NCI SBIR Federal Resources to Accelerate Commercialization (FRAC) Workshop

May 24 – May 26, 2016

NCI Shady Grove Campus Rockville/MD

Event Overview

The National Cancer Institute Small Business Innovation Research (NCI SBIR) Development Center will be hosting an informative workshop on Federal Resources to Accelerate Commercialization (FRAC) on May 24 – 25, 2016 at NCI’s Shady Grove Campus in Rockville, MD. The workshop aims to provide current SBIR/STTR awardees with valuable information and access to both federal and local resources that could ultimately help advance their cancer technologies to the market. In addition to multiple in-depth learning sessions with expert speakers, attendees will have a chance to engage in 1:1 conversations with NCI SBIR Program Directors, as well as speakers including representatives from the FDA, NSF, CDMRP and other NIH funding/resource programs.

The FRAC Workshop is an exclusive event for all current NCI SBIR/STTR awardees (up to 2 attendees per company). Registration is free but attendees are responsible for travel and accommodations expense. Early registration is recommended as 1:1 sessions with organization representatives are offered on first-come-first-serve basis. If you have any questions regarding the FRAC Workshop, please send us an email at NCIsbirEvents@mail.nih.gov.

Important Information on Registration

This year we are putting together a program book to help awardee companies learn more about one another to facilitate potential collaboration. The information you provide on the registration form will also be shared with external investors when necessary. Please include information that you are comfortable sharing with third party entities.

Registration deadline is May 5. Register early to secure 1:1 meeting with speakers.

FRAC Workshop 2016 Agenda

Day 1 (May 24, 2016)

Time	Session
1:00 PM – 2:00 PM	Welcome & Overview of NCI SBIR Initiatives
2:00 PM – 3:30 PM	Life Science Nation BootCamp: Fundraising & Branding for Translating Federally Funded Research
2:00 PM – 3:30 PM	Panel: Overview of NIH Grants Life Cycle : Hear from Grants Specialists & Scientific Review Officers
3:30 PM – 4:00 PM	Networking Break
4:00 PM – 5:30 PM	NIH Panel: Resources and Collaborative Programs at NIH (NExT/NCATS/PREVENT/Frederick National Labs)
4:00 PM – 5:30 PM	Life Science Nation BootCamp: Fundraising & Branding for Translating Federally Funded Research
6:00 PM -	Offsite Networking & Meet and Greet (Union Jack's)

Note: Meeting the NCI Program Staff is scheduled for half hour sessions through the day. Sign-up for the meeting is available on the registration page.

Day 2 (May 25, 2016)

Time	Session
8:00 AM – 8:30 AM	Check In & Introductions
8:30 AM – 9:00 AM	Opening Remarks on Cancer Centers Program
9:00 AM – 09:45 AM	Panel: Resources to Access Biospecimens and Patient Derived Animal Models
09:45 AM – 10:45 AM	Panel: Sources of non NIH Federal Funding to Advance Your Technology (BARDA/CDMRP/NSF)
10:45 AM – 11:05 AM	Break
11:05 AM – 11:55 PM	Panel: Perspectives from FDA CDER
11:05 AM – 11:55 PM	Panel: Perspectives from FDA CDRH (Seminar Room)
12:00 PM – 12:30 PM	CMS and Medicare Coverage Policies for New Medical Technologies (CMS)
12:30 PM – 2:30 PM	Networking Lunch/1:1 Sessions
2:30 PM – 3:30 PM	Panel: Local Resources for Small Businesses (JLabs/Indiana BIO/BioHealth Innovation)
3:30 PM – 4:30 PM	Brainstorm Breakout Sessions
4:30 PM – 4:45 PM	Closing

