FDAnews Announces — FDA’s New Clinical Biosimilars Guidance:Best Practices to Preparing a Successful 351(k) Application Webinar, June 27, 2014

Industry experts Kevin Nelson and Dr. Patrick Gallagher from Duane Morris LLP will use examples from leading companies that are currently attempting to demonstrate biosimilarity. In this session, attendees will learn the specifics of the FDA’s newest recommendations for showing that a proposed product is “highly similar” to a reference product, gain fuller understanding of the impact of the just-released clinical guidance, and get newly-updated ideas and strategies based on the recent guidance for how to file 351(k) applications.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) June 20, 2014

FDA’s New Clinical Biosimilars Guidance:
Best Practices to Preparing a Successful 351(k) Application
**FDAnews Webinar**
June 27, 2014 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/ClinBiosimilars

Industry experts Kevin Nelson and Dr. Patrick Gallagher from Duane Morris LLP will use examples from leading companies that are currently attempting to demonstrate biosimilarity.

In this session, attendees will learn the specifics of the FDA’s newest recommendations for showing that a proposed product is “highly similar” to a reference product, gain fuller understanding of the impact of the just-released clinical guidance on the original legislation, and get newly-updated ideas and strategies based on the recent guidance for how to file 351(k) applications.

Attendees will learn how, with the new guidance, the FDA’s thinking about clinical requirements for demonstrating biosimilarity is evolving. During the FDA’s New Clinical Biosimilars Guidance webinar attendees will gain:

  •     An understanding of the biosimilars application pathway, including the statutory requirements for an approvable application
  •     Insight into how the FDA’s thinking on the clinical requirements for showing biosimilarity has begun to evolve with the 2014 clinical guidance
  •     7 tips for preparing the application in view of the new guidance
o    Plan and talk with FDA early and often
o    Address FDA’s key concepts with details
o    Choose the correct assays and biomarkers
o    Demonstrate “safety first”: a safety and immunogenicity showing is necessary
o    Be creative in the proof: foreign data, simulation or predictive data
o    But justify creativity
o    Plan evolution/flexibility: step-wise approach means the plan may evolve
  •     Implementing these 7 tips in preparing an approvable 351(k) application through the use of the Biological Product Development Program (BPDP)
  •     An understanding on how to use the inter partes review (IPR) process to tackle patent barriers and to lessen the patent litigation budget

Attendees will also be introduced to the 4 areas in the new guidance that are most likely to be of significant value in filing:

1.    3 key concepts that are most relevant in the FDA's review of applications: exposure and response assessment, evaluation of residual uncertainty, and analytical quality and similarity

2.    3 key assays that the FDA deems “particularity important”: ligand binding assays, concentration and activity assays, and PD assays

3.    Use of foreign reference products and the need for bridge studies

4.    How modeling and simulation tools can be useful for designing PK and/or PD studies

Hear from top thought leaders on this critical topic. Attend FDA’s New Clinical Biosimilars Guidance: Best Practices to Preparing a Successful 351(k) Application on June 27, 2014.

Meet the Presenters:
Kevin Nelson is a partner in the Intellectual Property Practice Group of the international law firm, Duane Morris LLP. For 14 years, Mr. Nelson has represented generic companies exclusively in Hatch-Waxman litigation and related matters, and has been lead trial counsel and has argued before the Court of Appeals for the Federal Circuit.

Dr. Patrick Gallagher is an associate in the Intellectual Property Practice Group of Duane Morris. Dr. Gallagher has been involved in all aspects of Hatch-Waxman practice, including advising on Abbreviated New Drug Application filings, development of non-infringement and invalidity arguments for FDA-required notice letters, and in every phase of litigation through trial and appeal to the Federal Circuit Court of Appeals.

Who Will Benefit:

  •     Drug companies
  •     Biotech companies
  •     Contract research organizations
  •     Testing laboratories    

Webinar Details:
FDA’s New Clinical Biosimilars Guidance:
Best Practices to Preparing a Successful 351(k) Application
**FDAnews Webinar**
June 27, 2014 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/ClinBiosimilars

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/ClinBiosimilars    
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.