Industry Insights

  1. Unpacking The Latest Brexit Developments And Their Impact On Pharma

    As the divorce date approaches for the U.K. and the EU, one would be forgiven for thinking there would be a plan in place to deal with an event that will have such a profound global impact on the pharma industry. However, manufacturers have to prepare for any possibly scenario, while continuing to wait for clarity.

  2. How To Choose The Right Contract Laboratory For Your Drug Product

    Finding a contract laboratory to fit the needs of your product is often challenging. Especially in the clinical and preclinical space, laboratory support is critical to presenting a foundation to the agency that your product is of the right quality and safety, and the basis of this before validation batches have been made depends wholly on the quality controls in place.

  3. How Will Medicare’s International Pricing Index Model Affect Biosimilars?

    CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.

  4. Using The QTA To Align Data-Integrity Expectations

    Outsourced GMP-regulated activities have clear requirements, including the use of quality-technical agreements (QTAs). The principles described in this article may be applied to both commercial and precommercial stages of the product life cycle and to any relationship with suppliers that provide outsourced GMP-regulated activities.

  5. How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)

    Let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time. 

  6. Address Rare And Respiratory Diseases And Improve Clinical Success With Metabolomics - Part 5

    Breathing is an involuntary reflex action and one of the most basic yet important functions that the body performs. However, for millions who suffer from chronic lung problems and respiratory disease, a single breath is never taken for granted. Certain respiratory diseases are the leading cause of death in the US and include chronic lung problems, such as asthma, bronchitis, and emphysema. In addition, heart attack and accident victims, premature infants, and people with cystic fibrosis and lung cancer suffer from respiratory problems.

  7. Keep Your Eye On The Apple: Apple Makes A Move On The Watch Market—Could Pharma Be Next?

    CEO of Rolex sounds like a pretty desirable job title and it might have been fun a year ago, when Dufour took the job. Back then, rumors of the Apple Watch were just rumors, and the idea of a tiny computer on the back of your wrist seemed a touch ridiculous.  

  8. 2019 U.S. State Policy Trends Impacting Pharma Manufacturers

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

  9. Staying Flexible In Biomanufacturing

    The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. 

  10. How To Ensure End-To-End Visibility In Pharmaceutical Supply Chains

    The supply chain problems highlighted most frequently include lack of coordination, inventory management, absent demand information, human resource dependency, order management, shortage avoidance, expiration, warehouse management, temperature control, and shipment visibility.