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C B I ’ s 3 r d S u m m i t o n
Providing Timely and Relevant Insight on Political, Safety,
Regulatory and Strategic Implications of Pending Legislation
September 14-15, 2009 • Gaylord National • National Harbor, MD
Conference Legisl ative and R egul atory Addresses
Co-Chairs: The Pathway for the Biosimilars Act
Juliana Reed, Kay Holcombe, Senior Health Policy Advisor, Genzyme Corporation
Vice President Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc.
Hospira, Inc. Promoting Innovation and Access to Life-Saving Medicines Act
Gil Bashe, Ann M. Witt, Health Counsel, Office of Henry Waxman, U.S. House of Representatives
Executive Vice President,
Makovsky + Company Analyze Patient Safety Concerns and Biologic/Biosimilar Comparability
Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins,
Additional Office of Biotechnology Products, CDER, U.S. Food and Drug Administration
Assess Antitrust Concerns and the Competitive Impact of Biosimilars
BIO Suzanne Drennon, Counsel for Intellectual Property, Bureau of Competition,
GlaxoSmithKline Federal Trade Commission
Hogan & Hartson LLP Featur ed Sessions
HPS Group LLC Healthcare Policy and Payment Perspective —
MedImmune Reimbursement Payment System and Benefit Design Implications
NORD James Langley, Vice President Reimbursement, Accredo Health Group
Analyze the Commercial and
Economic Implications of Biosimilars Legislation
sanofi-aventis Biotech Market Analysis –
Vinson & Elkins LLP Mark Schoenebaum, M.D., Biotechnology Analyst, Deutsche Bank
Wyeth Biosimilars Market Analysis –
R.T. (Terry) Hisey, Vice Chairman and U.S. Life Sciences Leader, Deloitte LLP
Organized By: Visit Us Outstanding
on the Web at Support
www.cbinet.com Provided by:
For the last three years it has been said that this is the year that an approval pathway for biosimilars will be created.
With two competing bills in the House and one before the Senate, combined with the Obama administration
allocating budget funding, this year that prediction might actually be right. What great news this is for the slowing
pharma industry as biologics continue to outperform the global pharma market with premium prices and specialty
therapies that cannot be treated with conventional drugs. Biosimilar market entry carries high hopes for those
willing to take the risk, and it is becoming clear that many are.
For several years now, the bio/pharmaceutical industries have been debating the policy of this pathway, along with
many other political and government organizations. For much of this time, the data on which these arguments were
founded was dubious at best, but since the U.S. has found itself trailing other countries in creating this pathway,
more data is becoming available in terms of costs, pricing and market effects.
So although the actual market effects of an approval pathway for biosimilars in the U.S. will never truly be known
until they’ve happened, as an industry, we have enough collective information now on which to base our individual
company decisions and start taking our next steps – no matter if a company’s steps are to enter the biosimilars
market or to protect their innovative biologic from a lower priced alternative. Because the fact is, an approval
pathway is going to be created. And whether it occurs sooner or later, don’t you think you should be ready?
All of these considerations were in play in developing CBI’s 3rd Summit on Biosimilars and Follow-On Biologics,
taking place September 14-15, 2009 at the Gaylord National, National Harbor, MD. Through our esteemed and
diverse faculty, this meeting gathers the collective information from many facets of industry to share with the
delegates over two days of keynote presentations, panel discussions and case studies. Key policy makers,
regulators, analysts, healthcare organizations and bio/pharma companies are on hand to share their timely, relevant
and practical insights so that delegates can best advise their companies on next steps – and more importantly, start
As conference Co-Chairperson, I invite you to join us in September for this critical juncture in the evolution of
healthcare and the bio/pharma industry. I will be sharing the stage with an impressive group of representatives
from the Office of Henry Waxman, FDA, FTC, BIO, MedImmune, Pfizer, Sandoz, GSK, NORD, Deloitte, Deutsche
Bank, Genzyme, Genentech, Accredo Health and many more.
