Navigating payer challenges in rare disease
Clinical and economic evidence generation across rare diseases is challenging due to intrinsic disease characteristics, misalignment on treatment costs, and inadequate traditional evaluation frameworks.
Access solutions: Reconciling potential for improved patient access with implementation realities
Access to medicine and healthcare services poses persistent challenges, especially in low-income regions with high out-of-pocket expenses.
CRA Insights: A landscape assessment of newborn screening (NBS) in Europe
Newborn screening (NBS) has become an integral part of many public health programs.1 NBS programs have minimized patient s
Challenges to a dual: What makes a dual-brand approach viable?
Pharmaceutical and biologic therapies are increasingly demonstrating their effectiveness in the treatment of multiple diseases.
The Ozempic Dilemma: What makes a dual-brand approach viable?
This article was originally published in Life Science Leader.
Impact of the EU's general pharmaceutical legislation on Europe's innovation ecosystem and biotechnology companies
EuropaBio asked Charles River Associates to research the potential impact of the proposed changes included within the EU’s General Pharmaceutical Legislation (GPL) to Europe’s innovation ecosystem, with a particular focus on its impact on the growth of emerging and small biotechnology companies.
The emerging business models for digital therapeutics
This article was originally published at Med Device Online.
Supporting a Phase III R&D strategy within the anti-infective space
Client Issue An emerging pharmaceutical company sought to evaluate Phase III development strategies for an anti-infective drug with potential to treat a range of patient populations.
Establishing real-world testing and treatment patterns for EGFR NSCLC patients
Client issue Oncology-focused biotech was looking to establish real-world testing and treatment patterns among EGFR NSCLC patients in US, EU, Japan, and Greater China (mainland, HK, and Taiwan).
Rare Disease: 2023 in Review
As we look back at another busy year for the rare disease (RD) space, we also reflect on the continued growth of CRA’s rare disease capabilities and offerings.
Evolving business models: Pharmaceutical incubators
As pharmaceutical manufacturers grow, they often pursue external sources of innovation to supplement their own R&D efforts.
AI in drug discovery and development: Will it live up to the hype?
The recent explosion of generative artificial intelligence (AI) has fueled interest in and concern over the use of AI in drug discovery and research and development.
Where are we now? The promises and pitfalls of solid tumor CAR-T therapy
CAR T-cell therapy (CAR-T) has emerged as a therapeutic option with the ability to infiltrate and modulate the tumor microenvironment and control tumor growth.
The preferences of people with amyotrophic lateral sclerosis on riluzole treatment in Europe
The Patient Preference Survey aims to understand unmet needs related to riluzole management in people with Amyotrophic Lateral Sclerosis (ALS) and to identify which characteristics of a new formulation could better match their preferences.
Source of business for biosimilars in immunology
As of August 2023, there were 40 FDA-approved biosimilar products, including 25 commercially available products and four with interchangeable status.
Clinical considerations & payer perspectives
Late October saw the annual gathering of oncologists and industry in Madrid for ESMO 2023, bringing with it a wave of new clinical results across cancers and a fresh round of questions concerning pricing, access and reimbursement.
Strategies for combination therapy in oncology: Part two - Working with the “status quo”
This is the second article in a three-part series examining the commercial dynamics surrounding combination therapy in oncology across the US and Europe.
Antimicrobial Resistance Policy Solutions
It is difficult to imagine someone who hasn’t called on antibiotics to help them through an infection or protect them during a surgery. Thanks to developments over the last 150 years, once life-threatening bacterial encounters have been relegated to minor inconveniences. Or have they?
The Paradigm Shift: Navigating the emergence of value-based contracts for future gene therapies
Value-based contracting (VBC) has been difficult to execute in the pharmaceutical arena, especially in the gene therapy space.
3 Steps for cell & gene therapy medical affairs teams to provide strategic value
A phrase often recited within the pharmaceutical and biotechnology industries in recent years is that medical affairs is the third strategic pillar of success, along with R&D and commercial.
The Paradigm Shift: Navigating the emergence of value-based contracts for future gene therapies
Value-based contracting (VBC) has been difficult to execute in the pharmaceutical arena, especially in the gene therapy space.
A longitudinal perspective on innovation
There is growing interest in the innovation process in the biopharmaceutical industry, with particular public scrutiny around the composition of research and development (R&D) spending and the role of intellectual property.
Oncology vaccines: Are they positioned for PMA success?
With combinations taking center stage following the initial influx of immune checkpoint inhibitor monotherapies, the authors look ahead to the potential of mRNA vaccines in oncology and describe the pricing and market access opportunities and challenges that may await current and future competito
The burden of non-specific pain disorder in US women
Based on existing evidence on the delay, lack of recognition, and burden of pain conditions commonly afflicting women (specifically endometriosis, PCOS, fibromyalgia, IBS or migraines), CRA sought to understand how being diagnosed with these conditions impacts women’s mental health and healthcare
The longitudinal history of medicines innovation: Part two
The second of a two-part article, CRA’s Life Sciences Practice team, along with experts at The Janssen Pharmaceutical Companies of Johnson & Johnson, recently conducted a landscape review of how complex pharmaceutical innovation happens in practice, leveraging three therapy area case studies: