Overview and Highlights
NCI SBIR Workshop on Federal Resources to Accelerate Commercialization
May 7, 2013, 8:00am – 5:30pm (EDT)
NCI Shady Grove
9609 Medical Center Drive
Rockville, MD 20850
On May 7, the NCI SBIR Development Center hosted a free one-day workshop on Federal Resources to Accelerate Commercialization. This workshop represented NCI SBIR’s latest efforts to move funded technologies from bench to bedside and was hosted to inform NCI SBIR & STTR awardees about the various federal resources and processes pivotal to the commercialization and clinical adoption of cancer technologies. The workshop presented an opportunity for nearly 200 attendees to share experiences and learn from the challenges and successes of other SBIR & STTR awardees. The workshop included opportunities for one-on-one meetings with representatives of many of the presenting federal organizations as well as the NCI SBIR Program Directors.
Workshop Highlights
Experts at the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), the Office of Science & Technology Policy (OSTP), and the United States Patent and Trade Office (USPTO) discussed regulatory approval processes, policies on coverage reimbursement for new medical technologies, collaboration across the federal government, and special intellectual property resources for small businesses.
A panel session featured other sources of federal funding, including the Congressionally Directed Medical Research Programs (CDMRP) at the Department of Defense, National Science Foundation (NSF), and the Biomedical Advanced Research and Development Authority (BARDA).
Resources and collaborative programs at NIH were presented by representatives with the NCI Experimental Therapeutics Program (NExT), Clinical Assay Development Program (CADP), PREVENT Cancer Preclinical Drug Development Program, Frederick National Lab for Cancer Research and programs at the National Center for Advancing Translational Sciences (NCATS).
A panel discussion, moderated by David Parkinson of New Enterprise Associates (NEA), focused on how cancer startups can achieve success in today's financing climate and industry framework. The panel included representatives of unique life science investment organizations and past SBIR/STTR recipients, who shared experiences and discussed their personal challenges and successes as SBIR & STTR awardees.
Networking breaks and a networking lunch allowed for over 150 one-on-one meetings with experts from presenting federal organizations and other attendees.
If you have any questions about this workshop, please contact the NCI SBIR Development Center at ncisbir@mail.nih.gov.
Agenda
Monday, May 6, 2013
Meet Your NCI Program Director (1:00pm–5:00pm)
Optional Self Pay Meet and Greet at Café Deluxe (6:00pm–9:00pm)
Terrace Room
Rio Entertainment Center–9811 Washingtonian Boulevard Gaithersburg, MD 20878
Tuesday, May 7, 2013
Registration
Introduction and Logistics
Opening Remarks/Welcome
Michael Weingarten, Director, NCI SBIR Development Center
National Cancer Institute Priorities
Douglas Lowy, Deputy Director, NCI; Acting Director, Center for Strategic Scientific Initiatives (CSSI), NCI
Collaboration Across the Federal Government (White House)
Douglas Rand, Senior Policy Advisor, White House Office of Science & Technology Policy (OSTP), Executive Office of the President
Intellectual Property Resources for Small Businesses (USPTO)
Susan Anthony, Attorney, Global Intellectual Property Academy, Office of Policy and External Affairs, United States Patent and Trademark Office
CMS and Medicare Coverage Policies for New Medical Technologies (CMS)
Jeffrey Roche, Medical Officer, Division of Items and Devices, Coverage and Analysis Group, Centers for Medicare and Medicaid Services
Networking Break
Office of Biotechnology Products Perspective on Manufacturing and Characterization During Clinical Development (FDA-CDER)
Richard Ledwidge, Drug Reviewer, Division of Therapeutic Proteins, Center for Drug Evaluation and Research, Food and Drug Administration
In Vitro Diagnostics: Overview of the FDA Submission Process (FDA-CDRH)
Nina Hunter, Biologist, Division of Immunology and Hematology, Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health, Food and Drug Administration
Remarks and Afternoon Logistics
Networking Lunch/One–on–One Sessions
Panel: Lessons Learned: Innovative Ways Startups can Finance and Advance Their Technologies
David Parkinson, NEA and Former CEO of Nodality (Moderator)
Walter M. Capone, Chief Operating Officer, The Multiple Myeloma Research Foundation
Luis Carbonell, CEO, MagArray
Stephen Cary, CEO and Co-Founder, Omniox
Alex DeWinter, Director, Healthymagination Fund, GE Ventures
Robin Jackman, President and CEO, Zacharon Pharmaceuticals (now BioMarin)
Michael Rubin, Managing Partner and Co-Founder, Sands Capital Ventures
Networking Break
Panel: Sources of Federal Funding to Advance Your Technology (NIH/BARDA/CDMRP/NSF)
Matt Portnoy, NIH SBIR Program Coordinator (Moderator)
