Researchers participating in the Blueprint Neurotherapeutics Network receive grant funding (a UG3/UH3 award, or a U44 award if a small business) and no-cost access to drug development consultants and contract research organizations (CROs).
Research Grants (UG3/UH3 or U44)
All projects that enter the BPN will begin with a preparatory phase of up to one year, which should be used to complete any studies required to initiate Discovery or Development activities and to engage the LDT in establishing a detailed research plan and go/no-go milestones for all subsequent work.
Projects can enter the BPN during the Discovery or Development stage and may seek support through phase I/first-in-human testing. Discovery involves iterative medicinal chemistry to improve the potency and ADMET properties of compounds in order to identify a development candidate. During Development, a development candidate undergoes preclinical toxicology testing required for an IND and manufacturing, ultimately advancing into phase I/first-in-human testing. BPN-supported Development activities include chemical manufacturing and controls (CMC), formulation development, toxicology studies, regulatory support, and phase I/first-in-human testing.
External Oversight Committee
Michael J. Detke, M.D., Ph.D.
Mike Detke is a board-certified psychiatrist with over 25 years of research, clinical and drug development experience. Through his company, he consults to multiple pharma, biotech, and NIH customers regarding all aspects of CNS clinical trial design and conduct, serves on scientific advisory boards, data & safety monitoring boards, etc. As MedAvante CMO, he led a team dedicated to improving signal detection in CNS clinical trials, collaborating with almost all CNS pharmas & biotechs, NIMH, the VA, etc. Products included centralized ratings, central audio/video review, rater training, etc. As head of early phase CNS development at Eli Lilly, he oversaw all assets targeting psychiatric, neurological, and pain indications from candidate selection to proof-of-concept. Previously at Lilly, he was Senior Medical Director for Phase III development for Cymbalta and Phase IV for Prozac. This included all lifecycle indications for Cymbalta globally. Both roles also included general management of large teams of physicians/scientists and significant budgetary responsibilities. Dr. Detke has taught and supervised medical students and residents in patient care as an adjunct Clinical Professor of Psychiatry at Indiana University School of Medicine since 2000. He graduated summa cum laude with a BA and MS in Psychology at Yale University, and received his MA, MD, and PhD degrees at the University of Pennsylvania, where he was awarded NIH and NIMH fellowships. His training in medicine and psychiatry were conducted at Harvard Medical School, at the Mt. Auburn, McLean, and Massachusetts General Hospitals, and he completed a fellowship in psychopharmacology at Harvard Medical School and McLean Hospital. He has published over 70 manuscripts in peer-reviewed journals, serves as a reviewer for numerous such journals, and is a member of selective scientific organizations such as ACNP, ASCP, ISCTM and SOBP.
Peter Farina, Ph.D.
Dr. Peter Farina is an Executive in Residence at Canaan Partners, a venture capital firm he advises on pharma/biotech/healthcare investments, and is the managing partner of a consulting firm, Salient Science & Technology, LLC, which advises US and Chinese biotech firms on strategic and technical matter in pharmaceutical R&D. Dr. Farina currently serves as the Co-Chairman and Board Member of Connecticut United for Research Excellence (CURE); the Advisory Board of the University of Connecticut School of Pharmacy, Emory University DRIVE Advisory Board, and was a Founder and CEO of Developing World Cures, a nonprofit company working on neglected diseases. Dr. Peter Farina retired in 2008 as Senior Vice President of Development at Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT where he was responsible for North American development of drugs in the therapeutics areas of Immunology/Inflammation, Virology and Cardiovascular Disease. During his tenure as SVP at BI, his interdisciplinary team worked on the development and successful registration of Aptivus®, an HIV protease inhibitor, Viramune XR® for HIV and Atrovent HFA® for COPD and emphysema. Prior to this position he served as Vice President of Research at the Ridgefield Center. He has also held positions as Director of Inflammatory Diseases and Director of Biochemistry over his 28 year career with Boehringer Ingelheim. Prior to joining BI he spent 6 years in the Corporate Research Laboratories and Medical Products Division of Union Carbide Corporation in Tarrytown, NY where he did research and development of immunodiagnostics. Dr. Farina’s research interest has been generally at the interface of chemistry and biology. He has worked over his research career on inflammatory and immunological mechanisms, particularly cytokines and arachidonic acid mediators. In addition, he was engaged in HIV virology research which led to discovery and successful registration of one of the first non-nucleoside reverse transcriptase inhibitors Viramune® (nevirapine). He is the author of over fifty publications and patents. Dr. Farina has a Ph.D. in organic chemistry from SUNY Buffalo and did postdoctoral work in bioorganic chemistry at Pennsylvania State University with Dr. Stephen Benkovic.
