Dr. Kenimer founded BCG in 1993 after more than 15 years experience at the Food and Drug Administration (FDA) as researcher, laboratory chief, and inspector. Prior to leaving the Center for Biologics Evaluation and Research (CBER) he was Deputy Director of the Division of Vaccines and Related Products Applications (DVRPA) where he supervised the review of INDs and participated in the development of CBER policies and standard operating procedures (SOPs) for review of biological products. He has extensive experience in IND, PLA and ELA review as well as pre-license and annual inspections of biological manufacturers. Dr. Kenimer provides regulatory consulting from the firm's Virginia office.
Vice Presidents:
Kelly T. Boyle - Vice President
Ms. Boyle joined the group in 1994 after five years as a Biologist at CBER where she developed expertise in various aspects of the regulation of biological products, including lot release testing, IND and PLA review, development and validation of analytical methods, preparation of laboratory Sops, and facilities inspections. Currently Ms. Boyle works out of the firm's Virginia office as the accounts payable/receivable and manages technology integration company-wide.
Ann Sutton MPH - Vice President
Senior Consultant,
Ms. Sutton joined the group in January, 1998 after 27 years at CBER as a research microbiologist in the Division of Virology and the Division of Bacterial Products and as a reviewer in the Division of Biological Investigational New Drugs. She has an extensive knowledge of current CBER policies and procedures, particularly as they apply to bacterial products. Prior to leaving CBER she was extensively involved in preparation of the BLA CMC guidance document for vaccines.
Michael S. Williams - Vice President
Senior Consultant,
Mr. Williams joined the group in October 1996, after 28 years government service in the regulation of biological products. He has a broad and extensive understanding of all aspects of the regulatory process including INDs, licensing, label review, inspections, product testing, lot release, and compliance. He is a recognized international expert on influenza vaccines. Mr. Williams provides regulatory consulting from the firm's Virginia office.
Office Heads:
Eugene B. Johnston CQE, CQA - Office Head
Eugene Johnston joined BCG as the new Head of the North Carolina Office in July of 2007. Mr. Johnston has over 30 years of experience in FDA-regulated industries in Quality Assurance, Quality Control and validation. He was most recently the Vice President, Quality Assurance and Regulatory Affairs at Biolex, a biopharmaceutical company involved in the development and production of therapeutic proteins using the Lemna Expression System(LEX™) which is based on the aquatic plant, Lemna. Mr. Johnston was responsible for establishing the Quality Assurance, Quality Control and Regulatory Affairs functions and Biolex and established the Quality Systems programs for preclinical and clinical manufacturing operations.
Ronald A. Marchesani - Office Head
Mr. Marchesani joined the BCG team in February 2007 and took over as the Head of West Coast Operations in June 2007. Ron is a respected opinion leader in the field of Quality Systems. He has been invited as a speaker or facilitator at professional meeting and enjoys dealing with the different Regulatory GMP expectations during product development, vaccine and GMP compliance audits. Ronald's areas of expertise include: quality system assessment/development, GMP oversight of contract services (manufacturing and testing), GMP training, SOP development, inspection readiness (Routine/PAI), document system development/review.
Keith Wells Ph.D. - Office Head
Dr. Wells joined the group in October, 2000 and is now the Head of our New England office. He was previously a Senior Director of Vaccine manufacturing and Process Development with Oravax, Inc. He brings to the firm over ten years of experience in the biopharmaceutical industry, principally in the areas of process development, process validation and manufacturing.
Lei Zhang M.D., Ph.D. - Office Head
Dr. Zhang joined BCG April 1, 2007 as the Head of our China office. Prior to this position, Dr. Zhang served as a pharmacology and toxicology reviewer in the Division of Biologic Oncology Product, Office of Oncology Product, CDER, FDA where he reviewed the preclinical sections of new drug applications including products of antibody-based therapeutic proteins, growth factors, cytokines, toxins, enzymes, and tumor vaccines for treatment of cancer. Dr. Zhang has gained expertise in assessing whether submitted preclinical studies are compliant to FDA requirements and adequate for safe clinical trial. As an immunologist with medical background, he has a good understanding of mechanism of action of biologic drugs under development in the context of pathology and physiology of the targeted diseases.
