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Top Therapeutics Development Topics of 2023

Perspectives covers a wide range of topics within therapeutics development from advice on regulatory submission to adaptive clinical trial design to aligning your trial with investment priorities, and much more. Here are some of the top topics covered this year:


First-in-human clinical trials

Ulrika Andersson on First-in-Human Clinical Trial Development

First-in-Human Drug Substance and Formulation: The Challenge of Achieving Flexibility and Quality

Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials

Don’t Forget the Development of Your Placebo: Overcoming Common Obstacles


Regulatory considerations

How to Ensure Your Adaptive Trial Is Appropriate for Regulatory Submission

How to Ask the Right Questions at an Authority Meeting

New FDA Guidelines on Pediatric Studies and Potential Effects on Opportunities for Market Exclusivity


Aligning your trial with investment priorities

Aligning Clinical Trial Design with Investment Priorities


Bayesian strategies

Bayesian Strategies in Rare Diseases

Why Are There Not More Bayesian Clinical Trials?

Bayesian Approach in Oncology Trials


Early phase clinical trials

News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”

Design Considerations for Early Phase Trials of Immuno-oncology Drugs


Creating a clinical development plan

How to Create and Optimize a Clinical Development Plan


Drug manufacturer auditing

Drug Manufacturer Auditing: Ensuring Quality, Control, and Safety


A big thank you to all of the authors represented in these posts: Ulrika Andersson, Ari Brettman (Blackstone Life Sciences), Bodil Fornstedt Wallin, Michael Fossler, Martin Frenzel, Bengt Hedin, Åsa Holmgren, James Matcham, Natalia Muehlemann, and Ann-Kristin Spiik!

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