Regulatory Insights

  1. iPSP Considerations For Molecularly Targeted Cancer Drugs 5/4/2020

    This blog includes what an iPSP for a molecularly targeted cancer should address and what elements it should include.

  2. 5 Tips To Avoid An IND Clinical Hold: Regulatory Guidance And Insights 10/19/2020

    A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them.

  3. Risk Evaluation And Mitigation Strategies: FDA Guidances For Assessing Effectiveness 8/5/2019

    In January 2019, the Food and Drug Administration (FDA) released 2 draft guidance documents regarding assessment of Risk Evaluation and Mitigation Strategies (REMS). These documents are meant to provide industry additional information to more accurately assess the effectiveness of their REMS. This article gives an overview of each of these documents and what they could mean for you.

  4. Understanding Recent Regulatory Changes For Pediatric Oncology Trials 11/14/2019

    While children typically have a better cure rate for cancer, biopharma companies have traditionally shied away from pediatric oncology trials, resulting in fewer treatment options. However, the regulatory landscape is evolving, and the demand for innovative therapies for pediatric cancers is becoming increasingly vocal.

  5. Phlexglobal Innovation Tour 2020: Industry Survey Results & Expert Analysis 1/25/2021

    On July 15, 2020, we launched the Phlexglobal Innovation Tour to bring together experts from across our industry to discuss clinical and regulatory related topics and explore innovative approaches to making compliance faster, easier, and better. What follows are the results of focused audience polls done during each session and afterwards together with the thoughts of our Innovation Tour experts

  6. LSX 2021: The Path From Preclinical To And Through Clinical 3/29/2021

    Originally presented at the 2021 LSX World Congress virtual conference, this webinar series by Premier experts in oncology, rare disease, and cell and gene therapies focuses on development considerations for advanced therapies, highlighting these products’ unique challenges as well as their powerful potential to address a broad array of unmet patient needs.

  7. What You Can Do To Drive Collaboration Across Your TMF 2/10/2021

    Previously we had addressed why collaboration should be a key focus for organizations that want to up their TMF quality and inspection game. In this blog learn 5 steps to improve TMF collaboration and inspection readiness.

  8. Key Changes In The Revised EMA Guidance On Clinical Trials During COVID 4/26/2021

    In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent changes in the global health landscape. Here’s an overview of what’s new.

  9. Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial 5/4/2020

    A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.

  10. Regulatory Compliance: An Increasing Burden On Sites 6/25/2020

    As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. But a new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.