Uros Vojin Djekic '95 is Head of U.S. and Canada Regulatory Policy and Intelligence at Shire (now Takeda), a leading global biotech company that focuses on manufacturing and developing drugs to treat rare diseases. In January 2019, Shire was acquired by Takeda Pharmaceutical Company, a patient-focused, innovation-driven global pharmaceutical company, aspiring to bring better health and a brighter future to patients across the globe by translating science into life-changing medicines. Takeda is focused in the therapeutic areas of oncology, gastroenterology, neuroscience, vaccines, and rare diseases. Djekic's primary responsibilities continue to be developing and influencing domestic and international regulatory and health policy. 

Beginning his journey in Belgrade (which, at the time, was the capital of Yugoslavia and is now the capital of Serbia), Djekic moved to Santa Barbara with his parents in the 1980s; his mother was a Fulbright Scholar. Though the family returned to Belgrade, Djekic came to the U.S. again during high school. He arrived at Hotchkiss in 1993 as an upper mid, transferring from Winter Park High, where he played on the varsity tennis team. He recalls, "Like many pivotal and course-altering events in life, it was a result of quite a few serendipitous events marked by opportunity, preparedness, kindness, and, importantly, luck. I regularly practiced year-round at a local tennis club, where we often played with members to get more court time. Kevin Dineen became a friend and mentor; an alumnus of Deerfield, he introduced me to boarding schools in New England. Following research, applications, and conversations with school representatives, it came down to either Deerfield or Hotchkiss. Betsy Powers, Hotchkiss parent and admissions interviewer, and Dr. Parnell Hagerman, then Director of Admissions, significantly tilted the favor toward Hotchkiss, and they were ultimately the reason I had the honor and privilege of attending Hotchkiss."

Though Djekic's interest in science and medicine was already firmly established when he arrived in Lakeville, Joe Merrill and Jim Morrill's AP chemistry and biology classes confirmed that this interest would form the foundation for a career choice, which would evolve. "Beyond teaching the subject matter well, they conveyed excitement about scientific discovery and its real-world applications. I also found Mr. Merrill's witty, dry humor entertaining and memorable." 

Djekic played several varsity sports but was a tennis player first and foremost. He reminisces, "I believe it's incredibly important that the School encourages extracurricular activities, athletics being my preference; after all, Mens sana in corpore sano. Beyond that, the camaraderie and expression of school spirit are an integral part of team sports and an unforgettable part of my Hotchkiss experience. The Hotchkiss tennis team was the first time I played this inherently individual sport as part of a team - every personal win or loss counted for the overall team win or loss - which added pressure and responsibility. In both 1994 and 1995, we were Southern New England League Champs and had only one overall team loss in 1994, something we made sure wouldn't happen in 1995. In 1995, individually, in doubles with my amazing partner Eric Chen and overall as a team, we went undefeated for the season, beating a formidable Deerfield squad at Deerfield and repeating as the champs of the New England Invitational Championship tournament. I am proud to have been part of this team and our achievements, as it will likely stand as one of the highlights of my tennis career. As an added bonus, we met and played with Ivan Lendl, a former tennis World Number 1 and a personal favorite; he sometimes practiced at the state-of-the-art Hotchkiss William and Martha Ford Indoor Tennis Courts." 

Upon graduating from Hotchkiss in 1995, Djekic returned to Belgrade for medical school - one of the more obvious academic choices for those with a propensity for a career in applied biomedical sciences. "Unlike in the U.S. where students matriculate to medical school after college, enrollment into a six-year medical school program in Serbia occurs after high school. In addition to signs of political and economic optimism in the region, this was one of the major factors that drove the decision to return. However, in 1999, I was two years away from an M.D., when another conflict erupted and changed my career path." Djekic left Belgrade for the U.S. to continue his education, but the difference in school systems also meant a course correction - transfer was only possible to an undergraduate program. 

