Boston Bar | Life Sciences Conference

2017 BBA Life Sciences Conference

Tuesday, October 3, 2017
8:00 AM – 4:00 PM
Boston Marriott Cambridge – Kendall Square

HEADLINING SPEAKERS

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Vicki Sato
Professor of Management Practice
Harvard Business School

Dunsire_Deborah200x200

Deborah Dunsire
CEO and President
XTuit Pharmaceuticals, Inc.

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Mary Beckman
Chief of Healthcare and Fair Trade Competition Bureau
Attorney General’s Office

CONFERENCE AGENDA

Speakers

Deborah Dunsire
XTuit Pharmaceuticals

Vicki Sato
Harvard Business School

Biosimilars 2017

Hear from experts on recent developments and what’s ahead for the regulatory landscape governing biosimilar biological products. This panel will feature a top IP practitioner, an associate general counsel from Biogen, and the Director for IP Policy at the Biotechnology Innovation Center. 

Donald Ware
Moderator
Partner, Chair, Intellectual Property Department
Foley Hoag LLP

Melissa Brand
Director for IP Policy
Biotechnology Innovation Center (BIO)

Wendy Plotkin
Associate General Counsel
Biogen Idec

Non-Profit Research Institutions and Industry: Why can’t we all just get along?

Non-profit research institutions (universities, research institutes and research hospitals) play an increasingly important role as the source of innovations in the life sciences. Biotech and pharmaceutical companies are looking to partner with these institutions to help develop their early stage pipelines. However, organizational and cultural issues often “get in the way” of establishing the types of collaborations that are needed. How do these differences manifest themselves in contractual language? What are the primary issues that cause friction in establishing research agreements and how can they be resolved?

Catherine Ives
Moderator
Assistant Director, Industry Contracts & Alliances, Office of Sponsored Programs
MIT Office of the General Counsel

Meghan McCollum Fenno
Counsel
MIT Office of the General Counsel

Yogesh Sharma
Director Operational Alliances
Novartis Institutes for Biomedical Research

Disclosure Exposure

• Disclosure issues around trial results (e.g., when is the data fully baked, when are results so negative that you have a more immediate disclosure requirement, what are you required to report about FDA interactions)?
• Determining what agreements are “material” enough to require an 8-K filing; what must be filed as an exhibit and what can be redacted?
• What Disclosure issues are most litigated?
• Do Risk Factors really protect you? How much?
• FD Disclosure issues – what level of new or more detailed information requires an 8-K filing?
• Are disclosure standards different for patient and advocacy meetings? How about poster presentations at industry meetings, abstracts and manuscripts?
• Are you responsible for correcting (or stopping) unauthorized Third Party Disclosures?

Deirdre Cunnane
Moderator
Senior Vice President, General Counsel
Catabasis Pharmaceuticals, Inc.

Deborah S. Birnbach
Partner
Goodwin

Anne Marie Cook
Senior Vice President, General Counsel
Sage Therapeutics

Personalized Medicine

Hear perspectives from venture capitalists and private practice attorneys on new developments in precision medicine and what’s ahead.

Dina Ciarimboli
Moderator
General Counsel
Third Rock Ventures

Robert Ang, MD MBA
Chief Business Officer
Neon Therapeutics
 

David Dykeman
Shareholder
Greenberg Traurig LLP

Neil Exter
Partner
Third Rock Ventures

Marc Rubenstein
Partner
Ropes & Gray

Diane Wuest, PhD
Director, Precision Medicine Initiatives
GNS Healthcare

Developments from DC

Experts will discuss legislative developments in Washington, including the latest on healthcare reform and pharmaceutical pricing initiatives.

Rob Lehman
Senior Public Policy Advisor and Co-Chair, Public Policy and Legislative Affairs Practice
WilmerHale

Bruce Manheim, Jr.
Partner
WilmerHale

FDA Regulation Update

A discussion on the international conduct of clinical trials and issues that are important from a legal and regulatory perspective.

John Serio
Moderator
Partner, Chair of Food and Drug Law Practice
Burns & Levinson LLP

Farah Gerdes
Partner
Wilson Sonsini Goodrich & Rosati

John Hamilton
Law Office of John A. Hamilton

Marija Jankovich
Associate General Counsel
Biogen Idec

Sharmela Thevarajaha
Associate, Intellectual Property & Life Sciences
JAG Shaw Baker – London, UK

Mary Beckman
Chief of Healthcare and Fair Trade Competition Bureau
Attorney General’s Office

Hot Topics in Life Sciences IPOs

Panelists will discuss the current state of the life sciences IPO market and any recent trends, common regulatory issues, the market and the impact of developments in the M&A and licensing areas, and other challenges.

Danielle Lauzon
Moderator
Partner
Goodwin

Jon Civitarese
Managing Director
Leerink

Mike Landsittel
Vice President, Finance
Blueprint Medicines Corporation

Robert Puopolo
Partner
Life Sciences Group, Goodwin

Structuring License Agreements For IPO and M&A Exits

Panelists will examine different ways to structure license and collaboration agreements to maximize a company’s valuation and exit opportunities.  We will explore co-development and co-commercialization transactions, profit sharing, equity investments as part of broader collaborations, and structured M&A transactions.

