ANGELA MALLERY, EdDSPECIALTY AREAS: Expert on global regulatory requirements and strategy, particularly U.S. FDA; vast QMS requirements expertise
Angela Mallery, EdD, is a Principal Product Development Strategist at NAMSA with over 25 years of experience working in device regulatory affairs in small, medium, and large sized companies. Angela has experience in project management, regulatory strategies, pre-submission meetings; and has hands-on experience developing, writing, and receiving clearance/approval for 510(k), IDE submissions and reports, PMAs, CEP/CERs, and Technical File/Design Dossier submissions. Angela’s therapeutic experience includes cardiology, neurology, peripheral vascular devices, general surgical devices and orthopedic implants.
BARB ATZENHOEFERSPECIALTY AREAS: Expert on global regulatory requirements and strategy, particularly U.S. FDA; vast QMS requirements expertise; frequent interactions with the FDA and other regulatory agencies; expert with scientific communications
Barbara Atzenhoefer is a Product Development Strategist at NAMSA. During her 28+ years in the medical device industry, Barbara has held executive, management and staff positions in regulatory, clinical, quality and product development. In 2003, she joined NAMSA, specializing in regulatory affairs. Her regulatory experience includes authoring over 200 hundred global regulatory strategies, clinical and marketing applications. She has particular expertise in FDA strategy and requirements, and interacts frequently with the organization.
CARLA WIESESPECIALTY AREAS: Expert on U.S. FDA regulatory requirements and strategy; formerly served at the FDA as a lead reviewer and program lead for the Early Feasibility Studies (EFS) program
Carla is a Principal Product Development Strategist with over 20 years of experience in the medical industry. Prior to working at NAMSA, Carla worked for over five years at the FDA, serving as a lead reviewer and engineering consultant in the division of cardiovascular devices, and additionally as the program lead for the Early Feasibility Studies program. Carla also worked as a research and development engineer in industry for over a decade in both a large company and a startup.
CHRIS MULLIN, MSSPECAILTY AREAS: Expert on biostatistics, scientific communications, FDA regulatory meetings; has supported multiple FDA Advisory Committee (Panel) meetings; a recognized industry expert across the medical device community (including the FDA)
Chris Mullin is currently the Director, Product Development Strategy at NAMSA where he oversees and manages client partnerships surrounding product development, regulatory, clinical, and market commercialization strategies. Chris began his career working on National Institute of Health (NIH)-funded academic clinical trials, and over the last ten years, he has consulted for medical device organizations throughout the U.S., Asia, and Europe on various clinical trial programs.
A highly sought-after industry expert, Chris has helped more than one hundred global manufacturers optimize study design and research, providing proven strategies to address regulatory requirements for market approval and introduction. He has worked with multiple innovative technologies across a wide array of therapeutic areas, which has allowed him to provide valuable perspectives to clients on scientific and regulatory challenges – and suggested strategies for success – that impact the advancement of novel medical technology. Chris has authored multiple peer-reviewed publications, a book chapter on clinical study design for translational research, has served as a lecturer for multiple universities, and serves as a journal editor.
DON PALME, PhD, MSSPECIALTY AREAS: Expert on regulatory and preclinical testing; focus on designing preclinical in vivo testing for devices and biologics
Don Palme, PhD., has over 20 years of regulatory and preclinical testing experience. He specializes in designing and directing preclinical in vivo testing for devices and biologics to address safety, efficacy and biocompatibility endpoints. He also has experience in regulatory submissions and interactions with U.S. and international regulatory agencies.
Prior to joining NAMSA, Don was the Global Vice President of Toxicology and In-Life Services at Wuxi Apptec, responsible for toxicology and preclinical services including testing strategies, study designs, custom implantation work and client consulting. In addition, Don has held previous roles at Boston Scientific, Acorn Cardiovascular and Guidant Corporation. He has authored numerous journal articles, technical presentations and book chapters on biocompatibility, medical device performance, immunology and pharmacokinetics. He is currently a voting member of the American Association of Tissue Banks, Scientific and Technology and the ASTM Committee F04 on Medical and Surgical Materials and Devices.
