Law Seminars International Presents

An Important Two Day Conference on

Biopharmaceuticals

Running the Race from Drug Discovery to Commercialization

May 3 & 4, 2004
Holiday Inn-Brownstone in Raleigh, NC
Order      Download PDF Brochure

Who Should Order Homestudy

Attorneys, industry executives, industry representatives, consultants, government and university officials

Why Order

"The biopharmacutical sector has proven to be the most profitable yet also the most risky of the biotechnology industry. Successful blockbusters like EPO or TPA have co-existed with clinical disappointments in an environment of regulatory and patent conflicts. From basic discovery to market, a biopharmecutical product and its institutional sponsors must pass through a complex maze of intellectual property, contract, licensing, regulatory and financial issues, often interspersed with litigation and dispute management. Industry leaders and practitioners need a holistic approach to biopharmecutical development which takes into account all of these challenges. This two-day conference is an advanced level interactive session with national experts on leading issues of the day. It is an opportunity to meet with peers, to engage in thoughtful discussion, and to update and expand your understanding of these areas." ~ Program Co-Chairs: Jorge A. Goldstein, Esq. and Kenneth D. Sibley, Esq.

What You Will Learn

History, Science and Business of Biopharmaceuticals, Present Models for Novel Drug Development, Corporate Business Alliances, Legal Protections for Biopharmaceutical Companies, FDA Regulation of Drugs and Biologics, Medicare Prescription Drug Improvement and Modernization Act, The Academic Role in the Industry, Generic Pharmaceuticals and Biopharmaceuticals, Patent Infringement Exceptions Avoiding Antitrust Problems, Litigation and Other Dispute Resolutions, Hot Topics from the Press

What Attendees Said

' Overall, I was impressed w/ the curriculum and the quality of the speakers and the materials." "I plan to attend more LSI courses and will recommend my employees do the same."

Agenda

Monday, May 03, 2004
8:30 am At the Starting Line
  Jorge A. Goldstein, Esq., Ph.D., Program Co-Chair
 Sterne Kessler Goldstein & Fox PLLC / Washington, DC
  Kenneth D. Sibley, Esq., Program Co-Chair
 Myers Bigel Sibley & Sajovec, P.A. / Raleigh, NC
8:45 am The Biopharmaceutical Sector of Biotechnology: History, Science and Business
  Proteins as Drugs: From gene hunting to function hunting to 2nd generation protein design. Jargon; readinig materials and training resources for non-science professionals
  David Harper, Esq., Ph.D.
 McDonnell Boehnen Hulbert & Berghoff / Chicago, IL
9:30 am The Players: Present Models for Novel Drug Development
  Who is doing drug discovery? Who is doing clinicals?Who is commercializing? Who is paying? Academia; Small/medium Biopharma; Large Pharma; Venture Capital; Government
  Geoffrey R. Erickson, Ph.D., Senior Associate
 A.M. Pappas & Associates / Research Triangle Park, NC
10:15 am Break
10:30 am Corporate Business Alliances
  Why and when to partner; finding partners; valuing technologies and deals; M&A as a tool for growing a business
  Robert E. Duggins, Esq.
 Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. / Raleigh, NC
11:15 am The Rules of the Game: Legal Protections for Biopharmaceutical Companies
  What every biopharmaceutical developer needs to know about patents: genes, proteins, living organisms and treatment methods; requirements of patentability; patent claims; strategies for patent portfolios; patents do not provide a right to commercialize;
  James F. Haley, Jr., Esq.
 Fish & Neave / New York, NY
12:00 pm Lunch (on your own)
1:00 pm Other non-patent protections
  Trade secrets; CDAs MTAs, DMF/BMFs
  Alan J. Morrison, Esq., Member
 Cooper & Dunham LLP / New York, NY
1:45 pm Medicare Prescription Drug Improvement and Modernization Act 2003
  Brian Slater, Esq.
 Fitzpatrick, Cella, Harper & Scinto / New York, NY
2:30 pm Break
2:45 pm The Academic Role in the Industry: Three Models for Technology Transfer -- A Panel
  Corporate funding, Universitiy/Industry Partnerships: Which models have worked and which have not
  Mark Crowell, Assoc. Vice Chancellor, Director OTD
 UNC - Chapel Hill / Chapel Hill, NC
  Federal Funding: exclusivity and retained rights; royalty provisions; hybrid licenses; field of use definitions; What hve we learned from 25 years of Bayh-Dole?
  Donna Cookmeyer, Ph.D., Director OTT
 North Carolina State Univeristy, / Raleigh, NC
  Venture Funding and Spin Offs: The long haul toward commercialization; finding funding through research and start-ups
  Spencer Lemons, Ph.D., Director Technology Transfer Office
 Wake Forest University / Winston-Salem, NC
4:00 pm Keeping the Enterprise Funded
  Raising money, Going Public, Industry consolidations. M&A activity and prospects -- the practical aspects
  Deborah J. Hylton, Esq.
 Womble Carlyle Sandridge & Rice, PLLC / Research Triangle Park, NC
  Practical Aspects of Due Diligence Investigations. The role of SEC rules. Investigating IP issues such as protection, freedom to operate, third party rights, ownership of biological materials, encumbrances; opinion letters; privilege issues
  Eric K. Steffe, Esq.
 Sterne, Kessler, Goldstein & Fox, PLLC / Washington, DC
5:00 pm Reception for Faculty and Attendees
  Sponsored by: Myers Bigel Sibley & Sajovec, P.A. and Sterne, Kessler, Goldstein & Fox, P.L.L.C.

