13th Summit on Biosimilars & Innovator Biologics - DS

EARN CLE/ Ethics/Diversity CREDITS

2022 Co-Chairs:

June 28–29, 2022 • Hyatt Regency Boston

13th Summit on

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

Charles K. Sholtz, PhD, JD Director and AGC, Manufacturing IP Lead, Intellectual Property Genentech | A Member of the Roche Group Gillian Woollett Vice President, Head Regulatory Strategy and Policy Samsung Bioepis

Exclusive Insights from: Hon. Michelle Ankenbrand Senior Lead Administrative Patent Judge, PTAB USPTO Beckey Egeland Attorney, Bureau of Competition U.S. FTC M. Stacey Ricci Director, Scientific Review Staff Office of Therapeutic Biologics and Biosimilars U.S. Food and Drug Administration

Supporting Sponsors

Luncheon Sponsor

REGISTER NOW

Associate Sponsors

AmericanConference.com/Biosimilars • 888 224 2480

LOGO

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

2022 is signaling a renewed focus on innovator biologics and biosimilars, with new regulations and restrictions placed on anticompetitive practices.

ACI’s Biosimilars and Innovator Biologics Advisory Board Ali I. Ahmed Senior Vice President, Biosimilars Fresenius Kabi USA

The innovator biologics and biosimilars industries have reached an inflection point in the United States. With another major wave of loss of BLA exclusivities in the next five to ten years, it is imperative that industry is well prepared today. Now, more than ever, strategies to overcome these barriers are essential to improve the understanding of biosimilar products in the United States. The need for a solid guiding framework becomes more critical than ever before.

Even with a calendar year that included 4 FDA approvals, 3 launches in the United Sates, 2 approvals for interchangeable biosimilars, and myriad regulatory and legal developments, the traditional barriers continue to be complicated, interconnected, and best addressed by stakeholder collaboration.

In this context, we cordially invite you to explore the contours of the rapidly changing landscape for biosimilars and innovator biologics. This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Summit on Biosimilars & Innovator Biologics.

BOOK NOW

Venue Information The 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 & Innovator Biologics”.

Hotel: Address: Room Cutoff: Reservations:

Hyatt Regency Boston One Avenue de Lafayette, Boston, Massachusetts, 02111 June 6, 2022 617-912-1234

Please note that the guest room block cut-off date is June 6, 2022. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

2 | #ACIBiosimilars

twitter: @ACI_Pharma linkedin: ACI Pharmaceutical, Biotech and Life Sciences

Neal Dahiya SVP, Head of Litigation Moderna Henry Gu Vice President, Head of IP Morphic Therapeutic Brian McCormick Vice President – Chief Regulatory Counsel, Head of Global Regulatory Policy Teva Pharmaceuticals Julia Pike Global Head of IP Sandoz Chuck Sholtz Director and Associate General Counsel, Biosimilars Manufacturing & Litigation Readiness Lead Genentech Sonia Oskouei Vice President, Biosimilars Cardinal Health Gillian Woollett VP, Head Regulatory Strategy and Policy Samsung Bioepis

Media Partners

DISTINGUISHED FACULTY CO-CHAIRS Charles K. Sholtz, PhD, JD Director and AGC, Manufacturing IP Lead Intellectual Property Genentech | A Member of the Roche Group Gillian Woollett VP, Head Regulatory Strategy and Policy Samsung Bioepis GOVERNMENT Hon. Michelle Ankenbrand Senior Lead Administrative Patent Judge, PTAB USPTO Beckey Egeland Attorney, Bureau of Competition U.S. FTC M. Stacey Ricci Director, Scientific Review Staff Office of Therapeutic Biologics and Biosimilars U.S. Food and Drug Administration ASSOCIATIONS

