Innovation And Access: Fission Or Fusion? Interview With Jennifer Dent, President, BIO Ventures For Global Health (BVGH)

In the light of the UN High-Level Panel on Access to Medicines, this series of sponsored articles challenges experts to give their views on the policies that best support the development of solutions to societies’ greatest challenges and how enabling policy environments, including IP systems, influence the development and flow of new technologies and services in different sectors, fields of technology, and jurisdictions. The views expressed in the articles are those of the authors. Below is an interview with Jennifer Dent, President, BIO Ventures for Global Health (BVGH).

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What is WIPO Re:Search and why is it relevant to the discussions on the UN High Level Panel on Access to Medicines? In what way can LMICs benefit from the connections created through WIPO Re:Search and how can they improve access to medicines?

WIPO Re:Search is an example of how industry is sharing intellectual property assets with non-profit and academic researchers worldwide to advance therapeutic development for diseases that disproportionately burden individuals and communities in LMICs. It is a global platform through which research organizations such as biopharmaceutical companies, government research centers, and academic institutes can share their intellectual property with one another to accelerate product development for neglected infectious diseases – specifically for malaria, tuberculosis, and neglected tropical diseases (NTDs), which affect over 1.4 billion people worldwide.

This program has exceeded our greatest expectations. By identifying, proposing, and facilitating alliances, we are making ground-breaking progress in connecting researchers with drug development companies, establishing collaborations, and advancing product research and development across neglected infectious diseases. Scientists around the world have come together across multiple sectors to combine efforts to repurpose industry assets, work to develop new vaccines and diagnostics, accelerate product development, and evaluate products in the field.

WIPO Re:Search is relevant to the UN High Level Panel on Access to Medicines because it provides a concrete example of how improving access to medicines can be achieved by catalyzing the development of medicines where none currently exist. WIPO Re:Search is one of a number of initiatives that demonstrate that R&D-based pharmaceutical companies are willing to participate in collaborations that seek to address specific market conditions or solutions to overcome bottlenecks in R&D. WIPO Re:Search also shows how open innovation and collaboration is optimized when it is clear who owns what. Patents underpin this.

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. Initiatives like WIPO Re:Search should be scaled up to create new multi-stakeholder and cross-sector programs to solve the issues of access. This is not a simple or straightforward task; it will require people to work together and to understand each party’s position and capabilities.

How does WIPO Re:Search handle IP in its dealings? (Is IP a barrier or driver?) If and when WIPO Re:Search leads to breakthroughs, how much will the medicines or vaccines cost?

All WIPO Re:Search activities are governed by the WIPO Re:Search Guiding Principles – a set of statutes that all Members agree to abide by before joining the Consortium. These principles mandate that any product developed through a WIPO Re:Search collaboration will be provided royalty-free to the 49 least-developed countries. Members are encouraged to consider the issue of access to and affordability of these products for all developing countries, including those that do not qualify as LDCs.

IP drives the research and product development activities of WIPO Re:Search. We see the role of IP as an enabler rather than an inhibitor. Organizations join WIPO Re:Search in order to either share their IP assets or use others’ IP assets to advance their neglected infectious disease research. These IP assets are shared free of charge between Members. Without IP, these collaborations are rendered less meaningful. The Guiding Principles also protect new IP that is developed by organizations participating in a WIPO Re:Search collaboration. Users of another Member’s IP assets will retain ownership of any new IP developed through a WIPO Re:Search partnership, but are also encouraged to make these new IP assets available to other Consortium Members for their own neglected infectious disease research projects.

Is WIPO Re:Search a cost-effective, sustainable, and efficient way to accelerate the development of much needed medicines and vaccines? What do leading UN and internationally recognized bodies think about WIPO Re:Search?

WIPO Re:Search combines the product discovery and development expertise of the biopharmaceutical industry with the knowledge of neglected infectious disease experts. The Consortium provides Members with a direct, streamlined conduit to pharmaceutical company decision makers that can grant access to company assets that can be applied to neglected infectious disease research and product development. It supports the repurposing of drugs and prevents the unnecessary repetition of experiments.

While WIPO Re:Search is a new initiative – less than five years old – it has already demonstrated the time and financial impact that sharing IP can have. For example, two participating companies have shared data with other WIPO Re:Search Members. In one instance, the shared data prevented a research organization from unnecessarily repeating assays that had been performed by the company. In another instance, the Member used the data to obtain approval and funding for a Phase II clinical trial. Both Members were able to redirect the significant time and money that was saved towards other important neglected infectious disease research projects.

WIPO Re:Search is led by the World Intellectual Property Organization (WIPO) and BIO Ventures for Global Health (BVGH). The World Health Organization (WHO) is a technical advisor to the Consortium. There are 106 Member organizations from across the globe, including several leading international bodies. By joining and participating in WIPO Re:Search, these organizations have demonstrated their support for the objectives and activities of the Consortium.

If the WIPO Re:Search model is successful, can it be scaled up? 15 years from now, what do you hope will have been achieved with WIPO Re:Search?

The WIPO Re:Search platform is easily scalable. When the Consortium was first launched, it had 30 Members from ten countries. In the following years, membership tripled to 106 Members from 30 countries. These new Members bring new IP assets to share with other Members and drive more innovation into collaborations. Ten of the leading innovative biopharmaceutical companies are active members of WIPO Re:Search, including Eisai, GSK, Merck (MSD), Novartis, Pfizer, Sanofi, Alnylam, Takeda, Merck KGaA and Johnson & Johnson, and bring a broad array of IP assets and knowledge to our neglected infectious disease research projects. And while the pharmaceutical industry actively participates in new R&D models with varying degrees of engagement such as WIPO Re:Search, the reality is they would not be able to participate in these efforts if their businesses were not commercially sound.

With a successful collaboration model, managed by BVGH, this platform can be further developed to include capacity building activities such as fellowships, grant access support through the BVGH FundFinder program, and a more strategic and focused partnership development approach. A new Advisory Committee, led by Dr. Peter Hotez, has been established to guide the expansion of WIPO Re:Search. BVGH and WIPO are currently developing a strategic plan to ensure sustainability and impact over the next five years. With almost five years of exceeding annual objectives, WIPO Re:Search has tremendous potential for growth.

Current estimates suggest that it takes 10-12 years and over $1 billion to bring a drug from early discovery to the market. Unfortunately for those neglected infectious diseases with no medicines available, 12 years is a lengthy wait. WIPO Re:Search was established to accelerate the development of products for these diseases. In 15 years, it is my belief that the research collaborations established through WIPO Re:Search will have resulted in at least one new product on the market. Beyond products, many more questions about neglected infectious diseases will be answered. Long-lasting connections between neglected infectious disease researchers and the biopharmaceutical industry will have been created.

Jennifer Dent

Jennifer Dent is President, BIO Ventures for Global Health (BVGH). Jennifer joined BVGH in September 2011 and became President in November 2012 when she became a member of the Board of Directors.  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, USA. 

Jennifer testified at the UN High-Level Panel discussions on Access to Medicines in London. She has contributed her global health and pharmaceutical industry insights to the discussion and described opportunities to expand and scale up collaborations between industry, researchers, and governments to address issues around access to medicines in LMICs.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is the sponsor of this series. IFPMA advocates for solutions that take a holistic view of access to medicines, underpinned by strong innovation frameworks that provide incentives for investments in R&D and sustainable access to new health technology solutions for the long term benefits of patients.