Institute for International Research

PRE-EVENT SYMPOSIA: MONDAY, SEPTEMBER 17, 2007

7:45 Workshop Registration and Morning Coffee
8:30 Full Day Symposia and Morning Workshop Begins
10:00 30-minute Refreshment Break
12:30 - 1:30 Luncheon for Full Day and Morning Workshop Attendees; Registration Opens for Afternoon Workshop
1:30 Afternoon Workshop Begins
2:30 30-minute Refreshment Break
5:00 Afternoon Workshop Concludes

FULL DAY SYMPOSIUM

  GENERIC BIOLOGICS: Understanding the Scientific, Legal, Regulatory, Economic and Marketing Implications

Biological generics have been distributed for well over a decade around the globe. The EU has had legislation in place since 2002 for "biosimilars" and the first "biosimilar" was approved last year. FDA and Congress are moving forward in bringing these products to US patients. The development, marketing, branding, and pricing for biological generics are different than chemical generics. This symposium will provide an understanding of the scientific and regulatory aspects of biological products; how these factors translate into requirements for the development of biological generics; and the economic conditions, marketing style, and the role of patents to successfully market a product. The recent political developments will be debated the next morning at the Generic Drug Summit. The overview that this symposium provides will allow attendees to better understand the issues as policy evolves in the US.

Overview
Suzanne M. Sensabaugh, VP, Biopharmaceutical Development, MDS Pharma Services

Analytical and Molecular Characterization
Russ Blacher, Senior Director, Biopharmaceutical Development MDS Pharma Services

Manufacturing Process
Yashwant Deo, PhD, President & CEO, Avigenics

Preclinical Development 
Lena King, PhD, DABT, Director, Drug Development, MDS Pharma Services

Bioassays
Chris Beaver, PhD, Director, Bioanalysis, MDS Pharma Services

Clinical development
Suzanne M. Sensabaugh, VP, Biopharmaceutical Development, MDS Pharma Services

Regulatory
Candis Edwards, SVP, RA/Compliance, Interpharm

Immunogenicity Risk Assessments
Suzanne M. Sensabaugh, VP, Biopharmaceutical Development, MDS Pharma Services

Patents
Marc Goshko, Executive Director, Legal, Teva Pharmaceuticals

Economics
Henry Grabowski, PhD, Duke University

Marketing
James Harris, AS Biotech

About Our Distinguished Symposium Chairperson:
Suzanne M. Sensabaugh is VP, Biopharmaceutical Development, MDS PHARMA SERVICES, where she is responsible for managing and directing the consulting group in Development & Regulatory Services and providing professional guidance to clients. Prior to this position, she was VP, Regulatory Affairs, and Senior Director for Global Biogenerics, Teva Pharmaceutical Industries Ltd., where she developed regulatory strategy and submissions for biotechnology products. She has more than 10 years of experience at the FDA/CBER as a researcher, product reviewer, and inspector for biologics. She also was involved in the development and implementation of SOPs, Guidance, regulations, and laws. Prior to leaving the Agency, she was Special Assistant to the Associate Director of Policy, Office of the Center Director. She has experience in the industry as Associate Director, Regulatory Affairs, at Genzyme Corporation where she directed, planned, and implemented global regulatory activities, and as VP, RA & Quality, SICOR Inc., Biotechnology Division, where she was responsible for global regulatory affairs, quality assurance and control. Ms. Sensabaugh is the industry representative to numerous scientific committees and the ICH. She received her MBA from Duke University, MS in Biotechnology from Johns Hopkins University, and BS in Zoology from the University of Maryland.

MORNING WORKSHOP
 Strategies for Filing Successful Paragraph IV Certifications

Under Hatch-Waxman, companies can seek approval to market a generic version of a patented brand drug before the patent covering the brand drug expires. The first company to file an ANDA with the FDA gains the exclusive right to market the generic drug for 180 days - an important financial advantage in a tremendously competitive marketplace. The generic applicant must certify that either the product described in its ANDA does not infringe, or that the patent is invalid. This is known as "Paragraph IV Certification." Our legal expert takes you through the nuts and bolts of Paragraph IV certifications in an interactive workshop format.

What You Will Learn:

• Purpose of Paragraph IV certifications and Notice Letters
  
• Background of Hatch-Waxman
  
• Orange Book listings
  
• Types of Certification Letters
  
• Benefits of First to File
  
• 30-month stays and 180-day exclusivity period
  

Requirements and Strategies for Paragraph IV certifications and

Notice Letters

• Minimum Statutory Requirements
  
• Timing of Submissions and Notice
  
• Offering Additional Information to Patent Holder Effect of Certification and Notice Letters on Litigation
  
• Use of Certification and Notice Letters at Trial
  
• Difference between opinion letters and notice letters
  
• Willful Infringement and Privilege issues
  
• Pre-Launch Litigation v. Post Launch Litigation Recent developments in the Law

About Our Distinguished Workshop Leader:
Richard Basile is a member of the firm St.Onge Steward Johnston & Reens LLC. He has an extensive patent litigation practice with an emphasis on counseling and representing generic drug companies in Hatch-Waxman cases. He has successfully represented generic drug companies at both the trial and appellate levels and has written numerous patent opinions, notice letters and certification letters.

  Understanding How to Submit Quality ANDAs based on QbR to Reduce Approval Time

An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. This updated workshop provides an overview of the ANDA process including the components of an ANDA, as well as potentially problematic issues sometimes raised by FDA reviewers. Understand FDA expectations and learn why FDA submission approvals and corporate quality go hand in hand. Learn how quality submissions can reduce approval time and favorably impact your company's bottom line.

What You Will Learn:

• Tips for communicating with FDA
  
• The role preparation plays in beating the clock
  
• Common mistakes made during an ANDA submission
  
• Strategies for eSubmissions

About Our Distinguished Workshop Leader:
Candis Edwards, Senior Vice President, Regulatory Affairs & Compliance, INTERPHARM has over twenty years of experience in Regulatory Affairs, Research and Development, Project Management, Quality Assurance, cGMP Compliance and Quality Control. In her former role as Vice President of Regulatory Affairs at Clay-Park Labs, Inc., a generic topical drug manufacturer located in New York, Ms. Edwards had responsibility for establishing regulatory strategies for submission, approval and postapproval support of all products requiring FDA approval.