Presented by Liz Powell and Lindsay SaccoJune 12, 2017

Accessing Non-Dilutive Government Funding & Other Opportunities for Biosciences

Today’s Agenda� Background

� Government Funding Opportunities

� Timing

� Congress

� Case Studies

� Final Tips

� Q & A

G2G’s BackgroundTeam:

� Bipartisan � 70 years experience working in and with government� Raised over $153M for clients since 2007� Secured CMS reimbursement rates, shaped regulations, and

drafted and enacted policiesNiche:

� Biosciences and high-tech innovation� Worked with PLSG for years – secured federal and state funding

Offices:� Capitol Hill, Washington, D.C.� Midwest Offices:

� BioEnterprise in Cleveland, Ohio� Capitol Square in Columbus, Ohio

Government FundingCategories: Sources:

GrantsDiscretionaryLegislationProcurement

Defense&

Energy&

Health&

GSA&

NASA&

Grant Resourceswww.grants.gov www.fbo.gov

� http://innovationpartnership.net/news/2009-sbirsttr-solicitation-scheduleannouncements -SBIR/STTR Schedule of Solicitations

� http://www.mrmc.smallbusopps.army.mil/ - USAMRMC� http://www.darpa.mil - DARPA� http://cdmrp.army.mil/ - Congressionally Directed Military Research Program� https://momrp.amedd.army.mil/ - Military Operational Medicine Research� https://www.usamraa.army.mil/pages/baa_forms/index.cfm - US Army Medical Research

Acquisition Activity� http://www.sellingtoarmy.com/user/showpage.aspx?SectionID=9 – Small Business Contracts� http://www.onr.navy.mil/en/Contracts-

Grants/~/link.aspx?_id=6B898D4AA6CB48359B3F152AA3DC632A&_z=z – Office of Naval Research

� http://fhpr.osd.mil/about.jsp?topic=4 – Defense Health Program� http://www.dtra.mil/Business/CurrentSolicitations.aspx - Defense Threat Reduction Agency� http://www.wpafb.af.mil/afrl/rx/ - Wright Patterson Air Force Base� https://arpa-e-foa.energy.gov/ - Department of Energy Advanced Research Projects

Agency� http://healthit.ahrq.gov – Health Information Technology Agency for Healthcare Research

and Quality� http://www.eda.gov/InvestmentsGrants/jobsandinnovationchallenge - Economic

Development Administration

Researching Grants

http://www.G2Gconsulting.com/bioscience-cornerTHE LATEST NEWS IN HEALTH POLICY & FUNDING

GOVERNMENT BIOSCIENCE GRANT REPORT

Examples:

� US Special Operations Command Broad Agency Announcement (USARMAA) – Full Proposal Due: 5/4/18

� Integrative Computational Biology for Analysis of NHLBI TOPMed Data (R01) – Full Proposal Due: 7/6/17

� Implementation and Evaluation of New Health Information Technology (IT) Strategies for Collecting and Using Patient-Reported Outcome (PRO) Measures (U18) (AHRQ) – Full Proposal Due: 9/25/17

� Funding Opportunity Announcement for Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans – Full Proposal Due: 10/1/17

� DARPA Biological Technologies Office Open BAA on the intersection of biology with engineering and the physical and computer sciences – Open until 4/26/18

Types of DoD R&D GrantsResearch Phase

Basic Research/Idea Development (6-1 funding)

Applied Research (6-2)

Advanced Technology Development (6-3)

Demonstration and Validation (6-4)

Key Target

DARPA, Office of Naval Research (ONR), CDMRP, Air Force Research Lab (AFRL),

MRMC Science &Technology/JPC-6, Army Research Lab (ARL), NMRC/WRAIR

DARPA, ONR, CDMRP, AFRL, MRMC S&T/ JPC-6, SOCOM, ARL, NMRC/WRAIR

BARDA, DARPA (except clinical trials) ONR, AFRL, MRMC, SOCOM,

NMRC/WRAIR

BARDA, MRMC Advance Development Programs (USAMMA and USAMDA), VA

DOD/VA/BARDA FundingGrants:� SBIRs/STTRs – $150,000-$2M – NIH, DoD, DARPA, NSF, DoE, ARPA-E, etc� Broad Agency Announcements (BAAs), Program Announcements – $1-2M each� Rapid Innovation Fund (RIF) – Army, AF, Navy, Marines, Defense-wide – $1-3M each� Congressionally Directed Military Research Program (CDMRP) – $200,000-2M each� DARPA BAAs, SBIRs/STTRs, Program Announcements – $1-20M � Biomedical Advanced Research and Development Authority (BARDA) BAAs –

contracts of $10-50M each over 5 years� VA Office of Research and Development – intramural onlyContracts & Collaborations:� Cooperative Research and Development Agreement (CRADAs)� ProcurementLegislation:� Joint Warfighter Medical Research Program – $50M� National Defense Authorization Act (NDAA), 21st Century Cures Act, etc� Appropriations Bills

