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.
Stephen R. Anderson, Ph.D., Pharmaceutical development
Dr. Anderson (Director of Solid State Chemistry, Nalas Engineering Services) received his Ph.D. in Pharmaceutics/Industrial Pharmacy and has 25 years of experience in physical-chemical profiling of new chemical entities, solid state form selection, and crystallization development. While working at the interface between Drug Discovery and Early Development at Novartis, DuPont Pharmaceuticals, and Pfizer Dr. Anderson contributed to IND’s and investigator brochures in therapeutic the areas of oncology CVMED, CNS, and antibacterial/anti-infectives. He has led teams in the solid form screening and crystallization development of potent and highly potent compounds as well as developed a novel resonant mixing protocol for the formation and characterization of cocrystals of significance to the pharmaceutical and energetics communities. Dr. Anderson’s experience in Analytical Chemistry, Crystal Engineering, Pharmaceutical Formulation and Compaction Physics has enabled him to serve at the interface of the traditional disciplines of Chemical and Formulation Development. He has continuously been involved in developing and implementing solid state characterization methods to provide more thorough particle properties understanding to minimize development risks and enable cost-effective formulation. Dr. Anderson has contributed to multiple NDA’s Common Technical Documents Module 3 integrating API properties with formulation performance.
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.
Michael Day, Ph.D., Regulatory
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.
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 (Jim) Herman, Ph.D., Toxicology
Dr. Herman has more than 34 years’ experience managing the nonclinical development of novel pharmaceuticals from discovery through successful registration. Currently, he is Vice President of Toxicology at Certara USA, leading a group of 9 toxicologists providing strategic, operational, and tactical consulting services to small and large pharmaceutical companies worldwide. Previously, he was President of Integrated Nonclinical Development Solutions, Inc (INDS). Prior to establishing INDS, he spent 20 years at Pfizer and its predecessor in Ann Arbor (Parke‑Davis) in various scientific and managerial roles within the toxicology group. He has significant experience in serving on multidisciplinary drug development teams for small molecules and biologics in several therapeutic areas. He has also served as study director for exploratory and GLP toxicology studies, and is well-versed in study design, execution, and reporting. He also has significant experience in the regulatory toxicology field in all 3 regions (US, EU, and Japan), and has authored and/or critically reviewed over 200 nonclinical portions of IND and NDA/MAA submissions, including sections required for Investigator Brochures and product labeling. He was involved significantly in the development of the first-in-class drugs Cognex® (tacrine), Neurontin® (gabapentin), Rezulin® (troglitazone), Nexletol® (bempedoic acid), Onfi® (clobazam), and the blockbuster drugs Lipitor® (atorvastatin) and Lyrica® (pregabalin). Dr. Herman has also has experience as a nonclinical consultant in the National Institutes of Health’s Blueprint Neurotherapeutics Network.
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).
Amy Kimzey, Ph.D., D.A.B.T., Toxicology
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
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 Writing
Dr. Mendel, Senior Group Leader, Clinical Research, has extensive 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. He is skilled in developing and managing projects, supervising technical and scientific staff, serving as a scientific resource and pharmaceutical agent and/or medical device expert, providing nonclinical and clinical guidance, and interacting with clients. Dr. Mendel has managed regulatory submissions from IND through the NDA stage. His 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 IBs for eight compounds in five therapeutic areas: antivirals cyclic HPMPC and Tamiflu, oncology agents Sutent, SU14813, and CHIR-265, acute cardiovascular agent KAI-9803, pain inhibitor KAI-1678, and secondary hyperparathyroidism compound Parsabiv. In addition, he was responsible for several sections of the NDA and EU Marketing Authorisation Application filing for Tamiflu and had overall responsibility for the IB/IND nonclinical sections of Sutent, SU14813, CHIR-265, and Parsabiv. 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).
Frank Preugschat, Ph.D., Bioactivity Assay Development
Dr. Preugschat is a senior-level Bioactivity Assay Development SME consultant with Midnight Sun Technologies, LLC. Additionally, he is a paid consultant contributing to enzyme assay development, inhibitor design, chemistry SAR, and translational biomarker development for several bio/pharma companies. He also does pro bono consulting work for academics that work on interesting/challenging enzyme targets or technologies. He has 25 years of work experience at both pharmaceutical and biotechnology companies (both small molecule and antibody therapeutics). His main expertise is in the discovery and optimization of small molecule inhibitors for a wide range of enzymes. He has developed high, medium, and low throughput biochemical assays for the primary isolation and secondary mechanistic characterization of enzyme inhibitors. This work has resulted in numerous publications, issued patents, and the approval of marketed drugs. He is an experienced and talented scientist with the ability to quickly learn new technologies and apply them to scientific problems.
Nachimuthu Soundararajan Ph.D., Pharmaceutical Development
Dr. Soundararajan has over thirty-five years of outstanding performance in roles of increasing responsibility in Pharmaceutical R&D with 45+ publications and 60+ patents. Retired as a Director after a nearly 20 years of successful career at BMS where he was a leader in process development and CMC management for over 15 years. He led nine projects in the SUD/nervous-system conditions and has managed projects (CMC and process development) with more than 15 CROs and CMOs (both biologics and small molecules) over ten years. Among the approved drugs, Dr. Soundararajan had hands on experience in executing and managing drug discovery and development tasks for two drugs in CNS conditions and managing 11 to 17 drugs at executive level across the entire drug discovery and development process from discovery to clinical trials. He brings practical experience and expertise in working with ten to twelve interdisciplinary drug development functions that include but not limited to oncology, neuroscience, metabolic, cardiovascular, immunology and infectious diseases. While at BMS, Dr. Soundararajan submitted eleven INDs in infectious disease area, and contributed to at least seven NDAs in other areas. He brings extensive experience in preparation of CMC components of IND, CTA, NDA, and MAA. As a CMC consultant for several startup companies, he has demonstrated his expertise at executive level in managing, executing, drug discovery and development tasks for several drugs in US and Global markets. Dr. Soundararajan served five years as an Adjunct Faculty at Rutgers University Department of Chemistry and Chemical Biology teaching multiple undergraduate courses. Dr. Soundararajan has received numerous professional recognitions including three BMS Presidential Awards for process optimization and successful technology transfers, and several Star and Triumph Awards from BMS for Project Leadership and Innovation.
David J. Sweeney, Ph.D., Drug Metabolism and Pharmacokinetics
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.
Lynn Thomas, Ph.D., Regulatory
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.
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.
Kristina Ulrich, Ph.D., M.Sc., E.R.T., Toxicology
Dr. 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.
Devin Welty, Ph.D., Drug metabolism and pharmacokinetics
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. Dr. Welty 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, he 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.
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.
Marcie Wood, Ph.D., Toxicology
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.
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.