IBC's 6th Annual Global Follow-On Biologics · IBC's 6th Annual Global Follow-On Biologics Preparing for a Post-FOB Approval World November 17-18, 2008 Hyatt Regency Bethesda Bethesda,

IBC's 6th Annual

Global Follow-On BiologicsPreparing for a Post-FOB Approval World

November 17-18, 2008

Hyatt Regency Bethesda

Bethesda, MD

www.IBCLifeSciences.com/FOB

The Premier Follow-On Biologics Conference Offering Insights, Strategies and Tactics for Innovator and FOB Companies

PLUS!

• Participate in an FDA Question & Answer Session

• Share your Thoughts in Two Audience Interactive Panel Discussions

Premier Publication:

Keynote Presentations

The Follow-On Dilemma – A Global PerspectiveRobert Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc.

The Follow-on Biologics Landscape: A Pioneer's Perspective on the FutureJoerg Windisch, Ph.D., Head of Global Development Biopharmaceuticals, Sandoz Inc.

FDA PresentationsProduct Quality Issues Surrounding Follow-On BiologicsBarry Cherney, Ph.D., Deputy Director, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, FDA

Immunogenicity of Biological Therapeutics Following Major Manufacturing ChangesSusan Kirshner, Ph.D., Acting Associate Chief, Laboratory of Immunology, Division of Therapeutic Proteins, CDER, FDA

The future legal and regulatory pathway for Follow-On Biologic products will be as complex as protein products themselves. Questions range from How can you be certain of the similarity, safety, and efficacy of follow-on products? to What will be the key drivers for success in the future market place for Follow-on Biologics? and many more. As approval from U.S. Legislature for Follow-On Biologics becomes a reality, innovator and FOB companies will prepare for the future by taking a proactive, not reactive, approach to ensure success. This is the event to attend to find out what you need to know to position your company for success in a post-FOB approval world.

IBC’s 6th Annual Global Follow-On Biologics conference will assess the science and safety of Follow-On Biologics through an in-depth analysis of the questions posed above. Learn about likely challenges and strategies to help guarantee that your organization is poised for success and ready to maximize the forthcoming opportunities of Follow-On Biologics.

You will hear from scientific, legal and financial experts, along with innovator and FOB industry leaders who will provide the latest analysis of the immunogenicity and comparability concerns surrounding Follow-On Biologics. Attendees will also receive invaluable insight into regulatory guidelines, I.P. protection, along with current and future business opportunities.

Speakers will also address what some consider to be the most important aspect of the post-FOB approval world: How will patients be affected? Will more people have access to protein-based drugs that will treat diseases and improve quality of life?

Prepare Yourself for the Post FOB Approval World.

By attending IBC’s 6th Annual Global Follow-On Biologics conference you will:• Learn how FOB companies are implementing effective and economically sound methods for the development, manufacturing, and approval

of Follow-On Biologics.• Hear how first to market companies like Pfizer and Genentech will to continue to innovate and compete in the future FOB marketplace.• Interact with FDA representatives and present them with your questions and concerns regarding FOB’s.• Gain information from FOB companies from around the world that have already achieved or attempted legal and regulatory approval.• Discover how slight changes in next generation products could dramatically extend market exclusivity.

IBC's 6th Annual


IBC's 6th Annual


November 17-18, 2008 Hyatt Regency BethesdaBethesda, MD

Two Full Days of U.S. and Global PerspectivesScientific Advisory Committee:Mark I. Bowditch, Patent Attorney, Sandoz, Inc.Patrick Vink, M.D., Senior Vice President & Global Head of Biologics, Mylan Pharmaceuticals, Inc.Scott M. Wheelwright, Ph.D., President, Strategic Manufacturing Worldwide, Inc.Gillian R. Woollett, MA, D.Phil., Chief Scientist, Engel & Novitt, LLP

Distinguished Faculty:Geoffrey Allan, Ph.D., President and CEO, Insmed Incorporated

Marc Bisschops, Scientific Director, Tarpon Biosystems

Trent Carrier, Ph.D., Director of BioProcess Services, Invitrogen Corporation

Barry Cherney, Ph.D., Deputy Director, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, FDA

Robert Dodge, Ph.D., Laboratory Director, Immunochemistry, Pharmanet

Diane Dorman, Vice President for Public Policy, National Organization for Rare Disorders

Robert Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc.

