Development Strategy

Development Strategy

Development Strategy for Early-Stage Assets: The Commercial-Clinical Handshake

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...

Development Strategy

Premier Insight 284 | Leveraging Experienced Research Networks for Global Psychiatry Studies in Difficult-to-Access Populations

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...

Development Strategy

The Path to Acceleration: In Silico Modeling Launches New Wave of Rare Disease Drug Development

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...

Development Strategy

Beginning With the Patient in Mind: 6 Ways to Accommodate the True Rare Disease Patient Journey

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.

Development Strategy

Accelerating Innovation Together

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...

Development Strategy

Safety, Efficacy, Cost: The Trifecta for Increasing Access to CAR-T Therapies

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...

Development Strategy

Advancing from Research to Development: What Can Go Wrong?

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. With many steps in between, each as important as the next, multiple factors regarding development strategy and approach must be considered at the earliest stages. This blog post offers advice for...

Development Strategy

Product Development Checklist: Navigating the Four Critical Stages of the Drug Development Process

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...

Development Strategy

Premier Insight 283 | Rescuing a Phase 1 Oncology Trial: Long-Standing Experience Saves Study Momentum

Introduction For those who have been through it, a rescue study transition from one contract research organization (CRO) to another can be a difficult ordeal, often accompanied by logistical hurdles and communication challenges. When a sponsor of a Phase 1 dose expansion trial for a novel oncology therapy contacted Premier Research, they were more than...