I look forward to meeting you this September!
Vice President, Government Affairs
P.S. Don’t miss Accredo Health’s presentation on understanding the reimbursement and benefit implications for
biosimilars – it provides perspective from PBMs, CMS and Commercial Insurers!
• Understand how and why this bill differs from the
MaIN CONFereNCe 2007 Waxman bill (H.R. 1038)
• Discuss key components to the legislation and their
Day One — Monday, September 14, 2009 intended outcomes
8:00 Main Conference Registration and Ann M. Witt, Health Counsel, Office of Henry Waxman,
Continental Breakfast U.S. House of Representatives
9:00 Co-Chairs’ Opening Remarks 10:45 Networking and
Juliana Reed, Vice President Government Affairs, Hospira, Inc. Refreshment Break Hosted by:
Ms. Reed has overall responsibility for the Government Relations function
which includes the oversight of global government relations and public policy
initiatives for the corporation. As the first U.S. based company to launch a
biosimilar product in Europe, Retacrit® (epoetin zeta), Hospira — the world POLIC Y Pa NeL
leader in generic injectables — has the scientific expertise and manufacturing 11:15 Explore the Political Principles, Expectations and
capabilities to bring biogenerics to market in the United States. Ms. Reed Implications of Pending Biosimilars Legislation
has also held positions in health policy and reimbursement, both at Hospira
and Baxter Healthcare. In addition, Ms. Reed has extensive experience The 2009 versions of biosimilars legislation are currently
in U.S. healthcare, where she has worked as a hospital administrator and being debated among many parties with vested interests.
clinician. Ms. Reed holds a BS degree from Marquette University and While almost everyone can agree that it is time for a
a Master’s Degree from DePaul University. She is a licensed Physical regulatory pathway to approve biosimilars or biogenerics,
Therapist and Nursing Home Administrator in the State of Illinois. there is not yet a consensus of how to achieve this.
Gil Bashe, Executive Vice President, Makovsky + Company This, coupled with the enormity of potential implications
As executive vice president at Makovsky + Co., Mr. Bashe is counselor to resulting from this pathway, has industry keeping a close
pharmaceutical, biotechnology, medical-device manufacturers and patient- eye on biosimilars policy. This panel discusses the pending
advocacy groups. He has advised clients on follow-on-biologic (FOB) policies legislation, the principles in which they are based, the
and reimbursement, first in Europe and now in the United States. Through force behind enactment on the Hill and expectations for
the years, Mr. Bashe has left his mark on health-product access. At the implementation. The potential implications of pending
onset of the CMS Part D program, he helped change a Medicare drug benefit
– ensuring continued reimbursement for a leading heart-disease medication. legislation are also explored.
Mr. Bashe was CEO of CommonHealth, a WPP Group company, having • What is the public positioning of pending legislation?
served as vice-chairman for strategic planning. At sister-company Hill and • What timelines for enactment and implementation
Knowlton, he was worldwide Health Practice director overseeing policy, are most likely?
provider and product communications. In the frontlines of ensuring patients
retain access to care; Mr. Bashe served as paratrooper commander and • What are the potential implications for industry?
combat medic. He is an American Heart Association (AHA) New York * patient safety
past chair, and AHA regional affiliate board member. Mr. Bashe is co- * FDA’s resources
editor of Branding Health Services: Defining Yourself in the Marketplace * healthcare
and a member of the American Pharmacists Association, National Lipid
Association and the Society for Nuclear Medicine. * ability to manufacture biotech drugs
* ability to manufacture biosimilars
Policy Update and analysis Moderator: Steven Grossman, President, HPS Group LLC
Panelists: Ann M. Witt, Health Counsel, Office of Henry Waxman,
U.S. House of Representatives
L eGISL at I v e a DDr eSSeS
Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc.
9:15 Pathway for the Biosimilars Act
Elizabeth Seifert, Director Public Policy, GlaxoSmithKline
On March 17, 2009, Representatives Anna G. Eshoo,
Inslee and Barton introduced a bill that would create an Kent Jancarik, Director Federal Policy, Pfizer Inc
abbreviated pathway for the FDA to approve biosimilars. Diane Edquist Dorman, Vice President, Public Policy,
Eshoo’s bill differs significantly than the Waxman bill on National Organization for Rare Disorders (NORD)
several issues such as naming, clinical trials and exclusivity.
This address discusses Eshoo’s proposed legislation and the 12:15 Luncheon
intended outcomes of its provisions.
• Compare the 2009 bill to the 2008 version evaluate the regulatory Challenges
• Discuss key provisions of the bill, what they are and and expectations for Biosimilars
what they mean for industry
Kay Holcombe, Senior Health Policy Advisor, Genzyme Corporation
Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc. 1:30 Analyze Patient Safety Concerns and
10:00 Promoting Innovation and Access to Life-Saving
Medicines Act The foundation of the biosimilars debate is focused on
patient safety — whether biosimilars can achieve acceptable
On March 11, 2009, House Energy and Commerce
levels of safety, including immunogenicity, and what level
Chairman Henry Waxman and Representatives Pallone,
Deal and Emerson introduced their version of bill that would of clinical data is needed to ensure an acceptable risk.
give the FDA the authority to approve generic versions of This address evaluates the factors of biologic comparability
FDa and provides an assessment of available data in relation to
biotech drugs. This address discusses this bill and how it address
differs from Waxman’s bill that was introduced to the 2007 patient safety.
Congress, as well as key points that set it apart from other • Explore the criteria used to evaluate comparability
pending legislation. of biologics
“the conference gave me a good view of what important
issues should be investigated for impact on my company.”
— Previous Attendee, Eric A. Utt, Ph.D., Specialty Market Access, Pfizer Inc
• Assess available data supporting and opposing review antitrust Provisions
predictions on safety and immunogenicity and Lessons Learned from
Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry,
Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, Hatch-Waxman
U.S. Food and Drug Administration
Dr. Shacter received her Ph.D. in Biochemistry from Johns Hopkins
University in 1982, carried out basic research on cell regulation and cancer 4:00 Assess Antitrust Concerns and the Competitive
at the National Institutes of Health for twelve years, and then joined the Impact of Biosimilars
FDA in 1994. Dr. Shacter oversees the review of INDs and BLAs for The unintended competition and antitrust issues that
novel therapeutic proteins covering a wide range of clinical indications, stemmed from Hatch-Waxman are a source of concern
including cancer, hematopoiesis, tissue repair, hemostasis, inflammatory
diseases and bioterrorism. Dr. Shacter is engaged in establishing CDER among industry and government when considering the
policy regarding product manufacture and characterization and performs structure of an abbreviated approval pathway for biosimilars.
inspections of biotechnology manufacturing facilities. Dr. Shacter speaks The desire to avoid pharma Hatch-Waxman-like issues in
frequently at national and international meetings on a wide range of the biotech market prompted the FTC to take a proactive
topics related to the development and licensure of therapeutic proteins. role in evaluating and shaping this impact by encouraging
She is an Agency expert on scientific issues associated with evaluation of stakeholders to consider unintended consequences before
follow-on biologics. Dr. Shacter also runs an active laboratory research hand. This address discusses these potential unintended
program to support the scientific review of therapeutic proteins. Her address anticompetitive consequences and how they are addresses
laboratory research focuses on studying the cytotoxic mechanisms of
cancer chemotherapy drugs and understanding how elements of the immune in pending legislation, as well as the antitrust provisions and
system, such as oxidants and activated phagocytes, influence killing and what they could mean for industry.
