Pain Therapeutics Development Program (PTDP)

The HEAL Pain Therapeutics Development Program (PTDP) is part of the Helping to End Addiction Long-term® (HEAL) Initiative, a trans-NIH research effort focused on improving prevention and treatment for opioid misuse and addiction and enhancing pain management. The PTDP focuses on facilitating R&D in academic and small business settings to allow riskier, high-reward projects an opportunity to test the feasibility of their candidate non-addictive pain therapeutics.  In addition to grant support, the program provides access to consultants with extensive biopharma experience and CRO resources for a variety of activities including medicinal chemistry, manufacturing and formulation, DMPK, GLP toxicology and Phase I clinical testing.  These grants are milestone-driven and progress against milestones is evaluated on an annual basis for the 5-year grant period.

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Pain Therapeutic Development Program (RFA-NS-21-010) infographic
  • Phased (UG3 and UH3) Grant
  • Entering applications can be at Discovery or Development stages but must enter at UG3
  • Eligible institutions include academic institutions and small businesses
  • End Goals include IND submission, Phase I Clinical trial and formation of partnerships to progress candidate therapeutic through clinical testing
Show description of infographic

The Pain Therapeutics Development Program is supported by funding opportunity announcement: RFA-NS-21-010, “Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)”. The goal of this grant program is to accelerate the development of novel, non-opioid, non-addictive analgesics. Although projects can enter the program at either the Discovery or Development stage, all projects must enter at the UG3 phase and include both UG3 and UH3 phases. Discovery activities include hit/lead optimization, lead selection and lead characterization. Development activities include IND-enabling studies and phase I clinical trials. Projects entering the program at the discovery stage may progress to the development stage. Eligible institutions include academic institutions and small businesses. End goals include IND submission, completion of a Phase I clinical trial and formation of partnerships to progress candidate therapeutic through clinical testing.

 

Participating NIH Institutes, Centers and Offices

External Oversight Committee

The members of the Pain Therapeutics Development Program (PTDP) External Oversight Committee (EOC) have executive level drug discovery and development experience with experience in portfolio level decision making in academia and industry.  As individuals the committee members provide their perspectives independently on the oversight, strategy and implementation of the PTDP program. Based on their deep understanding of the drug discovery and development process the members provide feedback on NIH plans for project progression based on developing and monitoring project plans and milestones progression for individual teams and the PTDP program. As a link to the pain therapeutics development research community, the EOC will help the PTDP program adjust to changing landscapes to continue to provide a unique community scientific resource. Membership on this committee may be supplemented with ad hoc participation of individuals with expertise appropriate for specific programmatic matters within the PTDP program and the Division of Translational Research.

Peter Farina, Ph.D., Acting Chair
Dr. Farina has been a member of the Blueprint Neurotherapeutics Network EOC since its inception, is an Executive in Residence for the venture capital firm, Canaan Partners and was Sr. VP of Development at Boehringer-Ingelheim for 28 years. Peter is trained as an organic/medicinal chemist.

Jeff Kennedy, Ph.D.
Dr. Kennedy is a member of the Preclinical Screening Platform for Pain Executive Oversight Board (PSPP EOB), is VP of IP and Bioventures at Summer Road, LLC, was a Senior Fellow (Pain Research) at Eli Lilly for 5 years and was Director of Pain Research at Wyeth for 16 years.

Donna Hammond, Ph.D.
Dr. Hammond is a member of the Preclinical Screening Platform for Pain Executive Oversight Board (PSPP EOB), is Professor of Anesthesia, Neuroscience and Pharmacology, as well as Vice Chair for Research in the Department of Anesthesiology at the University of Iowa. Donna is trained as a pharmacologist and has focused much of her research career on the pharmacology and neurobiology of pain.

William Schmidt, Ph.D.
Dr. Schmidt is the Head of NorthStar Consulting and is the Parliamentarian and a Past-President of the Eastern Pain Association. He has over 25 years of pharmaceutical industry experience with a special emphasis on the discovery and development of novel analgesic and narcotic antagonist drugs. He has served in senior leadership positions in multiple biotech companies.  Bill is trained as a pharmacologist.

Vladimir Skljaravski, M.D.
Dr. Skljaravski is the Executive Medical Director at Cortexzyme and served in senior leadership positions at Eli Lilly for 19 years focused on pain, mood disorders, migraine and Alzheimer’s Disease therapeutics (including Cymbalta, Tanezumab and Galcanezumab for pain). Vlad is a trained neurosurgeon and neurologist.

Michael Palfreyman, Ph.D.
Dr. Palfreyman is the Chief Research and Development Officer at Cybin, Inc. and was VP, Research and Development at Marion Merrell Dow for 19 years. Michael has also founded, led and advised many start up companies focused on neuropsychiatric and neurology therapeutics. Dr. Palfreyman is a trained neuroscientist and pharmacologist.

Susan Hershenson, Ph.D.
Dr. Hershenson is the Deputy Director of Chemistry, Manufacturing and Controls at the Bill and Melinda Gates Foundation. Prior to that, she served as VP, Pharmaceutical Device and Development at Genentech and as VP of Pharmaceutics at Amgen for 17 years. Susan is trained as a chemist and biochemist.