FRAC Workshop 2016 List of Speakers

Organization	Name and Title
National Cancer Institute Office of Cancer Centers	Henry P. Ciolino, PhD Acting Director Office of Cancer Centers National Cancer Institute
Biomedical Advanced Research and Development Authority (BARDA)	Marcy Grace, PhD Division of Chemical, Biological, Radiological, and Nuclear Countermeasures Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services
National Science Foundation (NSF) SBIR Program	Jesus Soriano, MD, PhD, MBA Program Director, SBIR/STTR, National Science Foundation
Department of Defense Congressionally Directed Medical Research Programs (DoD CDRMP)	Donna M. Kimbark, Ph.D. Program Manager Congressionally Directed Medical Research Programs
	Shui-Lin (Stan) Niu, Ph.D. Science Officer ARP/BMFRP/PRCRP/SBIR Congressionally Directed Medical Research Programs
National Center for Advancing Translational Sciences (NCATS)	Lili M. Portilla, MPA Director, Office of Strategic Alliances National Center for Advancing Translational Sciences (NCATS), NIH
	Nora Yang, PhD Senior Scientist, Therapeutics for Rare and Neglected Diseases Director, Portfolio Management and Strategic Operations Division of Pre-Clinical Innovation National Center for Advancing Translational Sciences (NCATS), NIH
	Krishna “Balki” Balakrishnan, Ph.D., M.B.A. Senior Technology Transfer Manager Office of Strategic Alliances Office of Policy, Communications and Strategic Alliances Office of the Director National Center for Advancing Translational Sciences (NCATS), NIH
NCI Experimental Therapeutics (NExT)	Michael J. Difilippantonio, Ph.D. Program Manager for Therapeutic and Diagnostic Initiatives Office of the Director, Division of Cancer Treatment & Diagnosis (DCTD) National Cancer Institute/NIH
NCI Experimental Therapeutics (NExT)	Weiwei Chen, PhD Program Manager NCI Experimental Therapeutics (NExT) Program National Cancer Institute/NIH
NCI PREVENT Cancer Preclinical Drug Development Program (PREVENT)	Shizuko Sei, M.D. Medical Officer & Program Director Chemopreventive Agent Development Research Group Division of Cancer Prevention, NCI, NIH
	Elizabeth Glaze, PhD, DABT Program Director Chemopreventive Agent Development Research Group Division of Cancer Prevention National Cancer Institute
NCI Frederick National Laboratory for Cancer Research & RAS initiative	Nguyen K. Nguyen, PhD, PMP Partnership Alliance Manager Partnership Development Office (PDO) Frederick National Laboratory for Cancer Research
	Andrew Quong, Ph.D. Director, Partnership Development Office (PDO) Frederick National Laboratory for Cancer Research
NCI Frederick National Laboratory for Cancer Research Center for Advanced Preclinical Research	Sergei Kozlov, PhD, MBA, PMP Principal Scientist/Team Leader Center for Advanced Preclinical Research, Frederick National Laboratory for Cancer Research (NCI)
	Zoë Weaver Ohler, PhD Principal Scientist, Preclinical Evaluation Team Leader Center for Advanced Preclinical Research, Frederick National Laboratory for Cancer Research (NCI)
NCI Patient-Derived Xenograft (PDX) Repository	Yvonne A. Evrard, Ph.D. [Contractor] Operations Manager NCI Patient-Derived Models Repository, Support for DCTD Frederick National Laboratory for Cancer Research
FDA Center for Drug Evaluation and Research (CDER)	Shawna Weis, PhD Pharmacologist, Office of Hematology and Oncology Products, CDER, FDA
	Haw-Jyh (Brian) Chiu, PhD Toxicologist, Division of Hematology Oncology Toxicology Center for Drug Evaluation and Research/FDA
	Tiffany K. Ricks, PhD Pharmacologist, Division of Hematology Oncology Toxicology Office of Hematology and Oncology Products Center for Drug Evaluation and Research/FDA
	Lee Pai-Scherf, MD Medical Officer, Office of Oncology Drug Products Center for Drug Evaluation and Research/FDA
FDA Center for Devices and Radiological Health (CDRH)	Aaron Schetter, PhD, MPH Scientific Reviewer Division of Molecular Genetics and Pathology/OIR FDA Center for Devices and Radiological Health
Parexel	Reem Elbekai, BPharm, PhD, DABT Senior Consultant, PAREXEL International
	Barry S. Sall, RAC, FRAPS Principal Consultant PAREXEL Consulting
	Ted Carver, Ph.D. Principal Consultant PAREXEL International
Generic Devices Consulting	John Greenbaum, BS, MBA President Generic Devices Consulting, Inc
Indiana Bio	Kristin M. Jones President and CEO Indiana Health Industry Forum
J&J Innovation (JLabs)	Samantha Lifson J&J Innovation (JLabs)
BioHealth Innovation	Ethan Byler Managing Director BioHealth Innovation, Inc.
NCI Biospecimen Resources	Lokesh Agrawal, Ph.D. Program Director Biorepositories and Biospecimen Research Branch (BBRB) Cancer Diagnosis Program Division of Cancer Treatment and Diagnosis National Cancer Institute
Life Science Nation	Dennis Ford Founder & CEO Life Science Nation
Life Science Nation	Danielle Silva VP of Business Development Life Science Nation
Office of Grants Administration	Shane Woodward Branch Chief, Division of Cancer Treatment and Diagnosis Office of Grants Administration, NCI
NCI SRO	Nadeem Khan, Ph.D. Scientific Review Officer Technology Contract Review Division of Extramural Activities, NCI/NIH
CSR SRO	Syed M. Quadri, PH.D. Chief, Oncology Translational Clinical IRG Center for Scientific Review, NIH
Office of Acquisition	Donna Perry-Lalley, MS, MSM Contracting Officer, Acting Branch Chief Prevention, Control and Population Sciences Branch Office of Acquisitions, NCI
Centers for Medicare & Medicaid Services	Marc Harstein Director Hospital and Ambulatory Policy Group Center for Medicare Centers for Medicare and Medicaid Services
IGI Tech	William Plishker, PhD Co-Founder and CEO IGI Technologies
ImaginAb	Jennifer S. Keppler Chief Operating Officer ImaginAb

Logistics

Accommodation near the NCI Shady Grove Campus are available at group price in the following facilities:

Gaithersburg Marriott Washington Center (~~$189/night~~ Group Rate No Longer Available)
9751 Washington Blvd.
Gaithersburg, MD 20878
Reserve a room at Gaithersburg Marriott Washington Center
Hilton Garden Inn (Closest to NCI Shady Grove Campus; $164/night)
14975 Shady Grove Rd.
Rockville, MD 20850
Reserve a room at Hilton Garden Inn
Extended Stay America ($79.99/night)
2621 Research Blvd.
Rockville, MD 20850
Reserve a room at Extended Stay America
(To get group pricing at Extended Stay America, select "Extended Stay America - Rockville" and write NIH in the comments section of your reservation. The hotel will override the rate locally. You can also reserve a room at a discounted rate by calling the hotel at 301-987-9100.)

Day 1 Meet and Greet will be held at Union Jack's.