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Issue link: https://lifescienceleadermag.epubxp.com/i/111709
When Performance Matters ��� Choose Quorum Review IRB ��� AAHRPP Accredited ��� Privately-held Central IRB ��� 14 Board Meetings per week ��� 24-Hour Site Start-Up ��� 36-Hour Amendment Review ��� Same-day Site Changes ��� 100% Quality Control ��� Oncology Board based in Cambridge, MA ��� U.S. & Canadian Review ��� Secure Portal ��� Smart Forms ��� Study Support Available 8AM-8PM ET For IRB resources, news and events, visit QuorumReview.com 877-472-9883 8 The CRO Leadership Awards 2013 Contract Research Organizations According to John Hubbard, senior VP and worldwide head of development operations for Pfizer, the move to partner with fewer CROs was intended to provide the company���s collaborators with a significant volume of work on which to focus their attention, thereby increasing their accountability and, hopefully, their productivity. ���The industry as a whole had been very capital-intensive in terms of the amount of money spent versus each dollar received,��� stated Hubbard. ���We thought we should be able to get a higher efficiency against the amount of capital we spent.��� The pharmaceutical industry had one of its most productive years in 2012, with 39 FDA approvals. But the improved productivity came at a very high cost. Novartis for example, estimates the company���s R&D; costs to average $3.9 billion per new drug, which is obviously not sustainable. Companies are seeking a variety of means with which to reduce costs, while increasing productivity. CROs are playing an ever-increasingly important role. But outsourcing your clinical research, and placing more projects with fewer providers, entail greater risk. To discuss that theme, Life Science Leader reached out to eight industry experts to gain their insights. Their expertise ranges from virtual biotech up to and including the largest pharmaceutical company in the world. Armed with their wisdom, you should be better equipped in developing CRO strategic partnerships ��� whereby the CRO functions as a true extension of your internal team. The panel includes Dr. Kenneth Burhop, chief scientific officer, Sangart; Carolyn Green, president and director, Atreaon; Jim Hauske, president and founder, Sensor Pharmaceuticals; John Hubbard, senior VP and worldwide head of development operations, Pfizer; Mitch Katz, executive director of medical research operations, Purdue Pharma; Mary Rose Keller, VP of clinical operations, Sangart; Thomas Wessel, M.D., Ph.D, consultant and former chief medical officer, Acorda Therapeutics, Inc.; and Leslie Williams, president, CEO, and founder, ImmusanT. WHAT IS THE BIGGEST NEGATIVE PERCEPTION CROs SHOULD WORK TO OVERCOME? Carolyn Green, Atreaon: Smaller companies need to assure their clients that their facilities have a level of quality that ensures the work is well-controlled, repeatable, and documented in a sufficiently detailed and timely manner. This is necessary to overcome the perception that non-Good ���X��� Practice facilities, (i.e. GMP, GLP, GCP) are ���free-for-alls��� with little control and no layers of oversight. Take the time to explain what you do to ensure the quality of your work and the accuracy of your data. Large CROs need to overcome the perception held by small venture-backed firms that because we are small, and only have only a few projects, we might not get the same time and attention as larger firms with more projects. Large CROs need to demonstrate that the teams responsible for all the great data of the past are still around. Otherwise, you are wondering if you are getting new recruits who have never run a particular model before. John Hubbard, Pfizer: All CROs should seek to understand their customer product portfolios, needs, and challenges. They need to move away from transactional selling of services to a more solution-based approach. Many CRO teams still ask the sponsor ���tell me what you want��� as opposed to providing options and alternatives to the challenges we face in managing our clinical development portfolios. CRO leadership needs to invest in the education of their teams regarding the changing philosophy of outsourcing, and what it means to the way they work and interface with sponsors. There is still a disconnect in all large CROs that creates unnecessary friction as teams learn to work together. Change management training needs to occur in the sponsor organizations as roles shift from being ���doers��� to subjectmatter experts, area leaders, and project managers. Encourage open communication, set clear expectations, and build trust within these virtual teams.