Artificial intelligence (AI) is significantly transforming the healthcare sector, evolving from a tool used to streamline administrative tasks to one influencing essential clinical functions. For pharmaceutical manufacturers, understanding how their health system customers are using AI is crucial.

Understanding the role of infiltrating lymphocytes into tumors during clinical trials can provide insights into the complex interplay between the immune system and tumor microenvironment during treatment with novel immuno-oncology therapeutics.

Programmed death-ligand 1 (PD-L1) is a key immune checkpoint molecule that regulates immune responses by binding to PD-1 on T cells, contributing to immune tolerance and suppression

Cutting-edge cell and gene therapies have sparked ideas for new payment models that could reshape affordability and access to life-changing care.

Decentralized manufacturing could transform cell therapy delivery by reducing delays, costs, and logistical hurdles to improve patient outcomes.

Autologous cell and gene therapies show promise but face barriers such as high costs, limited access, and payer concerns over long-term effectiveness.

In the seven years since the approval of the first chimeric antigen receptor T-cell (CAR-T) therapy, the agents have proved to be effective in the treatment of non-Hodgkin lymphoma. But the one-time-use agents come with risks, including the potentially fatal cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), so the FDA requires patients remain near their treatment center for four weeks after administration, which can be onerous for patients.

The biopharma industry faces a relentless demand for evidence of real-world effectiveness (RWE), safety, and value throughout the product lifecycle to complement the clinical trial-based benefit: risk profile from the pre-approval development programme.

Since 1992, the FDA’s Accelerated Approval (AA) process has significantly reduced the time it takes for a drug to receive market approval. Consequently, many drugs with promising trial results have become available for public use quite rapidly, relative to the standard approval process.

Neurological disorders account for roughly 45% of rare diseases; and 85% of rare and ultra-rare disease trace back to a single gene defect. Given this, the potential for regenerative therapies to benefit patients with central nervous system-based disorders is vast.

The biggest trend in gene therapy development is the potential of several treatments for rare neurological diseases to move from the bench to the bedside.

Antibody drug conjugates (ADC) celebrate 25 years of U.S. regulatory approval this year and are widely regarded as a major scientific and medical advance in oncology, offering hope to many people who are struggling to overcome serious, often late-stage cancers that have proven resistant to existing treatment options.

The oncology landscape has been fundamentally reshaped over the past 25 years by antibody–drug conjugates (ADCs). By combining the precision targeting of an antibody with a potent cytotoxic payload, ADCs have evolved from early promise to established, high-impact therapies across multiple tumor types.

Antibody-drug conjugates (ADCs) have significantly reshaped the oncology treatment landscape since the first approval 25 years ago, offering new hope to many people who are struggling to overcome serious, often late-stage cancers that have proven resistant to existing treatment options. To date, 13 ADCs have been approved, collectively generating over $11 billion in sales, with nearly 130 ADC assets currently in development. The

Biospecimens are critical for advancing basic science, translational research, and clinical trials. Used for diverse applications ranging from illuminating the mechanisms of disease to identifying those patients most likely to respond to specific drugs, biospecimens play an integral function in advancing the development of targeted therapies and precision medicine. To realize the full potential of their value, biospecimens must be sourced and collected appropriately and ethically and then characterized and paired with relevant clinical information to generate actionable data.

Therapeutic antibodies are on the ascendancy, driven by a significant evolution in antibody engineering and an expanding market. Antibodies have become the fastest-growing class of biologic drugs and are used for treating a wide range of indications, from oncology and immunology to infectious and hematological diseases.

Best Practices for Designing Robust Assays and Navigating Regulatory Pathways

The prior authorization (PA) process has long presented challenges in terms of administrative burden, variability, and delays in care. With the release of CMS-0057-F, the regulatory landscape is shifting in a way that requires stakeholders across healthcare to reassess and redesign how PA is managed—especially from a technology and infrastructure perspective.

At its peak, bluebird bio stood as a beacon of hope and a pioneer in gene therapy, with a market cap of >$10B and FDA approvals for four ex-vivo cell and gene therapies: ABECMA® (idecabtagene vicleucel) for multiple myeloma (MM), ZYNTEGLO® (betibeglogene autotemcel) for beta-thalassemia, SKYSONA® (elivaldogene autotemcel) for cerebral adrenoleukodystrophy (CALD), and LYFGENIA® (lovotibeglogene autotemcel) for sickle cell disease (SCD). Despite these promising advancements, the company faced significant commercial and operational challenges that impeded the translation of these clinical breakthroughs into sustainable financial success.

At its peak, bluebird bio stood as a beacon of hope and a pioneer in gene therapy, with a market cap of >$10B and FDA approvals for four ex-vivo cell and gene therapies: ABECMA® (idecabtagene vicleucel) for multiple myeloma (MM), ZYNTEGLO® (betibeglogene autotemcel) for beta-thalassemia, SKYSONA® (elivaldogene autotemcel) for cerebral adrenoleukodystrophy (CALD), and LYFGENIA® (lovotibeglogene autotemcel) for sickle cell disease (SCD).

Rare diseases, impacting fewer than 200,000 individuals in the US, present daunting access and reimbursement obstacles, with 95% lacking approved therapy. As the median treatment cost exceeds $200,000 annually, concerns about affordability, access, and value persist for over 10,000 identified rare diseases, affecting 30 million Americans.

Artificial intelligence (AI) is significantly transforming the healthcare sector, evolving from a tool used to streamline administrative tasks to one influencing essential clinical functions. For pharmaceutical manufacturers, understanding how their health system customers are using AI is crucial.

Understanding the role of infiltrating lymphocytes into tumors during clinical trials can provide insights into the complex interplay between the immune system and tumor microenvironment during treatment with novel immuno-oncology therapeutics.

Programmed death-ligand 1 (PD-L1) is a key immune checkpoint molecule that regulates immune responses by binding to PD-1 on T cells, contributing to immune tolerance and suppression