clearance of dying cells. Her research expertise in the area of protein • Methods of patent disputes and resolution
oxidation is applied regularly to the review of protein therapeutics. • Settlements and reverse payments
• Authorized generics
r eGUL atOrY Pa NeL • Exclusivity
2:15 Regulatory Mechanisms, Considerations and • Forfeiture and other “parking” mechanisms
Implications of Biosimilar Policy Suzanne Drennon, Counsel for Intellectual Property,
The proposed regulatory pathways for the approval of Bureau of Competition, Federal Trade Commission
biosimilars greatly vary on the mechanisms by which Ms. Drennon focuses on antitrust and intellectual property policy and
approval takes place. The mechanisms, in addition to being
enforcement. Prior to joining the FTC, Ms. Drennon was an antitrust and
heavily debated, also bring up many questions and concerns
about our regulatory system in general, like whether or not intellectual property litigator in Los Angeles. She received her A.B. in
we are equipped to handle this change in our current state mathematics from Bryn Mawr College and her J.D. from the University of
and what is the potential fall out of legislation. This panel Minnesota Law School where she was Managing Editor of the Minnesota
discusses these issues in-depth from multiple perspectives. Law Review.
• What should the clinical data requirements be
for immunogenicity? 4:45 Close of Day One
• What should the clinical data requirements be
• How descriptive or flexible will the legislation be?
• How much authority will the FDA have to
• How would the regulatory mechanisms for a
pathway be established? Wine & Cheese Reception
* universal model or class systems? Join colleagues and friends in a relaxed setting.
• What should the naming requirements be
for biosimilars? photo by: Photolink / Getty Images
• What are the potential regulatory implications for
biologics currently on the market? Day Two — Tuesday, September 15, 2009
Moderator: Steven Grossman, President, HPS Group LLC
Panelists: Ross Lobell, Senior Director — Regulatory Affairs, MedImmune 7:30 Continental Breakfast
Brian E. Harvey, M.D., Ph.D., Vice President, Regulatory Policy,
sanofi-aventis 8:00 Co-Chairs’ Review of Day One
Philip Katz, Partner, Hogan & Hartson LLP
Juliana Reed, Vice President Government Affairs, Hospira, Inc.
3:30 Networking and Refreshment Break Gil Bashe, Executive Vice President, Makovsky + Company
to register Call toll Free 800-817-8601 (339-298-2100 outside the U.S.)
or Fax 781-939-2490. register on our website at www.cbinet.com
Identify the Commercial, economic and 10:30 Networking and
Str ategic Implications of Biosimilars Refreshment Break Hosted by:
Analyze the Biotech and Biosimilars Markets Understand the reimbursement and
The commercial and economic implications of biosimilars Benefit Implications for Biosimilars
legislation are largely debated by industry, but remain fundamental
to the business decisions of both biotech and biosimilar 11:00 Healthcare Policy and Payment Perspective —
manufacturers and their key stakeholders. The following sessions Reimbursement Payment System and
provide an in-depth analysis of biotech and biosimilars markets Benefit Design Implications
with top economic, commercial, risk and strategic considerations. This session evaluates likely government and commercial
insurer payment/reimbursement policy strategies for
8:15 Biotech Market Analysis biosimilars. The discussion focuses on three key areas
• Understand the top biotech therapeutic areas and including, 1) The PBM perspective — How will PBM’s view
patient population demographics biosimilars and what drug utilization management models
• Evaluate the EU system and experience to date might they consider? What are the major concerns/issues
• Analyze biotech pricing performance and impacting these models? 2) The Government Payor Policy
market share — Key issues around CMS payment policy, both based on
• Assess the commercial impact of biosimilars legislation current systems/tools and potential emerging legislative
• Forecast the long term effects of an abbreviated implications; and 3) Commercial Insurers — Potential
pathway on the risk-sensitive biotech industry strategies to be utilized by commercial insurers including
benefit category and payment systems considerations.
