By Ed Miseta, Chief Editor, Clinical Leader
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Pravin Jadhav has spent his entire career in the world of drug development. In 2003 he started working for the FDA as a research fellow in the Office of Clinical Pharmacology, eventually being promoted to Pharmacometrics team leader and Expert Regulatory Scientist. After that he spent four years at Merck in Pharmacology and Pharmacometrics before joining Otsuka where he now serves as Senior Director of Applied Innovation.
Jadhav was a featured speaker at the recent CNS Summit in Boca Raton, and we took that opportunity to talk to him about innovation in the pharmaceutical industry, and how companies can best acquire and implement new solutions.
Ed Miseta: What topics did you address at the CNS Summit?
Jadhav: I spoke on the topic of acquiring and implementing innovation and how pharma companies can make clinical trials and clinical development faster, better, cheaper, and smarter. As we all know, pharmaceutical drug development is a long and costly process. Unfortunately, even companies that have experienced success with drug development in the past are not assured of success in the future.
In the last few years, digital integration has opened new opportunities for clinical care and pharmaceutical development. However, a company needs to put ideas into action as well as manage the overload of ideas. At Otsuka, we strive to avoid shiny-object syndrome. We want all innovation to be tied to three key concepts: IDEA, ACTION, and VALUE. I also discussed our innovation process and how that puts ideas into action to create pilot opportunities and eventually realizing value through business transformation.
Miseta: How do you believe digital integration is improving clinical trials and clinical development?
Jadhav: While innovation is not limited to digital opportunities, there are several opportunities for the pharmaceutical industry to create value through digital integration. For me, the digital integration opportunities generally present in four areas when we look from an end customer viewpoint to receive a product or service. The four areas are:
- Specialization only due to access years of experience
With that framework in mind, digital integration has the potential to transform businesses from a company that puts a pill in a bottle to a company that provides therapeutic solutions to the patients prescribed its products. There are five major areas that can be impacted in a positive way by digital integration. We would hope to see better trial execution, better insights, better differentiation, improved therapeutic performance, and digital therapeutics.
Miseta: What is the core innovation process, and can you provide any examples of innovation focus?
Jadhav: Our core innovation process is centered on ideation, pilot, and business as usual – with a keen focus on what will deliver the biggest impact to our stakeholders (i.e., patients, HCPs, caregivers, business functions, etc.). Essentially, we receive several ideas or proposals from internal and external collaborators. In the last three years there have been over 300. Through a cross functional network, we prioritize a few of these to be piloted. We have implemented more than 40 pilots in the last three years. Our view is that those ideas, if the pilots are successful, will become business as usual at some point in the future. When it comes to clinical trial innovation, these opportunities were in areas such as siteless (decentralized) trials, digital biomarkers, recruitment, operations, and trial design.
Miseta: What are some challenges and lessons you’ve learned in acquiring and implementing innovation in pharma R&D?
Jadhav: The first challenge in acquiring and implementing innovation in an established industry such as pharma is the education and acceptance of value at levels within the organization. Here I am referring to things such as culture and organizational fitness. As others have often said, many industries tend to overestimate the impact of technology in the short term and underestimate the impact it can have on your business in the long term. The observation is certainly valid for the pharmaceutical industry. We divide into two camps at all levels in the organization. The first camp is those who try to overestimate the impending disruption. Those folks typically tend to be the early adopters. While their choice of the problem and the area chosen for the change could be questionable, they see the impending disruption and the impact it can have. On the other hand, there are others who view the early adopters as engaging in a theatrical exercise. They do not see the immediate need for change. Honestly, the answer always lies somewhere in the middle. The key is to create an innovation network that looks at an innovative idea from all levels within the organization. That approach will minimize the chaos caused by those ideas and create a more orderly process, which is something that senior management likes to see.
Another challenge is whether the organization can engage in “ruthless prioritization” versus working on all ideas simultaneously. It is also critical that prioritization be focused on short- and long-term business goals.
The final challenge and lesson learned is what I like to call focused execution. While ideas are great, what matters most is everything that comes after. The real world is a great teacher. How the team learns from and responds to those lessons is what makes the difference between a good idea with great results and a brilliant idea with decent results. The real world teaches about the assumptions as well as things that did not even cross the team’s mind. What we often see is teams changing the target in the face of challenges, rather than remaining laser-focused on outcomes. I discussed an example of clinical trial recruitment where the idea was great but the potential to deliver results was hampered by execution challenges.
Miseta: Any advice for a company that wants to be more innovative?
Jadhav: I think that any company wanting to be more innovative should engage in a “Learn Apply” cycle. I am reminded of Michelangelo and his experience and process in sculpting his masterpiece statue of David. To describe the creative process, he famously said, that he takes a stone block and chips away what doesn’t look like David. There is a lesson for us to learn from that. It is impractical for us to assume that the first test of any hypothesis will be successful and will provide a clear return on investment (ROI). To realize the ROI potential, it is important for us to carry forward the lessons to the next pilot(s). The organizations that support “Learn Apply” cycle will succeed on their innovation journey.