Archives: Speakers

Jenny Wakefield is an Adult and Pediatric Oncology and Critical Care Registered Nurse, ACRP-CP and CCRA Certified. Jenny graduated with her BSN from Florida International University in Miami, Florida, and has worked in Clinical Research since 1997 in a variety of roles, at the Site, CRO and Sponsor levels in all Phases of Global Clinical Trials and multiple disease indications. With her diverse experience, Ms. Wakefield brings a unique level of insight to the challenges faced in the management of Clinical Trials. Jenny currently is the Senior Director of Quality and Clinical Operations at Incyte. Ms. Wakefield’s specific focus is delivering Quality Programs with a humanistic approach, blending what’s expected from Clinical Research Professionals with what the real world presents.

Archan Sah is a clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women’s Health. She has held various global positions at Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON Clinical Research, two Oncology biotech start up companies and Medable- a leading technology platform provider. She is now an independent strategy consultant and Board Advisor provides strategic advisory services in clinical development and operations as well as on leveraging innovative patient centered digital health technologies in a fit for purpose approach to improve diversity, access and efficiencies within the healthcare ecosystem. She has been honored as Top20 women in immuno oncology drug development (2020) and featured in PharmaFEATURES (May 2022) on Oncology drug development and Digital Health technology.

She is a recognized leader/change agent leading industry collaborations and has been the co-founding chair and currently a member of Society for Clinical Research Sites Oncology Board and chaired the annual Oncology Summits. She is a past member of the Leadership Council for Decentralized Trials and Research Alliance and Digital Innovation in Oncology Roundtable with DiMe. She serves as an Advisor to American Cancer Society Cancer Action Network and has contributed to the clinical trial sites Standardization and Harmonization with the Forum on Drug Discovery and Development, National Academy of Sciences.

Dr. Ramachandran “TR” Thirucote is a founding Chair and CEO of TesoRx Pharma, LLC and its affiliate, LIPAC Oncology, Inc., clinical stage companies that are focused on delivering innovative, optimized therapies in areas of unmet medical needs.  Each of the companies leverage a novel drug delivery platform technology to target a range of treatments including  urology and oncology.  TR has several decades of experience in the design, development and launch of innovative therapeutics and dosage forms covering all dosage forms such as solid orals, parenteral and topicals.  At Roxro Pharma, LLC, a leading edge virtual pharma company model, TR was instrumental is design development and NBA launch of SprixTM, a novel nasal spray drug-device combination for a non-opioid for post-operative surgical pain.  At SRI International (formerly Stanford Research Institute), TR pioneered a contract pharma model (CRO), that encompassed government contracts with commercial pharma product development, setting the table for the successful establishment of several start up biotech and pharma companies across the country. He was also very successful as a PI and helped establish ongoing contracts with NIH affiliated institutes such as NIAID and NCI. At Agouron Pharma (now Pfizer), TR led the oncology portfolio development, moving the company’s first lead molecule in to clinical trials. As a scientist at Thermedics (now a division of Thermo Fischer Scientific), TR was responsible for the development of a novel polymeric wound dressing under a DOD contract, advised by Dr. R. Langer (MIT).

Edward joined the UCSF Office of Research as its Director of the Human Research Protection Program (HRPP) in May 2020. In this role, he oversees the UCSF HRPP, which is comprised of the Institutional Review Board (IRB) and its committees, the Quality Improvement Unit, and the Human Gamete, Embryo and Stem Cell Research (GESCR) Committee. Edward has a background in strategic planning and business plan implementation for clinical research activities; experience building and directing clinical and research programs at Academic Medical Centers; and familiarity with creating de novo core clinical research support services. He has served as co-investigator on the NIH Clinical Network for Contraceptive Research grant, clinical site investigator for an NIH-funded grant studying Antiphospholipid Pregnancy Loss, and co-investigator on a March of Dimes program grant on risk factors for prematurity. More recently, Edward was a Strategic Advisor for Clinical and Translational Research Programs at the Stanford University Center for Clinical & Translational Research & Education. He has also served as the Director of Clinical Research Operations for the Tufts Clinical and Translational Science Institute, a consult lead for the Johns Hopkins University/Tufts University Trial Innovation Center, as well as an Assistant Professor in the Department of Medicine at Tufts University School of Medicine.

Allyson Gunsallus is an Associate Director of Clinical Outsourcing at BridgeBio. She is a licensed California attorney and has spent more than 10 years in clinical vendor and contract management roles in the biotech and biopharmaceutical industries. In Spring 2023, she conducted a survey of colleagues related to how the pandemic shifted our use of technology on clinical trials. She is driven by identifying process gaps and building interdepartmental bridges to ensure internal and external relationship success.

Currently, Robert is the Global Head of Digital Innovation at Haleon, where he overseas and manages the organization’s Digital Innovation and Technology Portfolio across Research & Development and Laboratory Technologies. Robert formerly was the Global head of Digital Data and Delivery at CSL Behring, and prior, Head Of Digital Health & Clinical Innovation at CGI, and Head of Data Strategy and Digital Connected Solutions at Johnson & Johnson. Robert is an industry thought leaders and lecturer, often speaking on Digital Innovation and Data Strategy, internationally.

Dorian Chavez covering the Southern region of US including Puerto Rico, Central and South America.  With over 23 years experience and works closely with controlled environment customers to provide standard and custom cleaning solutions.