James LaFlamme, RPH, MS, FACHEFounder, Chief Executive Officer
James LaFlamme is the Chief Executive Officer and Founder of Biopharma Global. He has more than 30 years of healthcare operational experience and has held a variety of senior positions including Chief Executive Officer, Chief Operations Officer, Vice President of Clinical Services, and Administrative Director at several hospitals and health systems. In his current role as Chief Executive Officer he is responsible for leading global operations for BioPharma Global. This encompasses overseeing the development and delivery of all advisory opinions and client deliverables as well as a full complement of Client Development activities on a worldwide basis.
Prior to joining BPG, he was Executive Vice President at Coté Orphan where he oversaw all aspects of regulatory affairs and business development globally. Previously, he was Vice President for Accreditation and Recognition Operations at the National Committee for Quality Assurance (NCQA) where he was responsible for the delivery of NCQA’s nine accreditation and certification programs and three physician recognition programs. Earlier in his career he was the Director of the Healthcare Advisory Public Sector Practice at PricewaterhouseCoopers (PwC). At PwC, his primary focus was improving clinical and business operations for key healthcare clients.
James earned a BS degree in Pharmacy from the University of Connecticut School of Pharmacy and a MS degree in Management from Indiana Wesleyan University. He serves on the Deans Advisory Board at the UCONN School of Pharmacy and is a Fellow of the American College of Healthcare Executives.
Tom Ng, PhDChief Operating Officer
Dr. Tom Ng has 20 years of biotech experience on both the science and business side of the industry. He currently functions as the Chief Operating Officer and is a key member of the management team at BioPharma Global. In his current role, he is responsible for leading client development and operations activities on a worldwide basis.
Prior to joining BPG, he has held management level positions including R&D, Program/Project Management, Alliance/Channel Management, Marketing & Sales and Business Development, on a both national and international basis while working at various biotechnology companies along the I-270 tech corridor of Maryland, including Celera, Gene Logic and BioReliance. He more recently worked in the preclinical services arena with Noble Life Sciences and Epistem.
Dr. Ng’s academic background includes a B.S. in Biochemistry from the University of Maryland and a Ph.D. in Molecular Biology from Johns Hopkins University. He is also an Executive Board Member and President Emeritus of the CMNS Alumni Association Chapter at the University of Maryland.
Sandra Heibel, PhDChief Science Officer
Dr. Sandra Heibel is the Chief Science Officer for BioPharma Global. She has almost 20 years of experience with rare diseases, first as a researcher conducting preclinical and clinical drug development, and subsequently in the field of Regulatory Affairs with a focus on rare diseases. In her current role, Sandra is responsible for all client deliverables and advisory opinions. She has extensive knowledge of drug and biologic development for rare diseases, regulatory strategy, scientific writing, regulatory submissions, and project management. She has had regulatory experience in oncology, neurology, hematology, hepatology, metabolics, genetics, orthopedics, nephrology, ophthalmology, gastroenterology, immunology, endocrinology, and cardiology and rare disease research experience in genetic, metabolic, and autoimmune diseases.
Prior to and since joining BPG, Dr. Heibel has worked in the regulatory affairs field with a focus on rare diseases including with Dr. Marlene Haffner, the former head of the FDA Office of Orphan Products Development and preeminent expert in orphan drug regulatory affairs. Dr. Heibel conducted research at the Children’s National Medical Center in Washington, DC, the US Department of Agriculture, The University of Maryland, and Penn State University.
Dr. Heibel’s academic background includes a Ph.D. in Molecular Biology and Genetics from the University of Maryland, an M.S. in Animal Science and Molecular Biology from the University of Maryland, and a B.S. in Animal Bioscience from Penn State University. She is a passionate advocate for rare disease drug development and research, STEM education, mentoring, and women in the sciences and leadership.
Lee Shaughnessy, PhDManaging Director of Regulatory Affairs
Dr. Lee Shaughnessy has over 10 years of pharmaceutical industry experience spanning infectious diseases, antibody therapeutics, and regenerative medicine. She has contributed to product advancement at various stages of development including R&D, preclinical, clinical, and commercial readiness. She currently serves as the Director of Regulatory Affairs at BioPharma Global. Prior to joining BPG, Dr. Shaughnessy worked at Pfizer and Mallinckrodt where she served in various senior level positions in the departments of R&D, Operations, and Quality. At Mallinckrodt, Dr. Shaughnessy developed a broad base of regulatory experience including IND and BLA submissions and preparing teams for Type B/C FDA meetings.
Prior to joining the pharmaceutical industry, Dr. Shaughnessy’s academic background included a BS in Microbiology from the University of Illinois at Urbana-Champaign, a PhD in Microbiology and Immunology from the University of Michigan, and Postdoctoral research in Microbiology and Immunology at Stanford University.