IN-HOUSE COUNSEL Maureen A. Bresnahan Assistant General Counsel, Legal Department Eisai Inc. Ali I. Ahmed Senior Vice President, Biosimilars Fresenius Kabi USA, LLC K. Nicole Clouse IP Counsel Biogen Bart Newland General Counsel Atalanta Therapeutics Sonia T. Oskouei VP, Biosimilars Cardinal Health Jenny Johnson VP, IP Endo Pharmaceuticals Tara Rahemba Executive Director, IP Counsel Alexion, AstraZeneca Rare Disease LAW FIRMS Sarah Abraham Manager Cornerstone Research

Hans Sauer Deputy General Counsel, VP of IP BIO

Orion Armon Partner Cooley LLP

Karin Hessler Assistant General Counselor AAM

Rob Cerwinski Managing Partner Gemini Law LLP

David Korn Vice President, IP and Law PhRMA

W. Blake Coblentz Co-Chair Hatch-Waxman and Biologics Litigation Group Cozen O’Connor

Juliana “Julie” Reed Executive Director The Biosimilars Forum

Evan Diamond Partner King & Spalding LLP

Eldora L. Ellison, Ph.D. Director Sterne, Kessler, Goldstein & Fox P.L.L.C. Rachel Elsby Partner Akin Gump Strauss Hauer & Feld LLP Nicholas Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP Vishal Gupta Partner Co-Chair, Healthcare & Life Sciences Practice Steptoe & Johnson LLP Siegmund Y. Gutman Partner Proskauer Rose LLP Ryan Hagglund Partner Loeb & Loeb LLP Amanda Hollis Partner Kirkland & Ellis LLP Whitney Meier Howard Partner Venable LLP Eric R. Hunt Partner Rakoczy Molino Mazzochi Siwik LLP Susan Krumplitsch Partner DLA Piper Chad A. Landmon Partner Axinn, Veltrop & Harkrider LLP Otto Licks Partner Licks Attorneys Ashley N. Mays-Williams Associate, Litigation Department Paul Hastings LLP

REGISTER NOW

AmericanConference.com/Biosimilars • 888 224 2480

Nicholas Mitrokostas Partner Allen & Overy LLP John J. Molenda Partner, Co-Chair, Healthcare & Life Sciences Practice Steptoe & Johnson LLP Gregory A. Morris Partner Honigman LLP Kevin E. Noonan Partner McDonnell Boehnen Hulbert & Berghoff LLP Matthew A. Pearson Partner Akin Gump Strauss Hauer & Feld LLP Chad J. Peterman Partner, Litigation Department Paul Hastings LLP Maureen L. Rurka Partner Winston & Strawn LLP Alicia Russo Partner Venable LLP Melanie K. Sharp Partner Young Conaway Stargatt & Taylor, LLP Eva Temkin Partner King & Spalding LLP Steven R. Trybus Partner Locke Lord LLP Elizabeth Weiswasser Partner Weil, Gotshal & Manges LLP Huiya Wu Partner Goodwin Procter LLP

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

PRE-CONFERENCE WORKSHOPS • MONDAY JUNE 27, 2022

A

9:00 AM – 12:00 PM (Registration begins at 8:30 AM – breakfast will be served)

atenting mRNA, CRISPR, and Emerging Biotechnological P Inventions: Harnessing IP Protections to Ensure Successful Commercialization of New Technologies

microphone-alt Kevin E. Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff LLP Bart Newland, General Counsel, Atalanta Therapeutics Harnessing new capabilities such as AI, automation, and data analytics, as well as the manipulation of mRNA and CRISPR technologies are critical to how companies will commercialize innovation and ensure success of the business unit. Securing IP rights to these technologies and leveraging or licensing these rights appropriately is essential to successful commercialization, growth, and future development of these innovations.

This workshop will examine recent IP controversies with new technologies such as mRNA and CRSPR and provide an insightful exchange on addressing patent rights in this new era which has been dubbed “the New Biotech Revolution.”

Points of discussion will include: • Survey and analysis of current mRNA and CRSPR patent challenges • Looking at future uses of mRNA and CRISPR technologies, while being cognizant of current and potential IP challenges • Analyzing the future market opportunities and emerging biotechnological trends on a global level • Being mindful of freedom to operate parameters with these technologies as well as peripheral patent rights • How to appropriately leverage patent rights for new biotech inventions: when does a license make sense over a lawsuit?

