White Papers

Transformative Advances in Cancer Immunotherapy: Progress and Promise

Immunotherapy, which engages and harness the body’s own immune system to fight cancer, has revolutionized the field of oncology. Among the most promising immunotherapy approaches are immune checkpoint blockade, adoptive cell therapies, therapeutic vaccines, oncolytic viruses, and mono, bi and trispecific antibodies. These approaches all seek to elicit a T-cell-based immune response against tumor antigens,...

A New Frontier in Clinical Trials: The Promise of Synthetic Control Arms

Produced by Premier Research and InSilicoTrials In this white paper, we explore the concept of synthetic control arms (SCAs) and their potential to transform the clinical trial landscape. We begin by providing an overview of the emergence of SCAs before delving into the workflow of constructing an SCA. We discuss the methodology used in constructing...

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

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...

Data Management & Biostatistics

ePremier – Delivering clarity amid the complexity

Unifying Premier Research’s data-driven process, people, and resources to help propel biotech innovation We understand how important it is to capture the right data at the right time, access the data necessary to solve a problem, and ensure that critical data is complete, accurate, and conclusive. That’s why we developed ePremier. Both flexible and precise,...

Clinical Research: Phase 1 - Phase 4

Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines

Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of improvement in tumor response rates showed only 10 percent of these therapies...

Clinical Research: Phase 1 - Phase 4

Opportunities Beyond Hope: Immuno-Oncology Drug Development

Introduction Over the past decade, immune-oncology (IO) has become one of the most promising and fastest-growing areas of cancer research and drug development. Present-day advances in immuno-oncology can be attributed to an explosion of research in this area in recent years, leading to a paradigm shift in the understanding of cancer. Until the late 1990s...

Clinical Research: Phase 1 - Phase 4

Making the Switch from Rx to OTC

Introduction With the support of patients, regulators, and payers, pharma and biotech companies’ interest in converting prescription drugs (Rx) to over-the-counter (OTC) is growing. In 2021, the sales value of Rx-to-OTC switches was around $35 billion USD. According to Future Market Insights, it is expected to rise at 5.3 percent compound annual growth rate (CAGR),...

Clinical Research: Phase 1 - Phase 4

Making the Asia-Pacific Region a Destination of Choice for Oncology Clinical Trials

Introduction Over the past decade, the Asia-Pacific (APAC) region has seen the most robust growth in oncology clinical trial activity, with a 138 percent increase over the period from 2010 to 2020. In fact, APAC now ranks first in the world for total number of ongoing oncology clinical trials, with China accounting for more than...