On-demand US BLA Regulatory Strategy saved our client time and hiring costs

Up against a tight deadline? Too few resources inhouse? Or, a good number of documents in critical path? Solem recently proved how we can efficiently build the right team of regulatory and medical writing experts to deliver processes and solutions that were productive, cost effective and enabling.

The Challenge

A biotechnology company that develops drugs for cancer treatment needed to submit a BLA with the FDA for their lead drug candidate in one indication. With only six months left in their planned project timeline, they also had a number of documents in critical path for the same asset in another indication.

Under time pressures and low on in-house resource, the company reached out to Solem for regulatory and medical writing support.

Solution

Solem initially held meetings with the head of regulatory and head of clinical development for a better understanding of the drug, timelines requirements, and the indications in which they needed support. It became clear that they needed regulatory support with pre-BLA and BLA package documents. Additionally, they needed medical writing to support the authoring of a Briefing Book, Assessment Aid, CSR, SCE, among other studies and reports.

Solem promptly brought together an internal team of regulatory professionals with FDA experience, as well as a team of medical writers specializing in oncology.

After gaining access to the documents, our team got to work and updated the client with weekly meetings to ensure expectations were met.

Results

On the regulatory side, Solem’s qualified team carried out a quality check and review of all the required documents for the BLA package. This included a Priority Review, Exclusivity Claim, Nonclinical documents, Clinical Overview, Assessment Aid, among others.

Solem also delivered a meeting package review, patient population comparisons, a BLA risk assessment with a mitigation plan, and competitor landscape assessment.

We also participated in any strategy meetings where external input was required.

Our medical writers have authored patient narratives, briefing book, clinical overview, SCE, CSR, among others.

With our support, the company were able to submit the BLA as planned for one indication.  Clinical and non-clinical documents were also completed to support the regulatory submission of the second indication for with the FDA.

Our client not only achieved their deadlines, but demonstrated efficiency and cost effectiveness as Solem was engaged on a need basis.

Our client relationship has now shifted to support them in other indications as needed.

If your organization is up against a tight deadline or is struggling with in-house resources, we’re here to help support your work. Click here to contact us about an urgent or upcoming project. We’d love to chat.