Tuesday, May 04, 2004
8:30 am Generic Pharmaceuticals and BioPharmaceuticals
  What is a generic drug? The interface between IP and FDA law; ANDAs, Orange book, recent litigation on FDS authority and related ANDA case law
  Frank Grassler, Esq., V.P. Intellectual Property
 Glaxo-Smith-Kline / Raleigh, NC
  Generic Drug Competition and the Prospects for Follow-on Biologics
  Gregory J. Glover, MD, Esq.
 Ropes & Gray / Washington, DC
9:30 am What is the Scope of Exceptions to Patent Infringement?
  Public & Private Research Exemptions: Experimental use after Duke V. Madey: 11th Amendment issues
  Richard P. Vitek, Esq.
 Myers Bigel Sibley & Sajovec, P.A. / Raleigh, NC
  Researach Tools: Importing Data (Housey case); prec linical work (Integra case); mechanism-based use patents (Rochester on Cox-2 Inhibitors)
  Jorge A. Goldstein, Esq., Ph.D., Program Co-Chair
 Sterne Kessler Goldstein & Fox PLLC / Washington, DC
10:30 am Break
10:45 am Avoid Antitrust Problems
  Antitrust Issues: Alliances and M&As; scrutiny of litigation settlements (delaying introduction of generics) and interference settlements (collusive extension of patent term -- Immunomed v. Genentech)
  David A. Balto, Esq.
 White & Case LLP / Washington, DC
11:30 am Special Address
  Recent FTC Pronouncements on the patent system and proposals for change
  Matthew J. Bye, Esq., Office of General Counsel, Policy Studies
 Federal Trade Commission / Washington, DC
12:15 pm Lunch (on your own)
1:30 pm More Rules: FDA Regulation of Drugs and Pharmaceuticals
  What every biopharmaceutical developer needs to know about the FDAs role in getting a drug on the market
  Edward L. Korwek, Esq., Ph.D.
 Hogan & Hartson LLP / Washington, DC
2:15 pm The Battle Lines in Biopharmaceutical Litigation
  How the courtroom presents obstacles and opportunities on the road to commercialization.
  Hayden J. (Jay) Silver, III, Esq.
 Kilpatrick Stockton LLP / Raleigh, NC
3:00 pm Break
3:15 pm When and Why Commercialization Alliances Sour
  What are the most frequent reasons for conflict in business alliances? What are the different paths to resolving those conflicts? How can they be avoided?
  Pressly M. Millen, Esq.
 Womble Carlyle Sandridge & Rice, PLLC / Raleigh, NC
4:00 pm Hot Topics From the Press
  GMOs; stem cells; cloning; regulation and disclosure issues in clinical trials; ioterrorism; regional development of biotech industry
  Brady Huggett, Managing Editor
 Thomson BioWorld / Atlanta, GA
4:45 pm Questions and Answers
  Panelists and Audience
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 self-certifies CLE credits for Washington, California, and Alaska. For other locations, we automatically seek CLE credit approval for the state in which a seminar is held. On request, we will apply for credits from other bar associations or the accrediting bodies for other professions. The current credits status for this program is NC CLE 13.5 (Sponsor #2488, Course #5) | CA MCLE 13.75 | CO CLE 16 | GA CLE 13.5 | NY CLE 16 (no ethics, non-transitional) OH CLE12.75 (#000142259) | TN CLE 13.5 (#029439) | TX CLE 13.5 (#000061006) | VA CLE 13.5 (#RO1148) | WA CLE 13.5 (#117835)

