Dr. Rayner is President of Certara’s Integrated Drug Development and Strategic Consulting Services. In this capacity, he supports a global team of clinical and quantitative pharmacologists, pharmacometricans, regulatory strategy and drug development scientists who create value for clients across the drug development ecosystem and ultimately accelerate patients’ access to medicines. Craig has extensive global experience … Continued
This guide to dose selection for first-in-human studies explains the conceptual framework, methods, and tools for extrapolating in vitro and animal study data to humans.
Alison Dillman,1 Michael J Zoratti,2 Jay JH Park,3 Grace Hsu,2 Louis Dron,2 Gerald Smith,2 Ofir Harari,2 Craig R Rayner,4 Noor-E Zannat,2 Alind Gupta,2 Eric Mackay,5 Paul Arora,6 Zelyn Lee,7 Edward J Mills2 A multitude of randomized controlled trials (RCTs) have emerged in response to the novel coronavirus disease (COVID-19) pandemic. Understanding the distribution of trials among various settings is important to guide future research priorities and efforts. The … Continued
PRINCETON, NJ.— December 16, 2020 – Certara, Inc. (“Certara”), a global leader in biosimulation by 2019 revenue, today announced that on December 15, 2020, it closed its upsized initial public offering of 33,413,250 shares of common stock at $23.00 per share. The closing includes 4,358,250 shares sold upon full exercise of the underwriters’ option to … Continued
One of the most exciting things about working in the pharmaceutical industry is the ability to meet and work with colleagues all over the world. In particular, China is one of the fast-growing centers for drug development. Indeed, a report from McKinsey last year estimated the Chinese biopharma market to be worth $130B. I recently … Continued
By Tom Hemy The COVID-19 pandemic has made the development and commercialization of pharmaceuticals and medical devices even more challenging. For example, in the value communication and stakeholder engagement area, many field representatives found themselves refused entry to hospitals and surgeries and unable to meet in-person with payers, doctors, and other key stakeholders. These meetings … Continued
PRINCETON, NJ.— December 10, 2020 – Certara, Inc. (“Certara”), a global leader in biosimulation, today announced the pricing of its upsized initial public offering of 29,055,000 shares of its common stock at $23.00 per share. Certara is offering 14,630,000 shares of its common stock and certain selling stockholders are offering 14,425,000 shares of common stock … Continued
Due to the rapid and continuous physiological changes during growth and development, pediatric patients cannot be treated as “small adults.” These physiological and molecular differences include body composition (height and weight), organ function and size, receptor response (pathway, safety), and maturation of absorption, distribution, metabolism, and excretion (ADME) changes. In addition to ontogeny considerations, pediatric … Continued
