Today, Hogmanay, marks the last day of 2013 and my last day as Safety Pharmacology Society President. The Hogmanay celebrations and the singing of Auld Land Syne typically evoke a period of reflection on a year passed, and a looking forward with hope in to the New Year. As I reflect on the past year I have mixed feelings but overall a sense of progress and confidence. I'd like to draw out particular aspects of the year past.
This year the board of directors have been working on the strategic plan for SPS from 2014-2020. Although this is not yet complete the foundation is set and a framework has been created which I hope will allow the membership to be involved in the shaping of the goals and the activities of SPS in a much more 'bottom-up' manner. It is our society to build, shape and grow collectively. Supporting the strategic plan we also have the venues for the 2014, 2015 and 2016 meetings set as well as a mechanism to build continuity in leadership of SPS. At the same time we're seeing new people volunteer and make things happen within SPS.
At the annual meeting we also saw the first candidates take the exam to become Diplomat in Safety Pharmacology (DSP). This is a concrete manifestation of the distinct discipline we are involved in, the desire of people to progress in their knowledge and understanding of the field and a means of acknowledging and recognizing the experience of individuals. We are already hearing of further candidates keen to take the 2014 exam.
This year also saw the issue that may have provided the initial momentum for SPS re-emerge as an area of focus for safety pharmacologists. Proarrhythmia assessment is to see an overhaul in the coming year or two. The marked disappointment of 2005, where the ICH E14 guideline effectively meant that clinical assessment of QT interval prolongation was required regardless of our nonclinical findings, is being replaced with the incentive that if we can create a robust nonclinical and early clinical assessment of proarrhythmic risk we can influence and mitigate the need for later thorough QT interval assessments. The proposed paradigm is one where nonclinical data is combined with modeling and simulation.
On a more personal note I already mentioned at this year's annual meeting held in Rotterdam that I'd been reflecting on the level of change in our industry and how it could even be seen in the Society's presidential chain. I noted that many past, present and now future presidents had been elected to the VP Elect position whilst in one role or one company but end up serving their presidential term in another role or company. Myself, in March I took on additional responsibility as head of a group of PK/PD scientists and pharmacometricians looking after Lilly's Diabetes portfolio. Whilst this may seem a departure from the field of Safety Pharmacology I see it as a complimentary or extending role which emphasizes pharmacology but also the importance of modeling and simulation. I continue to believe that an emphasis on pharmacology and the quantitative aspects of our field is a distinctive characteristic of Safety Pharmacology in nonclinical and clinical safety assessment. I also firmly believe that modeling and simulation are critical in knowledge management and decision-making for modern pharma. The role modeling and simulation and early clinical concentration-effect modeling are to play in modernizing proarrhythmia assessment serves to emphasize this and give me cause to smile that unexpected opportunities have been created by me taking on a new role. I look forward to seeing how SPS adapts and grows in response to these needs.
My message for 2014? It is a message of confidence and hope. There is indeed much turmoil in our industry but there is a deepening need for pharmacologists experienced in developing drugs and navigating through the decisions necessary to take an idea all the way to a marketed drug helping patients. We are neither the "Safety Pharmacology Annual Meeting Company" nor the "ICH S7 Society"; we remain the Safety Pharmacology Society. We have the experience and toolset to meet the challenges our industry faces.
I've had the privilege to serve you as SPS president and to work with marvelous and gifted people. I'll miss the role. I'm also relieved to pass on the responsibilities of office as sharing the burden is the best way to execute against our shared vision. Hogmanay is a word of uncertain origin. One theory would suggest that it is of French roots and came to Scotland through the Auld Alliance between the nations of Scotland and France. So it is fitting that I pass the presidential baton to Jean-Pierre Valentin. I know I leave you in good hands.
Lastly, I wish you all success and happiness in 2014.
Derek J. Leishman, PhD
December 31, 2013