Dr. Baylor joins Biologics Consulting Group after 20 years with the Food and Drug Administration (FDA), most recently as the director of the Office of Vaccines Research and Review (OVRR). In his former position at FDA's Center for Biologics Evaluation and Research, Dr. Baylor was responsible for planning, developing, and administering CBER's broad national and international programs and operational activities involving vaccines and related products. He also served as the FDA's liaison to CDC's Advisory Committee on Immunization Practices, and the DHHS National Vaccine Advisory Committee. Dr. Baylor will continue to serve as an expert advisor to the World Health Organization on several global vaccine initiatives in his new position.
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.
Consultants Emeriti:
Consultant Emeritus status is awarded to founding partners who have retired from BCG. They are available for consultations with current BCG consultants and clients on a limited basis.
James G. Kenimer Ph.D. - Consultant Emeritus
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.
Peter Probst - Consultant Emeritus
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.
Mr. Probst retired from BCG in November of 2010 with a total of 46 years in the biologics industry as a regulator in the FDA and as a consultant.
Michael S. Williams - Consultant Emeritus
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.
Mr. Williams retired from consulting in March of 2011 with a total of 43 years in the biologics industry as a regulator in the FDA and as a consultant. He remains on the BCG Board of Directors and continues to maintain a role in management.
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.
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 - 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.
Business Strategy:
Trent A. Carrier Ph.D., MBA - Executive Director, Business Strategy
Dr. Carrier is a business leader with over 17 years of experience in developing new paradigms in the life science industry. Most recently, Trent was the Senior Director of Bioprocess Services and Cellular Medicine at Life Technologies. Dr. Carrier joined Invitrogen in 2005 to lead the launch of a new process development services business focused on cell line development and cell culture media optimization. Receiving numerous accolades for innovation and customer focus, PD-Direct grew over 40% per year overall and >100% per year in Asian markets under Dr. Carrier’s leadership. In 2010, Dr. Carrier completed his MBA from the University of Virginia, Darden Graduate School and assumed additional responsibility for cell therapy products and services. At Life Technologies, Dr. Carrier led multiple licensing transactions and was recognized for his ability to build high growth businesses.
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:
Debra Barngrover Ph.D., RAC - Senior Consultant
Debra comes to BCG with over 25 years of experience in the biopharmaceutical industry. Most recently, she was Vice President, Technology Development, at Genzyme Corporation. During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in over 40 countries, as well as managing the Technology Development group responsible for development of more than 15 small molecule, protein and viral vector products (seven commercial). She has provided managerial leadership to process development, analytical, formulation development, project management, manufacturing, package and label engineering and risk management functions. She has authored/reviewed several CMC BLA submissions and participated in agency meetings and plant inspections.
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.
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.
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 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 and also served as CBER Liaison to the Recombinant DNA Advisory Committee (RAC) and NIH Office of Biotechnology Activities (OBA). The focus of Dr. Miller’s consulting is to provide regulatory strategies for Regenerative Medicine (cell, tissue and gene based) product development, including interpretation of FDA and NIH/RAC regulations/guidelines, FDA submissions, and assessment of cGMP, cGTP and quality system compliance.
Vince Narbut MBA - Senior Consultant
Vincent J. Narbut joined Biologics Consulting Group, Inc., as a Senior Consultant (Biopharmaceutical Products) in February 2011. Vince comes to BCG with over 26 years of experience in the biopharmaceutical industry, all at Biogen Idec. Vince’s areas of expertise include biopharmaceutical clinical and commercial manufacturing, process development, engineering, IT and quality assurance. He has led and been involved in numerous manufacturing facility designs, startups and operations. He has provided managerial leadership for manufacturing, engineering and quality assurance functions. Vince also has significant experience in development and oversight of quality systems including the areas of IT and automation compliance. He has authored and/or reviewed several CMC BLA submissions and participated in numerous regulatory agency inspections.
