Stephanie Pasas-Farmer has held a range of scientific, business management and operational leadership positions across contract research and global pharmaceutical organizations, including Frontage Labs, Wuxi AppTec, Galleon Pharmaceuticals, BMS and Merck. She currently provides R&D, regulatory and commercial consulting services to early-stage pharmaceutical and biological drug development organizations in the field of bioanalysis. Dr Pasas-Farmer is a frequent contributor to peer-reviewed publications and industry conferences on current bioanalytical topics. She is also an active steering committee member of the Development and Discovery divisions of the national Applied Pharmaceutical Analysis (APA) meeting.BioData Solutions (PA, USA) provides consultation and hands-on implementation support to biopharmaceutical organizations and contract research organizations for small and large molecule projects. We help sponsors select a drug development path, build product development strategy, avoid costly mistakes and stay compliant at every phase of development. We also provide rescue services when drug development activity does not go according to plan. Biodata’s senior-level staff, each with a minimum of 15 years of bioanalytical experience, provides deep expertise across small molecule, biologics and hybrid technologies.
In what areas are the outsourced work you receive from?
At BioData, we support clients at all stages of development from early discovery and product strategy development to post marketing bioanalysis support. Early in our client’s project’s life cycle, we can assist in critical reagent/reference material strategies. In addition, we help with CRO selection, qualification and management providing due diligence and audit services. For CRO oversight, we can provide assay management, data review both from a scientific as well as regulatory point of view, through IND to BLA/NDA submission and beyond. For regulatory support, we advise clients during regulatory authority questions and interactions and help with any questions from clients or the health authorities.
What does your organization believe is important when being selected for outsourcing?
Hands down, quality is key, which stems from a deep understanding of regulatory requirements from both a regulatory compliance and a scientific intent perspective. Thought leadership and work style fit is also important. Biodata Solutions clients require different types of interactions and different levels of support from a CRO, so this is taken into consideration when assisting study placement with a lab. For example, a small biotech might have limited bioanalytical expertise internally, so they would require a lab with the ability to work independently, as an extension of the team. However, another client might need additional capacity assistance, but the expertise is retained in-house. In turn, this group would need to take instructions and follow them specifically.
What are the challenges you face when receiving outsourced work?
Trouble areas include: communication, especially during projects that involve troubleshooting; timelines due to long backlogs. One of the biggest challenges for drug developers is access to bioanalytical expertise, which is largely external. Incidentally, that is precisely why BioData Solutions exists.
Do you think the amount of outsourcing will change in the future?
This remains likely, as outsourcing has become an essential part of our drug development process. Much like small companies who drive discovery of new targets and therapeutic areas, bioanalytical outsourcing is a key way small companies can expand their capabilities and focus on core competencies internally, while large companies can increase their capacity.
What factors do you think will increase outsourcing?
Current trends for the industry include expansion into new therapeutic areas, new biological targets to address high unmet medical need, as well as complex biologics and gene therapies. Outsourcing support will grow to fit these key areas of growth in the biopharma industry.
Do you think the relationship between pharma and outsourcing companies will change in the future?
Yes, outsourcing relationships are poised to become more collaborative, so this makes communication even more imperative. Also, companies are placing more regional studies so shipping samples across the world is not as common anymore. However, the number of labs in the same region of the application filing is more typical now.