Mark your calendars for three upcoming conferences designed to provide insight into drug discovery, development and commercialization applicable to all therapeutic modalities.

the UNC Advanced Therapeutic Initiative team is in partnership with Cure. by Deerfield to host three upcoming conferences designed to provide high-level insight into drug discovery, development and commercialization applicable to all therapeutic modalities: small molecules, biologics and advanced therapeutic drugs.

Discovering New Therapeutics, featuring Michelle Cleary and Christine Brideau

March 9, 3:30-4:30 p.m. EST

Register online

The first conference will provide a high-level overview of the therapeutic discovery process with particular 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 features and biomarkers for clinical research. Translation.

Key themes

• Overview of the project stages, from discovery to launch
• Identify the 6Rs for a new therapeutic discovery program (right target, right tissue, right safety, right patient and good market potential) + Straight modality and straight end point
• Using a well-defined target candidate profile (TCP) and target product profile (TPP) to guide the drug discovery program
• High-level overview of the design of the selection cascade and choice of candidates for testing
• Building Developability Features into a Discovery-Stage Therapeutic Candidate
• Developing a biomarker strategy for clinical translation

Drug Development – From Discovery to Marketing Authorization, with Beth Garner and Ian Hardy

April 27, 3:30-4:30 p.m. EST

Registration link coming soon

The second conference will provide an overview of the interplay between preclinical, clinical, regulatory and CMC development to support the progression of new therapies from the nomination of clinical candidates to marketing authorization. Particular emphasis will be placed on designing an IND clinical development and enablement program to achieve the desired target product profile and product label.

Key themes

• Overview of the project stages, from discovery to launch
• Using the target product profile and product label to guide drug development strategy
• Design 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 interaction between clinical and regulatory, including special designations (e.g., fast track, orphan designation)

Commercialization and drug launch (Christine Miller and Molly Deiss)

June 8, 3:30-4:30 p.m. EST

Registration link coming soon

The third conference will focus on the commercialization and launch of drugs in order to maximize the commercial value of a new drug. Particular emphasis will be placed on early launch and go-to-market planning, highlighting some of the common go-to-market pitfalls, how to avoid them, and building an organization for launch success. .

Key themes

• Overview of the project stages, from discovery to launch
• Launch planning (at what point in development should planning begin)
• Forecasting product launch needs and integrating with manufacturing and supply
• Maximize product value through a successful launch
• Common pitfalls in marketing and product launch and how to avoid them
• Build an organization to support product launch