DAY ONE Monday, June 1, 2009
7:45 AM Pre-Conference Workshop Registration and Early Conference Registration
Pre-Conference Workshop*
8:30-10:45 AM
Economic Value-Based Product Design for Combination Drugs
Mr. Gill Eapen, MS, MBA, CFA, Managing Principal, Decision Options, LLC
Jennifer Miller, Executive Director, Pharmaceutical Sciences, Pfizer
R&D programs in pharmaceuticals show high levels of uncertainty and design flexibility in costs, timelines, risks and market potential. The design of such programs need to consider uncertainty and flexibility to impute an economic value. The economic value allows decision makers select and design programs as well as manage a portfolio. Using a case study on decisions made on a combination drug, this paper demonstrates the use of decision options in selection and design.
- How decision options interact with technical decisions in R&D
- What tools exist in this area for practical applications in your businesses
- Understand technical and regulatory risks specific to combination product decision making
- Take this understanding directly to applications in their organizations
The case study will also investigate the economics between two separate drugs and the combination product. The uncertainties in costs, timelines, risks and market potential as well as the decision flexibility provided by the two differing strategies are analyzed in a holistic framework of normative economics to reach better selection decisions. Same methodology then is used to design the R&D, manufacturing and marketing programs so as to maximize economic value to the company.
* Separate registration is required.
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10:45 End of Pre-Conference Workshop, Beginning of Main Conference
10:50 Organizer’s Welcome and Chairperson’s Remarks
Micah Lieberman, Executive Director, Conferences, Pharmaceutical Strategy Series, CHI
Introductory Remarks: Contemporary and Global Perspectives on Combo Product Lifecycle Management
Makarand S. Jawadekar, Ph.D., Director, Portfolio Management and Performance, Pfizer
Perspectives on developing ‘Combination Products’ and its role in “Product Life Cycle management”
Fixed Dose Combination products especially for the ‘Established Products’ Group
Challenges & Opportunities
11:00 The Renaissance In Pharma Fixed Combinations:
Where are We Heading Next?
John Ansell, President, John Ansell Consultancy
This presentation will offer an overview of recent progress of fixed combinations and serve as an orientation for the rest of the conference. The presentation will provide a broad commercial perspective on pharmaceutical-pharmaceutical fixed combinations and will focus on:
Reasons for recent successes and failures
You can formulate it - but what does it bring to the market?
Key issues emerging
Reaching saturation levels - in the most popular markets, how much room is there for me-too combinations?
Repurposing - likely to get off the ground?
Likely threats and opportunities
Vytorin’s progress - impact on attitudes generally to fixed combinations?
How fixed combinations make inroads in undeveloped markets (e.g.diabetes).
11:30 Extending the Life of Blockbuster Products with Innovative Drug Combinations
John Maki, President and Chief Executive Officer, Vicus Therapeutics
Over $100 billion worth of blockbuster product sales will be going off-patent and thus will be subject to generic incursion between 2008 to 2012. Traditional lifecycle management strategies have included reformulated, fixed-dose-combinations (“FDCs”) of drugs already approved for the same indication. While the US has generally been the prime market for such reformulated products, payors are increasingly looking to reduce costs and physicians are becoming more cynical regarding the compliance advantages such line extensions bring to patients. Consequently, traditional FDCs may find it harder to achieve high uptake and to protect the brand franchises. Recently, several venture-backed companies have pursued a strategy of developing innovative FDCs comprised of a repurposed-drug outside of a therapeutic area of a blockbuster product. This strategy offers the potential to create significant proprietary therapeutic value beyond that of the blockbuster by itself, while benefiting from the lower risks and accelerated development timeframe of the 505(b)(2) regulatory pathway. In addition, the Patent and Trade Office and the European Patent Office have recently granted composition-of-matter and method-of-use patent claims to such product candiDate. This session reviews examples and benefits of innovative drug combinations to extend the life of blockbuster products and discusses methods used by several start-up companies to identify and develop such candiDate.
Analyze the potential of innovative repurposed-drug combinations
Identify and develop innovative repurposed-drug combinations
Assess the approach through case study examples
12:00 PM Luncheon Presentation (Sponsorship Available. Please contact Arnie Wolfson at +1.781.972.5431, awolfson@healthtech.com.) or Lunch on Your Own
1:25 Chairperson’s Remarks
Anthony (Tony) Ellery, Ph.D., former Global Head, Mature Products and Lifecycle Management, Novartis; CEO, ellery pharma consulting
1:30 New Tech Presentation
Novel Antimicrobial Combinations in the Treatment of Resistant Bacterial Strains
Kenneth E. Kovan, CEO & President, Chaperone Technologies Inc.
Chaperone Technologies Inc. develops first-in-class antimicrobials and other drugs that work by targeting bacterial [or mammalian] hsp70 proteins. The company has a reproducible discovery capability that is providing a sustainable pipeline of unique drugs. The company has identified and synthesized libraries of novel low weight peptide and small molecule hsp70 (e.g. DnaK) inhibitor antimicrobial candiDate, with our unique understanding of hsp70 inhibition coming from broad biochemical data, a solid understanding of structural - activity relationships, and extensive molecular modeling. Chaperone is advancing clinically beneficial antimicrobial approaches using our compounds in combination with quinolones and other antimicrobials, where we have achieved significant antimicrobial synergy across a range of pathogens. Synergistic combinations of novel technologies with existing single agent antimicrobials should allow the use of lower concentrations of drugs in combination and thus diminish the incidence of dose-related antibiotic toxicity, and impart significant clinical and commercial benefit, including new life cycle management options and extending intellectual property protection for existing brands. The audience will gain an understanding of new antimicrobials technology which is being developed for drug resistant bacterial pathogens and the clinical/commercial benefits of combination antimicrobial use.
