Novel Therapeutic Modalities

Breakfast and Registration

Opening Remarks from the Chairs

Cristin Berkey
VP, IP and Legal Affairs
Abata Therapeutics

Forrester Liddle
Head of Intellectual Property and Legal, US R&D
Novo Nordisk

Adrian Looney
Chief Intellectual Property Counsel
Vertex Pharmaceuticals

Next Gen-Therapeutics at the Political and Economic Crossroads: Assessing the Impact of Market Shifts and Policy Changes on Novel Therapeutics and Regenerative Medicines

Chuck Sholtz
VP, IP
Nutcracker Therapeutics

Rebecca K. Wood
Partner
Sidley Austin LLP
(Former Chief Counsel, FDA)

This opening session will explore how the interplay between policy and economics – as well as the disconnect between science and the law – are affecting the novel therapeutics landscape. Panelists will detail how the latest regulatory and legislative developments are affecting biopharma R&D and commercial strategies and what the ramifications of these developments mean for novel therapeutics.

This session will also offer a pulse-check on the industry’s health, highlighting pivotal drug approvals, performance metrics and other biopharma market factors. Topics of discussion will include:

• Examining how recent legislative actions and regulatory shifts are impacting the research, development, and commercialization of novel therapeutics and regenerative medicines
  • Considering the impact of regulation on the structuring and negotiation of biopharma deals and alliances
• Understanding how recent policy changes are reshaping R&D priorities
• Analyzing of the biopharma market’s vigor post-March 2023, focusing on significant drug approvals and their technological underpinnings
• Examining therapeutics which have underperformed
  • Addressing the underperformance of COVID boosters and the implications for future therapeutic funding
• Best practices for biopharma companies to navigate market downturns, including diversification of therapeutic portfolios and reassessment of market strategies
• Exploring the regulations of laboratory developed tests (LDTs)
  • Utilizing companion diagnostics via smart tech

Reading the IRA Tealeaves: Interpreting How the Inflation Reduction Act (IRA) is Impacting Novel Therapeutic Advancements

Irena Royzman
Partner, Head of Life Sciences
Kramer Levin Naftalis & Frankel LLP

Jennifer Tousignant
Chief Legal Officer
Viridian Therapeutics

This session will provide an analysis of the IRA and its anticipated impact on novel therapeutics and regenerative medicines, particularly in the areas of R&D, pricing, and market access.

Panelists will explore the opportunities and challenges which the IRA presents for these novel biopharmaceutical treatments with a specific focus on the CMS’s role in approvals and reimbursement. Topics of discussion will include:

• An analysis of the key IRA provisions that pertain to novel therapeutics and regenerative medicines
• How the IRA influences R&D tax credits, grants, and other funding sources that could affect investment in these therapies
• Medicare drug price negotiation and the potential impact on the economic models for novel therapy development
• The implications of CMS formulary coverage for the development of novel therapeutics and regenerative medicines
• How changes in reimbursement policies may alter the pathway to commercialization
• The impact of the IRA on small startups versus large companies

FDA KEYNOTE

Julie Tierney
Deputy Center Director for Strategy, Policy and Legislation
Center for Biologics
FDA

Morning Break

Bridging the Gap: From Pre-Commercialization Research to Regulatory Approval for Novel Therapeutics and Regenerative Medicines

James Myers
Associate Director for Policy, CBER
FDA

Charles G. Raver
Attorney
Hyman, Phelps & McNamara PC

This panel will explore the pre-commercialization stage of developing novel therapeutic modalities, from early research to achieving regulatory approval. Panelists will dissect the critical elements of development and approval, offering insights into optimizing research outcomes, streamlining clinical trials, and successfully engaging with FDA. Topics of discussion will include:

• Designing effective clinical trials to accelerate timelines
• Implementing best practices for FDA pre-IND meetings and IND applications for novel therapeutics and regenerative medicines
• Understanding FDA’s guidance on novel therapeutic classifications and approval pathways
• Reviewing case studies of successful approvals
  • Detailing what works and potential pitfalls to avoid
• Preparing for market access challenges, including reimbursement strategies

Networking Luncheon

Comprehensive Due Diligence for Novel Therapeutics: Beyond IP and FTO

Jonathan S. Caplan
Partner Co-Chair, Intellectual Property
Kramer Levin Naftalis & Frankel LLP

Nishla H. Keiser
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

David Silverstein
Vice President, Intellectual Property
Rocket Pharmaceuticals, Inc.

