NIH Staff Present at BIO
During BIO’s 2012 Annual Meeting, NIH staff will participate in many sessions as chairs, discussants, and speakers.
To see the NIH at BIO schedule click here:
SESSIONS FEATURING NIH STAFF
Monday, June 18
New SBIR Program: Opportunities for Early-Stage and Venture-Backed Companies to Tap into Non-Dilutive Funding
10:00 a.m. – 11:30 a.m.
- Michael Weingarten (Speaker), Small Business Innovation Research Development Center, NCI, Bethesda, MD
The Small Business Innovation Research (SBIR) program is a critical source of non-dilutive financing for early stage companies, providing over $2B annually to develop next generation technologies. New legislation signed on December 31, 2011 introduced exciting changes that will increase the funding levels dedicated to the program and expand eligibility to small businesses that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms. These changes will make it possible for more companies and investors to capitalize on new initiatives at the National Cancer Institute’s (NCI) SBIR Development Center that go beyond funding to help promising startups advance technology development toward commercialization. These initiatives help fill the gap in the availability of early stage funding created when investors and strategic partners moved towards clinical-stage investments. SBIR funds serve as a key bridge between initial angel funding and more significant angel capital, venture capital, or strategic partnerships. New initiatives, such as the NCI SBIR Bridge Award ($3M awards where NCI co-invests with private investors) and an Investor Forum (connecting innovative SBIR awardees with top tier investors and partners) are examples of how SBIR programs facilitate the follow-on investments needed to move a product towards the market.
Panel Discussions: Strategies for Transitioning Basic Science into the Translational Research Arena
2:30 p.m. – 3:30 p.m.
Location: 205BC, Level 2
- Jodi Black (Speaker), Division of Extramural Research Activities, NHLBI, Bethesda, MD
- Stephen Flaim (Moderator), Division of Extramural Research Activities, NHLBI, Bethesda, MD
(Panel session included within the Translational Research Forum: From Bench to Bedside in a Bioeconomy Government, Industry and University Models to Catalyze Economic Growth and Patient Access)
Universities have historically been in the front lines of translating innovative research into novel medicines and technologies useful to patients. However, between discovery and development lies a gap-- in funding and in know-how. This forum will explore how universities and their funding partners can move early stage research forward in order to make them attractive to developers. Panels of high level experts will explore the unique role of universities in translational research, and their interactions with foundations, industry and other sources of funding and know-how. The forum will also provide specific examples of innovative university models which increase patient access to innovative products and spur economic growth in the region.
Tuesday, June 19
Selected NIH Initiatives to Promote Drug Discovery and Development—
NCI, NINDS, and NCATS
8:30 a.m. – 9:45 a.m.
- Christopher Austin (Speaker), Therapeutics for Rare and Neglected Diseases Program, NIH Center for Translational Therapeutics, NIH, Bethesda, MD
- Melissa Maderia (Speaker), Technology Transfer Center, NCI, Bethesda, MD
- Rajest Ranganathan (Speaker), Office of Translational Research, NINDS, Bethesda, MD
- D. Elizabeth McNeil (Moderator), NINDS, Bethesda, MD
NIH has multiple mechanisms, such as NeuroNEXT and OTR (NINDS) and technology transfer (at the NIH and Institute level), to facilitate working with biotech companies to promote the nations’ health. NINDS has two programs to spotlight in this regard: NeuroNEXT-a clinical trials network and the Office of Translational Research-which has many initiatives to promote translational research for neurological diseases. NIH technology transfer promotes collaborative research opportunities to develop, evaluate and/or commercialize products created at NIH. The National Center for Advancing Translational Sciences (NCATS) was just established in December 2011; its mission is “to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.” Public-private partnership of industry, government and advocacy may facilitate bringing novel therapeutic drugs, biologics and devices into clinical trials and ideally to market.
Increasing Cancer Drug Availability in Resource-Limited Settings: Models for the Future
10:00 a.m. – 11:30 a.m.
- Bhadrasain Vikraim (Speaker), Clinical Radiation Oncology Branch, NCI, Bethesda, MD
A panel of top experts from government, civil society and industry discuss how the industry can balance lower-income countries’ need for affordable non-communicable diseases (NCDs) drugs and devices with biotech companies’ need to recoupe their sky-high development costs.