John McCall, Ph.D.
Dr. McCall’s expertise is drug discovery, risk minimization, and medicinal chemistry. He has worked in a number of disease areas including acute and chronic neurologic disorders. He is currently President, PharMac LLC. He began his career as a medicinal chemist with Upjohn and has subsequently held positions with Pharmacia and Upjohn, Pharmacia, and Pfizer. Dr. McCall was Director of CNS Research with Upjohn, Vice President and Global Head of Chemistry for both Pharmacia and Pharmacia & Upjohn and Vice President Research with Pfizer. Dr. McCall is currently the chair of the development team for the NINDS Spinal Muscular Atrophy Project, serves on nineteen administrative and scientific advisory boards, consults, and has co-founded ReveraGen, a company that is developing new therapies for muscular dystrophy.
Jane Merkel, Ph.D.
Dr. Janie Merkel is the Director of the Yale Center for Molecular Discovery at Yale University. Through her training and professional experiences in biotechnology companies, she has focused on applying large scale biology technologies to answer biological questions across many fields. For over ten years at the Yale Center for Molecular Discovery, she has worked with the Center’s team of biologists and chemists in collaboration with faculty to develop assays for small molecule screening, perform high throughput screens, evaluate and optimize molecules identified in the screen. Working with faculty from more than 30 different departments in highly customized and service-oriented work, experienced staff bring their pharmaceutical industry experience to develop lead molecules towards novel biological endpoints. In 2016, the Center embarked on State-funded collaboration between Yale University and the University of Connecticut to rapidly translate ideas for novel targets into proof-of-concept data to promote venture investment in Connecticut. The program is open to projects across all therapeutic areas and with a focus, not reliance, on small molecule intervention. Janie received her Ph.D. from Yale University and her Bachelor’s Degree from Dartmouth College.
Daryl Schoepp, Ph.D.
Dr. Schoepp received his bachelor's degree in Pharmacy from North Dakota State University and his doctoral degree in Pharmacology and Toxicology from West Virginia University. Dr. Schoepp has over thirty years’ experience in the discovery and development of innovative Neuroscience therapeutics in pharmaceutical industry. This includes 20 years at Eli Lilly as a scientist and leader of Neuroscience research department, and 12 years at Merck as the Neuroscience research therapeutic area leader. He is recognized for having made major contributions in the investigation of the excitatory amino acid neurotransmitter glutamate in disease pathophysiology, pharmacology and therapeutics. He led early and current efforts to discover agents that act at the receptor level to activate, antagonize, or allosterically modulate excitatory amino acid neuronal transmission. With his colleagues at Lilly, Dr. Schoepp discovered many novel compounds that entered clinical development for the management of pain, migraine, epilepsy, anxiety, schizophrenia and neurodegenerative diseases.
