# Pain Therapeutics Development Program (PTDP)

> 
This page provides potential grant applicants with information relating to the HEAL Pain Therapeutics Development Program infrastructure for enabling discovery and development of new biologics and small molecule drugs to treat pain. 

> 
The open funding opportunity for this program is:

RFA-NS-24-019: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) (nih.gov)

Upcoming application due dates: May 24, 2024 | September 24, 2024 | January 24, 2025 | May 23, 2025

The HEAL Pain Therapeutics Development Program (PTDP) (RFA-NS-24-019) 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 drug discovery and development 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. Funded investigators work together with the NIH to build a lead development team that leverages drug discovery and development expertise to advance their basic research into human testing. To help accomplish this, 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.
              - Phased (UG3 and UH3) Grant
              - Therapeutics can be biologics or small molecules
              -  Grant features access to biopharma-experienced consultants and NIH-sponsored Contract Research Organizations 
              - 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

To learn more, 
              - View the HEAL Pain Therapeutics Development Program (PTDP) Webinar: Focus on “Non-Addictive Analgesic Therapeutics Development (Small Molecules and Biologics) to Treat Pain , held on December 1, 2023 
              - View the OPEN Stage: Drug Discovery & Development at NINDS - Funding and Training Opportunities Featuring First-hand Experiences from Awardees , held on July 26, 2022 ET
              - View the HEAL Pain Therapeutics Development Program (PTDP) Informational Poster  (pdf, 1119 KB) , updated May 2023

## Show description of infographic

The Pain Therapeutics Development Program is supported by notice of funding opportunity: 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

              - Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
              - National Center for Complementary and Integrative Health (NCCIH) 
              - National Eye Institute (NEI)
              - National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
              - National Institute of Dental and Craniofacial Research (NIDCR)
              - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
              - National Institute of Neurological Disorders and Stroke (NINDS)
              - National Institute on Alcohol Abuse and Alcoholism (NIAAA)
              - National Institute on Drug Abuse (NIDA)
              - National Heart, Lung and Blood Institute (NHLBI)
              - Office of Research on Women’s Health (ORWH) 

## 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.

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.

Kollol Pal, Ph.D.Dr. Kollol Pal is an experienced serial entrepreneur and research scientist with more than twenty-five years of experience in leading pharmaceutical and biotech companies. He spent the majority of his career in early-stage companies leading drug discovery programs and clinical development in a number of therapeutic areas including oncology, neuroscience, infectious diseases and dermatology. Most recently Dr. Pal was the founding CEO of Pyramid Biosciences, a company focused on the clinical development of NTRK inhibitors for oncology and dermatology. 

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)

PTDP researchers receive no-cost access to the network's Contract Research Organizations (CROs). Lead Development Teams plan and coordinate studies conducted by PTDP CROs.

### Medicinal Chemistry 

Curia

### Pharmacokinetics/Toxicology

SRI International

IITRI

Toxicology Research Laboratory (TRL)

### Data Management

Collaborative Drug Discovery

### Manufacturing & Formulation

Curia

MRIGlobal Research Institute

Battelle

Leidos

### Clinical Trials

Duke University School of Medicine

PPD

## PTDP Consultants

Each Lead Development Team receives support from PTDP consultants. Consultants are assigned to a project with considerations for the project team's individual needs and consultants' expertise.

### Assay Development 

### Lisa Minor, PhD

Dr. Minor is President of In Vitro Strategies, LLC, a consulting company involved in assay development and screening strategies, technology evaluation and development, and product marketability assessment. Prior to this, Dr. Minor was a long-term employee of Johnson and Johnson where she managed projects and developed strategies across multidisciplinary teams in areas such as target identification, screening strategy and lead optimization. At Johnson and Johnson, Dr. Minor developed cell-based and biochemical assays for high throughput screening as well as safety screens (hERG patch, hepatotoxicity and functional G-protein coupled receptor assays) for compound profiling. In other roles, she advised therapeutic area teams on data interpretation and follow-up, and participated in technology development projects resulting in marketed products, including Seahorse metabolic profiling instrumentation and Quantigene mRNA detection technology. Dr. Minor is a past board member of the Society for Laboratory Automation and Screening, is on the Board of Scientific Counselors for the National Toxicology Program, and has published the Handbook of Assay Development for Drug Discovery. Dr. Minor is well recognized in the field of high throughput screening, especially for cell-based assays, and has broad drug discovery experience including therapeutic area research, target validation, assay development, high throughput screening and safety profiling.     

