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 Regulatoium. 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.
Joyce James, Ph.D., is a strong leader with over twenty years of industry experience dedicated to the discovery and development of therapeutics, including small molecules, peptides, and biologics. Areas of expertise include nonclinical, early phase clinical trials, and bioanalytical, biomarker, and pharmacodynamic assays to support all stages of development, including related development and regulatory strategy. Founder of Corvid LLC, an early development and clinical pharmacology consulting company. Previously served as Vice President of Early Development and member of the management team for Odonate Therapeutics, an oncology-focused company. Founding and core member of Lyric Pharmaceuticals, serving as Vice President, Clinical Pharmacology & Early Development. Prior to Lyric, served as Senior Director and Head of Drug Metabolism and Pharmacokinetics & Analytical Chemistry at Cytokinetics, supporting numerous research and clinical programs. Held senior positions at Ambit Biosciences, playing a key role in the discovery and development of quizartinib for the treatment of FLT3-ITD positive acute myelogenous leukemia (approved in Japan). Provided critical support for the successful filing of multiple INDs and deep experience in nonclinical and clinical Phase 1 study designs. Consult for a number of biopharmaceutical companies providing ADME, analytical, clinical pharmacology, and bioanalytical support. Began a pharmaceutical career as a Research Fellow at Merck Research Labs, devoting time to both NMR spectroscopy and discovery DMPK. Ph.D. in Biophysical Chemistry, The University of California, Berkeley, Department of Chemistry and B.S. in Biochemistry, The College of Charleston, Department of Chemistry, summa cum laude.
Nicholas E. Johnson, MD, MSCI, FAANis an associate professor, division chief of neuromuscular, and vice chair of research in the department of neurology at Virginia Commonwealth University with a focus in inherited neuromuscular disorders. He received his undergraduate degree in molecular and cellular biology and psychology at the University of Arizona. He then obtained his medical degree at the University of Arizona. He completed his neurology residency and combined fellowship in neuromuscular medicine and experimental therapeutics at the University of Rochester. His laboratory is focused on identifying the pathogenesis of myotonic dystrophy, the limb girdle muscular dystrophies, and facioscapulohumeral muscular dystrophy and identifying appropriate clinical endpoints for these conditions. Johnson conducts therapeutic trials in many other inherited nerve and muscle disorders.
Translational laboratory focused on identifying genetic modifiers across muscular dystrophies, and developing clinical endpoints and patient reported outcomes for myotonic dystrophy, facioscapulohumeral muscular dystrophy, and the limb girdle muscular dystrophy. The laboratory uses cellular models to identify changes in RNA splicing in myotonic dystrophy.
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.