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.
Peter Probst - Vice President
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.
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.
Chief Legal Officer:
William F. Winslow PLLC - Chief Legal Officer
Mr. Winslow joined BCG in January 2006 and serves as general counsel to the company. Prior to joining BCG, Bill was a partner at Wilmer Cutler Pickering Hale and Dorr LLP in Washington, DC where he specialized in corporate, securities and transactional matters. His clients included private and publicly-held technology companies, venture capital firms and entrepreneurs. Bill has spoken frequently on venture investment and other topics and published several articles relating to emerging technology companies. Bill received his A.B. from Amherst College, his M.A. from Yale University and his J.D. from the University of North Carolina.
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.
Joseph C. Fratantoni M.D. - Senior Clinical Consultant (with MD)
Dr. Fratantoni is a clinical and research hematologist by training and brings over 30 years of experience in biologics research, development and regulation, with 18 of those years at the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA). In his final four years at CBER/FDA, he was Director of the Division of Hematology. After leaving CBER in 1996, he was a consultant, specializing in blood and blood-related products, until 1999 when he joined MaxCyte, Inc in Gaithersburg, MD as Vice President, Medical Affairs and Clinical Development. While with MaxCyte he managed the clinical and regulatory aspects of development of a cell-loading technology for use with clinical cell and gene therapy.
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.
Orest Hurko, M.D. joined Biologics Consulting Group, Inc., as a Senior Clinical Consultant (Neurologic and Mendelian Disorders, Translational Medicine) in June 2010.
Orest comes to BCG with 12 years of experience in the Pharmaceutical Industry in SmithKline Beecham, GlaxoSmithKline, Wyeth and Pfizer. Most recently, he was Assistant Vice-President, Translational Medicine, Pfizer, and, previously, Director of the Translational Medicine Research Collaboration between Wyeth, the Scottish National Health Service, Scottish Enterprise and the Universities of Aberdeen, Dundee, Edinburgh and Glasgow. Orest had oversight for biomarker development and validation for all therapeutic areas, including Neuroscience, Cardiovascular, Oncology, Inflammation, and Women’s Health. He has played a leading role in academic-industrial collaborations as a founding member of the Alzheimer Disease Neuroimaging Initiative (ADNI) where he continues on the Publications Core and the Industrial Scientific Advisory Board. His group at Wyeth made the first joint Voluntary Genome Data Submission to the FDA and the EMEA.
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:
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.
Blair A. Fraser Ph.D. - Senior Consultant
Dr. Fraser is a biochemist (Ph.D., The Pennsylvania State University) who brings 30 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). Until recently Director, Division of Pre-Marketing Assessment I, Dr. Fraser joined CDER, in 2004, as Deputy Director, Division of New Drug Chemistry II. In 2005, Dr. Fraser served as Chief, Branch 2, Office of New Drug Quality Assessment, prior to becoming Director in 2006. During this tenure, he engaged in the full range of CMC scientific and regulatory endeavors from review to policy. With BCG, Dr. Fraser will utilize his professional and regulatory experience in development of drugs, biologics, and vaccines.
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.
Michael Gross Ph.D, RAC - Senior Consultant
Michael Gross, Ph.D., RAC is a Senior Consultant with the Biologics Consulting Group. He has 28 years of experience working in senior regulatory affairs, quality assurance and compliance roles in the drug, biologics, biotechnology and medical device industries and the Food and Drug Administration and has more than eighteen years of cumulative experience working with combination products. Michael has worked with both large and small molecules in preclinical-clinical and CMC regulatory affairs and compliance and has worked with a variety of drug delivery and medicated device technologies. He has held senior level regulatory affairs, quality assurance and compliance positions with large pharmaceutical and medical device companies, biotech start-ups and the FDA. He is a frequent speaker at industry meetings on combination products and has a number of publications in this area. Michael leads or serves on a number of industry technical and regulatory committees focused on combination product development, manufacture and marketing. He assists clients in establishing development, and regulatory strategies and quality systems for drugs, biologics, medical devices, combination products, drug delivery systems and other novel medical products with challenging regulatory issues.