Dr. Schoepp's has over 200 publications and have been cited over 19,000 times, he holds 15 U.S. patents, and he developed many new approaches to treat psychiatric and neurological diseases along the way. At Merck, his group developed a treatment option for insomnia. He's won numerous honors for his research studying glutamate receptors. His bench and leadership roles have led to the discovery and introduction into patients of over 20 novel first in class agents for psychiatric and neurological diseases. These include the first AMPA/kainate and metabotropic receptor negative and positive modulators (e.g. tezampanel, talampanel, LY354740, LY341595, eglumetad and pomoglumetad) investigated for migraine, pain, cognition, anxiety disorders and schizophrenia. While at Lilly, he was a co-discoverer of the compound LY246736 (alipimovan/Entereg) a first in class peripherally restricted opioid antagonist for post-operative ileus.
Also at Merck as head of Neuroscience research, his team have built a pipeline of innovative first class agents for Alzheimer’s disease, Parkinson’s disease, pain/migraine, and schizophrenia. Merck Neuroscience successfully developed and launched the first in class orexin receptor antagonist Suvorexant (Belsomra) for insomnia and created the novel first in class oral CGRP antagonists ubrogepant and atogepant currently in registration trials for migraine treatment and prevention (by Allergan). His group made important contributions to the pioneering trials of the BACE inhibitor verubecestat in prevention trials for Alzheimer’s disease.
Barbara Slusher, Ph.D.
Dr. Slusher, Ph.D., MAS, is Professor of Neurology (primary), Medicine, Psychiatry, and Neuroscience at Johns Hopkins School of Medicine and the Director of Johns Hopkins Drug Discovery . Dr. Slusher received her undergraduate degree from Dickinson College, majoring in Chemistry. She received her Ph.D. in Pharmacology and Molecular Sciences from Johns Hopkins School of Medicine while simultaneously earning her Master's degree in Administrative Science from the Johns Hopkins Carey School of Business.Before joining Johns Hopkins in 2010, Dr. Slusher spent 18 years in the pharmaceutical industry, including several years at the level of Senior Vice President of Research and Translational Development. She has extensive experience in drug discovery through early clinical development and was involved in the successful development, launch and/or post marketing support of several branded medicines including Quetiapine (Seroquel TM) for schizophrenia, Palonosetron (Aloxi TM) for chemotherapy-induced nausea and vomiting, Azacytodine (Dacogen TM) for myelodysplastic syndrome, and Fospropofol (Lucedra TM) for monitored anesthesia care (MAC) sedation. In 2009 she joined Johns Hopkins to lead the largest drug discovery program on campus with a veteran team of 20 medicinal chemists, assay developers, pharmacologists, toxicologists, and pharmacokinetics/drug metabolism experts. The team is engaged in identifying novel drug targets arising from the faculty’s research and translating them into new drug therapies for clinical development.Dr. Slusher has also founded the first-ever International Consortium of Academic Drug Discovery (www.addconsortium.org) with over 150 university-led translational centers and 1500 members. She has served on multiple scientific advisory boards and steering committees including Janssen, Eisai, Inc., Bayer, Bluefield Innovations, Neurofibromatosis Therapeutic Acceleration Program, American Society for Experimental NeuroTherapeutics, Longeviti Neurosolutions, and Ashvattha Therapeutics. Dr. Slusher has published over 200 scientific articles and is the inventor on over 100 patents and applications.
Each Lead Development Team receives support from BPN consultants. Consultants are assigned to a project with considerations for the project team's individual needs and consultants' expertise.
Paul Anderson, Ph.D., Medicinal chemistry
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.
Gian Luca Araldi, Ph.D., Pharm.D., M.B.A., Pharmaceutical development
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.
Marc Bailie, D.V.M., Ph.D., Toxicology
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.