### William (Bill) Martin, PhD

Dr. Martin is a consultant for biotechnology companies with a focus on early drug discovery programs. Dr. Martin started his career in the pharmaceutical industry at Pfizer where he directed groups that focused on biochemical and cell-based assay development, high throughput screening and compound characterization for both potency and mechanism of action. Dr. Martin also led a group that developed high speed safety assays to evaluate the suitability of chemical series for pursuit in drug discovery programs. After leaving Pfizer, he joined Cara Therapeutics where he led a group responsible for in vitro biochemical and cell-based assays for several drug discovery programs. Dr. Martin is highly experienced in developing and applying biochemical and cell biological assays for high throughput screening, structure-activity relationships and safety assessment as well as leading cross-discipline projects to implement new processes and software.

### Medicinal Chemistry 

### Paul Anderson, PhD

Dr. Anderson is an independent pharmaceutical research consultant, specializing in medicinal chemistry. He has more than 25 years experience in drug discovery research and management, including more than 15 years in executive positions in large pharma and biotech. Dr. Anderson began his career at Merck Frosst then he spent more than 20 years at Boehringer Ingelheim where he held positions of increasing scientific and managerial responsibility, including head of research for the Boehringer Ingelheim research centers in Canada and the United States. He subsequently held senior chemistry management positions at Syndexa Pharmaceuticals and Ra Pharmaceuticals. Dr. Anderson has worked in many therapeutic areas including virology, cardiovascular and metabolic diseases, immunology and inflammation, and CNS diseases. He and his collaborators have advanced numerous compounds into preclinical and clinical development, including ciluprevir (BILN 2061), the first HCV NS3 protease inhibitor to demonstrate anti-viral activity in humans. Dr. Anderson has served on the Board of Directors of the Canadian Society for Chemistry and the Montréal Joint Center for Structural Biology, and on the Editorial Advisory Board of the Canadian Journal of Chemistry. He has 40 scientific publications and patents in the areas of synthetic and medicinal chemistry, and anti-viral research.

### Graham Johnson, PhD

During an extensive medicinal chemistry career, Dr. Johnson held a number of senior leadership positions in biotech, large pharmaceuticals and in pharmaceutical consulting. These roles have included: President of NuPharmAdvise LLC, Senior Vice President, Preclinical Development and Research for AVI BioPharma, Chief Research Officer for Rib-X Pharmaceuticals, Vice President of Bristol-Myers Squibb Discovery Chemistry for Connecticut and Canada, and Director of Neuroscience Chemistry for Parke-Davis Pharmaceuticals. Over his 33-year career, Dr. Johnson has worked in such diverse areas as neuroscience, infectious and genitourinary diseases, inflammation and in RNA therapeutics. Dr. Johnson is an inventor on more than 54 patents and has co-authored more than 60 peer-reviewed publications. Dr. Johnson was a permanent steering committee member and scientific advisor for the Spinomuscular Atrophy Project, an NINDS-sponsored collaborative program to accelerate therapeutics development for spinal muscular atrophy and until recently, an Independent Observer for the European Union’s Innovative Medicine Initiative. He currently sits on the scientific advisory board for and is a drug discovery consultant to Galenea Corporation (Cambridge, Mass).

