2014 Archived Content
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Wednesday, October 29
7:50 am Breakout Discussions with Continental Breakfast
Regulatory Environment in Antibiotic Development
Barry Eisenstein, M.D., Senior Vice President, Scientific Affairs, Cubist Pharmaceuticals Editor, Antimicrobial Agents and Chemotherapy
Topics to be discussed:
- Making Trials more feasible
- The value of rapid, point-of-care diagnostics
- Aligning the PI with the greatest medical needs
NIH Support for Antibacterial Research and Development
Rosemarie Aurigemma, Ph.D., Chief, Drug Development Section, DMID, NIAID
Topics to be discussed:
- Support for Basic Research
- Support for Product Development
- Support for Clinical Testing
Market Access and Pricing for Antibiotics
Carl Foster, Executive Vice President, Business Development, Cempra Pharmaceuticals
Topics to be discussed:
- Developing convincing value proposition for antibacterials
- Addressing payer needs in clinical development programs
- Building strong global pricing strategy for optimal market access
8:50 Chairperson’s Remarks
Christopher-Paul Milne, Ph.D., Director, Research, Tuft CSDD, Tufts University School of Medicine
9:00 Change and Challenge in the Global Marketplace for Infectious Disease
Christopher-Paul Milne, Ph.D., Director, Research, Tufts CSDD, Tufts University School of Medicine
This presentation will discuss three basic aspects of the evolving infectious disease marketplace. The first is how does the R&D pipeline for infectious diseases match up to the unmet medical needs in mature, emerging, and next wave markets? The second is to consider whether R&D incentive programs have created viable markets for infectious disease treatment and prophylaxis in the US and other mature markets. Lastly, we will look at the influence patients, public health and political stakeholders have on payer decision-making for pricing and reimbursement in the infectious disease marketplace?
9:30 Improving the Economics in the Antibiotic Market
Timothy D. Hunt, Senior Vice President, Public Affairs, Cubist Pharmaceuticals
10:00 Coffee Break with Exhibit and Poster Viewing
10:30 Early Pricing Planning and Negotiations for a Product in Clinical Development: Why Antibiotics Are Different than Other Therapeutic Areas
Carl Foster, Executive Vice President, Business Development, Cempra Pharmaceuticals
Building a global value dossier is a process that often gets little attention until NDA approval. However, to maximize pricing and market access, these activities should be run in parallel to late-stage clinical trials. Data collection to support pricing efforts can be built into the clinical trial protocols. This case study will illustrate global market access preparations in support of product launch for a new macrolide antibiotic to treat community acquired pneumonia.
11:00 New Business Models for Antibacterials
Kevin Outterson, J.D., Visiting Fellow, Chatham House, Professor, Law, Health Law, Bioethics and Human Rights, Boston University School of Law
The existing business model for antibiotics is broken, but it is unclear what should replace it. GAIN and NTAP payments in Medicare are unlikely to be enough to boost development and ensure responsible use, especially for drugs specifically targeting MDR gram negative pathogens. Important parts of the equation will include non-dilutive capital in phases II and III, perhaps on an orphan drug model, as well as enhanced reimbursement based on value. The key question for appropriate use is whether revenues should be delinked from volume. The speaker will discuss how these issues are being addressed in the ongoing Chatham House working group.
11:30 pm Panel Discussion: Market Access Strategies for Antibiotics
Moderator:Christopher-Paul Milne, Ph.D., Director, Research, Tufts CSDD, Tufts University School of Medicine
Panelists: Speakers of the Session
John Rex, M.D., Vice President and Head, Infection, Global Medicines Development, AstraZeneca
12:30 Enjoy Lunch on Your Own
1:30 Chairperson’s Remarks
Chi Bahk, Project Manager, Epidemico
1:40 Digital Disease Detection for Antibiotic Resistance
Chi Bahk, Project Manager, Epidemico
Explore how technologies like natural language processing and machine learning algorithms can be used to detect cases of antibiotic resistance. Thousands of online sources are aggregated then signal is seperated from noise. The backend design, sources, taxonomy, visualizations, and technology will be discussed along with how it can be modified for various geographic regions or diseases.
2:10 Partnering and Working with BARDA
Melissa Stundick, Ph.D., Acting Branch Chief, BARDA’s Broad Spectrum Antimicrobial Program
The Biomedical Advanced Research and Development Authority’s (BARDA) Broad Spectrum Antimicrobial (BSA) Program seeks to advance candidate antibacterial drugs in development to address the threat of antimicrobial resistance. BARDA’s BSA program utilizes novel, innovative partnering mechanisms to strategically invest in antibacterial drug development to enhance the pipeline of candidate therapies. This session will provide an overview of BARDA’s BSA program, highlight investments made to date, and provide insight into how to approach potential partnerships.
2:40 Panel Discussion: What Are Actual Investors Looking For?
Panelists:
Ankit Mahadevia, M.D., Atlas Ventures
Vikas Goyal, SR One
Kush M. Parmar, M.D., Ph.D., 5AM Ventures
3:30 pm End of Conference
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