Beth Burnside, Chemistry, Manufacturing, and Controls (CMC)
Dr. Beth A. Burnside has over 30 years of experience in the drug development process, with a proven record of success and in-depth experience providing creative solutions to meet strategic and business goals. Areas of expertise include drug delivery, enhanced drug absorption, regulatory affairs, quality and corporate compliance, and intellectual property strategy and negotiation. Products include Adderall XR®, Intunive® and MOXATAG®. Dr. Burnside has held executive roles with QRxPharma, MiddleBrook Pharmaceuticals (formerly Advancis Corporation) and Shire Laboratories, Inc.; her current position is Managing Member, Lowery Creek Consulting Group, LLC. As part of LCC, she consults for the NIH Blueprints Therapeutics program, and DisperSol Technologies, LLC. She also held research positions with Johnson & Johnson and Schering- Plough. She has 38+ issued US patents and numerous related international patents. She has authored numerous publications and presentations. Dr. Burnside earned a B.S. in Chemistry/Mathematics from Muhlenberg College, M.S. in Organic Chemistry and a Ph.D. in Physical-Organic Chemistry from Drexel University.
Steven K. Duddy, Ph.D., Toxicology
Dr. Duddy has over 25 years of toxicology experience in academia and the pharmaceutical industry, and he is currently a founder and Chief Scientific Officer at Integrated Nonclinical Development Solutions Inc. (INDS), a pharmaceutical development consulting firm. Prior to forming INDS in 2007, he spent 11 years at Parke-Davis/Pfizer, where he built a dynamic molecular toxicology group and focused on nonclinical drug safety research and compound development. Dr. Duddy has considerable experience as a drug discovery and development team representative, study director/monitor, author of nonclinical components of regulatory submissions (INDs, NDAs), and in formulating and implementing experimental and regulatory strategies to support development of promising preclinical drug candidates. Additionally, he has experience managing laboratory researchers and resources, solving difficult drug candidate toxicity issues through novel investigative strategies, supporting safety issue resolution for nonclinical drug candidates. Dr. Duddy has published and presented extensively on his research, has contributed to ILSI/HESI working groups on toxicology issues relevant to pharmaceutical development, and he regularly participates on NIH SBIR/STTR grant review panels. Before making the transition to pharmaceutical development, Dr. Duddy held academic research appointments at the W. Alton Jones Cell Science Center in Lake Placid, NY, and in the Department of Pathology, University of North Carolina-Chapel Hill.
Ronald B. Franklin, Ph.D., D.A.B.T., Pharmacokinetics
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 years 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.
James Herman, Ph.D., Toxicology
James “Jim” has 25 years of nonclinical drug safety research and development experience that included tactical and strategic support of nonclinical development projects and successive managerial appointments. Jim has significant experience in the regulatory toxicology field (US, EU, and Japan), and has contributed to over 100 IND and NDA submissions including, during his time at Pfizer/Warner-Lambert, those for Lipitor, Neurontin, and Lyrica.
Graham Johnson, Ph.D., Medicinal chemist
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).
Jon P. Lawson, Ph.D., Pharmaceutical development
Dr. Lawson is owner of J. P. Lawson Consulting LLC, advising the small molecule drug discovery community with drug development expertise. His experience includes over 10 years in discovery-related research and over 20 years in pharmaceutical process development at Monsanto, G. D. Searle, Pharmacia, and Pfizer. With Monsanto, Dr. Lawson was engaged in the discovery of new agricultural chemicals and in the synthesis of product metabolites to support Monsanto’s regulatory efforts. After transitioning to G. D. Searle’s chemical development group, he developed commercial processes for an important cardiovascular drug and led a team chartered with rapid identification of commercial manufacturing routes for a variety of drug candidates. With Pharmacia, he focused on early development, leading a team that developed initial manufacturing processes for compounds entering development. With Pfizer, he provided development guidance to the Inflammation Research group, and led the development and transfer of enabling processes into Pfizer’s global manufacturing facilities. Following the closure of Pfizer’s St. Louis research site, he founded J. P. Lawson Consulting and provides consulting services to a variety of drug discovery organizations as they move their candidates into early phase clinical trials. Dr. Lawson has 39 patents and publications in the development of synthetic methodology and drug manufacture.