Biomedical Advanced Research and Development Authority (BARDA): Marcy Grace, Project Officer, BARDA, Department of Health and Human Services
Congressionally Directed Medical Research Programs (CDMRP): Donna Kimbark, Program Manager, Peer Reviewed Cancer Research Program, CDMRP, Department of Defense
National Science Foundation (NSF): Jesus Soriano, Program Director, NSF
Panel: Resources and Collaborative Programs at NIH (CADP/NExT/NCATS/PREVENT/FNLCR)
Michael Weingarten, Director, NCI SBIR Development Center (Moderator)
Clinical Assay Development Program (CADP): James Tricoli, Chief, Diagnostic Biomarkers and Technology Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, NCI
NCI Experimental Therapeutics (NExT): Michael Difilippantonio, Program Manager for Therapeutic and Diagnostic Initiatives, Division of Cancer Treatment and Diagnosis (DCTD), NCI
National Center for Advancing Translational Sciences (NCATS): Lili Portilla, Acting Director, NCATS Office of Policy, Communications, and Strategic Alliances
PREVENT Program: Vernon Steele, Acting Chief, Chemopreventive Agent Development Research Group, Division of Cancer Prevention, NCI
NCI Frederick National Laboratory for Cancer Research (FNLCR): Atsuo Kuki, Chief Technology Officer, SAIC-Frederick, Frederick National Laboratory for Cancer Research
Closing and Thanks
Presentations
The presentations listed below are from the NCI SBIR workshop on Federal Resources to Accelerate Commercialization. For additional resources shared by the presenters, please see the Resources for Small Businesses.
Download the Speaker Bios.
Opening Remarks/Welcome
Michael Weingarten, Director, NCI SBIR Development Center
Overview of the NCI SBIR & STTR Programs, including the Phase IIB Bridge Award and goals of the NCI SBIR Development Center
Douglas Lowy, Deputy Director, NCI; Acting Director, Center for Strategic Scientific Initiatives (CSSI), NCI
Details on the priorities of the National Cancer Institute, ongoing projects and research areas of interest
Collaboration Across the Federal Government
Doug Rand, Senior Policy Advisor, White House Office of Science & Technology Policy (OSTP), Executive Office of the President
Overview of White House Office of Science & Technology Policy initiatives to accelerate commercialization and promote high-growth entrepreneurship
Intellectual Property Resources for Small Businesses
Susan Anthony, Attorney, Global Intellectual Property Academy, Office of Policy and External Affairs, United States Patent and Trademark Office
Intellectual property resources and considerations for small businesses
Jeffrey Roche, Medical Officer, Division of Items and Devices, Coverage and Analysis Group, Centers for Medicare and Medicaid Services
Policies on how CMS determines coverage for new medical technologies
Richard Ledwidge, Drug Reviewer, Division of Therapeutic Proteins, Center for Drug Evaluation and Research, Food and Drug Administration
Overview of the regulatory approval process for biopharmaceutical products
Nina Hunter, Biologist, Division of Immunology and Hematology, Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health, Food and Drug Administration
Overview of the regulatory submission and approval process for in vitro diagnostics products
Panel: Sources of Federal Funding to Advance Your Technology
This series of slides provides details on sources of federal funding for cancer technology, including:
- National Institutes of Health (NIH), Matt Portnoy, NIH SBIR Program Coordinator
- Biomedical Advanced Research and Development Authority (BARDA), Marcy Grace, Project Officer, BARDA, Department of Health and Human Services
- Congressionally Directed Medical Research Programs (CDMRP), Donna Kimbark, Program Manager, Peer Reviewed Cancer Research Program, CDMRP, Department of Defense
- National Science Foundation (NSF), Jesus Soriano, Program Director, NSF
Panel: Resources and Collaborative Programs at NIH
This series of slides provides details on resources and collaborative programs at NIH, including:
- Clinical Assay Development Program (CADP), James Tricoli, Chief, Diagnostic Biomarkers and Technology Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, NCI
- NCI Experimental Therapeutics Program (NExT), Michael Difilippantonio, Program Manager for Therapeutic and Diagnostic Initiatives, Division of Cancer Treatment and Diagnosis (DCTD), NCI
- National Center for Advancing Translational Sciences (NCATS) / Therapeutics for Rare and Neglected Diseases (TRND) / Bridging Interventional Development Gaps (BrIDGs), Lili Portilla, Acting Director, NCATS Office of Policy, Communications, and Strategic Alliances
- PREVENT Cancer Program, Vernon Steele, Acting Chief, Chemopreventive Agent Development Research Group, Division of Cancer Prevention, NCI
- NCI Frederick National Laboratory for Cancer Research (FNLCR), Atsuo Kuki, Chief Technology Officer, SAIC-Frederick, Frederick National Laboratory for Cancer Research
- Comparison of Resource and Collaborative Programs at NIH
