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C B I ’ s 4 t h S u m m i t o n
The Intersection of Science, Policy and Business for the Next Generation of Biologics
March 18-19, 2010 • The Fairfax at Embassy Row • Washington, DC
Conference Chairman: FDA Update: Legislative Per spective:
Robert Billings, Emily Shacter, Ph.D., Jessica McNiece,
Vice President, Policy, Chief, Laboratory of Legislative Assistant
Generic Pharmaceutical Biochemistry, Division of for Healthcare,
Association (GPhA) Therapeutic Proteins, Office of Senator
Office of Biotechnology Sherrod Brown
Products, CDER, U.S. Food
Hear lessons learned from Hospira’s and Drug Administration
EU biosimilars experience
Other Progr am highlights: E L I T E F A C U L T Y :
James Langley, Islah Ahmed, Medical Director,
• Analyze the health policy landscape
and the implications for the Vice President, Reimbursement, Specialty Pharmaceuticals,
bio/pharma industry Accredo Health Group; part of Hospira
• Understand the developing Medco Health Solutions Steven Grossman, President,
biosimilars framework in the HPS Group, LLC; Author,
United States and European Union Daniel A. Kracov, Partner,
FDA Matters: The Grossman FDA Report
Arnold & Porter
• Assess how to evaluate and
define similarity Robert Schinagl, Associate Vice
Bruce Myers, President, Product Champion,
• Evaluate how to design clinical programs Regional Sales Director, ImClone Systems
for biosimilar drug development Biogen Idec
• Review the European monoclonal Gil Bashe,
antibody draft guidance and what Brent Del Monte, Vice President, Executive Vice President,
this means for the U.S. Federal Government Relations, Makovsky & Co
• Understand payer and provider Biotechnology Industry
perspectives on biosimilars adoption Association (BIO) Director of Policy,
and usage MedImmune
John Fanikos, Associate Director,
• Learn how partnering with biobetters
can accelerate approval with an efficacy Clinical Pharmacy, John Maki, President and CEO,
claim and drive product uptake Brigham & Womans Hospital Vicus Therapeutics
Check for new speaker additions and program updates at www.cbinet.com/biosimilars
Organized By: Outstanding
“a n excellent blend of science,
m a r k et dyna mics, r egul atory, l aw
a nd politics discussed by experts.”
— Previous Attendee, Joseph Heissler, Director Safety and Risk Management, Pfizer Inc
David R. Marsh, Ph.D., Partner, Arnold & Porter
Main conference Dr. Marsh is co-chair of Arnold & Porter’s intellectual property practice.
He focuses extensively on intellectual property counseling, interferences
Day One — Thursday, March 18, 2010 and patent procurement, including in the biotechnology, business methods,
7:30 Main Conference Registration and chemical, clothing, computer media, consumer products and medical device
Continental Breakfast areas. Dr. Marsh has argued multiple matters before the United States
Patent and Trademark Office’s Board of Patent Appeals and Interferences.
8:30 Chairman’s Opening Remarks Dr. Marsh also manages multiple European Opposition proceedings and
Robert Billings, Vice President, Policy, represents clients in patent and other intellectual property litigation or
Generic Pharmaceutical Association (GPhA) dispute resolution proceedings. Dr. Marsh is also an American Arbitration
Association and World Intellectual Property Organization neutral
8 : 4 5 - 10 :15 arbitrator. As an adjunct professor at Georgetown Law School,
Understand ThE Developing Dr. Marsh teaches “Biotechnology and Patent Law.” He has also written
Biosimilars Fr amework In ThE numerous articles on patent law, is a frequent speaker at conferences in
united States anD European Union the U.S. and Europe and is an editor of BioScience Law Review.
Dr. Marsh carried out his graduate work in molecular biology at
I. Proposed Standards and Mechanisms for U.S.
Cambridge, England and his post-doctoral work at Yale University.
Biosimilar Licensure under Pending Legislation
His research experience includes molecular biology, immunology,
• Biosimilars application review processes
biochemistry and mammalian and plant genetics.
