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Amish |
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Patel |
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Senior Vice President Technical Operations |
Calidi Biotherapeutics |
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Dr. Amish Patel has over 20 years of leadership experience in the global biotech industry, providing strategic guidance throughout the entire biologic product life-cycle and been involved with fifteen+ INDs and commercial product launch. Dr. Patel is responsible for oversight of Global Manufacturing, Quality Control, Quality Assurance and Supply Chain to produce Clinical and Commercial cancer therapies utilizing Calidi’s innovative oncolytic viral therapies with stem cell-based delivery platforms to treat cancers with significant unmet needs. Dr Patel has managed the CDMO network and supplied clinical products for phase 1 and phase 3 trials globally. Dr Patel has extensive experience in licensing and out licensing several technologies from Academia and non profit organizations and even commercialized such assets. He serves as Technical Activities Committee of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) part of Manufacturing USA® and funded through the U.S. Department of Commerce with significant additional support from its members. He was most recently, the Senior Director of Product Development at Emergent BioSolutions (formerly PaxVax, Inc., prior to acquisition), where he successfully built and directed cross-functional teams working on numerous biologic Clinical and commercial products. |
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Catherynne |
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Cruz-Scheckner |
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Executive Director, Clinical Supplies |
Ionis Pharmaceuticals, Inc. |
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Catherynne is an Executive Director at Ionis Pharmaceuticals, heading up the clinical supplies department. She started her career as a pharmacist in a retail and hospital setting and has worked for large pharmaceutical companies such as Warner Lambert, Parke Davis, Pfizer, and Valeant Pharmaceuticals, as well as smaller biotech companies like Ascenta Therapeutics and Phenomix. Catherynne is a clinical supplies management professional with 28 years of pharmaceutical experience and a proven track record of building cross-functional collaboration resulting in on-time delivery of project goals. Background encompasses pre-formulation/formulation, manufacturing, clinical supplies, IRT development, supply chain, and CMC project management. |
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Janal |
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Urich |
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Vice President, Clinical Operations |
Atara Biotherapeutics |
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Over 25 years industry biopharma experience, with roles in nearly every facet and phase of Drug Development. The past 13 years have been in small, emerging biopharma companies, largely focused on building, refining, and optimizing infrastructure to streamline drug development.
A particularly enjoyable aspect of working through infrastructure challenges is leveraging problem solving and interpersonal skills that are required to successfully identify, navigate, and solve strategic, tactical, and cultural requirements. These requirements are key considerations to ensure changes are a successful fit for the respective culture, their stage(s) of drug development, and most importantly, foster an efficient and effective drug development practice.
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Joe |
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Castellanos |
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Senior Account Executive |
Peli BioThermal |
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Joe Castellanos is an experienced Senior Account Executive with a demonstrated history of winning business in the temperature controlled pharma packaging industry. With a strong background in Pharmaceuticals, Biotechnology, Life Science Manufacturing and Clinical Trial Requirements, Joe is well versed in the challenges and opportunities which exist in this dynamic marketplace. Joe has worked for Peli BioThermal since 2018 and has a BA focused in Philosophy from California Polytechnic State University, San Luis Obispo. |
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Joseph |
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Shan |
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Vice President, Clinical Operations |
Adcentrx Therapeutics |
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Joseph (Joe) Shan, M.P.H., VP, Clinical Operations at Adcentrx Therapeutics, has nearly 30 years of clinical experience in biopharma and medical device companies. Nearly 25 years were focused on clinical development of oncology therapeutics, including radiopharmaceuticals, small molecules, targeted therapy, immunotherapy and cellular therapy. Prior to Adcentrx, Joe held leadership roles in Clinical Development Operations at Mosaic ImmunoEngineering, MEI Pharma, Elevar Therapeutics, Kiadis Pharma (formerly CytoSen Therapeutics) and was VP, Clinical & Regulatory Affairs and a corporate officer of Peregrine Pharmaceuticals for nearly a decade. Mr. Shan received his M.P.H. from George Washington University and B.S. from UCLA |
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Karim |
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Mohammed |
