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

Wayne Hutman

H. Wayne Hutman, M.D.

President

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.

Wayne Hutman

H. Wayne Hutman, M.D.

President

  • Doctor of Internal Medicine; Autoimmune, Cardiology, Endocrinology
  • 20+ years in pharma industry
 

Julia Carrier

Julia Carrier, Ph.D.

Vice President, Nonclinical

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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

Julia Carrier, Ph.D.

Vice President, Nonclinical

  • Formerly of Pfizer
  • 18+ years of nonclinical PD, PK, and toxicology experience
 

Michele Dougherty

Michele Dougherty, Ph.D.

Vice President, CMC Biologics

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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

Michele Dougherty, Ph.D.

Vice President, CMC Biologics

  • Formerly FDA CDER OBP Review Chief
  • 17+ years of oncology & antibody experience
 

Yong Wang

Yong Wang, Ph.D.

Vice President, CMC Small Molecule

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

Yong Wang, Ph.D.

Vice President, CMC Small Molecule

  • Formerly FDA CDER CMC Review Team Leader, Small Molecule
  • 20+ years of pharma & regulatory experience
 

Suzanne Demko

Suzanne Demko

Vice President, Clinical

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Suzanne Demko, P.A.-C. has over 30 years of combined clinical, clinical trials, and regulatory experience in oncology, drug development, and regulatory review. She joined Data Revive on May 18, 2020. Prior to joining Data Revive, Ms. Demko was a clinical reviewer for four years and a clinical team leader for over ten years with the US FDA in the Office of Oncologic Diseases, Division of Oncology 2.


Initially, during her time at FDA, Ms. Demko was a full-time clinical reviewer responsible for a dossier of biologic products for all oncology indications. She subsequently led a clinical review team responsible for the review of drug and biologic products for indications involving neuro-oncology, pediatric oncology, and rare tumors. Before joining FDA, Ms. Demko spent 10 years as a clinician at NIH where she was involved in clinical care and research for inpatients enrolled in NCI Phases 0 – III clinical trials. Prior to joining NCI, she had a clinical role at Johns Hopkins University Medical Center, Oncology Center where she was responsible for the inpatient and outpatient care of adult and pediatric patients enrolled in bone marrow transplantation clinical trials.

In her role as clinical team leader with FDA, Ms. Demko provided leadership, supervision, and oversight of the review process for all phases of drug development. She also acted as cross-discipline team leader for NDA and BLA reviews, reviewed and responded to meeting dossiers, and provided development advice to industry.

She provided oversight and advice for expanded access programs and other FDA programs and initiatives; and she was involved in labeling negotiations, in the drafting of post-marketing requirements and commitments, ensuring product safety for drugs and biologics during their development programs, and in outreach to patient groups and other FDA stakeholders. In addition, Ms. Demko participated in Oncology Drug Advisory Committee meetings, Pediatric Oncology Drug Advisory Committee meetings, and she was a standing member of the Oncology Center for Excellence Subcommittee of the Pediatric Review Committee. Some of the new molecular entities and supplemental indications for drugs brought to market under her supervision are: everolimus (for renal angiomyolipoma and tuberous sclerosis complex), avelumab, cabozantinib, rasburicase, asparaginase Erwinia chrysanthemi, lenvatinib, cemiplimab-rwlc, lutetium Lu 177 dotatate, trametinib, sonidegib, regorafenib (for GIST), sunitinib, peginterferon alfa-2b, dabrafenib, pexidartinib, dinutuximab, denosumab, selumetinib, and selpercatinib.

Suzanne Demko

Suzanne Demko

Vice President, Clinical

  • Formerly FDA Oncology Clinical Review Team Leader
  • 15+ years of clinical experience
 

Audrey Jia

Audrey Jia, M.D., Ph.D.

Regulatory & CMC Principal Consultant

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Dr. Jia has 18 years of combined experience in biologic drug development and regulatory review. Dr. Jia spent 10 years from 1999 to 2009 in biopharmaceutical companies working on monoclonal antibody engineering, humanization, affinity maturation, expression, and purification. She holds several antibody humanization patents internationally. Dr. Jia has extensive hands-on experiences with biologic product CMC. She worked at PDL BioPharma and Facet Biotech (acquired by AbbVie), and Pfizer as a group leader to lead antibody development projects.


During her time in US FDA from 2009 to 2015, Dr. Jia was a full-time CMC reviewer for IND/BLA review of biological products including antibody fragments, fusion proteins, antibody-drug conjugate, combination products, and radiolabeled antibodies. She performed numerous IND reviews, several BLAs (including post-approval supplement reviews), and several US and international cGMP pre-approval inspections (PAIs). She is specialized in both novel proteins/ antibodies and biosimilar products reviews.

While working at the US FDA, Dr. Jia presented in international meetings for regulatory perspective of use of QbD for drug development, comparability studies, novel biological product development, and clonality of

the cell banks to support the IND and BLA. She was also one of the co-instructors for the MIT short course of formulation studies annually. Additionally, Dr. Jia was a key member in the policy development of breakthrough therapy in FDA and is very familiar with the regulatory requirements for fast track and breakthrough requests and how to develop a drug through the expedited pathway.

Dr. Jia holds a Master’s degree in Bioscience Regulatory Affairs from Johns Hopkins University, and a Ph.D. degree in Microbiology and Molecular Genetics from Emory University. Prior to that, Dr. Jia obtained her Bachelor’s degree in Medicine from Peking University. She also passed USMLE and obtained her ECFMG (certificates for foreign medical graduate).

Audrey Jia

Audrey Jia, M.D., Ph.D.

Regulatory & CMC Principal Consultant

  • Formerly of FDA CDER & Pfizer
  • 20+ years of experience
 

Margery Ma

Margery Ma, Ph.D.

