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Siena, a city in Tuscany, Italy and capital of the province of Siena, is one of the nation's most visited tourist destinations, known for its museums, art, cuisine, and famous horse race that’s held twice a year. It is also home to the University of Siena, one of the oldest institutions of higher learning—founded in 1240—and the first publicly funded university in Italy. Today, with an enrollment of 20,000 students, the university is best known for its Schools of Law, Economics and Management, and Medicine.

Brandon Thomas
Brandon Thomas
Senior Writer

It’s in this locale—with its rich, storied past that features a historic medieval cityscape—that an innovative partnership is shaping the future of clinical development and preparing the next generation of leaders in science, research, and medicine.

PRA Health Sciences has forged a unique partnership with the University of Siena’s Master’s in Vaccinology and Drug Development Program. This advanced degree program provides high-level instruction for young doctors, scientists, and related professionals, who will in turn use their training and hands-on experience in clinical development to serve parts of the world that are in desperate need of health practitioners. Students have come from around the globe to participate in this specialized training, including Latin America, Sub-Saharan Africa, India, and parts of Asia.

This internationally recognized master’s degree is offered through the University’s Institute for Global Health. The Institute describes its purpose as providing “specialized courses in select areas of global health, equipping program participants with the practical and professional expertise they need to lead the next generation of scientists, researchers, and health practitioners across the globe.” The Vaccinology and Drug Development Program is specifically designed to attract young professionals from underserved populations around the world.

The challenging program with a rigorous curriculum allows young doctors in medical and biological sciences to develop the skills, scientific knowledge, and practical knowhow to enter this noble field and share their public health expertise in underserved countries that need life-saving vaccines and medicines.

Students in this program have a unique opportunity to lead purposeful lives and serve people in underprivileged areas, many times returning to their own countries with this newfound knowledge. The program even caught the eye of the Bill and Melinda Gates Foundation, which provided a generous grant of more than $1,850,000 to help fund the Master’s Program.

PRA is enormously proud to lend its expertise and resources to such a meaningful and impactful scholarly program.

In the Classroom and on the Job

Students undertake a scientific core of courses carefully designed to provide a thorough overview of the clinical development process. The classroom and online instruction includes three months on campus in Siena studying topics divided into 10 focused modules, covering:

  • Public health, vaccine development process, and policy making
  • Epidemiology
  • Clinical methodology, statistics, and health economics
  • Vaccines preventable diseases
  • Pharmacovigilance
  • Clinical operations
  • Pharmaceutical clinical development
  • Vaccine immunology and pre-clinical research
  • Regulatory affairs
  • Manufacturing and quality assurance

Darin Seehafer and Lynlee Burton, Directors of Therapeutic Expertise at PRA’s Center for Vaccine Research, are experts that serve as visiting professors in the master’s program, providing on-site classroom instruction for the Clinical Operations module. Over the past two years, these highly skilled and trained subject matter experts–who have established themselves as leaders in the clinical development field–bring to the classroom real-world experience and knowledge and a unique insight into all aspects of clinical operations.

The Clinical Operations module is an incredibly intense high-level overview, and Seehafer’s and Burton’s passion for instilling knowledge—coupled with distinguished careers dedicated to preventing diseases—promotes deep engagement with the course content.

“It is an honor for me to teach these students. They are eager to learn and are interactive throughout our sessions,” said Burton. “But to be honest, at the end of the day, I believe I learn more from the students and have gained new perspective about how critical vaccines can be to the world.”

Students in the Master’s Program also take part in a full-time internship with international institutions and companies, providing the valuable opportunity to integrate classroom knowledge and theory with practical, hands-on application and skills that can only be fully developed in the actual workplace.

This spring, PRA will host two student interns who are pursuing their master’s degrees. Out of the classroom for the first time in three months, the interns will follow a rigorous schedule and hit the ground running to make the most of this unique opportunity to receive individual attention, mentoring, and a more thorough understanding of clinical research in an actual CRO setting. In fact, PRA is the only CRO partnering with the University of Siena for the Master’s in Vaccinology and Drug Development Program.

It is our hope that this experience will give them a better basic understanding and an appreciation for the many moving parts required for the successful conduct of a clinical trial, from feasibility to close-out.

Darin Seehafer, Director of Therapeutic Expertise at PRA’s Center for Vaccine Research

Over the course of five months, and under the guidance and watchful eye of Seehafer, the interns will be totally immersed in virtually all company operations. They will become familiar with both PRA’s internal operations and innerworkings as well as the myriad of services we provide to our many clients, partners, patients, and families around the world.

The PRA interns will assist in studies, work on a scholarly article to be published in professional publications, and will rotate among the various functional areas within PRA. They will observe, shadow, interact with, be mentored by, and collaborate with clinical research professionals throughout PRA’s global headquarters in Raleigh, NC and the Blue Bell, PA offices.

According to Seehafer, “Over a five-month period, these interns will be given an opportunity to practically apply all the knowledge they have gathered throughout their classroom instruction by shadowing mentors through most of the functional areas that PRA has to offer. This will provide the interns valuable, first-hand information and insights, which they will be able to use when they return to their home countries.”

“It is our hope that this experience will give them a better basic understanding and an appreciation for the many moving parts required for the successful conduct of a clinical trial, from feasibility to close-out.”

A Valuable Public Service

More than 100 professionals, mostly from developing countries, have successfully completed the University of Siena’s Master’s Degree in Vaccinology and Drug Development Program. They are now applying their education and experience gained through the program in the vaccine field and serving populations in more than 30 countries.

PRA is proud to play such a vital role in this lifechanging endeavor, helping to cultivate future leaders in clinical research who are willing to work in the trenches and on the frontline in the fight against infectious diseases in those countries where there is still a great need.

PRA is in the business of improving lives. Partnering with like-minded organizations often allows us to engage with people in hard-to-reach places and make lives healthier and happier. In 2017, PRA established a set of corporate sustainability goals that are directly aligned with United Nations’ 17 Sustainable Development Goals (SDGs). The SDGs are referred to as the blueprint to achieve a better and more sustainable future for all, and address the global challenges each of us face.

PRA is pleased that the University of Siena partnership embodies several of these SDGs, including Quality Education, Good Health and Well-Being, Industry, Innovation and Infrastructure, and Partnerships.

Providing innovative, pro bono instruction at a university that’s internationally recognized as a center of excellence in bioscience R&D and education is a service to the public that will continue to make a lasting impact on global health in the developing world for generations to come.

Meet PRA’s Interns

Keiko resized
Keiko Msusa
Nginache resized
Nginache Nampota

Keiko Msusa is a highly motivated licensed medical practitioner, possessing seven years of relevant medical experience. Keiko aspires to become a vehicle for positive change in the maternal and child health sector. Thrilled to be a part of the PRA Health Sciences team, Keiko believes this internship will provide her with a steppingstone to making a difference, strengthening her role in improving the health of mothers and children in Malawi and beyond. Outside of work, Keiko is a thrill seeker who may try to recruit you to join her for something fun that involves parachutes or shark cages.

The return on investment in global health is tremendous, and the biggest contributor comes from vaccines. Vaccination is now widely recognized as one of the world’s most successful and cost-effective public health interventions.

Keiko Msusa

Nginache Nampota is a physician researcher who leads an infectious disease research team at Blantyre Malaria Project in Malawi, Africa. As a passionate vaccine advocate and an aspiring clinical trial principal investigator, Nginache is excited to gain new skills for preventing infectious diseases in sub-Saharan Africa through research. She is also looking forward to the intercultural exchange – when you meet her, ask her about Malawi and she will tell you all about it in exchange for information about your culture.

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