompetitive practices. In this comprehensive session, topics of discussion will include:
- Understanding how courts are interpreting reasonable royalties, lost profits, and post judgment damages
- Applying that judicial cadence to your litigation or settlement strategy
- Learning the newest strategies for negotiating launch triggers and volume limitations in compliance with the law, avoiding costly litigation and associated penalties
- Reviewing the FTC’s approach to drug listings in the orange book and the evolution of pay-for-delay Examining recent listing and relisting of drugs in the Orange Book
- Understanding how this is influencing the dynamics of drug patenting and market exclusivity
- Analyzing recent antitrust lawsuits in the life sciences on pricing strategies, anticompetitive behavior, and life cycle management
- Reviewing recent life sciences M&As that have been challenged by the FTC and DOJ
Morning Networking Break
The Business of Biosimilars: Strategically Exploring Options for Sustainability Amidst Hurdles Faced by Industry
Dracey PooreDirector of Biosimilars Product and Solutions MarketingCardinal Health
Harshika SarbajnaVice-President, Commercial | Head, Global Alvotech
High manufacturing costs, complex reimbursement dynamics, and market competition are three of the onerous hurdles that biosimilar companies must currently navigate to become and remain sustainable. In this session, biosimilar business leaders will offer insights towards crafting a sustainable business model within the challenging economics of the current US healthcare landscape. Topics of discussion will include:
- Exploring the role of Pharmacy Benefit Managers in formulary placement and reimbursement decisions.
- Discussing strategies for negotiating favorable access and reimbursement rates for biosimilars against originator biologics.
- Examining potential barriers to formulary inclusion and reimbursement, including payer preferences and rebate structures.
- Analyzing the impact of pricing strategies on biosimilar profitability, considering factors such as list price, net price after rebates, and cost-effectiveness.
- Discussing innovative pricing models and contracting approaches to enhance biosimilar market competitiveness while maintaining profitability.
- Considering the implications of Average Sales Price (ASP) and its role in pricing negotiations and revenue forecasting.
- Assessing the competitive landscape and pricing pressures posed by originator biologic manufacturers.
- Examining the influence of originator biologic manufacturers’ incentive strategies such as bundling deals and loyalty programs, on biosimilar market dynamics.
Honorable Jacqueline BonillaDeputy Chief Administrative Patent Judge, Patent Trial & Appeal BoardU.S. Patent and Trademark Office
Honorable Linda HornerAdministrative Patent Judge, Patent Trial & Appeal BoardU.S. Patent and Trademark Office
Honorable Grace ObermannAdministrative Patent Judge, Patent Trial & Appeal BoardU.S. Patent and Trademark Office
Jordan MarkhamPartnerSteptoe LLP
In this panel, PTAB judges will reflect on:
- Surveying notable patent wins and losses
- Reviewing IPR, PGR and CBM filings involving pharmaceutical and biotechnology patents
- Examining the latest statistics for types of challenges brought and types of patents challenged
- Examining when the PTAB will issue a “good cause” extension of trial
- Considering emerging case law shaping the role of prior art in the PTAB’s discretionary denial of inter partes review
Networking Lunch
Mira A. MulvaneyAssociate VP – Assistant General Patent Counsel, IP LitigationEli Lilly and Company
Kurt MathasPartnerWinston & Strawn LLP
- Reviewing recent cases that impact the patentability of biologics
- e.g., Amgen v. Sanofi, Kite v. Juno, and recent subject matter eligibility case law
- Understanding the advantages for applicants to resolve prior art invalidity disputes via IPRs
- Establishing standing to appeal in an IPR in connection with BPCIA and the FDA approval process for biosimilars
- Appreciating the timing for applicants to file petitions for IPRs relative to filing BLAs and BPCIA litigation
- Analyzing biosimilars IPR filings and recent PTAB decisions, e.g., the PTAB challenges relating to SOLIRIS and STELARA
Steven D. MaslowskiPartner | IP Practice Group LeaderAkin Gump Strauss Hauer & Feld LLP
Peter SandelPartnerGroombridge, Wu, Baughman & Stone LLP
- Comparing the different standards of proof in BPCIA, the PTAB, and district courts
- Considering the possibility of multi district litigation
- Reviewing preliminary injunctions and the concept of irreparable harm
- Understanding how irrepealable harm is being quantified, and how it plays out in multiple markets, patents, and patent families
- Overcoming the hurdles created by the sealing process in district courts
- Learning the newest strategies relating to assessing scope:
- E.g., whether to sue everything or whittle down the patents?
Afternoon Networking Break
Artificial Intelligence from Molecule to Market: How AI Accelerates Innovation and Regulatory Approvals for Biologics and Biosimilars
- Learning the fundamentals and core terminology:
- Defining AI and machine learning (ML)
- Understanding what distinguishes traditional AI from generative AI
- Understanding how generative AI is revolutionizing areas like drug discovery, bioinformatics, and personalized treatments relative to traditional AI in the life sciences
- Knowing the key legal concepts to consider with respect to patent protection for AI-aided drug discovery and development
- Understanding AI capabilities towards accelerating regulatory approval:
- AI in clinical trial optimization and the collection of patient data
- AI in the manufacturing of biologics and biosimilars
- The FDA’s new AI based safety evaluation tool to help demonstrate biosimilarity
Diversity, Equity and Inclusion in the Research, Development, and Approval of Biologics and Biosimilars
Vanessa FordSupervisory Patent ExaminerU.S. Patent and Trademark Office
Jason MurataPartner | Chair of DEI CommitteeAxinn, Veltrop & Harkrider LLP
- Navigating corporate buy-in for DEI in company culture and practice amidst state legislature and political pressures advocating against DEI implementation
- Encouraging diversity and inclusion in innovation
- Exploring the USPTO’s various diversity initiatives for female patentees
- Exploring the consequences of biased data sets in clinical research and the importance of diversity in research
- Promoting diversity, equity, and inclusion in legal practice:
- Exploring the USPTO’s Notice of Proposed Rulemaking, seeking to expand the admission criteria to practice before the PTAB