Law Seminars International Presents

An Intensive One-Day Workshop on

Follow-On Biologics

Commercial opportunities thrive as patent protections expire

November 12, 2004
Hilton Torrey Pines in La Jolla, CA
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Who Should Order Homestudy

Attorneys, biotech industry executives, consultants, government and university officials involved in leading edge research and development

Why Order

“The recent success of follow-on biologic products as therapeutics has been accompanied by increased research and development expense and risk of late-stage failures. Similarly, as biologics have become essential components in the arsenal of medical treatments, legislators, consumers, and health care service providers have begun to focus on the cost of these innovative life-saving treatments. The confluence of increasing efficacy in biologic products, and concerns about costs of therapeutic products has generated strong interest in the commercial opportunities that might result from the expiration of patent protection for some biologic products. This new-found interest in an abbreviated regulatory process for the approval of follow-on biologic products has resulted in discussions focused on science, health and safety regulation, and intellectual property protection. The scientific, regulatory, and intellectual property issues will likely require a substantially different solution for post-patent market competition than provided by the Hatch-Waxman Act for traditional small molecule drugs. This one-day conference provides an overview of the issues through interactive sessions with national experts on the complex issues surrounding follow-on biologics. ” ~ Program Co-Chairs: Cathryn Campbell, Ph.D., Esq., Gregory J. Glover, M.D., Esq. and Kate H. Murashige, Ph.D., Esq.

Agenda

Friday, November 12, 2004
8:00 am Registration and Continental Breakfast
8:30 am Introduction & Overview
  Cathryn Campbell, Esq., Ph.D.
 McDermott, Will & Emery / San Diego, CA
  Gregory J. Glover, MD, Esq.
 Ropes & Gray / Washington, DC
  Kate H. Murashige, Ph.D., Esq
 Morrison & Foerster LLP / San Diego, CA
8:45 am Distinguishing Drugs from Biologics: Biogenerics vs. 2nd Generation Biologicals vs. Follow-On Biologicals vs. Small Molecule Drugs
  Definition of terms with examples; comparison existing statutory provisions for approval of generics regulated as drugs under Section 505(b)(2) of the Food & Drug Administration Act vs. biological products licensed through a Biological License
  Edward L. Korwek, Esq., Ph.D.
 Hogan & Hartson LLP / Washington, DC
9:30 am Biologics as Products
  How the products are made, the time required, and the implications about their suitability for abbreviated regulatory approval processes
  David E. Szymkowski, Ph.D.
 Xencor / Monrovia, CA
10:30 am The Current Regulatory Framework for Generic Drugs: What’s missing in the statutory framework for follow-on biol-ogics?
  Is there an Accepted Abbreviated Process for Proving Biologics? What is the current path for approval?
  Robert Church, Esq.
 Amgen, Inc. / Thousand Oaks, CA
11:15 am The Journey from Initiative to Submission
  Practical experience in the development of Follow-Ons
  Peter H. Kalinka, Managing Director & CEO
 Accelsiors Group International / 82467 Gramisch-Partenkirchen, Germany
12:00 pm Luncheon for Faculty & Attendees
  Compliments of McDermott, Will & Emery and Morrison & Foerster LLP
1:15 pm Patent Issues and Strategies for Pioneer Companies
  At the start: Complications from the overlap between product and process patents; legal overview
  David Harper, Esq., Ph.D.
 McDonnell Boehnen Hulbert & Berghoff / Chicago, IL
  How do you get broad enough protection to cover your commercial market if the eventual product is different from the original?
  Gregory J. Glover, MD, Esq.
 Ropes & Gray / Washington, DC
3:15 pm Section 505 (b) (2) and Trade Secrets
  Issues arising under Section 505(b)(2) of the Food & Drug Administration Act: Agency perspective on releasing data necessary to make a safe and effective product, and on the tension between public interest in development of generic biologicals
  Christina M. Markus, Esq.
 King & Spalding LLP / Washington, DC
4:15 pm Putting it All Together: The Route to Market from Research to Product through Successful Patent Strategies
  Cathryn Campbell, Esq.
 McDermott, Will & Emery / San Diego, CA
  Gregory J. Glover, MD.
 Ropes & Gray / Washington, DC
  Kate H. Murashige, Ph.D.
 Morrison & Foerster LLP / San Diego, CA
5:00 pm Adjourn

