To learn more about the relationship between these foundations and the CROs with which they work, Outsourcing-Pharma.com talked with Richard Soll, senior vice president, Research Service Division, WuXi AppTec and Salvatore La Rosa, vice president Research and Development, Children’s Tumor Foundation.
Both will be presenting at BIO 2017, which takes place this week in San Diego, CA.
Outsourcing-Pharma.com (OSP): How are disease-focused foundations bridging the gap between discovering new targets and initiating clinical trials?
Salvatore La Rosa: Rare disease foundations occupy a unique intersection that includes patients, researchers, clinicians and pharma. Second, rare disease foundations can act as targeted investors, directing funding towards integrated platforms of critical R&D endeavors. These include things such as creating a disease registry for patient recruitment, a biobank to guarantee tissue availability, an open data hub to share data and disseminate results.
Richard Soll: Many disease-focused foundations bridge the gap in several ways: (1) funding through grants to basic researchers and to clinical researchers, (2) patient registries, which are critically important today for patient registration / stratification trials; (3) access to tissues and cells from patients for R&D purposes, (4) key opinion leader (KOL) accessibility and availability, and (5) advocacy groups who can provide enormous support through their dedicated efforts.
OSP: How has this role evolved over the past few years, and why?
La Rosa: In the past, foundations publicized their impact by citing metrics such as the number of grants funded, the number of publications generated, the number of researchers that were attracted to the field, and the amount of follow-up funding secured from major governmental funders.
Although these parameters still hold a good deal of importance, over the past few years there has been an important shift in the philanthropic giving. Giving for a ‘good’ cause is not enough anymore, as the goal for donors has become not only investing in something they are interested in, but also impacting the field in a tangible way.
Medical foundations have become increasingly innovative in participating in the R&D process, helping to get the right drug candidates through the clinic and to the market. Additionally, staffing wise there has been a significant shift in management expertise: from grant managers to experienced pharma and biotech executives.
OSP: What role do CROs such as WuXi have in furthering the collaborations between early stage drug targets and foundations?
Soll: WuXi has worked with foundations in two ways: one by direct funding of R&D activities by the foundation and two, foundation-supported partnership with biotech or pharma who in turn contract to WuXi as part of the biotech/pharma efforts.
CROs, like WuXi, play a particularly important role in his process in so far as the CRO provides experienced personnel, high degree of flexibility particularly around resourcing and facilities, and cost advantages vs an internal, permanent hire.
OSP: What future trends or issues do you forsee emerging?
La Rosa: The evolution from a very flexible spending model (on a great year you fund 7 grants, on a bad one only 2) to a more rigid model (paying for long term strategic infrastructures) has resulted in the urgent need for a financial model that can sustain the infrastructure long term.
OSP: In the future do you expect disease-focused foundations will take a share in early stage companies or look for returns if a target is sold to a pharma company?
La Rosa: Some large foundations already have this type of approach; I see the vast majority of small and mid-size foundations securing capped returns or long-term revenues with those partners who agreed to partner and use their services.
Even very small patient organizations could monetize a revenue from a collaboration where prompt access to patients for clinical trial recruitment or disease experts for trial design could speed up development programs in a meaningful measureable way.
OSP: How do you see the relationship between biotech or early stage discovery companies, foundations, and research partners like WuXi changing?
Soll: We see open access platforms as a critical component to any company’s R&D effort, whether we run a fully integrated program or conduct a one-off study. Whereas the foundation may provide the capital, reagents, and other expertise related to a particular disease, it is the biotech that typically would drive towards key inflection points or milestones associated with a compound’s advancement in the biotech’s pipeline. WuXi supports this initiative throughout execution.