• Selecting a delivery method for new inventions • Deciding whether to in-license lipid nanoparticle (LPN) technologies v. patent protection on novel technologies • Reviewing the regulatory pathways for these technologies • Exploring the changing landscape relating to regulatory evaluation, drug development and commercial strategy • Understanding how the multi-stakeholder approach can be used to support efficient implementation

hands-helping BECOME A SPONSOR With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The 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

4 | #ACIBiosimilars

B

1:00 PM – 4:00 PM (Registration begins at 12:30 PM)

Biosimilar Patent Litigation Settlements Master Class: Practical Strategies and Tactics for Drafting

microphone-alt Rob Cerwinski, Managing Partner, Gemini Law LLP Over a dozen states have enacted provisions related to pharmaceutical price transparency and patent litigation settlements. As a result, pharmaceutical companies could face increasing anticompetitive scrutiny via sanctioning “pay-for-delay” settlements between generic and brand companies. This session will provide practical strategies and tactics for drafting biosimilar patent litigation settlements. Points of discussion will include: • Reviewing the requirements for agreements involving biosimilars to be reported to FTC and DOJ • Developing timelines for business and legal milestones relative to terms of the settlement • Understanding the application of antitrust law’s “rule of reason” to pharmaceutical patent settlements • Examining decisions concerning pharmaceutical patent settlements

EXCLAMATION

Due to the interactive nature, workshops will only be available in-person.The main conference will have a livestream option for those who can't attend in-person.

EARN CLE/ Ethics/Diversity 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 About us:

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

For over 30 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

twitter: @ACI_Pharma linkedin: ACI Pharmaceutical, Biotech and Life Sciences

DAY ONE • TUESDAY JUNE 28, 2022 7:00

Registration and Breakfast

8:00

Opening Remarks from the Conference Co-Chairs microphone-alt Charles K. Sholtz, PhD, JD, Director and AGC, Manufacturing IP Lead, Intellectual Property, Genentech | A Member of the Roche Group

Gillian Woollett, VP, Head Regulatory Strategy and Policy, Samsung Bioepis 8:15

THE POLITICS AND POLICIES OF BLAs AND aBLAs

Year in Review: Legislative and Regulatory Developments Impacting the Biopharmaceutical Industry

• Devising alternate strategies for drafting enforceable claims » Protecting newly-developed biopharma IP • Analyzing how these decisions (including further appeals to the U.S. Supreme Court) impact the enforcement of existing claims • Reconciling whether written description is met when the specification discloses formulas 11:45

The Current State of the Skinny Label Regime: Press Release Language, Marketing Materials, and the Liability for Insurance Companies microphone-alt Jenny Johnson, VP, IP, Endo Pharmaceuticals W. Blake Coblentz, Co-Chair, Hatch-Waxman and Biologics Litigation Group, Cozen O’Connor

microphone-alt Hans Sauer, Deputy General Counsel, VP of IP, BIO

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

Karin Hessler, Assistant General Counselor, AAM

Nicholas Mitrokostas, Partner, Allen & Overy LLP

David Korn, Vice President, IP and Law, PhRMA

MODERATOR:

Vishal Gupta, Partner, Co-Chair, Life Sciences Practice, Steptoe & Johnson LLP

Juliana “Julie” Reed, Executive Director, The Biosimilars Forum MODERATOR:

Susan Krumplitsch, Partner, DLA Piper

9:30

FDA KEYNOTE

Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation microphone-alt M. Stacey Ricci, Director, Scientific Review Staff, Office of Therapeutic Biologics and Biosimilars, U.S. Food and Drug Administration INTERVIEWED BY:

Eva A. Temkin, Partner, King & Spalding LLP

10:15

Morning Break

10:45

BPCIA TRIAL TRACKER: New Developments at the Federal Circuit, District Courts and the PTAB

