Example of a Lifecycle Management Strategy

Example of an Oncology Lifecycle Management (LCM) Strategy

Example of R&D and Commercial Strategy

Two real life examples of R&D and Commercial Strategy

Example Pharmacovigilance Strategy

Two real life examples from 2019 and 2020

Example of Regulatory Strategy Delivery

Two examples from 2019 and 2020

The Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development

How market exclusivities can affect your development program

Regulatory considerations from former FDA regulators

In this infographic, we’ve compiled some common questions our ex-FDA experts get asked when helping customers build their cell and gene therapy strategy.

Creating an effective cell or gene therapy communications strategy

In this infographic, we have outlined some engagement activities that can enhance your cell or gene therapy development and inspire your stakeholders.

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

Navigating new steps in how FDA is managing COVID-19 Products

Considerations for protecting your business and employees from COVID-19

This assessment highlights some planning considerations to help you maintain business operations, while protecting the safety of employees and customers during this pandemic.

Understanding the COVID-19 regulatory procedures the FDA is using

A diagram that shows various procedural steps when interacting with the FDA through CTAP.

Biocentury COVID-19 Resource Center

Viv podcast: Supply Chain Management During Times of Uncertainty

A discussion with Siegfried Schmitt

Could automating raw materials production bring down gene therapy prices?

CMC Considerations for Gene Therapy and Regenerative Medicine Studies

The unforeseen challenges with clinical trial execution in gene therapy and regenerative medicine studies, such as unchanging FDA regulations, discussed

Cell/Gene Therapy Manufacturing Readiness Urged As A Condition For US Expedited Designation

Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry