15th Summit on Biosimilars & Innovator Biologics

We’re Back in New York City!

Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilar Market Place

June 20–21, 2024 | New York City Bar Association, New York, NY

2024 Conference Chairs

Jessica Greenbaum Director, Regulatory Affairs Policy U.S. Sandoz Inc.

Alvotech

Apotex

Cardinal Health

Harshika Sarbajna Vice-President, Commercial | Head, Global Alvotech

Paki Banky Director | Senior IP Counsel | IP Lead, Cell & Gene Novartis

CLE/DEI CREDITS

Special Interview with the U.S. Food and Drug Administration

Meet and Network with Key In-House Stakeholders From:

Eisai Inc.

Eli Lilly and Company

Fresenius Kabi USA

Genentech

Novartis

Organon

Supporting Sponsors

Associate Sponsors

Laurel Goldberg Regulatory Counsel, CDER U.S. Food and Drug Administration

Regeneron Pharmaceuticals

Syneos Health

EARN

2024 is a make-or-break year for the biosimilar and biologic landscape — setting the stage for an era of transformation that will dictate the future of global innovation and accessibility

ACI’s Biosimilar and Innovator Biologics Advisory Board

The price control provisions of the Inflation Reduction Act and the possibility of march-in rights are influencing innovator biologic and biosimilar development.

These new policy considerations under the IRA and new EO's are influencing both sides of this market. Innovators who were initially concerned about looming biosimilar competition must now navigate even more financial risk under the price control provisions of the IRA and the Biden Administration's proposed expansion of march-in rights under the Bah-Doyle Act. This evolving landscape not only challenges the innovator biologic community — but also offers an opportunity for biosimilar makers to strategize and capitalize on these changes, fostering a more competitive and dynamic market environment.

What do the Humira and non-Humira launches say for the future of innovation?

Several of the Humira biosimilars have been on the market since 2023, with non-Humira biosimilars also making headway in market and patient access.

With more than 50 blockbuster biologics slated to lose exclusivity in the coming decade, the adoption of biosimilars will continue to be a defining factor across the healthcare continuum, and there are critical lessons to be learned from these launches and lawsuits.

Interchangeability and lack of prescriber knowledge continue to affect biosimilar market access

The complex interplay of prescriber awareness, questionable value of interchangeable status, and divergent state laws, shapes biosimilar adoption and patient access, adding layers of complexity to the healthcare terrain and educational efforts.

With so many developments changing the landscape and practice, attendance at this event is not optional

This June, join our faculty of global thought-leaders to discuss legal, regulatory, and commercial strategies for the innovator and biosimilars marketplace that are essential to the proliferation of these products.

Ali I. Ahmed

Global Head, Industry Advisory & Innovation, Pharmaceuticals and Therapeutics Salesforce

Larry Coury Vice-President, Associate General Counsel Regeneron Pharmaceuticals

Rebecca Charnas Grant Senior Director | Associate General Counsel Genentech

Henry Gu SVP, Head of IP Zentalis Pharmaceuticals

Brian McCormick Vice PresidentChief Regulatory Counsel, Head of Global Regulatory Policy Teva Pharmaceuticals

Mira A. Mulvaney Associate VP | Assistant General Patent Counsel, IP Litigation Eli Lilly and Company

Sonia Tadjalli Oskouei Vice President, Biosimilars and Specialty Sandoz, Inc.

Chuck Sholtz Vice President, Intellectual Property Legal Department Nutcracker Therapeutics, Inc.

Gillian Woollett VP, Head Regulatory Strategy and Policy

Samsung Bioepis

Distinguished Faculty

2024 Conference Chairs

Jessica Greenbaum

Director, Regulatory Affairs Policy U.S. Sandoz Inc.

Harshika Sarbajna Vice-President, Commercial | Head, Global Alvotech

Paki Banky

Director | Senior IP Counsel | IP Lead, Cell & Gene Novartis

Patent Trial and Appeal Board

Honorable Jacqueline Bonilla

Deputy Chief Administrative

Patent Judge

Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Honorable Linda Horner

Administrative Patent Judge

Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Honorable Grace Obermann

Administrative Patent Judge

Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Vanessa Ford

Supervisory Patent Examiner

U.S. Patent and Trademark Office

U.S. Food and Drug Administration

Laurel Goldberg

Regulatory Counsel, CDER

U.S. Food and Drug Administration

In-House Counsel & Associations

Christine Baeder President Apotex Corp. US

Aaron Barkoff

Associate VP | General Patent Counsel, IP Litigation Eli Lilly and Company

Maureen A. Bresnahan

Assistant General Counsel Eisai Inc.