Cost

Our complete Homestudy Course, consisting of a VHS or DVD recording and the written course materials, is available for $905. 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

Jorge A. Goldstein is a Director in the Biotechnology/Chemical Group at Sterne, Kessler, Goldstein & Fox P.L.L.C. Dr. Goldstein’s intellectual property experience has been principally in areas such as genomics, molecular and cell biology, and recombinant DNA technology. He has prepared and prosecuted patents before the U.S. and foreign patent offices. He has specialized in university-industry relations and in interferences, particularly in the area of biotechnology.

Jorge A. Goldstein is a Director in the Biotechnology/Chemical Group at Sterne, Kessler, Goldstein & Fox P.L.L.C. Dr. Goldstein’s intellectual property experience has been principally in areas such as genomics, molecular and cell biology, and recombinant DNA technology. He has prepared and prosecuted patents before the U.S. and foreign patent offices. He has specialized in university-industry relations and in interferences, particularly in the area of biotechnology.

Kenneth D. Sibley, Program Co-Chair, is a partner with Myers Bigel Sibley & Sajovec, P.A. where he focuses his practice on the biotechnology and chemical areas. He is also a Senior Lecturing Fellow at the Duke University School of Law, editor of The Law and Strategy of Biotechnology Patents and on the Board of the Triangle Intellectual Property Law Association. In 2004, he was ranked as the #1 patent and intellectual property lawyer in North Carolina by Business North Carolina magazine, based on a poll of North Carolina lawyers.

Matthew J. Bye is an attorney in the Office of General Counsel, Policy Studies, at the Federal Trade Commission. At the FTC, he primarily has worked on issues relating to the interserction of competition and patents, and healthcare. He was a principal author of the FTC's recently released report entitled "To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy," and the FTC study study on pharmacuetical industry competition entitled "Generic Drug Entry Prior to Patent Expiration." Mr. Bye graduate with first class honours in law from the Australian National University and is a member of the bar of the State of New York.

David A. Balto is a partner in the Antitrust Group of White & Case LLP. Prior to joining White & Case, he was with the Federal Trade Commission where he was Policy Director of the Bureau of Competition and attorney advisor to Chairman Robert Pitofsky.

Donna Cookmeyer is Director at the Office of Technology Transfer, North Carolina State University. Prior to joining OTT, she was a funding officer for the Army Research Office. She is also author of the book, Women, Science and Technology.

Mark Crowell is Associate Vice Chancellor for Economic Development and Director of the Office of Technology Development at the University of North Carolina at Chapel Hill. He is coordinating the development of Carolina North, an almost 1,000 acre mixed use campus development project located less than two miles from Carolina’s historic campus.

Rob Duggins is a partner in the Securities and Growth Companies group at Smith Anderson Blount Dorsett Mitchell & Jernigan, LLP in Raleigh, North Carolina. He works primarily with public and private life science companies and with life science venture investors. His practice includes M&A, joint venture, and R&D partnering transactions. Smith Anderson, founded in 1912, is the largest law firm based in the Research Triangle.

Geoffrey R. Erickson, Ph.D., is a Senior Associate with A.M. Pappas & Associates where he is responsible for sourcing investment opportunities, reviewing business plans and assisting with all aspects of clients' formal investment processes. He also holds a faculty appointment as an Assistant Adjunct Professor in the Department of Surgery at Duke University Medical Center.

Gregory J. Glover, 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.

Frank Grassler is Vice President Intellectual Property for Glaxo-Smith-Kline in Raleigh, NC.

James F. Haley is a partner in the New York office of Fish & Neave. He has extensive experience in the areas of intellectual property protection and licensing of patents and technology and with numerous United States and foreign patent litigations, European and other patent oppositions and United States interferences in biotechnology and biopharmaceuticals.

