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European Pharmaceutical Contractor

Immune Response

EPC: What was it that initially attracted you to the pharmaceutical industry?

Cynthia Dukes: I did not intentionally seek out a career in pharma. As a mid-level practitioner at a family medical practice, I was searching for a new opportunity, and took a position at Baylor College of Medicine, US, overseeing a clinical research team targeting vaccines and infectious diseases. From there, a colleague left for a pharmaceutical R&D role and returned a year later offering me a job at their firm as a clinical research associate and clinical research manager. Since then, I have taken on positions of growing responsibility within the pharma and CRO industries, culminating in my current role as Vice President, Global Project Management.

What does your job involve and how has it changed in recent years?

Through the many years I have spent in pharma, my job has evolved from working in small companies – where one wears many hats – to working in a large, global CRO in a more specialised role. The chances to learn and progress in the 1980s and 1990s afforded one the opportunity to have a much broader knowledge of the complete drug development process than someone starting out in the industry today.

In my current position, I am responsible for the therapeutic areas of infectious disease, vaccines, rare disease and women’s health. I also oversee project training and provide advice in my range of specialities.

Professionally, what has been your proudest moment?

Due to the number of years I have spent in the industry, I have had several ‘proudest moments’. The first few are related to five product approvals where I was either the Product Manager or Clinical Lead for the development.

More recently, I was extremely proud to be recognised as one of the world’s 50 most influential people in vaccines, in a 2014 industry survey conducted by Vaccine Nation. This also led to ICON receiving the Best Vaccine CRO accolade at the World Vaccine Congress’s Vaccine Industry Excellence Awards.

You have over 30 years of clinical research experience – what are the most common risks associated with vaccine studies?

Vaccine studies generally do well once they make it to clinical trial; however, in this age, the diseases which we are developing vaccines for tend to be rarer or emerging, which requires creative execution approaches, especially in developing regions. When designing and implementing efficacy studies, numerous and unique associated risks must be identified, and contingencies established and implemented early, in order to ensure a successful study.

How can new technologies help the industry overcome vaccine development challenges?

There are many technologies being developed or applied that can speed up the progress of new and effective vaccines; improve distribution relative to cold chain management; and increase the ultimate uptake as a result of novel methods of drug delivery (orally or via a skin patch, for example). Over the next decade, we should see these technologies drive much advancement in the area.

And what advice would you give companies in speeding product approval?

Vaccine development can move at a relatively fast speed compared to many other pharmaceuticals. To do this, it is critical to have proper planning, good regulatory communications and exceptional quality in the execution of the plan.

How is ICON unique in supporting clinical development?

The company has a dedicated group for the delivery of vaccine studies to the industry. Quality of execution, on-time delivery and completion within budget is supported by the active engagement of our Vaccine Center of Excellence and innovative technologies.

Which vaccination areas do you think need greater focus in the next few years?

Over the next few years there will be more attention given to vaccines for adults, and emerging diseases and markets. As they are currently in their infancy, going forward, there will also be greater application of therapeutic vaccines.

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Cynthia Dukes is Vice President, Global Project Management at ICON. During her 13 years with the company, she has been a significant contributor to the therapeutic areas of oncology, vaccines, infectious disease, women’s health and rare disease. Cynthia has participated in the development of more than 40 investigational new drugs, leading to eight product approvals.
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