Challenges and Considerations in Clinical Development of “Targeted Therapies”: AML as a Case Study

Clinical Trials, Drug Discovery & Development, Life Sciences,
  • Monday, November 11, 2019

Targeted therapies are the focus of much of the anticancer drugs in development today. From a clinical development standpoint, these exciting, novel approaches (immunotherapies, monoclonal antibodies, gene therapies, etc.)  bring new complexities, challenges and considerations. In this interactive webinar, Medpace experts will discuss key clinical, operational and laboratory considerations, lessons-learned, and best practices for accelerating the global development of safe and effective targeted therapeutics, using acute myeloid leukemia (AML) to highlight the complexities.

Case Study: AML is a heterogeneous disease characterized by a spectrum of clinical and molecular features. Within the last several years there has been a marked shift in the treatment of AML, from an intense/upfront chemotherapeutic approach for all patients, to a more defined and targeted treatment regimen based on specific disease features.

Our advances in the treatment of AML have resulted in large part from improved molecular techniques, such as next generation sequencing (NGS) which allows for the identification of specific molecular mutations within leukemic cells. The presence of such mutations not only provides prognostic information but may also function as target(s) for anti- AML therapy.

Such advances have led to a rapidly changing and competitive therapeutic landscape, perhaps best highlighted by the FDA’s approval of eight new drugs within the last 2 years. These drugs target key proto-oncogenes such as FLT-3, IDH1/2 and BCL-2. Given that the treatment landscape for AML is shifting to a target-driven approach, there are unique opportunities and challenges for clinical development of novel targeted therapies in AML.

Topics will include:

  • Clinical: How mutation analyses in AML allows for prognostic classification and a targeted treatment approach
  • Operational: Considerations for execution of AML clinical trials in a competitive landscape
  • Laboratory/Assays: How new standards for NGS based treatment decisions and monitoring have to be further defined

Speakers

Gregory Hale, MD, Senior Medical Director, Hematology & Oncology, Medpace

Dr. Gregory Hale is a physician with over 26 years of experience in all phases of clinical development, with expertise in hematopoietic stem cell transplantation, cellular and gene therapies and immuno-oncology. Dr. Hale has served as clinical director of the Transplant and Gene Therapy Program at St. Jude Children’s Research Hospital and medical director of the Division of Hematology/Oncology at Johns Hopkins All Children’s Hospital. Most recently he was Professor of Oncology at Johns Hopkins and has authored more than 200 peer-reviewed manuscripts, review articles and book chapters. He has held leadership positions in the National Marrow Donor Program (NMDP) and the Center for International Blood and Marrow Transplant Registry (CIBMTR). 

He earned his medical degree from the Joan C. Edwards School of Medicine at Marshall University. He completed his pediatrics residency at Children’s Hospital of Pittsburgh and his pediatric hematology/oncology fellowship at St. Jude Children’s Research Hospital.

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Jeffrey Vassallo, PhD, Associate Director, 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 at large pharmaceutical companies for more than 24 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 novel therapeutics for AML.

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El Mustapha Bahassi, PhD, Associate Director, Clinical Laboratory, Medpace

Dr. El Mustapha Bahassi is a research scientist with over 20 years of clinical and research laboratory experience. He is experienced in biomarker development and well-versed in various molecular biology techniques such as DNA cloning, PCR, protein purification, mass spectrometry, flow cytometry, mouse modeling, mammalian/bacterial cell culturing and cell-free DNA/circulating tumor cells manipulation.

He received his PhD in Molecular Biology and Biotechnology from the University of Brussels in Belgium. He then joined the University of Texas Southwestern Medical Center in Dallas as a postdoctoral fellow in Molecular Oncology. Following his training at UT Southwestern, Dr. Bahassi moved to the Department of Cancer Biology at the University of Cincinnati and later became a faculty member in the Division of Hematology/Oncology. As an independent faculty, Dr. Bahassi developed a translational line of research where he worked closely with clinical oncologists to develop new companion diagnostics using cutting-edge genomic technologies.

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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

Participants will learn about:

  • Clinical: How mutation analyses in AML allow for prognostic classification and a targeted therapy approach
  • Operational: Considerations for the execution of AML clinical trials in a competitive landscape
  • Laboratory/Assays: How new standards for NGS-based treatment decisions and monitoring have to be further defined

Xtalks Partner

Medpace

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. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,200 people across 37 countries.

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