We were asked to assist a growing global biopharmaceutical client in support of a recently licensed injectable product. The client needed an agile and flexible means of ensuring success across a diverse set of pre-conditions including contract manufacturing, alternate medical device suppliers and commercial alliances. The product was forecast to provide significant future revenue and it was imperative that the portfolio manager took all necessary measures to eliminate obstacles as quickly as possible and deliver on the brand’s strategy. At the onset of the project the client was uncertain if this project required a full time product portfolio manager. This and other uncertainties lead them immediately to considering a consultant. We offered the client the ability to fulfill their product portfolio needs with the appropriate expertise in an agile and flexible manner.
Business Need and Existing Issues:
The characteristics of the global product supply chain, device sourcing and out-licensing agreements made for a complex set of preconditions to quickly understand and master. Sourcing of kit components across alternate suppliers was required, with some suppliers unwilling to license their devices in certain markets. Client commercial needs emanated from Europe, Asia and North America. The portfolio manager would need to navigate various cultures, with competing priorities, and ensure a common understanding of obstacles and opportunities.
There was also a significant element of learning to be accomplished with the project. Would we need to license the medical devices separately from the drug product? What effect might alternative sources of medical devices have on regulatory filings and licensing in global markets? Will we encounter barriers with Islamic countries when we source components made in Israel? Most x-US markets accept or rely on a FDA CPP, but what happens as the US market files for new indications? These and many other questions were to be answered with the leadership of the portfolio manager.
SCS Partners’ Approach for Success:
At SCS Partners, we assigned the project to a colleague recognized as a leader and having significant medical device and pharmaceutical combination product expertise. We employed a leadership approach to portfolio management and product stewardship. Our leadership approach ensures project management is conducted with respect, cultural sensitivity and a high degree of emotional intelligence. We also emphasized collaborative knowledge management principles. These principles give the client the capability of sustaining the project without the continual need of SCS Partners if they so choose.
SCS Partners successfully delivered on the product portfolio management project within the 6 month contract. Regulatory filing and response targets were achieved. Obstacles identified emanating from the device suppliers were successfully eliminated. The complex set of documentation requirements for certain markets was achieved and captured using knowledge management best practices. Ultimately the SCS Partners portfolio manager delivered to the client a sustainable means to manage the needs on their own. And, what was initially estimated to require 30 hours per week was demonstrated to be manageable with only 10 hours per month – a significant cost avoidance for this client.