DON POHLSPECIALTY AREAS: Expert on biological safety of medical devices; frequent interactions with the U.S. FDA as well as other regulatory agencies; facilitates NAMSA Training Series on biocompatibility and delivers numerous webinars
Don Pohl joined NAMSA in 1993, and has over 25 years of experience in the medical device industry, having worked in various roles all involving the non-clinical/preclinical evaluation of medical devices. During his career, he has held a variety of positions ranging from laboratory supervision / management, GLP Study Director, technical specialist covering for in vitro/in vivo evaluation of medical devices, manager of biological safety and validation Services, and his current role of Principal Product Development Strategist.
Don’s expertise is specialized in the areas of sample preparation per ISO 10993-12 and the design of preclinical, in vitro/in vivo evaluations based on ISO-10993-1, FDA guidance and other relevant regional and international standards. He has led dozens of training courses on behalf of NAMSA, with thousands of students benefitting from his generous advice.
ED ARSCOTTSPECIALTY AREAS: Expert on sterilization and microbiology; extensive lab experience, including novel sterilization technologies
Ed Arscott, Senior Product Development Strategist, has 12 years of NAMSA laboratory experience with increasing responsibilities, culminating into managing both the microbiology and in vitro toxicology departments.
Prior to joining NAMSA, he spent 14 years at DePuy Orthopedics as the Global Manager of Microbiology, responsible for all aspects of the company’s sterilization- and microbiology-related activities for four manufacturing facilities. He has full knowledge of all routine sterilization modalities, along with novel sterilization technologies as developed within DePuy/J&J. He also has expertise in the areas of biological indicators and medical microbiology pertaining to antimicrobial testing. He holds two method patents on antimicrobial delivery systems.
GAËLLE CLERMONT, PharmD, PhDSPECIALTY AREAS: Expert in preclinical studies and biocompatibility
Gaëlle currently serves as Senior Product Development Strategist at NAMSA. She has over 15 years’ experience within the medical device industry, and has directed numerous preclinical studies in many fields, most notably cardiology, orthopedics, gastroenterology, dental, wound healing, general surgery, and drug delivery. Gaëlle has supported the development and regulatory approval of various devices, combination products and new biotechnologies through preclinical safety, performance and efficacy evaluations. She is an industry-leading expert in assisting global device manufacturers to accelerate clinical research and regulatory approval of innovative medical technologies.
Gaëlle holds a Doctorate in Pharmaceutical Sciences Degree and PhD in Cardiovascular Pharmacology from the University of Burgundy (France). She also earned a Medical Device and Biological Products Regulation Degree from the University of Paris.
JACK RISDAHL, DVM, PhDSPECIALTY AREAS: Expert in preclinical study design, particularly for the U.S. FDA; Doctor of Veterinary Medicine, PhD; participation in numerous FDA meetings to discuss submission requirements, preclinical study design and interpretation of results
Dr. Jack Risdahl holds two doctorate degrees in Veterinary Medicine (DVM and PhD). He has over 27 years of experience in medical research and laboratory animal medicine. He has held numerous medical research leadership positions in both academia as well as industry including: Professor, Global Director and Vice President appointments. In addition, he co-founded Integra Group Preclinical Services and acted as a managing partner in that firm. He has published multiple articles and papers on transplantation, inflammation, immunity, infectious diseases and medical devices.
Prior to his current role at NAMSA, Dr. Risdahl was the Director of Preclinical Studies for several years. Currently, he works with Sponsors to design preclinical studies for new medical products that meet regulatory requirements worldwide. His knowledge of in vivo models, research methods and regulatory requirements help provide the best possible study design to efficiently meet regulatory requirements for each Client.
KIRK HONOUR, MSSPECIALTY AREAS: Expert on global regulatory requirements and strategy; QMS requirements expertise
Kirk currently serves as a Principal Product Development Strategist at NAMSA. He is responsible for providing support and consulting to clients pursuing development of innovative medical technologies. With over 20 years’ experience in the medical technology industry, including multiple start-ups, Kirk’s background includes expertise on all phases of device development, global regulatory strategy and market access, including preclinical, clinical, approval and post-market. He has built and supported numerous regulatory submissions, new product development strategies, presentations and market assessments.
JASON KRZESAKSPECIALTY AREAS: Expert in clinical strategy; extensive experience with product development strategies
Jason has 15 years’ experience in product development of medical devices and joined NAMSA in 2018. Jason has led activities focusing on preclinical and clinical research of devices through the feasibility, premarket and post-market phases. Notably, Jason has held leadership positions within clinical affairs for both large and start-up companies, which included cross-functional leadership responsibilities. Mr. Krzesak has clinical experience in vascular (cardiac, aortic and peripheral vascular), cervical spine and urinary stones, in addition to numerous applications of medical technology in the preclinical environment.
