How a joined-up development strategy pays off for early-stage biotechs
Parexel Biotech’s Nate Akers and Vicky Hsu discuss how important it is for biotechs to align clinical execution with a clearly defined regulatory strategy to increase the chance of success for a new drug program.
Related Insights
Podcast
Enabling Successful Sites, Episode 2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training
Jun 28, 2024
Webinar
Accelerated Early Phase Decision-Making – Insider Insights to Speed Development
Jan 7, 2025
Article
Expedited Pathways Comparisons - US EU CHN
Oct 19, 2021
Video
Overcoming asset transfer challenges during a merger and acquisition (M&A)
Oct 20, 2021
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Article
8 things you need to know about eCTDs in China
Jul 1, 2022
Blog
Proof of product safety and efficacy: how to move ahead successfully in Phase 2 clinical development
Jan 22, 2025
Video
Part 2: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Video
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Blog
Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Nov 19, 2021
Article
Part 1 - Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct
Sep 14, 2021
Blog
Focusing on value drivers to reduce risk in early-stage drug development
Jan 6, 2025
Related Insights
Podcast
Enabling Successful Sites, Episode 2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training
Jun 28, 2024
Webinar
Accelerated Early Phase Decision-Making – Insider Insights to Speed Development
Jan 7, 2025
Article
Expedited Pathways Comparisons - US EU CHN
Oct 19, 2021
Video
Overcoming asset transfer challenges during a merger and acquisition (M&A)
Oct 20, 2021
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Article
8 things you need to know about eCTDs in China
Jul 1, 2022
Blog
Proof of product safety and efficacy: how to move ahead successfully in Phase 2 clinical development
Jan 22, 2025
Video
Part 2: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Video
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Blog
Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Nov 19, 2021
Article
Part 1 - Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct
Sep 14, 2021
Blog
Focusing on value drivers to reduce risk in early-stage drug development
Jan 6, 2025