2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities - WEB

2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities

March 20–21 | Seaport Hotel, Boston, MA

Leveraging Technology, Safeguarding IP, and Securing Funding to Accelerate Development in RNA, Gene Editing Tech, and Regenerative Medicines

FDA KEYNOTE

ĉ Abata Therapeutics

ĉ Argenx

ĉ Beam Therapeutics

ĉ Caribou Biosciences, Inc.

ĉ Dyno Therapeutics

ĉ Novo Nordisk

2024 CO-CHAIRS

ĉ ReNAgade Therapeutics

ĉ Rocket Pharmaceuticals, Inc.

ĉ Vertex Pharmaceuticals

Cocktail Reception Sponsor

Premium Exhibitor

Cristin Berkey Senior Director, IP and Contracts Counsel Abata Therapeutics

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

Adrian Looney Chief Intellectual Property Counsel Vertex Pharmaceuticals

Julie Tierney Deputy Center Director, Center for Biologics Evaluation and Research FDA

ACI's Novel Therapeutic Modalties Forum: Uniting Innovation, Law, and Strategy in RNA, Gene Editing Tech, and Regenerative Medicines

American Conference Institute is pleased to present the 2nd Annual Forum on IP, Funding, and Tech Strategies for Novel Therapeutic Modalities, where the brightest minds in RNA, gene editing, and regenerative medicine converge to shape the future of this rapidly evolving field.

Positioned at the critical juncture of innovation and commercialization, this premier event is dedicated to unraveling the complex interplay of evolving market trends, dynamic regulatory frameworks, and critical intellectual property strategies.

Join us on March 20–21 in Boston in this collaborative endeavor to drive forward the most groundbreaking advancements in novel therapeutics, marrying scientific discovery with strategic business acumen for global impact.

Attend to engage with leading industry thought leaders and legal pioneers who will illuminate the path from groundbreaking research to global market success. Here, we explore in-depth the nuances of funding methodologies, AI's transformative role in drug discovery, and the intricacies of navigating the legal and regulatory landscapes.

REGISTER NOW

INTRODUCING

ACI’S NOVEL THERAPEUTIC

MODALITIES ADVISORY BOARD

Cristin Berkey Senior Director, IP and Contracts Counsel

Abata Therapeutics

Maureen A. Bresnahan Assistant General Counsel

Eisai Inc.

Elbert Chiang VP, IP Beam Therapeutics

Geoffrey Levitt Head of Global Regulatory Law Argenx

Forrester Liddle

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

Adrian Looney

Chief Intellectual Property Counsel Vertex Pharmaceuticals

Gabriel J. McCool VP, Legal and IP ReNAgade Therapeutics

Sharick Naqi Director & Senior Counsel

Global IP Lead – Gene Therapies

Novartis Gene Therapies

David H. Silverstein

Vice President, Intellectual Property

Rocket Pharmaceuticals, Inc.

Olga Zimmerman Director, Intellectual Property

Caribou Biosciences, Inc.

ESTEEMED CO-CHAIRS

Cristin Berkey

Senior Director, IP and Contracts Counsel Abata Therapeutics

DISTINGUISHED FACULTY

Laurie Burlingame Partner

Morgan Lewis

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

Elbert Chiang VP, IP Beam Therapeutics

Jennifer Fang Partner

Wilson Sonsini Goodrich & Rosati

Emily Gardel Associate Director, Patent Attorney II

Dyno Therapeutics

Ryan Hagglund Partner

Loeb & Loeb LLP

Margaux J. Hall Partner

Ropes & Gray LLP

Michael B. Harlin Partner

Neal, Gerber & Eisenberg LLP

Matt Karlyn Partner

Morrison & Foerster LLP

Forrester Liddle Head of IP and Legal for US R&D

Novo Nordisk

Nishla H. Keiser Partner

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Roger Kuan Partner

Norton Rose Fulbright US LLP

Sam Kwon Partner

Kirkland & Ellis LLP

JM Lee

Director, Business Development

Novo Nordisk

Dan Liu

Attorney Loeb & Loeb LLP

Gabriel J. McCool

VP, Legal and IP

ReNAgade Therapeutics

David M. McIntosh Partner

Ropes & Gray LLP

James Myers

Associate Director for Policy, CBER FDA

Kevin E. Noonan, Ph.D Partner

McDonnell Boehnen Hulbert & Berghoff LLP

Charles G. Raver Attorney

Hyman, Phelps & McNamara

It was cutting edge. Hearing about CMS had us considering strategies for drug, formulation, and indication claiming.

