Two of the nation’s largest life sciences conferences are being held this week – and there definitely is no shortage of topics to dig into this year. The Biotechnology Innovation Organization’s (BIO) International Convention is taking place in San Diego, while the Drug Information Association’s (DIA) conference will be in Chicago. Several of my colleagues plan to share some of the industry’s latest thinking in sessions and meetings…and probably during informal coffee break chats, too.
“Breakthrough” is the theme of this year’s BIO meeting, which brings together leaders across the biopharma industry. Life sciences thought leaders will be conferring on a wide range of topics including funding strategies for small biotech companies, drug pricing, and the Food and Drug Administration’s (FDA) new administrator.
In the Windy City, “driving insights into action” is the theme for the DIA 2017 Annual Meeting. The conference will include more than 160 sessions and will host more than 450 exhibitors. The sessions will examine the evolving regulatory environment, including the potential impact of the 21st Century Cures Act (Cures) will have on the industry, pharmacovigilance (the monitoring of drug effects to identify and evaluate adverse reactions), and other issues tied to safety analytics.
I suspect much of the conversation at these two events will revolve around three broad topics:
- Drug pricing, value, and market access
- Real-world evidence (RWE) and the shifting regulatory landscape
- The growing importance of industry partnership and collaboration
Breakthrough treatments that don’t break the bank
At BIO, my colleague Tom Yang is participating in a panel where he will offer his perspective on how biopharma can align breakthrough treatments with innovative reimbursement models to improve value. Ralph Marcello, who leads our BioPharma segment, will also offer thoughts on the drug-pricing debate. He’ll explain how biopharma companies could use value-based contracting – backed by data and evidence – to tie higher prices to higher efficacy. The timing for this discussion could not be better, as the White House discusses plans for a possible executive order on drug pricing. At DIA, several sessions will touch upon 21st Century Cures. My colleague Asif Dhar, MD, will take part in a session that will look at how the Cures law helps lay the ground work for innovation through the adoption of a more patient-centered focus to inform the assessment of benefit and risk.
The Cures law, enacted last December, is already beginning to help alter the regulatory landscape. As the industry strives to meet the evolving needs of stakeholders – patients, providers, and health plans – the regulatory flexibility outlined by Cures will likely be imperative to driving both regulatory approval and market access. Cures, and related FDA guidance, can offer additional flexibility for companies to communicate economic evidence. This could lead to greater adoption of value-based contracting agreements.
Cures, RWE are already helping alter regulatory landscape
Cures includes several provisions intended to modernize drug-development and approval processes. Many provisions build upon existing initiatives and investments at the FDA, which can help create avenues for innovation and regulatory flexibility.
As Cures requires FDA to evaluate the use of RWE to help support faster drug approval of a new therapeutic indication for a previously approved drug, many life sciences companies are evaluating their strategies to integrate RWE into their value chain. Some firms, for example, are targeting the use of RWE to support research and development in areas such as trial design and patient recruitment.
The inclusion of RWE in the new law signals that we may see additions to the traditional gold standard of randomized controlled trials for testing drugs and devices, helping provide opportunities for the industry to innovate.
The plethora of health care data now available to life sciences companies has commonly become an invaluable asset in improving patient outcomes. Traditional data are often being combined with RWE to detect, assess, understand and help prevent safety-related issues and potentially uncover benefits that can lead to better results for patients. Life sciences companies could benefit from identifying ways to eliminate, automate, and simplify operations to help increase compliance, improve productivity, and shift resources from case processing to safety analysis and insight. Deloitte’s 2017 RWE benchmarking study, found that many biopharma companies are starting to invest in RWE capabilities and are exploring a number of use cases.
Life sciences firms will likely expand collaborations
Collaboration between life sciences companies, health care providers, and health plans are likely critical, and will likely continue to evolve. As I noted in a blog post early this year on our 2017 US Life Sciences Outlook, I expect 2017 will be a year of tighter collaboration among health care stakeholders.
Consider this: Our data indicates that about 9,000 new biopharma research and development (R&D) partnerships formed between 2005 and 2014 – at an annual growth rate of 4 percent during that 10-year period. The 9,000 new biopharmaceutical R&D partnerships formed between 2005 and 2014 are more than double the number created (approximately 4,000) in the preceding decade (1995-2004). The consortium model, a more open-source approach to innovation, alone saw a nine-fold increase between 2005 and 2014 versus the prior decade, with 334 new consortia formed, versus just 34 from 1995 to 2004.
Many pharma, biotech, and medtech companies are building new business models and are developing operating strategies based on broad collaborations with other industry players, as well as regulators, academic centers, and small enterprises where new ideas and potentially game-changing innovations are being developed.
If themes for this year’s life sciences conferences are any indication, 2017 will likely be a landmark year for the industry. We’re apt to see new groundbreaking therapies as well as innovations in other areas such as drug reimbursement models, value-based contracting, and collaborations. For our industry, “driving insights into action” and “breakthroughs” are themes that will likely resonate long after the summer life sciences conferences end.