Dr. King is President of Macnas Consulting International, Inc. Macnas specializes in strategic product development planning and execution for pharmaceutical, biotechnology and medical device companies and in due diligence consulting for venture capital, investment, and pharmaceutical firms.
Dr. King has more than 25 years’ experience managing business and development operations in the pharmaceutical, medical device, biotechnology and CRO (Contract Research Organization) industries. In particular, he has directed, or been directly involved in, development programs for more than 100 pharmaceutical, medical device and biologics products. The products have addressed clinical targets in a broad range of therapeutic areas and the development programs have included more than 250 separate clinical trials in multiple countries.
Dr. King graduated cum laude from the University of Notre Dame, majoring in English and Preprofessional Studies, and received his MD from the Ohio State University College of Medicine. He is board certified in Cardiology and Internal Medicine. He received his MBA from the Wharton School of the University of Pennsylvania.
Dr. King’s book on development entitled, Get It Right The First Time! Pharmaceutical Product Development: Intelligent Solutions for Challenging Issues was recently published by Macnas Press, San Diego, CA. It is available online at www.macnaspress.com and through Amazon.
Mo (Mohammad) Tabrizi, PhD brings over 25 years of experience in basic research, integrative pharmacology, translational sciences, and development of biologics. Prior to Joining Juvena Therapeutics, Dr. Tabrizi served in positions with increasing responsibilities at large companies such as Merck Research Laboratories, Medimmune (acquired by AstraZeneca), Abgenix (acquired by Amgen), and biotech companies such as Soteria Biotherapeutics and Acendis pharma. His product development experience spans many therapeutic areas including oncology, immune-oncology, and inflammatory diseases.
He has been an author or co-inventor on more than 50 original papers, reviews articles, published books and patents. Dr. Tabrizi has been an invited speaker to numerous national and international conferences. Dr. Tabrizi received his bachelor’s degree in Pharmacy from University of Houston (Summa Cum Laude) and his PhD from University at Buffalo, State University of New York (SUNY) in Pharmaceutical Sciences. He completed a postdoctoral training in Pharmacology at University of New York at Buffalo (SUNY) with a focus on therapeutics.
Meredith Brown-Tuttle has written and coordinated numerous drug and biologic submissions to US and international regulatory agencies, developed global regulatory strategies, and conducted worldwide regulatory intelligence.
Meredith Brown-Tuttle, RAC, FRAPS, has 31 years of industry experience from bench to clinic to approval of both drugs and devices. Meredith has written and coordinated numerous drug and biologic submissions to US and international regulatory agencies, developed global regulatory strategies and conducted worldwide regulatory intelligence. She is currently both Vice President of Regulatory & Quality at Lyric Pharmaceuticals, Inc. and a strategy/intelligence consultant at Regulatorium. Meredith has written, managed and led over 30 successful domestic and international IND and NDA submissions. She is a founding instructor at UC Santa Cruz Regulatory Certificate Program and author of two books: “IND Submissions: A Primer” and “Regulatory Intelligence 101.” Meredith graduated with a BA in biological psychology (neuroscience) from San Jose State University.
Tina Duong is the Director of clinical outcomes research and development at Stanford University Neuromuscular division. Clinically, she is a physical therapist with 20 years of clinical experience in evaluating, treating and validating clinical outcomes for patients with neuromuscular disease.
Her clinical and research interests are in developing, refining and understanding impacts of muscle imbalances and pathology on function and performance. Her work has contributed to improved understanding and characterization of disease phenotypes impacting clinical trial design and care management.
Currently, her research focuses on the effect of exercise and physical activity on human movement and disease physiology. She hopes to integrate technology and digital biomarkers as a complementary tool to performance based measures used in trials, in the clinic and remotely. She enjoys working on collaborative diverse inter-disciplinary teams, mentorship and creating patient focused solutions to improve the quality of life for individuals with neuromuscular disease.
Since 2011 John has been Professor of Neurology, Pediatrics (Genetics) and Pathology at Stanford University, where he is Director of the Division of Neuromuscular Medicine. He received his MD from the University of Minnesota, and PhD in Neuroscience from Albert Einstein College of Medicine, where he studied neuronal electrophysiology, synaptic physiology and plasticity. After completing neurology and neuromuscular training at UCSF, he was Professor of Neurology, Pediatrics and Genetics at the University of Minnesota, where he founded and directed the Paul and Sheila Wellstone Muscular Dystrophy Center.
John has investigated the genetic causes and multisystemic effects of neuromuscular disorders and has more than 35 years of experience designing and directing clinical trials of novel therapeutics. He spearheaded clinical research on spinal muscular atrophy (SMA) at Stanford, which resulted in the approval of antisense and AAV-gene replacement treatments, and led to nationwide newborn screening for SMA and institution of neonatal genetic treatment.
Shari Burgess brings over 25 years of clinical experience to the life science and healthcare industry working in a variety of indications such as but not limited to oncology, neuromuscular disorders, rare disease, regenerative medicine, burn and wound care and orthopedics. She is the Chief Clinical Operations Lead in her clinical consulting company, Clinsytes Inc., a niche clinical consulting company that provides global clinical operation insights and solutions for small to midsize life science companies for the improvement of clinical operational performance and delivery of measurables in drug/device development, trial management and business development strategies. Previous to Clinsytes, Shari held senior management roles at CROs and medical/biotech companies.
Mayowa is the founder of Clinical Scientist Group LLC (CSG), a clinical science consulting and recruiting firm providing regulatory writing services to Juvena Therapeutics. With more than 15 years experience in clinical development, her experience is wide-ranging and includes roles as a study coordinator and clinical research associate. From there she held roles in clinical trial management, and clinical science and medical writing consulting. She is a PGY-1 residency trained pharmacist.
Her therapeutic area experience includes but is not limited to: oncology (solid tumor), transplantation/immunology, cardiovascular, rare disease, ophthalmology, gastrointestinal, and hepatology.
Mayowa received her BSc in Biochemistry from Beloit College in Wisconsin, Masters of Public Health (Concentration in Epidemiology & Biostatistics) and Doctor of Pharmacy Degree at the University of Illinois at Chicago.
Jeff Welch has over 30 years of CMC experience in the process development, GMP manufacturing and facilities, and regulatory documentation.
In Jeff’s most recent role as a consultant he has had responsibility for authoring and reviewing regulatory filing sections related to process development and product characterization.
Over the past decade Jeff has focused on his role as a senior director for drug substance (DS) process development and director over process engineering and operations for a specialty pharmaceutical company working in biologics and vaccines and as a CDMO organization.
Jeff has also served as a project manager for large scale manufacturing and technology transfer projects and filled the DS team leader role. After a lead role in engineering and construction, he served as a senior manager over the start up effort for a stainless steel cell culture facility (1600 L scale), where he hired and managed personnel and led a 7-day-a-week cGMP manufacturing operation for the upstream portion.
In his early career he participated in design of a multi-product manufacturing facility and after start-up performed process fit and technology transfer activities for several microbial, yeast and cell culture products.