R&D/Clinical Trials

Early Vaccine Authorization Raises Ethical & Logistical Challenges for Trial Sponsors

October 18, 2020

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.

Moving Toward the Pharmaceutical Industry of the Future with Translational Medicine

October 15, 2020

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

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

September 20, 2020

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.

Success Factors for Orphan Drug Development

August 04, 2020

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.

Pharmaceutical Executive

Central Focus: Targeting Unmet Need in CNS

July 09, 2020

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.

Global Regulatory Collaborations Aim to Speed Access to New Vaccines & Drugs

June 29, 2020

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.

Tackling a "Genius Virus": Dr Patrick Soon-Shiong

June 15, 2020

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.

Spotlight on Science Gives Public New Perspective

June 10, 2020

Pharmaceutical Executive

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.

Cancer Patients Can Not Afford To Put Their Struggle on Hold

June 09, 2020

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.

Vaccine Production Key to Global Pandemic Response

May 17, 2020

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.

Drug Development in Wartime: Driving Tomorrow's R&D Decisions with Today's COVID-19 Data

May 10, 2020

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.

COVID-19: Testing Biotech's Ingenuity in New Ways

May 07, 2020

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

COVID-19 and the Evolving Science of Pharmacogenomics

April 28, 2020

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.

Blood Feud Divides Europe Over Plasma Shortfalls

March 09, 2020

The collection of source plasma for new therapies igniting debate.