Jiunn Lin, Ph.D., Drug metabolism and pharmacokinetics
Dr. Lin is an independent consultant who specializes in pharmacokinetics and drug metabolism. He currently provides consultation services for numerous Fortune 500 biotechnology companies in support of their drug discovery and development programs of small molecular compounds as well as large molecular biologics. He was formerly Executive Director at Merck Research Laboratories in charge of drug discovery and preclinical development. During his 26 year career at Merck, Dr. Lin made significant contributions to the FDA approval of 7 blockbuster drugs (Pepcid, Singulair, Fosamax, Crixivan, Trusopt, Cozaar, and Cancidas). Dr. Lin’s vast research experience and interests include dose- and species-dependent pharmacokinetics, in vitro-in vivo drug metabolism, renal handling of drugs, CNS drug delivery, and the role of drug transporters in tissue distribution and CNS transport. Recently, his research interest has focused on the pharmacokinetics of large molecules, including therapeutic monoclonal antibodies, proteins, and peptides. Dr. Lin has published more than 175 peer-reviewed research papers, 28 review articles, 10 book chapters, and 3 patents since 1978.
William H. Martin, Ph.D., Assay development
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.
Dirk Mendel, Ph.D., Medical writer
Dr. Mendel has extensive managerial and scientific experience in the discovery and early clinical development of novel compounds for oncology and antiviral indications, as well as for neurodegenerative, cardiovascular, pain, renal/metabolic, and respiratory/inflammation/autoimmunity disease areas. Dr. Mendel is an experienced project manager and has managed regulatory submissions from IND through the NDA stage. He also is an experienced medical writer, and was the lead author on several of the EPPIC-Net drug dossiers completed for BPN under CCSA's current BPN contract. He has been a key contributor to a recent phase 1 clinical trial manuscript for a commercial client and to regulatory submissions under our NCI, DCP contract. Dr. Mendel's primary focus has been on developing and executing translational strategies, such as pharmacokinetics/pharmacodynamics, biomarker, and patient segmentation, to aid the nomination of the best compounds and to ensure the effective clinical development of targeted therapeutics. He has worked with a variety of compound types including small molecules, antibodies, and peptides. Dr. Mendel has had primary responsibility for the nonclinical pharmacology sections of INDs and/or Investigator's Brochures (IBs) for seven compounds in five therapeutic areas: antivirals cyclic HPMPC and Tamiflu®, oncology agents Sutent® and CHIR-265, acute cardiovascular agent KAI-9803, pain inhibitor KAI-1678, and secondary hyperparathyroidism compound Parsabiv®. In addition, he was responsible for the NDA and EU Marketing Authorisation Application filing for Tamiflu® and had overall responsibility for the IB/IND nonclinical sections of SU11248 and CHIR-265. Dr. Mendel holds a PhD in physiology..
Lisa Minor, Ph.D., Assay development
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.
Paul G. Pearson, Ph.D., Pharmacokinetics
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).
Donna Romero, Ph.D., Medicinal chemistry
Dr. Romero is President of Pharma-Vation Consulting, LLC, which provides medicinal and synthetic chemistry expertise to small biotechnology companies, venture capital firms and the NIH Spinal Muscular Atrophy project. Trained as a synthetic chemist, Dr. Romero has over 20 years of experience working in positions ranging from lab leader to senior director in the pharmaceutical industry, including Upjohn, Pharmacia and Pfizer. While at Pharmacia, she led the Bacterial Genome project team which was responsible for the identification of novel antibacterial targets and subsequent identification of leads that inhibited those targets. Dr. Romero discovered Rescriptor®, a non-nucleoside reverse transcriptase inhibitor marketed for treating AIDS, has published 43 peer-reviewed articles, and is an inventor on many patents. She has experience working in a variety of therapeutic areas including infectious diseases, oncology, cardiovascular, and the central nervous system.
