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A Biotech Midsummer’s Madness

LifeSciVC

Drug development is a long process, and patients are waiting. What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Or maybe you are nearing the clinic. Have you identified and reached out to the PIs and potential clinical trial sites? Don’t get me wrong.

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How to Optimize Drug Development by Combining FSO and FSP Models

PPD

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

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Tech Transfer Tools: The Requirements and Uses of Manufacturing Process Descriptions

The Premier Consulting Blog

Definition of the manufacturing process description The Parenteral Drug Association defines the MPD as: A tool used to assist in execution of risk assessments, in the development of the Control Strategy, and for transfer of the process for commercial manufacturing.

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VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

The Pharma Data

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. About VTX-801.

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