Satisfying the Statutory Requirements for Enablement and Written Description: §112(a) and the Future of Genus Claims microphone-alt Maureen A. Bresnahan, Assistant General Counsel, Legal Department, Eisai Inc. Rachel Elsby, Partner, Akin Gump Strauss Hauer & Feld LLP Nicholas Groombridge, Partner, Paul, Weiss, Rifkind, Wharton & Garrison LLP Ryan Hagglund, Partner, Loeb & Loeb LLP Two recent Federal Circuit decisions, Amgen Inc. v. Sanofi and Juno Therapeutics, Inc. v. Kite Pharma, Inc., confirmed biopharma patents claiming a genus of antibodies may be especially susceptible to invalidation for lack of enablement or insufficient written description under 35 U.S.C. §112(a). Given that the scope of appropriate claims for antibodies is tightening, biopharmaceutical patent attorneys will need to consider:

REGISTER NOW

AmericanConference.com/Biosimilars • 888 224 2480

Subsequent to the Federal Circuit’s skinny label ruling in GSK v. Teva, the District of Delaware in Amarin v. Hikma (D. Del. 2022) embraced a narrower approach in dismissing an induced infringement claim based on an allegedly inadequate skinny label carve out. The Delaware court also examined the novel question of whether a health insurer’s formulary placement of the drug in question induced infringement of method-of-use patents. Further, confirming that without any bright line rules, and absent a decision from the U.S. Supreme Court or legislation, the fate of the skinny label remains in the balance.

• Considering whether the language of press releases, web pages and other marketing materials require more scrutiny • Analyzing potential liability faced by insurers for placement of skinny label on formularies » Does liability exist for induced infringement by listing a skinny label on a formulary » Taking stock of the potential impact to patients • 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 12:45

Networking Luncheon

2:00

Challenging Patents on Reference Drugs: Litigation Strategies for IPR Practice microphone-alt Whitney Meier Howard, Partner, Venable LLP Siegmund Gutman, Partner, Proskauer Gregory A. Morris, Partner, Honigman LLP Maureen L. Rurka, Partner, Winston & Strawn LLP MODERATOR:

John J. Molenda, Partner, Co-Chair, Healthcare & Life Sciences Practice, Steptoe & Johnson LLP Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DAY TWO • WEDNESDAY JUNE 29, 2022 IPRs offer biosimilar and generic drug manufactures the benefit of challenging innovator patents with comparative haste and efficiency. While IPRs continue to provide an alternative forum for biosimilar manufactures who seek a faster alternative to BPCIA litigation, successful IPRs of biologics patents remains a challenge. During this interactive session, points of discussion will include: • Reducing risk by challenging patents in advance of launching biosimilars at risk • Understanding the advantages for applicants to resolve prior art invalidity disputes via IPRs • Establishing standing to appeal in an IPR in connection with BPCIA and the FDA approval process for biosimilars • Anticipating an answer to the unresolved question as to how much investment is required in the biosimilar context under Article III to establish standing • Appreciating the timing for applicants to file petitions for IPRs relative to filing BLAs and BPCIA litigation » Assessing concerns surrounding multiple filer petitions and relevant timing considerations • Analyzing biosimilars IPR filings and recent PTAB decisions 3:00

Afternoon Break

Examining the Role of the ITC in Biotech Litigation: 337 Investigations, IP Infringement, and Trade Secrets microphone-alt Amanda Hollis, Partner, Kirkland & Ellis LLP Elizabeth Weiswasser, Partner, Weil, Gotshal & Manges LLP While infringement actions at the ITC under 337 investigations have increased for many industries over the years, the ITC remains a relatively uncommon forum for the bio-pharmaceutical industries.