Mary Alice Hefford, Ph.D., Research Scientist, Centre for Biologics Research, Biologics and Genetic Therapies Directorate, Health Canada, Canada

Alex D. Kanarek, Ph.D., Principal, AK Consulting Services, Canada

Susan Kirshner, Ph.D., Acting Associate Chief, Laboratory of Immunology, Division of Therapeutic Proteins, CDER, FDA

Pete Latham, President, BioPharm Services US

Roger Lias, Ph.D., President, Eden Biodesign

Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences

Janet McNicholas, Ph.D., Partner, Bell Boyd and Lloyd, LLP

Amit M. Patel, Senior Vice President, Corporate Development & Strategic Planning, Dr. Reddy's Laboratories

Ronald A. Rader, President, Biotechnology Information Institute

Anna Schwamlein Howard, Senior Legislative Representative, Federal Affairs, Health Issues, AARP

Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, OPS, CDER, FDA

Christopher Slavinsky, MSc, J.D., Director, Science & Technology Business Development, Pfizer, Inc.

Jaime Uribe, Biotechnology Director, Probiomed, Mexico

Joerg Windisch, Ph.D., Head of Development, Global Biopharmaceutical Operations, Sandoz Inc.

Visit www.IBCLifeSciences.com/FOB for up-to-date information on this event

8:00 Morning Coffee and Conference Registration

9:00 Conference Opening Remarks & Chairperson’s Introductory DiscussionMark I. Bowditch, Patent Attorney, Sandoz, Inc.

Legislation Around the World 9:30 Overview of Legislative Opportunities that will

Benefit Patients Locally, Nationally and GloballyEU biosimilar approvals already are having an economic impact in Europe. In the U.S., patients are making similar demands for access to “follow-on” versions of previously-approved biologics. With the establishment of a straightforward biosimilars pathway in the U.S. comparable to that in the EU, American patients and the U.S. health care system can expect even more profound impacts. As EU biosimilars trigger both direct competition against their reference medicinal products and market-based competition vis-à-vis other biologics with overlapping indications, the implications become more profound. In the EU, these impacts are being realized despite the absence of interchangeability classifications – all going to show what can be achieved locally, nationally, and globally through the launch of competing versions of off-patent biologics.Gillian R. Woollett, MA, D.Phil., Chief Scientist, Engel & Novitt, LLP

10:00 Development Strategy for Follow-On Biologics in the U.S.Legislation to develop an FOB regulatory pathway is under active discussion in the US. FOB’s potentially represent a diverse group of therapeutic biologics, the scientific issues and means to address them will be product specific. The development strategy of each product should be based on good scientific principles and a sound approach to the drug development process.Geoffrey Allan, Ph.D., President and CEO, Insmed Incorporated

10:30 Networking Refreshment Break

11:00 Comparing the European and North American Approaches to FOB LicensingEurope has had a proper regulatory pathway for follow-on biologics since 2005. Several biosimilar products have already been approved. In May, 2008, U.S. Representatives Anna Eshoo and Joe Barton introduced The Pathway for Biosimilars Act. This presentation will examine the European approach to the regulation of follow-on biologics and compare it with the current FDA attitude and the new US initiative. Alex D. Kanarek, Ph.D., Principal, AK Consulting Services

11:30 Probiomed and the Mexican Pathway PerspectiveMexico is in the process of reviewing the regulatory framework for the introduction of Subsequent Entry Biologics (SEB). Several proposals for amendment of current legislation are open for discussion both in the Mexican Senate (Senado de la República Mexicana) and the Mexican House of Representatives (Cámara de Legisladores). Nevertheless, Mexico has enforced generic versions of all pharmaceutical products that enter the Mexican Social Security System and has even assigned the Generic status to Insulin and Growth Hormone. The experience of subsequent entry biologics in Mexico will be presented and discussed during this talk.Jaime Uribe, Biotechnology Director, Probiomed, Mexico

