Typically, pharmaceutical companies engage a contract research organization (CRO) to design, conduct, and analyze their clinical pharmacology studies. On the surface, selecting and managing a CRO for this part of clinical drug development is straightforward provided the sponsor company has the necessary experience and bandwidth. However, oftentimes sponsors run into numerous challenges with this process: Navigating a confusing bid process: How do you compare CROs and select the best one to suit your program’s needs and deliver on their proposals? Managing study startup and conduct: How do you ensure that your clinical pharmacology studies are designed and conducted appropriately? For example, are the drugs prepared, handled, and administered properly in studies using radiolabeled compounds? Are study assessments feasible? Do you have resources that can immediately address any issues that arise at study sites? Ensuring proper data management and analysis: How do you know that the right data is collected and that it is analysis-ready? Time line control: Most large CROs have extended time lines for database lock and delivery of tables, listings, and figures (TLFs) and draft clinical study reports. How do you mitigate this against the planned new drug application (NDA) time lines? Cohesive Clinical Pharmacology Program: How do you maintain cross-functional collaboration with several different studies ongoing, often in parallel? Are you able to place these studies’ results in the context of your larger clinical development plan? In short, a suboptimal clinical pharmacology program wastes time and money, and it impedes your ability to make critical decisions on future clinical studies.
Certara’s global team has the expertise you need. In this webinar, Darrell Nix and Jo Ann Malatesta explained how Certara partners with sponsors and CROs to provide flexible solutions that fit your drug program’s needs.
Darrell Nix, Ph.D.
Dr. Nix joined Certara in June 2018 as Vice President, Integrated Drug Development. Dr. Nix has nearly 30 years of experience as Chief Science Officer, Head of Research and Development, Senior Director and Director level positions in drug development from major pharmaceutical firms spanning multiple clinical indications including oncology, CNS, inflammation (RA/OA), cardiovascular, pain management, metabolic disease, rare complement disorders and supportive care (antithrombolytics and antiemetics). Specific areas of experience and expertise include IND/NDA enabling GLP toxicology, nonclinical and clinical protocol and study report writing, PK data analysis (including PK/PD modeling), pharmacology and MOA studies, ADME, regulatory support and product strategy planning. Darrell is the President and founder of a drug development consulting firm, DDC, LLC and acting VP of Drug Development for Aquilus Pharmaceuticals (2011 – current) and Chief Science Officer of Recardio Inc. (2014-current). Previously Dr. Nix was the Senior Director of Drug Development of Gloucester Pharmaceuticals from 2008 -2010 culminating in the successful Global registration of ISTODAX® (romidepsin) prior to being acquired by Celgene. From 2004-2007 he headed up drug development at Alantos Pharmaceuticals and was part of the M&A team that lead to the company’s acquisition by Amgen in 2007. Prior to Alantos, from 2000-2004 Dr. Nix was Director, Preclinical Development and later Senor Director of Drug Development at Millennium Pharmaceuticals supporting the commercialization of the first in class boronic acid proteasome inhibitor VELCADE™ during pre-launch and launch following US FDA approval. Dr. Nix was a distinguished member of the U.S. Army’s Medical Corp assigned to the US FDA in the Div. of Clinical Pharmacology at the USUHS in Bethesda. Darrell has a BS in analytical chemistry and completed his graduate studies in Clinical Pharmacology at the Uniformed Services University of the Health Sciences (F. Edward Hebert School of Medicine), Bethesda, MD.
Jo Ann Malatesta
Clinical Operations Director at Certara working directly with clients, CROs and team members in providing clinical study oversight for projects, meeting aggressive timelines and ensuring a project is audit ready.
Ms. Malatesta is a clinical research professional with 30+ years of pharmaceutical industry experience in the successful planning and implementation of Phase 1 through 4 clinical studies (in adult and pediatric populations) in multiple therapeutic areas. Ms. Malatesta recognizes identification and early collaboration with key opinion leaders in the area of expertise is critical in the synopsis and protocol development process. Other experiences includes project management, budget forecasting, overall clinical operations responsibilities, preparation and review of study manual(s) and study plans, clinical oversight in the development of case report forms, edit checks and user acceptance testing, medical writing (Informed Consent and Clinical Study Report) and quality assurance responsibilities to ensure the start up and study conduct are compliant with regulations.