Clinical Development Therapies White Paper 
PPD
OCTOBER 8, 2024
The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.
FDA Law Blog: Drug Discovery
JANUARY 4, 2023
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).
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Conversations in Drug Development Trends
DECEMBER 20, 2023
You can learn more about biomarkers and how to use them in oncology studies in this white paper. Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.
PPD
OCTOBER 2, 2024
Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.
PPD
JUNE 17, 2024
For a developer using an FSO model but looking to evolve the way they undertake clinical trials, a bespoke FSP/FSO hybrid solution can provide a smooth transition to FSP outsourcing. This approach enables unbroken continuity of support and resources across clinical trial operations.
Conversations in Drug Development Trends
JULY 29, 2024
Clinical development programs must acknowledge the complexity and variability of obesity as a condition. However, the complex nature of T2D requires a multidimensional treatment approach that extends beyond drug therapy. Gene therapy, immunology, and CGM innovations provide new treatment possibilities.
The Pharma Data
AUGUST 7, 2020
As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.
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