Agenda
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Day 1
March 19, 2025
Co-Chairs Opening Remarks
Charting the Course for Tomorrow’s Advanced Therapeutics: Exploring How Legislation, Policy and Market Dynamics Will Shape Next-Gen Medicines in 2025 and Beyond
John FeoreDirector, Health Policy & AdvocacyInstitute for Gene Therapies (IGT)
Lisa KahlmanExecutive Director, Public Policy & Public AffairsUltragenyx
Deirdre ParsonsVP Public Policy and Government RelationsAlnylam
Eva TemkinPartnerArnold & Porter
Our opening panel will delve into how the latest legislative initiatives and policy changes are influencing strategic decision-making in R&D, investments and market entry for cutting-edge therapies. Additionally, explore how the results of the election may impact the future regulatory landscape for novel therapeutics and how companies can prepare to ensure both compliance and competitiveness in a rapidly changing environment.
Topics of discussion will include:
- Examining updates in key policies surrounding drug approval pathways, pricing negotiation frameworks, intellectual property, patient access, and post-market surveillance, and their implications for advanced therapies as we enter 2025
- Highlighting recent trends in biopharma, major drug approvals, and global market dynamics to support data-driven decisions and capture growth in emerging markets
- Analyzing the potential impact of election outcomes on healthcare priorities, FDA and EMA authority, and innovation funding to help companies adapt proactively
- Understanding how regulatory foresight can guide company strategies for advancing innovative therapies
Morning Coffee Break
Industry Perspectives on Overcoming FDA Hurdles: Insights from Companies and Their Counsel on Tackling Key Regulatory Challenges in Advanced Therapeutics
Jae KimPartnerDLA Piper
Joseph VittiglioChief Business & Legal Officerbluebirdbio
Rebecca WoodPartnerSidley Austin LLP
Following on the comments of Julie Tierney, hear from regulatory counsel who routinely work in the trenches with the FDA on what they perceive to be the biggest FDA regulatory hurdles impacting advanced therapeutics. Explore real-world strategies for managing regulatory uncertainties, accelerating development timelines, and preparing for shifts that could redefine the path to market for advanced treatments.
Preparing to Launch: Designing Your Commercialization Blueprint for Advanced Therapies and Companion Diagnostics
Chia-Feng LuShareholder Greenberg Traurig
Charles G. RaverAttorneyHyman, Phelps & McNamara PC
Kirsten DetrickChief Executive Officer, Co-FounderStealth
Chief Representative, USA
Basel Area Business & Innovation
For advanced therapies and companion diagnostics, successful commercialization requires a strategic roadmap that addresses both regulatory requirements and market readiness from early stages. This panel will provide actionable insights into creating a streamlined pre-commercialization plan that aligns regulatory compliance with commercial objectives. Topics of discussion include:
- Identifying key considerations for designing a robust regulatory approval plan that aligns with FDA and EMA standards for advanced therapies
- Designing effective clinical trials to accelerate timelines
- Coordinating development timelines and regulatory paths for therapies requiring companion diagnostics
- Identifying and mitigating potential regulatory, clinical, and market risks early in the development process
- Optimizing market access: techniques for aligning clinical trial and economic evidence to support payer engagement and ensure smooth market entry
Networking Luncheon
Redefining Due Diligence for Future-Forward Treatments: Tailoring Evaluation Strategies for Novel Drug Modalities
Forrester LiddleHead of Global Research and Early Development Legal
Head of IP and Legal for US R&DNovo Nordisk
Ryan HagglundPartnerLoeb & Loeb LLP
Allison GlasunowPartnerPerkins Coie
As companies pivot toward developing and acquiring advanced therapeutic modalities such as cell and gene therapies, RNA therapeutics, and regenerative medicine, traditional due diligence practices are often insufficient to address the unique complexities of these cutting-edge treatments. This panel will delve into how biopharma companies can adapt their due diligence frameworks specifically for advanced therapies. Key discussion points include:
- Establishing due diligence processes to ensure a comprehensive evaluation of scientific, regulatory, IP, and commercial factors unique to advanced therapies
- Assessing the scientific foundations and clinical feasibility of your novel therapeutic modality
- Tackling challenges in production, manufacturing, supply chain, and scalability that can impact the success of advanced therapies
- Evaluating market demand, competitive positioning, and payer perspectives specific to novel therapeutic categories
- Freedom to Operate and beyond: structuring due diligence to account for unique financial risks and intellectual property considerations critical to advanced therapies
CUSTOMIZING YOUR IP STRATEGIES FOR ADVANCED THERAPEUTICS
