FDA submission consultants

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Working with xFDA you will have access to more than 60 former FDA experts, now FDA consultants. All of our scientific xFDA consultants have FDA experience and are biologic or drug development consultants or device development consultants. xFDA has expertise in the areas of drug and medical device development consulting including animal drug consulting, biologics, and botanicals. All were FDA experts in CDER, CBER, CDRH, CVM and the Office of Regulatory Affairs at the FDA. Many of our FDA consultants have experience as well.
Following is an example of some of our FDA consultants.

ALEXANDER APOSTOLU, D.V.M., Ph.D.
Dr. Apostolou provides expertise in the areas of carcinogenicity, dermatology, and ophthalmology, pharmacology/toxicology, and regulatory affairs in human and animal drug consulting. He has over 30 years of experience in drug R&D and regulation with the pharmaceutical industry, contract labs, and state and federal governments. He has been a pioneer in SOP/GLP preparation, and compliance, since 1979. He has prepared and appraised a great number of IND/NDA sections, Introductory Statements, Investigator's Brochures, Integrated Summaries and other documents in support of new drugs/devices, and has been involved successfully with industry representation at the federal agencies, litigation support, and expert witnessing. He has several publications, and has won numerous awards and international distinctions. Dr. Apostolou received his DVM in Paris, France, his PhD, in Comparative Pharmacology and Toxicology, from the University of California (Davis and San Francisco), a CRA certificate from DIA, and he is a DABT Founding Member, (1980).

JOHN M DAVITT, M.S.
Mr. Davitt provides expertise in preclinical development (pharmacology and toxicology) and has experience in a very broad spectrum of therapeutic areas including dermatologic, ophthalmic, antibacterial, antifungal, antiviral, and antiparasitic drug products. He has been involved with the formulation of FDA policy for dealing with safety issues, and he has participated in developing the non-clinical toxicology guidances. Mr. Davitt served 24 of his 27 year FDA career as a supervisory pharmacologist actively involved in the FDA's decision making concerning new drugs. He has a 13 year career as a consultant to the pharmaceutical industry in the areas of pharmacology, toxicology, and regulatory soundness. Mr. Davitt received an MS in Pharmacology from the University of Michigan and he is a licensed pharmacist.

WILLIAM R. FAIRWEATHER, Ph.D .
Dr. Fairweather consults with pharmaceutical and bio-tech companies in the statistical arena for chemistry stability studies (including bracketing and matrixing), animal toxicological studies, carcinogenicity studies, and clinical trials, and interprets current regulations and guidances. He is an internationally recognized, expert regulatory statistician who served at the FDA for 25 years. Dr. Fairweather assists in: clinical and pre-clinical study design and data analysis; methodological research in statistics, and computer program validation; study designs to optimize power and sample size, electronic submission of data to regulatory authorities. Dr. Fairweather has received numerous awards including the FDA Commissioner's Special Citation "for outstanding and sustained application of statistical methodology in the areas of post marketing risk assessment, carcinogenicity, and animal toxicology with the aim of promoting public health," 1999, and the Commissioner's Special Citation for service on Tobacco Working Group, 1994. He has presented lectures and has numerous publications. He received his PhD in Biomathematics from the University of Washington

CHARLES KYPER, B.S.
Mr. Kyper, FDA expert in device development consulting. As an FDA medical device consultant, his services include the interpretation, applicability, and enforcement of FDA, regulations, guidances and policies; development of regulatory and testing strategies; responses to FDA correspondence; preparation and critique of device labeling and advertisements; preparation of 510 (k), IDE, and PMA submissions; QSR/MDR compliance audits; and due diligence investigations. He is recognized internationally as an expert on the FDA regulation of medical devices. The last seventeen years of his 28-year FDA career as a compliance officer and regulatory scientist were spent in the Center for Devices and Radiological Health (CDRH) - during which period he was involved in the development of regulations and programs implementing the Medical Devices Amendments of 1976 and the Safe Medical Device Amendments of 1990. Positions held by Mr. Kyper included the Director of the Premarket Approval Staff and Associate Director for Reclassification and Compliance in the CDRH Office of Device Evaluation (ODE). He also served as the liaison between ODE and the CDRH Office of Compliance on compliance matters involving 510(k)s, IDEs, PMAs, labeling, advertisements, and promotion. Among his FDA publications are the Premarket Approval Application Manual and ODE Device Labeling Guidance. Mr. Kyper is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professionals Society (RAPS). He received his B.S. degree from Loyola College.

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MEDICAL OFFICERS

Medical officer MD served for 8 years at the FDA offers medical and regulatory assistance to the pharmaceutical and medical device industries. Expert has written protocols, prepared companies to meet with FDA staff, participated in FDA meetings with companies, served on Data Safety Monitoring Boards, and assisted companies in preparing IND, NDA, ANDA, IDE, PMA and 510(k) for Drug/Device and Biologic/Device Submission. These submissions have included both drug/device and biologic/device products. Expert has conducted pre-FDA audit inspections in the US and Europe, Clinical (QA) quality assurance audits and GCP (good clinical practice) audits. Expert examines safety reviews to assess study sites. Expert conducts GCP training, reviews Adverse Event Reports for FDA filing; and reviews and evaluates safety summaries. Expert writes clinical protocols, case report forms (CRF’s), the label, informed consent forms, patient packet inserts, advise on need for Data Safety Monitoring Committee.