However, this trend many soon change for the biotech industry. In March of 2021, AbbVie filed a trade secret complaint against Alvotech, followed by similar allegations asserted in an additional ITC action in December of 2021. The complaint alleges misappropriation of trade secrets and tortious interference with contractual relations. In this session, our panelists will consider: • Reviewing recent ITC cases with trade secret allegations • Anticipating when reference product sponsors may seek to bring these claims • Protecting against misappropriation claims » Developing robust policies against the use of another party’s confidential information • Ensuring compliance with strong internal policies INTERACTIVE ETHICS DRILLS

Ethical Considerations in Biologics and Biosimilars Litigation microphone-alt Ashley N. Mays-Williams, Attorney, Litigation Department, Paul Hastings LLP • Understanding conflicts of interest leading to possible disqualifications » Establishing standards for determining when attorneys and/or firms should be disqualified • Determining who is a client based on actual representation » Appreciating duties to former clients • Assessing concurrent conflicts via hypothetical scenarios 5:15

Day One Adjourns

6 | #ACIBiosimilars

Registration and Breakfast

8:00

Co-Chairs’ Recap of Day One and Opening Remarks 8:15

THE PTAB LIVE!

The APJs Speak on Practice, Policy and Procedure microphone-alt Hon. Michelle Ankenbrand, Senior Lead Administrative Patent Judge, PTAB, USPTO MODERATOR:

Eric Hunt, Partner, Rakoczy Molino Mazzochi Siwik LLP 9:15

SPOTLIGHT ON ANTI-TRUST

FTC Keynote: Antitrust Developments Impacting Biosimilars and Innovators microphone-alt Beceky Egeland, Attorney, Bureau of Competition, U.S. FTC

3:15

4:15

7:15

9:45

Morning Break

10:30

Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations microphone-alt Sarah Abraham, Manager, Cornerstone Research Orion Armon, Partner, Cooley LLP Evan Diamond, Partner, King & Spalding LLP Antitrust enforcement is routinely triggered via the approval of a biosimilar. Many believe that anti-competitive behavior exhibited by reference products represents the most formidable barrier to entry. In response, FDA and FTC recently issued a joint statement regarding a collaboration to advance competition in the biologic marketplace. This session will consider the economic implications of patent payment litigation, the competitive effects, and economic damages.

Topics of discussion will include: • Assessing whether developing a patent thicket is an antitrust violation » UFCW Local 1500 Welfare Fund v. AbbVie Inc. (7th Cir. Dec. 28, 2020)  Reviewing what is deemed “anti-competitive activities” • Do you need to prove that all the patents in the ‘thicket’ around a drug are invalid?

• Reviewing the proper standards of antitrust review and the rising call for a legislative response » Analyzing the current legislative and regulatory framework » Mergers, acquisitions and exclusive licenses » Anticompetitive agreements » Abuse of dominance » Life cycle management and contracting » Pricing strategies • Avoiding costly litigation and associated penalties by effectively complying with the law

twitter: @ACI_Pharma linkedin: ACI Pharmaceutical, Biotech and Life Sciences

11:30

COMMERCIAL STRATEGIES FOR THE INNOVATOR AND BIOSIMILARS MARKETPLACE

GLOBAL STRATEGIES: From Patent Protection to Cost and Market Access microphone-alt Otto Licks, Partner, Licks Attorneys Huiya Wu, Partner, Goodwin Procter LLP Biosimilars and innovator biologic markets and regulation have steadily evolved in Europe and the United States, with the European marketplace experiencing the most commercial success.

However, the cost of these products – whether innovator or biosimilar – continues to be of global concern, especially as new products will soon emerge from the pipeline.

Not far behind, and thanks to a favorable regulatory environment, the Chinese biosimilar marketplace is booming. Although the regulatory approaches are similar in general scientific content, certain key differences have amplified acceptance and market growth in China relative to the United States and Europe.

This session will contemplate what is next for biosimilars in established markets like Europe, and emerging markets like China.