Mark Schoenebaum, M.D., Biotechnology Analyst,
Deutsche Bank • Review/discuss the major Reimbursement System
categories impacting biosimilar adoption
9:00 Biosimilars Market Analysis • Evaluate the conflicting perspectives driving the
• Review key factors affecting biosimilar market different major reimbursing entities — PBM’s,
creation and entry Government Payors and Commercial Insurers and
• Examine lessons learned from the EU discuss current and likely tools they may use
• Discuss key considerations that will impact • Linking likely Payment System strategies with key
biosimilar adoption clinical/patient safety considerations
• Identify the commercial opportunities for biosimilars James Langley, Vice President, Reimbursement, Accredo Health Group
R.T. (Terry) Hisey, Vice Chairman and U.S. Life Sciences Leader,
examine Patent Dispute Mechanisms,
9:45 Biosimilars versus Biobetters — IP Issues and Litigation Concerns
A Side-By-Side Strategic Analysis
Since the actual cost savings for biosimilars is still unknown, 11:45 Analyze the Methods of Patent Dispute and
some of industry has been looking at a different “follow-on” Resolution in Pending Legislation
biologic opportunity in biobetters. Biobetters are considered The methods of patent dispute and resolution in pending
biologics that are similar to the original product but better biosimilars legislation differ substantially from those
in some way i.e. less side effects, reduced dosing schedule, set forth in Hatch-Waxman and are a key component
better delivery system, higher absorption rate, multiple of the biosimilars debate. This session analyzes the
Case indications, etc. Biobetters may be considered traditional methods outlined in pending legislation to provide a better
analyses “Fast Follower” therapeutics where the strategy is to launch
understanding of what the mechanisms are and how they
into established categories with a “best-in-class” brand impact patent dispute strategies, while incorporating lessons
profile. The evolving regulatory landscape will determine learned from Hatch-Waxman and what they tell us for
if Biobetters will face greater scrutiny or benefit from a biologic patent disputes.
streamlined development program. This session compares
the opportunities and challenges to consider when deciding • Methods for filing disputes
biosimilars or biobetters. • Timelines for notification and response —
• Traditional Biobetters — Recent case studies Potential areas to delay or speed up litigation
• Capture market share through price or • Which comes first — Approval or litigation?
therapeutic benefits? • Are there penalties involved?
• Are improvements in delivery sufficient to • Will settlements and authorized generics be allowed
accelerate adoption ? or encouraged?
• Is a novel indication a requirement for regulatory Sean Ryder, Director of Intellectual Property, Glenmark Generics
and commercial success? David Fox, Partner, Hogan & Hartson LLP
Robert Ward, Vice President, Corporate Development,
NPS Pharmaceuticals 12:30 Luncheon
1:45 Current and Future IP Challenges for Biogenerics
Players — A Global Perspective Here are Just a Few of the Organizations
As the U.S. finds itself trailing other countries in creating a that have Benefitted from
pathway to approve biogenerics, a global (and strategic) approach
to patent issues is warranted. In this session, we knock down attending CBI’s Previous Summits
the domestic “silo” approach to biogenerics patent issues as we on Biosimilars and Follow-On Biologics:
consider the following issues from a global perspective:
• The differences between pharma and biopharma AARP * Abbott Diabetes Care Inc * Abbott Laboratories * Accredo Health Group
patent landscapes Inc * Allergan * American Ent Institute for Public Policy Research * American
• Strategic implications of the patent landscape differences Pharmacists Association * AmerisourceBergen Specialty Group * Amgen
• Current and future patent challenges for global Amylin Pharmaceuticals Inc * ASCP * Axinn Veltrop & Harkrider LLP * Ballard
biogenerics players Spahr Andrews & Ingersoll LLP * Barr Pharmaceuticals Inc * Baxter Health