• Requirements for FDA guidance
• Standards for biosimilar and
10:15 Networking and Refreshment Break
• Proposed data requirements and FDA
• Exclusivity for innovator biologics and EvaluaTE ThE SCIEnCE anD
interchangeable biosimilars SaFETy OF BIOSIMIlaRS
II. Mechanisms for Patent Disputes in Pending 10:45 Biologics Similarity — How Will This Be Defined?
U.S. Legislation and the Impact on Biotech Since the complexities of biologics make exact duplication
Patent Litigation unfeasible, it is necessary for industry and government
• Processes for handling biosimilar patent disputes P to determine the biochemical and clinical characteristics
• Impact on strategies for innovator biologic product a for similarity before any real deductions on biosimilars’
patenting, patent disputes and resolution n implications can be made. This panel discusses the many
• Potential biosimilar patent strategies E characteristics of biologics from biochemical and clinical
l perspectives, as well as how these characteristics could/
III. Overview of the EU Framework for Biosimilars
would differ by class of biologics.
• The EU pathway for biosimilars
• Experience to date under the EU • What characteristics need to be measured?
biosimilars framework • How should we demonstrate comparability?
Daniel A. Kracov, Partner, Arnold & Porter Similarity?
Mr. Kracov heads the Pharmaceutical and Medical Device Practice, • Should this differ by class of biologics?
assisting clients, including start-up companies, trade associations and
large manufacturing companies, in negotiating the challenges relating • When does similar equal substitutable?
to the development, approval and marketing of drugs, biologics and Moderator: Gil Bashe, Executive Vice President, Makovsky & Co
medical devices. Mr. Kracov’s expertise in FDA strategic advice and Panelists: Robert Schinagl, Associate Vice President, Product Champion,
crisis management won him a spot on the Fall 2005 Legal Times list
of “Leading Lawyers in Food & Drug Law.” Mr. Kracov regularly
handles product and compliance-related investigations, the development Islah Ahmed, Medical Director, Specialty Pharmaceuticals,
of regulatory corporate compliance programs and due diligence in Hospira
financings, mergers and acquisitions. He has a widely-recognized
expertise in biomedical product-related public policy matters, including John Fanikos, Associate Director, Clinical Pharmacy,
Congressional investigations and FDA-related legislative strategies. Brigham & Womans Hospital
• What is the current state of reform?
F D a a D D R E S S
• What are the expectations for implementation and
11:45 FDA Update on the Scientific Issues Associated additional guidance?
with Evaluating FOB Submissions • What are the most significant areas impacting the
Once an approval pathway is established, the FDA needs to bio/pharma industry and how?
set guidelines on how FOB regulatory submissions are going Steven Grossman, President, HPS Group, LLC;
to be evaluated and how the FOB is going to be compared Author, FDA Matters: The Grossman FDA Report
to the innovator product. This address provides an update
on the Agency’s research in evaluating similarity between
FOBs and innovator products, the clinical significance of 2:45 Networking and Refreshment Break
variations between products and any known physiological
implications of a products structure. 3:15 From the Hill —
Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Biosimilars Legislative Perspectives
Therapeutic Proteins, Office of Biotechnology Products, CDER, The legislative process for developing an approval pathway
U.S. Food and Drug Administration for biosimilars has been a long one. Numerous bills have
Dr. Shacter received her Ph.D. in Biochemistry from Johns Hopkins been introduced, support has wavered from side-to-side
University in 1982, carried out basic research on cell regulation and cancer and amendments have been made, but there is still much to
at the National Institutes of Health for twelve years, and then joined the be done in this complex area of healthcare reform.
FDA in 1994. Dr. Shacter oversees the review of INDs and BLAs for This session provides an update on the legislative process
novel therapeutic proteins covering a wide range of clinical indications, for a biosimilars approval pathway, including an assessment
including cancer, hematopoiesis, tissue repair, hemostasis, inflammatory of the main points of each perspective.
diseases and bioterrorism. Dr. Shacter is engaged in establishing CDER Brent Del Monte, Vice President, Federal Government Relations,
policy regarding product manufacture and characterization and performs Biotechnology Industry Association (BIO)
inspections of biotechnology manufacturing facilities. Dr. Shacter speaks Jessica McNiece, Legislative Assistant for Healthcare,
frequently at national and international meetings on a wide range of Office of Senator Sherrod Brown
topics related to the development and licensure of therapeutic proteins.