• Assessing regulatory and legislative developments impacting the biopharmaceutical industries in each region • Understanding the economics and market influences » Considerations for market access, sustainable pricing and reimbursement policies » Market uptake of biosimilar products » Biosimilar v. biosimilar litigation in a crowded market 12:30

Preparing for the Future: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies microphone-alt Tara Rahemba, Executive Director, IP Counsel, Alexion, AstraZeneca Rare Disease Alicia Russo, Partner, Venable LLP Chad J. Peterman, Partner, Litigation Department, Paul Hastings LLP • Calling attention to the products coming off-patent » Analyzing approved and marketed biosimilars while looking ahead and considering clinical insights, pricing and dosages • Predicting what problems future competitors may run into with respect to their IP profiles • Forecasting which segments or regions will drive market growth • Reviewing key sustainability tactics adopted by leading market players • Evaluating the impact of off-patent drugs on competition and growth strategies • Developing techniques for an accurate assessment of the current value of your portfolio while devising forward-thinking product strategies 4:30

The Economics of Biosimilars: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies microphone-alt Ali I. Ahmed, Senior Vice President, Biosimilars, Fresenius Kabi USA, LLC Sonia T. Oskouei, VP, Biosimilars, Cardinal Health Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP • Evaluating the clinical pipeline by company, indication and phase » Analyzing the market share for biosimilars in the United States » Target drugs with highest spending » Current market dynamics and considerations for biosimilar adoption » Comparing the European Union biosimilar experience • Considering the implications of insurers placing biosimilars on “primary tiers” and what that means for the future • Reviewing the implications of the House passed Lower Drug Costs Now Act » Understanding the implications of empowering the government to negotiate directly with manufacturers Afternoon Break

REGISTER NOW

AmericanConference.com/Biosimilars • 888 224 2480

DIVERSITY, EQUITY & INCLUSION

Advocating for Diversity in IP Bio-Pharmaceutical Practitioners: Practical Ideas for Implementing Change microphone-alt Jason Murata, Partner, Chair, Diversity, Equity & Inclusion Committee,

Axinn, Veltrop & Harkrider LLP Melanie K. Sharp, Partner, Young Conaway Stargatt & Taylor, LLP Eldora L. Ellison, Ph.D., Director, Sterne, Kessler, Goldstein & Fox P.L.L.C. K. Nicole Clouse, IP Counsel, Biogen

Luncheon Break

2:00

3:00

3:15

The Director of the National Institutes of Health (NIH) recently announced that the agency plans “new ways to support diversity, equity, and inclusion,” and will also correct policies within the agency “that may harm our workforce and our science”. The growing call to action seems clear: the bio-pharmaceutical IP community must support equity-mindedness and conscious inclusion if they are to realize the full benefits of a diverse workforce. In this interactive session, points of discussion will include: • Growing the awareness of the bio-pharmaceutical IP underrepresented by racial and ethnic groups » Championing in the bio-pharmaceutical IP work force » Advocating for diverse and young attorneys appearing in the court room and conference room • Reviewing data showing the benefits of a diverse workforce • Accelerating the advancement of a more diverse bio-pharmaceutical IP community via mentoring and networking • Understanding what specific evidence of diversity bio-pharmaceutical companies, and IP departments, are seeking from their law firm counterparts • Implementing organizational changes that promote diversity » How clients can seek out partnerships with firms that promote:  Utilizing NAMWOLF lists  Abiding by the Mansfield Declaration  Using a DuPont Legal Model • Identifying best practices for evaluating your outside firm’s efforts in promoting diversity » Reviewing firm statistics on women, minorities, sexual orientation, etc.

• Sharing data-driven strategies to address current diversity challenges in STEM 5:30

Conference Concludes Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Planning Ahead for Live Conferences: ACI’s All Secure Safety Plan As American Conference Institute and our partners plan for in-person events, we are committed to building and enhancing the planning and preparation with a view to offering our guests a safe place for live conference delivery. In addition, to ensure your safety, our event staff is fully vaccinated.

All our events will adhere to official government and local authority guidance in addition to venue or location-specific regulations, and will follow the commitments below.

Attendance Screening All attendees will need to assert that at the time that they first attend the conference and for the 14 days prior: y They are not experiencing COVID-19 symptoms. y Have not traveled from an area under a travel health advisory. y Have not provided care for or had close contact with any person with or reasonably suspected of having COVID-19, or with any person who traveled outside of your home country or to an area under a travel health advisory. y Have not been advised by any health authority, government agency or regulation to selfisolate due to possible exposure to COVID-19.