12:00 Regulation of Subsequent Entry Biologics in Canada: Science and Guidance Canada has now published guidance for Subsequent Entry Biologics, and, as a result is beginning to see sponsor requests for the marketing of these products. As Subsequent Entry Biologics become reality, science and regulation meet and guidance must be interpreted and applied. This talk will discuss the Canadian guidance and experience and the research undertaken at Health Canada to help address some of the practical, scientific issues we are encountering.Mary Alice Hefford, Ph.D., Research Scientist, Centre for Biologics Research, Biologics and Genetic Therapies Directorate, Health Canada, Canada

12:30 Networking Luncheon

1:45 Chairperson's Remarks & Session OverviewEmily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, OPS, CDER, FDA

The U.S. FDA Perspective 2:00 Product Quality Issues Surrounding

Follow-On BiologicsProtein products are complex and have variability associated with structural heterogeneity and folding. In addition to structural complexity, the source materials and manufacturing processes for proteins may lead to a variety of impurities that impact on product quality. This presentation will focus on the many factors including comparative physiochemical and biological characterizations, mechanistic knowledge and immunogenicity issues that need to be considered when evaluating similarity of follow-on protein products.Barry Cherney, Ph.D., Deputy Director, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, FDA

2:30 Immunogenicity of Biological Therapeutics Following Major Manufacturing Changes Major manufacturing changes can impact critical product quality attributes thereby altering product safety and/or efficacy. This talk will provide a regulatory perspective on immunogenicity assessment as part of a protocol for establishing comparability following major manufacturing changes. Susan Kirshner, Ph.D., Acting Associate Chief, Laboratory of Immunology, Division of Therapeutic Proteins, CDER, FDA

3:00 FDA Question & Answer Session


Audience Interactive Panel Discussion 4:00 Preparing for Post-FOB Approval Legislative Guidelines

A follow-on biologics pathway is inevitable, both in the U.S. and abroad. In order to create a viable, robust pipeline of both innovative and follow-on biologics, regulators and the industry will be challenged to strike the best balance between science and market forces, patient needs and business interests. Topics to be discussed will include: • Bioequivalence and safety • Standards of structural and functional comparability • Exclusivity • Lessons from the European follow-on experience • Lessons from the U.S. Hatch-Waxman experience • Role of clinical studies Moderator: Mark I. Bowditch, Patent Attorney, Sandoz, Inc.Panelists: Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, OPS, CDER, FDAMary Alice Hefford, Ph.D., Research Scientist, Centre for Biologics Research, Biologics and Genetic Therapies Directorate, Health CanadaGeoffrey Allan, Ph.D., President and CEO, Insmed IncorporatedGillian R. Woollett, MA, D.Phil., Chief Scientist, Engel & Novitt, LLP

5:15 End of Day One

Main Conference Monday, November 17, 2008


8:00 Morning Coffee

8:30 Chairperson's Remarks & Session OverviewTrent Carrier, Ph.D., Director of BioProcess Services, Invitrogen Corporation

Audience Interactive Panel Discussion 8:45 The Role of Service Providers and Suppliers in

Follow-On Biologics Development Sponsored by:

Follow-On Biologics represent a new opportunity for service providers and suppliers, but how well are these companies prepared to meet the demands of this new market segment? The speed of FOB development accelerates investments in product and process development that may necessitate new tools and services. What role do services and suppliers play in supporting the emerging FOB market and what needs are not being met?Topics to be discussed include:• Market viewpoint from supply side • Analytical and DSP development• Clinical and regulatory support • Off the shelf production systems• Rapid scale-up to “commercial” production • Sales strategies and

customer supportModerator: Trent Carrier, Ph.D., Director of BioProcess Services, Invitrogen CorporationPanelists: Roger Lias, Ph.D., President, Eden BiodesignJerold Martin, Senior Vice President, Scientific Affairs, Pall Life SciencesAdditional panelists to be announced

The Science and Technology of Follow-On Biologics 9:30 Assays to Monitor Immunogenicity

The types and formats of assays currently available for detection of antibodies to biologic drugs as well as implications for comparison with innovator drug assays will be discussed. In addition, the characterization of an antibody response, such as neutralizing or blocking potential, antibody isotype, and binding epitope followed by comparison to innovator drug antibody responses, will be reviewed.Robert Dodge, Ph.D., Laboratory Director, Immunochemistry, Pharmanet