She is an Agency expert on scientific issues associated with evaluation of 4:15 European Monoclonal Antibody Draft Guidance —
follow-on biologics. Dr. Shacter also runs an active laboratory research What Will This Mean for the US?
program to support the scientific review of therapeutic proteins. Her
In July of 2009 the EMEA held a workshop on biosimilar
laboratory research focuses on studying the cytotoxic mechanisms of
cancer chemotherapy drugs and understanding how elements of the immune monoclonal antibodies with the hopes of developing
system, such as oxidants and activated phagocytes, influence killing and guidance for the approval of these “second generation
clearance of dying cells. Her research expertise in the area of protein biosimilars.” In addition to EU regulators, industry
oxidation is applied regularly to the review of protein therapeutics. organizations, patient groups and bio/pharma companies,
the FDA was present at this meeting. This session discusses
the highlights from this workshop, expectations for next
12:30 Luncheon steps and what this guidance means for the U.S. biotech and
• What are the differences between mAb guidance and
understand the Developing other FOB guidance in the EU?
Biosimilars Policy landscape and • What are the expectations for implementation?
legislative Outlook • How will this impact mAb guidance in the U.S.?
Mark Mlynarczyk, Director of Policy, MedImmune
STaTE OF ThE InDuSTRy aDDR ESS
5:00 Close of Day One
1:45 Update on Healthcare Reform Policy and
Implications for Bio/Pharma
Healthcare reform has been a hot topic since Presidential
campaigns kicked off in 2007. Much headway has been
made since that time, but it is clear that a system overhaul
and the desired outcomes of reform will not be experienced Wine & Cheese Reception
for quite some time. This session reviews the health policy Join colleagues and friends in a relaxed setting.
landscape in Washington with a particular focus on the most
imminent areas impacting the bio/pharma industry. Photo by: Photolink / Getty Images
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/biosimil ars
Day Two — Friday, March 19, 2010 10:15 Networking and Refreshment Break
8:00 Continental Breakfast SPOTlIghT SESSIOn
8:30 Chairman’s Review of Day One 10:45 Lessons Learned from Hospira’s EU
Robert Billings, Vice President, Policy, Biosimilar Experiences
Generic Pharmaceutical Association (GPhA) Hospira is currently in the process of developing biosimilars
for branded products that have $18 billion in sales. Although
Payer and Provider Perspectives on the company does not expect biosimilars to have a large
Biosimilars adoption impact on their financial forecasts for at least another five
years, they are learning some major lessons from going up
8:45 Update on Reimbursement Systems, against biotech giants like Amgen and J&J. This case study
Benefit Design Implications and Clinical/
analyzes Hospira’s EU experience with biosimilar Epogen,
Patient Safety Considerations for Biosimilars
launched in Europe in 2008, as well as the company’s plans
Beyond the creation of an approval pathway for Case
biosimilars, there are many questions surrounding how for their 2010 launch of a biosimilar of Amgen’s Neupogen.
they will be adopted into the U.S. healthcare system. • Clinical development
Are patients going to be subscribed lower cost alternatives? • Regulatory experiences
Will payers be required to incorporate biosimilars into their
reimbursement policy strategies? Where do clinical and • Reimbursement considerations
patient safety considerations play into benefit design? • Commercialization considerations for a
How will this differ between reimbursement entities — successful launch
PBMs, government and commercial? This session provides
Islah Ahmed, Medical Director, Specialty Pharmaceuticals, Hospira
an update on how managed care is viewing and planning for
biosimilars in the U.S. market.
