Guest Columns

  1. Is Continuous Manufacturing Right For Your Drug?

    Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.

  2. Developing A Set Of Usability Guidelines For Mobile Health Applications

    Most mHealth does not have to meet the FDA requirements for application of human factors and usability engineering. Thus – to date -- the processes used to design and assess mHealth have been widely variable and developer dependent.

  3. Could Microbiome-Based Therapies Upend The Asthma And COPD Markets?

    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. 

  4. Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?

    The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.

  5. Unboxing The Results: The State Of Medical Devices Development Survey 2019

    This annual survey of medical device professionals provides insight into how device development has changed in the past 12 months, current views on market challenges and trends, and the potential implications of these findings.

  6. “Work Harder” — And Other Ways To Completely Miss The Mark On Quality

    Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.

  7. Talking The Talk: How AI-Informed Virtual Assistants Are Changing Clinical Development

    The pharmaceutical industry as we know it today has roots that reach back to the apothecaries and pharmacies of the Middle Ages, when drug discovery largely involved sourcing plants and herbs for natural remedies and drug development and testing was an unstructured concept that relied on the hit-or-miss reactions patients experienced.1 Failure was arguably more common than success and, unfortunately for the patients, treatment courses often did not yield optimal results.

  8. Establishing Data Models To Support Cell And Gene Therapy Adoption

    Cell and gene therapy offers extended-term relief from disease states but comes at high cost with a complex reimbursement model. What proportion of intervention costs should be levied up front, and what proportion can be phased into the future (when the patient benefits accrue and are proven)? Separating the payment timeline from the treatment schedule is often referred to as outcome-based costing.

  9. Know Your Market: Leverage Data Transparency To Inform Precise Patient Journey Models

    The patient journey is unique to each patient, but organizing these journeys according to macro-level similarities for a given condition can pinpoint opportunities for therapy intervention and create far more effective market development and commercialization strategies.

  10. Mystery And Danger: Flammables And Oxidizers In Pharma Filling Operations

    BPO, benzyl peroxide, a compound that has both a fuel source and oxygen (two legs of the fire triangle) built into it, can make handling of a purified version of this compound very interesting.