Chief Legal Officer:
William F. Winslow - Chief Legal Officer
Senior Clinical Consultants(With M.D.):
Julia Barrett M.D., MPH - Senior Clinical Consultant (with MD)
Dr. Barrett specializes in Internal Medicine and joined BCG as a senior consultant in December 2004 after working as an affiliate with the company for several years. As a senior clinical reviewer at CBER from 1992-1997, Dr. Barrett was responsible for providing comprehensive clinical review of INDs and BLAs, as well as providing advice on clinical product development Her regulatory expertise, coupled with her clinical experience, provides her with a unique perspective on FDA requirements for the design, preparation and implementation of Phase 1, 2, & 3 clinical protocols, as well as overall clinical development strategy.
Wilson W. Bryan M.D. - Senior Clinical Consultant (with MD)
Dr. Bryan will began with BCG in February 2007. As a medical officer and team leader for FDA's CDER and CBER, Dr. Bryan was responsible for the clinical review of Investigational New Drug (IND) applications for drugs and biologics, including monoclonal antibody, cell, and gene therapies, for a wide range of neurologic indications, including cerebrovascular disease, multiple sclerosis, Alzheimer's disease, Parkinson's disease, other movement disorders (e.g., cervical dystonia), headache, amyotrophic lateral sclerosis and other neuromuscular disorders, insomnia and other sleep disorders, and a variety of other neurologic indications. As team leader, Dr. Bryan also ensured the quality and consistency of clinical reviews, actively participated in sponsor meetings, and was intimately involved with regulatory decisions and policy affecting the development and approval of numerous investigational products, primarily for neurology indications.
John E. Humphries M.D. - Senior Clinical Consultant (with MD)
Dr. Humphries joined the group in February 2008. He has acquired diverse skills and competencies during his 20+ year professional career. While at the University of Virginia, he was an accomplished researcher, educator and clinician with over 40 peer-reviewed journal publications, focused in the field of hemostasis, thrombosis and fibrinolysis. While at Bayer he was involved in the clinical development and regulatory interactions with FDA and EMEA on a transgenic alpha-1-antitrypsin, was responsible for early clinical development of a plasma-derived plasmin, clinical strategy for development of intravenous immunoglobulin in neurologic disorders and clinical strategy for new indications for plasma-derived antithrombin III. Dr. Humphries will utilize his expertise in clinical strategy and clinical development of therapeutic proteins to assist clients in drug development and commercialization.
Stephen D. Litwin M.D. - Senior Clinical Consultant (with MD)
Dr. Litwin joined BCG in October 2003. He retired from the U.S. Food and Drug Administration after an active prior career in government and academia. He has served over the last twelve years as a Senior Medical Reviewer in the Center for Biologic Evaluation and Research in the Office of Therapeutics (Division Clinical Trial Design and Analysis) and more recently in the newly created Office of Cell, Tissue and Gene Therapy.
Peter A. Patriarca M.D. - Senior Clinical Consultant (with MD)
Dr. Patriarca joined BCG in May 2005. Dr. Patriarca has acquired diverse skills and competencies during his 25+ year professional career. While at CDC, he was an accomplished field and clinical investigator, with ~100 peer-reviewed journal publications, and was a major contributor to immunization programs and policy promulgated through the Advisory Committee on Immunization Practices (ACIP). While at CBER, he directed activities related to the research, regulatory and public health aspects of licensed and investigational viral vaccines and served as FDA liaison representative to the American Academy of Pediatrics' Committee on Infectious Diseases ("Redbook Committee"). As Division Director, Dr. Patriarca also ensured the quality and consistency of CMC and clinical reviews, actively participated in sponsor meetings, and was intimately involved with regulatory decisions and policy affecting the development and approval of numerous investigational products. While at MedImmune, Dr. Patriarca was responsible for regulatory strategy and compliance oversight for all infectious disease-, immunology- and oncology-related programs, and was a member of key strategic and commercial operations committees.
Senior Consultants(With M.D.):
Stuart Portnoy M.D. - Senior Consultant (with MD)
Medical Devices
Dr. Portnoy joined the group in August of 2007. He has expertise in regulatory strategy for medical technologies, product development for drug/device and biologic/device combination products, assisting clients with strategy and development of preclinical testing, and designing clinical protocols and drafting other documents that comply with FDA regulations and expectations. He has served as a Medical Officer and Clinical Reviewer at Center for Device Evaluation and Radiological Health and was most recently a medical device consultant for PharmaNet.
