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FRAC Workshop 2013

  • Overview
  • Agenda
  • Presentations

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:
 
Panel: Resources and Collaborative Programs at NIH
This series of slides provides details on resources and collaborative programs at NIH, including:


 

Updated: July 1, 2015