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.
Dominique Pifat Ph.D., MBA - Senior Consultant
Dominique comes to BCG with over 25 years of experience in both government and the pharmaceutical industry. Most recently, she was Senior Director for marketing and training for the International Division of Talecris Biotherapeutics. As such she was responsible for training product distributors worldwide on the science behind the company’s entire product portfolio. She was also responsible for developing science driven marketing plans in 48 countries, remaining cognizant of applicable regulatory requirements.
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.
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.
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 as a Senior Consultant. She brings approximately 19 years of multi-office experience with the Food and Drug Administration, including 4 years as a Consumer Safety Officer with FDA/CBER, and 15 years as a Field Investigator with the FDA Office of Regulatory Affairs/ Florida District Office (Miami & Orlando). In that capacity she specialized in GMP Compliance inspections of Blood & Blood Products (achieving FDA Level II certification on the National Biologics Cadre), Plasma-derived products, Human Tissue establishments, Drug and Dietary Supplement Manufacturers, Clinical Investigators, IRBs, Sponsors, as well as performing quality systems inspections. As a Senior Field Investigator, she was also responsible for the training of new field personnel and development of District Procedures. Holly uses this experience to assist clients with compliance analysis, GMP audits, and regulatory support in all of these FDA-regulated areas.
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.
Alice Varga M.S., M.A. - Senior Consultant
Ms. Varga comes to BCG with 20 years of industry experience in areas ranging from small molecules to stem cell therapies as has spent the last 4 ½ years at the first company to receive FDA clearance for a clinical trial using a human embryonic stem cell (hESC) product. Ms. Varga’s experience with hESC products includes the preclinical, CMC and clinical areas of planning for these types of products and includes close interaction with the FDA review team in the Office of Cell Therapy and Gene Therapy (OCTGT).
Larry K. Winberry Ph.D. - Senior Consultant
Process Development and Manufacturing, CMC, and Quality Systems support. Larry joined the group in September 2001; prior to that he was the Vice President of Manufacturing and Process Validation (Anthrax Vaccine) Team Leader with BioPort Corporation. He brings to the firm over twenty five years of experience in the biopharmaceutical industry, principally in the areas of process development, process validation, manufacturing, and Quality Systems. Larry uses his experience to assist clients with process development/process validation support, GMP audits, mock-FDA pre-approval inspections, person in the plant manufacturing support and CMC regulatory support during the BLA submission/review/approval process.
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 RAC - 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.
Anne M. Zurbay RN, MSN, ND - Consultant
Dr. Zurbay joined the group in January 2005. She began her career as a Clinical Research Associate at the University of Colorado School of Medicine, and joined BCG after working for three years in the pharmaceutical industry, where she was responsible for pharmacovigilance activities for a variety of products in Phases 1-3 of development in several regions of the world. Dr. Zurbay subsequently attended the University of Chicago’s Graham School Medical Writing and Editing program. Her consulting experience includes the preparation of the clinical sections of multiple successful IND, NDA and BLA submissions, as well as other regulatory documents, and the management of pharmacovigilance activities for Phase 1 and 2 clinical trials.
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., RAC - 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 joined BCG in March 2000 with 12 years of prior regulatory affairs experience. She has provided clients with regulatory guidance, project management and submission support with respect to INDs, marketing applications and all related amendments and supplements (paper and electronic, legacy and CTD format). Ms. Vaughan also assists with U.S. Agent requirements, Orphan Drug Designations, establishment registrations and product listings, and document QC.
Ben Wimmer - Associate
Ben Wimmer joined BCG in 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.
Sherri Pike C.P.A. - Administrative
Accountant at the Virginia Office
Heather Poginy - Administrative
Administrative Assistant at the Virginia Office
Jessica Shaw - Administrative
Financial Assistant at the Virginia Office
Carol Urps - Administrative
Contracts & Human Resource Coordinator at the Virginia Office.
