August 9, 2011
Management Implications of the Global Regulatory Environment
BOSTON—Aug. 9, 2011—As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.
"What a company does in one region can very likely affect how regulators treat it elsewhere," said Tufts CSDD Associate Director Christopher-Paul Milne. "Understanding local regulatory requirements and trends, and how competitors' activities are shaping those trends, has become a minimum requirement for engaging in global drug development."
He noted that flexibility may be the decisive success factor when it comes to drug development strategy: "What's true today in the regulatory environment in a particular region may not hold sway when trials are completed in a few years' time, requiring a rapid shift in development strategy."
According to Tufts CSDD, the number of pre-clinical and clinical studies in process around the world grew rapidly during the past decade — from about 4,900 in 2000 to 8,600 in 2010. This, in turn, has stressed regulatory authorities to keep up with added demands relating to monitoring studies and reviewing results.
The industry executives, who met as part of the Tufts CSDD Executive Forum Roundtable, also agreed that:
* Growing global regulatory complexity is generating more data, requiring developers to improve the way they manage information.
* Success of internal regulatory affairs groups will depend on their ability to understand and respond to sometimes conflicting requirements of regulatory agencies and authorities on a global basis.
* Developers need to solicit the views of new stakeholders, including payers and patients, and incorporate those perspectives into drug development programs early to properly define the product development plan.
SCHEDULED TUFTS CSDD EXECUTIVE FORUM ROUNDTABLES
Upcoming Tufts CSDD Executive Forum Roundtable meetings will focus on the following topics:
Sept. 15, 2011 — Designing and Maintaining Successful Innovation Partnerships
Nov. 3, 2011 — Strategies to Optimize Performance and Manage Pipeline Risk
Feb. 23, 2012 — Managing the Transition from Nonclinical to Early Clinical Development
May 17, 2012 — Academic-Industry Partnerships: Opportunities and Pitfalls
To learn more, call 617-636-2170.
ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Contacts: Tufts Center for the Study of Drug Development
Business Communication Strategies