### Chemistry, Manufacturing and Controls (CMC) 

### Gian Luca Araldi, PhD, PharmD, MBA

Dr. Araldi is a pharmaceutical and biotechnology executive with more than 25 years of experience having responsibilities ranging from basic research through clinical development at major pharmaceutical companies including Glaxo, Forest Laboratories and Merck-Serono. Dr. Araldi has been involved in the development of key medicines such as Teflaro®, Dutogliptin®, Gavestinel®, Sanfetrinem® and Sanfetrinem® Cilexetil and is inventor of 113 granted patents. His areas of expertise span from medicinal chemistry to process development, manufacturing, and project management. Throughout his career, he has worked in diverse therapeutic areas which include oncology, cardiovascular disease, neurological disorders and immunology where he has obtained many breakthrough results. He has fostered constructive relationships with many academic labs, biotech, pharma companies and government institutions both domestic and foreign. Dr. Araldi has a doctorate degree in Organic Chemistry and a doctorate degree in Pharmacy awarded both from the University of Parma (Italy) and recently received his M.B.A. in Finance from Long Island University Post and Project Management certification from Stony Brook University.

### Robert (Bob) Timko, RPh, PhD

Dr. Timko has over 45 years of experience working in the pharmaceutical industry in various technical and managerial positions at Johnson & Johnson and AstraZeneca Pharmaceuticals. Dr. Timko founded RhoTau Pharma Services to provide consulting expertise in the Pharmaceutical and Regulatory Sciences with a focus on assisting clients achieve their product goals of a fast submission and seamless approval, while assuring a cost-effective product and secure supply chain. He has worked with a variety of traditional and novel dosage forms across therapeutic areas and interacted with global Health Authorities on a diverse range of CMC topics. He is well versed in the technical and regulatory documentation requirements for INDs/IMPDs, NDAs/MAAs, and sNDAs/Variations. Dr. Timko is considered a subject matter expert with in-depth knowledge of Quality-by-Design, Process Analytical Technology, and Real Time Release in the current regulatory environment. Over the years, Dr. Timko has been involved in preparing and/or reviewing more than 35 marketing applications either in a pharmaceutical development or regulatory capacity for innovator and generic compounds for a variety of small and large molecule dosage forms, including but not limited to, immediate and extended release solid dosage forms, injectables, and liquids. He has hands-on experience in dosage form development, scale-up to commercial manufacture and production troubleshooting, preparing CMC briefing and regulatory documentation, preparing teams, and leading face-to-face meetings with Health Authorities. Additionally, Dr. Timko has provided technical expertise and served as a subject matter expert witness on formulation development in patent litigation cases. He holds several formulation patents and has written and co-authored numerous articles for peer-reviewed journals and technical publications. He has also made presentations on formulation and process development and regulatory affairs topics as an invited speaker at association meetings and scientific conferences. Dr. Timko is an active member of the American Association of Pharmaceutical Scientists (AAPS), the International Society of Pharmaceutical Engineers (ISPE), the International Academy of Compounding Pharmacists (IACP) and the Pennsylvania Pharmacist Association (PPA). He is a Registered Pharmacist in New Jersey and Pennsylvania.

## Drug Metabolism and Pharmacokinetics (DMPK)****

### Ronald Franklin, PhD, DABT

Dr. Franklin is Chief Scientific Officer and Founder of Franklin ADME Consult, LLC, a consulting company advising pharmaceutical companies on all aspects of ADMET in discovery, development and early clinical studies. Prior to entering big pharma in 1981, he was Assistant Professor in the Department of Pharmacology and Toxicology at The Medical College of Wisconsin where he conducted research into lung toxicity with the aid of an R01 grant from NIH (NHLBI). Subsequently, during his 14 year tenure at Eli Lilly and Co., he worked on predominantly cardiovascular and CNS drugs, including isomazole, quinelorane, flumezapine, olanzapine (Zyprexa) and dapoxetine (sold and later named Priligy). He had a brief spell at Amgen in Boulder, CO and then 7 years at Merck Research Laboratories in Rahway, NJ as Director of Discovery Metabolism and then Director of Development Metabolism involved primarily with PPAR agonists. Dr. Franklin became Senior Director of Drug Metabolism, Pharmacokinetics and Clinical Pharmacology at Array Biopharma, Inc in 2004 where he stayed for 10 years before founding his own company. He has 81 peer-reviewed papers and 4 book chapters. He was on the Editorial Board of Drug Metabolism Disposition for 19 yearsB and he is a Field Editor for the Journal of Pharmacological and Toxicological Methods. He is also on the Editorial Board Current Drug Metabolism and Drug Metabolism Letters. He has been a Diplomate of the American Board of Toxicology since 1981.