In a landscape as multifaceted as biopharma, due diligence extends beyond the realms of intellectual property and Freedom to Operate. It’s a crucial business exercise that encompasses clinical, regulatory, financial, and commercial aspects—each a foundational pillar for the successful launch of novel therapeutics. This session presents a strategic guide for conducting thorough due diligence in the biopharma industry, ensuring that investments, partnerships, and acquisitions are sound, strategic, and positioned for success. Topics of discussion will include:

• Evaluating clinical trial data, regulatory compliance, and approval prospects of the due diligence process
• Analyzing a company’s financial metrics, forecasting revenues, and understanding valuation models specific to biopharma
• Scrutinizing market potential, the competitive landscape, and market strategies for novel therapeutics
• Assessing the scalability of production, supply chain robustness, and quality control systems
• Considering the alignment between entities in M&A, partnerships, or joint ventures

TAILORING YOUR IP STRATEGIES TO FIT NOVEL THERAPEUTICS

Optimizing Patent Portfolio Strategies for Novel Therapies: IP and Business Tactics for Monetization and Value Maximization

Thomas L. Irving
Senior Partner
The Marbury Law Group, PLLC

Sam Kwon
Partner
Kirkland & Ellis LLP

Olga Zimmerman
Director, Intellectual Property
Caribou Biosciences, Inc.

As the biopharma landscape evolves, so does the need for robust patent portfolio strategies that not only protect inventions but also add significant value to therapeutic innovations.

This session will help you implement effective strategies for monetizing IP assets and maximizing value in an increasingly competitive marketplace. Topics of discussion will include:

• Tailoring your IP strategy to cover key aspects of novel therapies and regenerative medicines, from composition to method of use
• Balancing breadth and enforceability in patent claims for novel therapeutics
• Identifying and leveraging opportunities for licensing, cross-licensing, or selling IP rights
• Structuring IP-driven deals to attract investors and partners
• Conducting thorough IP audits to eliminate redundancies and focus on high-value assets
• Aligning IP strategy with business goals in partnerships and M&A activities

Afternoon Break

Navigating the Next Frontier of Patent Disputes and Licensing Opportunities in Novel Therapeutics

Elbert Chiang
VP, IP
Beam Therapeutics

Gabriel J. McCool
VP, Legal and IP
ReNAgade Therapeutics

Dan Liu
Attorney
Loeb & Loeb LLP

As the dust settles on the initial CRISPR and mRNA patent battles, the landscape of IP conflicts in novel therapeutics continues to evolve. This session will bring you up to speed on the latest developments in these high-profile patent wars, while outlining emerging areas of contention within novel therapeutic modalities. Topics of discussion will include:

• Analyzing developments in CRISPR and mRNA patent litigation
• Understanding how these disputes are influencing R&D investments and collaborations
• Identifying new technologies and therapies becoming hotspots for IP litigation, like CRISPR-Cas12 and CRISPR-Cas13, single-cell genomics, bispecific antibodies, and gene silencing therapies
• Devising strategies for navigating the complex patent landscape of novel therapeutics and regenerative medicines
• Understanding how ongoing and potential patent wars could shape the trajectory of novel therapeutics

Conference Adjourns to Networking Cocktail Reception Sponsored by

Breakfast and Registration

Opening Remarks from the Chairs

Cristin Berkey
VP, IP and Legal Affairs
Abata Therapeutics

Forrester Liddle
Head of Intellectual Property and Legal, US R&D
Novo Nordisk

Adrian Looney
Chief Intellectual Property Counsel
Vertex Pharmaceuticals

Valuing Innovation: Market Dynamics and the Commercial Viability of Novel Therapeutics

Margaux J. Hall
Partner
Ropes & Gray LLP

Matthew Rizzo
General Partner
OrbiMed Advisors LLC

This opening session will help you navigate the intricacies of market valuation for groundbreaking innovations. Session leaders will examine how market forces shape the financial landscape and determine the commercial viability of novel therapeutics. Topics of discussion will include:

• Identifying key market drivers, analyzing trends influencing investment and adoption, and projecting the financial sustainability of cutting-edge therapies.
• Anticipating market fluctuations and strategically positioning novel therapeutics for enduring success in a competitive healthcare market