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Principal CEO |
Tranquil Clinical Research and Consulting Services |
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Michael |
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Rosenblatt |
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Former Vice President, Clinical Operations |
Roche |
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Michael Rosenblatt is a Life Sciences professional with over twenty years of industry and consulting experience. Most recently he was a Vice President of Clinical Operations in Roche’s Late-stage Clinical Operations Group. In this role his accountabilities included overall strategy for running the Late-stage Clinical Operations Organization; oversight of registrational clinical trials for Roche’s Gastroenterology and Hepatology portfolio; and accountability for several countries in Roche’s Asian operational footprint. Michael also brings deep experience in technology used to support clinical operations and regulatory. Prior to joining Roche, Michael was a consultant in IBM’s life sciences consulting and Business Process Management practices working with multiple pharmaceutical companies to introduce processes and technology designed to streamline and simplify work across finance, commercial, regulatory, and other business units. |
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Sandra |
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Wiley |
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Director, Translational Sciences |
MEI Pharma |
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Sandy Wiley, PhD is the Director of Translational Sciences at MEI Pharma, Inc, a clinical stage oncology drug development company. Dr Wiley has over 25 years of experience in translational science, drug discovery, and drug development with an emphasis on cancer, autoimmune diseases, neurodegeneration, metabolic diseases, and rare diseases. Her career has included both academic and industry environments. She is part of Clinical R&D at MEI and has close cross-functional engagements with Medical Affairs, Clinical Development, and Clinical Operations |
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Prasun |
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Mishra |
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CEO, Founder / CEO, Founding President |
r, Agility Pharmaceuticals / American Association for Precision Medicine (AAPM) |
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Dr. Prasun Mishra is an investor, co-founder and board member of a few US based corporations. He leads the research efforts focused on preventing and curing COVID-19, cancer, and other chronic diseases. He has numerous publications, patents and several drugs in clinical trials to his credit. He is a recipient of over 40 prestigious awards and honors, including a recent recognition by Thrive Global and Authority Magazine as a ‘Social Impact Hero’. Due to his unique perspective and selfless service, he is a highly respected and sought-after mentor to many. |
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Rose |
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Satz |
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Founder & CEO |
AIP |
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Tanya |
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Russell Kirkpatrick |
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VP Clinical Operations Head – Oncology, Global Product Development |
Pfizer |
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Tara |
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Lehner |
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Vice President, Clinical Operations |
INmune Bio Inc. |
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Ms. Lehner is Vice President of Clinical Operations at INmune Bio. She has spent over 24 years in the pharmaceutical industry as an employee and consultant working across pharma, biotech, and CROs in Phases I–IV, with a focus on oncology and CNS. She has led long-term strategic partnerships between CROs and pharma and emphasizes the humanness of business relationships. Ms. Lehner holds an MS from the Temple University School of Pharmacy. Tara lives on a ranch in Southern California with her partner and two daughters, ages 7 and 8. |
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Will |
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Junker |
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Head of Vector Manufacturing Quality |
Kite Pharma |
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Vadim |
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Klyushnichenko Ph.D. |
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Vice President, Bio/ Pharmaceutical Development & Quality |
Calibr-Skaggs Institute |
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Dr. Klyushnichenko has over 20 years of experience in Bio/Pharmaceutical Development and Manufacturing. Vadim is responsible for the development of biologics, gene, and cell therapy products as well as their supply chain, which involves multiple CDMOs in the US, EU, India, and China. Vadim has developed his growing managerial and scientific responsibilities serving as Vice President of Drug Development at Paragon, Terapio, and Coldstream Laboratories, Sr/ Principal Scientist at Pfizer, Baxter, Aventis and Altus.
Vadim has received his B.S. in Physics from Moscow Institute of Physics and Technology (FizTech), Ph.D. in Chemistry from the Russian Academy of Sciences, and continued his postdoctoral research in Germany and Canada. |
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