All Secure

Enhanced Communication y Advance communication to all attendees on what to expect and prepare for at the conference: from registration to conference materials to room layout to food and beverage options and more. y Education and training for the team to ensure we provide a safe and secure conference experience. y Distribution of local health-resource information in advance of the event. y Ongoing communication and advance planning with the venue regarding enhanced cleaning and sanitizing measures, response strategies and other onsite protocols.

Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html We are closely monitoring industry best practices and will be evaluating further additional measures pertaining to vaccinations and on-site screening based on the advice of health authorities.

Increased Cleaning and Sanitation y Placement of hygiene stations throughout the conference including the registration area, meeting spaces and high frequency areas. y Availability of personal hygiene and safety products including facial coverings where available.

Safety and Physical Distancing y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference. y A conference room layout with planned seating for appropriate physical distancing. y We continue to work closely with our venue partners to ensure the safety of our attendees.

Please check back frequently as we monitor and evolve our plan in the weeks ahead.

8 | #ACIBiosimilars

Reduced Touchpoints y Reduction of the physical distribution of onsite materials. y Food and beverage options that ensure minimal handling and exposure.

twitter: @ACI_Pharma linkedin: ACI Pharmaceutical, Biotech and Life Sciences

Related Events

Book with confidence!

WORRY FREE Registration

GUARANTEE

April 26–27, 2022

Intercontinental New York – Times Square, New York, NY

Register and pay to lock in your early rate and be eligible for a full refund until June 17.

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.

May 24 – 25, 2022

All cancellations and changes must be submitted to customerservice@americanconference.com by June 17.

Westin Washington, D.C. City Center, Washington, DC

June 2 – 3, 2022

Interested in attending virtually?

Harvard Club of New York, New York, NY

Emma McAdam VP, Government Affairs

If you choose to attend via livestream you can expect true interaction virtually — from start to finish. Contact our customer service team at 1-888-224-2480 or customerservice@americanconference.com to learn more about this option.

Janet Smith VP, General Counsel

Olivia Thomson Chief Compliance Officer

Luis Santos Director

Ramesh Kumar Partner

Jean Roux VP, Business Development

2022 CO-CHAIRS:

Patricia Harden Head of Sanctions Miyuki Johnson VP, Manufacturing

Chuck Sholtz Director and Associate General Counsel, Biosimilars Manufacturing & Litigation Readiness Lead Genentech

July 27 – 28, 2022

Gillian Woollett VP, Head Regulatory Strategy and Policy Samsung Bioepis

Boston, MA

Looking to Register?

Contact our Customer Service Representatives:

Mark Parrish, American Conference Institute  M.Parrish@AmericanConference.com  1 212 352 3220 x7207 Use Registration Code: B00-999-MPH22

Daniel Manganiello, American Conference Institute  D.Manganiello@AmericanConference.com  1 212 352 3220 x5464 Use Registration Code: B00-999-DMO22

Register & Pay by April 8, 2022

BEST PRICE

Register & Pay by May 20, 2022

Register & Pay after May 20, 2022

IN-PERSON Conference Only – In-House Rate*

$1695

$1795

$1895

IN-PERSON Conference Only

$2095

$2195

$2395

PRICING

$600/each

IN-PERSON Workshop(s) LIVESTREAM Conference Only – In-House Rate*

$1395

$1495

$1595

LIVESTREAM Conference Only

$1795

$1895

$2095

*In-House Counsel rates are available for pharmaceutical and biotech organizations.

All program participants will receive an online link to access the conference materials as part of their registration fee.

Additional copies of the Conference Materials available for $199 per copy.

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/.

Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/

CONFERENCE CODE:

658L22-BOS

Bringing a Team?* 3–4

10% Conference Discount

5–6

15% Conference Discount

7

20% Conference Discount

8+

Call 888-224-2480

* Team/group registrations must be from the same organization/firm and register together in one transaction.

Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.

© American Conference Institute, 2022