Lead Author: Jennifer Dent
Organization: BIO Ventures for Global Health
Ensuring access to medicines is a complex and multifaceted challenge that requires the buy-in of key stakeholders within the public, private, and civil sectors. There are specific models and activities through which each stakeholder group can leverage its expertise to actively and productively address this public health challenge. The following contribution represents the experiences of BIO Ventures for Global Health (BVGH) and its President, Jennifer Dent, working with the biopharmaceutical industry to augment medicine access. Specific examples of companies’ activities are described. These activities include drug donation programs targeting highly-burdensome communicable and non-communicable diseases; the contribution of resources and assets to advance product development for poverty-related diseases; and the sharing of industry’s knowledge and expertise with biomedical researchers from low- and middle-income countries. These activities address several of the key barriers to access: product affordability, lack of effective products, and limited capabilities of LMICs to contribute to medical product development. The expansion of the aforementioned programs and the initiation of other innovative, multi-sectorial programs is essential to ensure that patients worldwide receive proper and beneficial healthcare.
Secretary-General’s High-Level Panel Secretariat
Dear Secretary-General Ban Ki-moon and the Secretary-General’s High-Level Panel Secretariat,
I write as the President of BIO Ventures for Global Health (BVGH), a nonprofit organization based in Seattle, WA, to praise the High-Level Panel on Access to Medicines for undertaking a mission to increase access to lifesaving treatments in all low-, middle- and high- income countries across communicable and non-communicable diseases. BVGH shares your public health goals and I believe there are initiatives underway and opportunities in front of us that will move us toward these common objectives.
In 2004, Carl Feldbaum, the President of the Biotechnology Innovation Organization (BIO), which represents over 1,200 biotechnology and pharmaceutical companies worldwide, issued a call to action to its members to commit to sharing the benefits of new scientific discoveries with all people, including those living in low- and middle-income countries (LMICs). With that goal in mind, BVGH was established. BVGH is charged by its stakeholders to develop and manage programs that leverage technologies and industry assets and resources to address unmet medical needs of people living in developing countries and to create partnerships that advance biomedical research and development for these regions.
BVGH has sought to fulfill its mission through a collection of collaboration-based research, technology transfer, and knowledge sharing programs. These programs are designed to ensure that the process of new drug research continues to be encouraged in all countries. New drug development is a risky and capital-intensive venture. In fact very few countries, even in developed regions, have the resources or the entrepreneurial culture to take on the challenges of an industry where the failure rate for the search for new therapies is so high. Most of the capital for later stage research comes from private investors who are willing to support new research with the inherent risks and with an expectation of rewards. The financial rewards are continually re-invested in new research and product development programs. This system, which is based on intellectual property protection for the pioneering companies, has delivered the medical advances we have today.
One example I would like to highlight is a program called WIPO Re:Search that BVGH manages with the World Intellectual Property Organization (WIPO). This program demonstrates the willingness of companies to share intellectual property assets and other valuable resources to advance research and development for neglected tropical diseases (NTDs), malaria, and tuberculosis. The WIPO Re:Search consortium was launched in October 2011 with 30 Member organizations. This program has exceeded our greatest expectations. By identifying and facilitating alliance opportunities, BVGH has made ground-breaking progress in connecting researchers with drug development companies, establishing collaborations, and advancing research and development in diseases of poverty. Scientists around the world have come together across multiple sectors to combine efforts to repurpose industry assets, develop new technologies, accelerate product development, and evaluate products in the field. Today we have over 100 organizations on board and engaged as Members, including 22 in Africa, and almost 100 collaborations have been established. Ten of the leading biopharmaceutical companies participate in WIPO Re:Search, including Eisai; Pfizer; Novartis; GlaxoSmithKline; Sanofi; Merck (MSD); Merck KGaA, Darmstadt, Germany; Takeda; Johnson & Johnson; and Alnylam Pharmaceuticals, to share their intellectual property assets and other valuable resources.
