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
  • Preclinical Team
  • Clinical Team
  • Regulatory / Delivery Leads

Wayne Hutman

H. Wayne Hutman, M.D.

Managing Director

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.

Managing Director

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

Julia Carrier

Julia Carrier, Ph.D.

Vice President, Non-Clinical

LinkedIn

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, Non-Clinical

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

Michele Dougherty

Michele Dougherty, Ph.D.

Vice President, CMC Biologics

LinkedIn

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

LinkedIn

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
 

Monica Hughes

Monica Hughes, M.S.

Vice President, Delivery & Project Management

LinkedIn

Monica Hughes, M.S. has 18 years of combined regulatory affairs, inspections, and investigation experience at the U.S. Food and Drug Administration (FDA). She joined DataRevive in May 2020. Prior to joining DataRevive, Ms. Hughes was a Regulatory Health Project Manager (RPM) for four years, a Regulatory Project Manager Team Leader for five years, and a chief project manager for almost 10 years with the US FDA in the Office of at the Center for Drug Evaluation and Research (CDER) as part of the Office of Hematology Oncology Products (OHOP), Division of Oncology Products 2 (DOP2). 


During her time at FDA, from 2003 to 2007, she was an RPM and managed 150+INDs along with numerous marketing applications, including the approval of Vectibix.  As an RPM Team Leader from 2007-2012 she continued to manage applications, including the approval of Stivarga, while also training and mentoring the regulatory project management staff; and, from 2012-2020 where she served as a Chief Project Manager, supervising a regulatory project management staff in one of CDER’s busiest review divisions responsible for an average yearly incoming workload of 300+ new PDUFA/BSUFA meeting requests, 750+ new INDs, 250+ individual expanded access requests, 60+ efficacy supplements; and 5-10 NME NDA/BLA, 505 (b)(2), and biosimilar applications.  During recent years, DOP2 was responsible for managing the approvals of: Alecensa, Portrazzo, Cotellic, Tagrisso, Yondelis, Lonsurf, Odomzo, Unituxan, Lenvima, Lartuvo, Bavencio, Alunbrig, Mvasi, Vitrakvi, Lobrena, Libtayo, Vizimpro, Bravtovi, Mektovi, Lutathera, Azedra, Turalio; and Rozlytrek.

During her time working on oncology applications, and personal experience with her father battling cancer, she became passionate about broadening the knowledge on how physicians could access treatment for their patients using individual and emergency use INDs.  She helped develop a video series to provide an overview for physicians submitting these applications using the FDA form 3926 for the Agency.

Ms. Hughes earned her B.S, and M.S., degrees in Combined Science (Biology and Chemistry) and Molecular Biology respectively.  Early in her career, she worked for as a primary care pharmaceutical sales representative and served as an adjunct Biology faculty member at Youngstown State University, Cleveland State University, and at the University of Pittsburgh.

Monica Hughes

Monica Hughes, M.S.

Vice President, Delivery & Project Management

  • Formerly of FDA CDER
  • 17+ years of Regulatory Affairs experience
 

Audrey Jia

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

Regulatory & CMC Principal Consultant

LinkedIn

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
 

Team Robert Fenton

Robert Fenton, M.D., Ph.D

Clinical Principal Consultant

Dr. Fenton received undergraduate training at the University of Cincinnati, graduating with a BS in Biology. He then attended NYU School of Medicine as part of the MD/Ph.D. program, graduating in 1983. His Ph.D. dissertation described the transcription of viral genes in Polyoma virus-transformed cells. He then undertook Internal Medicine training at the Brigham and Woman’s Hospital followed by an Oncology Fellowship at the Dana-Farber Cancer Institute. He received post-doctoral research training in the Department of Genetics, Harvard Medical School.


After training, Dr. Fenton began his professional career as a Senior Investigator at the NCI in Frederick, Maryland. He was PI of a lab studying cancer vaccines and developed a number of Phase I studies using cancer vaccines in renal cell and melanoma. Clinical responsibilities included outpatient care of patients with non-Hodgkin Lymphoma, Hodgkin Disease, Hairy Cell Leukemia, melanoma, and renal cell cancer and attending on the clinical research ward.

After the NCI closed the program at the Frederick facility, Dr. Fenton became an Associate Professor of Medicine at the University of Maryland Greenebaum Cancer Center. He was an attending physician on the Stem Cell Transplant Service and performed laboratory studies aimed at identifying novel therapeutic targets in Multiple Myeloma. He was funded by a number of peer-reviewed research grants, trained post-doctoral fellows, medical interns, and residents, and published a number of papers in upper level scientific and medical journals. His clinical responsibilities evolved to attending on the Adult Leukemia Service, and then became a Clinical Investigator and PI on the Gastrointestinal Cancer Service. As a member of the Cancer Center, clinical responsibilities included close interactions with the clinical research team, as well as writing protocols, interacting with investigators at other research sites, monitoring the safety of subjects in clinical trials, and submitting SAEs to health authorities as required, etc. During this period, Dr. Fenton was a member of the Experimental Therapeutics Study Section of NCI, performing quarterly reviews of R01, R21, and P01 grants submitted by academic researchers to NIH.

