Recently Fundamentals of Clinical Outsourcing Certificate Program speaker Scott Sawicki, the Director/US Head, Outsourcing Management, at Novartis Pharmaceuticals sat down to to share with us how he has seen outsourcing change in the recent past, the trends developing, innovation in research and development, the sustainability of research and development and more.
How has the outsourcing function changed within the pharmaceutical industry within the last 5-7 years?
With the increase of patent cliffs in the last decade and Pharma companies restructuring as a result, companies are scrambling to contain costs while at the same time trying to reinvest in R&D and also meet investor expectations. As a result, some companies have decided to increase their clinical outsourcing while minimizing the need to increase internal overhead. Also, change in management has also determined how the change in outsourcing has impacted Pharma companies. For example, the philosophy of one company to outsource their entire portfolio to several different partners make work today, and if that regime of management leaves and the new management believes that working with multiple service providers at a functional level versus a full service level will change the way that companies outsources. When these trends If occur across the Pharma landscape, CROs will see Pharma companies going through cycles of outsourcing paradigm shifts.
What trends are you seeing within Big Pharma and why are they developing that way?
Scott: The trends in Big Pharma are ‘do more with less while at the same time do not compromise time and quality’. One of the reasons is the rise in patent cliffs and the need to contain costs. Big Pharma need to meet the needs of investors while at the same time reinvesting their profit into R&D. Also companies are scrambling to invest to look into ‘first in class’ products to stay ahead of their competition. By doing this, companies are looking to partner with CROs in a ‘soup to nuts model’: from pre-clinical through submission, so that there is business and science continuity throughout the lifecycle of the product and indications. This model has benefits to both the sponsor and CRO as both have the ability to increase productivity while at the same time contain costs.
With sustainability of the R&D business in question, how are pharmaceutical companies responding to the need for clinical innovation?
Innovation is hot trend in the industry. Companies are continuing to look at different ways to reinvest into R&D and getting drugs to market quicker and faster, while at the same time maintaining the integrity of the clinical R&D process and meeting the requirements of the health authorities, without compromising quality and patient safety data. Advances in technology from drug delivery, biosensor and tele-health systems have led to this paradigm shift. Also, companies like Google and Microsoft have entered into the Pharma R&D business partnering with Pharma, looking taking advantage of their innovation methodologies. Crowdsourcing, the practice of obtaining needed services, ideas, or content by soliciting contributions from a large group of people, and especially from an online community, rather than from traditional employees or suppliers, has led to the increase of innovation to Pharma companies. There term has been around for almost a decade, but you would never hear about this is Pharma R&D until the last few years. Pharma companies are participating in these different types of forums in order to increase innovation and partner with service providers who they may not have had any interest in the past. And finally, as there are shifts in technologies, companies are looking into novel settings to run their clinical trials. Universities, medical schools, virtual settings, shopping malls, optical centers, commercial pharmacies, visiting nurse networks are just a few different avenues on novel settings which could be considered. These approaches could combine different settings to run and participate in clinical trials.
What are you most looking forward to at the Fundamentals of Clinical Outsourcing Certificate program?
I am looking forward to participating as a speaker in this program, and at the same time partnering with my colleagues from different companies to give something back to those folks who are new in the clinical outsourcing arena. I am looking forward to sharing my experiences with the attendees while at the same time sharing new ideas. I also look forward to meeting attendees who are new to the clinical outsourcing space and including them into our clinical outsourcing network.
Meet Scott at the Fundamentals in Clinical Outsourcing Certificate Program which will take place March 30-31 in Las Vegas. As a reader of this blog, when you register to join us and mention code XP1901BLOG, you'll save $100 off the current rate.
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