Podcast: Navigating IND Applications & Pre-IND Meetings: Key Considerations And Misconceptions

Business concept - high speed abstract MRT track of motion light for background in tokyo, japan

Advancing Investigational New Drugs (INDs) can be a complex process, especially for smaller companies. Listen to your free podcast now as Marcus Delatte, PhD, Vice President at Allucent and Harshini Neelakantan, Executive Director at Ridgeline Therapeutics discuss best practices and considerations for leveraging your pre-IND meeting and submitting a successful IND application.

Listen now for insights into:

  • Current trends and challenges related to IND submissions
  • The purpose and benefits of pre-IND meetings with regulatory bodies
  • Indicators that should prompt companies to request a pre-IND meeting
  • The role of consultants in supporting sponsors in pre-IND meetings
  • Getting the most from your pre-IND meeting and tips for IND application success
  • How IND submissions will evolve in the future

Citeline · Navigating IND Applications & Pre-IND Meetings: Key Considerations And Misconceptions

Citeline · Navigating IND Applications & Pre-IND Meetings: Key Considerations And Misconceptions

More from Archive

Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

More from Scrip

In partnership with

Building a Stronger Pharma Industry for Patients and Providers

Learn more about the challenges faced by today’s drug developers and the critical factors to consider as sponsors navigate the supply chain, keep up with regulatory requirements, and ensure patient access. Discover more about the role of generics and how Aspire Pharma can help.

In partnership with

Podcast Series: Navigating Regulatory & Market Shifts — CRO Perspectives on Clinical Trials

Insights from Novotech on Evolving Trends Impacting Global Clinical Development

In partnership with

Podcast: Navigating the Future of Hepatology Clinical Trials

Join Andrew Warmington, Manufacturing Editor at Citeline, in conversation with Tom Hickey, Director of Therapeutic Strategy at Novotech, a global full-service clinical CRO dedicated to accelerating the development of advanced and novel therapeutics.

In partnership with

Podcast Series: Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials

Insights from Novotech on Evolving Trends Impacting Global Clinical Development