Cancellation

There is a $25 cancellation fee for Course Materials orders and $50 for Homestudy orders

Continuing Education Credits

Law Seminars International automatically obtains CLE credit approval for the state in which a seminar is held. On request, we will apply for CLE credits in other states and other types of credits. Current credits status: CA MCLE 6.75 | NY CLE 7.5 (0 ethics, non-transitional) | WA CLE 6.5 (#127056)

Cost

Our complete Homestudy Course, consisting of a VHS or DVD recording and the written course materials, is available for $605. The course materials alone are available for $100. We will ship your homestudy order via UPS ground within two weeks after the seminar or the date we receive payment (which ever is later).
Order Homestudy

Faculty Bios

Cathryn Campbell, Program Co-Chair, is a partner in the San Diego office of McDermott, Will & Emery. Dr. Campbell serves as head of the firm’s Life Sciences Intellectual Property practice where she concentrates her practice on biotechnology patent law.

Gregory J. Glover, Program Co-Chair, is a partner at Ropes & Gray LLP and coordinator of the Life Sciences Practice. He is a licensed physician and registered patent attorney with experience in food and drug law, intellectual property law, and technology licensing. His practice focuses on providing advice to life sciences companies and trade associations on the strategic interaction of FDA regulations, IP law and technology licensing.

Kate H. Murashige, Program Co-Chair, is a partner at Morrison & Foerster LLP and co-chair of the firm’s Patent Group, focuses her practice on the pharmaceutical and healthcare industries. She is especially skilled at shepherding new products to market.

Robert Church is an Associate General Counsel at Amgen Inc. and the head of Amgen’s Regulatory and Compliance Law Group. His practice focuses on all areas of FDA regulation and on Amgen’s Corporate Compliance Program. Before joining Amgen, Mr. Church served in FDA’s Office of the Chief Counsel and participated in litigation and regulatory proceedings involving drugs for human use, biologics, and medical devices. During his time at FDA, he held the titles of Associate Chief Counsel for Drugs and Associate Chief Counsel for Enforcement.

David Harper is a partner with McDonnell Boehnen Hulbert & Berghoff. Dr. Harper’s practice focuses on counseling biotechnology, pharmaceutical, and diagnostics companies on a wide variety of intellectual property matters, including patent and trademark procurement, licensing, enforcement, and opinion work, with a particular focus on counseling start-up and early phase biotechnology companies, as well as groups investing in such companies.

Peter Kalinka, Ph.D., is Managing Director for Accelsiors GmbH, Germany and CEO for Accelsiors Group International is co-founder and partner of the Accelsiors Group International and consultant for Biotech Drug Development. He has managed all phases of drug development, including regulatory requirements and preparation of clinical research and management of CROs both in North America and Europe. He has more that 15 years' experience in developing therapeutically active proteins, and was responsible for the development and filing of the first generic Biopharmaceutical in history.

Edward L. Korwek is a partner in the Washington, D.C. office of Hogan & Hartson LLP. Dr. Korwek’s practice is primarily in the areas of food, drugs, and biologics. He also concentrates on biotechnology issues pertaining to these practice areas.

Christina M. Markus, a partner in King & Spalding’s Washington office, focuses her practice on the regulation of drugs, biologics, and other products by the Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (DEA), and related state agencies. She represents companies in a broad range of regulatory compliance and enforcement matters involving product safety, composition, approvals, labeling, and advertising.

David E. Szymkowski is Director of Biotherapeutics at Xencor. Xencor uses computational structural biology, high-throughput protein production, and advanced cell biology to create protein drugs with novel mechanisms of action, reduced immunogenicity, and improved safety and efficacy. Prior to joining Xencor, Dr. Szymkowski was a principal scientist in the inflammation group at Roche Bioscience. He currently serves on the editorial boards of Drug Discovery Today and TARGETS.