10:00 Considerations for Selecting FOB Manufacturing Technologies As a part of a Follow-On Biologics development program, potential FOB manufacturers are developing rationales for selecting manufacturing technologies that fit best into the business case of lowering overall production costs. Through economic models, we will offer rationale for choosing the downstream optimum manufacturing technologies, both in terms of COG and in terms of flexibility. This technical modeling presentation will compare batch chromatography of a mAB to a generic follow on biologic process looking at the process economics. Finally, we will evaluate hardware, operational, logistical, quality and analytical implications surrounding FOB manufacturing.Marc Bisschops, Scientific Director, Tarpon Biosystems


Impact of Next Generation Products in a Post-FOB Approval World

11:00 Legal IP Protection for Next Generation ProductsIntellectual property (IP) protection, particularly patent protection, has been an essential component for the commercialization of innovative biotechnology and pharmaceutical products. What is the role of IP in a world of follow-on biologics and how will Next Generation/Second Generation products be affected? Will follow-on biologics drive further innovation and further IP creation/protection? Will improved biologics be “patent protectable” in the U.S., Europe, India and China? Opportunities for obtaining and maintaining patent protection in a challenging U.S. market and a growing global market will be discussed.Janet McNicholas, Ph.D., Partner, Bell Boyd and Lloyd, LLP

11:30 Lifecycle Management in View of Follow-On BiologicsAs the demand for global access to biopharmaceuticals expands, the traditional paradigm of lifecycle management, based in part on secondary patent protection and limited data exclusivity, may be insufficient to drive further R&D activity. To counter this pressure, innovators must continue to improve analytical technologies to better characterize biologics, develop formulations that are more patient friendly, and adopt a culture of continuous improvement across their business, including manufacturing and supply chain, to manage costs. Strategies in these areas will be discussed, including partnering and risk-sharing models in use at Pfizer.Christopher Slavinsky, MSc, J.D., Director, Science & Technology Business Development, Pfizer, Inc.

Keynote Presentation 12:00 The Follow-On Dilemma –

A Global Perspective The biotechnology industry, after a quarter century of incredible successes, is poised to face the challenge of low cost biogeneric competition. The need for low cost follow-on biologics coupled with the patent expiration of many of the block buster biotechnology products paves the way for the emergence of a $20-40 billion global follow-on industry. Unlike generic copies of small molecule drugs, the regulatory approval of follow-on biologics will need to be based on a combination of analytical characterization, in vitro biological activity measurements and potentially human clinical trials, in order to answer important public health questions about efficacy, safety and immunogenicity. This keynote presentation will also address analytical considerations about the possible detection of contaminated follow-on biologics products outsourced from third world countries.Robert Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc.

12:30 Lunch on your Own

Main Conference Tuesday, November 18, 2008

Marketing Opportunities atIBC’s Global Follow-On Biologics

IBC’s Biopharmaceutical Production Series events provide a number of sponsorship opportunities you can choose from to meet your sales and marketing goals before, during and after the event. IBC’s sponsorships ensure you can spend more time developing your deals and less time searching for potential partners.

Sponsorship opportunities include Technology Workshops, Session Sponsorships, Receptions, Luncheons and Break Sponsorships, Focus Groups, and much more.

For more information on sponsorship, please contact Kristen Schott at (508) 614 1239 or email [email protected]

Invitrogen develops products and services for life science research, drug development, and commercial bioproduction.

To Register, Tel: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: [email protected]

Venue & Travel InformationHyatt Regency Bethesda

7400 Wisconsin Ave, 1 Bethesda Metro Center, Bethesda, MD 20814 Phone: (301) 657-1234 • Fax: (301) 657-6453

DISCOUNTED AIR TRAVEL RESERVATIONS: For all air travel arrangements, including international, please call or write IBC’s official air travel agency, Commonwealth Travel Advisors, to book your travel. E-mail: [email protected] or call: USA: (888) 703-4286 or (508) 366-3660; International: (508) 366-3660. Please be certain to mention IBC along with the conference title, dates, and conference code B8194 when e-mailing or calling. Please note that there is a $29.00 booking fee for using Commonwealth Travel.DISCOUNTED HOTEL RESERVATIONS: Please call Hyatt Regency Bethesda at (301) 657-1234 before October 21, 2008 to be included in IBC’s dedicated room block for this conference. Please be sure to mention IBC, along with the conference title and date.

