ARTICLES BY SUE WOLLOWITZ

• What Are “Critical Minutiae” In Drug Development … And How Can You Best Manage Them?

  10/24/2018

  In every tech transfer, each transfer point from one step to the next requires some piece of information, some material, some result, some decision, and/or some signed document.

• The Consultant — Just Another Outsourced Provider

  4/10/2018

  Expert consultants are integral members of the small pharma community. As with all outsourced providers, a better understanding of their abilities and limitations makes for a more successful program.

• Is It Time For A Standardized CMC Knowledge Base?

  9/12/2017

  At small pharma companies, most of the CMC (chemistry, manufacturing, and controls) knowledge base is generated by a global array of outside providers.  The companies are challenged to create and manage a high-functioning knowledge base of information with little or no support staff. 

• Taking (Better) Control Of Your Outsourced Analytical Activities

  6/8/2017

  When a sponsor signs a contract with a CDMO, the analytical chemistry to-do list may look like the easiest part of the agreement. However, it can be the most challenging to manage in a total outsourcing model of drug development. 

• The Small Pharma–CDMO Marriage: How We Can Make It Even Better

  3/13/2017

  Unlike Big Pharma, which may outsource internally developed processes and formulations, small and midsize pharma/biotech firms are dependent on contract development and manufacturing organizations (CDMOs) for much of their product development and GMP manufacturing activity.