DoD & VAMilitary Health System:

� 9.4 million beneficiaries: � 19,700 inpatient per week and 1,031,000 in year� 1,417,000 outpatient per week and 74,000,000 in year

� 55 military hospitals � 373 military medical clinics� $48 billion budget – 10% of entire DoD budget

Veterans Affairs:� 23 VISNs, 152 medical centers, 800 community-based outpatient clinics, 126

nursing home care units, and 35 domiciliaries� $176 billion budget

Key Areas of Interest:� DoD – Wound healing, regenerative medicine, sensors, traumatic brain injury,

and PTSD; Prolonged Field Care is prioritized � VA – rehabilitation, chronic conditions, health IT, and hospital care� Cost-savings is valued nearly as much as the improvement of care

Military Operations

Infectious Disease

Clinical & Rehabilitative Medicine

Medical Simulation and Health IT

Combat Casualty CareResearch:

Medical Chemical Biological Defense

Blast Injury Research

Key Conferences:

� Special Operations Medical Association's (SOMA) Scientific Assembly (SOMSA) – “Back to the Future: Gaining New Ground and Preserving Lessons Learned”

� Conference Details: May 21-25 in Charlotte, NC

� 1,000+ attendees – Focused on pre-hospital, trauma, tactical, wilderness, austere, disaster and deployed medicine, it is the largest gathering of SOF medical providers in the world. Researchers, clinicians, first responders and industry all gather to exchange information and collaborate to bring new solutions to SOF and the general population.

� http://www.specialoperationsmedicine.org/Pages/scientificassembly.aspx

Key Conferences:

� Military Health Services Research Symposium (MHSRS)

� Abstract Deadline: March 17th

� Conference Details: August 27-30 in Kissimmee, FL

� 3,000+ attendees – Focused on Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, Medical Simulation and Information Sciences, and Military Infectious Disease, it is the largest annual military medical conference. DoD and VA clinicians, researchers, warfighters, institutions, industry, small businesses, and consultants attend.

� https://mhsrs.amedd.army.mil/SitePages/MHSRS_2017.aspx

Timing� January, April, August and December each year – NIH SBIRs� Monthly – Vendors Days at Fort Detrick and NIH, TATRC monthly meetings� January-February – DoD program announcements released� March – MHSRS abstract submission, RIF announcements per service� March/April – USAMRMC Medical Research, Development & Acquisition

Conference� May – SOMSA Conference and SBIR/STTR Innovation Summit� August – MHSRS� September – BARDA BAAs released� October 1 – USAMRMC BAA released� November-December – BARDA Industry Days, final funding levels

determined for fiscal year enabling agencies to allocate funds� Workshops throughout the year led by Health and Medicine Division within

National Academies of Sciences, Engineering, and Medicine (formerly Institute of Medicine), FDA, etc

Policies and RegulationsLegislation:

� 12 appropriations bills are passed each year

� 100s of authorization bills move through committees each year

� What you can do à shape directive language, funding levels, policy reforms, etc

Regulations:� FDA approval process� CMS reimbursement codes and rates� DoD R&D programs� What you can do à shape grant program definitions, criteria,

timing, collaborations, etc

Case Studies

Never reinvent the wheel

Case Study: Multiple Funding Sources

� Goal: Obtain federal funding for cellular therapy research to accelerate wound healing.

� Results:Ø Developed a multi-state strategy for working with DoD and Congress

and tied medical R&D to job growth in each stateØ Provided introduction to the DoD, developed relationships and

garnered funds from several program managersØ Leveraged TATRC relationships to access DARPA contract and insert

language in NDAAØ Organized tours, demonstrations and media events with Members of

CongressØ $11.3 Million in FY2008-10Ø $3 Million in FY2012 in NDAAØ $10 Million BARDA grant in FY2013 – up to $100 Million if hit all

benchmarks over 5 years

Case Study: VA Procurement� Goal: Obtain authorization to sell therapeutic device within the

VAMCs across the country

� Results:Ø Identified the decision-maker blocking the ability to sell and met

with her and her colleagues repeatedly to educate on need for device among veterans

Ø Targeted Members of Congress and committees of jurisdiction and worked with all of them to exert consistent pressure on the VA to reverse this decision

Ø Wrote legislative language to include in House and Senate Veterans Affairs Appropriations bills as well as floor amendment

Ø Secured Congressional mandate and developed plan for funding the devices within the VA

Case Study: RIF Funding� Goal: Obtain access to the DoD and pursue funding for helmet

technology.