### Paul G. Pearson, PhD

Dr. Pearson is President and Chief Executive Officer of Pearson Pharma Partners, a consulting organization that specializes in pharmacokinetics, drug metabolism and translational science for biopharma and venture capital companies. In prior positions, he served as Global Head and Vice President of Pharmacokinetics and Drug Metabolism at Amgen and as Executive Director of Preclinical Drug Metabolism at Merck Research Laboratories where he was responsible for drug metabolism support for drug discovery and development programs. Dr Pearson has published extensively in the areas of pharmacokinetics, drug metabolism, reactive drug metabolites, drug-drug interactions and drug-induced toxicities, as well as co-edited the Handbook of Drug Metabolism. His research interests are focused on pharmacokinetics and drug metabolism, including the understanding of factors that influence the pharmacokinetics, metabolism, efficacy and safety of novel therapeutic agents in humans. For a period of almost 20 years, Dr Pearson has made major contributions to the approval of important new therapeutics to treat cancer (Camposar, Vectibix), Parkinson’s disease, hematological disorders (Nplate), HIV (Isentress) and fatal fungal infections (Cancidas).

### David Sweeny, PhD

Dr. Sweeny is a senior-level DMPK consultant with Midnight Sun Technologies. LLC. He has over 33 years of experience in the pharmaceutical industry, having worked at Abbott Laboratories, Gilead Sciences, SUGEN (Pfizer) and Rigel Pharmaceuticals.  Most recently, he was a Senior Research Fellow at Rigel Pharmaceuticals where he supported the DMPK needs for Drug Discovery and Development projects that included CNS targets. Currently, he is a DMPK consultant for several pharmaceutical companies working on projects for small molecule, SiRNA and protein therapeutics. During his 18 years at Rigel, Dr. Sweeny made significant contributions for the approval of fostamatinib in the US, Europe and Canada. During his career, he has also contributed to the approval of Sutent, Tamiflu, Tenofovir and Zileuton.  Dr. Sweeny has over 30 peer-reviewed research articles, two book chapters and one patent. 

### Devin Welty, PhD

Dr. Welty has more than 30 years’ professional experience in Drug Metabolism and Pharmacokinetics and Clinical Pharmacology. His expertise is in the areas of pharmacokinetics, pharmacodynamics and translational medicine of small molecules, biologics and gene therapy. He guides modeling and simulation to support drug discovery and development programs. In his current position as Vice President, Nonclinical and Clinical Pharmacology at Allucent, he is responsible for consulting to sponsors in bringing preclinical assets into early clinical development and supporting early clinical development.  Prior to this role, Dr. Welty served as Global Head of DMPK, Shire Pharmaceuticals; Head of Pharmacology and Pharmacokinetics, Forum; Sr. Director, DMPK, Allergan; and Sr. Research Fellow, Neurology, Parke-Davis, Warner-Lambert. He has supported more than 25 worldwide approvals for products in Neurology, Ophthalmology and in Rare Diseases. He holds bachelor’s and doctor’s degrees in Chemistry, Pharmacy and Pharmacokinetics from the University of Florida and the Medical College of Virginia. Most recently, Dr. Welty has served as Chair of the University of Washington, School of Pharmacy, Corporate Advisory Board, and on the Board of Directors, Innovation and Quality Consortium.

