At the 2014 DCAT (Drug, Chemical and Associated Technologies Association) meeting in New York City last week, consultants and speakers from industry and the regulatory world discussed some of the change taking place in the pharmaceutical industry, and what companies should be ready for. The clear message: Clinging to the status quo, and remaining on autopilot is the way to extinction.  
 
Risk management and a focus on innovation, quality and patient outcomes will be critical to future success, as will proactive partnering from the earliest stages of pharmaceutical and biopharmaceutical R&D.
 
Here’s a brief summary of some of what speakers on the program’s PharmaChem Outlook had to say.
 
On the broadest level, said Roger Green, founder and CEO of Roger Green and Associates, the drug industry is being driven by larger social and healthcare issues, rather than defining them, as it did in the past.  “Pharma’s no longer the center of the healthcare universe,” he said.  And that statement applies, not only to the U.S., now wrestling with the impact of “Obamacare,” but all over the world, where drug pricing and availability are key issues. 
 
Payers wield more clout than ever before.
 
Green discussed what new U.S. healthcare options mean for drug companies, analyzing insurance coverage for three patients from different economic groups in different parts of the country.
 
Globally,  “pharmemerging markets” continue to grow in importance, and will represent over half the small-molecule generics market by 2017,  said Graham Lewis, VP Europe of Global Pharma Strategy with IMS Health.  
 
Pharma and bio companies cannot approach markets monolithically, speakers emphasized, given differences in demographics and market needs.  The developed nations, where populations are aging and birth rates trending down, tend to prefer the cost advantage of unbranded generics, where, in contrast, developing markets, driven by a growing and increasingly affluent younger population, prefer branded generics. The concept of quality is critical to these newer pharmaceutical markets, Lewis said.  He also emphasized the importance of focusing on unmet needs, rather than marginal replications, in any effective strategy.
 
Some quick sound bites from the program?
 
·      Small and midsized pharma companies are proving the most agile and innovative in today’s environment
 
The 10 fastest growing innovator companies in pharma today are outside of the Big Pharma world: Vertex, Reckitt Benckiser, Actelion, Celgene, Gilead, Endo, Shire, Chiesi, Otsuka and Hisamitsu, noted IMS Health’s Lewis.
 
 
·      Partnering will be critical to any corporate strategy, as will studying drug effectiveness, based on real patient outcomes, noted Priya Chandran, partner and managing director with the Boston Consulting Group, who also discussed gaging the value and effectiveness of pharma R&D.
 
 
Chandran pointed to Sweden, which measured healthcare performance and made data public, creating incentives to improve outcomes.  Those hospitals that had the lowest ratings made the most dramatic improvements, Chandran said, suggesting that “what gets measured gets done.” 
 
This environment of measured outcomes is a “new ecosystem in which pharma needs to participate,” Chandran noted.
 
At DCAT, FDA officials and observers also discussed recent regulatory changes and plans within the Agency, including Ilisa Bernstein, Deputy Director of FDA’s Office of Compliance, who discussed her office’s priorities and focus, LINK
http://www.dcat.org/Public/Pdfs/DCAT%20Week%2014/slides/BERNSTEIN%202014%20DCAT%20FINAL%2031014%20.pdf
 
 
Brian Hasselbach, Acting Director, Division of Policy Collaboration and Data, Office of Manufacturing and Product Quality, Office of Compliance, who discussed the FDA’s new office of Drug Quality LINK
http://www.dcat.org/Public/Pdfs/DCAT%20Week%2014/slides/Brian%20Hasselbalch%20FDA%20OPQ%20overview%2011March2014%20to%20DCAT%20NYK%20final-noNotes.pdf
and Consultant Vince Ventimiglia, who discussed new serialization and traceability requirements.
 
http://www.dcat.org/Public/Pdfs/DCAT%20Week%2014/slides/Vince%20Ventimiglia%20Slides%203.7.14.pdf
 
 
We will be covering these programs in greater depth in our next print issue and online, so stay tuned.