Full Description: As the worldwide burden of infectious disease has leveled off, health researchers and policy-makers have come to recognize that NCDs such as cancer, heart disease and diabetes constitute an increasing threat to global public health. This reality is underscored by the recent UN Summit on NCDs held in September 2011, which recognized the need to forge new mechanisms that would decrease health disparities caused by relative the lack of availability of drugs for treatment of NCDs in low- and middle-income countries (LMCs). Conversely, due to the complexity of diseases such as cancer, the cost of bringing new drugs to market has become prohibitively high. This session brings together top experts from government, civil society, and industry to present and discuss means of balancing needs for new NCD drugs and devices at affordable prices and recouping of their development costs to allow companies to expand their ability to innovate and discover new therapies.
Wednesday, June 20
Pre-Competitive Collaboration: Innovation of the Future?
2:00 p.m. – 3:30 p.m.
- Francis Collins (Speaker), NIH, Bethesda, MD
Pre-competitive collaboration is a growing driver for innovation and increased productivity in biotechnology. This Super Session will explore the benefits and challenges of pre-competitive collaborations to advance research and development of novel medicines. This session will also cover how best to foster a seamless interplay between the elements of the R&D continuum.
Thursday, June 21
Thinking Outside the Box: A New IP-Sharing Model Brings Biopharma, Government Agencies, and Non-profits Together to Accelerate R&D Collaborations for Neglected Tropical Diseases
11:00 a.m. – 11:30 a.m.
- Mark Rohrbaugh (Speaker), Office of Technology Transfer, NIH, Bethesda, MD
Neglected tropical diseases (NTDs), malaria, and tuberculosis impair more than 1 billion lives in impoverished regions and remote global communities. Although some treatments exist, many are outdated, have toxic side effects, or are facing drug resistance. Recognizing the need for more progress in NTD product development, the WIPO Re:Search consortium was formed in October 2011, in an unprecedented collaboration among 8 of the world’s leading pharmaceutical companies, the World Intellectual Property Organization (WIPO), and BIO Ventures for Global Health (BVGH). WIPO Re:Search members recognize that intellectual property (IP) forms the foundation for investment in new drugs, vaccines, and diagnostics, and that strategic partnerships are the key to accelerating R&D for these diseases. That’s why WIPO Re:Search members have joined together to provide access to IP for pharmaceutical compounds, technologies, know-how, and data that have, until now, resided within industry’s walls. By leveraging a centralized database of these assets and a partnering facilitation component, WIPO Re:Search is one example of a novel, innovative solution that enables biopharmaceutical companies to benefit from investments and expertise in product development. It is the latest in a budding trend toward “open innovation” initiatives that offer new opportunities to save significant time and increase resource-sharing in the race to develop new drugs, vaccines, and diagnostics for NTDs, malaria, and TB. The program’s Partnership Hub is actively managed by BVGH to identify potential collaboration opportunities so that all assets are used as productively as possible. This session will introduce WIPO Re:Search, with an overview of the project structure, process, and successes as an innovative global health collaboration model. With the public database, and an actively managed Partnership Hub component, WIPO Re:Search is charting new territory in industry’s new push towards “open innovation”.
American Invents Act Comes to Campus: the Impact on Commercialization and Technology Transfer Offices
8:30 a.m. – 9:45 a.m.
- Charles Niebylski (Speaker), NIDDK, Bethesda, MD
- Christina Sarris (Speaker), Office of Technology Transfer, Bethesda, MD
Panelists will discuss how the AIA affects universities and non-profit research institutions and what new strategies they can use to secure and enforce U.S. patents. Learn pragmatic approaches to satisfy the AIA’s new requirements for patent procurement while improving your goals of timely technological disclosures.
Full Description: The recently enacted Leahy-Smith America Invents Act 2011 (“Act") is the most significant change to U.S. patent law in recent decades. Certain provisions of the Act will greatly affect how universities and non-profit research institutions disclose technological information, implement IP strategies, and license their innovations to third parties. This panel will discuss the impact of the Act on the missions and policies of universities and non-profit institutions. The panel will address new strategies for universities and non-profits to balance their need to function as centers of public learning and the necessity to act as proprietors of new technology. The Act will ultimately impact the competitive position of universities and non-profits to secure commercially valuable IP. Participants will explore pragmatic approaches for universities and non-profits to satisfy these new requirements for patent procurement while improving their goals of timely technological disclosures.