R&D/Clinical Trials

The recent FDA approval of Biogen’s controversial drug aducanumab is the first drug approved for Alzheimer’s disease in nearly 20 years, and highlights the urgent need for new disease modifying approaches in drug development in this indication.

The field of longevity therapeutics — with the goal “of not just adding years to life but adding life to years” — is already disrupting the medical industry, writes Marco Quarta.

Annovis Bio's Maria L. Maccecchini, Ph.D., talks about why she, as a scientist and biotech company entrepreneur, became focused on protecting nerve cells in the brain and in the body, as a way to treat neurodegenerative disease.

Pascal Descargues, Ph.D., founder of Genoskin, talks about how the company is responding to the US government’s push to help pharma and biotech leaders speed clinical drug development and testing.

Insights and examples of how collaborative efforts can lead to the development of innovative therapies that target unmet patient needs.

The shift to clinical-grade support offers great opportunity.

Dr. Matthias Schmidt talks about his new role leading the US subsidiary of Japan’s JCR Pharmaceuticals after a “far-from-easy” merger last year.

Presenting a structured, decision-making approach for executive management to make sound strategic decisions for drug development and life cycle management.

Francesca Properzi and Sudip Sinha talk about how the results of an inaugural Clinical Trial Digital Tracker Survey indicate that many clinical trials organizations are still reluctant to integrate digital technologies into their processes.

Decentralized tools and technologies will continue to provide new opportunities for patient engagement post-COVID.

R&D on medical treatments lags notable success with vaccines.

Jill Wechsler reports on FDA's newly published strategies supporting broader eligibility criteria for Phase III studies.

Utilizing natural language processing technologies to improve search capabilities and advance the development of therapies.

Oral solid dose formulations (OSD) continue to lead the market as a preferred dosage form. To gain better insight into drug dose delivery technology trends, Laura Child spoke to leaders from five top contract development and manufacturing organizations to find out what is on the horizon for patient-centric drug delivery.

Hannah Brown & Elizabeth Baynton explore the atopic dermatitis patient-doctor dynamic and identify opportunities to optimize patient outcomes.

With pharma increasingly exploring the therapeutic potential of psychedelic drugs, Pharm Exec looks at how three companies in this space are developing their pipelines.

Michael Henderson, Chief Business Officer, BridgeBio spoke to Pharm Exec about his efforts in developing potential treatments for rare diseases.

Anthony Finbow, CEO of Eagle Genomics, talks to Pharm Exec about how adding microbiome-based evidence to disease modeling will enable the life sciences industry to understand the subtleties of how drugs interact with different human ‘host’ environments, unlocking new potential for stratified treatments.

Dr. Husseini Manji talks to Pharm Exec about his new role as J&J's Head of Science for Minds and how he hopes to foster new ways to treat dementia and serious mental disorders and provide holistic mental care.

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.