Remove Clinical Development Remove Clinical Supply Remove International Remove Trials
article thumbnail

A Biotech Midsummer’s Madness

LifeSciVC

Clinical Trials Are your clinical trials on track? Companies fortunate enough to have reached the clinical stage are asking this question. 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.

article thumbnail

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. Overseen by an insourced project manager. Contracts are milestone- or unit-based.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

The Premier Consulting Blog

technical operations, product development or process development) to an internal or external receiving unit (e.g., clinical manufacturing, commercial manufacturing, or contract manufacturing organization). Development of the manufacturing process description The development of the MPD is an iterative process.

article thumbnail

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

The Pharma Data

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. Pfizer is collaborating with Vivet on the clinical supply of VTX-801 for the Phase 1/2 clinical trial.

Disease 52