DataRevive Senior Consultants
The DataRevive team includes a truly one-of-a-kind roster of former FDA CMC and clinical professionals and industry operators who specialize in critical regulatory pathways globally.
Our experts aren’t just consultants but hands-on partners in your success. They work alongside you to accelerate time-to-market while upholding high quality from the earliest stages on.
- All
- Leadership
- CMC Team
- Nonclinical Team
- Clinical Team
- Regulatory / Delivery Leads
- Business Development
Dr. Dougherty received her Ph.D. from Georgetown University in Tumor Biology and completed her post-doctoral training in the Laboratory of Cell and Developmental Signaling at the National Cancer Institute, where she defined novel mechanisms of c-Raf and B-Raf regulation and characterized the function of Kinase Suppressor of Ras 2, a scaffold protein for the ERK signaling pathway.
Dr. Dougherty joined the FDA in 2008 as a product quality reviewer in the Office of Biotechnology Products. During her 8 years with OBP, she developed expertise across the manufacturing and product quality lifecycle, including review of early phase INDs, BLAs, post-approval manufacturing changes, and participating in GMP inspections. She managed a diverse portfolio of products including monoclonal antibodies,
antibody-drug conjugates, antibody cocktails, growth factors, enzymes, and biosimilar products. She held multiple leadership roles within OBP, including Team Lead and Review Chief. In 2017, she joined the Therapeutic Biologics and Biosimilar Staff in the FDA Office of New Drugs, where she was focused on supporting review of biosimilar products and participated in guidance and policy initiatives related to the biosimilar development pathway.
Michele Dougherty, Ph.D.
President of DataRevive
- Formerly FDA CDER OBP Review Chief
- 17+ years of oncology & antibody experience
Dr. Hutman is an internal medicine doctor by training and has worked in the pharmaceutical industry for over 20 years. Dr. Hutman was the principal investigator at a phase 1 unit of a contract research organization and conducted over 100 clinical studies including oncology, first in man, drug-drug interaction, PK, PD, food effect, and bioequivalence.
He was formerly Associate Director at Aventis Behring and led a phase 3 study for a surgical sealant used in liver resections. For almost nine years at Johnson and Johnson, Dr. Hutman worked in phase 3 and 4 studies in oncology, women’s health, dermatology, and interventional cardiology. He spent nearly five years as an independent consultant on medical, safety and regulatory issues for diabetes, oncology, and cardiovascular diseases.
Finally, in 2014, he joined AstraZeneca as the lead study physician for two multi-national phase 3 study in systemic lupus erythematosus involving over 250 clinical sites worldwide.
Dr. Hutman received his B.S. from the University of Miami in chemistry and an M.D. from Ross University. He completed his residency in internal medicine in Phoenix, and he is licensed to practice medicine in Florida.
H. Wayne Hutman, M.D.
Vice President, Clinical
- Doctor of Internal Medicine; Autoimmune, Cardiology, Endocrinology
- 20+ years in pharma industry
Shagun Popli joined DataRevive in May 2022. As a Project Management leader, she has expertise in Pharmaceutical/Biotech and Medical Device Industry. Ms. Popli has breadth of industry knowledge from early development to Launch. She has extensive experience in managing projects with global Cross-functional teams. Her skills go beyond the project management expertise from planning and managing Resources, Project Profile, Timelines and Budget to Vendor management and Business Analysis. Ms. Popli has a proven track record of delivering results and leading diverse projects for industry leaders like Astellas, Intuitive Surgical and Genentech and J&J.
Shagun Popli joined DataRevive in May 2022. As a Project Management leader, she has expertise in Pharmaceutical/Biotech and Medical Device Industry. Ms. Popli has breadth of industry knowledge from early development to Launch. She has extensive experience in managing projects with global Cross-functional teams. Her skills go beyond the project management expertise from planning and managing Resources, Project Profile, Timelines and Budget to Vendor management and Business Analysis. Ms. Popli has a proven track record of delivering results and leading diverse projects for industry leaders like Astellas, Intuitive Surgical and Genentech and J&J.
Ms. Popli has joined DataRevive following a distinguished career of 10 years with Janssen, a Johnson & Johnson (J&J) company. During her J&J tenure, Ms. Popli served as a Project Management consultant. At J&J, she managed Device Development processes in conjunction with Drug Development to deliver novel and innovative patient-centric Combination Products. Provided Project Management leadership and support to a global cross-functional team for developing Medical Devices. She was responsible for applying Design Controls to generate technical documents throughout the Planning, Input, Verification and Validation stages of development.
Prior to joining J&J, Ms. Popli’s experience involved Project Management leadership and support for IEC 60601-1 3rd Edition regulatory compliance project for electromechanical medical devices at Intuitive Surgical. Her experience also includes providing Project Management support for Strategic Pricing and Contracts department within Genentech and Lifescan where she consulted as a project manager to support to Strategy Managers for Provider and Payer contracts and launch of Medical Devices in OUS regions.