Craig Burton

Executive Director |

Senior Vice President, Policy and Strategic Alliances Biosimilars Council | Association for Accessible Medicines

James T. Evans, Ph.D.

Senior Director, Assistant General Counsel, Dispute Resolution

Regeneron Pharmaceuticals

Jon Martin

Associate Vice President, US Biosimilars Business Unit Organon

Mira A. Mulvaney

Associate VP | Assistant General Patent Counsel, IP Litigation Eli Lilly and Company

Jonathan Olefson

General Counsel

Syneos Health

Dracey Poore

Director of Biosimilars Product and Solutions Marketing Cardinal Health

Hans Sauer

Deputy General Counsel | Vice-President for IP Biotechnology Industry Organization

Ash Verma

Executive Director, Pharmaceuticals Equity Research UBS

Sarah Wohl

Senior Counsel Specialist | Assistant General Counsel, Antitrust Genentech

Former Deputy Assistant Director, FTC

Esteemed Speakers

Larry Coury Vice-President, Associate General Counsel Regeneron Pharmaceuticals

Rajesh Desikan

Vice President & Head, Marketing & Commercial Operations Excellence Fresenius Kabi

James Boaini Shareholder Epstein, Becker & Green P.C.

Aziz Burgy Partner Axinn, Veltrop, & Harkrider LLP

Robert Cerwinski Managing Partner Gemini Law LLP

Edric Engert Venture Partner | EVP, Commercialization and Business Development Social Impact Capital | RxGuardian Inc.

Raj Gandesha Partner White & Case LLP

Vishal C. Gupta Partner | Co-Chair Life Sciences Practice Steptoe LLP

Ryan Hagglund Partner Loeb & Loeb LLP

Sara W. Koblitz Director

Hyman, Phelps, McNamara P.C.

Susan Krumplitsch Partner

DLA Piper LLP

Jordan Markham Partner

Steptoe LLP

Steven D. Maslowski Partner | IP Practice Group Leader

Akin Gump Strauss Hauer & Feld LLP

Kurt Mathas Partner Winston & Strawn LLP

Mark C. McLennan Partner

Kirkland & Ellis LLP

Jason Murata Partner | Chair of DEI Committee Axinn, Veltrop, & Harkrider LLP

Kevin Noonan, Ph.D. Partner | Co-Chair Biotechnology and Pharmaceuticals Practice Group

McDonnell Boehnen Hulbert & Berghoff LLP

Matthew A. Pearson Partner

Akin Gump Strauss Hauer & Feld LLP

Mark A. Perry Partner | Co-Head Appeals & Strategic Counselling Weil, Gotshal & Mangers LLP

Alison Hanstead Partner White & Case LLP

Jeremiah J. Kelly Partner Venable LLP

Maarika L. Kimbrell Partner Morgan, Lewis & Bockius LLP

Chad J. Peterman Partner

Paul Hastings LLP

Cody Powers Principal, Portfolio and Business Development ZS Associates

John Christopher Rozendaal Partner | Director | Chair of Trial & Appellate Practice Group

Sterne Kessler Goldstein & Fox LLP

Alicia A. Russo Partner Venable LLP

Peter Sandel Partner

Groombridge, Wu, Baughman & Stone LLP

Hassen Sayeed Partner O'Melveny & Myers LLP

Keri L. Shaubert, Ph.D. Member

Cozen O'Connor

Eva Temkin Partner

Arnold & Porter LLP

DAY ONE

JUNE 20, 2024

7:00am Registration and Breakfast

8:00am Opening Remarks from the Chairs

Microphone-alt Jessica Greenbaum, Director, Regulatory Affairs Policy U.S., Sandoz Inc.

Harshika Sarbajna, Vice-President, Commercial | Head, Global, Alvotech

Paki Banky, Director | Senior IP Counsel | IP Lead, Cell & Gene, Novartis

8:15am

The Politics of Innovation and Cost: The Impact of the Biden Administration’s Cadence on Manufacturer Pipelines, Product Launches and Pricing Strategies

Microphone-alt Hans Sauer, Deputy General Counsel | Vice-President for IP, Biotechnology Industry Organization

Maureen A. Bresnahan, Assistant General Counsel, Eisai Inc.

