Author: Claudia Campbell-Matland, PMP
At the Companion Diagnostics 2016 Symposium, the role of the project manager in aligning the CDx and drug (Rx) development processes resonated with me. Woven into many of the day's presentations, the concept was addressed by Dr. Blythe Anderson (Merck), Dr. Steve Anderson (Covance), Dr. Robert Holt (Hologic), Dr. George Green (BMS). Project managers must combine hard skills ("science") with soft skills ("art") to lead product development programs. Merck’s Dr. Anderson described how this "art & science" of project management is taken to an even higher level for a CDx project, to ensure market availability of the CDx along with the associated drug.
Since I am an in vitro diagnostics project manager and also a fan of the arts, I'm going to expand the art portion of her theme.
The CDx project manager can be likened to an all-in-one:
• Producer - ensuring the project budget is available and project sponsors regularly champion the project.
• Director - leading and overseeing the project (or in the art world - the "production"). Aligning the project goals, schedules and development activities for the CDx company with those of its pharma partner.
• Choreographer - designing the "movement sequences" of multiple teams bridging the CDx and Rx partners.
CDx and Rx teams, as well as executive managers, rely on the PM to balance multiple constraints - schedule, budget, scope, risk, quality and resources - to achieve overall objectives. The PM’s art also includes aligning these constraints to product development efforts, for example:
• Scope - Managing project scope alignment with the CDx product scope - i.e., meeting requirements and fulfilling intended use
• Risk - Managing project risks alignment with managing potential product risks as per applicable regulatory standards
• Quality - Managing project quality alignment with implementing the analytic/design verification and validation testing as per applicable quality (and regulatory) standards
Coordinating this complex "dance" of CDx and Rx project and product elements is no easy feat. The CDx project manager must have:
• Superior leadership skills, communication skills and business acumen ("art").
• The technical expertise needed to bridge the CDx and Rx development efforts ("science").
The CDx project manager is therefore the ultimate Renaissance person, combining art & science and much more, to lead the CDx project to a successful conclusion.
I have been fortunate to attend a few of the BRC's conferences this year, and continue to be impressed with the content and networking opportunities at their events. I look forward to next year's CDx conference and continuing the conversation on these and other CDx topics that began in November.