Ms. Popli earned her B.S. in Industrial Chemistry at Delhi University in New Delhi, India and her B.Ed. in Chemistry/Biology at Jamia Millia Islamia in New Delhi, India. She has received certification in Drug Development Process at UC Berkeley in Berkeley, California. Ms. Popli also received her MBA/MPM at Long Island University in Long Island, New York and the George Washington University in Washington, DC.
Shagun Popli
Vice President, Project Management
- Project Management leader with expertise in managing global cross functional teams within Pharma/Biotech industry.
- Former Project Management Lead Consultant for J&J, Genentech and Intuitive Surgical.
Tram Duong
Director, Regulatory Affairs
Ms. Duong joined DataRevive as Director, Regulatory Affairs with over 16 years of pharmaceutical/biotech experience in global strategic development, licensing and post-marketing regulatory activities for drug, biological and biotechnology products.
She has extensive experience in regulatory affairs including managing (from authoring to submission) original INDs/CTAs and global marketing authorizations (NDAs/BLAs/MAAs/ANDAs) as well as routine submissions (IND amendments, DSUR/Annual Report/post-approval supplements) along with Breakthrough Therapy and ODD applications with success. This includes strategic negotiations with US FDA (EOP2, Type C, PSP/PIP) and global regulatory authorities to gain valuable feedback.
She has in-depth expertise in the development and management of early to late-stage drug development program with global collaborators and partners (China, Japan, and EU). Her skills go beyond the regulatory from program management to managing timelines, clinical budget and leading the marketing authorization GCP inspection readiness along with managing the eTMF system. Ms. Duong earned her B.S degree in Chemistry and M.S degree in Clinical Science from the University of Montréal.
Tram Duong
Director, Regulatory Affairs
- 16 + years in US and International Regulatory Affairs (Clinical/CMC)
- Experience in all stages of drug development from proof of concept to global commercialization
Dr. Carrier received her Ph.D. in Immunology and Molecular Pathogenesis from Emory University and then pursued her postdoc study at Harvard University in the area of T cell biology with a focus on T cell differentiation and cytokines milieu.
Dr. Carrier has fifteen years of experience in nonclinical studies of biologic and small molecules. She worked at Pfizer for seven years on immunology and oncology drug development and nonclinical studies. She was responsible for the nonclinical perspective of many projects including monoclonal antibodies, immune-related proteins, human regulatory T (Treg) cells, IL-36, human T/ B cell biology, cytokine and co-stimulation molecules, adaptive and innate
immunity, with an emphasis on novel cytokine, co-stimulation pathway, and subset-specific surface markers of immune cells. She was responsible for designing the nonclinical studies, writing the study reports, nonclinical sections of the IND documents, and project management. She has broad knowledge of DMPK and toxicology studies, and also holds a project management certificate (PMP).
Julia Carrier, Ph.D.
Vice President, Nonclinical
- Formerly of Pfizer
- 18+ years of nonclinical PD, PK, and toxicology experience
Barbara Clendenen
Global Head of Business Development
As the Global Head of Business Development for Data-Revive, Barbara is responsible for driving business through identification of new markets, implementation of growth strategies, and the design of business processes.
Barbara brings over 20 years of sales management and business development experience in biotech and pharma, health care, and regulatory and clinical services. From February 2021 to June 2022, she oversaw business development, client relations, and operations at DataRevive, a Validant Group company. She has negotiated and closed numerous complex transactions while leading sales teams at Fisher Scientific, Quorum Review IRB (an independent ethics review board), and NDA Group AB (a drug development consultancy for the U.S. and Europe). These results were driven by Barbara’s passion for building relationships with organizations to cultivate long-term growth.
Barbara’s sales expertise is complemented by scientific understanding from her previous career as an immunology researcher for both Immunex and Bristol-Myers Squibb. She holds a Bachelor of Science in microbiology from the University of Washington and an MBA from Seattle University.
Barbara Clendenen
Global Head of Business Development
- 20+ years of sales management and business development experience in biotech and pharma, health care, and regulatory and clinical services.
- Former sales leader at Fisher Scientific, Quorum Review IRB (an independent ethics review board), and NDA Group AB.
Dr. Yong Wang has over 20 years of combined regulatory and industry small molecule CMC experience. He has 11 years of FDA small molecule CMC review experience. He was an acting CMC team leader/senior reviewer in the Office of New Drug Products/Office of Pharmaceutical Quality/Center of New Drug Evaluation and Research.
Dr. Wang obtained extensive knowledge in submission and reviewing IND, ANDAs, NDAs, and DMFs and approved many new and generic drugs in different dosage forms. In addition, he has a deep understanding of cGMP and conducted many prior approval and cGMP inspections.
