3 Key Trends Transforming the Future of Rare Disease Clinical Development

Dr. Ann 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 nine 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.

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.

Jackie Widmer has over 18 years of global industry experience leading Phase I-IV studies across multiple therapeutic areas, including over 13 years of Medpace global project management in progressive leadership roles. She has over five years of pharmaceutical experience leading global rare disease and gene therapy clinical development programs.