CBI\'S 4TH ANNUAL SUMMIT ON BIOSIMILARS AND FOLLOW-ON BIOLOGICS

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  • 1. 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 CLE Credits Biosimilars and Available Pending Approval Follow-On Biologics 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 Spotlight Session: 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ImClone Systems for biosimilar drug development Biogen Idec • Review the European monoclonal Gil Bashe, antibody draft guidance and what Brent Del Monte, Vice President, Executive Vice President, this means for the U.S. Federal Government Relations, Makovsky & Co • Understand payer and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 Mark Mlynarczyk, 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 Support Provided by:
  • 2. “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 interchangeability determinations 10:15 Networking and Refreshment Break • Proposed data requirements and FDA waiver authorities • 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 ImClone Systems 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
  • 3. • 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 biosimilars market. • 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 5:00-6:00 Networking, 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
  • 4. 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. Study 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 of biobetters • 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
  • 5. 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 market share. 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.” Momenta (invited) – 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 : CBI Research, Inc’s corporate sponsors represent select companies that share a common mission: business advancement through thought leadership, strategic interaction and innovation. The company represented below is a proud contributor on this program and has carefully selected messaging, branding or positioning statements to encourage the evaluation and investigation of quality products and/or services available. We applaud this company, as well as others that wish to join the conference, as important members of this event’s delegation. If you are interested in sponsorship or exhibit opportunities, please call Alexa Moore at 339-298-2107, fax 781-939-2694 or email alexa.moore@cbinet.com What Can You ExpECt from a CBI ConfErEnCE? for morE InformatIon: As a delegate, speaker or sponsor you receive timely information, future projections as well as an extensive opportunity to network and discuss the issues of the day with senior policy Phone: 800-817-8601 makers and industry leaders. CBI serves senior-level executives and government officials in Fax: 781-939-2490 bio/pharmaceutical, medical device/diagnostic and healthcare industries by providing unbiased platforms for networking and the exchange of real-time information. Eighty percent of our Email: cbireg@cbinet.com events focus on investment opportunities, business strategies, domestic and international regulatory issues, operations and applied technologies within the bio/pharmaceutical arena. Web: www.cbinet.com/biosimilars
  • 6. 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 — Biosimilars and • 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 The Fairfax at Embassy Row • Washington, DC follow-on products cD-rom compendiums CBI PRSRT STD 600 Unicorn Park Drive • Woburn, MA 01801 U.S. Postage If you are unable to attend the conference or you would like extra copies for your colleagues, PAID you can order your conference CD-Rom today. Gallery Don’t miss out on the valuable information presented by industry leaders exclusively at this event. The CD-Rom is available for only $198 and includes the conference agenda, presentations and speaker biographies. Simply fill out the order form and the CD-Rom will be shipped to you photo by: Keith Brofsky / Getty Images 2 weeks after the conference occurs. • Registration Fee: Standard Advantage Pricing 2-Day Conference $2,095 $1,695 Advantage Pricing — Register by January 22, 2010 and SAVE $400. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and CD-Rom Compendium. Please make checks (in U.S. funds drawn on a U.S. bank) payable to CBI Research, Inc. (No personal checks accepted.) Advantage Pricing registration card DO NOT REMOVE MAILING LABEL. PLEASE RETURN ENTIRE FORM. PC10014 may not be combined with other discount offers, special category rates or promotions. Discounts only apply to standard rates. Yes! Please register me for CBI’s 4th Summit on Biosimilars and Follow-On Biologics • Team Discount: Your organization may send 1 executive free for every 3 delegates registered. I am registering for ADVANTAGE PRICING All registrations must be made at the same time to qualify. We would like to take advantage of the TEAM DISCOUNT (see left for details). • Discount Accommodations & Travel: To receive CBI’s special discounted hotel rate online or by phone, go to: I cannot attend. Please send me a Confe rence CD-Rom Compendium. Register 3 • Online: Direct access to hotel web link will be available on line at Do you have any special needs? ________________________________________________ Get 1 FREE CBI’s Biosimilars webpage after December 11, 2009. KEY CODE (appears above mailing address): ___________________________________ • Phone Reservations: 1.888.627.8439 and mention CBI’s Biosimilars Conference. Cut-off date is February 24, 2010. Reservations made after the cut-off date or 1. NAME POSITION after group room block has been filled (whichever comes first) will be accepted on a space 2. NAME POSITION and rate availability basis. Rooms are limited so please book early. All travel arrangements subject to availability. 3. NAME POSITION • Venue: 4. NAME POSITION The Fairfax at Embassy Row • 2100 Massachusetts Avenue • Washington, DC 20008 free Phone Reservations: 888.627.8439 COMPANY DIVISION Hotel Direct Line: 202.293.2100 • Substitution & Cancellation: ADDRESS Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or CITY STATE/COUNTRY ZIP/POSTAL CODE before March 4, 2010 will be refunded, less a $195 administrative charge. No refunds will be made after this date; however, the registration fee less the $195 TELEPHONE FAx E-MAIL administrative charge can be credited to another CBI conference if you register AUTHORIZED SIGNATURE within 30 days from the date of this conference. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. CBI reserves the right to alter this program without prior notice. Payment Options: Payment in full is required to process registration. Please call with any payment questions. Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement Enclosed is a check for payment in full (No personal checks accepted) Please will be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or The Center for Business Intelligence. MC/Visa: photocopy this form for additional • Satisfaction Guaranteed: Amex: delegates. CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable NAME (AS APPEARS ON CARD) ExP. DATE CBI conference of your choice. Please contact 800-817-8601 for further information. CARDHOLDER SIGNATURE Advanced preparation for CBI conferences is not required. WeBSiTe Phone faX e-Mail Mail 5 EASY WAYS www.cbinet.com/ biosimilars 800-817-8601 781-939-2490 cbireg@cbinet.com Registration Dept. 339-298-2100 Please include all information CBI TO REgISTER outside the U.S. requested on registration card. 600 Unicorn Park Drive Woburn, MA 01801