Evolving Advisory Committee Processes: Key Updates From ODAC

By Nadine Bouchard (VP, Regulatory Affairs, Head of Program Management) and Lisa Sanders, PhD (Sr. Director, Regulatory Affairs)  Background To help in their decision-making, the US Food and Drug Administration (FDA) sometimes makes use of an Advisory Committee, as defined in various regulations. An Advisory Committee provides independent expert advice and makes non-binding recommendations to […]

Neurotoxic Risks in Therapeutics: Nonclinical Considerations

By Marcus Delatte, PhD (VP, Regulatory Strategy), Rachel Rozakis, PhD (Sr. Clinical Pharmacologist), Devin Welty, PhD (VP, Clinical Pharmacology), and Alison Wakeford, PhD (Nonclinical Scientist I) Introduction Central nervous system (CNS) toxicity is a major reason for failure of drugs developed to target this system and others. Therefore, the early detection of potential CNS toxicities […]

EU Pharmaceutical Legislation Reform – Towards a Resolution

   By John McIntyre, PhD (Director, Clinical Strategy) and Sugato De, MSc (Vice President, Regulatory Strategy) Introduction In April 2023, the European Commission adopted a proposal for a new Directive1 and a new Regulation2 which revise and replace the existing general pharmaceutical legislation in the EU. The proposed change represents the largest reform of the European pharmaceutical legislation […]

Strengthen Your Regulatory Submissions Through Strategic Storyboarding

By Young-Sil (Anna) Yim, Senior Director, Regulatory Affairs at Allucent Introduction A successful marketing authorization application is expected to convey the complete story of the drug in a clear, harmonized, and strategic manner.  The process is rarely easy, as the authoring process requires distilling the full product development journey, starting from early activities including CMC […]

Crossover Designs in Oncology: Statistical Perspectives

By Vanessa Beddo, PhD (VP, Global Head of Biostatistical Consulting) Introduction There are several factors to consider when adding a crossover design feature to an oncology study.  These designs typically allow for patients to crossover from placebo or standard of care (SoC) to investigational product after disease progression on their randomized therapy.  It is also […]

Optimizing Your Clinical Development Plan: Strategies for Biotech Success

Winding path with Allucent brand overlay

By Sugato De (VP, Regulatory Strategy, Head of Medtech), Josh Taylor (Sr. Director, Regulatory Affairs), Lisa R. Sanders (Sr. Director, Regulatory Affairs), John McIntyre (Director, Clinical Strategy) Critical Importance of the Clinical Development Plan Imagine you walk onto a plot of land and decide it is the perfect place to build your next home. You […]

Enabling Patient-Centric Drug Development: Opportunity for Clinical Pharmacology to Leverage Innovation and Advance Diversity and Inclusion in Clinical Trials

cartoon silhouettes of people in different solid colors against a purple background

Excerpted from keynote address at the American Conference on Pharmacometrics, November 2023 By Lisa Benincosa, PhD (Senior Vice President, Clinical Pharmacology Strategy) In today’s ever-evolving landscape of healthcare, the concept of patient centricity has taken center stage. Patient-centric drug development means putting the patient at the center of all we do. We strive to develop […]

Exploring the Complexities of Healthcare-Associated Infections: Challenges and Insights

Infection with blood cells

By Mila Grieg, Senior Medical Director, Therapeutic Area Medical Lead Introduction Healthcare-Associated Infections (HCAIs or HAIs), also known as nosocomial infections, are infections that patients acquire while receiving treatment for other conditions within a healthcare setting. They develop within the first 48 hours or more after hospital admission, or within 30 days after having received […]

Sifting Through Rarity: Advanced Patient Screening for Rare Disease Trials

By Maria-Cruz Morillo (Global Therapeutic Operations Lead, Rare Disease) Because rare diseases affect a small population of people who are dispersed across the world, it makes country and site selection, patient identification, clinical trial recruitment and long-term retention particularly complex. Furthermore, many rare diseases are difficult to diagnose — in some cases they have been […]