Registration InformationREGISTRATION SUBSTITUTIONS/CANCELLATIONS: In order to receive a prompt refund, your notice of cancellation must be received in writing (by letter or fax) 10 working days before the conference. We regret cancellations will not be accepted after that date. However, we will be pleased to transfer your registration to another member of your company at any time. If you plan to send someone in your place, please notify us as soon as possible so that materials can be prepared. All cancellations will be subject to a $395 processing fee. If IBC cancels an event, IBC is not responsible for any airfare, hotel or other costs incurred by registrants. Speakers subject to change without notice.SPECIAL NEEDS: If you have a handicap or have special needs, please let us know in order that we may address your special needs for your attendance at this conference. Please send your special needs via email to [email protected] or FAX (508) 616-5522.For security precautions, photo identification will be required of ALL attendees at check-in.

1:30 Chairperson’s Remarks & Session OverviewPatrick Vink, M.D., MBA, Senior Vice President & Global Head of Biologics, Mylan Pharmaceuticals, Inc.

Global Strategies for the Future

Keynote Presentation 1:45 The Follow-on Biologics Landscape:

A Pioneer's Perspective on the Future Biosimilars, both simple and complex, are already a reality in Europe. Some of these products are now also available in the U.S. Today, Sandoz is shaping the scientific concepts and development strategies that will pave the way to the registration and commercialization of a follow-on biologic in many countries based on a single, global development program. Follow-on versions of additional product classes are also moving rapidly through development pipelines. These trends will enhance access to high quality biological medicines around the world - and spur further innovation on all sides.Joerg Windisch, Ph.D., Head of Global Development Biopharmaceuticals, Sandoz Inc.

2:15 Emerging Markets as a Platform 'Today' for the 'Future' Global FOB Opportunity While the scientific, regulatory and intellectual property landscape of the global FOB industry continues to take shape in markets such as Europe and the United States, Emerging Markets are already moving along. In certain instances, there are significant commercial opportunities for FOBs "in" these Emerging Markets. In other instances, Emerging Markets are providing a base "out" of which companies can position themselves to pursue global FOB opportunities. FOB case studies and trends from Emerging Markets will be discussed, and their implications on today's and the future's FOB industry will be highlighted. Amit M. Patel, Senior Vice President, Corporate Development & Strategic Planning, Dr. Reddy's Laboratories (Invited)


3:00 Featured Presentation Patient Perspective on FOB and the Need for Affordable TreatmentsBiologics are becoming increasingly important in U.S. health care. The costs of these treatments can be prohibitively expensive for individuals and the overall U.S. healthcare system. Discussion will include what FOB legislation will mean to patients and consumers, as well as address the need for affordable treatments for patients suffering from rare disorders. This featured presentation will focus on the importance of striking a balance between access, affordability and increased innovation and will stress the importance of ensuring cooperation between varied interests.Anna Schwamlein Howard, Senior Legislative Representative, Federal Affairs, Health Issues, AARPDiane Dorman, Vice President for Public Policy, National Organization for Rare Disorders

Future Perspectives on Global Follow-On Biologics 3:45 What Will the Market for FOB's Be? What Forces will

Shape the Market? How will New Entrants Compete and Innovators Adapt?What types of companies will be involved in the U.S. and world markets? How will the market evolve? What will be the controlling factors in the marketing and uptake of FOB's in the U.S.? Many aspects that will control FOB's marketing involve information, including product nomenclature (e.g., unique vs. generic names) and information/educational resources and programs for the medical, pharmacy, payer, general public and other involved communities. Once legislation is resolved, information, which will control how FOB's are perceived and handled, will be the next battleground.Ronald A. Rader, President, Biotechnology Information Institute

4:15 Future Business Models for Success in Follow-on BiologicsWhat will be the key drivers for success in the future market place for Follow-on Biologics? The emergence of FOB's will allow for different business models that can be applied in order to benefit from the new opportunities. The key benchmarks and challenges of these business models will be discussed as well as the suitability for the generic companies active in this area Patrick Vink, M.D., MBA, Senior Vice President & Global Head of Biologics, Mylan Pharmaceuticals, Inc.

