Anisha Wharton serves as Head of Regulatory Affairs at AVEO and brings more than 16 years of global regulatory leadership to support the development, registration and life-cycle management of biologics and pharmaceutical products. Prior to joining AVEO in 2021, Ms. Wharton served as Director, Global Regulatory Affairs – Oncology at Merck & Co., Inc. where she served as the Global Regulatory Lead for early and late-stage clinical development programs for advanced metastatic tumors, women’s cancers, melanoma, and multiple myeloma. While at Merck, Ms. Wharton led a global regulatory team responsible for the approval of a new dosing regimen of KEYTRUDA® across all approved adult indications in over 35 countries. Prior to Merck, she served in global Regulatory Affairs roles of increasing complexity and responsibility at Nektar Therapeutics, InterMune, Inc. (acquired by Roche), InSite Vision, Inc. (acquired by Sun Pharma), and Genentech, Inc. She helped lead a cross functional team in the approval of ESBRIET® and AZASITE®, as well as the development of a global regulatory intelligence database. Ms. Wharton earned her Bachelor of Science degree from Clark Atlanta University and her Master of Business Administration degree from the University of San Francisco School of Management.
Michael has extensive experience counseling life sciences companies to achieve clinical and commercial goals while responsibly managing compliance and enforcement risks. He previously held in-house Legal and Compliance positions at PDL BioPharma, Mylan and Dendreon. Michael began his legal career with the FDA Drug and Biotechnology practice at an international law firm in Washington, DC. Prior to his career as an attorney, Michael was a marketer with Procter & Gamble and Bristol-Myers Squibb. Michael earned Juris Doctor and Master of Public Health degrees from the University of Virginia and a Bachelor of Arts degree from the University of Notre Dame.
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Noelia Rycerz brings more than 17 years of global drug development experience to her role at Aveo Oncology. Ms. Rycerz has held roles of increasing seniority in Clinical Operations and Program Management at Amgen Inc., Pfizer Inc., and Odonate Therapeutics, Inc. She led and executed clinical phase 1 – 3 clinical trials in varying therapeutics areas including oncology, rheumatology and cardiovascular disease. During her time at Amgen Inc. as a Program Manager, she supported CMC, Regulatory and Safety Affairs to ensure delivery of marketing applications leading to approval of Corlanor®. While at Pfizer, Ms. Rycerz was accountable for oversight of pivotal clinical trials and support of regulatory inspections leading to marketing application approvals for Xeljanz®, Besponsa® and Daurismo®. Ms. Rycerz received a Bachelors of Science at Boston University.
Sharon Reinhard serves as Vice President of Quality Assurance at AVEO and brings more than 25 years of pharmaceutical executive industry experience holding roles in Clinical Development, Clinical Operations, Quality and Compliance. Ms. Reinhard began her career building and running the Emergency Medicine research program at the Hospital of the University of Pennsylvania. Once she transitioned into the industry, she worked in a variety of different size companies such as Wyeth, LLC, Shire plc, Merck & Co., Inc. and CSL Behring where she managed responsibility for GMP, GLP, GVP, GCP and Device/combination product quality. She has also worked on numerous NDA/BLA filings and supported dozens of regulatory inspections and audits. Ms. Reinhard focuses on employing risk-based and quality by design approaches. She has published over 20 abstracts and papers related to clinical research. Ms. Reinhard received her undergraduate degrees from the University of Pennsylvania in Biology and English and earned her Masters of Science degree from Temple School of Pharmacy in Pharmaceutical Drug Development- Regulatory Affairs and Quality Assurance.
Scarlett Spring currently serves as Co-Founder and Chief Executive Officer of TapRoot Interventions & Solutions, a platform technology company focused on providing real-time, tailored interventions to caregivers managing patients with Alzheimer’s and dementia behaviors. She previously served as President and Chief Commercial Officer for VisionGate, Inc., a clinical-stage pharmaceutical and diagnostics company developing products for the early detection, prevention, and treatment of lung cancer. Prior to VisionGate, Ms. Spring served in various sales and commercial roles of increasing responsibility at Merck and AstraZeneca Pharmaceuticals. At AstraZeneca, she was involved in the successful launches of Prilosec®, Nexium®, Crestor® and Iressa®, and managed the hormonal portfolio for AstraZeneca Oncology. Ms. Spring also previously served as Executive Vice President and Chief Operating Officer of the Greater Phoenix Economic Council. She currently serves on the Arizona Bioscience Board and Risk Capital Committee of the Flinn Foundation, as well as on the Boards of Republic Bank of Arizona and the Arizona Sports and Tourism Authority. Ms. Spring received a Bachelor’s degree in Marketing from the University of Texas at Austin and a Master’s in Business Administration from Pepperdine University. Ms. Spring has served as a director of AVEO since 2019 and is chairperson of the compensation committee and a member of the audit committee.