Contract Research Organizations (CROs)

Curia - Medicinal Chemistry, in vitro ADMET, Formulations, and GMP manufacturing

Collaborative Drug Discovery - Data management

Duke University School of Medicine - Clinical trials

MRIGlobal Research Institute - Formulations and GMP manufacturing

PPD - Clinical trials

Southern Research - in vivo PK and Toxicology

SRI International - in vivo PK and Toxicology

Connection to Other NIH HEAL Initiative® Programs

PTDP is part of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, a trans-NIH research effort focused on improving prevention and treatment for opioid misuse and addiction and enhancing pain management. The NIH HEAL Initiative® consists of six research focus areas; PTDP falls into the Preclinical and Translational Research in Pain Management focus area. PTDP is part of a suite of funding opportunities that support the development of safe, effective, and non-addictive therapeutics to treat pain. Planning for Therapeutic Development R61 and Initial Therapeutic Development U19 grants serve as feeder programs to PTDP, and PTDP projects graduate to EPICC-Net or Phase II opportunities once all milestones have been met.

Associated Funding Opportunities:

Planning for Therapeutic Development R61 | RFA-NS-21-029 (R61)
2-year exploratory/planning award that lays the groundwork for a subsequent Initial Therapeutic Development U19 application. The R61 award supports the establishment of a strong research team and a strategy to collect preliminary data linking putative therapeutic targets to the proposed pain indication.

Initial Therapeutic Development U19 | RFA-NS-22-052 (U19)
Up to 5 years of funding to support team-based research projects to develop assays, screening and early optimization work to develop a non-addictive therapeutic to treat pain. The result of the project should be to advance a hit or lead to the point where they can meet the entry criteria for PTDP within the 5 years of the award.

EPICC-Net |OTA-22-002(pdf, 288 KB)
Once projects graduate from PTDP, this funding mechanism provides academic and industry investigators with expert infrastructure, Phase 2 clinical trial development and conduct for pain therapeutic development across populations and the lifespan.

 

Other Research Programs in the NIH HEAL Initiative® Preclinical and Translational Research in Pain Management Focus Area

Funded Projects

File
This is a preview of the Data Table. Only the first three rows are displayed.
Disease Indication Category Title PI / Lead Investigator Institution
Chronic Pain Novel, non-opioid, non-addictive intrathecal therapy for the treatment of chronic pain CAMPBELL, JAMES N CENTREXION THERAPEUTICS CORPORATION
Osteoarthritis Knee Pain Disease Modifying Analgesia with CA8 Gene Therapy LEVITT, ROY C UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
Chronic Pain Novel mGlu5 negative allosteric modulators as first-in-class non-addictive analgesic therapeutics ROOK, JERRI MICHELLE VANDERBILT UNIVERSITY
Neuropathic Pain Development and Optimization of MNK Inhibitors for the Treatment of Neuropathic Pain SAHN, JAMES JEFFREY 4E THERAPEUTICS INC.
Neuropathic Pain Development of MRGPRX1 positive allosteric modulators as non-addictive therapies for neuropathic pain TSUKAMOTO, TAKASHI JOHNS HOPKINS UNIVERSITY
Chronic Pain Development of a CCKBR-targeting scFv as Therapy for Chronic Pain Patients WESTLUND-HIGH, KARIN N UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
Diabetic Neuropathic Pain Selective Kv7.2/3 activators for the treatment of neuropathic pain SIGNORE, ARMANDO KNOPP BIOSCIENCES, LLC

 

Resources and Tools

Contacts

Mary Ann Pelleymounter, Ph.D. | Program Director and Program Officer
mary.pelleymounter@nih.gov

Mohamed Hachicha, Ph.D. | Scientific Project Manager
mohamed.hachicha@nih.gov

Pascal Laeng, Ph.D. | Scientific Project Manager
pascal.laeng@nih.gov

Oreisa O'Neil-Mathurin, MPH | Scientific Project Manager
oreisa.o'neil@nih.gov

Shamsi Raeissi, Ph.D. | Scientific Project Manager
shamsi.raeissi@nih.gov

Rebecca (Becky) Roof, Ph.D. | Scientific Project Manager
rebecca.roof@nih.gov

Carolyn Bondar, Ph.D. | Health Program Specialist
carolyn.bondar@nih.gov

Rakonda Medley, B.S. | Operations Coordinator
Rakonda.Medley@nih.gov

Funding Opportunities 

HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

Closed

HEAL Initiative: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain - (U44 Clinical Trial Not Allowed)

Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)

News & Events

View the HEAL Pain Therapeutics Development Program (PTDP) Webinar: Focus on “Non-Addictive Analgesic Therapeutics Development (Small Molecules and Biologics) to Treat Pain
April 28, 2022: 3:30pm EDT

IASP 2022 World Congress on Pain
September 18 - 23, 2022 | Toronto Canada

 

Related Topics 

FDA Resources

Investigational New Drug (IND) Application

Drug Application and Approval Process - "Questions and Answers"

FDA Guidances

Biologics Guidances

Guidances(Drugs)

Clinical Trials Guidance Documents

Development of Non-Opioid Analgesics for Acute Pain Guidance

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