In 2001, Djekic graduated with a B.S. in Physiology and Neurobiology from the University of Maryland at College Park and was facing a dilemma - should he pursue a medical degree again, or track toward graduate school? "It was a really difficult decision to make, as both paths would have led to careers with an impact on patients' health and wellbeing, albeit in a different manner. In medical school, I gained a better understanding and appreciation of the healthcare ecosystem complexity and renewed affirmation of the importance of biomedical research to medicine - it provides the foundation to advance medicine. The greater impact to patients by potentially contributing to the development of novel therapies, combined with my interest in HIV/AIDS, led me to matriculate to a biomedical graduate program at the University of Alabama at Birmingham (UAB) - renowned for programs and faculty in microbiology, immunology, cell & molecular biology."

Djekic's interest in HIV/AIDS was ignited by his grandmother. A talented pedagogue who played a prominent role in his upbringing, she recognized and nurtured his affinity toward science and medicine as a child. "The first time I heard about HIV was when my grandmother told me about a 'mysterious new disease' she read about in the paper. In retrospect, the decision to study HIV/AIDS was a result of my interest in and curiosity with infectious diseases in general, combined with memorable experiences making clear that new and better treatment was needed; these included seeing HIV-positive patients at clinics and a performance/presentation at Hotchkiss by a group that brought awareness of the disease and educated audiences to reduce stigma." 

In 2002, Djekic joined Dr. Casey Morrow's laboratory at UAB. In a general sense, his research aimed to further understand and explain steps in the HIV infection process, basic scientific knowledge that can potentially contribute to developing medication. "Understanding molecular mechanisms of disease is critical to potentially identifying viable targets for drug development." This work was only possible due to techniques and tools that are foundational to modern biotechnology, such as genetic engineering - in this case applied to genetically modify HIV. Djekic comments, "Perhaps most importantly, the research helped develop logic and problem-solving methodology - skills applicable in most any profession." 

However, interest in a career outside of academia began to percolate in part due to a course Djekic took in graduate school entitled "From Idea to Initial Public Offering (IPO)," which covered various topics of the technology commercialization lifecycle, including how to bring a technology to market. He notes: "Returning to the tenet of impact and translating science into medicine, I learned of the many steps and pitfalls from discovery to the patient's being able to take a drug; one of those steps was regulatory approval of a medical product (i.e., drug) so that it can reach the patient. Aided by guidance from Drs. Gail Cassell and Gillian Woollett, I took the opportunity to join the Food and Drug Administration (FDA) at the U.S. Department of Health and Human Services; this decision ultimately led me to the regulatory policy career path."

Proud of his public service at the FDA, Djekic explains the paramount role it plays in protecting and promoting public health through regulation, enforcement and policy-making. "By way of background, FDA-regulated products include drugs, biologics, medical devices, food, tobacco, and almost everything necessary for daily life and account for approximately 20 percent of every consumer dollar spent in the U.S. FDA's regulatory authority is afforded by enacted laws. For example, FDA approval is needed before new drugs can legally come to market. While approval itself is a legal requirement, the basis for it includes scientific evidence demonstrating that the drug is safe and effective for its intended use. Regulatory policy lies at the intersection of science and law and deals with interpretation and implementation of legal requirements by providing a greater level of specificity, granularity, and instruction through various mechanisms, including through development of regulation and guidance documents. While at the FDA, I used my scientific knowledge and training in two ways - to review and assess data submitted in support of medical product approval applications as well as for regulatory policy-making. The latter was some of the most professionally rewarding and impactful work so far. For example, at first, FDA approval of rapid HIV tests came with sale and use restrictions - they could be sold to clinical laboratories only. However, it was estimated that about 20 percent of the 1.2 million HIV-positive people in the U.S. were unaware of their infection and that access to a test that can be used at home would contribute to reducing this number. The benefits of a diagnosis include that individuals would potentially seek treatment earlier (associated with better health outcomes) and modify behavior, reducing HIV transmission - in 2010 CDC estimated 50,000 new infections per year in the U.S. As part of a team, I contributed to a science-based and data-driven approval of a rapid HIV test as well as policy change that would allow the sale of HIV tests to consumers over-the-counter in pharmacies to address the public health need. Additionally, there was contribution to stemming the HIV/AIDS pandemic internationally, contributing to regulatory capacity-building goals as part of the President's Emergency Plan for AIDS Relief." 