Dr. Fenton was recruited to the National Institute on Aging, NIH, where he was involved with research in changes in metabolism and muscle physiology in the elderly, and designed a randomized Phase II study of resveratrol to study its effects on muscle physiology with the hope of improving strength and mobility of elderly subjects. This was followed by a brief period of Private Practice, but Dr. Fenton chose to get back into clinical research.

For the past 8 years, Dr. Fenton has worked as a consultant for large and small pharmaceutical companies and CROs. The work has encompassed a number of medical fields including oncology, infectious disease (e.g. HIV/AIDS), congenital diseases, and other Rare Diseases with Orphan Drug candidates. During this time his expertise has come to include Medical Monitoring of clinical studies, including SUSAR determination and submission to Health Authorities per ICH guidelines, and speaking directly with clinical site investigators or other members of the clinical team when necessary.  He has written a number of clinical protocols including randomized, international Phase III studies in early-stage bladder cancer that are now accruing patients. Additionally, he has authored or participated in writing numerous regulatory documents including pre-IND, IND, clinical study reports, Orphan Drug Applications to the FDA and EU, and a number of clinical protocols as mentioned. He has been involved in numerous high-level meetings with Health Authorities, helped arrange and participated in pre-IND meetings and Investigator Meetings, and had numerous close interactions with clinical research members during the development and implementation stages of clinical trials.

Dr. Fenton continues efforts to help bring novel therapeutic agents to the patients in greatest need. He continues to read extensively the medical and scientific literature so that he can make novel and important contributions to the clinical research team.

Team Robert Fenton

Robert Fenton, M.D., Ph.D

Clinical Principal Consultant

  • Formerly of Harvard University/NCI
  • 30 years of clinical oncology experience
 

Denise Casey

Denise Casey, M.D., M.S.

Clinical Principal Consultant

Dr. Casey is a pediatric hematologist/oncologist by training and has combined clinical and regulatory experience of 11+ years. Prior to joining DataRevive, Dr. Casey was a clinical reviewer in the oncology office at FDA for over 7 years and an Assistant Professor at University of Rochester Medical Center for 4 years.


Dr. Casey completed her pediatric hematology/oncology training and obtained a Master of Science in Clinical Investigation at Memorial Sloan Kettering Cancer Center/Weill Cornell Medical Center. She subsequently spent four years as an Assistant Professor in the Division of Pediatric Hematology/Oncology at Golisano Children’s Hospital, University of Rochester Medical Center in New York. There she was responsible for clinical care of patients and supervision and education of fellows, residents and medical students, and served as a subinvestigator for Children’s Oncology Group and Dana Farber Cancer Institute clinical trials.

Dr. Casey joined FDA in 2013 where she spent 6+ years as a clinical reviewer on the neuro-oncology, pediatric and rare tumors team in the Office of Oncologic Diseases (former Office of Hematology and Oncology Products) prior to her most recent position as Clinical Team Leader (acting) for the melanoma/sarcoma team. Dr. Casey was the primary clinical reviewer for several marketing applications for new molecular entities, efficacy and safety supplements, as well as numerous Breakthrough Therapy Designation Requests, Fast Track Designation Requests, and Proposed Pediatric Study Requests (PPSRs). She provided consult services to other divisions to advise on topics such as rare tumor drug development, pediatric oncology indications, co-development of devices for oncologic diseases, and radiopharmaceutical development in pediatric and adult oncology indications. She participated in internal and external outreach to further FDA’s mission to facilitate access to safe and effective drugs. She was a member of the Pediatric Oncology Working Group, participated in meetings of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee, and was invited to several conferences and workshops to present on topics including trial design for rare tumor drug development programs, radiopharmaceutical safety, and pediatric legislative initiatives.

Denise Casey

Denise Casey, M.D., M.S.

Clinical Principal Consultant

  • Formerly of FDA Office of Oncologic Diseases, CDER

    7+ years of experience

 

Avi Gnatt

Averell Gnatt, Ph.D.

Non-Clinical Principal Consultant

LinkedIn

Dr. Gnatt has 30 years of experience across the biomedical discovery and development spectrum. His findings were published on the cover of Science, Cell, and Molecular cell, others in PNAS and EMBO, and he was a major contributor to the 2006 Nobel prize in chemistry. His Masters and Ph.D. focused on neurobiology and Cholinesterases. After 10 years of research at Stanford University in transcription, biophysics, and structural biology he joined the University of Maryland School of Medicine, Pharmacology, directed a research lab, and taught in the Graduate and Medical schools. In the biomedical industry, Dr. Gnatt held positions such as director of biopharmaceuticals and director of biopolymer development. His expertise includes upstream to downstream drug development, cancer, transcription, regenerative bone therapeutics, diagnostics, antibiotics, and structural biology.


