Congressionally Directed Medical Research Programs
FreeMind Group WebinarMeytal WaissApril 13, 2016
FreeMind Group, LLC www.FreeMindConsultants.com
FreeMindGroup
@FreeMindGrp
April 13, 2016
FreeMind Group
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
FreeMind Group
FreeMindGroup, LLC Est. 1999
55 Fulltime Employees
Diverse Client Base:
• Academics, University Medical Centers, and Independent Research Institutes
• Industry – Small Startups to Large Pharmaceutical Companies.
~400 Applications Annually
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Identify the most relevant funding opportunities
Strategize to maximize the application’s chance of success
Manage complex project production processes
Lead joint application writing
Support final contract negotiations
A Tool to Max. Your Funding Potential
FreeMindGroup, LLC
Non-Dilutive Funding – A Strategic Financial Tool
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Role of Non-Dilutive Funding in the Market
Future Returns on Investment
Milken Institute “Estimating Long-term Economic Returns of NIH on Output in the Bioscience” August 31st 2012
US ROI = $2.3
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Role of Non-Dilutive Funding in the Market
Milken Institute “Estimating Long-term Economic Returns of NIH on Output in the Bioscience” August 31st 2012
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
CDMRPs
Congressionally Directed Research Programs
Evolved as a mechanism for congressto appropriate funds for researchon specific diseases
Organized in programs for specific indications
Focus areas can change each year
Review process modeled on NIH
Expedited review process!
Non-US entities are also eligible!
CDMRP Mission: “to Eradicate Diseases and Support the War Fighter”
Congressionally Directed Research Programs
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Military Relevance: Relevanceto the healthcare needs of themilitary Service members,Veterans, and beneficiaries
http://www.cdmrp.army.mil
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
April 13, 2016 FreeMind Group, LLC
Congressionally Directed Medical Research Programs (CDMRP)
CDMRP 2016 budget of $836.4M approved:
Oncology: $285M
General Medical Research: $278.7M
Warfare & Trauma: $ 201M
Neurological Disorders: $58.5M
Genetic Disorders: $46.7M
Environmental Disorders: $100.5M
Issued annually by the DOD, typically around March.
Follow: http://www.cdmrp.army.mil
CDMRP Programs 2016• Alcohol and Substance Abuse• Amyotrophic Lateral Sclerosis• Autism• Bone Marrow Failure• Breast Cancer• Duchenne Muscular Dystrophy• Epilepsy• Gulf War Illness• Joint Warfighter Medical• Lung Cancer• Military Burn• Multiple Sclerosis• Neurofibromatosis• Neurotoxin Exposure Treatment
Parkinson's• Orthotics and Prosthetics
Outcomes• Ovarian Cancer• Peer Reviewed Alzheimer's• Peer Reviewed Cancer• Peer Reviewed Medical• Peer Reviewed Orthopaedic• Prostate Cancer• Reconstructive Transplant• Spinal Cord Injury• Tick-Borne Disease• Trauma Clinical• Tuberous Sclerosis Complex• Vision
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Congressionally Directed Research Programs
Stage 1 Whitepaper
REVIEW
Stage 2Full Application
REVIEW
AWARD $$$
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Congressionally Directed Research Programs
Whitepaper submission is the first and one of the most crucial steps for award.
Typically limited to 2 pages
Majority of applications do not make it past the whitepaper stage. To mean, if you are called to submit a full application your chances increase dramatically.
Carefully craft your whitepaper ensuring your science is well presented and represented and meets the guidelines and specification of the solicitation.
Stage 1 Whitepaper
REVIEW
Stage 2Full Application
REVIEW
AWARD $$$
Congressionally Directed Research Programs
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Bone Marrow Failure - $3.0 million
Breast Cancer - $120.0 million
Lung Cancer - $12.0 million
Ovarian Cancer - $20.0 million
Peer Reviewed Cancer - $50.0 million
Prostate Cancer - $80.0 million
Stage 1 Whitepaper
REVIEW
Stage 2Full Application
REVIEW
AWARD $$$
April 21st
April 27th
April 28th
March 29th
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Congressionally Directed Research Programs
Stage 1 Whitepaper
REVIEW
Stage 2Full Application
REVIEW
AWARD $$$
Gulf War Illness - $20.0 million
Joint Warfighter - $50.0 million
Military Burn - $8.0 million
Orthotics and Prosthetics Outcomes - $10.0 million
Peer Reviewed Orthopaedic - $30.0 million
Reconstructive Transplant - $12.0 million
Spinal Cord Injury - $30.0 million
Tick-Borne Disease - $5.0 million
Trauma (Clinical) - $10 million
Vision - $10.0 million
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Congressionally Directed Research Programs
Stage 1 Whitepaper
REVIEW
Stage 2Full Application
REVIEW
AWARD $$$
Amyotrophic Lateral Sclerosis - $7.5 million
Epilepsy - $7.5 million
Multiple Sclerosis - $6.0 million
Neurofibromatosis - $15.0 million
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Congressionally Directed Research Programs
Stage 1 Whitepaper
REVIEW
Stage 2Full Application
REVIEW
AWARD $$$
Autism- $7.5 million
Duchenne Muscular Dystrophy - $3.2 million
Neurofibromatosis - $15.0 million
Peer Reviewed Alzheimer's - $15.0 million
Tuberous Sclerosis Complex - $6.0 million
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Congressionally Directed Research Programs
Stage 1 Whitepaper
REVIEW
Stage 2Full Application
REVIEW
AWARD $$$
Alcohol and Substance Abuse - $4.0 million
Epilepsy - $7.5 million
Gulf War Illness - $20.0 million
Joint Warfighter - $50.0 million
Neurotoxin Exposure Treatment for Parkinson's-
$16.0 million
Orthotics and Prosthetics Outcomes - $10.0 million
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
General Medical Research: $278.7M
Acute Lung Injury
Antimicrobial Resistance
Chronic Migraine and Post-
Traumatic Headaches
Congenital Heart Disease
Constrictive Bronchiolitis
Diabetes
Dystonia
Emerging Infectious Diseases
Focal Segmental
Glomerulosclerosis
Fragile X Syndrome
Hepatitis B
Hereditary Angioedema
Hydrocephalus
Inflammatory Bowel Disease
Influenza
Integrative Medicine
Interstitial Cystitis
Lupus
Malaria
Metals Toxicology
Mitochondrial Disease
Nanomaterials for Bone
Regeneration
Nonopioid Pain Management
Pancreatitis
Pathogen-Inactivated Dried
Plasma
Polycystic Kidney Disease
Post-Traumatic Osteoarthritis
Psychotropic Medications
Pulmonary Fibrosis
Respiratory Health
Rett Syndrome
Rheumatoid Arthritis
Scleroderma
Sleep Disorders
Tinnitus
Tuberculosis
Vaccine Development for
Infectious Disease
Vascular Malformations
Women's Heart Disease
April 13, 2016 FreeMind Group, LLC
Congressionally Directed Medical Research Programs (CDMRP)
Most programs contain more than one Mechanism.
