As the cell therapy research and development landscape continues to advance, so do the complexities and challenges associated with clinical trials. Conducting cellular therapy trials presents a unique set of challenges, especially in early phase development. Successful preclinical to clinical transition requires careful planning with the aim of avoiding mistakes and surmounting barriers common to the development and operation of cell therapy trials.
In this webinar, Medpace medical, operational and regulatory experts will analyze previous cell therapy case studies and draw on their 30+ years of integrated, global experience to examine strategies to successfully manage complex cell therapy trials and increase the probability of clinical and regulatory success.
Register for this webinar to learn how drug sponsors in the pharma and biotech industry can overcome common challenges associated with complex cell therapy trials through medical, regulatory and operational considerations, including engaging an experienced and full-service clinical research partner with cross-functional expertise.
Click here to learn more about Medpace’s cell therapy solutions.
Ann Woolfrey, MD, Vice-President, Medical Department, Medpace
Dr. Woolfrey is board certified in internal medicine and pediatric hematology/oncology and provides clinical and scientific expertise in cellular therapies, transplantation immunology, hematology/oncology, and gene therapy. Dr. Woolfrey joined Medpace five years ago, after a 25-year career in translational and clinical research in cell and gene therapies at the Fred Hutchinson Cancer Research Center (FHCRC)/ University of Washington (UW). In addition to her role as the Medical Director of the Unrelated Donor Program at FHCRC/Seattle Cancer Care Alliance, she was principal investigator on numerous clinical trials and has more than 150 scientific publications in the fields of stem cell transplantation, transplant immunology, HIV, and autoimmune diseases. Since joining Medpace, Dr. Woolfrey has focused on supporting biotech in the development of cellular and gene therapies.Message Presenter
Lauren Holton, MSN, APRN, FNP-BC, Advanced Clinical Practitioner, Medpace
Ms. Holton is a board-certified family nurse practitioner with over eight years of direct clinical care experience in hematology and oncology, hematopoietic cell transplantation, and hospice and palliative medicine. During her tenure at Medpace, Ms. Holton has provided internal and external support to the Medical Monitors and Clinical Operations Teams, working on global Phase I-III trials in hematologic malignancies, solid tumors and cellular and gene therapies. Ms. Holton is an active member of the Oncology Nursing Society and has presented at professional meetings and community outreach programs.Message Presenter
Jeffrey Vassallo, PhD, Senior Director of Clinical Trial Management, Medpace
Dr. Jeffrey Vassallo has a PhD in molecular biology with postdoctoral training in experimental hematology. He has worked in drug development, including pre-clinical and clinical research for more than 27 years. In this capacity, he led research and project teams internally and in collaboration with scientists and clinicians from pharmaceutical companies, academia and the FDA. During his tenure at Medpace, Dr. Vassallo has managed global Phase I-III trials in hematology and oncology, with an emphasis in advanced therapies. This diverse experience gives him a unique perspective on the operational aspects in the clinical development of cellular and gene therapies.Message Presenter
Jan Ohotski, PhD, Principal Regulatory Submissions Technical Advisor, Medpace
Dr. Ohotski is a Regulatory Submissions Technical Advisor in Medpace’s clinical operations team. He holds a PhD in clinical biotechnology and specializes in developing advanced therapy medicinal products. He has eight years of experience in developing pharmaceuticals with particular focus on discovery of novel cancer therapeutics. As a Technical Advisor, he has experience across various therapeutic areas and trial phases in developing medicinal products. He also specializes in regulatory CMC surrounding the development of ATMPs and genetically modified organisms.Message Presenter
Who Should Attend?
This webinar will appeal to VPs, directors, managers and department heads working within:
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Outsourcing
- Project Management
- Regulatory Affairs
- Medical Affairs
What You Will Learn
Attendees will hear from Medpace’s regulatory, medical and operational experts as they:
- Conduct an investigational analysis of complex cell therapy studies
- Examine the quantitative data on the common challenges and pose strategies for biopharma companies looking to efficiently transition from preclinical to clinical and execute this with speed to market and reduced spending
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective.
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