Life Science Leader Magazine Supplements

CRO Supplement 2015

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19 LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2015 COLOMBIA AND PANAMA Be Aware Of Travel Requirements James Bainbridge has been with Prolong Pharmaceuticals for three years, currently serving as associate director of clini- cal development. He has worked in the pharmaceutical industry for just under 20 years, working in a clinical capacity for Covance, Ortho McNeil, Ethicon, and Medarex. He also provided legal sup- port to the New Jersey Office of Attorney General and the U.S. District Court in New Jersey before joining Prolong. How long have you been doing trials in Colombia/Panama? Prolong Pharmaceuticals is developing products to treat anemias and cancers and has a portfolio of hematology and oncology products in development. The company's lead product, SANGUINATE, is in clinical testing and is focused on treat- ing the comorbidities of sickle cell disease and other disorders caused by ischemia, hypoxia, and/or hemolysis. It is the company's research in this area that led it to trial sites in Colombia and Panama. The first trial for Prolong Pharma- ceuticals in this region was in 2012, so we have been performing trials there for just under three years. Personally, I have had experience performing trials in this region for approximately 10 years. We are able to find patients of sickle cell disease not only in Colombia and Panama but also in other Latin American countries. We certainly have those patients in the U.S. as well, but in looking at patient populations, the regulatory environment, and other con- siderations, we felt these locations would work well. Are there specific challenges to performing trials there that are due to the current political climate? The answer to that is no, and I often find people to be a little surprised when I tell them that. Panama has three branches of government, just like in the U.S., and an elected president. I believe Colombia is currently the fastest growing large economy in South America. While Panama does not have issues with stability, there is certainly less infra- structure than you might find in more developed countries. Ensuring ethics committees are compliant with ICH-GCP standards can also provide a bit more of a challenge due to the number of ICH-GCP certified ethics committees that exist in Panama. Editor's Note: Panama was a democ- racy for most of the 20th century until a coup in 1968 brought the military to power. After the U.S. operation to remove General Noriega from power in 1991, the country became a constitutional repre- sentative democracy. The current armed conflict in Colombia started in the 1960s and is a low-intensity war between vari- ous groups including the Colombian government, paramilitary groups, crime syndicates, and left-wing guerrillas. However, Colombia has become much more stable of late. President Juan Manuel Santos Calderon, elected in 2010 and reelected in 2014, has made ending the conflict a priority of his presidency. Getting needed medicines to patients can always be a challenge, but even more so when performing trials in different parts of the world. Were there any supply chain issues you had to deal with? I find this is not an issue in most major cities, particularly in Colombia. That being said, it may be more of a concern in Panama due to a smaller population. However, using a depot is recommended, when feasible, to avoid import delays. Depots can be used for different reasons, but we had multiple centers so we imported drug in bulk to one location. That way we can provide each site with the mini- mum supply we believe is required. If a patient comes in, the drug will be avail- able to them. But if no patients enroll or come in, we can minimize the amount of wasted drug. Once you ship a drug to a site, you don't want it back. By having a depot handle the distribution we can Clinical trials are never an easy endeavor. Issues with patient recruitment, retention, regulatory, supply chain, and a myriad of other reasons present challenges for both pharma and CROs. When performing global trials, many of those issues are compounded as political turmoil could get added to the mix. To gain an understanding of the challenges that exist when performing global trials, we enlisted the help of three experts to describe issues they have experienced firsthand. Our panel consisted of: J A M E S B A I N B R I D G E Associate Director, Clinical Development, Prolong Pharmaceuticals, discussing Colombia and Panama L I N D A S T R A U S E , P H D Principal and Founder, Strategic Clinical Consultants, discussing France E R I N B E T T I N E , M B A , R P H , Founder and Clinical Supply Chain Consultant, Erin Bettine Consulting, discussing Eastern Europe

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