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Clinical Acceleration

The development of therapies for central nervous system (CNS) diseases has lagged behind other areas, despite these diseases affecting over one billion individuals worldwide (1). As the population ages, the incidence of disorders like Alzheimerís disease, Parkinsonís disease, and stroke are expected to rise, further increasing their impact on society.

CNS drugs take longer on average than drugs in other therapeutic areas and are half as likely to reach the market (2). Development programmes in CNS are lengthier and more complex for several reasons; the most consequential of which include the heterogeneous nature of CNS disorders, suboptimal preclinical models, bloodbrain- barrier penetration impediments, and challenges in recruitment and retention of patients. Furthermore, overly lengthy development timelines can shorten the initial investment time span of a new compound. Changing or unestablished regulatory requirements can halt drug development if they occur too late in the process for the clinical development plan to be adapted. The pharmaceutical industry needs new strategies to increase the success rate of CNS therapy development and approval.

Over the past few years, there has been a trend for pharma companies to target orphan indications, essentially utilising rare diseases to obtain the initial clinical proof-of-concept and approval for a compound. This approach offers advantages in a competitive landscape, minimising risk and potentially availing new or repurposed drugs to eventually be studied in broader indications. With the growing number of gene therapies targeting subpopulations in diseases like muscular dystrophy, Huntington's disease, Friedreich's ataxia, etc, studies in smaller homogenous CNS populations are often appropriate.

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Dr Kemi Olugemo is a Neurologist and Senior Medical Director at PAREXEL. She received her bachelorís degree from the University of Massachusetts, US, and her MD from the University of Maryland School of Medicine, US. Kemi initially joined PAREXEL International in September 2011 as a Clinical Research Physician. She served as the Principal Investigator or Sub-Investigator for over 50 studies spanning from Phase 1-4 in several therapeutic areas, including CNS, oncology, endocrine, cardiovascular, and infectious disease. Kemi re-joined PAREXEL International as Medical Director in June 2014. Her current responsibilities include medical monitoring; consulting in clinical drug development from pre-clinical through post-marketing, support for protocol development, regulatory submissions, and manuscript development; training on therapeutic areas, specific disease states, adverse events assessment/ management; and addressing medical and scientific questions for PAREXEL. Kemi is certified by the American Board of Psychiatry and Neurology
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Dr Kemi Olugemo
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