In this free webinar, learn about drug substance, formulation development, and regulatory considerations for improving downstream clinical outcomes. Attendees will gain insights into the benefits on an integrated approach to accelerate from candidate selection and onwards into the clinic. Mapping out key early development milestones, our featured speakers will share strategies on how to remove obstacles from the critical path and shorten the pathway to the clinic. Attendees will also learn about the regulatory challenges to be aware of when bridging from discovery to IND and beyond. The speakers will also present case studies that demonstrate the benefits of an integrated drug substance and drug product approach.
TORONTO, Jan. 5, 2023 /PRNewswire-PRWeb/ -- Navigating the small molecule CMC pathway from discovery to the clinic comes with its own set of challenges and regulatory hurdles. Once a lead candidate has been selected to move into development, what's next?
Bridging from discovery to clinical development can present many questions and unknown challenges for drug developers: What are some of the drug substance, drug product and clinical supply considerations in advancing a drug candidate towards a First-in-Human clinical study? Would an integrated drug substance and drug product development strategy be the best approach when trying to rapidly achieve a Phase 1 milestone? What regulatory considerations does one need to be aware of? And how long does each critical step take before reaching the clinic?
With the stakes high, having trusted and experienced guidance at this stage can help streamline the pathway from discovery towards IND and beyond, reduce risk and improve the likelihood of both clinical and commercial success.
Consulting group NGT BioPharm Consultants and Quotient Sciences have helped hundreds of customers achieve their IND milestones and beyond. By offering strategic guidance and integrated services spanning the entire development pathway, both have supported programs with lead candidate selection, drug substance, drug development, biopharmaceutics, clinical and regulatory services, all focused on accelerating development and expediting strategies to address regulatory expectations toward clinical development.
Join the featured speakers as they share their expertise around the challenges and considerations that drug developers may face in early development and strategies on how to overcome them.
Join Eleanor Row, Executive Director of Commercial, Quotient Sciences; Mark A. Krook, Head, Early Development, NGT BioPharma Consultants; and Roger Nosal, Head of Regulatory Strategy, NGT BioPharma Consultants, for the live webinar on Thursday, January 19, 2023, at 8:30am PST, 11:30am EST (4:30pm GMT/UK).
For more information, or to register for this event, visit Navigating the Small Molecule CMC Pathway: Strategies for Avoiding Regulatory Hurdles and Early Drug Development Pitfalls.
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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: [email protected]
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Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected]
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