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The Berke Report: People Movement for the First Week of May 2023

Vera Therapeutics Appoints Kerry Cooper, M.D., as Senior Vice President of Medical Affairs (PR)

Dr. Cooper brings nearly 40 years of experience in nephrology across a variety of senior positions within industry, clinical practice and academia. He has led medical affairs strategies for drug development programs in chronic kidney disease (CKD), hyperparathyroidism, hyperkalemia and other renal conditions. Over twelve years, he served in leadership roles in medical affairs at several leading pharmaceutical companies, including AstraZeneca and Amgen, where he served as Global Medical Affairs Leader for Nephrology. He joins Vera from ProKidney, where he led the development of the medical affairs function.

Ambrx Expands Leadership Team with Appointment of Andrew Aromando as Chief Operating Officer (PR)

Mr. Aromando has served in C-level roles for 15 years across multiple oncology-focused biopharmaceutical companies. He has also held senior executive positions at IQVIA, Syneos Health and WCG focusing on the development of clinical and commercial programs for early and late-stage clinical product candidates, new products, and mature brands across many therapeutic areas.

Veranova, an API CDMO Appoints Mike Riley as CEO (PR)

Mr. Riley is a seasoned executive, with over 25 years of professional experience, of which nearly 19 years have been spent in the pharmaceutical contract development and manufacturing operations (CDMO) industry building, leading, and growing global businesses. Most recently, Mr. Riley served at Catalent, Inc. (NYSE: CTLT) as President of the Biotherapeutics business, a multi-site business unit with 6,500 employees and revenue over $1B.

Xenetic Biosciences, Inc. Adds Business Development Expertise with Appointment of Scott N. Cullison (PR)

Mr. Cullison currently serves as the Owner/Consultant for Stride BDCOM Consulting, where he provides senior executive level business development and commercial planning strategy/execution services in the biotech/pharma industry. Most recently he exited his role as Vice President, Business Development and Commercial Planning at Peloton Therapeutics following the completion of $2.2 billion acquisition by Merck. Prior to that, he served as Vice President, Commercial Planning and Program Management at Bellicum Pharmaceuticals where he led the commercial planning activities and pre-launch strategic initiatives for a late-stage gene modified T cell therapy product adjunctive to allogeneic hematopoietic stem cell transplant (HSCT) for orphan inherited blood disorders and malignant diseases. He also held a number of roles over 13 years at Targacept, Inc. including Vice President, Business Development, Senior Director, Business & Commercial Development (Therapeutic Area Leader - Mood Disorders), Director, Business & Commercial Development, Senior Manager, Licensing & Commercialization, and Business Development Analyst.

Cerevel hires former Translate Bio head Renaud as new CEO (biopharmadive)

Biotechnology industry veteran Ron Renaud will take over the top job at Cerevel Therapeutics after a series of delays producing clinical trial results shook investor confidence in the company. Renaud will replace Tony Coles as CEO on June 12, Cerevel said Wednesday. Coles will continue in his post as chairman of the board. Cerevel expects results from seven studies of experimental drugs in 2024, among them a closely watched schizophrenia medicine known as emraclidine. The biotech also said it has plenty of cash to support that research and fund operations into 2025.

Curve Biosciences Appoints Industry Veterans to Leadership Team, Announces Commercial Advisory Board (PR)

Stanford Spin-Out Using Proprietary Chronic Disease Tissue Atlas to Bring Precision to Patient Care. Nathan Hunkapiller, PhD, Former Head of R&D at GRAIL and Natera, Appointed Chief Scientific Officer. Chuba Oyolu, PhD, Founding Scientist at Counsyl, Named Chief Technology Officer.

Pulse Biosciences, Inc. Appoints Dr. Gan Dunnington as Chief Medical Officer (PR)

Dr. Dunnington is a cardiothoracic surgeon and the Director of Cardiothoracic Surgery at St. Helena Hospital (Napa Valley). He specializes in minimally invasive complex cardiothoracic procedures including the Hybrid Cox-Maze procedure for the treatment of atrial fibrillation (AF). Prior to his time at St. Helena Hospital, Dr. Dunnington was an assistant professor at Stanford University and assistant director of cardiothoracic surgery at El Camino Hospital, a

Stanford University affiliate. Dr. Dunnington obtained his medical degree from the Medical College of Virginia. He completed his residency at Stanford University, where he served as Chief Resident of Surgery, and completed a fellowship in cardiothoracic surgery at the University of Virginia.

