BioPharma Services, Inc. Welcomes Abuse Liability Experts, Dr. John Oldenhof, VP of Clinical Pharmacology and Dr. Isabella Szeto, Principal Investigator to the BioPharma Team
Published: Apr 12, 2018
BioPharma welcomes Dr. Oldenhof who has 18+ years of Sr. Management experience in Phase I clinical pharmacology, product development, biostatistics, data management and regulatory and scientific affairs. His published work and experience includes the development of novel methodologies, innovative study designs and direct collaboration with the US Food and Drug Administration (FDA) to advance human abuse potential studies and pharmacometrics analyses. Over his tenure in Clinical Pharmacology, Dr. Oldenhof has provided scientific and regulatory guidance to biotech and pharmaceutical sponsors on over 200 clinical pharmacology studies including FIM, SAD/MAD, DDI and TQT studies to support pre-IND, NDA, ANDA and product launches.
Dr. Oldenhof who will lead the units of Scientific Affairs/PK, BioStatistics, CDM and Medical Writing under the new umbrella of Clinical Pharmacology at BioPharma Services, Inc. stated, “I am excited to be joining an agile, Early Phase focused company. I look forward to contributing my skills to the BioPharma team and in turn help our clients to maximize their Early Phase efforts.”
Dr. Szeto comes to BioPharma with 13+ years of Phase I clinical research experience as Principal and Sub-Investigator. Having started her clinical research career under the mentorship of Dr. Ed Sellers, Dr. Szeto has continued on to conduct over 150 clinical studies on various CNS products to evaluate their abuse liability or abuse potential. In addition to her AL/AP expertise, she also has managed a variety of early stage clinical research trials which include FIM, QT, DDI, BA/BE, Food-Effect, Skin Irritation/Sensitization and vaccine trials.
“The addition of these two medical and pharmaceutical experts has further propelled us into the CNS, pain and HAL/HAP sector. Our current research and development initiatives in cannabinoids, opioids and numerous other controlled substances has set up apart as a research leader in this domain,” said Renzo Dicarlo, CEO at BioPharma Services, Inc.
About BioPharma Services Inc.
BioPharma Services Inc. is a fullservice Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Medical Writing and Data Management.