Christine Baeder, President, Apotex Corp. US

Eva Temkin, Partner, Arnold & Porter 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 lawsuits

9:45am Morning Networking Break

10:00am BIOSIMILAR MARKET RETROSPECTIVE

Unpacking the Humira and Non-Humira

Biosimilar Launches and Lawsuits: Lessons Learned and Insights for the Future

Moderator:

Paki Banky, Director, Senior IP Counsel, IP Lead, Cell & Gene, Novartis 2024 Conference Chair

Microphone-alt Craig Burton, Executive Director | Senior Vice President, Policy and Strategic Alliances, Biosimilars Council | Association for Accessible Medicines

Robert Cerwinski, Managing Partner, Gemini Law LLP

Raj Gandesha, Partner, White & 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

11:30am

Implications for Product Launch and Market Exclusivity: Decoding In Re Cellect, USPTO Guidance on Patent Term Adjustments and OTDP

Microphone-alt James T. Evans, Ph.D., Senior Director, Assistant General Counsel, Dispute Resolution, Regeneron Pharmaceuticals

Alicia A. Russo, Partner, Venable LLP

Matthew A. Pearson, Partner, Akin Gump Strauss Hauer & Feld LLP

John Christopher Rozendaal, Partner | Director | Chair of Trial & Appellate Practice Group, Sterne Kessler Goldstein & Fox LLP

Mark A. Perry, Partner | Co-Head Appeals & Strategic Counselling, Weil, Gotshal & Mangers 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

12:30pm Networking Lunch

2:00pm

FDA Keynote Interchangeability and Data Requirements

Laurel Goldberg Regulatory Counsel, CDER U.S. FDA

Interviewed By:

Maarika L. Kimbrell, Partner, Morgan, Lewis & Bockius LLP

2:45pm

Adapting to Regulatory Shifts in Approval Pathways, Labelling, and Staying Ahead of Induced Infringement

Microphone-alt Jeremiah J. Kelly, Partner, Venable LLP

Sara W. Koblitz, Director, Hyman, Phelps, McNamara P.C.

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

4:00pm Afternoon Networking Break

4:15pm

Investor’s Roundtable:

Biosimilar and Innovator Biologic Market Trends, and Strategic Insights for Portfolio Planning

Moderator: Rajesh Desikan, Vice President & Head, Marketing & Commercial Operations Excellence, Fresenius Kabi

Microphone-alt Edric Engert, Venture Partner | EVP, Commercialization and Business Development, Social Impact Capital | RxGuardian Inc.

Cody Powers, Principal, Portfolio and Business Development, ZS Associates

Ash Verma, Executive Director, Pharmaceuticals Equity Research, UBS

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?

5:15pm Conference Cocktail

6:15pm Conference Adjourns

EARN CLE/DEI 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

DAY TWO

JUNE 21, 2024

7:00am Registration and Breakfast

8:00am

Opening Remarks from the Chairs

Microphone-alt Jessica Greenbaum, Director, Regulatory Affairs Policy U.S., Sandoz Inc.

Harshika Sarbajna, Vice-President, Commercial | Head, Global, Alvotech

Paki Banky, Director | Senior IP Counsel | IP Lead, Cell & Gene, Novartis

8:15am

Reviewing Cases and Distilling Trends: The Key Federal and District Court Lawsuits Shaping the BPCIA Landscape

Microphone-alt Larry Coury, Vice-President, Associate General Counsel, Regeneron Pharmaceuticals

Aziz Burgy, Partner, Axinn, Veltrop, & Harkrider LLP

Hassen Sayeed, Partner, O'Melveny & Myers LLP

Alison Hanstead, Partner, White & 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

9:15am

Balancing Innovation and Competition in BioPharma:

Best Practices for Avoiding the FTC's Crosshairs Within and Outside the BPCIA

Microphone-alt Sarah Wohl, Senior Counsel Specialist | Assistant General Counsel, Antitrust, Genentech, Former Deputy Assistant Director, FTC

Vishal C. Gupta, Partner | Co-Chair Life Sciences Practice, Steptoe LLP

Kevin E. Noonan, Ph.D., Partner | Co-Chair Biotechnology and Pharmaceuticals Practice Group, McDonnell Boehnen Hulbert & Berghoff LLP

Aaron Barkoff, Associate VP | General Patent Counsel, IP Litigation, Eli Lilly and Company

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

10:15am Morning Networking Break 10:30am

The Business of Biosimilars: Strategically Exploring Options for Sustainability Amidst Hurdles Faced by Industry

Moderated by:

