Bernadette Wendelken, Senior Director, Pharmaceutical Business Development

Bernadette has more than 35 years’ experience in the healthcare industry. In her role at Simtra BioPharma Solutions, , she specializes in working with pharmaceutical start-ups and companies that do not have development and manufacturing infrastructures in place to help bring their potentially lifesaving products from the development stage to commercialization. In this interview, Bernadette shares her thoughts on the role she plays in working with smaller pharmaceutical clients to help them reach their full potential through partnering with a contract development and manufacturing organization (CDMO).

Why should a small pharma or biotechnology company consider Simtra BioPharma Solutions to help them with their development and commercialization needs?

Simtra BioPharma Solutions has extensive development experience and the proven capability to take products from the clinical stage all the way to market, where they can get to the clinicians and patients who need them. We also have extensive experience working with a variety of different product types, which enables us to anticipate and mitigate any potential challenges that may arise throughout the scale-up process. Smaller biotech companies often do not have the necessary manufacturing expertise needed to commercialize their product. Many clients turn to Simtra BioPharma Solutions to be their trusted advisor to help them navigate the complexities of sterile injectable manufacturing.

Finally — perhaps most importantly — we place top priority on quality. We have robust and mature global quality systems. Each project is manufactured to meet current Good Manufacturing Practice (cGMP) standards, and we work closely with our clients’ quality teams to share experiences and best practices.


What are the key differences you see when working with larger pharma companies compared to smaller companies?

Larger companies often bring larger teams, but having more people isn’t always more effective. Smaller companies tend to be more nimble and often have a more defined strategy with clear goals, and we are happy to help them by sharing our experience, expertise and capabilities.


“Tech transfer” frequently poses challenges for pharma and biotech companies, large and small. How does Simtra BioPharma Solutions help overcome this challenge?

Technology transfer is a crucial milestone in the development and manufacture of any pharmaceutical product, and it requires the sharing of knowledge, processes and, of course, technology between the two parties. For us, this usually means a client transferring this information to our technical teams.

Long before a tech transfer — even before a contract is signed — we have discussions with our clients to ensure that the project is a good fit and that all parties have a clear understanding of everything required for a smooth tech transfer. Beginning early in the relationship, we have ongoing development discussions that involve the many cross-functional experts important to executing a successful tech transfer. This requires many individuals, specialized skills and experience, but we have successfully completed hundreds of tech transfers, which demonstrates our commitment to collaboration and trust with our partners.


When has Simtra BioPharma Solutions served as a “trusted advisor” to a company rather than just providing a service?

One example that comes to mind is when we provided our development and formulation expertise to a prospective client — without having a commercial manufacturing contract signed — enabling them to take a product from a vial to a prefilled syringe, which is a technically challenging process. The company did not end up selecting us as their manufacturer for this particular project, and that’s okay. We are here to build relationships and create a foundation for working with companies in the future in addition to delivering on the projects we work on today.


What is something potential clients might not know about Simtra BioPharma Solutions that you think they should know?

Clients are often pleasantly surprised to learn about the extensive experience each member of our team brings to the table in diverse areas including Marketing, R&D, Program Management, Quality and Operations. We’re fortunate that some members of our team have been with us for decades and have literally built their career at Simtra BioPharma Solutions. In turn, our goal is to grow with our clients and help ensure that they are successful.