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LLM Masters, Scientist, Pharmacy Regulation

February 18, 2017


In a spacious conference hall in Hilton hotel in Seoul, Korea, June 2015,  I had a half day meeting with two officials from CDER (Center for Drug Evaluation and Research) at US FDA, and three other officials each from EMA (European Medicines Agency), Merck USA and Korean MFDS (Ministry of food and drug safety). I was invited to discuss the very first implementation of RMP (Risk Management Plan) of pharmaceutical drugs in Korea as a member of task force to draft the guidelines for a risk management plan with several other colleagues from major multinational pharmaceutical firms including Lilly, Merck and Pfizer. 

Over the last 5 months or so, I have been heavily engaged in providing guidance to enable compliance with newly enforced law that became effective as of July 2015 in Korea. The new legislation requires pharmaceutical companies to submit a 200 to 300 page document setting out comprehensive safety, efficacy, clinical trials and pharmaco-epidemiological data of new and orphan drugs and any potential or identified risk factors associated with their administration. The document must be submitted when an application is made for marketing authorization to national health authority.

I made a 5 day trip to Berlin, Germany to Bayer Health Care’s headquarters, then spent 7 days at Bayer’s Asia Pacific regional headquarter in Singapore and also passed many  hours in teleconference and email communication with pharmacovigilance, medical advisors, regulators and regulatory colleagues in the US and Korea. Following this considerable effort, I was able to successfully complete drafting guidelines and annex to the amendment of Korean MFDS law <Regulation on approval and review of marketing approval of pharmaceutical drug> and  also contributed in developing training module and tracking tool of RMP preparation and submission that is to be used to track and manage any risk minimization activities conducted by Bayer health care offices around the world. This 5 month project was the most challenging one I had undertaken since I was a project manager of Enbrel® biosimilar drug “SB4”, a monoclonal antibody biopharmaceutical to treat Rheumatoid Arthritis at Samsung Bioepis back in 2012, but at the same time the fruitful outcome of this work brought me the same feeling I had when I learned the news that clinical trial application of SB4 was successfully approved from BfArm, a German Federal Institute for Drugs and Medical Devices. Hard work always pays off and I love to be involved in bridging between science and law.

I already work at the interface of science and the law and it has been necessary for me to become familiar with the law as it relates to my area of responsibility.  During this time, I have become increasingly interested in the interaction and relationship between the two disciplines.  There are some obviously overlapping skills between the scientist and the lawyer, including the application of analytical skills and a well-developed ‘eye for detail’.  However, I am also aware that advocacy calls for skills not necessarily apparent in the laboratory and that these obviously include an ability to persuade and also to present scientific data in a form comprehensible to non-scientists. I believe that I possess the characteristics necessary to enable me fulfil my ambition to become a highly successful lawyer/scientist specialising in patent law and health law.

The US is the key international regulator of pharmaceutical/biotechnology industry and so, naturally, I seek to study the subject in the US. I am aware that the purpose of such regulation is not only to protect the rights of those who invest significant sums in developing new products but also to protect the consumers of such products from undue risk. I have researched some of the history of pharma-regulation and one case that has made a great impression on me was that of ‘Thalidomide’. The FDA in the US proved itself to be highly effective in the case of this drug which was marketed in the sixties as a preventative for nausea in pregnant women. The drug caused fetal death in around 5,000 cases and serious defects in a further 5,000 cases in the dozens of countries in which its use had been approved. The FDA had blocked sale of the drug in the US.

It is clear to me that the law in this area is of enormous importance. If the rights of those who undertake investment of time, finance and creativity are not properly protected then progress in the world of pharmaceuticals and biotechnology will either cease or, at least, be gravely damaged, to the detriment of all. It is just as important to ensure that the producers do not recklessly pursue profit at the expense of the users of their products. I can think of few more important roles than that of being one of the ‘gatekeepers’ by coupling my current scientific knowledge and experience to the specialist legal knowledge and skills that I now seek to acquire, and this is the reason for my application.

My goal is to become a general counsel advising and representing various clients including government, industry or academic researchers particularly in the area of biotechnology. I am very interested in assisting in legal and policy research relating to the areas of: biotechnology from micro-organisms, plants, and animals to human genes and stem cells, law and bioinformatics, haplotype mapping, proteomics, pharmacogenomics, nanotechnology and patent law and human embryos.

