spacer
home > white papers > Clinical Trials in Emerging Markets: Goldmines or Landmines? - Pharm-Olam, LLC
WHITE PAPERS
logo_Pharm-Olamo.jpg

Pharm-Olam, LLC

phone +1 (713) 559-7900
email info@pharm-olam.com
web http://www.pharm-olam.com
email 79 T.W. Alexander Drive Building 4401, Suite 240, Research Triangle Park, NC 27709

Clinical Trials in Emerging Markets: Goldmines or Landmines?

Over the past decade, biopharmaceutical companies have increasingly turned to emerging markets as a way to reduce clinical trial costs and timelines. Areas such as Eastern Europe, India, and Latin America—with their ready population of treatment naïve patients—can be an answer to the intense competition for patients seen in developed markets. Many of the countries within these regions may now be considered as “emerged” countries but yet, conducting trials in these regions does require some special attention and expertise. Before deciding to conduct studies in these areas, companies should have a full appreciation for the ethical, medical, regulatory, legal, and operational hurdles that must be surmounted for success. Here we highlight a number of those issues and offer our recommendations for how sponsor companies can deal with them effectively.

The Allure of Emerging Markets Sponsors’ interest in emerging markets as loci for clinical trials has been mounting for at least a decade. (See Figure 1A and 1B.) In 2011, this phenomenon reached a tipping point: for the first time, more data were submitted to the European Medicines Agency in marketing-authorization applications on patients from outside of Europe and North American than from within those areas. While the “Rest of the World” designation includes some mature markets such as Australia and Japan, there is, nonetheless, a clear takeaway: emerging markets have become a hot bed of trial activity.

Clinical Trials in Emerging Markets: Goldmines or Landmines?
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Breakthrough in the global battle against polio: AJ Vaccines granted WHO prequalification for new polio vaccine

Despite ongoing concerted efforts to eradicate polio, it appears to be on the rise again with more cases registered in 2019 than 2018. Looking ahead, AJ Vaccines’ dose sparing technology provides a significant opportunity to expand supply, with the potential to deliver up to 100 million doses over the five-year period 2020-2024 to help meet the currently unmet global demand for inactivated polio vaccines.
More info >>


White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
More info >>


Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement