12:30-1:30 pm Conference Registration
1:30 Chair’s Opening Remarks
Ken Gustavsen, Ph.D., M.B.A., Director, Global Product Donations, Office of Corporate Responsibility, Merck
1:40 Operational Lessons Learned through 20+ Years of the MECTIZAN Donation Program
Ken Gustavsen, Ph.D., M.B.A., Director, Global Product Donations, Office of Corporate Responsibility, Merck
In 1987, Merck initiated the MECTIZAN Donation Program (MDP), committing to donate its anti-parasitic drug MECTIZAN, as much as necessary for as long as necessary, until onchocerciasis (river blindness, or RB) is eliminated as a public health problem. In 1998, Merck expanded the commitment to include the elimination of lymphatic filariasis (LF) in African countries where RB and LF are co-endemic. With valued input from governments, NGOs, local communities, finance partners, and academic and scientific experts, key improvements have been made in the drug supply chain and drug presentation; dosing determination methods; disease surveillance and community-level distribution approaches; and general partnership issues. As a result, the program has enjoyed steady growth, and recent studies indicate the possibility of eliminating the transmission of both RB and LF in many endemic regions. Additionally, newer programs to control and eliminate other tropical diseases have drawn on the MDP’s experiences to create robust, effective partnerships.
2:10 Pyrazinamide Analogs: An Example of the Difficulties for New TB Drug Development
Michael Cynamon, M.D., Department of Medicine, SUNY Upstate Medical University
The development of new anti-tuberculosis agents is complicated by both scientific and commericial issues. Pyrazinamide analogs with enhanced in vitro activities have been extensively studied, yet there has been little interest in commerical development of these structures. Examples of other contemporary anti-infectives will be discussed to explore difficulties with development of new anti-tuberculosis agents.
2:40 From Clinical Research to Clinical Drug Development to Drug Regimen Development: The Case of TB Drugs
Jan Gheuens, M.D., Ph.D., Senior Program Officer, Tuberculosis, Global Health Program, Infectious Diseases, Bill and Melinda Gates Foundation
Current TB drugs are 40 years old, and much clinical research has been done to optimize their use, but no new drugs have been developed. We do see an increase in TB drug R&D activities, and a worldwide pipeline that has a number of promising new TB drug candidates in pre-clinical or clinical development. Moreover, there is a broad awareness that we do not only need new TB drugs; we need new TB drug regimens. If done traditionally, it would take decades to develop new regimens, because the drugs would be approved individually first before they would be tested in combination. However, a new initiative aims to accelerate the development of new TB drug regimens by testing novel combinations before the drugs are individually approved. This initiative, which is called the “Critical Path to TB Drug Regimens”(CPTR) is a innovative public-private partnership that is formed to address this challenge.
3:10 Networking Refreshment Break, Poster and Exhibit Viewing
3:45 The Essential role of Public-Private Partnerships in Neglected Diseases
Prof. Patrick Nef, Ph.D., Chief Business Officer, Medicines for Malaria Venture (MMV)
Ensuring the discovery, development and dissemination of novel, safe, efficacious and affordable treatments for the neglected disease Malaria in developing countries is the core mission at Medicine for Malaria Venture (MMV). The product-development partnership model for a major global health impact has been initiated 10 years ago and the successes and lessons-learned will be discussed. The MMV partnering and funding strategies to defeat malaria can now be extrapolated to other neglected diseases. In particular, open R&D innovation, IP and in-kind contributions by our pharmaceutical partners are now becoming gold standards.
4:15 The Global Health Accelerator: A New Model to Support and Expand Emerging Economies’ Private-Sector Capabilities in Addressing Neglected Diseases
Beatrice Sequin, Ph.D., Assistant Professor, Leslie Dan Faculty of Pharmacy; Program Leader, Commercialization in Emerging Economies, McLaughlin-Rotman Centre for Global Health, University Health and University of Toronto
Local solutions to health challenges in the developing world are vital if we are to overcome the neglect of research into diseases affecting the world’s poor. Research has shown that for major pharmaceutical firms, innovation is driven by a combination of the size of a potential market and the income level of a potential market. Since income levels are low in the developing world, most innovation investment by major pharmaceutical firms is targeted at health concerns in the advanced economies where consumers are able to pay prices that ensure a profit. The Global Health Accelerator (GHA) would help Southern firms get their products from the lab to the market. It would create a virtual platform to connect a diverse international community of scientists, entrepreneurs and financiers focused on finding solutions to the diseases of the South, with the added goal of building core strengths, capabilities and companies in the South. The GHA model will be presented.
4:45 Breakout Roundtable Discussions
Table 1: Creative Solutions to Intellectual Property Management, Sharing and Protection
Host: Jacqueline B. Fine, Ph.D., Assoc. Director, External Scientific Affairs, Merck Research Laboratories
Table 2: Issues Related to Project Financing Beyond Discovery
Host: Lydia Pan, Ph.D., Director, Science Policy, Pfizer, Inc.
Table 3: Facilitating R&D Partnerships for Neglected Diseases
Host: Richard M. Keenan, RMK Drug Discovery Consulting, LLC (formerly with GlaxoSmithKline)
Table 4: Engaging Entities in Developing Countries for Research and Evaluation
Host: Rashmi H. Barbhaiya, Ph.D., CEO & Managing Director, Advinus Therapeutics Pvt Ltd.
Table 5: Strategies for Gaining Management Support for Investing in Neglected Diseases
Host: Jerry Zeldis, M.D., Ph.D., CEO, Celgene Global Health
5:45 Reception
6:45 Close of Day One