Agenda
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Day 1
June 2, 2025
Registration and Networking
Mary Jo CardenHead, PolicySandoz
Tara RahembaVice President, Intellectual PropertyApogee Therapeutics
Katie Nolan-StevauxHead of General Litigation, Associate General CounselGenentech
Be sure to join this engaging and interactive session as our panelists assess how landmark policy changes, FDA draft guidance on the use of AI to support regulatory decision-making, shifting IP strategies, global market pressures, and other regulatory updates are shaping the landscape. This session will provide a comprehensive breakdown of the past year’s most critical legal, regulatory, and commercial developments and explore what’s ahead for 2025 and beyond.
Topics of discussion will include:
- Examining the FDA’s plans to apply a risk-based credibility assessment framework to evaluate the use of AI models in support of regulatory decision-making
- Evaluating the impact of Medicare drug pricing negotiations, IRA policies, and the 2025 Trump Administration on biosimilar adoption and market access
- Assessing the Loper Bright Enterprises v. Raimondo decision and its impact on FDA authority, industry compliance, and regulatory interpretations
- Navigating evolving patent litigation and the increasing use of Section 1782 actions
- Exploring global harmonization efforts and the competitive landscape shaping adoption
- Predicting the future of biosimilars, biobetters, and next-gen biologics as competition intensifies post-patent cliff
Innovator Strategies in a Biosimilar Era: Managing Competition, Driving Innovation and Maintaining Market Position
Bo HanVice President, Intellectual PropertyOrbital Therapeutics
Chad J. PetermanPartnerPaul Hastings, LLP
Mercedes K. MeyerAttorneyBanner Witcoff
Innovators that are concerned about biosimilar competition have to navigate even more financial risk under the ongoing price control provisions of the IRA and the possible expansion of march-in rights. This landscape not only challenges the innovator biologics community — but also offers an opportunity for biosimilar makers to strategize and capitalize on these changes. Join us as we discuss these legal, regulatory and commercial challenges, along with strategies to overcome these issues. Topics for discussion include:
- Developing next-generation biologics with improved efficacy or new indications
- Actively managing IP to extend exclusivity
- Engaging in robust clinical trials to solidify the safety and efficacy profile of the original drug
- Exploring new therapeutic areas with high unmet medical needs
Extended Networking Break
Honorable Grace ObermannAdministrative Patent Judge, Patent Trial & Appeal BoardU.S. Patent and Trademark Office
Hon. Susan MitchellLead Judge Patent Trial & Appeal BoardU.S. Patent and Trademark Office
Gregory A. MorrisPartnerO'Melveny & Myers LLP
Be sure to join us in this special session as we look at the policy, procedure and practice points with the PTAB that resulted in some of the most critical decisions to date. We will examine:
- 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
Rachel J. ElsbyPartnerAkin Gump Strauss Hauer & Feld LLP
Vishal C. GuptaPartnerSteptoe LLP
Chandrika ViraDirectorSterne, Kessler, Goldstein & Fox PLLC
Key decisions at the Federal Circuit, District Court and PTAB have transformed the BPCIA landscape. As such, a thorough understanding of how courts are interpreting reasonable royalties, lost profits, and post judgment damages is critical for determining the best course of action to avoid costly litigation and associated penalties. Topics for discussion include:
- Examining lessons learned from the Humira biosimilars and exclusivities afforded under the BPCIA and IRA
- Breaking down the Regeneron litigation and the push to establish a biosimilar MDL
- Coordinating BPCIA litigation with parallel IPR/PGR petitions for maximum advantage
- Analyzing the legislative and regulatory framework
- Navigating anti-competitive agreements and regulatory hurdles impacting biosimilar market access
- Negotiating launch triggers and volume limitations to secure favourable settlements
- Understanding how courts are interpreting reasonable royalties, lost profits, and post judgment damages
Networking Luncheon
Global Strategies for Aligning Biologic and Biosimilar Pathways: Streamlining Approvals and Accelerating Market Access
Ricardo CampelloPartnerLicks Attorneys
Biologics and biosimilars are transforming modern healthcare, but high costs, complex manufacturing, and regulatory barriers continue to slow global adoption. Join our international faculty as they examine the commercial aspects and market perspectives in key regions, and their outlook on the biologic and biosimilar markets.
Session leaders will review commercial strategies in Europe, the United States and emerging markets by looking at multifaceted approaches to achieve widespread adoption, such as:
- Reforming reimbursement policies to enhance market penetration and access
- Educating prescribers, payers, and patients to improve adoption rates
- Developing competitive pricing models to drive cost savings
- Overcoming the inherent complexities of the manufacturing processes that impact scalability and affordability
- Navigating exclusivity periods and regulatory barriers to accelerate approvals
Networking Break
The Future of Biosimilars Under a Second Trump Administration: Policy Shifts, Market Incentives & Regulatory Uncertainty
Craig BurtonExecutive Director | Senior Vice President, Policy and Strategic AlliancesBiosimilars Council | Association for Accessible Medicines
Sean HilscherSenior Director, Science and Regulatory AdvocacyPhRMA
Biosimilar pricing, approvals, and regulatory oversight are entering a new era of uncertainty. Will policy shifts accelerate adoption, or will deregulation introduce new market complexities? As the administration rolls out executive orders and potential reforms, the industry must anticipate shifts in pricing, access, and oversight. Join us for this critical discussion as we examine:
- Assessing the IRA’s future and its impact on pricing and competition
- Evaluating whether FDA will adopt a less-stringent review process under new leadership
- Exploring how the FDA may regulate biobetters and whether clearer pathways will emerge
End of Day One / Networking Cocktail Reception
Day 2
June 3, 2025
Ryan HagglundPartnerLoeb & Loeb LLP
The compound interplay of prescriber awareness, uncertain value of interchangeable status, and disparate state laws shapes biosimilar adoption and patient access, which ultimately adds layers of complexity to the healthcare terrain and educational efforts. Join us as we review interchangeability barriers and ways to overcome them. We will also address features of the unique U.S. interchangeability designation to further advance biosimilar adoption.