### Gene Williams, PhD

Dr. Gene Williams has more than 25 years of experience in strategic planning and review of drug metabolism and pharmacokinetics-related elements of comprehensive drug development programs (from nonclinical IND enabling studies through NDA/BLA submission and post-marketing studies). Gene worked on over 600 different drugs as a Clinical Pharmacology Team Leader at FDA and over 400 as an FDA Primary Reviewer. Molecule types included non-biologics of all types, peptides, oligonucleotides, glycoprotein mixtures, antibodies and antibody-drug conjugates, liposomes and nanoparticles. The diversity across drug types has continued in his current role as a consultant where he has worked on small molecules through gene therapies. As a post-doctoral fellow at what was then the Neurobiology and Anesthesiology Branch of the National Institute of Dental Research at the NIH, Gene investigated the quantitative effects, i.e., additive-ness, synergy or antagonism, of small molecule drug combinations in a rat analgesia model and opioid-induced pruritus in a primate model. Gene’s doctoral dissertation was on the neurochemistry of feedback control of serotonin release in the rat spinal cord.

### Ronald E. White, PhD

Dr. White is President of White Global Pharma Consultants, LLC in Cranbury, New Jersey. He was formerly Distinguished Research Fellow, Pharmaceutical Candidate Optimization at Bristol-Myers Squibb and Vice President at the Schering-Plough Research Institute in charge of all ADME, pharmacokinetics and bioanalytical in both discovery and clinical development. In that position, he developed Noxafil® (posaconazole), PEG-Intron® (pegylated interferon-alpha), Victrellis® (bocepravir), Vorapaxar® (thrombin receptor antagonist), and Zetia® (ezetimibe). Prior to joining industry in 1987, he was Associate Professor of Pharmacology at the University of Connecticut School of Medicine. He is a past member of the Pharmacology Study Section of the National Institutes of Health and of the Drug Metabolism Technical Group of Pharmaceutical Research Manufacturers of America and was Chair of the Gordon Research Conference on Drug Metabolism. He is currently a member of the Editorial Board of the journal Drug Metabolism and Disposition and Adjunct Professor of Chemical Biology in the Rutgers University School of Pharmacy. Dr. White holds a Ph.D. in Organic Chemistry from the University of Wisconsin and completed post-doctoral research in biochemistry at the University of Michigan. He has lectured and published extensively in the areas of drug metabolizing enzymes, pharmacokinetics and drug discovery, and is the holder of five United States patents.

## Toxicology

### Amy Kimzey, PhD, DABT

Dr. Amy Kimzey is a Senior Managing Scientist with more than 16 years of experience in pharmaceu­tical discovery and regulatory toxicology. Dr. Kimzey has served as the lead project toxicologist for multiple programs addressing various indications for small-molecule and biologics candidate drugs, and she has advised project teams and colleagues on central nervous system (CNS) drug development. Dr. Kimzey also has experience in discovery toxicology, including identifying and solving toxicology prob­lems during the pre‐candidate stage and identifying potential drug candidates with the highest probability for success in collaboration with multidisciplinary project teams. In addition, Dr. Kimzey is also the lead or co-author of numerous manuscripts, posters, and regulatory submissions, including nine successful IND submissions to FDA and an additional three IND/IND equivalent submissions pending for 2022. She presented a poster titled, “Case Studies Demonstrating the Process and Challenges of Deriving Exposure-Based Limits for Impurities in Pharmaceutical Drug Products Administered Directly to the CNS,” at the American College of Toxicology’s 2021 meeting. Dr. Kimzey has provided toxicology support for multiple CNS drug candidates supported by the NIH HEAL Initiative, including a highly complex pain program for which the small molecule test article is administered via the intrathecal route, as well as an oral small molecule drug candidate to treat pain.