� Results:Ø Identified the Rapid Innovation Fund opportunity that matched the

company's expertise

Ø Wrote and edited pre-proposal application

Ø 1 of 28 invited to submit full proposal application out of 1,034 submissions – U.S. Special Operations Command, Defense Threat Reduction Agency, Missile Defense Agency, Joint Science and Technology Office for Chemical and Biological Defense

Ø Introductions to Fort Belvoir where design specs made for products the company produces

Ø $3 Million in FY2013-16

Case Study: MHSRS� Goal: Target the Program Manager for resuscitation device, explain

capabilities and change his mind on how device can help him achieve his goals.

� Results:Ø Wrote and disseminated 1-page white paper to align with DoD

focus areas prior to MHSRS, had made introductions and tried to work with the Program Manager but he was not interested because working with another company

Ø Maintained communications in 5 months leading up to MHSRS, researched the other company and its capabilities, then arranged to meet Program Manager at MHSRS

Ø Gave tailored, thorough explanation of how device aligns with other company he was working with and of how can fund both

Ø Made submission for funding

Ø $300,000 allocated from USAMRMC in FY2013

Case Study: CMS Reimbursement� Goal: Gain access to CMS decision-makers and explain the complexity

of a procedure in order to increase the current reimbursement rate.� Results:Ø Explained criteria and process for changing the reimbursement rate,

then created the strategy of targeting CMS and Capitol Hill to educate, develop champions for the cause, and influence the process.

Ø Built a coalition of medical professionals to share their expertise and demonstrate the complexity and value of the procedure.

Ø Coached the company on who to target, what messages to use, and when to time meetings and interactions.

Ø Organized meetings with CMS to review medical publications and data on the procedure.

Ø Secured dozens of calls, letters and communications to CMS from Capitol Hill and other established medical professionals explaining the appropriate cost for the procedure and need for increased rate.

Ø CMS increased the rate 11X the initial rate over two rulings.

Case Study: Advocacy

� Goal: Change the standard of care to prevent infant mortality.

� Results:Ø Created messaging campaign and simplified education communications

Ø Made target list of Members of Congress and agencies must educate

Ø Met with targets to educate and build champions

Ø Organized Congressional Briefing on Infant Mortality with media coverage

Ø Drafted and sent letter from key Members of Congress to HHS explaining the data and why standard of care must be updated

Ø Organized meetings with HHS – Maternal Health and Child Health Bureau, Division of Healthy Start and Perinatal Services, Secretary's Advisory Committee on Infant Mortality and CDC’s Division of Reproductive Health

Ø Built coalition of medical maternal health and Medicaid associations to keep educating, advocating and improving the standard of care

Case Study: Coalition Influence� Goal: Establish Washington, D.C. presence and strategy for national

consortium of 36 state consortiums for advocacy and funding.� Results:Ø Explained the legislative process to coalition members and mobilized for

grassroots impact in Washington, D.C.Ø Maintained regular communications – Action Alerts, calls, emails and

Capitol Hill DaysØ Educated and enlisted Congressional championsØ Drafted bipartisan Authorization bill and led campaign to pass the House

and Senate committees and floorØ Developed and used targeted messages through White Papers, meetings,

events and media outreachØ Organized Congressional Hearing – ensured coalition members served as

the witnesses giving testimonyØ Recognized Members of Congress with awards – developed champions Ø $1 Million in federal grants per year and $10 Million in authorization bill

Final Tips� Assess your funding and/or policy needs and make a plan � Track RFPs, BAAs, Program Announcements, RIF, policies and/or regulations� Write White Papers – tailor to targets and hone message à Problem,

Solution & Results� Set up meetings or phone calls with targets in Congress and agencies� Build relationships over time for long-term success� Listen and be resourceful� Register for key conferences – e.g. SOMSA and MHSRS – and network,

talking with key Program Managers at these conferences � Respect timing and matchmaking process� Submit applications for funding using intel gained and meet criteria� Follow-up, ask questions, engage and build strong relationships with targets

Never give up!

www.G2Gconsulting.com

Liz Powell & Lindsay Sacco1000 E. Capitol Street, NE, Suite 4

Washington, D.C. 20003(202) 445-4242

lpowell@G2Gconsulting.com