Congressionally Directed Medical Research Programs · Congressionally Directed Research Programs...

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



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



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



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



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”




Military Relevance: Relevanceto the healthcare needs of themilitary Service members,Veterans, and beneficiaries

http://www.cdmrp.army.mil



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



http://www.cdmrp.army.mil/




Stage 1 Whitepaper

REVIEW

Stage 2Full Application

REVIEW

AWARD $$$




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


REVIEW

AWARD $$$




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


REVIEW

AWARD $$$

April 21st

April 27th

April 28th

March 29th




Stage 1 Whitepaper

REVIEW


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




Stage 1 Whitepaper

REVIEW


REVIEW

AWARD $$$

Amyotrophic Lateral Sclerosis - $7.5 million

Epilepsy - $7.5 million

Multiple Sclerosis - $6.0 million

Neurofibromatosis - $15.0 million




Stage 1 Whitepaper

REVIEW


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




Stage 1 Whitepaper

REVIEW


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



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



Most programs contain more than one Mechanism.

Breast cancer:

6 funding mechanisms: $300K – $10M











Most programs contain more than one Mechanism.






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




eBRAP



Some Interesting Statistics

FreeMind Group, LLC www.FreeMindConsultants.com

April 13, 2016

Awarded domestic, for-profit organizations



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



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



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



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



Contact Us!

Thank you!

Meytal WaissDirector, Business Development

[email protected]

(617) 648-0340 ext. 288

www.freemindconsultants.com

FreeMindGroup FreeMindGrpFreeMind Group

mailto:[email protected]

Congressionally Directed Medical Research Programs · Congressionally Directed Research Programs...

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