ACT

JULY 30/2019


news roundup

Anju Software Acquires OmniComm Systems

OmniComm Systems has entered into a merger agreement to become a wholly-owned subsidiary of Anju Software, a provider of data and application software to life sciences companies, contract research organizations, and medical device manufacturers.


Latest People Moves and Business News

Highlights from Elligo Health Research, Antidote, SCRS, QPS, PPD and more.


PPD Unit Collaborates with Cancer Treatment Centers of America

Optimal Just-in-Time, a service of PPD's Accelerated Enrollment Solutions (AES) business unit, and Cancer Treatment Centers of America (CTCA) are collaborating to bring under-represented cancer populations into clinical trials. The JIT service addresses community sites for faster site acitivation and patient recruitment.


Blog Posts

FDA, Too Fast or Too Slow for Regulatory Review Requirements

Washington correspondent Jill Wechsler discusses the current concerns around fast-track reviews against the backdrop of patient advocate concerns that reviews can delay access to potentially life-saving remedies. A main point of agreement between many parties is that products approved based on preliminary evidence should be priced much lower than the usual steep launch prices, until further research can document long-term efficacy and safety.


CMC Concerns in Cell and Gene Therapies

In this Q&A, Mo Heidaran, Vice President Technical, Regulatory and Technical CMC Consulting Cell, Gene Therapy and Tissue Engineering at Parexel, discusses unforeseen challenges with gene and cell therapy clinical trial execution including supply chain, therapy preparation, and administration.

In this edition

Latest People Moves and Business News
FDA's MyStudies Digital Platform for Patients
FDA, Too Fast or Too Slow for Regulatory Review Requirements

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Articles

FDA's MyStudies Digital Platform for Patients

The FDA updates the status of MyStudies, a digital platform for capturing the patient experience and bringing it –front and center– to drug development and regulation, which was introduced last year.


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Lisa Henderson
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Todd Baker
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