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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Mo (Mohammad) Tabrizi, PhD

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.

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Meredith Brown-Tuttle, RAC, FRAPS

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.

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Dan Furlong, DHA, PMP, MBA

Dr. Dan Furlong serves as the project manager for the CIRM-funded TRAN-12890 project at Juvena Therapeutics. He has over 35 years of project management and leadership experience, serving in the healthcare industry for the past 24 years. In healthcare he and his teams were responsible for projects that included up to 300 staff and were valued at over $80M USD. Beyond project management, Dr. Furlong also brings leadership, business, and strategic planning skills to the team.

Dr. Furlong has served regularly as the Project Management Institute (PMI) subject matter expert for healthcare at the annual PMI Global Congress and has consulted, lectured, and trained thousands of people for dozens of international organizations both at home and abroad. He was a speaker at the HIMSS Annual Conference ten times, including leading several all-day seminars for them. He was awarded the HIMSS Fellow designation for his service to HIMSS and the healthcare community. He was awarded a full scholarship for the 2022 CHIME CIO Bootcamp and was one of 50 people accepted into the 2008 PMI Leadership Institute Masters Class, a full scholarship leadership program.

Dr. Furlong co-authored the textbook Healthcare Project Management along with Dr. Kathy Schwalbe (1^st & 2^nd editions) as well as the PMP Last Chance Review. Dr. Furlong is a faculty member at the Medical University of South Carolina where he has been teaching in their MHA and MSHI programs since 2009. He currently teaches Healthcare Project Management, Systems Analysis & Design, and Database Concepts courses there, but also holds faculty appointments with the College of Charleston and Walden University.

Dr. Furlong earned his BS in Computer Science from the College of Charleston, his MBA from The Citadel, and his DHA from the Medical University of South Carolina.

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Angela Genge, MD, FRCP(c), eMBA

Dr Genge is recognized internationally for her work in clinical trial design and execution in the field of rare disease, particularly Amyotrophic Lateral Sclerosis, Myasthenia Gravis, and FSHD. Currently the Executive Director of the ALS center of excellence at the Montreal Neurological Institute, McGill University, she recently stepped down from executive director of the MNI’s clinical trial unit after a 20 year tenure. She serves as scientific advisor for a number of clinical trial networks including ENCALS , CALS and is a member of the executive committee of the WFN ALS section. Her current activities include CMO of Quralis, Global PI of AL-S Pharma and serves as an advisor to sponsors for ALS, FTD, Myotonic Dystrophy, FSHD and Myasthenia Gravis among many others. A regular invited speaker on many topics from novel therapies in neuroscience to regulatory challenges internationally she has received a number of awards including the Forbes Norris Award, the Wings over Wall Street award, the YWCA woman of distinction, and a founder award from Community Cares. She advocates tirelessly for therapeutic innovation in neuroscience and access to therapeutics for the rare disease community.

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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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Mayowa Agbaje-Williams, PharmD, MPH

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, MBA, RAC (US, EU)

Mo (Mohammad) Tabrizi, PhD

Meredith Brown-Tuttle, RAC, FRAPS

Dan Furlong, DHA, PMP, MBA

Angela Genge, MD, FRCP(c), eMBA

Andrew Campbell

Zhihua Li, PhD

Jeff Welch

Shari-Anne Burgess, RN

Mayowa Agbaje-Williams, PharmD, MPH

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