Optimizing Your Patent Prosecution Playbook for Cell and Gene-Based Therapies: Key Tactics for Maximizing Monetization and Value
Elbert ChiangVice President, Intellectual PropertyBeam Therapeutics
Mary TillOf CounselFinnegan, Henderson, Farabow, Garrett & Dunner, LLP
Jonathan S. CaplanCo-Chair, Intellectual PropertyKramer Levin Naftalis & Frankel LLP
Innovators in the cutting-edge fields of cell and gene therapies, CAR-T, and CRISPR-based treatments need robust, forward-looking patent strategies to secure strong, defensible IP portfolios that support their market position and attract investment. This panel will bring together legal and industry experts to discuss effective prosecution strategies tailored to the unique challenges of advanced therapeutics. Topics of discussion include:
- Exploring the types of claims that best protect advanced therapies, including claims on methods, compositions, vectors, and delivery technologies
- Anticipating patent eligibility challenges in emerging therapeutic areas
- Understanding recent trends in patent eligibility rulings and how to adapt prosecution strategies to address evolving standards for cell and gene-based therapies
- Best practices for differentiating advanced therapeutics from prior art, addressing written description and obviousness challenges, and securing favorable examination outcomes across global jurisdictions
- Strategies for harmonizing patent timelines with regulatory approvals and market launches, maximizing the protection and impact of each therapeutic innovation
Afternoon Break
Tactical Tools for Patent Lifecycle Management: Adopting Robust Strategies to Protect Your Advanced Therapy IP and Maximize Market Exclusivity
Marcus A. ColucciSpecial CounselKramer Levin Naftalis & Frankel LLP
Erin FoleyCounselFoley Hoag LLP
Meghann TeagueHead of Intellectual PropertyNewAmsterdam Pharma Corporation
Bonnie Weiss McLeodOf CounselCooley LLP
For companies entering the advanced therapeutics market, effectively managing the lifecycle of your patents is crucial. This panel will delve into patent lifecycle management strategies specifically tailored to advanced therapies, including best practices for maximizing the commercial potential and patient impact of these innovations. Topics of discussion include:
- Comprehending the scope of allowable exclusivity in advanced therapeutics
- Understanding ow to effectively extend patent lifecycles within regulatory frameworks, including strategies for patent term extensions (PTEs), supplementary protection certificates (SPCs), and market exclusivities
- Strengthening patent protection through strategic filing of secondary patents on formulations, processes, and delivery mechanisms
- Strategies for harmonizing patent timelines with regulatory approvals and market launches, maximizing the protection and impact of each therapeutic innovation
Lessons from the Latest mRNA and LNP Patent Litigation: Understanding How Ongoing and Potential Patent Wars Could Shape the Trajectory of Novel Therapeutics
Dan LiuAttorneyLoeb & Loeb LLP
Elaine Herrmann BlaisPartner - Co-Chair, Intellectual Property LitigationGoodwin Procter LLP
Daniel ShoresMemberRothwell Figg
As companies vie for control over foundational IP in the advanced therapeutics space, the outcome of recent mRNA and LNP patent wars could significantly impact the development, accessibility, and cost of future therapeutics. This panel will unpack key lessons from the latest litigation and provide insights on the potential ripple effects of these disputes for stakeholders in advanced therapeutics. Topics of discussion include:
- Assessing the impact of recent pivotal cases, including contested patent claims and judicial rulings, with a focus on what these cases reveal about IP vulnerabilities and priorities in mRNA and LNP technologies
- Exploring how evolving case law is impacting patentability criteria and freedom-to-operate analyses for advanced modalities
- Understanding the broader implications of these disputes on therapeutic development pipelines, collaborations, and accessibility, and how the outcome of these cases might shape patenting approaches across the biotech sector
Conference Adjourns
Cocktail Reception Sponsored by 
Day 2
March 20, 2025
Opening Remarks from the Co-Chairs
AI and the Future of Next-Gen Medicines: Harnessing AI for Drug Discovery & Development While Minimizing IP Challenges
Jocelyn RamIP Counsel The Broad Institute of MIT
Chris MammenManaging PartnerWomble Bond Dickinson (US) LLP
AI is rapidly transforming the advanced therapeutics industry, offering unprecedented opportunities for innovation in areas like drug discovery, precision medicine, and clinical trials. However, integrating AI also presents significant challenges, from patent prosecution to inventorship and licensing issues. This panel will explore both the opportunities and the complexities that AI brings to advanced therapeutics.
Key discussion points will include:
- Exploring how AI can reduce timelines and costs in drug discovery, streamline clinical trials, and enhance the development of novel therapies through big data analysis, predictive modeling and enhanced targeting.