Since regulatory policy was only part of his responsibility at the FDA, Djekic joined Shire (now Takeda) when the opportunity presented itself. "The guiding principles for the work are equivalent, but the scope and priorities are aligned with company vision and research and development goals. Regardless of specific priorities, patient-centricity is a credo of both Shire and Takeda - and very much in line with my own. Activities associated with established priorities may get turned upside down, depending on the political environment (e.g., government shutdown), but include: assembling teams of subject matter experts to develop a position and response to relevant FDA policy (e.g., guidance) documents (e.g., proposing and substantiating a change to FDA's recommendations); assisting teams in developing regulatory strategy by helping interpret regulation/guidance or researching regulatory precedent; and helping to analyze legislative proposal and assess policy implications." 

Biotechnology is the technological application of science; harnessing and manipulation of biological organisms for particular applications of interest to humans has been around in one form or another for a long time. "Some of the most notable include Gregor Mendel's heritability experiments - a form of genetic engineering - and Edward Jenner's development of the first vaccine to prevent infection with smallpox, a deadly disease that was eradicated in the 1980s."

As to the origin of the modern biotechnology industry, Djekic says, "Today's biotech industry is possible because of a series of scientific discoveries, notably the double helix structure of DNA, recombinant DNA technology (cutting and combining genes/DNA to form a hybrid molecule), and monoclonal antibody technology. In 1982, FDA approved the first genetically engineered product - recombinant human insulin. Prior to this seminal scientific, medical, and regulatory milestone, diabetics depended on insulin extracted from pig and cattle pancreases - an alternative was necessary to meet the increased need for insulin. Since then, there have been many biotechnology drugs approved for treating cancer, infectious diseases, hematologic diseases, immunologic diseases, genetic disease and others." 

As to the overall importance of biotechnology, Djekic says, "To borrow from the Biotechnology Innovation Organization (BIO), one of the most elegant ways to express the beneficial promise of biotechnology is that it has the potential to help 'heal, feed and fuel the world'; perhaps it's obvious, but noteworthy that it has the potential to do harm and raises many ethical considerations. For example, the FDA recently approved several gene therapies; one of these utilizes recombinant gene techniques to treat vision loss that could lead to blindness, by delivering a normal copy of the gene directly to retinal cells in the eye, which then produce normal protein. Sequencing of the human genome through the Human Genome Project (HGP) and technological advances in sequencing technology provide the basis for personalized medicine and rare disease identification and diagnosis, as well as drug development. There is very little doubt that biotech has already revolutionized human life via medicine and agriculture and will likely continue to do so in the future." 

Djekic speaks several languages fluently. "Written and oral communication is the main tool for creating, influencing, or implementing regulatory policy, so mastery of language is crucial. Issues are often complex; therefore, logical and clear articulation is paramount to achieving desired outcomes." 

Reflecting on his academic pursuit, careers, and jobs, Djekic says, "I was a medical student, who became a scientist, then a regulator and now a policy-maker. Biomedical education and training underpin all these professions. Natural affinity for subjects in school can be a relevant indicator for a career choice, but evolution of and success in career goals are in large part influenced by friends, family, professors, mentors, and institutions - Hotchkiss academics and athletics were key for mine. Given the situation in Serbia at the time, without financial aid, I wouldn't have been able to attend. Amazingly, it's quite possible, although unverified, that I was the first student in Hotchkiss's history to be from Serbia. If accurate, from a personal perspective, this would be a great honor. From Hotchkiss's, I'd say it is a testament to demonstrating the commitment to inclusion and diversity, a key component and tenet of the School mission and motto Moniti Meliora Sequamur, irrespective of the pre- or post-2017 translation - 'After instruction, let us move on to pursue higher things,' and 'Guided by each other let us seek better paths,' respectively."

"Clearly, I'm an advocate for an education and training in science; it provides a platform for a multitude of career choices in academia, industry, and government and spans the gamut from physician, professor, biomedical engineer, microbiologist, and research scientist to policy-maker. With the right intellect and discovery, perhaps even a Nobel Laureate or industry pioneer."