Consultants of Biologics Consulting Group, Inc. - Complete Regulatory Support for the Biologics Industry

About the Biologics Consulting Group LLC staff

Board of Directors (View)

Management

James G. Kenimer, Ph.D. - President & CEO. 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.

Kelly Boyle, RAC – VP, Finance, Corporate Secretary, Treasurer. 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.

Eugene B. Johnston, CQE, CQA- Head, North Carolina Office. 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. See Announcement.

Keith H. Wells, Ph.D. - Head, Massachusetts Office Dr. Wells joined the group in October, 2000 where he was most recently 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. See Announcement.

Ronald A. Marchesani - Head, West Coast Office. Mr. Marchesani joined the BCG team February 28th 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. See Announcement

William F. Winslow - Chief Legal Officer Bill was formerly 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.

Lei Zhang, M.D., Ph.D. - Head, China Office Dr. Zhang joined BCG April 1, 2007. 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. See Announcement.

Vice Presidents

Peter Probst - VP, Audits & 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 - VP, Bacterial Products. 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 - VP, Viral Products. 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.

Directors:

John J. Jessop, Ph.D., M.P.H. - 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. See Announcement.

Andra E. Miller, Ph.D. - 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. See Announcement.

Ruth Wolff, Ph.D. – 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.

Senior Consultants:

Carl Anderson - Senior Consultant - Mr. Anderson has come to BCG after 23 years and varying positions at the FDA. He started his career with FDA in 1987 as a biologist, transferred in 2000 to the Seattle District where he conducted inspections of clinical investigators, institutional review boards (IRBs), GLP laboratories, and sponsors of clinical research. In 2001 Carl became a member of the FDA international inspection cadre, conducting inspections in Canada, Switzerland, and the European Union. He also broadened his expertise to include conducting "PADE" inspections for reporting adverse events by drug and biologic company pharmacovigilance departments. In 2004 Carl was assigned to the Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health. As a Senior Consultant with Biologics Consulting Group, Inc. Carl will utilize his private sector and FDA regulatory compliance experience to assist sponsors and clinical sites conduct research that meets FDA standards. See Announcement.

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. See Announcement.

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. See Announcement.

Julia Barrett, MD, MPH - Sr. Clinical Consultant 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.See Announcement.

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. See Announcement.

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. See Announcement.

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. See Announcement.

Wilson W. Bryan, MD - Sr. Clinical Consultant Dr. Bryan will begin 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. See Announcement.

Nebojsa M. Djordjevic, Ph.D. - Senior Consultant. Dr. Djordjevic joined BCG in January of 2008. Dr. Djordjevic 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. See Announcement

Thomas J. Gerteisen, Ph.D. - Senior Consultant. Dr. Gerteisen joined BCG August 1, 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. See Announcement.

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. See Announcement.

Melanie Hartsough, Ph.D. - Senior Consultant. Dr. Hartsough joined the BCG team on February 20th. 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. See Announcement

John E. Humphries, MD.- Sr. Clinical Consultant 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. See Announcement

Louise Johnson, M.S. - Senior Consultant - Ms. Johnson is joining the BCG team March 1st. 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. See Announcement

David Lin, Ph.D. - 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. See Announcement.

Stephen D. Litwin, M.D. - Sr. Clinical Consultant. Dr. Litwin joined BCG in October 2003. He recently 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.
See Announcement.

Maritza C. McIntyre, Ph.D. - Senior Consultant. Dr. McIntyre joined BCG in April 2006. Dr. McIntyre brings to BCG over 6 years of experience in the Division of Cellular and Gene Therapies (DCGT)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), where she was actively involved in regulation and policy development in the area of gene therapy, as well as cell therapy and immunotherapy. Dr. McIntyre's recognized expertise in regulation and policy development for gene therapy and related products will allow BCG to provide clients an unparalleled level of expertise and service in these areas. See Announcement.

James McIver, Ph.D - Senior Consultant. Dr. McIver joined the BCG team in July of 2003. He comes to BCG with 20 years experience as 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. See Announcement.

Reginald D. Neal - Senior Consultant - Reggie Neal joined the BCG team in March 2006.Reginald 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. See Announcement.

Peter A. Patriarca, M.D. - Sr. Clinical Consultant. Dr. Patriarca joined BCG on May 17, 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. See Announcement.

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. See Announcement.

Stuart Portnoy, M.D. - Senior Consultant - 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. See Announcement.

Ellen Raaf, MT, ASCP- Senior Consultant. Ms. Raaf joined the group in November 2007. Ms. Raaf 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. See Announcement.

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. See Announcement.

Ronald A. Salerno, Ph.D. - Senior Consultant. Dr. Salerno joined BCG in February of 2008. Dr. Salerno 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. See Announcement.

Gilbert T. Salud - 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. See Announcement

Nanda K. Subbarao, Ph.D. - Senior Consultant. Dr. Subbarao joined the group in June of 2007. She is a Bio-organic Chemist and comes with 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. See Announcement.

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. See Announcement.

Ruth E. Wager, Ph.D. - Senior Consultant. Dr. Wager joined the BCG team April 1, 2008. Dr. Wager joined BCG in April of 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. See Announcement.

Darin J. Weber, Ph.D. - Senior Consultant, Cell & Gene Therapies. Dr. Weber joined the BCG team in February 2004. He comes to BCG after 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. See Announcement.

Janice B. Wilson, Ph.D. - Senior Consultant - Dr. Wilson joined the group in December 2007. She is a quality and compliance executive with over 25 years of global and international experience in the highly regulated bioscience industries. Dr. Wilson was most recently the Global Head of Compliance for Novartis Vaccine and Diagnostics working out of the Emeryville, CA office where she was a member of the executive team providing oversight for the development and implementation of the division's Quality Manual. Her experience includes development, implementation, and directing of sustainable Quality Systems, Quality Assurance programs, and extensive Regulatory Compliance programs for GMP and ISO activities. See Announcement.

Larry K. Winberry, Ph.D. - Senior Consultant, Process Development and Manufacturing. Dr. Winberry joined the group in September, 2001. He was most recently, 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. See Announcement.

Consultants:

Kerin L. 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. See Announcement.

Raphael Bartholomeusz, Ph.D. - Consultant. Dr. Bartholomeusz joined BCG's West Coast Operations in 2002. He provides preclinical program management, preparation of US FDA regulatory IND submissions to allow entry into the clinic and set-up and management of Phase I and II clinical trials. Raphael has over 10 years of clinical trials experience and therapeutic experience with HIV, HBV, bacterial infection and autoimmune and renal disease, encompassing the development of both small molecule and biologic products.

Anne McElderry Zurbay, RN, MSN, ND - Consultant. Dr. McElderry 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 See Announcement.

Daniel P. Offringa - Consultant. Mr. Offringa joined the group in Feb. 2005. From 2001-2005, Mr. Offringa was an IT Specialist in the Office of Information Management, CBER. He 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.See Announcement.

Associates:

Kelly H. 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 recently 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.

Page Updated: April 22, 2008