Blogs

Mike Hennessey Sr., Chairman and Founder of MJH Life Sciences, pushes for the celebration of the pharmaceutical industry after nine grueling months of fighting COVID-19.

Despite all the hopes and wishes for a better new year, the start to 2021 in Europe is proving to be grimly similar to the end of 2020.

This industry won't be going back to “the old way.” Oracle GM and SVP, Henry McNamara, makes predictions for sponsors and CROs in 2021.

NeuroRx CEO, Jonathan Javitt, and Head of Operations/CCO, Robert Besthof, discuss the logistics and trial progress of their COVID-19 drug.

The EU has its first COVID vaccine authorized.

Europe's leaders find themselves in a strange situation as their defense of their systematic approach to drug registration via the EMA has come under fire not only externally, but from some of their own politicians as well.

Changes predicted to change the face of clinical research in 2021.

What has changed in 2020? How will 2021 shape up? Let’s evaluate.

As the UK's Medicines and Healthcare products Regulatory Agency gave approval to the Pfizer/BioNTech COVID vaccine—questions about how they had been so quick, or why the EU had been so slow, have risen.

Ralph Passarella, CEO and Co-Founder, and Michael Lin, Executive Chairman and Co-Founder of Reify Health, discusses how workflow optimization technology adapts to address clinical trial recruitment issues.

Craig Serra, who works in Clinical Technology and Innovation at Novartis, discusses his perspectives on clinical innovation implementation during COVID.

European health ministers are meeting later this week to review what has been, and what can be, done to strengthen future defenses to counter the COVID pandemic.

A discussion of various topics amongst TMF experts from Questex’s 2020 Global TMF Summit.

While the UK's departure from the EU is imminent, NICE will continue to influence thinking around the continent.

Cue Biopharma has managed to persevere through the COVID pandemic by employing a variety of strategies. President and Chief Scientific Officer, Anish Suri, and Ken Pienta, acting Chief Medical Officer discuss their experiences.

President-elect Biden has announced initiatives to combat the widening coronavirus pandemic including a 13-member COVID advisory board.

A discussion of how sponsors, CROs, and sites are adapting their operational models to maintain patient safety, data quality, and integrity in the COVID-19 pandemic.

With various COVID-19 vaccine trials underway, a seamless clinical research process has never been more critical.

Dilemmas are multiple and stakes are high as the framework for thinking about medicines development frequently fluctuates because of the COVID-19 pandemic, making it harder to foresee all implications for the future.

Both quality personnel and the FDA have predicted some of the issues with pandemic operations, but much is still unknown on the impact these rapidly implemented pandemic processes.

As the EU moves towards the next stage in its review of intellectual property incentives for pharmaceuticals, some unusually direct exchanges occurred between those who advocate patents—and those who oppose them.

Declarations made by Beate Wieseler don't align with those of many regulators and HTA bodies in Europe and will prove tough to transform.

A discussion of the forces currently impacting global operations, FDA foresight on operating clinical studies during COVID, and the subsequent compliance issues manifesting from poorly executed decentralized clinical trial operations.

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.

Hassan Kadhim, Director, Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at Bristol Myers Squibb, discusses his perspectives on how the pandemic has shifted clinical innovation.

FDA has published updated Emergency Use Authorization (EUA) requirements for new coronovirus preventives.

Sudarshan Hebbar, CMO of CalciMedica, reveals how the FDA, ethics committees, and safety consortia have responded to helping to advance the application of novel therapeutics towards COVID.

The COVID-19 pandemic has pushed several focus areas to the forefront of the industry.

Europe's research ministers are will meet to attempt to reach agreement on European Union research plans for the next seven years, including a cluster devoted to a broad range of health goals that range from general objectives to subjects of more specific interest to the community.

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available.