Clinical and regulatory physician has both an M.D. and Ph.D. and is board certified in Neurology and Clinical Neurophysiology. He has over 20 years of combined clinical, regulatory, and pharmaceutical company experience. In addition to his experience as a medical reviewer at the FDA in the Division of Neuropsychopharmacological Drug Products, he has over seven years experience as the Vice-President of Clinical Research. During that time his team had four NDAs approved. He also served as the Medical Director. His duties included the managing the Pharmacovigilance program for over 100 drug products, assisting with business development, and working with the Marketing departments. For the last three years, he has been actively working as a consultant to pharmaceutical companies, investment groups, and academic institutes. He has served on mock advisory panels, assisted companies with clinical hold issues, performed due diligence on products and companies, prepared INDs, Protocols, Clinical study reports, integrated summaries of safety and efficacy.

The expert is an MD with an MPH in Epidemiology. Three years as Medical Officer in the Division of Metabolism and Endocrine Drug Products. Risk Assessment. Preventative Medicine. One year as Medical Epidemiologist and four years as Branch Chief, Division of Epidemiology and Surveillance, Office of Epidemiology and Statistics. Advisor to WHO. Member of the Working Group on Fertility Regulatory Methods, Special Programs Research, Development, and Research Training in Human Reproduction.

MD board certified in Internal Medicine and Rheumatology. FDA expert 9 years lastly as
Chief-Immunology and Infectious Disease Branch, Division of Clinical Trial Design and Analysis, Center for Biologics. Earlier, Chief Medicine Branch. Previously a Staff Fellow at NIH (NCI, 3 years; NIAMSD, 2 years). Experience and expertise in pulmonary medicine, cardiology, neurology, hepatology, rheumatology, infectious disease, wound healing, psoriasis/treatment of Cosmetic Defects, orthopedic Medicine, renal and hepatic allograft transplantation/xenotransplantation.

The expert is an MD board certified in Internal Medicine and held positions with the FDA for 8 years and now consults in the domains of drugs, biologics and devices.
Medical review officer, Division of Blood Applications, Office of Blood Research and Review, Center for Biologic Evaluation and Research (CBER) working with clinical trial design and xenograft transplantation. Acting Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (CDRH), responsible for monitoring safety and effectiveness of all medical devices marketed in the US. Medical Review Officer, Division of Antiviral Drug Products, Center for Drug Evaluation and Research (CDER) reviewer for initial clinical trials of new drugs developed to treat HIV, Herpes, Vericella – Zoster and other human viral pathogens. Deputy Director, Office of AIDS and Special Health Concerns, Office of the Commissioner, US FDA National and international representative for FDA policies on regulation of HIV-related products for diagnosis and treatment. Staff Epidemiologist, Office of Epidemiology and Biostatistics, CDER monitored post market safety and effectiveness of market drugs, Consultant to CBER for drugs and biologic evaluation and research on epidemiologic issues and problems.

Expert has both a DDS and an MPH. With the FDA 11 years including AIDs Coordinator for CDRH and as Director of the Human Tissue Program, in CBER, which expert established. Developed the current permanent regulations for tissue intended for transplantation. Has consulted with medical device, biologic, and human cell and tissue entities on pre-market and post market issues.
Provides consultation and expert witness services to companies marketing or manufacturing drugs, biologic products, human tissue and cellular products, or medical devices on FDA regulation Includes GMP audits, developing FMPs, GTP audits,

quality mapping, gap analysis, clinical trial design, preparation of submissions, liaison with FDA, adverse event reporting, health hazard evaluations, and epidemiological modeling.

MD with Board Certifications in
Internal Medicine and Infectious Diseases. MPH Biostatistics/ Epidemiology Track.
6 years at the FDA as Medical Officer/Team Leader Division of Clinical Trial Design and Analysis, Immunology and Infectious Diseases Branch. Reviewed all phases of clinical trial evaluations of biological agents for the treatment of autoimmune and inflammatory diseases and the treatment of infections diseases, e.g., sepsis, HIV/AIDS, inflammatory bowel disease and rheumatoid arthritis. Provides assistance in the clinical development strategy for biopharmaceutical therapeutics Indications for these therapeutics include inflammatory disease, cancer, and diseases responsive to immunomodulation, e.g., rheumatoid arthritis, inflammatory bowel disease, sepsis, psoriasis. Other indications include infectious diseases, neurology, dermatology, angiogenesis, and ophthalmology. Types of products include monoclonal antibodies, proteins, antisense, and cell and gene therapies. Served as clinical monitor for clinical trials at a CRO.

