11 AM EST
Despite the impact on women’s health worldwide, significant unmet needs exist in the diagnosis and treatment of gynecologic cancers. Located in the female reproductive system, many have a reputation for being “silent,” as they are often detected in later stages when treatment options are limited.
However, the recent introduction of novel medicines — targeted therapies in particular — has led to improvements in patient care and uncovered new research opportunities, creating a competitive research environment. With investment in research on the rise, investigators face challenges in patient identification, site selection, and an ever-changing regulatory landscape.
Topics will include:
- Current trends in maintenance therapy
- The use of biomarkers for patient selection
- Program planning considerations
- Regulations and the FDA perspective
Mary Gunn, Ph.D., COO, Women’s Health and Diagnostics, Premier Research
Dr. Mary Gunn is a senior-level scientist with more than two decades of clinical development experience. Dr. Gunn has led development programs through various steps in the R&D lifecycle, from preclinical development to post-approval marketing. She has served as a senior strategist for large and small pharmaceutical, biotechnology and diagnostics companies supporting large, global healthcare programs in women’s health, autoimmune disorders, and oncology.
Rupa Doshi, Ph.D., Vice President, Program Strategy, Oncology, Premier Research
Rupa Doshi is an Executive Director, Oncology at Premier Research. With more than 23 years in the industry, Rupa is an experienced professional with demonstrated leadership skills in clinical operations, global project/program management, customer management and strategy development. Her experience spans the clinical development spectrum from pre-IND to NDA, and she has also led global teams in the execution of full-service complex clinical trials across all phases.
Rupa brings drug discovery and clinical development experience with biologics, small molecules as well as cell and gene therapy products over a range of indications. Her doctoral research focus was on breast cancer, her post-doctoral research was in site-directed mutagenesis, and she holds patents in the area of angiogenesis. Rupa has also supported three products resulting in agency approval.
Andrew Berchuck, M.D., Medical Advisor, Gynecologic Oncology, Premier Research
Dr. Andrew Berchuck is Director of the Duke Division of Gynecologic Oncology and holds the James M. Ingram Distinguished Professorship. As a practicing oncologist, he is actively involved in surgical and chemotherapy management for women with ovarian, endometrial, and lower genital tract cancers. Dr. Berchuck also leads research efforts focused on the molecular-genetic alterations involved in the malignant transformation of ovarian and endometrial epithelium.
Irene Figari, Senior Director, Regulatory Affairs, Premier Consulting
Irene Figari brings 40 years of biotech experience to the Premier Consulting regulatory affairs team. She spent 16 years in basic research and development, focusing on immunology, cell biology, tumor model systems, and molecular biology, then moved to the regulatory side in roles of increasing responsibility and leadership. She led a team of regulatory professionals in providing strategic and tactical guidance across therapeutic areas and disciplines in the clinical; nonclinical; and chemistry, manufacturing, and controls arenas. She has also provided regulatory leadership and strategy development for products from the pre-investigational new drug (IND) stage through post-marketing in multiple therapeutic areas, with a focus on oncology.