Senior Consultants:
Ellen M. Areman MS, SBB - Senior Consultant
Ms. Areman joined Biologics Consulting Group as a Senior Consultant in December 2005. She comes to BCG from the Office of Cellular, Tissue and Gene Therapies at FDA/CBER. She joined the regulatory community in 2001 after 15 years of developing and managing cellular therapy laboratories in academic, government and clinical centers; and is considered one of the pioneers in the field of cellular processing and graft engineering. In the years before she joined FDA, Ms. Areman collaborated with numerous clinical and laboratory scientists as well as biotechnology companies in the development of new techniques for the manipulation of bone marrow, peripheral blood stem cells, umbilical cord blood, and lymphocytes. She has been involved in many aspects of the development, production and quality control of cellular products, including the design and implementation of in vitro experiments and validation studies to support clinical trials.
Loriann N. Baranauskas - Senior Consultant
Effective September 11, 2006, Loriann Baranauskas has joined Biologics Consulting Group, Inc. as a Senior Consultant in the Massachusetts office. Lori has over 11 years of experience in the biotechnology industry. Prior to joining Biologics Consulting Group, Lori spent the past 11 years in Quality and Regulatory leadership roles at Antigenics, Inc. and Aquila Biopharmaceuticals, Inc. (acquired by Antigenics in 2000).Prior to Antigenics, Lori has over 10 years of experience in the diagnostic and medical device industries. From 1989 through 1995, Lori managed the Regulatory Affairs group at Behring Diagnostics, Inc. (formerly PB Diagnostic Systems) where she and her staff were responsible for strategic planning and preparation of 510(k), PMA and international regulatory filings for the company's in vitro diagnostic and auto-analyzer product pipeline.
Lourdes Bermejo M.S. - Senior Consultant
Ms. Bermejo joined the BCG group in October 2007. She was most recently the Senior Manager of Process Engineering at Biolex Therapeutics, a biopharmaceutical company involved in the development and production of therapeutic proteins using the aquatic plant Lemna. She played a pivotal role in the development of innovative production platforms, as well as, the improvement of processes through integration of process development, scale-up and facility design. Her expertise is in project management for technology transfers and start-ups, manufacturing for biological products, process improvements upstream development & scale-up.
Angela Blackwell M.S. - Senior Consultant
For the past 13 years, Ms. Blackwell was a Scientific Reviewer in the Division of Anesthesiology, Infection Control, General Hospital, and Dental Devices (DAGID), Center for Device Evaluation and Radiological Health (CDRH), FDA. As a Senior Consultant at BCG Ms. Blackwell will utilize her broad engineering, clinical, and regulatory expertise to continue to assist clients in the following areas related to gaining FDA approval of medical devices.
Susan M. Bowley Ph.D. - Senior Consultant
Dr. Bowley joined the BCG group mid-April 2008. Susan has over twenty years of diverse experience as a Mechanical and Biomedical engineer. Susan spent four years as a reviewer at the FDA working predominately on balloon catheters, arthrectomy devices, stents, and drug eluting stents. Most of her time was spent on reviews for the unique and dynamic area of development in drug eluting stents, being involved in all of the submissions for these novel products.
Dr. Djordjevic joined BCG in January of 2008 and has over 20 years of experience in Analytical Chemistry utilized in Pharmaceutical and Biopharmaceutical Industry. During this time he has played an active role at virtually every phase of drug development from target identification, lead identification, compound selection and characterization, and pharmaceutical product development. He was most recently the Director of Analytical Chemistry at Cytokinetics Inc., a biopharmaceutical company involved in the discovery and development of oncology and cardiovascular drugs.
Thomas J. Gerteisen Ph.D. - Senior Consultant
Dr. Gerteisen joined BCG in August 2004. Tom has more than 20 years experience in the area of QA/QC of therapeutic protein products. Prior to joining BCG, Tom worked for 12 years with Genzyme Corporation, beginning as Director of Quality Control and most recently as Vice President of Quality Operations, Therapeutic Manufacturing and Development. In this position he was responsible for QA, QC, validations, stability/statistics, LIMS, training, and analytical method development and validation. During his tenure the Quality organization supported multiple protein product filings worldwide and commercial launch and distribution of those products in the US, Europe, Asia and South America.