4:45 Preparing for the Likely Challenges and Opportunities of Follow-On Biologics ManufacturingKey drivers for FOB manufacturing will certainly include cost of goods and capacity utilization, along with the need to maximize investment, flexibility and speed. As the industry prepares for the post-FOB approval world, some companies are positioning themselves as potential manufacturing partners with FOB companies. This talk will review the new sector of FOB manufacturing by reviewing some of the latest technologies for decreasing the cost of goods, including tools for the evaluation and optimization of your current and future performance.Pete Latham, President, BioPharm Services US

5:15 Close of Conference

Premier Publication:

Media Partners:

IBC Upcoming Events

• Biopharmaceutical Manufacturing and Development Summit December 8-9, 2008 • Washington Duke Inn & Golf Club Durham, NC

• Process Validation for Biologicals • Technology Transfer for Biopharmaceuticals • Outsourcing Manufacturing of Biopharmaceuticals

March 2-3, 2009 • La Costa Resort and Spa • Carlsbad, CA

• Antibody Development and Production • Therapeutic Protein Development and Production

March 4-6, 2009 • La Costa Resort and Spa • Carlsbad, CA


Global Follow-On Biologics: Preparing for a Post FOB Approval World

First Name Last Name

Title E-mail

Company Department

Street Address

City

State Zip Country

Telephone Fax

Approving ManagerData Protection: The personal information shown on this form, and/or provided by you, will be held on a database and may be shared with companies in the Informa Group. Sometimes your details may be obtained from, or made available to, external companies for marketing purposes. If you do not wish for your details to be used for this purpose, please email [email protected]

On or Before On or Before On or Before Standard Rate Industry Fees August 22, 2008 Sept. 19, 2008 OCt. 17, 2008 After Oct. 17, 2008

Main Conference o $1599 o $1699 o $1799 o $1899

Academic/Government Fees*

Main Conference o $699 o $799 o $899 o $999* Rate extended to full-time employees of government, universities and university-affiliated hospitals who have NO affiliation to a for profit entity. Total:

For security precautions, a photo identification will be required of ALL attendees at check-in. For on-site registration, please add $100 to the total fee. Prices include lunch, refreshments and speaker documentation. See inside for policies regarding Substitutions, Cancellations and Special Needs.Unable to Attend? Purchase the Conference Materials. The Conference Materials containing a selection of speaker presentations will be available for purchase following the event. o I cannot attend. Please send ______ Conference Material(s). Enclosed is my payment

for $399 each, plus shipping and handling ($25 in the U.S., $45 outside the U.S.).

Payment (Required 30 days in advance of the conference. If registering within 30 days, payment is due immediately)

o Mastercard o Visa o American Express o Check o Wire TransferPlease make check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC USA Conferences and attach to the registration form. Confirmation of your booking will be sent. Wire Transfer: Please tell your bank to include the conference code, invoice number, person attending, name and date of the conference in the transfer instructions. Wire transfers and EFT payments: please contact accounts receivable at [email protected] for banking details.

Card #Exp. Date

Name (as appears on card) Signature

The Premier Follow-On Biologics Conference Offering Insights, Strategies and Tactics for Innovator and FOB CompaniesNovember 17-18, 2008 • Hyatt Regency Bethesda • Bethesda, MD

FDA Presenters:Barry Cherney, Ph.D., Deputy Director, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, FDA

Susan Kirshner, Ph.D., Acting Associate Chief, Laboratory of Immunology, Division of Therapeutic Proteins, CDER, FDA

Keynote Presenters:Robert Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc.

Joerg Windisch, Ph.D., Head of Global Development Biopharmaceuticals, Sandoz Inc.

IBC's 6th Annual


How to RegisterOnline: www.IBCLifeSciences.com/FOB

Phone: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: [email protected]: IBC USA Conferences, P.O. Box 414525, Boston, MA 02241-4525

Product Code: B8194PDFWDL

Documents

IBC's 6th Annual Global Follow-On Biologics · IBC's 6th Annual Global Follow-On Biologics Preparing for a Post-FOB Approval World November 17-18, 2008 Hyatt Regency Bethesda Bethesda,