Translational Clinical Pharmacology in Cell and Gene Therapy
Learn more about the accelerating growth caused by transformative, curative and durable effects for unmet medical needs. The challenges that come along when growth happens so rapidly. As well as translational clinical pharmacology in AAV and CAR-T therapies. Presented by Vice President of Clinical Pharmacology – Devin Welty. Watch Here
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 […]
Achieving Operational Excellence in Clinical Research Organizations: A Catalyst for Biotech Success
By Diane Francisco, Senior Director, Operational Excellence, Global Clinical Operations In a 2023 quantitative survey from Industry Standard Research (ISR) of 239 Phase II/III pharma and biotech outsourcers “Operational excellence” ranked number two out of 24 categories, when asked “What were the top reasons for choosing to work with a CRO” (ISR Phase II/III CRO […]
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 […]
Podcast: Advancing Oncology Research: Regulatory & Development Path for ADCs & RDCs
Join Allucent experts Sugato De, MBE (VP, Regulatory Strategy, Head of MedTech) and Alex MacDonald, PhD (VP, Model Informed Drug Development) in BioPharma Dive’s new podcast. In this episode, we will delve into the innovative realm of antibody drug conjugates (ADCs) and radionuclide conjugates (RDCs) by exploring the tremendous growth potential of these targeted oncology […]
Podcast: Strategic Alliances in the Development and Execution of Pharmacovigilance Strategy
Join Ian Kovacs (Global Head of Pharmacovigilance) for a BioPharma Dive podcast where he examines the pivotal role of strategic partnerships in pharmacovigilance (PV) between biotech companies and CROs. Ian discusses the long-term implications of the traditional study-by-study outsourcing approach versus the formation of a strategic PV alliance and how they can foster a more cohesive, cost-effective and competent PV strategy from clinical […]
Optimizing Your Clinical Development Plan: Strategies for Biotech Success
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
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 […]