Craig Halverson M.S. - Senior Consultant
Craig A. Halverson joined the Biologics Consulting Group, Inc. as a Senior Consultant in May, 2010.
Craig has over 25 years of scientific, regulatory and quality experience in the biopharmaceutical and in vitro diagnostics industries. This experience was gained at six biotechnology companies, a clinical reference laboratory, and an in vitro diagnostics company. He is an experimental pathologist with product development experience that spans pre-clinical characterization, manufacturing process and analytical method development through IND and BLA/NDA acceptance.
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.
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.
Bruce Pearce Ph.D. - Senior Consultant
Bruce Pearce joined the BCG team in July of 2010. Bruce is a pharmacologist who brings 20 plus years of academic and industry experience encompassing many aspects of biologics development including design, development, analysis, oversight, and regulatory reporting of pharmacology, toxicology, pharmacokinetic, safety pharmacology, physiologic research and Phase I-III clinical trials. Expertise in non-clinical and clinical pharmacology/toxicology, program strategic/technical design, quantitative outcomes analysis, and benefit-risk balance assessment. Therapeutic areas include; treatment of anemia due to surgery, trauma, chemotherapy, emergency research under exception to informed consent (21 CFR 50.24) including in/pre-hospital resuscitation from hemorrhagic shock due to trauma. Treatment of cardiac, cerebral and peripheral ischemia and therapeutic use of botulinum toxin.
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.
Barbara J. Potts Ph.D. - Senior Consultant
Barbara has 28 years experience in the science , compliance and business aspects of the control of adventitious agents (TSE, viruses, mycoplasma) in the bio pharmaceutical, HIV vaccine and immuno therapy, xenotransplantation and cell therapies industries This experience was gained at the University of California, School of Medicine, San Francisco, the NICDS/NIH, NIAID/NIH, University of MN School of Veterinary Medicine, two contract testing companies and three biotechnology companies. She is an experimental pathologist with a specialty in virology and has experience from product R&D to IND and BLA acceptance. She has interacted with regulatory agencies, biotechnology companies, Veterinary, Medical, animal owner communities (raw material sources) and recently with the manufacturing diagnostic industry on the development of a commercial PCR kit for the detection of mycoplasma in GMP lot release testing.
Miriam C. Provost Ph.D. - Senior Consultant
Miriam comes to BCG with over 13 years of experience with the Food and Drug Administration, Center for Devices and Radiological Health. Most recently, she was the Deputy Director for Science and Engineering Review in the Office of Device Evaluation. The Office of Device Evaluation is responsible for the review and approval of all medical devices in the U.S., with the exception of in vitro diagnostic devices. Miriam previously worked for M Squared Associates as a Senior Project Manager, advising medical device and combination product manufacturers on regulatory strategy, FDA submissions and product development issues.
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.
Stephen Rhodes M.S. - Senior Consultant
Stephen P. Rhodes, M.S. joined Biologics Consulting Group, Inc., as a Senior Consultant (Medical Devices) on March 15, 2010.
Mr. Rhodes comes to BCG with a wealth of knowledge from over 20 years of experience with the Food and Drug Administration, Center for Devices and Radiological Health. Mr. Rhodes will utilize his broad technical and regulatory expertise to assist clients in the following areas:
Short and long term regulatory strategy for medical device technologies, biomaterials, combination products and tissues, assisting clients with navigating the regulatory process and developing preclinical and clinical testing plans, representing clients in interactions with FDA, assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings, preparing and assisting in the preparation of RFDs, Pre-IDEs, IDEs, HDEs, 510(k)s and PMAs and providing clients with a comprehensive "FDA style" review of submissions.
