Life Science Leader Magazine Supplements

CRO Guide 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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Page 19 of 45

CROs OUTSOURCING LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 18 IS TRUE STANDARDIZATION JUST A DREAM? Paul Colvin, EVP, global clinical devel- opment for PPD, believes the time to change is now because the industry continues to see increased complexity, rising costs, and greater pricing pres- sures. According to Colvin, CROs and pharma must find ways of partnering to bend the cost and time curve. Competition in our business is normal and healthy. However, we should not compete around things like stan- dardization of metrics and definitions, because that only drives inefficiency, duplication, miscommunication, and significant costs. The real competition should be around the best molecules, the strongest talent, and the creation of a system-agnostic development process that supports the seamless integration of best-in-class technology and disruptive innovations. But CROs cannot do it alone. It must be a collaborative effort across the entire drug development industry. It is our joint mission to improve the health of patients and lower the cost of development PAUL COLVIN EVP, global clinical development for PPD Colvin would like to see a level of stan- dardization throughout the industry that would allow everyone to use the same set of metrics and definitions, which he says will allow for faster and better data integration and will set a clear baseline across all trials for improved predictive analytics. But is it possible to accom- plish that true standardization? The idea of a total integration is far toward strategic partnerships. Those partnerships have obviously pushed millions of dollars into the CRO space and made sponsors more dependent on CRO services. But can all of this growth in the CRO industry continue? The largest growth right now seems to be in the biotech space, but the main factor poised to drive CRO growth in the future is wheth- er or not service providers can adapt to pharma needs in the future. In fact, this concept of identifying and provid- ing services for the future needs of the biopharma industry is exactly what will keep the CRO industry growing. Solomon Babani, global VP, alliance management for Covance, believes there are hurdles CROs will need to overcome. In talking to biotech firms, he has found many of them do not believe the larger CROs have what it takes (or really care) to engage profitably with smaller companies. He now spends a lot of his time educating these companies not only on what they should be asking for, but how to ask for it. CROs have the capability to put funda- mentally different types of teams in place; they just need to understand the needs of their clients," he says. "We can customize a program to meet their development needs as long as companies are able to articulate what they need. The ability to put these teams in place has been enhanced by the ability of CROs to attract top talent. Now that CROs have that expertise, they are better able to design development programs for companies of any size. SOLOMON BABANI global VP, alliance management for Covance he world of clinical trials is changing. New technologies are changing how trials are performed. The internet and social media have enabled greater patient connections, which will continue to change how patients are recruited. And Big Data, genomics, biosimilars, and precision medicine will change the industry in still unknown ways. With all of the clinical work being outsourced, there is no question these changes will affect CROs as well. In fact, it makes you wonder what exactly the CRO of the future will look like. Our world has changed, and our way of getting the work done has changed. CROs started off as companies providing services for pharma companies in areas where they did not have a lot of volume. But since then they have transitioned more to providing services in niche areas, such as biostatistics, preclinical toxicity development, and assay testing. When these companies started spreading across the world, greater collaboration with Big Pharma companies came with that expansion. Nowadays they can even help companies to commercialize their prod- ucts. We have gotten to the point where there is almost nothing they can't do. ANDREW LEE SVP, head of global clinical trial operations at Merck, speaking at Disruptive Innovations 2015 When major consulting firms started advising pharma companies to focus on their core competencies, that led many to strip down to just R&D, which consequently created the current trend T By E. Miseta WHAT WILL THE CRO OF THE FUTURE LOOK LIKE? What Will The CRO Of The Future Look Like? E D M I S E T A Chief Editor, Clinical Leader @EdClinical

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