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CMO 2017

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By K. Hammeke PHARMA INDUSTRY LACKS CONSENSUS ON KEY ATTRIBUTE OF A SPONSOR-CMO RELATIONSHIP INDUSTRY STANDARD RESEARCH Report LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 34 and Western Europe (27 percent); a small proportion are based out of the Middle East and Japan (2 percent). Interestingly, four out of five respondents mentioned the company they work for has a large molecule offering; in fact, most respondents work at companies that currently have both marketed biologics and biologics in develop- ment (57 percent). All this is to say, the data that identifies the CMO Leadership Award winners comes from a well- qualified group. To help Life Science Leader's readers understand more about these industry peers, ISR asked participants in the research to prioritize a list of metrics as "Top 5" and the "Most Important" when it comes to selecting a contract manufacturer. This information will help new outsourc- ers know which attributes have contributed to successful outsourcing relationships in the past, and it will help experienced outsourcers identify CMOs based on infor- mation from peers who share their same outsourcing priorities. This can be especially important when there is a lack of consensus around the most important attribute for a CMO to possess. For the second year in a row, A Strong Regulatory Track Record topped the list as the most important attribute influencing CMO selection according to 12 percent of respondents and was in the top 5 selection criteria for one- third of respondents. The Proven Ability To Manufacture API/The Dosage Forms We Require placed second with 11 percent of respondents indicating this is the most impor- tant selection criterion and one-quarter of respondents including the attribute in their top 5. With 10 percent of the vote, Reliable, On-Time Delivery netted third position for the most important selection attribute and captured 37 percent of respondent votes as a top 5 selection attri- bute. Following closely at 9 percent and in fourth place for the most important selection attribute is a Track Record For Meeting Quality Performance Metrics. This attribute was among the top 5 for 28 percent of respondents. After these first four attributes, which were each deemed the most important criterion by ~1 in 10 respon- ver the past several decades, the practice of outsourcing has evolved from transac- tional, client-vendor relationships where cost savings were the primary focus, to preferred provider relationships with pre-vetted compa- nies to start up projects quickly and then to relationships more strategic in nature to gain access to technologies, skills, or expertise not possessed in-house. Regardless of your level of outsourcing experience and approach, it is important to know there are tools available to make this time-consuming and complex process of selecting and vetting a manufacturer simpler and more effective in meeting your needs for a qualified supplier. Life Science Leader's annual CMO Leadership Awards is one of these tools. The data — collected by Industry Standard Research, a full-service market research provid- er to the pharma and pharma services industries — that serves as the foundation for the awards is experience- based and brings an important component into the CMO selection process: how the CMO performed for its cur- rent and recent customers relative to their expectations. While the adoption and implementation of outsourcing strategies is diverse, feedback from peers on their expe- riences when working with specific manufacturers is inherently valuable for guiding your own CMO selections. The 2017 CMO Leadership Awards result from the feedback of 339 industry peers and reflect 1,755 ser- vice encounters with more than 80 CMOs' offerings, including drug substance (small molecule and biologic) and drug product manufacturing activities. ISR screens for involvement with outsourced manufacturing and/ or decision-making influence on contract manufacturer selection to ensure the respondent group is relevant for providing feedback on outsourced manufacturing activi- ties. This year, the respondent group includes 44 percent of participants from large biopharma (R&D $1B+) compa- nies and 56 percent from small and midsize biopharma companies. The majority of respondents work for com- panies headquartered out of North America (71 percent) Pharma Industry Lacks Consensus On Key Attribute Of A Sponsor-CMO Relationship K A T E H A M M E K E O

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