Non-Clinical Principal Consultant

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

Margery Ma, Ph.D.

Non-Clinical Principal Consultant

  • Formerly of Pfizer
  • 20+ years of experience in immune-oncology, inflammation & autoimmunity
 

Vincent Li Datarevive

Vincent Li, Ph.D.

CMC Small Molecule Principal Consultant

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 Datarevive

Vincent Li, Ph.D.

CMC Small Molecule Principal Consultant

  • Formerly of GSK & FDA Biopharmaceutics Reviewer
  • 30+ years of CMC experience
 

Kathleen Retterson

Kathleen Retterson

Biologics Principal Consultant

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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

Kathleen Retterson

Biologics Principal Consultant

  • Formerly of Spectrum, Charles River, Genzyme & Amgen
  • 30 years of experience in CMC/GMP
 

Anuja Patel (002)

Anuja Patel, M.P.H.

Director, Regulatory Affairs

Anuja has more than 10 years of regulatory experience at FDA’s Center for Drug Evaluation and Research (CDER) as a Designated Federal Official (DFO) for Division of Advisory Committee and Consultant Management (DACCM) and Tobacco Product Science Advisory Committee (TPSAC) at Center for Tobacco Products (CTP), Office of Science (OS), and as a Regulatory Affairs Expert and Team Leader in the Office Oncologic Diseases (OOD), Division of Oncology 2 (DO2). Anuja also has more than 5 years of combined experience in pharmaceutical drug development as a clinical trials study coordinator, pharmaceutical professional representative for bone health and allergy drugs, and as a Senior Project Manager at a Contract Research Organization. 


Anuja has significant expertise in US regulatory affairs, given her extensive experience working at the Food and Drug Administration. During her stay at the FDA from 2009 to 2020, Anuja took multiple leadership positions including Designated Federal Official (DFO), Health Science Administrator, Senior Regulatory Affairs Expert, and Team Leader.

When she was the DFO for Division of Advisory Committee and Consultant Management (DACCM), she was responsible for the administrative and scientific review of Investigational New Drug Application (IND), New Drug Application (NDA), licensing or other health science issues presented to advisory committee members for detailed review, including a high profile joint meeting to discuss the occurrence of suicidality in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder and other psychiatric disorders which led to development of guidance and new regulations.

After she became Oncology Regulatory Affairs Expert, she independently managed more than 150 active INDs daily per 21 CFR 312s, and served as a member of CDER’s Regulatory Operations Advisory Board that consisted of Division Directors, CPMS, and Senior RPMs.

In addition, Anuja participated in the development of FDA Draft Guidance Document entitled, “Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics” which provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers.

Furthermore, she oversaw the implementation of the Federal Advisory Committee Act on the establishment and activities of the Tobacco Product Scientific Advisory Committee (TPSAC) during her time as the DFO and Health Science Administrator at the Center for Tobacco Products (CTP), Office of Science (OS).

Anuja holds a Master of Public Health in Epidemiology at the George Washington University, and a Graduate Certificate in Patient and Product Safety from the University of Southern California. She obtained her bachelor’s degree in Food Science and Human Nutrition from the University of Florida. Her hobbies include traveling, event coordinating, and spending time with her family on hiking trails.

Anuja Patel (002)

Anuja Patel, M.P.H.

Director, Regulatory Affairs

  • Formerly of FDA CDER
 

Mimi Biable Photo (002)

Missiratch (Mimi) Biable, M.S.

Director, Regulatory Affairs

Missiratch (Mimi) Biable, M.S., has 18 years of experience in the biotech industry, which includes over 10 years of experience in regulatory affairs with the U.S. Food and Drug Administration (FDA) and Astrazeneca/Medimmune LLC. She joined DataRevive in February 2021. Prior to joining DataRevive, Ms. Biable was a Regulatory Health Project Manager (RPM) for five years, a Regulatory Project Manager Team Leader for two years, and a Chief Project Manager in 2020 with the US FDA in the Office of at the Center for Drug Evaluation and Research (CDER) as part of the Office of Regulatory Operation (ORO), Division of Oncology 2 (DO2).


Ms. Biable earned her B.S, and M.S., degrees in Combined Science (Biology) and Bioscience Regulatory Affairs respectively. Early in her career, she worked as an associate scientist, and served as a clinical supply specialist in Medimmune LLC.


During her time at Medimmune LLC/ Astrazeneca, from 2009 to 2012, she delved into regulatory affairs and worked as a Regulatory Affairs associate. In this role, she helped developed strategies in support of investigational drug development submission to the US FDA and Rest of World. This included collection, evaluation, preparation, and assembly of documentation required for regulatory submissions (INDs, CTAs and IMPDs) to the US, Canada, EU, and Japan. During her time at FDA, from 2012 to 2017, she was a RPM and managed 150+INDs along with numerous marketing applications, including

Approvals of few new molecular entities (NMEs). As a RPM Team Leader from 2018-2020 she continued to manage applications, including approval of NMEs and supplemental applications, while also training and mentoring the regulatory project management staff.


From 2020-2021, she served as a Chief Project Manager, where she staffed up the Regulatory Project Management team, and lead in supporting and executing regulatory milestones for the Division of Oncology 2 (DO2). In that role, she worked in conjunction with the Division Director, Cross Discipline Team Leaders, and Discipline Team Leader at the FDA, to oversee the day-to-day management of a broad range of application reviews while ensuring timely completion of projects and timely resolution of regulatory conflicts to avoid delays in achieving goals.

Mimi Biable Photo (002)

Missiratch (Mimi) Biable, M.S.

Director, Regulatory Affairs

  • Formerly of FDA & AstraZeneca
  • 18+ years of experience