ARTICLES BY BARBARA BERGLUND

• Nickels & Dimes: What To Do When Your CDMO Charges You Unexpected Fees

  In many cases, the business development and sales teams from your organization and the contract service provider work separately. What happens when the invoices have unexpected costs?

• What To Do When Your CDMO Receives A Warning Letter

  You have just completed a full technical transfer to a CDMO for your commercial drug product. This has been a two-year program and you are gearing up to launch the opening campaign. Then, the regulatory team from the CDMO alerts you that it has been issued a warning letter by the FDA.

• Critical Considerations In Outsourcing Nanotechnology Drugs

  If the mission statement of nanotechnology is “to perform precise interventions at the cellular or molecular level to improve health and promote quality of life,” then the contract manufacturer might seek a mission statement such as, “to enable novel therapy in a safe, effective way, advancing medical science one medicine at a time.”

• 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.

• Tips For Choosing The Right CMO For Your New Nanotech Drug Delivery System

  It is difficult to be the pioneer seeking a partner who wants the opportunity to be on the cutting edge of new technology — and to participate in the future of medicinal chemistry.

• What To Do When Your CMO Overpromises And Under-Delivers

  At some point, you may face the looming reality that your critical timeline will not be met, and you are struggling to get a believable commitment from the CMO to report back to your own organization.

• What To Do When Your CMO Implements New Technology (That Impacts Your Product)

  Innovation and improvement efforts need to consider all aspects of the impact, including quality and regulatory considerations, supply constraints, market constraints, and cost.

• How To Prevent (Or Resolve) Communication Issues With Your CMO’s Project Manager

  You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it.

• What To Do When Your CMO Has To Transfer Your Product To A New Facility

  You just received an official notification from your CMO: It is going to remediate the facility in which you have been making a commercial product for six years. Now, you look at your options. You can stay with your current CMO, or you can take this opportunity — forced though it may be — to determine if it is time for a change.