MERCEDES MEYER, PARTNER, BANNER WITCOFF

Media Partners:

Adrian Looney Chief IP Counsel Vertex Pharmaceuticals

Matthew Rizzo General Partner OrbiMed Advisors LLC

Irena Royzman Partner

Head, Life Sciences Kramer Levin Naftalis & Frankel LLP

Chuck Sholtz

Vice President, Intellectual Property Nutcracker Therapeutics

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

Julie Tierney Deputy Center Director, Center for Biologics Evaluation and Research FDA

Jennifer Tousignant Chief Legal Officer

Viridian Therapeutics

Margaret Welsh Partner Baker Botts LLP

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

Olga Zimmerman Director, Intellectual Property Caribou Biosciences, Inc.

Very knowledgeable and insightful information on the IRA. CHUCK SHOLTZ, VP, INTELLECTUAL PROPERTY NUTCRACKER THERAPEUTICS

DAY ONE Wednesday, March 20, 2024

7:45 Breakfast and Registration

8:45

Opening Remarks from the Chairs

microphone-alt Cristin Berkey, Senior Director, IP and Contracts Counsel, Abata Therapeutics

Forrester Liddle, Head of IP and Legal for US R&D, Novo Nordisk Adrian Looney, Chief IP Counsel, Vertex Pharmaceuticals

9:00

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

microphone-alt 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

10:00

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

microphone-alt Jennifer Tousignant, Chief Legal Officer, Viridian Therapeutics

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

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

11:00

FDA KEYNOTE

microphone-alt Julie Tierney, Deputy Center Director, Center for Biologics Evaluation and Research, FDA

11:30 Morning Break

11:45

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

microphone-alt James Myers, Associate Director for Policy, CBER, FDA

Charles G. Raver, Attorney, Hyman, Phelps & McNamara

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

12:45 Networking Luncheon

1:45

Comprehensive Due Diligence for Novel Therapeutics: Beyond IP and the FTO

microphone-alt David Silverstein, Vice President, IP, Rocket Pharmaceuticals, Inc.

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

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

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

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

3:45 Afternoon Break

4:00

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

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.

microphone-alt Elbert Chiang, VP, IP, Beam Therapeutics

Gabriel McCool, VP, Legal and IP, ReNAgade Therapeutics

Dan Liu, Attorney, Loeb & Loeb LLP

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

5:00

Conference Adjourns to Day Two, Cocktail Reception

2:45

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

microphone-alt Olga Zimmerman, Director, Intellectual Property, Caribou Biosciences, Inc.

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

Sam Kwon, Partner, Kirkland & Ellis LLP

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.

Sponsored by

DAY TWO

Thursday, March 21, 2024

7:45 Breakfast and Registration

8:45

Opening Remarks from the Chairs

microphone-alt Cristin Berkey, Senior Director, IP and Contracts Counsel, Abata Therapeutics

Forrester Liddle, Head of IP and Legal for US R&D, Novo Nordisk

Adrian Looney, Chief IP Counsel, Vertex Pharmaceuticals

9:00

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

microphone-alt 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

10:00

Innovative Funding Strategies: Fueling the Next Wave of Breakthroughs

microphone-alt 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

11:00 Morning Break

11:15

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

microphone-alt 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

• 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

12:15

USPTO KEYNOTE

microphone-alt Mary Till, Senior Legal Advisor, Office of Patent Legal Administration, USPTO

Moderator: Cristin Berkey, Senior Director, IP and Contracts Counsel, Abata Therapeutics

12:45 Networking Luncheon

Great overview of FDA issues, highlighting of key considerations, and providing new and useful information not easily accessible elsewhere.

DEBORAH CHO, ATTORNEY, HOGAN LOVELLS (FORMER ASSOCIATE CHIEF COUNSEL, FDA)

C ASE STUDIES

2:00

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

microphone-alt 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

3:00

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

microphone-alt 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

4:00

Conference Concludes

EARN CLE CREDITS

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation. ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board. ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

For more information on ACI’s CLE process, visit:

www.AmericanConference.com/Accreditation/CLE

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