### Marc Bailie, D.V.M., Ph.D.

Dr. Bailie is the Chief Development Officer at Integrated Nonclinical Development Solutions Inc., a drug development consulting company, and the Director of the In Vivo Facility in the Department of Pharmacology and Toxicology at Michigan State University. Prior to his current roles, he spent 11 years at Parke-Davis/Pfizer, building and directing the Safety Pharmacology Group within Drug Safety Research and Development. Dr. Bailie also has extensive experience in a broad array of animal models for the evaluation of pharmacologic and toxicologic activity of compounds. Over his tenure at Parke-Davis/Pfizer, he served on numerous Discovery and Development project teams across a variety of therapeutic areas, provided scientific direction for safety pharmacology both locally and on a global basis, and served as expert council for cardiovascular and general safety pharmacology within and outside of Pfizer. Dr. Bailie has published over 30 papers in peer-reviewed journals, and has led or participated in several expert working groups sponsored by the ISLI Health and Environmental Sciences Institute.

### Kristina Ulrich, PhD, MSc, ERT

Dr. Kristina Ulrich is a Senior Managing Scientist with more than 18 years of experience working in or with the pharmaceutical industry, including 15 years as a toxicologist supporting drug discovery and development programs, with a focus on neurology (psychiatry and neurodegeneration) and pain indica­tions. Dr. Ulrich has provided nonclinical study oversight and written regulatory documents for FIH studies and Phase 2 and 3 clinical trials, including five INDs/CTAs. Dr. Ulrich led the nonclinical safety strategy for a neuroscience portfolio in a large pharmaceutical company. This included mentoring project toxicologists, developing nonclinical safety plans, critically reviewing toxicology and safety pharmacol­ogy data, and providing data summaries for internal governance interactions and regulatory submissions. Dr. Ulrich is also a former nonclinical assessor at the MHRA in the UK, where she reviewed nonclinical data packages submitted with applications for clinical trials to be conducted in the UK and Europe. Currently, Dr. Ulrich provides scientific and regulatory advice to numerous pharmaceutical companies regarding nonclinical development in support of clinical trials and marketing authorization for a wide range of therapeutic approaches (small molecules, biologics, cell and gene therapies). She specializes in designing and implementing nonclinical safety strategies, as well as health authority interactions, data review, problem solving, and recommendations for further scientific investigations. She has also supported development of an intra-articular gene therapy drug candidate in the NIH HEAL program for pain due to osteoarthritis, including providing guidance on the design of preliminary *in vivo* safety and biodistribution studies.

### Marcie Woods, PhD

Dr. Marcie Wood is a Principal Scientist and Director of ToxStrategies’ Biopharmaceutical/ Pharmaceu­tical Practice. She is a toxicology consultant with more than 20 years of experience in toxicology and drug discovery and development, including 7 years at the FDA as a pharmacology/toxicology reviewer and supervisor. Through her career, she has gained extensive knowledge of regulatory agency nonclinical expectations for the development of drug products for pulmonary, rheumatology, oncology, and ophthal­mology, dermatology, and neurology and pain indications, as well as experience in addressing challenging scientific and regulatory issues (e.g., nonclinical hold deficiencies). In addition, Dr. Wood has experience with unique or complex routes of administration (e.g., intra-articular, intranasal, inhalation, and dermal routes), for both biological and small-molecule products. She also has experience in the design, monitor­ing, and data interpretation of animal (rodent and non-rodent) toxicology studies (GLP and non-GLP), in developing nonclinical sections (pharmacology, pharmacokinetics, toxicology) of regulatory documents (e.g., preIND, IND, BLA/NDA), and regulatory agency interactions. To date, Dr. Wood has overseen or contributed to the nonclinical aspects of successful regulatory submissions, including nine INDs/CTAs and three NDAs, with another NDA currently under FDA review. She has also supported development of an oral small-molecule drug candidate in the NIH HEAL program, including providing feedback on late-stage developmental toxicology data and recommendations for pharmacokinetic, maximum-toler­ated-dose, and dose-range-finding non-GLP toxicology studies.