John R. Godshalk MSE, MBA - Senior Consultant
During his tenure at DMPQ, John gained experience with products that include drugs, drug/device combination products, viral and bacterial vaccines, recombinant therapeutic and fractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspection experience includes leading inspections of active pharmaceutical ingredient manufacturers, aseptic filling and finishing facilities, and contract manufacturers. He has performed numerous pre-approval and pre-licensing inspections for biological and biotechnology products. In addition, he has evaluated industry responses both for technical and regulatory merit during FDA regulatory compliance actions, and has assessed these responses and offered alternative solutions to resolve technical issues and regulatory concerns.
Melanie T. Hartsough Ph.D. - Senior Consultant
Dr. Hartsough joined the BCG team in February 2007. She has experience as both a CMC reviewer at CBER and a pharm/tox reviewer at CDER. She has reviewed cytokines, growth factors, enzymes, toxins, thrombolytics and monoclonal antibody products. Her experience includes IND and BLA submissions, design and interpretation of toxicology studies, including relevant species and immunogenicity issues and appropriate PK/TK studies, product review for biotechnology-derived products, planning and participating in FDA meetings, insights into the changes occurring with the review of nonclinical studies for biotechnology-derived products in CDER.
John J. Jessop Ph.D., MPH - Senior Consultant
Director, Pharmacology/Toxicology
Dr. Jessop joined the group in August 1999, and has 30 years experience as a toxicologist and pharmacologist. He has expertise in product and pharmacology/toxicology review of biological products, pharmacology/toxicology review of drugs and all regulatory aspects of NCE development (biologics and drugs) and marketed product maintenance from his work experience at CBER, CDER and private industry, respectively. He, therefore, provides a strong and unique background in the regulatory review and development of biologics and drugs.
Louise C. Johnson M.S. - Senior Consultant
Ms. Johnson is joined the BCG team in March of 2007. Her experience includes management of and strategic planning for regulatory affairs and quality assurance functions, participation in in-licensing and M&A activities, where she provided regulatory and developmental assessments and participated in due diligence, supported regulatory filings and negotiations from pre-IND meetings through development, NDA filing and approval, and post-marketing support. She has worked with small molecule, monoclonal antibody, and vaccine submissions and has experience with FDA, Health Canada's HPFB, and the UK's MHRA.
Steven C. Kunder Ph.D., DABT - Senior Consultant
Dr. Kunder joined Biologics Consulting Group, Inc. in June, 2008. Dr. Kunder is a toxicologist (Ph.D., Medical College of Pennsylvania, Philadelphia, PA) who brings 12 years of experience with the U.S. Food and Drug Administration (FDA) in both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). His training, research and regulatory experience with vaccines and adjuvants, immunosuppressants for organ transplantation and antiviral drugs provides an excellent understanding of these products acting by stimulation or suppression of the immune system.
David T. Lin Ph.D., MBA - Senior Consultant
Dr. Lin joined the group in January of 2005. From 1997-2001 he was a Chemistry Reviewer in the Division of Reproductive and Urologic Drug Products, Center for Drug Evaluation and Research (CDER), FDA, and in 2001 became the Team Leader in the same Division. He had been serving as the acting Deputy Division Director in the Division of New Drug Chemistry III (DNDCIII), Office of New Drug Chemistry since 2003, and was promoted in 2004 to the acting Division Director.
Jim McIver Ph.D. - Senior Consultant
Dr. McIver joined the BCG team in July of 2003 with 20 years experience as the Assistant Director of the Massachusetts Biologic Laboratories and upon retirement one year experience as an independent consultant. Dr. McIver's expertise is in therapeutic immune globulins, human plasma proteins, fibrinogen and platelet clotting, blood products, bio-separations, and bioreactor culture for monoclonal antibody manufacture.
Andra E. Miller Ph.D. - Senior Consultant
Director Cell and Gene Therapies
Dr. Miller joined the group in July, 2000 with 9 years experience as a molecular biologist and product reviewer with the FDA. As Gene Therapy Group Leader and Expert Microbiologist in CBER’s Division of Cellular and Gene Therapies, Dr. Miller has been very influential in the development of policy in the cell and gene therapy areas. She has actively participated in national and international meetings in the field of gene therapy where she frequently represented the FDA as an invited speaker. For the past several years Dr. Miller has served as the FDA Alternate Representative to the Recombinant DNA Advisory Committee (RAC) and CBER Liaison to the Office of Biotechnology Activities (OBA), NIH.