Harshika Sarbajna, Vice-President, Commercial | Head, Global, Alvotech, 2024 Conference Chair

Microphone-alt Dracey Poore, Director of Biosimilars Product and Solutions Marketing, Cardinal Health

Jon Martin, Associate Vice President, US Biosimilars Business Unit, Organon

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 costeffectiveness

• 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

11:30am

Policy, Procedure and Practice Points with the PTAB

Microphone-alt

Honorable Jacqueline Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

Honorable Linda Horner, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

Honorable Grace Obermann, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

Interviewed by:

Jordan Markham, Partner, Steptoe LLP

In this exclusive interview, the APJs will answer questions touching on:

• Fintiv and the current policy relating to discretionary denials of institution

» How the Judges consider denials (e.g., serial petitions, parallel petitions, 325(b))

» Recent Director Review decisions relevant to discretionary denials

• The new Guidance on obviousness and the new Guidance on written description and enablement, post-Amgen v. Sanofi

• The latest statistics for types of challenges brought and types of patents challenged

• Best practice tips, i.e., what judges find helpful, unhelpful, the secondary considerations

12:30pm Networking Lunch

2:00pm

Reference Drug Patent Challenges:

Unpacking Recent PTAB Decisions and Insights

Microphone-alt

Mira A. Mulvaney, Associate VP | Assistant General Patent Counsel, IP Litigation, Eli Lilly and Company

Kurt Mathas, Partner, Winston & Strawn LLP

Ryan Hagglund, Partner, Loeb & Loeb LLP

• Analyzing recent cases that impact the patentability of biologics

» E.g., Amgen v. Sanofi, Kite v. Juno, and Daiichi Sankyo v. Seagen Inc.

• Reviewing the recent USPTO guidance on obviousness; the post-Amgen guidance; and the notice of proposed rule-making with respect to discretionary denials

» What if any changes to current filing and litigation strategies should be considered in light of the above?

• Understanding the advantages for applicants to resolve prior art invalidity disputes via PTAB proceedings

• Establishing standing to appeal in an IPR or PGR in connection with BPCIA and the FDA approval process for biosimilars

» Appreciating the timing for applicants to file petitions for IPRs and PGRs relative to filing BLAs and BPCIA litigation

• Analyzing biosimilars filings and recent PTAB decisions, e.g., the PTAB challenges relating to SOLIRIS and STELARA

3:00pm

To Dance or Not to Dance? Updated Venue Selection Matrices for a Maturing Biosimilar Industry

Microphone-alt Steven D. Maslowski, Partner | IP Practice Group Leader, Akin Gump Strauss Hauer & Feld LLP

Peter Sandel, Partner, Groombridge, 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?

4:00pm Afternoon Networking Break

4:15pm

Artificial Intelligence from Molecule to Market:

How AI

Accelerates Innovation and Regulatory Approvals for Biologics and Biosimilars

Microphone-alt James Boaini, Shareholder, Epstein, Becker & Green P.C.

Susan Krumplitsch, Partner, DLA Piper LLP

Jonathan Olefson, General Counsel, Syneos Health

Chad J. Peterman, Partner, Paul Hastings LLP

In this session, the speakers will provide a foundational exploration of the rewards and risks of AI's productivity promise. Topics of discussion will include:

• 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

5:15pm

Diversity, Equity and Inclusion in the Research, Development, and Approval of Biologics and Biosimilars

Microphone-alt Vanessa Ford, Supervisory Patent Examiner, U.S. Patent and Trademark Office

Jason Murata, Partner | Chair of DEI Committee, Axinn, Veltrop, & Harkrider LLP

Mark C. McLennan, Partner, Kirkland & Ellis 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

6:15pm Conference Concludes

From Patents to Regulatory Challenges: C5's

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Conference Sponsor

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Building VENUE INFORMATION

New York City Bar Association 42 West 44th Street, New York, NY 10036

Bed HOTEL ACCOMMODATIONS

Sofitel New York 45 West 44th Street

Reservations: anna.li@sofitel.com or 212-782-3015

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote "ACI's Biosimilars".

Please note that the guest room block cut-off date is May 20, 2024. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Global Sponsorship Opportunities

With conferences in the United States, Canada, Latin America and Europe, the C5 Group of Companies: American Conference Institute, Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com

Book with Confidence!

If you are unable to attend for any reason, you will have the following options:

y A full credit note for you, or a colleague to attend another event.

y A full refund.

All cancellations and changes must be submitted to CustomerService@AmericanConference.com by June 6, 2024.