WIPO Re:Search brings the benefits of modern medical research to developing countries through a series of partnerships between industry and academic researchers. It is a program that actually leverages intellectual property to benefit the needs of developing nations and it fosters innovation in medicine, vaccines, and diagnostics. Public-private sector partnerships are created through WIPO Re:Search to help developing country researchers and institutions gain access to intellectual property and facilitate technology transfer. The growth in membership, number of collaborations and agreements, and the commitment of the private sector are clear signals of the success of this program. In addition to these metrics, relationships are being forged between researchers in LMICs and industry scientists. To view the impact WIPO Re:Search is having please see a recent BVGH publication, Accelerating R&D for Neglected Diseases through Global Collaborations, which highlights 25 collaborations established. You can also review our progress our 2015 BVGH Partnership Hub Annual Report. A few collaborations are described below:
GlaxoSmithKline (GSK) & University of California, San Francisco (UCSF): GSK provided researchers at UCSF with a set of small molecule protein kinase inhibitors to screen against the parasite that causes schistosomiasis. The results of the UCSF researchers' screens - which were recently published- were promising.
Pfizer & 60 Degrees Pharmaceuticals (60P): Pfizer provided 60P with its Investigator's Brochure for its drug, modipafant, which 60P was interested in repurposing for dengue fever. These data helped 60P design a dengue fever clinical trial. 60P plans to start a Phase II clinical trial on dengue fever patients in Singapore in March 2016.
Merck KGaA, Darmstadt, Germany & University of Buea: Merck KGaA, Darmstadt, Germany provided a researcher at the University of Buea in Cameroon with a subset of highly potent Hsp90 inhibitors to screen against the parasitic worms that cause onchocerciasis.
Merck & Walter and Eliza Hall Institute of Medical Research (WEHI): Merck shared a set of small molecule aspartyl protease inhibitors with researchers at WEHI to screen against malaria parasites. The initial results of WEHI’s screens are promising, and Merck has offered to share its medicinal chemistry expertise to help advance the initial hits.
Alnylam Pharmaceuticals & National Institute of Immunology (NII): Alnylam designed and synthesized optimized siRNAs for a researcher at NII in India to use to assess the role of specific hepatocyte proteins on the severity of liver-stage malaria.
The Consortium represents just the beginning of what can be accomplished through new models of partnership, cooperation, project management, and innovation sharing. WIPO Re:Search should be scaled up and similar programs developed to facilitate product development partnerships for poverty related diseases. Our experience with WIPO Re:Search indicates that companies are willing and even enthusiastic to participate and share knowledge and IP assets to support R&D for diseases of poverty.
There are a many, many initiatives underway that support and provide access to medicines in LMICs, across therapeutic areas. And there are a number of new programs being developed that will soon be implemented. The good news is we are seeing more collaboration and coordination across companies and sectors to implement access programs. Below are a few examples of access to medicines programs:
• Merck has been donating Mectizan (ivermectin) to low income countries in Africa since 1987. Mectizan is a treatment for the NTDs, onchocerciasis and lymphatic filariasis. The company has committed to donate Mectizan for as long as needed. This program is now a multi-sectoral partnership involving the World Health Organization (WHO), the World Bank, ministries of health, nongovernmental development organizations (NGDOs), and local communities.
• GlaxoSmithKline donates one billion tablets of its drug, Albenza (albendazole), every year to treat children in poor countries whose growth and learning capacity is threatened by intestinal worms. The company has invested significantly in manufacturing capacity to enable this program.
• Novartis introduced a new access to medicines program focused on 15 on- and off-patent medicines addressing four highly-prevalent non-communicable diseases: cardiovascular diseases, diabetes, respiratory diseases, and breast cancer. The products are offered at a batch price of USD 1 per treatment per month to governments, NGOs and other institutional organizations. This relatively new initiative was launched in Kenya and Ethiopia in 2015 with plans to expand to additional countries over the next few years.
• Merck KGaA, Darmstadt, Germany has been donating Biltricide (praziquantel) tablets to African countries since 2007. The company has donated more than 200 million tablets to WHO, and has committed to increasing the number of tablets donated to 250 million per year. To date, more than 54 million patients have been treated.