## Regulatory

### Michael Day, PhD

Dr. Michael Day has over 24 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services, having worked on the review, preparation, and maintenance of numerous regulatory documents and submissions, including INDs, ANDAs, BLAs, and NDAs. Prior to joining VCLS, Dr. Day was the Managing Director of CMC/Global Regulatory Affairs at Cardinal Health Regulatory Sciences where he was responsible for providing comprehensive regulatory and CMC global strategy to clients at various stages of their product development. Michael has led and attended multiple Agency meetings and interactions with numerous divisions of the FDA, including information requests, pre-IND, end-of-phase 2, pre-NDA, and Type C/Scientific advice. Dr. Day received his PhD in Pharmaceutical Sciences and Chemistry from the University of Missouri-Kansas City. He also currently serves as adjunct faculty for University of Missouri-Kansas City, School of Pharmacy and is the Vice-President of the Pharmaceutical Technical Exchange Association.

### Lynn Thomas, PhD

Dr. Thomas, Senior Group Leader, Regulatory Science, is a drug development scientist with extensive experience in pharmacokinetics, safety, and toxicology research. She has experience in multiple aspects of nonclinical development for new chemical entities, including interactions with clinical research organizations, study design, and preparation of regulatory documents such as pre-INDs/ INDs, NDAs, annual reports, Investigator’s Brochures (IBs), Clinical Development Plans, protocols, and informed consents, as well as scientific manuscripts and presentations. She supervises the Regulatory Operations staff responsible for submission and maintenance of regulatory dossiers with regulatory agencies and is responsible for the direct management of the design, publishing, review, submission, and archiving of electronic submissions to regulatory authorities. Dr. Thomas has experience in regulatory document management and eCTD publishing (drug/device/biologics) and an in-depth understanding of eCTD structure, as well as FDA and ICH specifications for eCTD submissions. She provides scientific oversight and project management support and ensures quality control standards for regulatory submissions, working with Agent Project Managers on CTD content and organization, and has interacted with US, UK, and German regulatory authorities. She is experienced in formulation of regulatory strategy for drug development projects, from initial nonclinical planning through IND and NDA submission. She has served as Program Director for clinical stage (phase 1–2) projects, as well as planned and led drug development projects for new and existing chemical entities. Dr. Thomas has performed literature reviews and summarized information on a variety of clinical and nonclinical subjects, including safety assessments on various excipients and impurities of drug products. Dr. Thomas holds a PhD in Pharmacology/Toxicology.

## Connection to Other NIH HEAL Initiative® Programs

PTDP is part of the Helping to End Addiction Long-term® Initiative, or NIHHEAL 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

              - Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain
              - Preclinical Screening Platform for Pain
              - Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder
              - Translating Discoveries into Effective Devices to Treat Pain
              - Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions

## Active Funded Projects

## Resources and Tools

## Contacts

> 
Mary Ann Pelleymounter, Ph.D. | Program Director and Program Officermary.pelleymounter@nih.gov

Mohamed Hachicha, Ph.D. | Scientific Program Managermohamed.hachicha@nih.gov

Pascal Laeng, Ph.D. | Scientific Program Managerpascal.laeng@nih.gov

Oreisa O'Neil-Mathurin, MPH | Scientific Program Manageroreisa.o'neil@nih.gov

Shamsi Raeissi, Ph.D. | Scientific Program Managershamsi.raeissi@nih.gov

Matthew Rice, Ph.D. | Scientific Program Managermatthew.rice@nih.gov

Rebecca (Becky) Roof, Ph.D. | Scientific Program Managerrebecca.roof@nih.gov

Rakonda Medley, B.S. | Operations CoordinatorRakonda.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: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

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 PainApril 12, 2023 2:00pm EST | Webinar

View the OPEN Stage: Drug Discovery & Development at NINDS - Funding and Training Opportunities Featuring First-hand Experiences from AwardeesJuly 26, 2022 12:30PM EST | Webinar
> 
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