John M. "Jay" Sisco, Ph.D., Pharmaceutical development
Dr. Sisco is a well-seasoned pharmaceutical executive with extensive experience in the pre-clinical IND-enabling and Chemistry, Manufacturing, and Controls (CMC) arenas of pharmaceutical product development. Currently he is President and Founder of the consulting firm, JM Sisco Pharma Consulting, LLC. In his most recent industrial position, he was Senior Vice President of Preclinical and Pharmaceutical R&D at King Pharmaceuticals/Pfizer. He also has held executive positions at Nektar Therapeutics, Pfizer, Parke-Davis/Warner Lambert, and Oread, as well as scientific positions at Glaxo, Boehringer Ingelheim, and Schering. Over the course of his career, he has contributed to nearly 100 IND and 15 approved NDA filings. Dr. Sisco has a broad industry background, having worked for start-up companies and large multi-national pharmaceutical companies. His managerial experience includes overseeing colleagues and programs at multiple sites in multiple countries. He has worked on both sides of the fee-for-service industry and has experience with various R&D business models ranging from purely virtual to highly inward-focused. Dr. Sisco has been involved in the leadership of the American Association of Pharmaceutical Scientists (AAPS), holding elected positions as AAPS President and Executive Council Member-at-Large. He remains active in the association with his participation in the AAPS Mentoring Program. Dr. Sisco received his Ph.D. in pharmaceutical chemistry from the University of Kansas where he studied the mechanisms responsible for the unexpected stability and pharmacokinetics of a bis-imide anti-neoplastic agent under Dr. Valentino J. Stella.
Lynn Thomas, Ph.D., Regulatory Affairs Science
Dr. Thomas 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, Clinical Development Plans, protocols, and informed consents, as well as scientific manuscripts and presentations. Dr. Thomas 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. Under CCSA’s current BPN contract, Dr. Thomas served as the regulatory consultant for the EicOsis IND project, participating in Lead Development Team teleconferences and coordinating the activities necessary for IND submission. 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. She holds a PhD in pharmacology/toxicology.
Robert J. Timko, R.Ph., Ph.D., Pharmaceutical development
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.
Ronald E. White, Ph.D., Pharmacokinetics
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.
Steven D. Young, Ph.D., Medicinal chemistry
Dr. Young is a retired Vice President, Basic Research and former Head of the Department of Medicinal Chemistry at West Point, and currently Acting Head of Chemistry for BeiGene LTD, an innovative oncology-focused biotech in Beijing, China. During his tenure at Merck, the Medicinal Chemistry Department’s programs worked on drug candidates for a variety of diseases, including HIV/AIDS, Hepatitis C, endocrine problems, sleep disorders, depression, pain, migraine, schizophrenia, and Alzheimer’s disease. Dr. Young’s research at Merck, which began in 1982, focused on designing and synthesizing small molecule antivirals targeting the HIV protease, reverse transcriptase, and integrase enzymes. This led to efavirenz (StocrinTM, Merck; SustivaTM, Bristol-Meyers-Squibb), a widely prescribed non-nucleoside reverse transcriptase inhibitor. In conjunction with the antiviral research group, his work toward an effective HIV integrase inhibitor to treat HIV/AIDS led to the first clinical proof of concept for this mechanism . Continued work led to altegravir (IsentressTM, Merck), which gained regulatory approval in 2007. Dr. Young completed his Ph.D. in organic chemistry in Professor Clayton Heathcock’s laboratory at the University of California, Berkeley, after graduating from Stevens Institute of Technology. He has published extensively in journals on synthetic organic chemistry and drug design, and has 34 U.S. patents covering an array of drug candidates. He is a member of the Editorial Board for the journal ChemMedChem, and is a member of the Medicinal Chemistry Section of the American Chemical Society, AAAS, Sigma Xi and Scientific Advisory Boards for the University of Pennsylvania and University of California, Berkeley.
Contract Research Organizations
BPN researchers receive no-cost access to the network's Contract Research Organizations (CROs). LDTs plan and coordinate studies conducted by BPN CROs.
AMRI - 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