R&D/Clinical Trials

This week's much-anticipated meeting of FDA’s vaccine advisory committee will address critical issues related to the testing and approval of vaccines to prevent COVID-19 infection.

Gabi Hanna, MD highlights the need for an effective therapy for acute pancreatitis.

With all eyes on efforts to research and test potential vaccines and therapies to combat the coronavirus pandemic, fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

Dr. Manuel Hermosilla shares his thoughts on how the pharmaceutical industry reacts to challenges that arise during trials, specifically during the search for an effective COVID-19 vaccine.

EXUMA Biotech's Dr. Greg Frost talks about his work making CAR-T cell therapy readily accessible and affordable.

When approached correctly, drug development in the rare disease space can be quite successful – especially when powerhouses across the industry join forces and leverage the power of data to help drive potential treatment options.

Former physician and clinical researcher Antony Loebel, now president and CEO of Sunovion Pharmaceuticals, discusses his career-long mission to advance novel treatments for patients suffering from serious and underserved CNS disorders.

The need for treatments to combat the spread of COVID-19 is promoting greater cooperation among drug regulatory authorities around the world, with FDA officials communicating more frequently with their counterparts in Europe, Canada, Japan and other nations through established programs and agreements.

Physician, company CEO, surgeon, philanthropist, and owner of the LA Times, Dr. Patrick Soon-Shiong talks about his progress developing a COVID-19 treatment and his goal to produce a billion doses to tackle the virus worldwide.

As government turns to the pharma industry not just for therapies or a vaccine but for tests and data to evaluate these treatments, people are receiving an education.

With widescale collaboration among companies, academia, and the science community to solve COVID-19, we can hope that this crisis has acted as a catalyst to increase positive perception for the biopharma industry.

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.