Clinical & Nonclinical Archives - Juvena Therapeutics

Bernard (Barney) D. King, MD, MBA, RAC (US, EU)

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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Andrew Campbell

Andrew Campbell has 35 years of multi-disciplinary pharmaceutical Quality Assurance experience in both development and commercial stage companies. He has broad experience with parenteral, tablet, and suspension dosage forms. He has assisted several clinical-stage companies through the development cycle, culminating in successful regulatory filings, regulatory inspections, and marketing authorizations.

He has extensive experience with design, remediation, and implementation of Quality Systems. He is an accomplished trainer, speaking to industry groups on the topics of Supplier Management, Auditing, Investigations, and Change Management.

Andrew obtained his Bachelor’s degree in Chemistry from UC Davis.

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Zhihua Li, PhD

Dr. Li is a biologist with a multidisciplinary background in Biochemistry, Immunology, Cell and Molecular Biology, with 7 years of research experience in academia and 4 years in industry. He joined Juvena Therapeutics as a Protein Engineering Scientist to build protein expression and purification pipelines and to improve Juvena Therapeutics’ pipeline library of rejuvenating proteins for therapeutic purposes.

Following a BS in Biochemistry and Master’s Degree (MS) in genetics from scientific and technical universities in China, and a second MS in Molecular Microbiology and Immunology from the University of Southern California all during which he conducted research, Dr. Li completed his PhD (2007) and postdoctoral training (2014) in Cell and Molecular Biology from UT Austin, where he studied protein-protein interactions in different ways: first by combining computational predictions with experimental validations to discover 15 new protein factors functioning in the biogenesis of ribosomes; then by combining powerful mass spectrometry with protein fractionation techniques to create protein complex maps for both yeast and human cells. Continuing his exploration of novel protein interactions in his postdoctoral research, Dr. Li elucidated the self-cleavage mechanism of a novel membrane-bound transcription factor that drives oligodendrocyte differentiation. He’s published multiple co-authorships and first authorship studies along the way.

Before joining Juvena, Dr. Li worked in industry and biotech startups as Lead Scientist, Life Science Consultant, Scientific Advisor and R&D director. As Lead Scientist at BMLogic, Dr. Li developed and optimized the protein secretory production system in Pichia, leading to improved protein secretion efficiency and greatly reduced protein degradation.

Besides his passion for science, he enjoys spending time with his kid and exploring nature.

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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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Shari-Anne Burgess, RN

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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Bernard (Barney) D. King, MD, MBA, RAC (US, EU)

Andrew Campbell

Zhihua Li, PhD

Jeff Welch

Shari-Anne Burgess, RN

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