Sponsored by the NIDCR Center for Biotechnology and Innovation
November 7-8, 2005
Bethesda, MD
The goals of the meeting, Pathway to Product Development, were to:
- establish an ongoing dialogue among the various stakeholders (e.g., NIDCR/NIH, Academia, Industry, FDA and other Federal Agencies)
- identify specific areas ripe for synergy and collaboration, and
- facilitate the translation of discovery science supported by the NIDCR into products that will advance craniofacial health.
The immediate objectives were to educate each of the stakeholders and demonstrate the value of academic-industrial participation in cross-disciplinary and multidisciplinary science projects.
The goals and objectives were achieved through:
- plenary talks on key technology transfer topics
- NIDCR portfolio overviews
- paired academic and industry presentations of cutting-edge science and technology developments in topics related to orofacial health
- posters highlighting technologies ripe for commercial development
- formal discussions, and informal interactions.
The group assembled for the meeting was intentionally small—about 100 registrants—and diverse—recruited from entrepreneurial scientists, developers, administrators and technology transfer specialists. The attendees were highly interactive as evidenced by the specific recommendations offered during the animated discussion at the end of the meeting.
Challenges
A significant challenge to translational research is the difficulty in attracting venture capital at early and unproven phases of product development. There is a real and persistent “funding gap” between the end of the “discovery” phase and early clinical validation.
Some broad consensus themes emerged from the discussions. Key issues were:
- Building mutual understanding and trust to promote effective communication and subsequent collaboration.
- The costs associated with translational research are significant and may not be well identified at the outset.
- Lag between discovery science and its practical development is often long, with patients and consumers becoming increasingly impatient.
- Market size and time to market are critical factors in determining whether or not to proceed with development.
- Therapies for small or disadvantaged patient populations (and thus limited markets) may fill a significant societal need whose development may need additional resources.
- Industry and the university have two diverse cultures that must be reconciled for effective partnerships to be established.
- Key hurdles in commercializing products include regulatory pathways, intellectual property issues, obtaining adequate funding (particularly in early and mid-phase), and the cost to get to market vs. a realistic market size.
Recommendations
Different perspectives on addressing oral health challenges emerged from selected academic and industrial speakers. A summary of the recommendations is provided below.
- NIDCR should hold this meeting annually or every other year, and focus on specific topics (e.g. partnerships with intramural scientists, intellectual property within joint ventures and centers, valuing technology transfer activities in promotion and tenure evaluations, etc.).
- Between the regularly scheduled technology transfer events such as this meeting, NIDCR should foster and/or create opportunities for ongoing dialogue and interaction between the various stakeholders.
- Future meetings should continue bringing together representatives from industry, academia, NIDCR, and FDA and add attendance from more university technology transfer officers and representatives of large companies marketing oral care products.
- Partnering with an established company can enhance the process by leveraging the R&D, regulatory, and marketing/sales expertise of the partner at all levels of product development.
- Research with near-term commercial potential (i.e. 3-5 years to market), should be identified and targeted for support. Such projects may be more focused on development with corresponding larger budgets, should be milestone-driven, and periodically evaluated both during and after the award period.
- Demonstrate the worth of diagnostics (e.g., saliva-based diagnostic technologies) to healthcare providers by improved clinical outcomes, to payers by a cost benefit, and to patients by improved quality of life.
- Support research on the identification and validation of biomarkers for toxicology, clinical safety, and efficacy in order to facilitate getting safer products to market more quickly.
- Appropriate animal models that would be predictive of experience in humans, for testing the safety of novel devices/combination products, before clinical trials.
- Early determination of the FDA organizational unit and regulatory pathway appropriate for the product type is critical, and should be followed up by interactions between the sponsor and the FDA with reference to applicable guidance document(s) to establish approval requirements. Such formal or informal meetings are encouraged to obtain FDA advice and direction, clarify procedures and expectations, and help resolve disputed issues.
Implementation Strategies
In general there was consensus that the NIDCR can play an important and pivotal role in facilitating technology transfer and translational research. Several follow up activities were recommended by the meeting participants, as listed below:
- Multidisciplinary training will be crucial for producing investigators skilled in translational research, and NIDCR should investigate ways to facilitate and support such advanced education. Such opportunities might include “biology for engineers” short courses, contact with other scientists on interdisciplinary teams, experiences in open laboratories and/or technology cores, formal seminars, hands-on training, and websites.
- A website that includes a glossary listing terminology used by the various stakeholders should be developed, cross-referenced, and posted to a technology transfer web site.
- NIDCR should develop Requests for Applications in selected areas reflecting clinical needs matched to available technology to maximize the “return on investment” with timely, productive initiatives.
- The NIDCR’s SBIR and STTR programs might be expanded and marketed to a wider group of investigators not included in the “traditional” distribution lists.
- NIDCR could direct funding mechanisms at establishing partnerships between the various types of organizations (e.g. academic, commercial, non-profit, and combinations thereof) where appropriate to accomplish specific science and technology goals.