DAY TWO TUESDAY, JUNE 2, 2009
7:45 AM Morning Coffee (Breakfast Workshop Sponsorship Available)
8:20 Chairperson’s Opening Remarks
Gangadhar Sunkara, Ph.D., MBA, Associate Director, Exploratory Development, Novartis
8:45 FDA 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
To be compliant and competitive in the marketplace, combination product companies must stay current with regulatory developments and initiatives impacting the combination product industry. This presentation will upDate participants on key developments in FDA’s regulation of combination products, including Good Manufacturing Practices for combination products, adverse event reporting requirements, and technology-specific developments. We’ll also examine where FDA may be headed next and how the agency’s future direction could impact the industry.
9:15 Regulatory Strategy for Combination Products
Chitkala Kalidas, Director, Worldwide Regulatory Affairs, Merck & Co.
9:45 Coffee Break
10:30 Key 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
With drug pipelines too weak to replenish product portfolios depleted by patent expiries, companies turn increasingly to lifecycle management. Combination products play an important role here, and can revitalize sales of existing brands. They can also be valuable earlier in the brand life cycle, for reducing pill burden, increasing compliance and reducing side effects. But some companies are placing too much reliance on combination products as a way of compensating for a lack of R+D innovation. This presentation will examine the factors which determine whether a combination strategy will be successful, from a variety of viewpoints, including:
Development
Regulatory
Patent
Patient
Physician
Payor
Thus, this presentation is designed to help participants to evaluate the viability of the combination strategies planned for their own projects and products, and how to optimize those strategies.
11:00 Combination Products in Allergic Conjunctivitis: Lessons Learned from Asthma and Rhinitis
Pierre Belichard, COO, Fovea Pharmaceuticals
New classification of upper respiratory tract allergy “intermittent vs. persistent” has drastically changed both therapeutic practice and market dynamics in Asthma and Rhinitis allowing for widespread use and commercial success of combination therapies. This approach has now to be properly integrated in the ocular conjunctival field. Fovea is developing a series of combination drugs in this field to address this open market.
11:30 A Novel Therapeutic Area for Combination Drug: Serious Unmet Medical Needs of Polygenic and Multi-Factorial Complex Diseases
Newell F. Bascomb, Chief Operating Officer, Vicus Therapeutics
Fixed Dose Combinations (“FDCs”) have traditionally been viewed as one of the most attractive life-cycle management options to extend the patent life and maximize the commercial returns of branded drug products. FDCs can also be viewed as a potential new class of multi-targeted therapeutics. FDCs have the unique potential to address serious unmet medical needs of polygenic and multi-factorial complex diseases that are not amenable to mono-targeted intervention. This session will review the scope of the opportunity for this new class of multi-targeted therapeutics and provide a case study of the steps used to discover and develop VT-122. VT-122 is a promising Phase 2, multi-targeted, FDC drug candiDate for the treatment of cancer cachexia, a complex, debilitating muscle wasting condition with no FDA-approved therapy.
12:00 PM Luncheon Presentation (Sponsorship Available. Please contact Arnie Wolfson at +1.781.972.5431, awolfson@healthtech.com.) or Lunch on Your Own.
1:40 Chairperson’s Opening Remarks
John Ansell, President, John Ansell Consultancy
1:45 P&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
The numbers and percentage of patients utilizing multiple therapies are high and increasing. The therapy may well be worthwhile, but there is a real concern that the costs of multiple medications and adherence to complicated regimens may detract from value. Thus, fixed-dose combination therapy may work well towards cost and compliance – but only if combinations can convince P&T committees first and get adopted. Many of the fixed combinations proposed to committee are priced at more than the sum of the two items separately, which puts the applicant at a strategic disadvantage. If manufacturers are going to really sell combo therapy, it had better be less expensive or lead to improved compliance (value). This talk will address this key issue and suggest clear advice on how to approach P&T committees.
Understand polypharmacy from a managed care perspective
Understand factors affecting patient adherence
Use pharmacoeconomic decision-making principles
2:15 Co-Presentation: Better Practices in Marketing and Pricing Combination Products
Wendy C. Goldstein, Shareholder, Chairperson of the Pharmaceutical Industry Health Regulatory Practice Group, Epstein Becker & Green, P.C.
Kathleen Peterson, Senior Associate, Health Care and Life Sciences Practice, Epstein Becker & Green, P.C.
Those who market and sell combination products must often navigate complex Federal and State marketing and pricing requirements. Applying these requirements to combination products can be challenging in light of the multiple components comprising combination products. This presentation will help participants understand how Federal and State law marketing and pricing requirements apply to combination products and what best practices companies are using to ensure compliance with these laws and regulations. Specific issues will include:
State law marketing reporting
Potential Federal reporting requirements
Part D coverage issues
Medicaid Drug Rebate implications
Average Sales Price considerations
2:45 War Stories: Combining a Drug and Device in the Development of Inhalation Products
John S. Patton, Ph.D., former Co-Founder and Chief Research Fellow, Nektar Therapeutics; Founder and President, Dance Pharmaceuticals
Inhalation delivery systems are some of the most challenging device/drug combination products to develop. Reliably producing standard aerosol doses that reproduceably deposit in the lungs of a huge variety of different patient types and sizes, in a low cost and convenient inhaler, has not been easy. Fortunately new innovations in the past 10 years are making development of inhalation delivery systems much easier.
Off the shelf systems preferred by far
Formulations need to be co-developed with the device
New powder technologies can eliminate a lot of device challenges
Efficacy and safety can trump device size
3:15 Development Challenges of Combination Products: How Differences in Organizational Culture and Time Horizons Impact Combination Product Development
Mr. Barry Sall, RAC, Principal Consultant, Integrated Product Development, PAREXEL Consulting
Device and pharma companies often have quite different organizational cultures and business objectives. This session will discuss areas where diverse team members will need to bridge gaps and adapt to new priorities in order to generate a successful combination product.
All parties involved with the development of a combination product must understand the priorities of the other participants.
Attendees with a pharma background will gain an understanding of device industry product development regulatory and business expectations and attendees from the device industry will gain an understanding of the pharmaceutical industry approach to product development.
3:45 Closing Comments
4:00 PM Close of Executive Forum
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