Development Archives - Juvena Therapeutics

Mayowa Agbaje-Williams

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.

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Bernard (Barney) D. King, MD

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.

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Shari-Anne Burgess

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.

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Meredith Brown-Tuttle

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.

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Jeff Welch

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.

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Daniel David Gretler, MD

Dr. Gretler is Board Certified in Internal Medicine and Clinical Pharmacology and has worked in drug development for almost 30 years with the last 10 spent as a consultant in clinical pharmacology and early drug development. He received his MD from the University of Bern in his native Switzerland and his graduate medical training in Internal Medicine, Critical Care and Clinical Pharmacology at the University of Southern California and The University of Chicago, where his last position was Assistant Professor in the Committee on Clinical Pharmacology, Section of Cardiology. He started his drug development career at Syntex and held various positions there and later at COR Therapeutics, Millennium Therapeutics and Portola Pharmaceuticals. His last full-time position was Chief Medical Officer at Portola Pharmaceuticals. He has been Adjunct Clinical Associate Professor of Medicine at Stanford University for over 20 years. He has contributed to the development and approval of a number of drugs including CAMZYOS, NULIBRY, OXBRYTA, ANDEXXA, BEVIXXA (betrixaban), INTEGRILIN, CELLCEPT.

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