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Combination Products

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!

  

Featured Presentations:

John AnsellThe Renaissance in Pharma Fixed Combinations: Where Are We Heading Next?

John Ansell, President, John Ansell Consultancy

 

 

 

 

John MakiExtending the Life of Blockbuster Products with Innovative Drug Combinations

John Maki, President and Chief Executive Officer, Vicus Therapeutics

 

 

 

 

John PattonWar Stories: Combining a Drug and Device in the Development of Inhalation Products

John S. Patton, Ph.D., Co-Founder and former Chief Research Fellow, Nektar Therapeutics; Founder and President, Dance Pharmaceuticals

 

 

 

 

Mak JawadekarContemporary and Global Perspectives on Combo Product Lifecycle Management

Makarand S. Jawadekar, Ph.D., Director, Portfolio Management and Performance, Pfizer

 

 

 

 

Tony ElleryKey Success Factors for Combination Products (patents; approvals; pricing and reimbursement; physician and patient acceptance)

Anthony (Tony) Ellery, Ph.D., former Global Head, Mature Products and Lifecycle Management, Novartis; CEO, ellery pharma consulting

 

 

 

 

Dean SmithP&T Committee Perspective: Economic and Therapeutic Imperatives for Fixed-Dose Combination Products and Combination Therapy

Dean G. Smith, Ph.D., Professor and Senior Associate Dean, Health Management & Policy, School of Public Health, University of Michigan

 

 

 

 

Chitkala KalidasRegulatory Strategy for Combination Products

Chitkala Kalidas, Director. Worldwide Regulatory Affairs, Merck & Co.

 

 

 

 

Brad ThompsonFDA Regulatory Requirements: UpDate from the FDA Office of Combination Products

Bradley Merrill Thompson, Shareholder, Health Care and Life Sciences Practice, Epstein, Becker & Green, P.C.; General Counsel to the Combination Products Coalition

 

Sessions:

  • Creative Product Development, Portfolio Management, and Line Extension Strategies using Combination Products
  • Regulatory Implications – Anticipating Regulatory Hurdles and New Developments
  • The Market Advantage of Combination Products – Analysis and Strategies for Positioning
  • Commercial Strategies for Success – Market Acceptance and Reimbursement
  • Develop Challenges of Combination Products

 

INTERACTIVE BREAKOUT ROUNDTABLES:

Discuss the Issues with a Small Group of Your Peers

 

NEW TECH PRESENTATIONS:

Novel Therapeutics and Combinations – Technologies and Trends

 

PRE-CONFERENCE WORKSHOP

Economic Value-Based Product Design for Combination Drugs


New! From the Office of Combination Products
Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors
Intended for Use with Drugs and Biological Products 


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