Biotechnology Focus

BioFocus AugSept2017_digital

Biotechnology Focus is Canada's leading authority on Canada's life science news. From biopharma and healthcare to ag-bio and clean tech, our readership includes life science professionals, C-level executives and researchers.

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clinical trials August/September 2017 BIOTECHNOLOGY FOCUS 11 Clinical trials of the future are already becoming smaller, faster, and involve fewer participants. To see this story online visit https://biotechnologyfocus.ca/renovate- to-innovate-ich-gcp-e6-revision-2-and-new- clinical-trial-standards/ lowing changes to GCP guidelines, ICH has given us not only an interesting challenge, but a wonderful opportunity to do better. Interest- ingly enough, and rightly so, ICH still leaves enough ambiguity and room for interpretation even within the new updates to E6. Most clinical research professionals would find this frustrating since we often demand straight- forward answers to issues we might encounter while conducting research studies. However, ICH has recognized the fact that leaving room for interpretation and providing more of a guide rather than a recipe book will foster out-of-the-box thinking. This also allows the new guidelines to have more flex- ibility in a fast-changing world of evolving technologies. Again, many of us would probably be out- right disappointed to see that after 20 years of no changes, ICH provides us updates that cer- tainly clarify lots of contentious issues (such as use of e-records, certified copies, investigator oversight responsibilities, validation of com- puter systems, etc), yet still falls somewhat short of leaving zero doubt in other areas of one of their most valuable team players, not to mention a marketing guru with effective patient-recruitment ideas; another employee, a highly-motivated drug discovery scientist with over 10 years of lab research experience became one of their most valued clinical monitors, who could easily discuss scientific concepts with principle investigators. These are just some examples of how cre- ating a diverse, engaged and open-minded workforce helps bring about the necessary cultural shift towards innovation. Vantage BioTrials also uses the diverse backgrounds and experiences of their staff in their protocol optimization process, where they carefully and meticulously scrutinize study designs, protocol procedures, and scientific concepts in order to realize best outcomes for their sponsor clients and ultimately remain compli- ant with ICH GCP E6 (R2). Because of innovations that have increased the value and power of data in trials today, clinical trials of the future are already be- coming smaller, faster, and involve fewer participants. With more patient involvement and input and continued progress in the areas of technology platforms, recruitment strate- gies, and building partnerships, we expect to see more responsive and flexible trial de- signs, making it possible for studies to make adjustments to protocols in response to trial data and refine and improve outcomes in the midst of a trial. Reaching this ideal state and realizing all of the potential for future clinical trials requires more than just innovation amongst indus- try stakeholders, and we now finally see international policies aligning with industry efforts through ICH's amended guidelines. Ultimately, this is what is needed to get life- saving treatments to patients; and in the drug development world, it is the only thing that should truly matter. References 1. ICH Harmonized Guideline; Inte- grated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2), Current Step 4 version dated 9 November 2016. 2. Ivey Business Journal; Reinventing Innovation, by Arkadi Kuhlmann, May/ June 2010 issue Vatche Bartekian is president of Vantage BioTrials Inc. interest. One particular section of the new updates, number 5.0, Quality Management, shines a much-needed light on a topic that has, for many years, baffled even some of the most experienced of us all. During one particular conference a year ago, the author probed audience members during a presentation on Quality by Design and asked, "What is your definition of Quality Management?" Ten people raised their hands and provided 10 very different answers. Indeed, ICH recognizes that "one-size- does-not-fit-all" when it comes to Quality Management (QM) systems, but provides a well-thought-out generalized roadmap for organizations to get started with setting-up a solid QM foundation that promotes principles of continuous process improvement strategies throughout the lifecycle of a clinical trial. This is when true innovation is achieved. You cannot attain or even begin to claim that your organization is "innovative" without fostering a culture of innovation, and it all begins with hiring the right type of people. It starts at the interview process. At Vantage BioTrials – an innovative Ca- nadian CRO – they have learned to hire individuals that do not fit in a perfect mold. The best people are often found in unusual places. For example, one of their clinical project managers with an M.BA and a his- tory of entrepreneurial ventures proved to be TAblE 1 wHERE ARE THE CHANGES IN ICH E6 (R2)?

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