Prior to his job at FDA, he held various research positions at J&J, Novartis, and Roche pharmaceuticals for drug product and API
process research and development, where he gained extensive hands-on experiences in pharmaceutical development and research for different stages of clinical studies, including process validation and product launch.
Dr. Yong received his Ph.D. in Organic Chemistry from the University of Iowa in 1994. After graduation, he was a post-doctoral fellow at Chemistry Department, Cornell University from 1994 to 1996.
Yong Wang, Ph.D.
Vice President, CMC Small Molecule
- Formerly FDA CDER CMC Review Team Leader, Small Molecule
- 20+ years of pharma & regulatory experience
Dr. Ma has a Ph.D. in Cellular Immunology and Molecular Pathogenesis from Emory University. Prior to joining DataRevive, she worked at Pfizer for more than fourteen years in the areas of immune-oncology, woman’s health, inflammation, and autoimmunity.
She has extensive nonclinical knowledge in immune-oncology, inflammation/autoimmunity, and in vitro/in vivo assay development. While at Pfizer, she has served in leadership positions such as senior principal scientist, group leader, project leader, and postdoc mentor. Dr. Ma has extensive experience with FDA regulations on small molecule and biologic drug development.
She is responsible for the PK/PD and toxicology part of regulatory dossier preparation and leads face-to-face meetings with FDA officials.
Dr. Ma is a senior consultant providing scientific and regulatory guidance to the clients for nonclinical Pre-IND and IND document preparation at DataRevive.
Margery Ma, Ph.D.
Non-Clinical Principal Consultant
- Formerly of Pfizer
- 20+ years of experience in immune-oncology, inflammation & autoimmunity
Dr. Li has 30+ years of hands-on research, regulatory, and management experience in Rx, OTC, and generic CMC product development for US, EU, and China markets. He worked at Allegan, Schering-Plough (now Merck), Wyeth (now Pfizer), Eisai, Frontage, GSK, and FDA prior to joining DataRevive. He had hands-on CMC product development experience with sterile and non-sterile products. He was formerly Director of Drug Delivery at Eisai, US, and Science Excellence Director at GSK Consumer Healthcare, China.
From 2014 to 2019, Dr. Li was a Biopharmaceutics reviewer in the Division of Biopharmaceutics/Office of New Drug Products, CMC Drug Product reviewer in the Office of Lifecycle Products, and a 4-month assignment in the Office of Surveillance. In the Division of Biopharmaceutics, he reviewed the biopharmaceutics data in IND, NDA, and ANDA submissions, including bridging study data. In the Office of Surveillance, he drafted site dossiers for inspectors to help them focus on residual cGMP gaps and recurring quality issues in recent cGMP inspections. In-Office of Lifecycle Products, Dr. Li reviewed ophthalmic and injectable generic product submissions. He collaborated with the OGD Science team to develop guidance for complex ophthalmic generic products. He was a member of the Ophthalmic Product Working Group to discuss challenging review issues.
His industrial experiences include: CMC product development from candidate selection to commercial launch, marketing communication by translating science into easy-to-understand language, evaluation of a broad range of drug delivery systems to solve developability challenges of new drugs, and lifecycle management of marketed products, and managing CRO & CMO. His industrial and FDA experiences allow him to understand the point of view of both sides on a particular issue.
Dr. Li holds an MS and Ph.D. degree in Pharmaceutics from the University of Wisconsin-Madison and a Bachelor degree in Chemistry from Hamilton College.
Vincent Li, Ph.D.
CMC Small Molecule Principal Consultant
- Formerly of GSK & FDA Biopharmaceutics Reviewer
- 30+ years of CMC experience
Kathleen has more than 30 years’ experience in the biologics industry. Kathleen has served as site head and general manager at Amgen, Genzyme, and Charles River, where she oversaw manufacturing, QA, QC, process development, and supply chain. The majority of her professional career was spent at Amgen. Over the course of her tenure at Amgen, Kathleen held a variety of positions of increasing responsibility, including VP / GM of Amgen’s Rhode Island Facility and Site Head of Amgen’s multi-plant Thousand Oaks manufacturing site.
Over her career, Kathleen has been responsible for the successful manufacture of a number of top biologics including EPOGEN®, Neupogen®, Aranesp®, Neulasta®, Infergen®, Enbrel®, Cerazyme®, Fabrazyme® and Myozyme®.
Kathleen was a founding member of Amgen’s Sales and Marketing Department where she served as EPOGEN® product manager during the product’s first three years, and where she led the team that secured the first-ever Medicare reimbursement for a biologic. Kathleen also served as Controller for Amgen’s Operations and Capital Investments groups for two years.
Kathleen holds an undergraduate degree from Brown University, and a Master’s degree from Stanford University.
Kathleen Retterson
V.P. CMC Biologics
- Formerly of Spectrum, Charles River, Genzyme & Amgen
- 30 years of experience in CMC/GMP