Highlights of Dr. Gnatt’s earlier biomedical career include the first cloning, expressing, and mutational analysis of human cholinesterases, and pharmacological analysis using agents that affect their function. For this work, he was awarded the European Society of Neurobiology young lecturers award. From 1990 to 2000, as a Post-doctorate and then PI, Dr. Gnatt worked at Stanford University and spearheaded the structure of 10-subunit RNA Polymerase II structure while it was actively transcribing RNA. The work was highlighted in a Nobel Award lecture, presented to congress, and highlighted on the cover of Science.  

As a pharmacologist, Dr. Gnatt spent 13 years at the University of Maryland School of medicine. His Lab focused on human transcription, cancer therapeutics, bone therapy, antivirals, and diagnostics.

Dr. Gnatt also taught Pharmacology in the Graduate and Medical Schools. He developed curriculum for graduate pharmacology students, and thereafter directed major sections (molecular biology, genetics, proteins) in pivotal courses.  Some achievements include two new cancer targets, expression of over 60 proteins, and new diagnostic methodologies.

In the biopharma industry, Dr. Gnatt held various positions, such as director of biopharmaceuticals where he developed new bone regeneration products, from initial cloning, directed up and downstream production, and from formulation to animal studies.

Dr. Gnatt was also a consultant for the AI/biomedical interface, and for noninvasive devices for diagnostics.

Avi Gnatt

Averell Gnatt, Ph.D.

Non-Clinical Principal Consultant

  • 2006 Nobel Prize Chemistry main contributor (Roger D. Kornberg)
  • Formerly of University of Maryland
 

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
 

Ellen Maher

Virginia Ellen Maher, M.D.

Clinical Principal Consultant

Dr. Maher has 17 years of FDA clinical oncology review experience and joined DataRevive from FDA on July 1, 2019. Dr. Maher has been an oncology clinical team leader for 10 years in the CDER Office of Hematology and Oncology Products and for three years in the CBER Office of Cellular, Tissue, and Gene Therapies. Before that, Dr. Maher was a medical officer for biological oncology product review in the Office of Oncology Drug Products.


She also functioned as a clinical project director at Schering-Plough Research Institute and worked at NIH for four years at NCI. She was an assistant clinical professor in hematology and medical oncology in Tulane University Medical Center and oncology chief for four years.

She reviewed numerous efficacy supplements for both New Drug Applications and Biologics Licensing Applications, participated in FDA-Industry meetings, including advice to industry concerning their product development pathway, and reviewed of many Investigational New Drug applications for small molecules and biologics.

Dr. Maher reviewed numerous oncology products including:

  • Durvalumab
  • Avelumab
  • Atezolizumab
  • Radium-223
  • Enzalutamide
  • Vandetanib
  • Crizotinib
  • Pazopanib
  • Romidepsin
  • Bevacizumab
  • Sunitinib
  • Apaziquone
  • Tivozanib
  • Everolimus
  • Ridaforolimus
  • Vandetanib
  • Pixantrone
  • Pazopanib
  • Romidepsin

Ellen Maher

Virginia Ellen Maher, M.D.

Clinical Principal Consultant

  • Formerly of FDA CDER OHOP & CBER OCTGT
  • 17+ years of experience
 

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

LinkedIn

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
 

Allan Hong

Allan Hong, Ph.D.

Principal Consultant

Dr. Hong has 30 years industrial experience in pharmaceutical and general management field. Dr. Hong spent 5 years from 1990 – 1995 in pharmaceutical process development and chemical portfolio management in Hoffmann-La Roche in Nutley, NJ, USA where he started his inspection practice.


Dr. Hong has about 10 years cGMP auditing experience as senior GMP Manager with USP and cGMP Group Inc. During this period, Dr. Hong inspected 100 pharmaceutical and intermediate and CDMO companies and reviewed many dossiers.

Dr. Hong also has had 18 years general management experience with CASI Pharmaceuticals, Matrix Pharmaceuticals (A Mylan Company). Greenwich pharmaceuticals and other US companies in China.

Dr. Hong was also a cGMP consultant for Bill & Melinda Gates Foundation USA for the public health projects in China.

Dr. Hong holds a Ph.D., a Master of Philosophy. and a Master of Science all in Chemical Engineering from Yale University. Prior to that Dr. Hong obtained his bachelor degree of Chemical Engineering from University of Delaware.

Allan Hong

Allan Hong, Ph.D.

Principal Consultant

  • Formerly of CASI Pharmaceuticals, Matrix Pharmaceuticals
  • 30 years of experience in pharmaceuticals
 

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