Four reasons to conduct robust natural history studies before clinical trials

Lucas Kempf, former regulator, reflects on his time at the FDA and outlines why companies should invest in a high-quality natural history study.

The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief...

Three ways to improve your chances that insurers will pay for a new CGT

When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...

How market exclusivities can affect your development program

Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

Virtual meetings are easy, right?

Recommendations for navigating the "new normal" and how to prepare for the future.

The impact of COVID-19 on clinical trials in rare disease and oncology

NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...

Top 10 Myths About Working with the FDA for an Oncology Drug Approval

Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices.  Numerous...

Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

During the COVID-19 pandemic, challenges to the conduct of clinical trials may arise, e.g. due to travel restrictions or quarantines, interruptions to supply chains, or when site personnel or...