David Harper is a partner with McDonnell Boehnen Hulbert & Berghoff where he is responsible for preparing and prosecuting the complete U.S. and foreign patent and trademark prosecution docket of clients, with a particular emphasis on biotechnology, drug discovery, diagnostics, reagents, pharmaceuticals, and instrumentation.

Brady Huggett is Managing Editor for BioWorld Today, BioWorld Financial Watch, BioWorld Week and BioWorld International, and serves as overseer for the organization's sourcebooks and BioWorld Phase III Report.

Deborah counsels business clients from various industries in strategic business and corporate matters. She has 20 years of experience in mergers and acquisitions, private and public securities offerings, equity and debt financings, and implementing business development initiatives. She regularly leads teams of lawyers with expertise in different areas of the law to effectuate a variety of complex transactions, including early stage financing through initial public offerings, expansion through new facility construction, leveraged acquisitions, acquisitions and sales of multi-site or multi-purpose facilities, public mergers of equals, and implementation of new divisions and product offerings. Deborah has worked extensively with companies in the pharmaceutical and related life sciences industries. She has also represented clients in a broad range of industries, including software companies, traditional industrial and manufacturing companies and financial institutions. Deborah was selected for the 2001-2002 edition of The Best Lawyers in America for her work in Corporate Law. Professional Activities Director, North Carolina Biosciences Organization 

Edward L. Korwek, Ph.D.,  is a partner in the Washington, D.C. office of Hogan & Hartson L.L.P. 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.

Spencer Lemons is Director, Technology Asset Management at the Wake Forest University Technology Transfer Office. His background includes sales, marketing, teaching, and medical research experience. He has successfully negotiated commercialization agreements for new technologies in a broad range of fields and has been involved in the creation and funding for over a dozen new start-up companies and over 30 new businesses.

Pressly Millen is a trial attorney who has litigated a wide variety of antitrust and other complex business cases, including class actions, in federal and state courts throughout the United States. Press has been named by Business North Carolina as one of the top antitrust lawyers in North Carolina. He achieves success for his clients in litigation by being ready, willing and able to take those cases to trial.  Press has represented both defendants and plaintiffs in antitrust cases tried to verdict in federal courts. For example, he represented two North Carolina insurance company plaintiffs in a monopolization and conspiracy action in which the jury found liability on all claims after a seven-week trial ultimately resulting in a multi-million settlement for plaintiffs. Lawyers Title of North Carolina, Inc., et al. v. Investors Title Co. (U.S.D.C., M.D.N.C.). In another trial, he obtained  directed verdict in favor of a defendant-manufacturer on monopoly claims brought against it. Implus, Inc. v. Schering-Plough Healthcare Products, Inc. (U.S.D.C., M.D.N.C.). Among the clients Press has represented in antitrust litigation are Reebok International Ltd., Microsoft Corporation, Jefferson-Pilot Corporation, Mi

Alan J. Morrison is a member of Cooper & Dunham LLP based in New York. He specializes in biotechnology patent and transactional law, and has lectured internationally on various topics in U.S. patent law.

Jay Silver joined Kilpatrick Stockton’s Litigation Group in September 2000. With more than 20 years of trial experience, Mr. Silver concentrates his practice on commercial litigation, primarily intellectual property, business torts and ERISA fiduciary litigation. During his career, he has litigated a variety of multi-million dollar cases across the country. Mr. Silver has also been named to Business North Carolina’s 2003 “Legal Elite” list, recognizing him as one of North Carolina’s leading litigation attorneys.

Brian Slater is a partner in the New York office of Fitzpatrick, Cella, Harper & Scinto. He specializes in patent and trade secret litigation, as well as opinions and the intellectual property aspects of transactions.

Mr. Steffe counsels domestic and foreign clients in various matters involving biotechnology patent law. He has prepared and prosecuted patent applications in the areas of genomics, immunology, gene therapy, and molecular and cell biology. Further, he has prepared validity and infringement opinions, been involved in interferences, and has extensive experience managing patent portfolios for Biotech companies.

Richard P. Vitek, a partner with Myers Bigel Sibley & Sajovec, P.A., focuses his practice on patent litigation and includes other IP litigation, prosecution, and client counseling. Besides patent trial experience he has made several appearances before the Court of Appeals for the Federal Circuit briefing and arguing patent appeals.