Sarah Solomon
Moderator
Partner
Goodwin

Jeb Keiper
Chief Financial Officer and Chief  Business Officer
Nimbus Therapeutics

Nishla Keiser
Deputy General Counsel
Intellia Therapeutics

Freedom-to-Operate: What is it and strategies to mitigate risk

The panel will explore FTO considerations from the perspective of start-ups, mid-size companies; big pharma diligencing potential target companies and from the perspective of VCs. We will consider the various risk mitigation strategies that are available and the value of legal opinions in a post-Halo world.

  • What is FTO? 
  • How do you mitigate?
  • Do you get a formal legal opinion?
  • Injunctions vs. Damages
  • Compare with FTO considerations in Europe

Anita Varma
Moderator
Partner
White & Case

Damon Banks
Patent Counsel
Compass Therapeutics

Kimya Harris
Senior Director
Immunogen

Jim Kastenmayer
Senior Patent Director
AstraZeneca

Sara Nayeem, MD
Partner
New Enterprise Associates

Jeffrey M. Arnold
Moderator
President
Arnold Strategies

Marc E. Goldberg
Co-Founder and Managing Partner
BioVentures Investors

Michael Greeley
Co-Founder and Partner
Flare Capital Partners

Steve Gullans, PhD
Managing Director
Excel Venture Management

Paulina Hill
Principal
Polaris Partners

Technology Trends

Hear from senior VC investors from the biotech, medical device, and healthcare industries about new technologies that are new and exciting, getting funded, on the horizon or past their prime.

Collaborating with Competitors

Developing and commercializing life science products requires working with many other companies—research institutions, CROs, consultants, manufacturers, distributors, licensees, among others. Many of these companies are working in the same space as your company and could be—or are—competitors to your business. This panel will discuss the legal and business considerations in doing transactions with competitors.

Belinda Juran
Moderator
Partner
WilmerHale

Soojin Chung
General Counsel and Chief Administrative Officer
Kyruus

Jane Pritchett Henderson
Chief Financial Officer
Voyager Therapeutics

Deborah Palestrant, Ph.D.
Vice President of Corporate Development and Strategy
Relay Therapeutics

Simona Levi
General Counsel
Cell Signaling Technology

Pricing and Reimbursement Strategy and Communication:  Product Development,
Labeling and Launch

Panel discussion on pricing and reimbursement considerations impacting product development, labeling and launch planning.  Topics will include FDA’s role in drug pricing, reimbursement planning as part of the drug development and launch process, ex-US pricing and reimbursement highlights including European Medicines Agency health technology assessment developments.

Katherine Chaurette
Moderator
Regeneron Pharmaceuticals

Katlin McKelvie Backfield
Backfield PLLC

Julia Aledort Gaebler
Vice President
Health Advances

Join confirmed attendees from:

AbbVie

AlixPartners

Arnold Strategies

AstraZeneca

Attorney at Law Office of John A. Hamilton, LLC

Attorney General’s Office

Backfield PLLC

Biogen Inc.

BioVentures Investors

Bluebird Bio

Blueprint Medicines

Burns & Levinson LLP

Catabasis Pharmaceuticals, Inc.

Choate Hall & Stewart LLP

Chu, Ring & Hazel LLP

Compass Therapeutics

Deloitte, LLP

Dispute Resolution Services

Duane Morris LLP

Duff & Phelps

Ernst & Young LLP

Excel Venture Management

Faber Daeufer & Itrato PC

Flare Capital Partners

Foley Hoag LLP

General Counsel

Goodwin

Goodwin Procter LLP

Goulston & Storrs PC

Greenberg Traurig

Harvard Business School

Harvard Pilgrim Healthcare, Inc.

Haug Partners LLP

Health Advances

Immunogen

Intellia Therapeutics

JAG Shaw Baker

Jones Day

Kyruus

Latham & Watkins LLP

Lathrop & Gage LLP

Leerink

Locke Lord LLP

Major, Lindsey & Africa

MIT Office of the General Counsel

Morgan Lewis

Neon Therapeutics

New Enterprise Assoicates

Nimbus Therapeutics

Nixon Peabody LLP

Novartis Institutes for Biomedical Research

Pierce Atwood, LLP

Polaris Partners

Relay Therapeutics

Robinson & Cole LLP

Ropes & Gray

Sage Therapeutics

Sally Byrne LLC

Sarepta Therapeutics, Inc.

Shire Pharmaceuticals

StoneTurn Group LLP

Sunstein Kann Murphy & Timbers LLP

Third Rock Ventures

Verrill Dana LLP

Voyager Therapeutics

White& Case

William B. Meyer, Inc.

WilmerHale

Wilson

XTuit Pharmaceuticals

2017 CONFERENCE ADVISORY COMMITTEE

Christine Bellon

Senior Vice President

Relay Therapeutics

Chinh Pham

Shareholder

Greenberg Traurig LLP

Andy Brookes

Head of Immunology and Biologics

Abbvie

Dina Ciarimboli

General Counsel

Third Rock Ventures

Stuart Falber

Co-Chair Life Sciences Group

WilmerHale

Lauren Foster

Director of IP and Strategic Alliances

MIT Koch Institute

Kingsley Taft

Senior Partner and National Co-Chair Life Sciences Practice

Goodwin

THANK TO OUR PARTNER LEADERS IN LIFE SCIENCES

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