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CMO 2017

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 36 By K. Hammeke PHARMA INDUSTRY LACKS CONSENSUS ON KEY ATTRIBUTE OF A SPONSOR-CMO RELATIONSHIP INDUSTRY STANDARD RESEARCH Report Survey Methodology: Industry Standard Research's Contract Manufacturing Quality Benchmarking research is conducted annually via an online survey. For the 2017 CMO Awards data, more than 80 con- tract manufacturers were evaluated on 27 different performance metrics. Research participants were recruited from biopharmaceutical companies of all sizes and screened for decision-making influence and authority when it comes to working with contract manufacturing suppliers. Respondents only evaluate companies with which they have worked on an out- sourced project within the past 18 months. This level of qualification ensures that quality ratings come from actual involvement with a business and that companies identified as leaders are backed by experiential data. dents, there is a drop-off, and the next three attributes are perceived most important by ~1 in 20 respondents; the next drop-off is more substantial, and the following 18 attributes were ranked as most important by any- where from 1 in 33 to 1 in 100 respondents. This pattern shows how some metrics carry a substantial amount of influence for different parties in the outsourced services buying audience; this lack of consensus leads to a cloudy decision-making process because no specific criterion dominates the CMO selection deci- sion. Unfortunately, ISR's research suggests this trend toward greater diversity in selection criteria is going to continue to grow rather than to consolidate around specific metrics. These same attributes are used as evaluation criteria for each contract manufacturer included in the study. Figure 1 displays how the perfor- mance metrics are classified by buy- ers of outsourced services and the performance metrics that correspond to the award categories. Respondents who have worked with a company within the past 18 months or are cur- rently engaged with the CMO can rate the contract manufacturer on its per- formance relative to expectations. Using insight from industry peers on the CMO attributes that contribute to a successful outsourcing relation- ship along with performance ratings can help your outsourcing decision- making unit streamline the shortlist- ing process. Match your own priori- ties and project needs with compa- nies that have proven to excel in those areas — and feel confident because the process is guided by data based on recent customer feedback and insight from experienced outsourcers. The 2017 CMO Leadership Awards win- ners represent the CMOs that have performed the best on these metrics for their customers. A variety of con- tract manufacturers in terms of size and offering are winners this year. So, whether your company's preference is for a one-stop shop with an end- to-end offering, or your projects have unique requirements only available at niche providers, know that these companies come with the "seal of approval" from your industry peers. L QUALITY RELIABILITY CAPABILITIES EXPERTISE COMPATIBILITY DEVELOPMENT TOP 5 MOST IMPORTANT AWARD CATEGORY PERFORMANCE METRICS PRIORITY Strong regulatory track record 34% 12% Proven ability to manufacture API/dosage forms we require 27% 11% Reliable on-time delivery 37% 10% Track record for meeting quality performance metrics 28% 9% Scientific knowledge 31% 7% Has capacity to meet our demands 32% 7% Low cost 31% 6% Ability to smoothly scale up manufacturing and transfer technology 21% 4% Stability testing capabilities 16% 3% Well-regarded within the industry 20% 3% Experience level of staff 27% 3% Right first-time measurements 27% 3% Facility has most up-to-date manufacturing tech- nologies 15% 2% Flexibility to adjust schedule for special requests 16% 2% Offers innovative solutions 11% 2% Complementary core competencies to in-house or other manufacturing contractors 9% 2% Metrics for meeting overall project timelines 12% 2% Timely project communications 16% 2% Access to desired markets 8% 2% Provides regulatory support for filing 14% 2% Cultural fit 12% 2% Up-front contingency planning, risk management 11% 2% Accessible senior management 8% 1% Financial strength/stability 14% 1% All facilities fully owned (i.e., not subcontracted) 7% 1% Storage capabilities 10% 0% Process development capabilities N/A N/A Analytical method development, qualification, and validation N/A N/A Regulatory support for filing IND or NDA N/A N/A Figure 1 Source: Industry Standard Research, CMO Quality Benchmarking Report Suite (2017)

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