R&D/Clinical Trials

Biopharma companies have been working overtime to supply billions of doses of any safe and effective preventive. But the tight timeframe means they can't wait for final clinical test results to begin preparing large-scale manufacturing operations and to address critical supply chain issues.

The only way for pharma companies to know where to focus their COVID-19 R&D efforts is for the industry to have access to real-time, real-world evidence of what’s working to keep people alive, write Travis Leonardi and William Kirsh.

Startup biotechs need to ensure that life-changing and potentially lifesaving treatments continue to be developed in in the midst of the COVID-19 pandemic. Ohana Biosciences' Amber Salzman outlines how her company is

Initial studies pointing to how genetic variations can impact disease states such as COVID-19 help to illustrate the growing importance of genomic medicine, writes Mark. J. Stevens.

Amy Butcher evaluates the current treatment options for prostate cancer and the looks to the future as clinical outcomes evolve.

Janita Good looks at some of the therapeutics currently under investigation and the issues they have highlighted in the context of a pandemic.

The collection of source plasma for new therapies igniting debate.

How current barriers along the roadway between biomarker testing and drug prescribing can affect decision-making for precision medicines.

Weighing new strategies to accelerate biomedical product development.

Continued investment will mean new cures in a new decade.

Challenges will mount to established models for researching, developing, and marketing new therapies.

AstraZeneca's Joris Silon outlines the company's efforts in CVRM (Cardiovascular, Renal and Metabolism) and the potential impact on type-2 diabetes and chronic kidney disease of SGLT2 inhibitors such as Forxiga.

Pharrm Exec's 2020 Pipeline Report

As the microbiome "moves into the mainstream," Pharm Exec looks at how industry activity in the space is heating up.

Though uncertain market dynamics remain at play, the current magnitude of innovation in biopharma is staggering, and, at times, overwhelming.

With pursuits of complex therapies more routine, biotech platform companies are tasked with aligning their science with process and manufacturing proficiency to stand out in an increasingly crowded investment field.

Jennifer Buell, chief operating officer at Agenus, discusses the need for additional immunotherapies and combination strategies in cancer-building on learnings from the first wave of immune checkpoint inhibitors.

In comparison with other industries, the use of AI is modest in life sciences. However, even within life sciences, adoption of AI in regulated environments, such as in the R&D value chain, is further behind. Sivakumar Thiagarajan

Getting real about the R&D capabilities required to win in the gene therapy space.

A look at how Medical Affairs is transitioning to a new and fundamental strategic role within pharma and ways MA can step up to own this role within a pharma company, particularly within emerging markets.

With a growing abundance of clinical and health information now available and achievable, the need for industry to apply common structures and rules to interpret and act on this data is critical.

Lapse spotlights wider actions to ensure data accuracy.

Reoccurring disappointment in development portfolios-why it happens and how to mitigate it.

Pharm Exec’s annual feature profiling a selection of notable biopharma brands focuses this year on new beginnings and new promise-spotlighting five products with compelling product launch stories that tie strongly with the industry’s broader and evolving market-entry landscape.

Outlining the critical steps for companies in controlling market exclusivity for their gene therapies.

Advice for developers in steering gene therapies from concept to trials to hopeful approval in what is an uniquely complex path.

Pharm Exec speaks with Geoff MacKay, co-founder and CEO of AVROBIO, about the company’s mission to advance potentially curative lentiviral-based gene therapies, his career building businesses and innovation in regenerative medicine, and his most important quest to date-moving gene therapy into the mainstream.

Agency focused on advancing testing and production methods, seeking input from other regions on common approaches.

The cell and gene therapy space remains fertile territory for growth, exploration, and discovery. How applying a data-driven model may be the best way to approach this complex ecosystem and assess the innovations of tomorrow.

Exploring the EU’s struggles and new efforts in promoting cell and gene drugs.