Innovative Funding Strategies: Fueling the Next Wave of Breakthroughs

Jennifer Fang
Partner
Wilson Sonsini Goodrich & Rosati

Michael B. Harlin
Partner
Neal, Gerber & Eisenberg LLP

JM Lee
Director, Business Development
Novo Nordisk

The path to groundbreaking therapeutic innovation is often as complex as it is costly. In this session, we’ll explore the innovative funding strategies that are fueling the next wave of breakthroughs. Topics of discussion will include:

• Examining how forward-thinking financial models and strategic partnerships can accelerate the development of novel therapeutics from early-stage research to market realization
• Shedding light on the latest trends in capital sourcing, investment partnerships, and how to secure funds in a risk-averse market
• Understanding how venture capital is adapting to the demands of novel therapeutic development
  • Detailing what alternative funding streams are yielding positive results

Morning Break

The AI Advantage in Novel Therapeutics: Understanding how Artificial Intelligence is Revolutionizing Drug Discovery and Development

Emily Gardel
Associate Director, Patent Attorney II
Dyno Therapeutics

David M. McIntosh
Partner
Ropes & Gray LLP

Margaret Welsh
Partner
Baker Botts LLP

AI is transforming the landscape of drug discovery and development with unprecedented speed and precision. This session details the AI advantage that is revolutionizing the field of novel therapeutics. Topics of discussion will include:

• Detailing how AI offers precision and speed in the discovery and development of targeted, effective, personalized treatments
• Uncovering the ways in which AI algorithms and machine learning are accelerating the discovery of new drugs, optimizing development pathways, and predicting patient responses
• Understanding the role of machine learning in improving the predictability of drug efficacy and safety in the pre-clinical stage
• Evaluating AI’s impact on transactions, M&A and investment trends
  • Risk assessment and due diligence in AI ventures
• Navigating unique deal terms in AI transactions
  • Exploring how AI-related transactions are developing unique deal structures
  • Data ownership, usage rights, and the financial implications of each
• Leveraging AI to design more efficient clinical trials, enhance patient selection, and monitor real-time data
• Addressing ethical, legal, and practical challenges of using large datasets in AI
  • Data privacy, quality, and integration

USPTO KEYNOTE

Mary Till
Senior Legal Advisor
Office of Patent Legal Administration
USPTO

Moderator:

Cristin Berkey
VP, IP and Legal Affairs
Abata Therapeutics

Networking Luncheon

CASE STUDIES

Collaborate to Innovate: Ownership and IP Challenges in Different Categories of Partnerships and Collaborations

Ryan Hagglund
Partner
Loeb & Loeb LLP

Matt Karlyn
Partner
Morrison & Foerster LLP

Roger Kuan
Partner
Norton Rose Fulbright

This case study will detail into the nuances of IP challenges within various forms of partnerships and collaborations, from joint ventures and alliances to academia-industry collaborations. Attendees will gain insights into structuring agreements that protect IP rights while fostering innovation, ensuring that all parties can thrive in the shared pursuit of breakthrough therapies. Topics of discussion will include:

• Establishing clear ownership terms within different partnership models to prevent future disputes
• Managing IP rights in joint ventures, including contributions, shared developments, and commercialization strategies
• Navigating challenges specific to collaborations between universities and companies and other private/public partnerships
• Addressing the complexities of IP management when companies collaborate
• Understanding the international implications of IP rights and the importance of harmonizing IP strategies across jurisdictions

The Launch Trajectory of a Novel Therapeutic: Developing a Blueprint for Success

Laurie Burlingame
Partner
Morgan Lewis

Kevin E. Noonan, Ph.D
Partner
McDonnell Boehnen Hulbert & Berghoff LLP

In this case study, our leaders will analyze the trajectory of a novel therapeutic’s journey from concept to commercial approval, providing a blueprint for success. Through an in-depth exploration of a real-world approval, attendees will gain insights into the strategic, regulatory, and market factors that converged to catapult a novel therapeutic from the lab to the patient. Topics of discussion will include:

• Identifying key R&D milestones that lay the foundation for a successful launch
• Insights into effective engagement with the regulatory agencies to streamline the approval process
• Strategizing to overcome market access barriers
• Examining the ongoing efforts for market expansion post-launch, including lifecycle management and broadening of indications

Conference Concludes