Featured Pharma Online Editorial

  1. 3 CMC Mistakes That Could Cost You Billions 2/24/2020

    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.

  2. New FDA Draft Guidance: Qualification Process For Drug Development Tools 2/3/2020

    The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.

  3. Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away 1/30/2020

    Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.

  4. Rebels Vs. Clones: Constructive Dissent In The Pharma Industry 12/20/2019

    The pharma industry is in the middle of an identity crisis, but not in the way you may think. Rather than a period of uncertainty and confusion typically brought on by a change in role or expectations, this crisis is far more insidious. It’s brought on by a mind-set in which industry leaders believe they know exactly what the industry should be doing.

  5. A Biopharma Year In Review — And A Look Ahead To 2020 12/16/2019

    The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.

  6. Trends To Watch In China’s Biopharma Industry 10/18/2019

    China’s biopharma segment has experienced double-digit growth for the past decade, and the landscape is poised for robust growth for the near future. The country's biopharma sales are on track to reach over $50 billion. Here's why that matters to you.

  7. 4 (More) Critical Considerations For Drug Delivery Device Development 8/12/2019

    The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

  8. 4 Important Things To Consider Before Developing A Drug Delivery Device 8/6/2019

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.

  9. Could Microbiome-Based Therapies Upend The Asthma And COPD Markets? 5/28/2019

    Respiratory diseases are an appealing target for future microbiome development, with the combined asthma and chronic obstructive pulmonary disease (COPD) market approaching $30 billion by 2020 in the U.S. alone, and with significant unmet needs remaining in both markets. 

  10. Big Data And AI In Pharma Development And Manufacturing: An Inside Look 2/27/2019

    Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.