Expert is an MD board certified in Internal Medicine and Rheumatology, at the FDA for 8 years in the Center for Biologics and Research (CBER). Deputy Director, Division of Vaccines and Related Product Applications, Medical Officer, Division of Vaccines and Related Product Applications, Medical Officer, Hematologic Products Branch Division of Biological IND’s. Expert in biologic agents with emphasis in the development of drugs and therapeutic proteins for the treatment of autoimmune and inflammatory diseases such as rheumatoid arthritis and multiple sclerosis, clinical trials in systemic sclerosis, coronary artery disease, sepsis, solid tumors, and hematological malignancies, monoclonal antibodies, cytokine inhibitors, systemic lupus erythematosus, and acute/ chronic pain syndromes. Has organized and participated on medical advisory panels in the U.S. and Europe, designing clinical trials, analyzing clinical data, participating on safety monitoring committees, and submitting marketing applications to regulatory authorities in the U.S., Europe and Japan.
In positions with big PHARMA firms served as Medical Director.

An MD clinical reviewer and medical officer at the FDA –Neuropharm. He reviewed antidepressants, antipsychotics, sedative-hypnotics, and anxiolytics. 6 years as researcher in the intramural program of the NIMH . Pfizer and Wyeth, which sell two of the drugs included in the study, declined to comment on the article. Both companies told the WSJ they had committed to disclose all of their study results, but not necessarily in medical journals.

This expert is a DVM with clinical, regulatory and pharmaceutical company experience. At the FDA (in the Center for Veterinary Medicine -CVM) for over 14 years. Supervisory Medical Officer for more than three years in the Office of New Animal Drug Evaluation/Division of Theraoeutic Drugs for Non-Food Animals including the review of labeling within the division. Three years as a Master Reviewer. Reviewed companion animal drug products including a broad range of classes, equine and small animal. Reviewed protocols, safety and efffectiveness studies, and labeling for cattle antimicrobial drugs. Performed milk safety work; served on the Teat Dip Committee Mastitis Council. Over four years at the Office of Surveilance and Compliance. Reviewed annual drug experience reports, labeling, supplemental applications, and promotional material. Expertise in adverse drug experience reporting. Two years as a consultant to the pharmaceutical industry. While in industry, the expert was Product Development Manager managing clinical aspects from Phase I to Phase III including protocols for the US and EU. Responsible for negotiations with EMEA, and the FDA. Prepared Safety and Efficacy Technical sections of new submissions for Veterinary Medical Products/New Animal Drugs; provided clinical and trend analysis for pharmacovigilance reports to relevant regulatory authorities.

The expert has a DVM and a PhD in Comparative (Human and Animal) Pharmacology and Toxicology and served as the Director, Division of Toxicology at the Center for Veterinary Medicine at the FDA for five years. This position involved assistance to pharmaceutical and food industries in new drug develop and food safety. Board certified in Toxicology; Founding Member. Foreign languages French (fluently), Greek (fluently), English (fluently), Italian and Spanish (technical literature).
Provides expert technical advice to the Center for Veterinary Medicine (CVM), the Center for Drug Evaluation and research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Biologic Evaluation and Research (CBER) and other Agencies (USDA, EPA). Expert held positions in the pharmaceutical industry and the California Department of Agriculture.

CHEMISTS

Expert has analytical and organic expertise with an MS in both. Sixteen years with the FDA as a reviewer of NDAs and other submissions. Eighteen years in the pharmaceutical Industry developing analytical methods, setting specifications, and test methods for proposed drug products. Familiarity with small molecules and biologics. Has conducted research on organic compounds.

Expert has PhD and eight years of experience at the FDA with five years of reviewing applications from firms wanting to market drugs in the United States. She has over 20 years of accomplishments in regulatory science, research and preformulation in industry and academia and reviewing new and generic drug products at the FDA.

Expert holds a PhD in organic chemistry and minrs in biochemistry and microbiology. Nineteen years at the FDA. Fourteen years as senior scientist in the pharmaceutical industry. Chemistry reviewer of neuropharmacological Drug Products while at the FDA. Chair of Taskforce on two FDA guidelines and ICH expert on quality of drug products.

The expert holds a PhD in phytochemistry and provides advice in the area of over-the-counter (OTC) drug products, natural products, and prescription topical products. As a chemistry, manufacturing and controls expert, reviewed IND and NDA submissions to market new drugs in the United States. Responsible for drafting monographs for OTC products and Federal Register notices. Involved in the development of FDA standards and regulations for marketing OTC topical and natural drug products.

The CMC expert has twenty five years at the FDA and has been a consultant to the pharmaceutical industry since 2007. The expert holds a PhD in Medicinal Chemistry. Areas of expertise include inhalation and other pulmonary drug products, oncology drug products and radiopharmaceuticals. Experience with Combination Drug Products. A Risk-Based Approach (QbD/PAT/QS) expert.

Chemist holds a Ph.D. in Analytical Chemistry and was involved with the approval of new and generic drug products for sixteen years at the FDA. CMC reviews are provided for both small molecule and biologic products. rt held positions as executive director CMC regulatory affairs and Director of Scientific Affairs in big Pharma companies. Reviewed specifications development systems for Pharmaceutical Sciences and for Chemical Development units from the standpoint of design space analysis.

xFDA consulting - your drug and device experts