Reginald D. Neal - Senior Consultant
Reggie Neal joined the BCG team in March 2006 and has 27 years experience working for the U.S. federal government, including the Department of Health and Human Services/U.S. Food and Drug Administration, Department of Agriculture, Department of the Navy, Department of Commerce, and Department of Interior/U.S. Fish and Wildlife Service. Mr. Neal has experience in CGMP, regulatory affairs, validation, aseptic processing, personnel training, and CBT issues.
David J. Pepperl Ph.D. - Senior Consultant
Dr. Pepperl joined the BCG team in January of 2004. As a toxicologist and preclinical development manager, David has managed numerous development projects ranging from small peptides, small molecules, monoclonal antibodies, cell and gene therapy products, adenoviral therapies, bacterial based oncology therapies and hormonal therapies. At BCG, David will provide services including development and review of preclinical product development programs, strategic planning of program implementation capabilities, review and preparation of nonclinical study reports and regulatory submissions, and GLP auditing and study monitoring services for both emerging and established biopharmaceutical companies. Prior to joining BCG, David served as toxicologist and Manager of Preclinical Development at TherImmune where he drafted preclincial development strategies, authored nonclinical sections of regulatory submissions and managed preclinical development programs for clients. In this capacity, he designed and managed nonclinical pharmacology and toxicology studies, performed GLP and scientific audits and reviewed study data on behalf of clients.
Peter Probst - Senior Consultant
V.P. Audits and Inspections
Mr. Probst joined the group in October 1997 after 33 years at CBER where he served as a Biologist in the Division of Pathology and the Division of Bacterial Products and as a GMP reviewer/inspector in the Division of Establishment Licensing. He combines an extensive biological product technical expertise with a current knowledge of CBER GMP/facility expectations.
Ellen Raaf MT, ASCP - Senior Consultant
Ms. Raaf joined the group in November 2007. She is a microbiologist who brings to the firm over 22 years of government and biopharmaceutical experience with a principal focus on assay development, qualification and validation, managing stability and laboratory programs, and optimizing Quality systems. Most recently, Ms. Raaf was the Quality Assurance Manager for Biolex, Inc., a biopharmaceutical company involved in the development and production of therapeutic proteins using Lemna, an aquatic based plant. While at Biolex, she was responsible for directing the Quality Systems, Product Release and Document Control.
Nadine M. Ritter Ph.D. - Senior Consultant
Nadine has over 12 years of industry experience in the technical, quality and regulatory requirements of biopharmaceutical product development and commercialization. She is an analytical biochemist with expertise in R&D, GLP and cGMP activities from startup organizations to multinational pharmaceutical corporations. Her specialties include biotechnology product characterization, release and stability testing, analytical test method development and validation, product and process comparability studies, biotechnology transfer projects, laboratory quality and compliance, and the effective management of outsourced biopharmaceutical testing and manufacturing.
Ronald A. Salerno Ph.D. - Senior Consultant
Dr. Salerno joined BCG in February of 2008. He has eighteen years of experience in Regulatory Affairs. Since June 2006, Dr. Salerno was the Global Regulatory Therapeutic Area Head for Wyeth Vaccines leading a regulatory group responsible for bacterial and viral vaccines in early development as well as licensed bacterial vaccines. From June 2001 to June 2006, he was the Regulatory Liaison for Wyeth's Translational Medicine Research using pharmacogenomic biomarkers that are predictive of drug response and/or are new targets for discovery research. He lead the submission of three voluntary genomic data submissions (VGDS) and agency meetings, which included the first submission of a VGDS to the FDA and the first joint FDA/EMEA VGDS briefing meeting. Ron's expertise is in global regulatory strategy and registration for vaccines, biologics and drugs including application of pharmacogenomics and biomarkers for regulatory decision-making.
Gilbert T. Salud M.S. - Senior Consultant
Gil joined the BCG team in April 2008. Gil has over 14 years of industry experience in the technical, quality and regulatory requirements of biologic, small molecule, and medical device product manufacturing and commercialization. Gil's most recent position was at the FDA with CDER at the Office of Compliance where he held the position of Team Leader of the Biotech Manufacturing Team, overseeing the manufacturing regulatory review of BLA and sBLA (PAS, CBE, and AR) applications and conducting pre and post approval inspections.
Nanda K. Subbarao Ph.D. - Senior Consultant
Dr. Subbarao joined the group in June of 2007. She is a Bio-organic Chemist and and has more than 13 years hands-on industrial experience in stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from pre-clinical to clinical and commercial phases. She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase.
