Life Science Leader Magazine Supplements

CMO 2016

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 33 9 Opportunity Way | Newburyport, MA 01950 | Tel: (978) 462-5555 88 Jackson Road | Devens, MA 01434 | Tel. (978) 772-2111 Our clinical drug substance development and manufacturing team of more than 100 professionals at two Massachusetts based locations are ready to execute on your most challenging project. Whether your compound is a pre-clinical candidate or you need a partner for full scale commercial launch, PCI's unique mix of scale and capabilities are unmatched in the industry. Come see where problems get solved! VISIT PCISYNTHESIS.COM TO LEARN MORE ABOUT HOW WE CAN HELP YOU. Together. Moving Ideas Forward. the more standard metrics. These broader measurements became an important part of an overall supplier scorecard. "We measured items that were subjec- tive by applying a numeric rating to them and then presenting these ratings as parts of our quarterly review meetings with the supplier. We actually spent a fair amount of time talking about these items with our its WIFI (purified water) system. Again, the issue was not occurring in McDade's part of the facility, so by a strict reading of the quality agreement the CMO was not obligated to inform McDade's company. In fact, McDade only found out about the problem after the CMO was inspected by the FDA and received a warning letter. "By strict measurement, both CMOs were within the language of the contract, but only one was within the spirit of the relationship. Which one did I trust and continue to work with? You could look at the numbers on the metrics reports and they might be similar, but the quality of the relationships was totally different," she explains. CAN YOU METRICIZE TRUST? The OPW panel agreed that the trust factor would not diminish in importance because more and better metrics are put in place at the sponsor to measure provider performance. In fact, the same reason for an increased need for CMO metrics also bolsters the need to have the intangibles — like personal relationships — contributing positively to outsourcing outcomes. As one panelist said, "You can't have a relationship with an organization; you have a relationship with individu- als." While systems and processes are set up so that projects, processes, and relationships are not "completely person- dependent," sponsors will always be "somewhat dependent upon the individu- als on the other end." It's important to have an open structure where the letter and spirit of the relation- ship can be transitioned as personnel changes — at either the sponsor or pro- vider. One panelist talked about work- ing with a supplier who had to replace project leaders a few times, but "how the transition was accomplished had a huge impact on how successful and seamless we continued to move forward." Trust as an independent variable gets high marks for how well productivity, quality, and reliability — and the relationship itself — are sustained over time and as people change. That trust then becomes the yardstick for the entire organization as a fully reliable partner. McDade has had outsourced supply chains find ways to document intangibles to head off any paradox cropping up in CMOs so they understood the importance to us," says McDade. She adds: "We mea- sure and measure. On paper, performance can look similar, but from a relationship standpoint, performance can turn out to be completely different. For me there is always another equally important ingre- dient in that relationship, and that is trust." L

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