Applied Statistics
Combination Products
Royal Sonesta Hotel
5 Cambridge Parkway
Cambridge, MA
Keywords: Combination Products, Cambridge Healthtech Institute

Schedule of Presentations:

Monday, June 1, 2009
10:45:00 Strategies using Combination Products
10:45:00 Creative Product Development, Portfolio Management, and Line ExtensionCreative Product Development, Portfolio Management, and Line Extension
10:50:00 Organizer’s Welcome and Chairperson’s Remarks Micah Lieberman
10:50:00 Introductory Remarks: Contemporary and Global Perspectives on Combo Product Lifecycle Management Makarand S. Jawadekar
11:00:00 The Renaissance In Pharma Fixed Combinations: Where are We Heading Next? John Ansell
11:30:00 Extending the Life of Blockbuster Products with Innovative Drug Combinations John Maki
13:20:00 Novel Therapeutics and Combinations – Technologies and Trends
13:25:00 Chairperson’s Remarks Anthony Ellery
13:30:00 Novel Antimicrobial Combinations in the Treatment of Resistant Bacterial Strains Kenneth E. Kovan
13:30:00 New Tech Presentation
13:50:00 New Tech Presentation
13:50:00 Stratified Medicine: Co-Development of Drug(s) and Theragnostic Test as Combination Products Vijay Ramakrishnan
14:10:00 Afternoon Refreshment Break
15:00:00 New Tech Presentation
15:05:00 Tiltan Pharma Anti-Angiogenic Drug-Combination to Treat Cancer Dan Goldstaub
15:20:00 Case Study-based UpDate on Current Trends and Innovation in Combination Products from Concept to Product: Increasing Productivity through the Latest in Research and Strategic Alliances Shobha Parthasarathi
15:20:00 New Tech Presentation
15:40:00 New Tech Presentation
15:40:00 Nano-Scale Ratiometric Dosing Systems for Combination Chemotherapy Lawrence Mayer
16:00:00 Informal Break-out Roundtables
16:00:00 Informal Break-out Roundtables
16:05:00 Coming into Compliance with Combination Product GMPs: How can companies effectively and efficiently address current FDA requirements for combination product GMPs? What regulatory ambiguities and pitfalls are facing manufacturers? Leah Kendall
16:10:00 Drug-drug Combinations in Hypertension: Are there still unmet needs and business opportunities? Anthony Ellery
16:15:00 Negative PR on Fixed Combinations: How can we forestall development? For example, could negative attitudes on Vytorin spread to a criticism of fixed combinations generally? What can we do about it? John Ansell
16:25:00 Best Practices for Performing Risk Assessment: How are small and large companies doing this? Gangadhar Sunkara
16:30:00 Structured vs. Intuitive Anti-cancer Combos at the Patients’ Bedside: Is Cancer a Feasible Area for Combo Products? Or, is it going to remain more a co-prescription than a fixed combination area? Dan Goldstaub
16:45:00 When Companies Need to Work Together on Combos, What Are the Best Modes for Doing So? John S. Patton
17:00:00 Differentiating Your Existing Drug Products: How do you utilize novel combos for near- and long-term lifecycle management? John Maki
17:00:00 Networking Cocktail Reception
18:00:00 Close of Conference Day
Tuesday, June 2, 2009
07:45:00 Morning Coffee (Breakfast Workshop Sponsorship Available)
08:00:00 Regulatory Implications – Anticipating Regulatory Hurdles and New Developments
08:20:00 Chairperson’s Opening Remarks Gangadhar Sunkara
08:45:00 FDA Regulatory Requirements: Update from the FDA Office of Combination Products BRADLEY MERRILL THOMPSON
09:15:00 Regulatory Strategy for Combination Products Chitkala Kalidas
09:45:00 The Market Advantage of Combination Products – Analysis and Strategies for Positioning
09:45:00 Coffee Break
10:30:00 Key Success Factors for Combination Products (patents; approvals; pricing and reimbursement; physician and patient acceptance) Anthony Ellery
11:00:00 Combination Products in Allergic Conjunctivitis: Lessons Learned from Asthma and Rhinitis Pierre Belichard
11:30:00 A Novel Therapeutic Area for Combination Drug: Serious Unmet Medical Needs of Polygenic and Multi-Factorial Complex Diseases Newell F. Bascomb
12:00:00 Luncheon Presentation (Sponsorship Available)
12:05:00 Commercial Strategies for Success – Market Acceptance and Reimbursement
13:40:00 Chairperson’s Opening Remarks John Ansell
13:45:00 P&T Committee Perspective: Economic and Therapeutic Imperatives for Fixed-Dose Combination Products and Combination Therapy Dean G. Smith
14:15:00 Co-Presentation: Better Practices in Marketing and Pricing Combination Products Wendy C. Goldstein, Kathleen A. Peterson
14:40:00 Development Challenges of Combination Products
14:45:00 War Stories: Combining a Drug and Device in the Development of Inhalation Products John S. Patton
15:15:00 Development Challenges of Combination Products: How Differences in Organizational Culture and Time Horizons Impact Combination Product Development Barry Sall
15:45:00 Closing Comments
16:00:00 Close of Executive Forum
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