Michael A. Trapani MS, MBA - Senior Consultant
Mr. Trapani joined the group in January of 2007. He has extensive experience in regulatory affairs, new product registration and approval, regulatory compliance and quality assurance. He has held management positions in a broad selection of the industry including big Pharma, Biopharma, clinical research organizations (CRO) and diversified medical products companies. Mr. Trapani started his career as an Investigator with the U.S. Food & Drug Administration and was most recently Vice President, Worldwide Regulatory Affairs for Ethicon Inc.
Ruth E. Wager Ph.D. - Senior Consultant
Dr. Wager joined the BCG team in April 2008. While at the FDA from 2002-2005, she was a CMC reviewer for biologics, small molecules, and combination products. Her industrial employment experience includes participation at all stages of product development for protein and small molecule therapeutics, as well as in vivo diagnostics. Her expertise is in product development and characterization, release and stability testing, and cGMP. Her most recent position was at Amgen where she held the position of Director of Corporate Product Quality, overseeing the quality of Amgen's products throughout their lifecycle.
Darin J. Weber Ph.D. - Senior Consultant
Cell & Gene Therapies
Dr. Weber joined the BCG team in February 2004. He had 7 years of government service at CBER, FDA and most recently served as Chief of the Cell Therapies Branch within the Office of Cellular, Tissues and Gene Therapies (OCTGT). Dr. Weber's areas of expertise include regulation and policy development for cell and tissue-based therapy products, particularly with still evolving areas of regulatory oversight, such as regenerative medicine, stem cells and human tissues.
Larry K. Winberry Ph.D. - Senior Consultant
Process Development and Manufacturing
Dr. Winberry joined the group in September 2001. Prior to that he was the Vice President of Manufacturing and Process Validation Team Leader with BioPort Corporation. He brings to the firm over fifteen years of experience in the biopharmaceutical industry, principally in the areas of process development, process validation, manufacturing, and Quality Systems.
Ruth Wolff Ph.D. - Senior Consultant
Director, Therapeutics
Dr. Wolff joined the group in May, 1998, after six years at CBER where, as Chief of the Hybridoma and Hematologic Products Branch in the Division of Application Review and Policy, she was involved in the review of regulatory applications for monoclonal antibodies, cytokines and hematologic growth factors. She was also the lead FDA representative to the ICH Expert Working Group preparing the Cell Substrate and the Viral Safety guidance documents.
Consultants:
Kerin Ablashi M.S. - Consultant
Ms. Ablashi joined the BCG group in May of 2005. Ms. Ablashi will utilize her GMP manufacturing, quality, and project management expertise to assist clients in various areas of clinical drug development.
Daniel P. Offringa - Consultant
Mr. Offringa joined the group in Feb. 2005. For the previous 5 years he was an IT Specialist in the Office of Information Management, CBER. Mr. Offringa served as technical lead for the CBER electronic submissions program and system administrator of the electronic document room and secure e-mail infrastructure. His duties included quality control and loading of eIND, eBLA and eCTD submissions, technical editing of electronic submissions guidance documents, reviewing and providing feedback regarding demonstration electronic submissions, assisting Industry with the establishment of secure e-mail communications with CBER, and recommending solutions to problems with electronic submissions.
Anne M. Zurbay RN, MSN, ND - Consultant
Dr. McElderry-Zurbay joined the group in January 2005 after leaving a Clinical Safety Associate II position at OSI Pharmaceuticals. Her expertise includes the global management of clinical trial safety data, from planning to review, coding, database reconciliation and query generation, and the training and supervision of clinical trial Investigators and Study Coordinators in the area of Clinical Safety
Associates:
Kelly Reich M.S. - Associate
For the past several years Ms. Reich has provided regulatory support including preparation of INDs and amendments, BLA supplements, CTDs, and drug product listings from the firm's Virginia office. Ms. Reich completed a Masters Degree in biotechnology from Johns Hopkins University in 2006.
Holli S. Vaughan M.S., RAC - Associate
Ms. Vaughan has over 12 years of industry experience in regulatory affairs. She has been directly involved with product development strategies, planning and management as well as being responsible for all regulatory activities, including the preparation of regulatory submissions, the drafting of protocols and reports, the establishment of SOPs and the assurance of data quality and integrity.
Administrative:
Mary Croucher - Administrative
Administrative Assistant at North Carolina Office.