- Effective strategies for patent prosecution for AI innovations in the life sciences and advanced therapeutics space
- Navigating IP and inventorship challenges associated with patenting and licensing of AI-driven therapeutics
Morning Coffee Break
Creative Funding Solutions for New Modalities: Accelerating Advanced Therapeutics Through Venture Financing and Non-Traditional Funding Models
Derek JohnsonManaging Director and General CounselPortal Innovations
Todd TrattnerPartnerGibson, Dunn & Crutcher LLP
Jennifer FangPartnerWilson Sonsini Goodrich & Rosati
Securing funding for advanced therapeutic companies is increasingly challenging as these innovations often require substantial investment and long development timelines. As traditional funding models may fall short for cutting-edge therapies like gene editing, CAR-T, and mRNA platforms, it is essential to explore new financial strategies that meet the unique demands of this sector. This panel will examine the key funding challenges for advanced therapeutics and present:
- Key considerations for venture capital firms when identifying and measuring the value of investment opportunities in the advanced therapeutics industry
- Insights into venture philanthropy, milestone-based financing, and royalty-based investments as alternatives to traditional venture capital
- Considerations when weighing the pros and cons of government grants, public-private partnerships, and collaborations with large pharmaceutical companies to secure diverse funding streams
- Insights into securing grants and subsidies that offer financial support without equity dilution
Critical Considerations for Advanced Therapeutic Partnerships: Overcoming IP, Compliance, and Commercialization Challenges in Strategic Alliances and Licensing
Kristin Anne ConnarnPartnerHogan Lovells
John HaugenSenior University Counsel Stanford University, Office of the General Counsel
Roger KuanPartnerNorton Rose Fulbright
Laurence ShumwayVice President, Intellectual Property CounselFlagship Pioneering
For companies in the advanced therapeutics space, collaboration with major pharmaceutical companies and licensing agreements with universities can accelerate innovation and market entry. However, these partnerships come with their own set of challenges, from IP ownership and data rights to regulatory hurdles and commercialization terms. This panel will offer guidance on navigating these complex relationships to maximize benefits and mitigate risks.
Key discussion points will include:
- Negotiating IP rights and ownership to align with both short-term R&D goals and long-term commercialization strategies
- Protecting proprietary data, managing shared research results, and establishing clear boundaries around data use and access
- Understanding regulatory obligations, compliance requirements, and risk-sharing strategies in partnerships that span global markets
- Designing financial arrangements, including royalties, milestone payments, and profit-sharing, to ensure alignment and value creation for both parties
Networking Luncheon
Preparing for the Arrival of Advanced Therapeutic Biosimilars: Future-Looking Strategies for Market Access and IP Protection
Lulu WangHead of Intellectual PropertyOrna Therapeutics
Jennifer ChhedaPartnerJones Day
As biosimilars for advanced therapeutics approach market readiness, stakeholders across the industry must brace for the unique opportunities and challenges that lie ahead. This panel will explore what companies can do to prepare for and capitalize on the arrival of advanced therapeutic biosimilars, with a focus on navigating IP, market access and compliance challenges. Topics of discussion include:
- Examining the evolving regulatory landscape for advanced therapeutic biosimilars and understanding the guidelines, timelines, and data requirements for approval in key global markets
- Providing insights into pricing, reimbursement policies, and how to address payer hesitations to facilitate broader adoption of biosimilars for complex therapeutics
- Exploring the anticipated market dynamics, including strategies for branding, differentiation, and managing IP challenges to gain a competitive edge
- Strengthening IP portfolios to safeguard proprietary advances: strategies for building robust IP protection around proprietary technologies, manufacturing processes, and delivery systems to maintain a competitive advantage as biosimilars enter the field
Balancing Disclosure and Protection: Strategies for Safeguarding Trade Secrets in Early-Stage Advanced Therapeutics
Olga ZimmermanDirector, Intellectual PropertyCaribou Biosciences, Inc.
Rebecca (Reba) RabensteinPartnerLatham & Watkins LLP
For early-stage advanced therapeutic companies, securing investment often requires a delicate balance between sharing enough information to attract potential partners or investors and safeguarding proprietary knowledge critical to their competitive edge. This panel will discuss how advanced therapeutics companies can strategically navigate disclosure and protection to attract investment while maintaining robust trade secret protection. Topics of discussion include:
- Establishing clear boundaries on information sharing: determining what information to disclose to investors and partners versus what to keep as proprietary, with a focus on minimizing exposure without diminishing investment appeal
- Implementing best practices for NDAs and confidentiality clauses that effectively protect sensitive information while allowing for meaningful engagement with potential investors and collaborators
- Developing internal policies, processes, and employee training that reinforce the confidentiality of proprietary methods, formulas, and data from early stages onward
- Navigating the due diligence process with prospective investors to best protect valuable IP