Soligenix Announces Appointment of Timothy R. Coté, M.D. to its Board of Directors

Dr. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Centers for Disease Control (CDC), Dr. Coté served as the Director of the FDA Office of Orphan Products Development (OOPD) from September 2007 to May 2011. In this role, he implemented the U.S. Orphan Drug Act and personally signed decisions on more than 1,400 orphan drug designation applications. After leaving FDA, Dr. Coté founded Cote Orphan (with a consultancy of 450 clients), where he served as Chief Executive Officer (CEO) until its sale in 2017 to IQVIA for $20 million. He is currently CEO of Only Orphans Cote LLC, a regulatory affairs consulting firm leveraging his expertise and commitment to delivering drugs for rare diseases. He also serves as the CEO of Silk Road Therapeutics, a privately held rare disease company from which Soligenix recently acquired an exclusive option to purchase a novel topical formulation of Pentoxifylline (PTX), a non biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient's suffering from Behçet's Disease.

GlycoEra AG Expands Board of Directors and Appoints Santiago Arroyo, MD to its Board of Directors as an independent board member (PR)

He is currently the Chief Development Officer of Bicycle Therapeutics. Prior to joining Bicycle, Dr. Arroyo held the Chief Medical Officer position at Momenta Pharmaceuticals, leading the company's clinical development programs until Momenta's acquisition by Johnson & Johnson. Previously, he was the Chief Medical Officer of Boston Pharmaceuticals and before that held multiple senior clinical development leadership roles at leading pharmaceutical companies including Pfizer, Inc., Bristol-Myers Squibb, Eisai Global Clinical Development and Schwarz Biosciences.

Frontage welcomes Dr. John Kapeghian as the Senior Vice President of Global Safety & Toxicology (PR)

Dr. John Kapeghian joins Frontage with over 35 years of experience in global preclinical safety evaluation and development. After working in regulatory and experimental toxicology units at large pharma (Ciba now Novartis) and in contract research (Sierra Biomedical/Charles River), he established his own company, Preclinical Safety Associates, which provides toxicology strategy and regulatory services for over 90 companies worldwide since 2006.

Alladapt Appoints Louise Peacock as Chief Regulatory Affairs and Quality Officer (PR)

Prior to joining Alladapt, Ms. Peacock was Head of Pharma R&D at Nestle Health Science, where she was responsible for global regulatory affairs, program management, pharmacovigilance, biometrics and clinical science for drug products in food allergy, gastrointestinal and metabolic disorder therapeutic areas. Previously, Ms. Peacock served as SVP Global Regulatory Affairs at Aimmune Therapeutics, where she was responsible for activities supporting the development and marketing approvals in the U.S., E.U., U.K. and Switzerland of Palforzia®, an oral immunotherapy product for the treatment of peanut allergy. Ms. Peacock’s earlier career included leadership positions of increasing responsibility at Abbott, Auxilium, Intermune and Circassia.

Galera Expands Commercial Leadership Team, Patrick Campbell as Vice President of Sales & Account Management, Elizabeth Turner as VP of Market Access, Henning Thorsen as VP of Commercial Operations (PR)

Prior to joining Galera, Dr. Bachleda served as Vice President & U.S. Business Unit Head of the CAR T Cell Therapy Franchise at Bristol Myers Squibb (BMS), launching Breyanzi® (liso-cel), a CD19 CAR T in large B cell lymphoma, and Abecma® (ide-cel), the first BCMA CAR T in relapsed/refractory multiple myeloma. He held the same role at Celgene Corporation before its acquisition by BMS for $74 billion in 2019. He served as Vice President, Sales & Account Management at Juno Therapeutics before its $9 billion sale to Celgene in 2021.

Dr. Walker joined Galera as Vice President of Marketing in February of 2021 and has been leading pre-launch efforts including strategy, insight generation, commercialization readiness, and brand development. Previously, Dr. Walker served in multiple global marketing roles at Novartis, including Executive Director, Global Brand Lead at Novartis Oncology, where she led the global marketing team for the successful global launch of Rydapt® for FLT3+ Acute Myeloid Leukemia (AML) and Advanced Systemic Mastocytosis (AdvSM).

Mr. Campbell joins Galera from Amgen, Inc. where he recently served as Executive National Sales Director for Amgen’s oncology solid tumor portfolio. He led the buildout of a new U.S. oncology sales division responsible for the successful launch of Lumakras® to treat KRAS G12C-mutated non-small cell lung cancer.

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