Nadine M. Ritter Ph.D. - Senior Consultant
Nadine has nearly 20 years of industry experience in the technical, quality and regulatory requirements for the physiochemical and functional analysis of biopharmaceutical products. She is an analytical biochemist with expertise in the analytical and stability studies necessary for product development and commercialization. She has worked with R&D, GLP and cGMP laboratories from startup organizations to multinational pharmaceutical corporations. Her specialties include biotechnology product characterization, comparability, release and stability testing. She is an expert in methods for identity, purity, concentration, impurities and potency, as well as immunogenicity assays. She has conducted analytical test method development, qualification and validation, and test method tech transfers. She routinely audits analytical laboratories for quality and compliance and due diligence, and delivers internal training classes on CMC studies and quality practices for biotech products.
David Rouse M.S. - Senior Consultant
David comes to BCG with over 23 years experience in the research, review and regulation of biological products within FDA/CBER and the biopharmaceutical industry. Most recently, David was the head of CMC Vaccines regulatory affairs group for Pfizer Pharmaceuticals, Inc. (previously Wyeth Pharmaceuticals, Inc.) at the Sanford, NC location. David led a department of nine regulatory affairs professionals responsible for the development of global regulatory strategies to support successful domestic and international regulatory submissions for licensed and clinical vaccines. Prior to joining Wyeth, David was a biologist for over 12 years at the Food and Drug Administration's Center for Biologics Evaluation and Research, Office of Vaccines Research and Review.
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.
Holly Scott - Senior Consultant
Holly joined BCG in September 2009 and comes to the group with over 18 years of multi-office experience with the Food and Drug Administration, including 4 years as a Consumer Safety Officer with the Center for Biologics Evaluation and Research, and 14 years as a Field Investigator with the Office of Regulatory Affairs Florida District Office (Miami and Orlando), specializing in the inspections of Blood, Plasma, and Human Tissue establishments, and Dietary Supplement Manufacturers. In addition, Holly brings many years of experience as a Clinical Investigator, IRB, Sponsor/Investigator, and Drug GMP Inspector. In 2002, Holly was awarded her FDA Level II Certification in Blood Banks and Plasma Centers, recognizing her expertise in the area of Biologics 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.
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.
Calley Herzog - Consultant
Calley comes to BCG with over 8 years experience in various technical engineering roles, including 3 years experience as a Biomedical reviewer at FDA in the Office of Device Evaluation, Division of General, Restorative and Neurological Devices, General Surgery Devices Branch. At FDA, Calley was involved in the review process for 510(k)s, IDEs and as lead reviewer for PMAs. Calley's combination of industry and FDA experience positions her to provide clients with a specialized understanding of regulatory processes and the challenges they may encounter when interacting with the agency.
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.
Rebecca Spence Ph.D. - Consultant
Rebecca (Becky) Spence, Ph.D. joins Biologics Consulting Group, Inc., as a Medical Writer on February 1, 2010. Becky comes to BCG with 10 years of experience in the clinical development industry, with Expertise in evaluating clinical data and communicating science through clinical, regulatory, and commercial documents.
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:
Kathleen Hewitt - Associate
Since joining BCG in May of 2009, Kathleen has provided assistance with document preparation and other project management activities in the BCG Corporate Office.
Kelly Reich M.S. - Associate
Ms. Reich joined BCG in July 2001. For the past several years she has provided regulatory support including project management for original applications and drug product listings from BCG's Corporate office. Ms. Reich also assists in the preparation of original applications and maintenance management of application amendments and supplements both paper and electronic, legacy and CTD format.
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.
Ben Wimmer - Associate
Ben Wimmer joined BCG as of November 2009 as an Associate and provides electronic submissions assistance. He is experienced in publishing and submission of electric documents to the FDA, familiar with legacy IND format (following form 1571) and CTD format, with expertise in publishing of clinical study reports and provides regular support to US Agent clients with regard to IND and BLA maintenance (amendments).
Administrative:
Shannon Beeby - Administrative
Office Assistant for Virginia office.
Mary Croucher - Administrative
Administrative Assistant at North Carolina Office.
Jessica Shaw - Administrative
Financial Assistant at the Virginia Office
Carol Urps - Administrative
Contracts & Human Resource Coordinator at the Virginia Office.