1:50 New Tech Presentation
Stratified Medicine: Co-Development of Drug(s) and Theragnostic Test as Combination Products
Vijay Ramakrishnan, Ph.D., Founder and CEO, Pikamab, Inc.
One-size-fits-all approach does not work as response rates can be low for many drugs. Regulatory agencies and healthcare providers will soon embrace the ‘pay for performance’ model such that therapies are expected not only to be efficacious but also to have acceptable safety and toxicity profiles in each patient. Stratifying patients into distinct groups based on clinically relevant genetic markers, and developing customized therapies [Drug-Theragnostic Test combination products] for each patient group could be a rational solution to achieve this goal.
2:10 Afternoon Refreshment Break
3:00 New Tech Presentation
Tiltan Pharma Anti-Angiogenic Drug-Combination to Treat Cancer
Dan Goldstaub, Ph.D., Chief Operating Officer, Tiltan Pharma
Anti-angiogenic therapy is one of the most promising strategies to treat cancer. Angiogenesis is a multi-faceted process. Therefore, Tiltan has developed a combination of well-characterized FDA-approved drugs, currently used for other indications. This combination, simultaneously targets non-overlapping aspects of the angiogenic process, is administered orally as a unit dosage-form. It is composed of (1) an NSAID,(2) a Histamine-Receptor-Blocker,(3)NF-kappa inhibitor and (4)a mild cytotoxic agent. It was tested in over 150 patients and preliminary safety, efficacy and tolerability data were encouraging. Consequently, a phase-IIb trial in prostate cancer is launched. Such a drug-combination should be a candiDate for approval via the 505(b)(2) regulatory path.
Tiltan Pharma is using a combination of drugs, approved for other indications, in order to treat cancer, showing that novel combinations can teach old molecules new tricks.
3:20 New Tech Presentation
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, Ph.D., Technology Development Director, Business and Technology Development Program, North Carolina Biotechnology Center
Several key case studies from academic research and private sector development in combination products will be presented. The case studies will be representative of technology development across the State of North Carolina. Resources and trends for early commercialization of technology will also be presented. The proposal will capture trends and innovation in this field and will be across multiple disciplines in its scope.
Share upDate on combination product development and commercialization across the State
Review the latest in research and technological trends from member companies
Offer examples of strategic alliances increasing productivity
3:40 New Tech Presentation
Nano-Scale Ratiometric Dosing Systems for Combination Chemotherapy
Lawrence Mayer, Ph.D., President and Head of Research, Celator Pharmaceuticals
Cancer chemotherapy treatments typically employ drug combinations in which each agent is pushed to the maximum tolerated dose. However, emerging evidence indicates that anticancer drug combinations can act synergistically or antagonistically against tumor cells depending on the ratios of the individual agents comprising the combination so that the optimal combination may not be based on maximum tolerated doses. We have utilized nano-scale drug delivery vehicles to translate such in vitro information on synergistic drug ratios into improved anticancer products based on maintaining synergistic drug ratios in patients to achieve markedly improved efficacy. This “ratiometric” approach to treatment opens new opportunities to enhance the effectiveness of existing and future combination regimens for cancer and other complex human diseases.
Understand the pharmacological impact that drug ratio-dependent synergy can have on combination treatments
Examine technical means whereby drug ratio information obtained in vitro can be translated into more effective pharmaceutical combination products
Clinical and regulatory implications of this approach will also be presented
4:00 Informal Break-out Roundtables
ROUNDTABLE DISCUSSIONS
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4:00 Informal Break-out Roundtables
Attendees will join a table with their peers and a moderator to discuss some of the more pertinent questions facing the industry. It’s an informal yet informative format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive session and format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
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, Senior Associate, Health Care and Life Sciences Practice, Epstein, Becker & Green, P.C. Drug-drug Combinations in Hypertension: Are there still unmet needs and business opportunities?
Anthony (Tony) Ellery, Ph.D., former Global Head, Mature Products and Lifecycle Management, Novartis; CEO, ellery pharma consulting 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, President, John Ansell Consultancy Best Practices for Performing Risk Assessment: How are small and large companies doing this?
Gangadhar Sunkara, Ph.D., MBA, Associate Director, Exploratory Development, Novartis 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, Ph.D., Chief Operating Officer, Tiltan Pharma When Companies Need to Work Together on Combos, What Are the Best Modes for Doing So?
John S. Patton, Ph.D., former Co-Founder and Chief Research Fellow, Nektar Therapeutics; Founder and President, Dance Pharmaceuticals Differentiating Your Existing Drug Products: How do you utilize novel combos for near- and long-term lifecycle management?
John Maki, President and Chief Executive Officer, Vicus Therapeutics &
Makarand S. Jawadekar, Ph.D., Director, Portfolio Management and Performance, Pfizer
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5:00 Networking Cocktail Reception
6:00 PM Close of Conference Day
DAY TWO, Tuesday >