Manoj Patel, PharmD
Manoj Patel has more than 20 years of experience in the pharmaceutical industry, over 15 of which are directly in the development of oncologic treatments and joins AVEO as Vice President of Program Management. Prior to joining AVEO’s management team, Dr. Patel led the development of several biologics programs as a Project Leader within Teva’s specialty pharma group. Prior to Teva, he held several senior level positions within Project and Program Management as well as Customer Solutions at PRA Health Sciences (now part of ICON) and IQVIA. During his tenure at these CROs, Dr. Patel oversaw the development of oncology treatments for several major pharmaceutical and biotech clients. Prior to IQVIA, he worked at GlaxoSmithKline for more than 10 years across multiple functions that included Clinical Development, Medical Affairs and Project Management. Dr. Patel was also Sr. Director of Program and Alliance Management at ImClone Systems and was involved in the process leading to the ultimate sale of the company to Eli Lilly. Dr. Patel received BS degrees in Chemistry and Pharmacy from the University of North Carolina at Chapel Hill and a Doctorate of Pharmacy from Campbell University.
Jason Noto brings over 20 years of broad commercial leadership experience to his role as Senior Vice President of Market Access at AVEO Oncology. Prior to joining AVEO, Jason served as Vice President at 1798 Consultants, a strategic market access consultancy specializing in integrated channel strategy, patient support services (HUB), payer contract development and assessment, financial impact analysis, and related Access functions. Earlier, Jason served as Senior Director of Market Access Strategy and Payer Marketing at Amag Pharmaceuticals, leading Payer marketing efforts across all business units totaling >$600M in revenue in 2019.
Prior to his tenure at Amag Pharmaceuticals, Mr. Noto held various launch, in-line, and multi-channel marketing leadership roles of increasing responsibility at Sunovion Pharmaceuticals, Alkermes, and Bristol-Myers Squibb Company. During his career, Mr. Noto has had responsibility for the US commercial launch of various specialty products in oncology, immunology, CNS, & ultra-orphan disease states. Mr. Noto received a B.S. in Business Administration from Le Moyne College and an M.B.A. in finance from the Carroll School of Management at Boston College.
Mr. Ledell serves as Chief Operating Officer of AVEO. He joins AVEO from Enzyvant Therapeutics, a biotechnology company dedicated to developing novel, transformative regenerative therapies for people with devastating rare diseases, where he served as Chief Operating Officer and led key business operations during the recent U.S. Food and Drug Administration approval of RETHYMIC®. Prior to Enzyvant, Mr. Ledell served as the Chief Operating Officer at Compass Therapeutics and Horizon Discovery Group. He was responsible for leading operations at both organizations through several changes in scale. Prior to Horizon, he held multiple technology, operations and development roles at Zalicus Inc. Mr. Ledell holds a BS degree in Chemical Engineering from Worcester Polytechnic Institute.
Vijay Kasturi, MD
Dr. Vijay Kasturi, Vice President, Clinical Development and Medical Affairs, brings more than 25 years of experience establishing and executing global and regional strategies that have brought innovative new treatment options to patients in hematology and oncology. Prior to joining AVEO, Dr. Kasturi was Senior Vice President of Scientific Affairs at FerGene, where he also led both Medical Affairs and Clinical Development. He has also led U.S. Medical Affairs, Oncology for EMD Serono where he had broad leadership responsibilities, including external stakeholder management, evidence generation, medical education and publication strategy. During his time with EMD Serono, Vijay also developed and managed the global medical strategy and launch plan for the company’s anti-PD-L1 agent (avelumab), including indications in Merkel cell, urothelial, and kidney cancer.
Earlier in his career, Dr. Kasturi served as an Assistant Professor of Medicine, Division of Hematology-Oncology at the University of Massachusetts Medical School and was the program leader for genitourinary oncology at UMass Memorial Cancer Center. He trained in Hematology-Oncology at the National Cancer Institute and worked as an investigator and physician at the National Cancer Institute and at Dartmouth Hitchcock Medical Center.