The Complexities of Pediatric Rare Disease Clinical Trials: Regulatory and Operational Strategies for Success

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

Dr. Gregory Hale is a physician with over 28 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.

Tanya Konovalenko, MPharm, RAC, Director, Regulatory Affairs, Scientific and Strategic Development, Medpace

Tanya Konovalenko has over 25 years of international experience in drug development of small molecules and biologics through all phases of clinical research, authorization and post approval. She has worked in Canada and Switzerland and has served as a principal interface for interactions with major regulatory agencies including EMA, FDA, Health Canada and various National Competent Authorities in Europe. Tanya has extensive experience with pre-submission meetings, interactions and negotiations with the agencies, and has designed and executed effective global regulatory strategies, submission review and post approvals.

Kyle Haas, MBA, Associate Director, Clinical Trial Manager, Medpace

Kyle Haas has over 7 years of experience in clinical research with a strong background in healthcare. As a Clinical Trial Manager, he has collaborated with key opinion leaders and Sponsors worldwide to successfully coordinate and manage operations of Phase 1 to 3 neuromuscular trials. Kyle started at Medpace as a Clinical Research Associate monitoring and managing sites. Kyle obtained his Master of Business Administration and degree in Biology at the University of Cincinnati.