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Posts Tagged ‘drugs’


Improving imaging based assessment of tumours’ response to treatment

Writer: Dror Nir, PhD.

The protocol for imaging-based assessment of cancer patients’ response to oncological drugs is known as the RECIST 1.1 criteria; The Role of Medical Imaging in Personalized Medicine . RECIST is mainly relying on morphological evaluation of tumors’ size . I recently participated to a webinar organised by Oncodesign which presented the potential use of more advanced imaging techniques as tools to improve the assessment of cancer patients’ response during oncological clinical trials.

It’s first part, describes a methodology developed based on the original approach of the DITEP* at the “Institut Gustave Roussy”. A method that takes into account kinetics of tumor growth at the pre-treatment phase and along the entire treatment sequence. The conclusion is that adding Tumor Growth Rate (TGR) assessment in Phase I and Phase III clinical trials is simple and provides clinically relevant information: (i) It allows for an early and precise assessment of the tumor growth, (ii) It reveals drug-specific profiles, suggesting its potential use for the early assessment of drug activity, (iii)TGR is independently associated with prognosis both in early clinical trials and in phase III setting.

The second part  presents two functional imaging modalities based on MRI: diffusion-weighted imaging (Dw-MRI) and Dynamic Contrast-Enhanced MRI (DCE-MRI). Dw-MRI gives measures of tissue architecture at the cellular level, whereas DCE-MRI provides information on the vascular status of tumors. Both methods have been standardized and used extensively as early PD biomarkers of the efficacy of anticancer therapies. The presentation goes through preclinical and clinical case studies illustrating how these two techniques can be used to evaluate the activity of novel drug candidates.

I recommend watching a recording of this webinar on YouTube . Note, the voice recording is not so good but, the effort is worthwhile….

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The red tape challenge

reporter and curator: Dror Nir, PhD

Large part of the time and cost for developing a new medical device or a new drug is allocated for achieving regulatory compliance. While quality and safety are desired, having to continually spend additional time and  money throughout the product’s life cycle just on the proof of its quality and safety is painful to all, especially for the health systems which eventually have to pay for it.
On this issue, I bring you the following post:
It has almost become routine: under narratives of increased patient safety and improved efficiency new regulatory requirements are developed, resulting in increased requirements on the industry. The new European pharmacovigilance legislation and the upcoming European medical device regulatory updates are only two examples. Being part of the industry you have very limited impact on the regulations but have to comply with them anyway. That is – if you were to continue marketing your device or drug. Under certain circumstances the cost of meeting legal requirements is so great it may bring into question the viability of continuing certain business activities. This is especially the case for smaller companies or niche products.
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It is clear, thus, that you have a huge incentive to try to achieve compliance with minimal effort. If we take a bird’s eye view on the challenge of reaching compliance, two major elements become evident:
  1. The quality system is, in itself, a high maintenance object which consumes ongoing resources:
    • It needs to be revisited often due to changes in the regulatory system or in the business environment.
    • Each change may affect many components of the system and a quick modification may cause inconsistency.
    • Each modification needs to be accepted, signed-off formally by several people and be disseminated via formally recorded training.
    • The organization should withstand audits and inspections in regards to the quality system.
  2. Living with the quality system: Each SOP and work instruction has to be followed, and typically forms need to be filled, signed and filed.
Information Overload

Young companies which are just embarking on the regulatory path often do not realize these two characteristics of the quality system. Quick fixes in the form of SOP texts copied from other organizations or generic templates are being used to get the initial certification. However, as the organization evolves it realizes that a quality system is not a one-time effort and cannot be glued on from external sources.  It has to be streamlined and become part of the way that the organization lives and does business. Companies are enjoying the benefits of improved process design and automation on a large scale every day, in many areas. When recently did you see a delivery person arriving to a pickup without a Barcode reader, so that he does not need to fill any form manually? When was the last time that a software package was released without an automatic consistency check? So too your quality system and related processes may be dramatically engineered to serve you better.

Better efficiency in quality compliance should thus be achieved through careful analysis and optimization of two types of processes:
How do we better maintain the quality system? How do we make it easier to change the system, keep it consistent, train in it, etc.
The SOPs and work instructions: SOPs cannot be just imported from outside or suggested by a QA/RA consultant who does not know the organization very well. SOPs should be a true marriage between the legal and business requirements and should be the result of a careful consideration by all stakeholders. From my experience, the best SOPs are written by the process owner, with the guidance of the regulatory expert. For example: the R&D manager should be the one drafting the design control SOP, with input of the regulatory expert. Such a SOP is much more likely to fit the business needs, and also more likely to be followed by the process owner.
Yes, I realize that thinking this way is very often not what companies do when they rush compliance. I insist that this is what has to be done to achieve sustainable compliance. The good news is that, when companies do look at their quality system in this way, they see many opportunities for significant improvement. Some of those improvements are achieved through use of better IT tools. These tools would typically be in the area of document management and versioning, workflow automation, improved collaboration and electronic signatures. Like any other change, this also requires a vision and a certain effort. However, the long term business impact may be as significant as the difference between business success or failure.

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