Advanced Technologies

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.