Newsletter | November 21, 2022

11.21.22 -- Why iTolerance Is Our Company To Watch

Featured Articles
Companies To Watch: iTolerance

iTolerance is dedicated to curing diabetes and other conditions by inducing local immune tolerance in implantation.

Cashing In On Collaboration

Our conversation with Philogen CEO, CSO, and Cofounder Prof. Dario Neri reveals his company’s metered emergence from academia, its avoidance of venture capital, and its rapid realization of revenue through pre-pipeline collaboration.

5 Steps To Avoid Mismanaging Biopharma Grant Funds

Here’s how to ensure you’re successfully maximizing that infusion of money and setting yourself up for further success in the grant world.

Overcoming 4 Challenges In Orphan Disease Clinical Trials

Developing innovative treatments for patients with orphan and rare diseases offers substantial challenges. This article shares the author's tips for recruiting from small patient populations, collaborating with the FDA, choosing to work with a CRO or not, and determining a patient-centric approach.

Industry Insights
Establishing A Stage-Gate Approach To Biomanufacturing

Biotech leaders highlight how to perform critical activities leveraging process and analytical development resources from early-stage clinical to commercialization.

Nasal Delivery Technology, QbD Processes, And Outsourcing

Understand the advantages of unit/bi-dose nasal delivery technology, application of QbD process for inhaled product development, and why to outsource inhalation development and manufacturing.

Reliability And The Future Of Cell & Gene Therapies

Mayo Pujols, CEO of Andelyn Biosciences, discusses how companies are focusing on reliability and predictability to further advance this innovative therapy.

Rapid Characterization Of Impurities

Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

From Discovery To Commercial Promise With Philogen’s Dr. Dario Neri

In a recent episode of The Business of Biotech, Philogen CEO Dr. Dario Neri sat down to explore his journey from academia to startups, as well as Philogen's own trajectory.

Now In Effect: 3 Key Functions Your eTMF Needs To Meet New EMA Regulations

The European Union Clinical Trial Regulation No. 536/2014, which went into effect in January, introduced the most significant changes to the processes for clinical trial applications in at least the past 15 years. Learn how it impacts the trial master file and consider three key functions that an electronic TMF must have to achieve compliance and maintain organizational success.

Digital Edition
November 2022 Digital Edition

Inside you will find more on:

  • Industry Research
  • Reader Feedback
  • Pharma Exec Interviews
  • Outsourcing Issues

View the digital edition.

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