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Innovative Indication

In the early days, biomarkers were used primarily as physiological indicators for blood pressure or heart rate, as examples. A biomarker is an objective indication of a particular medical state observed from outside the patient, which can be measured accurately and reproducibly.

More recently, biomarkers, such as elevated prostate specific antigen, can be used as a molecular biomarker for prostate cancer or enzyme assays used as liver function tests. A biomarker is anything that can be used as an indicator of a disease state or some other physiological state of an organism.

According to Strimbu and Jorge, the use of biomarkers in basic and clinical research, as well as in clinical practice, has become so commonplace that their presence as primary endpoints in clinical trials is now accepted almost without question (1).

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Professor Christene Leiper attended Sydney University, RMIT Melbourne, and Bond University, Australia, and achieved a Professorship of Medicine and Life Sciences at Bond University in 2006. She also undertook research at Edinburgh University, Scotland, as part of her PhD. Christene has been a principal investigator for clinical trials, which enables her to operate across many disciplinary boundaries within clinical research in a coherent and productive manner. In 2007, she was appointed Director of Research at a Scottish CRO, which, in turn, led her to start her own CRO, Onorach, in 2009.
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Professor Christene Leiper
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Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
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