Industry Insights

1. 4 Future Scenarios For Cell And Gene Therapy Adoption 8/8/2018

   Cell and gene therapies: Will their use become ubiquitous, changing the landscape forever as many have promised? Or will applications be confined to rare diseases as they have been thus far?

2. Can Your In-House Strategy Handle Uncertainties Of Biologics Development?

   A company has to be able to withstand the highs and lows of biologics development. To avoid costly mistakes and wasted efforts, a company must prepare for surprises along the drug development pathway.

3. Considerations For Formulating Microparticle-Encapsulated Drugs — Part 1 12/26/2018

   The emulsion system created when forming microparticle can quickly become complex. Following are critical factors to consider when beginning work with microparticle formulation for a large protein molecule.

4. How Well Are Your HCP ELISAs Covered? 3/27/2019

   Validating host cell protein ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE approach combines the best of existing methods.

5. Learn Pfizer’s Guiding Principles For Externalization At Outsourced Pharma West 8/4/2014

   Firelli Alonso-Caplen has been managing outsourcing for 10 years, first at Wyeth and then Pfizer. “The key really is the initial selection process for the CDMO,” she said in a recent conversation regarding our panel at Outsourced Pharma West, in San Francisco, November 10-11. 

6. Process Characterization: The Foundation For Validation 11/22/2019

   Process characterization is the foundation for process validation activities. Too often, validation activities fail due to the lack of process characterization using sound statistical and scientific methods, including design of experiments (DOE).

7. Screening Prospective CROs: What Are Their Data Capabilities? 9/25/2014

   Clinical development is the most costly aspect of getting a drug, medical device or diagnostic to market.  Previously priced at $1.3 billion, getting a product approved is now estimated to cost as much as $5 billion. If you entrust management of your clinical trial to a CRO, what criteria should you look for in a partner to ensure the most reliable results with the greatest efficiencies at the most affordable price?

   One major issue for sponsors partnering with CROs for analytic services is the ability to directly access and retrieve their raw data, which may only be accessible from the CRO's data warehouse, source systems, or down-stream analysis platforms.  Requesting and receiving both ad-hoc/custom and periodic standard reports from their CRO can potentially result in critical time lags and inefficiency for program, country, study and data managers, as well as for clinical research associates, investigators, clinicians and safety officers. 

8. How To Adapt To Changing Single Parcel Testing Standards 5/4/2020

   Medtech manufacturers currently following the ISTA 2A package performance testing standard may wish to consider more modern standards that allow customization of some testing criteria to better evaluate real-world conditions of their packaging and distribution environments.

9. Recommendations For Managing Complexity In Biopharma Operations 1/21/2020

   There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.

10. Will We Have Harmonized Standards By The MDR’s Date Of Application? 7/22/2019

    The EU Commission has requested that EU Standardization Organizations draft revisions to their existing standards, adapt some international standards, and issue new standards in support of the MDR and IVDR before May 26, 2020. Which standards could meet the deadline, and where are there likely to be issues?