Are you working on a drug development project and need feedback on regulatory path for your product? CU Innovations will be holding regulatory office hours on August 26th, 2020 for drug development projects for faculty to have their regulatory questions answered by experts.
Please book a 1:1 virtual one-hour session here. Come prepared with your questions about regulatory path and requirements pertaining to preclinical development and/or CMC or any other questions you might have.
This is a free service provided by CU Innovations to CU Anschutz faculty. Both consultants are under confidentiality agreement and for them to be prepared to answer your questions we request you to submit 3-4 slides describing your project, and the data you have so far to email@example.com by August 24th.
Melanie Hartsough, PhD
Dr Hartsough utilizes her expertise in the strategy and development of drug products to assist clients with nonclinical development of biologics and small molecules. She received her PHD in Pharmacology from Pennsylvania State University, College of Medicine. After a postdoctoral fellowship at the NIH, she joined US FDA’s Center for Biologic Evaluation and Research (CBER), Division of Therapeutic Proteins, as a full-time product reviewer. During this time, she performed chemistry, manufacturing and controls (CMC) and immunogenicity reviews for biotechnology-derived products. In 2004, she transferred to the Division of Biologic Oncology Products, Center for Drug Evaluation and Research (CDER), as a pharmacology/toxicology reviewer. During this time she also performed consult reviews for the Office of Vaccines Research and Review and Office of Blood Research and Review (CBER). In 2006, she left the US FDA and joined Aclairo Pharmaceutical Development Group, Inc as a consultant. In 2007, Melanie left Aclairo and joined the Biologics Consulting Group, Inc. Dr Hartsough’s expertise focuses primarily on US FDA regulatory issues and strategies associated with nonclinical pharmacology and toxicology development of biologic (including cell and gene therapies, prophylactic and therapeutic vaccines, blood products and recombinant therapeutic proteins and monoclonal antibodies) and small molecule products.
Christina Vessely, Ph.D., Senior Consultant, Biologics Consulting
Dr. Christina Vessely is a Senior Consultant, CMC Analytics and Formulation Development at Biologics Consulting, where she is in charge of supporting analytical organizations and global regulatory agency interactions for biopharmaceutical clients. Her current role includes development, qualification and validation of analytical methods, developing strategies for formulation, characterization, comparability and biosimilarity, and managing CMC strategy and execution for investigational drugs, regulatory agency briefings and marketing applications. She has over 10 years of experience in the biotechnology industry, with various leadership roles managing analytical development, characterization and formulation development programs for large proteins and biologics at Insmed, Inc., KBI Biopharma and Merck, Inc., respectively. She received a Bachelor’s Degree in Chemical Engineering from the Colorado School of Mines and a doctorate degree in Pharmaceutical Sciences from the University of Colorado, Health Sciences Center.