PAMELA WOLFE, MBA, MS, CCRP, ACRP-CP, ACRP-MDP, FACRPSPECAILTY AREAS: Expert in clinical strategy; Past-President of ACRP (Minnesota Chapter) and award recipient for outstanding clinical research leadership
Pamela is a versatile healthcare and clinical research professional with 25+ years of expertise. She is currently a Principal Product Development Strategist for global medical device clinical studies for NAMSA. Her responsibilities include development and hands-on management of clinical trials from concept to completion. She regularly collaborates with Sponsors to develop well-designed protocols that translate into effectively run clinical studies, both pre- and post-market.
Prior to joining NAMSA, Pamela was the Director of Clinical Research and Operations at Magellan Medical Technology Consultants and Director of Clinical, Quality, Regulatory and Biomedical Engineering with Frestedt Inc. She has worked on a diverse variety of projects in a wide range of therapeutic areas with client companies around the world. She has provided expertise in clinical investigations, regulatory support and quality systems for biotech, medical device, pharmaceutical and food products.
Pamela currently serves as the immediate Past-President of the Minnesota Chapter of the Association of Clinical Research Professionals (ACRP). She was previously on the Board of Directors of the Minnesota Medical Group Management Association (MMGMA). In 2012, she was named the international award recipient for “Outstanding Leadership in Clinical Research by a Project Manager” by ACRP.
RICHARD KOTZSPECIALTY AREAS: Expert in biostatistics, FDA regulatory strategy, study design and powerful methods for using data; spent 25 years at the FDA/CDRH; awarded the FDA’s 2016 Lifetime Achievement Award
Prior to joining NAMSA, Richard worked for 25 years at FDA as a statistical reviewer and manager at CDRH’s Division of Biostatistics. During his last 10 years with the FDA, he managed statisticians reviewing clinical trials for OB/GYN, Urology, Gastroenterology, Renal, Respiratory, Diabetes, Oncology, Anesthesiology, Infection Control and General Surgery Devices. Richard and his team reviewed hundreds of clinical trial protocols and have worked closely with clinicians, engineers, scientists and counterparts in the medical device industry to develop efficient pilot and pivotal clinical trials to evaluate medical devices.
Richard has also been involved in several regulatory and statistical organizations in various capacities, including president of the FDA Statistical Association and recent chair of the Medical Device and Diagnostic Section of the American Statistical Association. In 2016, he was awarded FDA’s 2016 Lifetime Achievement Award.
VINCENT LEGAY, PhD, MBASPECIALTY AREAS: Expert on EU regulatory strategy, QMS requirements, as well as ISO 10993 (biological safety), microbiology/sterilization and clinical evaluation
Vincent currently serves as NAMSA’s Director of Global Product Development Strategy. He has over 15 years’ experience at NAMSA where he has been responsible for a range of activities covering the entire medical device lifecycle continuum, including management of sterilization, biocompatibility, risk management, clinical evaluation and quality management systems for Clients worldwide.
Currently, Vincent oversees a global cross-functional team of medical device strategists and project managers, and also directly supports medical device manufacturers with preclinical and clinical research strategies for regulatory approval and commercialization.
STEVE ULLERY, MSSPECIALTY AREAS: Expert on biostatistics; vast experience in all phases of clinical studies
Steven is a Principal Product Development Strategist at NAMSA where he is responsible for providing support and consulting in the area of biostatistics. Steven is a biostatistician by training, holding a Master’s Degree in Statistics from the University of California, Riverside. He has supported numerous regulatory submissions, manuscripts, presentations, marketing materials and other publications with a focus on statistics and scientific considerations.
With over 30 years working in medical device, IVD and clinical research, Steven’s background includes experience on all phases of clinical studies, including preclinical, clinical, post-market, shelf-life for drug/device combination products and in vitro diagnostics.
TYSON ROGERS, MSSPECIALTY AREAS: Expert on biostatistics; vast clinical trial design strategy expertise
Tyson is a Senior Product Development Strategist with NAMSA. He received his Master’s in Biostatistics from UCLA and has been working on clinical trials for the past 12 years, assisting companies—both large and small—develop and execute on clinical evidence plans. His statistical interests and expertise focus on trial design, including strategy for interim analyses and adaptive sample size re-estimation.