A milestone for Diagnostics R&D
With the successful closure of Phase II on November 28, 2006, Diagnostics R&D has moved a crucial step forward in the development of a new product, and also closer to a significant organizational milestone. Developed as part of the Joint Business with Ortho-Clinical Diagnostics Inc. (OCD), the new product is a serologic blood test for HBV and represents the first time that a group within Diagnostics R&D has successfully shepherded a product from initial research through scale-up, transfer to manufacturing, and claims testing.
The new test is designed to recognize a wide variety of Hepatitis B strains without any alteration of protocol, time to first result, or throughput when used as part of diagnostic panels. This is a critical capability as the virus evolves under pressure from vaccination programs and drug treatments, and the health prospects for those infected will be greatly impacted by our ability to keep step with variations.
The Process
Not that it's been easy. Says team member Christine Ching, "This project has really shown me how incredibly hard it is to create a viable, marketable product, and how much work is involved in doing so."
Historically, Diagnostics R&D has been involved in research and the production of raw materials to be handed off for development into a finished assay by their counterparts at OCD. In this case, laying the scientific groundwork was only the beginning. In addition to years of concerted effort, many late nights in the lab, and tens of thousands of samples run, the team was required to learn how product development experiments are planned, executed, and documented, and to become proficient in satisfying internal customers in Quality Assurance, Manufacturing, Regulatory (both US and Rest of World) and Clinical Affairs.
With new tasks came a new overall focus. Explains team leader Mark Van Cleve, "In feasibility, your customers are basically other scientists - you just want the answer. In later stages, your customers are Regulatory, Manufacturing, and Quality. And instead of trying to find the answer, you already know the answer and are trying to document it! It's really a very different kind of pursuit."
The R&D team's achievement is even more impressive considering that they functioned as part of an overall project team spread across two companies, five locations, and two continents
The People
Taking a product all the way through the R&D process is not just a milestone for the organization as a whole, but also a first for most of the individual team members. The new assay was built on a strong foundation laid by David Chien and Bill Andrew's groups. Mark Van Cleve, Heather Todd, and Sodany Son have been with the team from the time the first research materials were received in 2003, with Christine Ching joining the group in 2004. Together, Heather, Sodany, and Christine have done an enormous amount of work on the assay, including all of the Phase I technical assessment and the vast majority of Phase II as well. More recently, Gabriela Cheveresan and Victoria Torres have joined the team and made important contributions as well. The team worked in close collaboration with their technical counterparts at OCD, who were unfailingly helpful in supplying critical insights, information, and reagents.
The Payoff
Making a product requires the efforts of many people, but the R&D team has a special feeling of ownership towards this one, having built it from the ground up. There is tremendous gratification, both personal and professional, in seeing one's efforts applied directly to the needs of patients. In the words of team member Heather Todd, "For me it evolved from being just one more interesting puzzle to solve into being something that I felt personally responsible for..something I want the end user/customer to be happy with. We have a lot of time and energy invested in this, and it definitely feels good to know it will make a tangible contribution to human health!".