• “Patently obvious” lessons learned from biogeneric Care * Bayer Healthcare LLC * Bexton Dickinson * Bi Pharma GmbH & Co KG
launches to date BIO * Biogen Idec * Biolex Therapeutics Inc * BioMarin Pharmaceuticals
Naomi Pearce, IP Director & Counsel Lawyer & Patent Attorney, Hospira, Inc. Biotechnology Industry Organization * Biotechnology Information Institute
Boehringer Ingelheim GmbH * Brigham & Woman Hospital * Brinks Hofer Gilson
2:30 A Change in the Patent Litigation Dynamic — & Lione * Bristol-Myers Squibb Co * Centocor * Congressman Waymans Office
Will “Big Pharma” Become “Big Generic?” DataMonitor * DDN * DDN Obergfel LLC * Department of Business & Econ De
Traditionally (with some exceptions), patent litigation under Duane Morris LLP * Eisai * Eli Lilly & Co * EMD Serono Inc * Engel &
Hatch-Waxman has been thought of as a dispute between
P a “big pharma” and “small generic” company, but early Novitt LLP * Enzon * Express Scripts Inc * Federal Trade Commission
Finston Consulting * Foley Hoag LLP * Food & Drug Administration
a observations of the biosimilars big pharma companies have
different picture. A number of
market is painting a much
Forest Laboratories * Genentech Inc * Genzyme * Gibraltar Associates llc
GlaxoSmithKline * Glycofi Inc * GlycoFi Merck and Co Inc * Health Results
N already shown interest in entering the follow-on market and Group * Healthpoint * Hoffmann-La Roche Inc * HPS Group LLC * Hyman
more are popping up all the time. So what does “big generic”
Phelps & McNamara PC * ImClone Systems Inc * Insmed Corp * Johnson &
e pharma mean to “small biotech” companies in the court room?
How will this change in dynamic affect the biologics industry? Johnson * Kardiatech Inc * Loyola University Medical Center * Makovsky & Co
L The pharma industry? Only time will tell, but this panel of McDermott Will & Emery LLP * MedImmune Inc * Merck & Co Inc * Momenta
experts attempts to shed light on the future of patent litigation. Mylan Pharmaceuticals Inc * National Economic Research Associates Inc
• Analyze the Hatch-Waxman IP and patent landscape NERA Economic Consulting * Novartis * Novo Nordisk Pharmaceuticals
• Evaluate how the size of a company and litigation Nucleonics Inc * Pfizer * Pharmaceutical Executive Magazine * Pharmaceutical
resources impacts litigation Strategic Initiatives * Pink Sheet * Plasma Protein Therapeutics
• Understand the role of risk assessment in patent Association Procer & Gamble * Questcor Pharmaceuticals * sanofi -aventis
disputes and how this may differ from a change in Shire Human Genetic Therapies Inc * Taro Pharmaceuticals USA Inc
the dynamic Technology Catalysts International * Teva Neuroscience * Teva Pharma AG
• Consider how biosimilars legislation could change the Teva Pharmaceuticals Europe BV * The Henry L Stimson Center
patent litigation dynamic across industry Thomas Jefferson University * Thomson Reuters * Vinson & Elkins LLP
Moderator: Constance S. Huttner, Partner, Vinson & Elkins LLP VirSci Corp * Watson Pharmaceuticals Inc * West Pharmaceutical Services
Panelists: Naomi Pearce, IP Director & Counsel Lawyer & Patent Attorney,
Widener University * Zuckerman Spaeder LLP * Zymo Genetics Corp
Hans Sauer, Ph.D., Associate General Counsel, BIO
Mark Bowditch, Patent Attorney, Sandoz
Geoffrey Levitt, Vice President, Chief Regulatory Counsel, Wyeth
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C B I ’ s 3 r d S u m m i t o n — Top Reasons to Attend —
• Key policy updates from the
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of Representatives, Genzyme, NORD,
Genentech, GlaxoSmithKline and Pfizer
• Biotech and biosimilar market analyses by
Deutsche Bank and Deloitte LLP
Providing Timely and Relevant Insight on Political, Safety, • Healthcare policy and payment perspective
by Accredo Health Group
Regulatory and Strategic Implications of Pending Legislation • Patient safety concerns addressed by the
U.S. Food and Drug Administration
September 14-15, 2009 • Antitrust and competition insights by the
Gaylord National • National Harbor, MD Federal Trade Commission
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