• Gilead is making Sovaldi and Harvoni available at significantly reduced prices in more than 100 countries including all low-income countries and most LMICs. They are working with governments and health ministries to support HCV medical education and prevention efforts. In Georgia, Gilead is working with the Ministry of Health and CDC to eliminate HCV - the company is providing Sovaldi and Harvoni free of charge. Their goal is to treat 20,000 patients per year for five years to eliminate HCV from the Georgian population.
These are just a few examples of company programs focused on increasing access to medicines. The London Declaration and Uniting to Combat NTDs program is another excellent example that we can learn from. Donations from several biopharmaceutical companies are a cornerstone of that program. Pharmaceutical companies have pledged drugs valued at USD 17.8 billion for the ten diseases through 2020.
I strongly believe that, with the right programs and opportunities, companies will participate in more research and access initiatives focused on the needs of LMICs. I advise the Commission to complete a full analysis of access to medicines programs. A proactive approach to developing innovative, multi-sectorial initiatives to address the complex issues of access to medicines is needed. So much more can be done when we communicate and work collaboratively to develop solutions. LMIC governments must be at the table and committed to implementing access to medicines programs. The recommendations of this panel should include specific outreach plans and recommendations to scale up existing programs like WIPO Re:Search and develop new multi-stakeholder and cross-sector programs to solve the issues of access.
Access to medicines in LMICs and emerging regions is complex and requires a multi-stakeholder commitment including governments, industry across sectors, enablers and implementers like BVGH. I would be pleased to volunteer my time to support the Panel in developing recommendations and programs. This is not a simple or straightforward task; it will require people to work together and to understand each party’s position and capabilities.
BVGH is currently exploring an exciting partnership around an oncology hospital and access program in Côte d’Ivoire. Cancer is a growing threat to Africa. Cancer survival rates in Africa are much lower than in the more developed world. With financing provided by South Korea and support from leading Korean companies – Samsung and GE Korea - the Côte d’Ivoire government is building a new state-of-the-art National Radiotherapy and Oncology Center. Côte d’Ivoire currently has only one cancer center with 21 beds, no radiotherapy capacity, and limited ability to expand and meet patient needs. This multi-stakeholder initiative is poised to provide a model on which healthcare needs and access can be addressed with the support of multiple stakeholders working together, including biopharmaceutical companies. This is another example of how the benefits of modern medicine and modern therapies can be shared by all. This program will also give African researchers, oncologists, and health care professionals further opportunities to collaborate with oncology companies and leading oncology centers.
BVGH also taps into the scientific know-how and expertise of companies to approach the problems of global health through capacity building programs. Sharing the scientific knowledge of companies with academic researchers in LMICs helps to jumpstart their own drug development efforts. Capacity building has included scientist exchanges, fellowships and training sessions, equipment donation and training programs. While many large pharmaceutical companies have been generous in sharing drugs to those who need them, empowering researchers and helping them strengthen their own ability to find solutions for local disease challenges is ultimately a very effective public policy approach to public health and human rights.
I understand the commission may still be accepting nominations for advisory members. I would be pleased to be considered and to contribute to the panel in any manner that would be helpful.
Bibliography and References
Jennifer Dent joined BVGH in September 2011 and was elected President in October 2012. She has 20+ years of broad-based pharmaceutical and biotechnology experience, including negotiation and structuring of deals, and management of global discovery and commercial alliances. Jennifer began her career as a sales representative in Canada working in a variety of positions for Parke Davis/Pfizer and Genentech. Following the acquisition of Genentech Canada by Roche, Jennifer held a number of senior management positions in marketing, life cycle management, global product strategy, business development, and alliance management at Roche and Genentech in Canada, Switzerland, New Jersey, and South San Francisco. Jennifer co-founded Sound Biotechnology, and prior to that, served as Vice President, Business Development, Marketing, and Sales at CombiMatrix Corporation in Washington. Prior to working in the pharmaceutical industry, Jennifer was a registered nurse working in surgical oncology at Toronto General Hospital in Canada. Jennifer obtained her R.N. from Fanshawe College and graduated from the University of Western Ontario with a BSc. She received her executive MBA at Western's Richard Ivey School of Business.