Drug Development is More than Life Science
BERLIN, GERMANY - Oct 12, 2015 - Dr. Anna Baran is Chief Medical Officer at KCR and in this strategic role she has developed a complex viewpoint on the challenges her position entails for a CRO. In the following interview Dr. Baran talks about R&D complexity, high industry standards and collaborative approach needed to bring new drugs to the global community.
What is your role as Chief Medical Officer at KCR?
Anna Baran (AB): This is a very good question and I wonder sometimes myself. But seriously - at KCR we decided to interpret the role of Chief Medical Officer (CMO) as a position linking medical expertise with commercial aspects of the CRO business. A core element of our strategy at KCR is that Knowledge Sells and with this in mind the scope of the CMO role at KCR has been shaped.
I am responsible for bringing a network of medical experts and expertise together with our business development efforts. It has been working very well so far. As we engage with new clients the majority of our discussions focus on execution strategies as well as protocol designs and refinements to allow for effective execution. Medical aspects are critical at that stage. Of course I am supported by an excellent operations and regulatory team for input as well.
What are the most demanding areas of clinical trial operations nowadays? What kind of challenges do they create for a CMO?
Anna Baran (AB): Standards of care and the regulatory environment are constantly evolving, and staying close to these developments, whilst supporting ongoing projects is a challenge for every CRO today. The needs and knowledge of our clients base differ. On the one hand we are working with well-established pharma companies with clear expectations, but on the other we are engaging with emerging biotech companies, which are in the process to transition from early stage to late stage development. The constant re-calibration of what knowledge and expertise the client requires is challenging, but it is also the reason why I am so passionate about my job.
Another aspect that makes the life of a CMO interesting, and I prefer calling it interesting rather than challenging, is that research trends have been changing quite frequently. Five years ago all focus was on oncology, subsequently orphan indications and rare diseases became a parallel trend. Today I can see an increasing call for CNS development programs as the environment is still coping with a number of incurable, or almost incurable, neurodegenerative disorder and psychiatric disease.
Pharma is currently focused on accelerating the process when it comes to R&D. Could this affect quality standards? What is the biggest challenge to keep them on a high level?
AB: I think first we need to distinguish between quality standards. The one area for quality is simply the process execution according to GCP and SOP standards, and the second is the actual patient quality, if I may call it this way. I would insist that we need to look at these aspects separately. Of course R&D is focusing on accelerating timelines, but R&D always did and will continue to do so in the future. High execution standards start with feasibility: do we understand the protocol, do we understand the patient population, and does the investigator share that understanding? These are important questions. Once we know that, we can and need to define an implementation strategy that is aligning recruitment speed with process execution capabilities to allow for the best possible results. Of course on top of it, we need to balance that with an optimal cost structure for the trials. It is not always an easy task, but we consider ourselves successful in this field.
Rising complexity is anotheraspect impactingclinical trialsof today. With your KCR experience in mind, what do you thinkwould be key for a successful study?
AB: The key is a compromise between the urge to test recent scientific news on new biomarkers and the recognition of burden related to multiplied procedures created for all stakeholders involvement, most importantly patients and clinical researchers. According to a 2012 report from the Tufts Center for the Study of Drug Development, only half of all procedures - 54.3 per cent of Phase II procedures and 47.9 per cent of Phase III - support primary and key secondary endpoints. This compromise is particularly a challenge for Central Nervous Systems (CNS) research, which is still missing clear effectiveness measures and being constantly tempted by evolving imaging techniques and newly validated clinical outcome assessment.
Measuring the success of clinical research can be both: very simple and very complicated. In the best case scenario we run projects to confirm therapeutic efficacy and safety of any new drug, alternatively to confirm clinical equivalence of a biosimilar. However, we all know that not every drug candidate makes it to the market and the real challenge is to gather this in the early stage development. Again, and I am once more returning to the Tufts report, 18 percent of a typical clinical trial budget, or $1.1 million, is spent on direct costs to administer procedures for supplementary secondary, tertiary, and exploratory endpoints. That said, we encourage our clients to detail feasibilities concerning both, profile of target population and doability of certain assessments in selected geographies. Understanding how critical certain endpoints can be for the future development, we always pay attention to challenges related to extensive sampling, frequency repeated imaging procedures and numerous COAs.
Do Late Phase studies undergo the same effectiveness pressure as the R&D sector?
AB: Constantly evolving pharmacovigilance legislation makes the late stage research increasingly complex and challenging. Its not sufficient to prove the safety and efficacy of an investigational medicinal product during phase II/III studies, the quality and safety of the drug should be constantly monitored to evaluate the long-term safety and benefit-risk profile of a medicine, to determine the proper risk minimization strategy. Effectiveness of KCRs late stage service line is the core value. Hence the priority is on technology tools facilitating its delivery.
What is most challenging yet appealing in your position as Chief Medical Officer (CMO) at KCR?
AB: Working with Biotech and Pharma, staying close to the latest trends in the pharmaceutical industry - these key aspects keep me continuously fascinated about my job.
I also very much appreciate the ability to interact with various life science professionals. The evolution of pharmaceutical, device and diagnostic sectors has definitely pushed us, physicians and pharmacists, beyond standard comfort zones of the medical community. For the last couple of years drug development has been done by the collaborative framework of the medical community, biotechnology, engineering and mathematicians, supported by intellectual property lawyers and communication experts what proves that drug development is more than life science. Only such a collaborative approach can facilitate bringing novel-class therapies to the global community. I am here with passion to support that.
If you would like to learn more about KCR's offer and/or speak to Dr. Anna Baran directly, please contact Joanna Lewandowska, PR & Marketing Manager, at joanna.lewandowska@kcrcro.com.
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Email: joanna.lewandowska@kcrcro.com
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