• Review/discussion of the major reimbursement
system categories impacting Biosimilar adoption Business Development
• Evaluate the conflicting perspectives driving the Consider ations for a Mixed
different major reimbursing entities — PBMs, Biologics/Biosimilars Market
Government Payers and Commercial Insurers —
and discuss current and likely tools they may use 11:30 Partnering with Biobetters to Facilitate Approval
• Linking likely payment system strategies with key and Increase Product Update
clinical/patient safety considerations
The study requirements to get a biosimilar approved in
James Langley, Vice President, Reimbursement,
Accredo Health Group, part of Medco Health Solutions the U.S. have not yet been determined, but the resulting
cost-savings of an abbreviated pathway have been
9:30 Understand Provider Perspectives on the questioned for many years. Because of this, there has been
Use of Biosimilars much discussion on biobetters and the benefits that they
The first line of communication with the patient is the could offer to the patient population as well as biologic
provider. Providers are tasked with understanding all of the manufacturers. This session discusses how partnering
scientific information about different therapies and making with biobetters can facilitate a study design that accelerates
treatment decisions based on this, combined with the patient
needs. This session discusses providers views on what the regulatory approval, increases adoption and further expands
ideal biosimilar would be, what their considerations are for on labeling claims.
using a biosimilar versus the originally licensed product, as • How to partner with biobetters for accelerated
well as provides some early insight into the questions and/or approval with an efficacy claim
concerns that patients are expressing.
• The clinical, regulatory and commercial benefits
• Patient safety concerns for using biosimilars
• Information needs and requirements for
biosimilar products • The use of biobetters for a competitive advantage as
• Recommended clinical studies to demonstrate safety a new or established entrant
and efficacy of biosimilars John Maki, President and CEO, Vicus Therapeutics
John Fanikos, Associate Director, Clinical Pharmacy,
Brigham & Womans Hospital 12:15 Luncheon
WhO ShOulD aTTEnD
1: 3 0 - 3 : 0 0
The Biosimilars Business Model — You will benefit from attending this event if you are a
Opportunities anD Pitfalls VP, Director or Manager of a Pharmaceutical or Biotech
Company with responsibilities in the following areas:
The explosive growth in biologics drug development
combined with emerging product and technology • Policy • Government Affairs
opportunities is generating strong optimism in this • Regulatory Affairs • Scientific Affairs
market. Pharmaceutical and biotechnology companies
are examining their current strategies and business • Patient Safety • Legal
models to take advantage of this exciting market, while • Intellectual Property • Business Development
reducing risk as they build their product portfolios.
These sessions offer insight to the evolving business • Strategic Planning • Economics
models that are resulting from the anticipated arrival • Portfolio
of biosimilars in the US market from both innovator
and follow-on perspectives. Hear how companies are This conference will also benefit Scholars, Analysts,
planning to build the capabilities to capitalize on the CMOs, CROs, HMOs, MCOs, law firms, consultants,
follow-on landscape, as well as how companies are discovery firms and patent software service providers.
preparing to compete in the new market and defend their
PR E v IOuS aCCl a IM
1:30 Follow-On Perspective
“Very robust discussion, good perspectives. Learned the issues
Ganesh Venkataraman, Co-Founder and CSO,
surrounding the passage of legislation.”
– Previous Attendee, Nancy Tuffin, Director,
2:15 Innovator Perspective Government Affairs and Healthcare, Healthpoint Ltd
Bruce Myers, Regional Sales Director,
Biogen Idec “Valuable leading edge information. Get multiple points-of-view
from all segments of the industry.”
– Previous Attendee, James Langley, Vice President Reimbursement,
3:00 Close of Conference Accredo Health Group, part of Medco Health Solutions
I n R E C O g n I T I O n O F O u R S P O n S O R :
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regulatory issues, operations and applied technologies within the bio/pharmaceutical arena. Web: www.cbinet.com/biosimilars
Register by January 22, 2010 and Receive $400 Off of Your Registration Fee!
C B I ’ s 4 t h S u m m i t o n — Top Reasons to Attend —
• Legislative updates from the Office of
Senator Sherrod Brown and BIO
• Payer and provider perspectives on
Follow-On Biologics biosimilars adoption
• The clinical, regulatory and commercial
opportunities of biobetters
The Intersection of Science, Policy and Business • FDA update on evaluating comparability
for the Next Generation of Biologics of biosimilar products
• Strategies to enter the biosimilars
March 18-19, 2010 market and defend market share from
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