CROs and Their Role for Nano-rare
December 14, 2022
“Clinical research organizations help service the nano-rare community”
We’d like to thank our partner and sponsor, Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services. Parexel provides clinical operations, real-world data solutions, medical and regulatory expertise and innovative clinical research tools that significantly enhance and streamline n-Lorem’s therapeutic development efforts. Their depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, like rare disease.
Jamie Macdonald, CEO of Parexel, joins Stan to discuss the moment he realized his desire to make a difference in therapeutics, Parexel’s role in clinical trials and their critical partnership with n-Lorem aimed to serve patients.
On This Episode We Discuss:
- Jamie’s motivation to help make a difference in therapeutics
- Relocating to the United States and his career path that led him to Parexel
- The numerous challenges of conducting clinical research trials
- R&D industries are changing to support smaller patient communities
- The shared mission between n-Lorem and Parexel
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Jamie Macdonald, the CEO of Parexel, realized that he wanted to play a larger role in helping create new and better therapies for patients after he tragically lost both of his parents to cancer. He entered the clinical trials industry in an unusual way. After growing up in a rural area in the UK, he obtained his degree in economics at Heriot-Watt University in Scotland and in 1994 became a chartered management accountant with Syntax, now acquired by Rosche. Jamie always had an interest in science and even though he pursued a role in finance, Syntax’s integrated development site operated preclinical and clinical studies, manufacturing, pharmaceutical sciences, and regulatory affairs all in the same area, allowing him to grasp an all-around understanding of the industry. Jamie transitioned into operations and project management of multiple phases of clinical trials, and held several senior leadership roles for Quintiles and INC Research before becoming CEO of Parexel.
Parexel is on the service side of the industry and provides organizations with clinical operations, real-world data solutions, medical and regulatory expertise and innovative clinical research tools. Their involvement with both first in-human and patient studies help prove the safety and efficacy of new therapies at a large enough scale to be statistically significant to support registration and market authorization. With over 20,000 experts around the globe, they are one of the world’s largest CROs.
Parexel entered the rare-disease space as a business opportunity and with an organizational motivation to help these underserved patients. Jamie notes that the drug development industry was designed for large disease populations and alienated those in the minority. Now, with the continuing progression of science and the drug discovery and development industry, personalized medicine is the future. A greater understanding of biology and genetics, paired with evolving technology, and infrastructure set in place by regulatory agencies, now allows organizations the opportunity to treat thousands of rare-disease patients over the next decade.
n-Lorem’s partnership with Parexel is vital for treating nano-rare patients. In 2022, n-Lorem, with support from Parexel, remarkably filed four investigational new drug (IND) applications, which have all been approved. Those personalized medicines will be administered to four patients that have hope for a better life.
Jamie Macdonald is Chief Executive Officer of Parexel. He has more than 25 years of experience in leading global biopharmaceutical services companies.
Prior to joining Parexel, Jamie served as Chief Executive Officer of INC Research, now known as Syneos Health, from January 2013 through September 2016, where he led the company through a successful Initial Public Offering in 2014. He also served as INC’s Chief Operating Officer from July 2011 through December 2012, and previously held several leadership positions in the biopharmaceutical services industry, including Senior Vice President and Head of Global Project Management at Quintiles, now known as IQVIA. Prior to this, he held various senior operational and finance roles at Quintiles. He has previously served on the Board of Directors for the Association of Clinical Research Organizations (ACRO) and as its Chairman in 2015. Jamie’s recent experience also includes serving as Chairman of the Board for Certara, a drug development consultancy with solutions spanning discovery, preclinical and clinical drug development, from 2017 to 2018.
Jamie began his career in the pharmaceutical industry with Syntex Corporation (acquired by Roche Holdings, Inc.). A native of Scotland, he holds a B.A. in Economics from Heriot-Watt University in Edinburgh, Scotland and is a qualified Chartered Management Accountant (ACMA).
Visit Parexel on LinkedIn www.linkedin.com/company/parexel/
Hosted by: Dr. Stan Crooke.
Videographer: Jon Magnuson of Mighty One Productions.
Producers: Kim Butler, Colin Delaney, Kira Dineen, Jon Magnuson, Andrew Serrano and Amy Williford.
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