Newsletter | March 17, 2023

03.17.23 -- Circumstances For Delaying/Refusing An FDA Inspection

New Podcast Episode
Featured Articles
Circumstances For Delaying, Denying, Limiting, Or Refusing An FDA Inspection

Delaying, denying, limiting, or refusing a drug or device inspection without a reasonable justification will result in a less than collegial atmosphere during an FDA inspection.

Preparing For A Biosimilars Future

A future of biosimilars will not only affect current access to lifesaving medications for patients through lower costs but give manufacturers the room to focus on even more innovative therapies — and this future is approaching faster than we think.

Ongoing Economic Uncertainty And The Exit Of Generalist Investors From Biopharmaceuticals Continue To Put Pressure On Biopharma Company Leaders. What Advice Would You Offer?

See the answer from Kenneth Moch, president at Euclidean Life Science Advisors and a faculty affiliate at the Division of Medical Ethics at the NYU School of Medicine.

Web-Exclusive Content
Biotech’s Market Outlook In 2023 & Beyond

This article discusses three key themes in 2023 that are likely to have an outsized impact on biotech companies as well as the notable longer-term trends to watch over the next few years.

Industry Insights
The Wider Use Of mRNA To Treat Various Forms Of Cancer & Autoimmune Diseases

Each of the diseases discussed is going to be different in the way that it manifests, and the target cell arguably is going to be different as well. Strapps and Kalayoglu break it down disease by disease.

How Distributed Automation And DPM Support Resilient Biomanufacturing

Embracing digital transformation, when combined with biomanufacturing best practices, supports increased productivity and efficiency in a biomanufacturing environment. Learn how distributed automation and digital plant maturity support resilient biomanufacturing.

The Digital Future Is Now

Discover best practices, and see real examples, of how to successfully drive the transformation of clinical development to get higher patient engagement and retention using digital technologies.

The Secret Sauce In Successful Clinical Trial Payments Programs

More than 80 percent of sites surveyed want to get paid in 30 days, and many clinical technology companies offer specialized software solutions to address the site payments process. However, these systems still require a large effort by the sponsor to operate. What is the secret sauce for success?

Digital Edition
March 2023 Digital Edition

Inside you will find more on:

  • Biohaven CEO Interview
  • Industry Research
  • Diversity Of Boards
  • Tax Legislation

View the digital edition.

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