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Global Guidelines

 
• By Doro Shin

A sampling of global guidelines on the use of genomic biomarkers in drug development.

The US Food and Drug Administration established the Genomics and Targeted Therapy Group, within their Office of Clinical Pharmacology, to enable integration of genomics into the development, use and regulation of medication.

Guidelines have also been developed within the International Conference on Harmonization framework to harmonize activities among regulatory agencies in the...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

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.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

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 In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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Rising Leaders 2025: Namrata Saroj On The Importance Of Authenticity In Ophthalmology

 
• By Sushmita Panda

Namrata Saroj, chief business officer of Ocular Therapeutix, is highly respected in the retina community for her contributions to drug development. She talked to In Vivo about her journey in ophthalmology, leadership philosophy and the importance of authenticity in a close-knit specialty.

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the hurdles in scaling digital innovation and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

Rising Leaders 2025: Emma Hodcroft On Taking Initiative When “Plan A” Falls Short

 
• By Anabel Costa-Ferreira

Emma Hodcroft, co-founder of Pathoplexus and a key Nextstrain contributor, stresses the importance of career flexibility for young scientists. She urges early-stage researchers to embrace curiosity, using her unconventional path as an example of how curiosity can lead to impactful success.