Topics for discussion include:
- Assessing the impact of interchangeable status on biosimilar and market uptake
- Navigating the FDA’s attempts to streamline data requirements for biosimilarity and interchangeable status
- Comparing conflicting state laws on interchangeability
- Implementing appropriate regulatory flexibilities for well understood therapies
- Expanding the use of real-world evidence to collect post-market data
- Re-evaluating the current suffix-based naming policy
J. Jay Cho, Ph.D.CounselPatterson Belknap Webb & Tyler LLP
Whitney Meier HowardPartnerVenable LLP
Katie Nolan-StevauxHead of General Litigation, Associate General CounselGenentech
Jeanna WackerPartnerKirkland & Ellis LLP
It is no secret that BPCIA favors speed and demands certainty for approvals, but the “need for speed” can have its drawbacks. Join us in this session as we examine:
- Recent case law and developments
- Guidelines to work within the timelines of PTAB proceedings alongside a concurrent District Court action
- The factors that may influence litigation strategy, early case resolution, and market entry
- The different standards of proof
- Ways to identify market dynamics, pricing strategies, and other factors influencing update disparities
Networking Break
After decades of experience, there is not much data to show that comparative efficacy trials yield information that indicates a clinically meaningful difference between a biosimilar and the reference product. There is increased confidence in comparative analytical data, and it is accepted that clinical endpoints are not as sensitive as analytical data to detect any differences.
Join us as our panelists discuss how to rely less on clinical trials in the development of biosimilars, and the benefits this affords, such as:
- Time and cost savings for R&D, manufacturing, and production
- Increased pace for patient access to biosimilars
- Reduction of unnecessary testing and redundancy
- Elimination of arbitrary clinical judgments
- Potential changes in the regulatory approval requirements for biosimilars
Networking Luncheon
Andrej BarbicAssistant General Counsel, Innovation LawBristol Myers Squibb
Mark T. DemingHatch-Waxman & Biologics Vice ChairPolsinelli
Daniel J. KleinPartnerGroombridge, Wu, Baughman & Stone LLP
Steven D. MaslowskiPartnerAkin Gump Strauss Hauer & Feld LLP
As BPCIA litigation and PTAB challenges becoming more complex, mastering the interplay between district court litigation, IPRs, and PGRs is more critical than ever. As patentability standards shift and biologics patents face heightened scrutiny, companies must refine their legal strategies to stay ahead. Topics for discussion include:
- Executing best practices for managing parallel BPCIA litigation and PTAB proceedings
- Adapting to evolving patentability standards for biologics, including:
- Obviousness
- Written description
- Enablement
- Understanding when to challenge patents in IPR or PGR proceedings in advance of BPCIA litigation
Coverage of Reference Products and Biosimilars in Medicare and Commercial Markets: Trends and Opportunities
Aron FischerPartnerPatterson Belknap Webb & Tyler LLP
Katie Nolan-StevauxHead of General Litigation, Associate General CounselGenentech
As the 2025 patent cliff reshapes the industry, both innovators and biosimilar manufacturers must adapt to evolving litigation, market access strategies, and payer dynamics. With new Medicare policies governing formulary placement for innovator biologics and biosimilars, PBMs playing a decisive role in formulary placement, and lessons from the IRA, companies are navigating an ever-changing and reimbursement landscape. Join us as we discuss:
- Understanding the evolving framework for coverage under Medicare Parts B and D
- Trends in commercial market coverage
- Enrollee uptake of biosimilars versus innovator biologics
- Decoding PBM formulary decisions and their impact on pricing, reimbursement, and market share
Networking Break
Lillian WallaceAttorneySteptoe LLP
As the industry evolves, ethical challenges emerge in litigation, regulatory decisions, clinical research, and market access. Stakeholders must navigate fair competition, patient equity, and responsible innovation while ensuring compliance with shifting legal and policy landscapes. This session will examine the ethical responsibilities of those in the industry. Join us for this interactive session as we discuss:
- Balancing fair market competition in BPCIA litigation while ensuring patient access to affordable treatments
- Addressing the role of pricing strategies, formulary decisions, and exclusivity periods in shaping healthcare equity
- Mitigating the risks of biased data sets in clinical research and ensuring diverse patient representation
- Upholding ethical standards in patent litigation, including challenges to evergreening and anti-competitive practices
- Examining professional responsibility and ethics in legal practice, including access to PTAB representation and emerging regulatory considerations