EDITOR'S DESK

CDER-ETP: A Resource For Innovative Biopharma Firms

The FDA’s Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP), is yet another step toward removing slow-moving bureaucracy and red tape that stands in the way of innovative new technologies that drive drug development. 

A Disruptive Approach To Oncology Therapy Development

CureLab Oncology CEO Alex Shneider’s lament is a biopharma industry that exhibits little appetite for those discoveries made while coloring outside the lines. We caught up with him for an update on the maverick path of lead candidate Elenagen.

Biosimilar Industry Advancements To Watch In 2020

Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

How BlueWillow Biologics Is Pioneering Mucosal Vaccine Tech

CPA-wielding business and finance executive Dave Peralta is leading a pioneering intranasal nano vaccine developer through the advent of next-generation immunotherapies.

GUEST COLUMNISTS

  • 3 CMC Mistakes That Could Cost You Billions

    The end game for many small biotech startups is acquisition by Big Pharma. How should small biotech companies prepare their chemistry, manufacturing, and controls (CMC) documentation for due diligence review? What are the mile markers that measure how far product and process have developed? While the CMC section may not add zeros to the sales price, poorly documented development can remove them.

  • U.S. Sites Play Surprise Starring Role In FDA’s Drug GMP Warning Letter Report

    Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

  • An Analysis Of FDA’s Recently Issued Gene Therapy Guidances

    The FDA has finalized six draft guidance documents intended to serve as part of a modern, comprehensive framework for how the agency will help advance the field of gene therapy. At the same time, it issued a new draft guidance on determining “sameness” of gene therapy products for the purposes of orphan drug designation/exclusivity. This article highlights key changes made in each of the final guidances and also reviews the new draft guidance.

  • Experimental Methods For Microorganism Challenges On Online Water Bioburden Analyzers

    Implementing online water bioburden analyzer (OWBA) technology often includes laboratory microorganism challenge testing to verify that the instrument is suitable for its intended use. This requires the end user to select microorganisms for testing and successfully create quantifiable suspensions of these microorganisms for OWBA analysis. While this would seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.

  • Applying The Johari Window To Manage Pharmaceutical Supply Chain Risk

    The recalls of generic versions of the drug valsartan and related products losartan and irbesartan due to high levels of nitrosamine impurities have once again put the spotlight on sourcing strategies and the globalization of the pharmaceutical supply chain. Learn how the Johari Window model can help minimize risk and shrink the unknown risks inherent in any complex manufacturing supply chain.

  • Valentine’s Day Heartbreak: How To Let Your (Underperforming) CMO Partner Go

    We read many articles about building relationships in the business environment to improve transactions, fortify the supply chain, and increase profits. But, what if the CMO has a deteriorating plant that directly impacts your production, or personnel turnover creates an environment of never-ending deviations and senseless retraining?

  • What’s Driving The Booming Microbiome Market? 4 Factors Pharma Needs To Know

    Rates of investment in the microbiome category are increasing as both venture capital firms like Seventure and pharmaceutical companies like Johnson & Johnson and Takeda make significant investments and establish partnerships with a variety of start-ups that are commercializing novel offerings in the microbiome space.

  • FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?

    At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, recently published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” indicating their undoubted primacy in the Task Force’s overall assumption as to their influence on drug shortages.

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This e-book shares some of our experiences in the more hazardous areas, and in turn challenges you to look at your facilities and operations to apply some basic safe design philosophies to whatever you are working with, potent or not. We sincerely hope you enjoy them and continue to be safe.

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