 

I am aware that there are a growing number of scientists seeking to enter the legal profession so, though aware that I am not unique, I do believe that my career to date and especially that of my current role as a Pharmacovigilance Officer provides me with highly relevant and useful experience which, even if not entirely unique among my fellow students, will enable me to ‘add value’ to the academic community in providing valuable insights. I look forward to sharing the fruits of my experience and knowledge and to benefiting from the diverse experiences of my fellow students.

Because of the success in my academic career, I was offered the opportunity to teach chemistry and math and took every opportunity to do so. I thoroughly enjoyed passing on my knowledge and my efforts were appreciated by both students and superiors. I believe that my skills and experience in teaching has provided me with the type of communication skills that will assist me in explaining technical matters to non-scientists with clarity and accuracy. I know that this will be an important aspect of the work that I seek to undertake in the future.

In my work, academic career and during my voluntary activities, I have interacted happily with people from a wide variety of social and cultural backgrounds and ages. It was necessary for me to adapt quickly to a contrasting culture in the US and to ‘fine tune’ my English language skills. I empathise with those who face similar challenges and have sought to assist them where I have had the opportunity to do so.  

I enjoy sharing knowledge of my own culture and in hearing from other people about their own. I am currently resident in Korea but, having studied in the US for five years, I am familiar with the US academic and social environment. I took part enthusiastically in several extra-curricular activities during my bachelor degree program including membership of my university ski-club and I made many friends. My voluntary work in the Buffalo General Medical Center was particularly satisfying and useful in providing exposure with the variety of cultures in the US and in witnessing at first-hand the importance of pharmaceutical advances in people’s lives. I also served for two years as a conscript in the Korean Army achieving senior NCO rank and was stationed in South Sudan for 6 month as part of Korean Army and United Nations peace keeping operation mainly taking responsibility for interpretation. This part of my background provided me with an increased self-discipline, self-confidence as well as an experience of humanitarian aid work  and gave me experience of exercising leadership and in getting along and cooperating with people of diverse academic ability, attitudes and socioeconomic backgrounds.

I am fluent in the English and Korean languages and can converse confidently in German.

I excelled in my bachelor degree program at the University of XXXX and graduated ‘magna cum laude’ and was awarded several other honours. This will provide an assurance of my academic ability and of my potential not merely to succeed in the program but to excel within it, which is my firm intention to fulfil. I know, from observing the progress of fellow students over the years, that there is sometimes a tendency among the most academically gifted to ‘coast along’ and pursue only limited academic goals. This is a ‘trap’ that I have always sought to avoid since my earliest school-days. Doing ‘just enough’ is a tempting prospect but one that I have successfully avoided. My aim always is to excel and so meet my potential rather than merely to succeed and I always encourage others to do the same.

I am a strong believer in the maxim ‘all work and no play makes Jack a dull boy’ and I seek to be a ‘well rounded’ person outside of my work and studies. Although it may not be obvious from this statement so far, I have a well-developed sense of humour. Although life is a serious business, I consider it unwise to take it, or oneself, too seriously.  I pursue several interests some of which stretch me physically and others which provide pure relaxation and joy. These pastimes include scuba diving, travel, basketball, playing guitar, watching movies and reading a wide variety of fiction and enjoy reading biographies of those who led inspiring lives.

To summarise, I believe that my background demonstrates academic ability and potential, an ability to relate well with others, communication and teaching skills, the ability to rapidly absorb and apply information, an ability to adapt and to be flexible in new situations and cultures, determination, diligence and, not least, a firm intention to ‘make a difference’ rather than merely to ‘make a living’ and to do so for the benefit of others as well as for my own financial and other goals in life .

I am aware that, even for the gifted student, the program will offer challenges and am determined to meet them. If admitted, it is my firm intention to participate with a very high degree of enthusiasm and diligence. In addition to working hard to excel in the program curriculum, I look forward to interacting with my fellow students and faculty members for our mutual benefit, assisting with at least one valuable research project, contributing to law journals and helping in voluntary projects for the benefit of those who have been less fortunate than I have been in life.

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