Product development from translation to registration has become increasingly more difficult and costly. Ambitions are high but success rates are low. If development is a tough path, commercialization is even harder. In 2022, the average year one sales per branded product were a mere $65MM. In 2021, 45% of all prescriptions were rejected or blocked....
Developing a new biopharmaceutical product is a lengthy, high-stakes journey. It takes, on average, at least 10 years and more than $2 billion to successfully bring a new drug to market, and only 10 to 15 percent of products ultimately receive regulatory approval. A comprehensive plan and the right regulatory and therapeutic expertise can significantly...
Expert Solutions from Concept to Commercialization Across the development lifecycle, our integrated solutions and cross‑functional team provide customized support for your program—Built for Biotech declares our mission and our mantra. Our all‑encompassing and all‑in perspective blends strategic thinking with hands‑on experience across every aspect of development, helping biotech, specialty pharma, and MedTech innovators turn brilliant...
March 19th, 202411 a.m. EDT Product development from translation to registration has become increasingly more difficult and costly. Ambitions are high but success rates are low. If development is a tough path, commercialization is even harder. In 2022, the average year one sales per branded product were a mere $65MM. In 2021, 45% of all...
Introduction When approached for an early-in-illness schizophrenia trial, Premier Research knew that patient recruitment would be challenging and require creative approaches for success. Based on our experience in mental illness studies and with this indication, we recognized the importance of identifying sites where patients were already being diagnosed and treated. To achieve this, the Premier...
Advancements in artificial intelligence, machine learning, and computing technologies have fueled progress in the use of sophisticated computational modeling and simulation as a tool for facilitating preclinical and clinical research in rare diseases. In this white paper, we explore the promise of in silico approaches to rare disease drug development and share real world scenarios...
Designing patient-centric programs can have a resoundingly positive impact on clinical research and the health and life of patients. Consider these six ways to “reverse engineer” development strategy to accommodate the true rare disease patient journey. To read more, download the complete white paper.
Expert Solutions from Concept to Commercialization Across the development lifecycle, our integrated solutions and cross‑functional team provide customized support for your program—Built for Biotech declares our mission and our mantra. Our all‑encompassing and all‑in perspective blends strategic thinking with hands‑on experience across every aspect of development, helping biotech, specialty pharma, and MedTech innovators turn brilliant...
With hundreds of companies and clinical trials investigating CAR T-cell therapies, there exist opportunities to expand the applications of—and broaden access to—these novel therapeutics to address unmet medical needs. Fundamental to these efforts to make CAR T-cell therapies more broadly available is the need to improve the safety, efficacy, and cost of these treatments. In...