Breast cancer:
6 funding mechanisms: $300K – $10M
Issued annually by the DOD, typically around March.
Follow: http://www.cdmrp.army.mil
CDMRP Programs 2016• Alcohol and Substance Abuse• Amyotrophic Lateral Sclerosis• Autism• Bone Marrow Failure• Breast Cancer• Duchenne Muscular Dystrophy• Epilepsy• Gulf War Illness• Joint Warfighter Medical• Lung Cancer• Military Burn• Multiple Sclerosis• Neurofibromatosis• Neurotoxin Exposure Treatment
Parkinson's• Orthotics and Prosthetics
Outcomes• Ovarian Cancer• Peer Reviewed Alzheimer's• Peer Reviewed Cancer• Peer Reviewed Medical• Peer Reviewed Orthopaedic• Prostate Cancer• Reconstructive Transplant• Spinal Cord Injury• Tick-Borne Disease• Trauma Clinical• Tuberous Sclerosis Complex• Vision
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
April 13, 2016 FreeMind Group, LLC
Congressionally Directed Medical Research Programs (CDMRP)
Most programs contain more than one Mechanism.
Issued annually by the DOD, typically around March.
Follow: http://www.cdmrp.army.mil
CDMRP Programs 2016• Alcohol and Substance Abuse• Amyotrophic Lateral Sclerosis• Autism• Bone Marrow Failure• Breast Cancer• Duchenne Muscular Dystrophy• Epilepsy• Gulf War Illness• Joint Warfighter Medical• Lung Cancer• Military Burn• Multiple Sclerosis• Neurofibromatosis• Neurotoxin Exposure Treatment
Parkinson's• Orthotics and Prosthetics
Outcomes• Ovarian Cancer• Peer Reviewed Alzheimer's• Peer Reviewed Cancer• Peer Reviewed Medical• Peer Reviewed Orthopaedic• Prostate Cancer• Reconstructive Transplant• Spinal Cord Injury• Tick-Borne Disease• Trauma Clinical• Tuberous Sclerosis Complex• Vision
Era of Hope Scholar Award $2.5M 4 years
Innovator Award $5M 4 years
Breakthrough Levels 1 and 2 Award
L1: $375K / $600K (When partnering) 3 years
L2: $750K / $1M (When partnering)
Breakthrough Levels 3 and 4 Award
L3: $2.5M / $4M (When partnering) 3 years
L4: $10M
Distinguished Investigator Award
$3M 4 years
Breakthrough Fellowship Award (NEW!)
$300K 3 years
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
eBRAP
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Some Interesting Statistics
FreeMind Group, LLC www.FreeMindConsultants.com
April 13, 2016
Awarded domestic, for-profit organizations
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Major Challenges
Whitepaper submission –
Are you responsive?
Adhere to the guidelines! Different solicitations have different stipulations
Is your scientific story compelling? Innovative? Strong Leadership?
Unique sections – not your standard NIH RO1
Project Management and coordination
Short timeline! April deadlines!
Turning out a winning proposal
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Key Issues
Maximizing your Chances
Know the interests of the Agency
Present a complete, focused project
Ask for what is necessary
Leverage on research collaborations
Systematic Approach
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Key Issues
Maximizing your Chances
Different “pockets of money”
Different size of award/success rates
Conduct a thorough strategic assessment
Multi-Submission Granting Strategy
Target the Right Mechanism
FMG Professional Process
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Core Service 1- Strategic Assessment
Long term Strategic approach Outline projects Tasks to be completed Link with existing pockets of money Solicited vs. Unsolicited Map of relevant funding opportunities
Core Service 2- Application Production Process
Project Management - coordinating Comprehensive templates Ongoing feedback and edits Budgets Converge information Final outcome – single coherent presentation
April 13, 2016FreeMind Group, LLC
www.FreeMindConsultants.com
Contact Us!
Thank you!
Meytal WaissDirector, Business Development
(617) 648-0340 ext. 288
www.freemindconsultants.com
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