The effects of technological advances and an uncertain political environment were the focus of this year’s Illinois Biotechnology Innovation Organization (iBIO) Industry Expo (IndEx).
The meeting featured speakers from a variety of industry perspectives, including policy experts (such as Stephen Ubl, president and CEO of PhRMA), investors (such as Lester Knight, founding partner of RoundTable Healthcare Partners), pharmaceutical leaders (such as Timothy Walbert, chairman, president, and CEO of Horizon Pharma PLC), and start-up founders (such as Harry Rowland, PhD, co-founder and CEO of Endotronix).
Each year, the iBIO IndEx aims to bring together members of the Illinois life science community. Said John Conrad, executive vice president and corporate secretary of iBIO:
“The iBIO IndEx theme, Converge to Emerge, reflects a strong a call to action—a call to collaborate for the continued advancement of our exciting industry.”
Technological Advances and the Potential of Data
Much of the day’s discussion focused on the advances made possible by new methods of data collection, management, and analysis. Biotech executives identified several key challenges in using data collection to advance treatment and medical device approvals.
Working Across Internal Silos
The first panel of the day began with discussion about overcoming organizational barriers to the improved use of data. All panelists identified centralization of data management as a key trend in the industry.
Tony Hebden, vice president of health economics and outcomes research at AbbVie, elaborated on this trend. At AbbVie, data analysis has been moved above the level of individual organizational structures, allowing data to be incorporated into overall organizational planning. Although specialization is tempting, Hebden advises industry players to “keep fighting that desire to split into silos and focus on pooling people together.”
Data Analysis Talent Is in High Demand
Walt Johnston, senior VP, sales & marketing, urology and hospital markets, Astellas Pharma US, stated that there is currently a gap between the demand for data analysis talent and the number of people with the appropriate skill sets, a sentiment echoed by other panelists.
All panelists agreed that the analysis of real-world evidence (RWE) presents unique challenges. RWE naturally produces data that reflects the effects of drugs and devices in actual patients but, as Hebden warned, RWE is rarely as clean as the data collected in controlled clinical trials.
This limitation, coupled with the difficulty of consolidating data from multiple sources, culminates in increased demand for skilled analysts. Some companies are forced to outsource their analysis for the simple reason that they do not have the internal expertise to generate insights from their own data sets.
The panelists were largely in agreement on the solution: internal talent must be built over time. Hebden said, “We’ve got to be looking to the future instead of one, two, or three quarters ahead.” Johnston agreed, saying, “I think it’s critically important to invest in long-term capabilities.”
Scattered Sources of Real-World Evidence
Although the United States still produces the majority of data, there are significant international efforts at data collection. At the same time, data generated within the United States can be fragmented. Jeff Morgan, specialist leader at Deloitte Consulting LLP, pointed out that many organizations are not even aware of the databases they have at their disposal.
The wide variety of databases available is a relatively recent development, and most organizations still draw on the same data sets. As RWE data becomes available from more sources, organizations will need to devote resources to ensure data quality. These challenges, and the inherent restrictions of RWE, mean that collaboration will become increasingly important for the effective use of data in planning therapeutic approaches and guiding business decisions.
Increasing Collaboration in the Life Sciences
When Stephen J. Ubl, president and CEO of PhRMA and the top lobbyist for drug makers, took the stage, he had a clear message: Drug and device approvals take too long. The life science industry produces life-changing advances, and we need to better communicate the value of that science.
Much of the industry advancement will be driven by collaboration. From a data management perspective, partnerships with international and domestic organizations will enable improved data sharing and analysis.
From an R&D perspective, acquisitions are an important ingredient for scientific advances. As the science becomes increasingly complex, even large pharmaceutical organizations are missing in-house capabilities. Acquisitions and partnerships serve to grant access to those capabilities.
Partially for this reason, panelists lauded the Chicagoland life science ecosystem. Timothy P. Walbert, chairman, president and CEO of Horizon Pharma PLC, commented that the Midwest has three critical components of an innovative atmosphere: cutting-edge academic science, venture capital, and entrepreneurs with experience bringing drugs and devices to market.
Finally, collaboration is increasingly important in the face of uncertain policy.
As members of the global community, international organizations are affected by international events. Supply chains and substantial markets exist overseas, and global collaboration will be necessary to respond to events, such as Brexit, and maintain a presence in overseas markets.
Domestically, collaboration and negotiation can help facilitate beneficial policy change. Ubl proposed several avenues for reducing drug costs, from value-based contracting to reduced regulation of generics and “modernization of the FDA.” Pharmaceutical and medical device companies will need to collaborate with each other and policy makers in order to reach agreeable regulations.
Ubl’s talk, and much of his panel discussion, raised a provocative question: “why isn’t the industry doing a better job telling its story?”
With collaborative initiatives such as Go Boldly, industry leaders seek to communicate the incredible scientific advances being made in today’s laboratories and clinics. Telling the story of science will remain a collaborative effort, one crucial to the policy discussions in Washington.
Wavering Policy Generates Apprehension
Of course, the day would not have been complete without discussion of changing and uncertain policy. Attempts to repeal the Affordable Care Act will undoubtedly affect organizations and investors, as will the potential for regulatory change under a new FDA head.
The political climate is likely to stabilize eventually, but the current uncertainty is casting ripples throughout the industry. Walbert astutely noted that mutual fund investors and generalists are quick to sell; because they do not see the inner workings of the industry, they are likely to drop stock as uncertainty rises. Of course, this leaves a much smaller pool of investors in the know.
Scott Whitaker, president and CEO of AdvaMed, commented on the likely effects of uncertainty: “The worst thing about uncertainty is that it does not incentivize innovation in the system.”
Lester Knight, founding partner of RoundTable Healthcare Partners, echoed this sentiment, saying, “If you’re looking as an investor, uncertainty is the worst thing you can have.”
The industry already faces long timelines for return on investment, and increased political uncertainty is likely to generate apprehension among venture capitalists. Especially for early-stage investments, VCs are more likely to try their hand in arenas such as tech, where return is somewhat faster and lower risk.
Despite this apprehension, conversations tended to err on the side of optimism. Regulatory agencies are unusually open to communication, and there is hope that adopting new policies can help combat both increasing time to market and rising drug prices, hot political topics.
Although the consensus seems to be that R&D transparency, imported drugs, and Medicare negotiations are not effective policy, value-based pricing, reduced cost of generic approvals, and changing agreements with third parties have been advanced as potential avenues for change.
Ultimately, each of these topics interact; data collection and analysis will require increased collaboration, but a more precise understanding of results may aid in facilitating clinical trials or implementing value-based pricing. Policy questions have yet to be answered, but access to data and shared resources enable the industry to advance its aims from a powerful position.
Disclosure: CG Life was a sponsor of iBIO IndEx.