Paula Garcia Calavia, PhDScientific Officer
“Dr Paula Garcia Calavia currently functions as Scientific Officer at BioPharma Global. She has experience in drug development, particularly in medical therapeutics and diagnostics. Her regulatory education includes the completion of a drug discovery, development, and regulation course at UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). At BPG, Paula is involved in feasibility and strategy consulting, novel data analysis, authoring expedited approval applications to FDA and EMA, project management, writing pre-IND and IND level submissions to FDA, and preparing clients for Type B FDA meetings. She has worked in diverse projects covering all stages of drug development, from early first-in-human trials to Phase 3 trials, and a variety of indications including oncology, hematology, gastroenterology, immunology, and COVID-19. She is particularly interested in drug development and regulations for rare diseases with unmet medical needs.
Prior to joining BPG, Paula worked as a research scientist in R&D towards the development of rapid diagnostic tests for infectious diseases, such as influenza virus and norovirus. Her academic background includes a Master of Chemistry (MChem) in Forensic and Investigative Chemistry, with a focus on drug detection and quantification from fingerprint samples, and a PhD in Cancer Bio-nanotechnology, where she worked in the development of nanoparticles for targeted photodynamic therapy using cancer in vitro models and various nanomaterials, both from the University of East Anglia in the United Kingdom. , wp>
Ruth Hill, RACDirector of Regulatory Affairs, CMC
Ruth Hill, RAC is our Regulatory Affairs consultant with over 27 years of industry experience developing and implementing regulatory and product development strategies for a variety of dosage forms at all stages of development in a wide variety of therapeutic areas. Ruth is currently the Senior Regulatory Affairs Officer at BioPharma Global where she leads key regulatory projects providing a wide variety of regulatory consulting services to small and large companies in the pharmaceutical industry. Ruth has authored more than 35 INDs, 18 CTDs (NDA, BLA, and ANDA), and 50 Post Approval Supplements in a wide variety of therapeutic areas, such as oncology, neurology, dermatology, pulmonology, and analgesia, as well as therapies in the orphan drug and rare disease space. In addition, Ruth has decades of experience in negotiation with regulatory agencies, risk assessments for development strategies, and CMC and cGMP regulatory compliance.
Although Ruth has developed a broad base of experience throughout her career, Ruth’s area of expertise has consistently been the development of the pharmaceutical itself (also known as CMC), the FDA regulations supporting that development (also known as CMC regulatory), and the preparation of those portions of the regulatory submissions supporting that pharmaceutical development. She has held management-level positions in regulatory departments at biotechnology companies including, Mayne Pharma (Vice President of Regulatory and Medical Affairs), Perrigo Company (Head of Regulatory Affairs), Synthon Pharmaceuticals (Senior Director, Regulatory Affairs), and UCB Pharma (US Head of CMC Regulatory Affairs). , wp>
Antony Kaprielian, RAPS CertifiedRegulatory Affairs Manager
Antony Kaprielian has been with Biopharma Global since its launch, initially assisting with developing company infrastructure and policies in addition to regulatory writing. He currently manages the company’s in-house regulatory team, using his expertise in early- to mid-phase FDA applications to ensure all projects meet both agency and company standards. In addition, he also specializes in electronic submissions to FDA, feasibility and strategy consulting, and writing expedited approval applications to FDA. He has authored and supported numerous successful applications to FDA and EMA, including orphan drug designation (ODD), rare pediatric disease designation (RPD), investigational new drug (IND), agency meeting requests and briefing packages, fast track designation (FTD), breakthrough therapy designation (BTD), qualified infectious disease product (QIDP) designation, annual reports, and others.
Antony has received his Bachelor of Science in Neuroscience from the University of California, Riverside, with additional post baccalaureate education in Hematology and Clinical Laboratory Science from the University of California, Berkeley Extension. He has also been certified by the Regulatory Affairs Professional Society for completing regulatory affairs coursework for pharmaceuticals.
James Knox, MBADirector of Devices and Combination Products
Knox has over 30 years of FDA regulatory affairs expertise. In the last 20 years, he is considered by many to be the top device regulatory affairs expert, having worked on projects for Genzyme, Novartis, and GSK. He has experience in direct negotiations with the FDA and helping formulate project team strategies, US and EU pre- and post-approval projects, like CTA applications. His work includes pre-clinical and clinical program design, clinical trial monitoring, clinical auditing, adverse event evaluation and reporting, new and existing facility compliance auditing, drug substance and drug product manufacturing, CMC activities from pilot work through full-scale production and post-approval product changes, microbiology, quality assurance, training, scientific affairs, drug and device regulatory affairs, publications, labeling and package inserts, and a wide range of other clinical and regulatory functions to assure compliance with US, EU and some Japanese regulations. He is an expert in performing labeling due diligence and subsequent data remediation.