Mark your calendars for three upcoming lectures designed to provide an overview of drug discovery, development, and commercialization applicable to all therapeutic modalities.
The UNC Advanced Therapeutics Initiative team is partnering with Cure. by Deerfield to host three upcoming lectures designed to provide a high-level overview of drug discovery, development and commercialization applicable to all therapeutic modalities: small molecules, biologics and advanced therapeutic medicinal products.
Discovery of New Therapeutics, featuring Michelle Cleary and Christine Brideau
March 9, 3:30–4:30 p.m. EST
The first lecture will provide a high-level overview of the therapeutic discovery process with specific emphasis on defining the goals of the discovery program, designing relevant screening tools and test articles and preparing for the next stage of development by integrating developability characteristics and biomarkers for clinical translation.
Key Themes
- Capstone overview of project stage gates from discovery through launch
- Identifying the 6Rs for a new therapeutic discovery program (Right target, Right tissue, Right safety, Right patient, and Right commercial potential) + Right modality and Right endpoint
- Using a well-defined Target Candidate Profile (TCP) and Target Product Profile (TPP) to guide the drug discovery program
- High level overview of screening cascade design and deciding which candidates to test
- Building developability characteristics into a therapeutic candidate at the discovery stage
- Developing a biomarker strategy for clinical translation
Drug Development – from Discovery through Market Authorization, featuring Beth Garner and Ian Hardy
April 27, 3:30–4:30 p.m. EST
Registration link to come
The second lecture will provide an overview of the interplay between preclinical development, clinical, regulatory and CMC in supporting the progression of novel therapeutics from clinical candidate nomination through market authorization. Specific emphasis will be placed on the design of an IND enabling and clinical development program to achieve the desired target product profile and product label.
Key Themes
- Capstone overview of project stage gates from discovery through launch
- Using the target product profile and product label to guide drug development strategy
- Designing an IND enabling program that integrates clinical goals, safety assessment and CMC
- Overview of clinical phases and clinical study design(s)
- Clinical supply chain considerations
- High level overview of the interplay between clinical and regulatory including special designations (e.g. fast track, orphan designation)
Drug Commercialization and Launch (Christine Miller and Molly Deiss)
June 8, 3:30–4:30 p.m. EST
Registration link to come
The third lecture will focus on drug commercialization and launch to maximize the commercial value of a novel therapeutic. Specific emphasis will be placed on early planning for launch and commercialization, highlight some of the common pitfalls during commercialization and how to avoid them and building an organization for launch success.
Key Themes
- Capstone overview of project stage gates from discovery through launch
- Launch planning (how early in development should planning begin)
- Forecasting product launch needs and integrating with manufacture and supply
- Maximizing product value through a successful launch
- Common pitfalls during product commercialization and launch and how to avoid them
- Building an organization to support product launch