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Posts Tagged ‘Regulatory process improvements’


8:20AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

REAL TIME Coverage of the Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

8:20 a.m. Special Guest Keynote Speaker – The Future of Personalized Medicine

The Future of Personalized Medicine

Special Guest Speaker

Margaret Hamburg, M.D.
Commissioner of Food and Drugs Administration

[Her Father was President of IOM said at the introduction to the Keynote]

How to ask the right question is what HMS taught me best 

Increasing the knowledge of Biology, response to disease, preventive strategies.

2004 — Monumental year — One year after completion of sequencing the Genome

2008/9 – Breast Cancer – pharmacotherapy approved, a protein involved in triggering the disease.Target therapy – risk of disease identified

WHAT FDA is doing on Genetics Information as PARTNERS in Medicine

25% of drugs approved are Targeted therapies

LABELING drugs on genetic information

diagnostics test — identify good respondents

Companion Diagnostics – should be used in Targeted therapies. IGF1, HER2 expression and amplification

PM more important in ONCOLOGY , HepB, Cystic Fibrosis, differential response, CVD – expansion, more to be done

In 2002 — a Program to discuss Genetic information VSDS – New Genomics Program, National Center for Toxicology Research a participants

Translational Scientist are added.

Completion Genome sequencing — push to PM 2011 – Genomics evaluation Team for Safety.

Challenge – Drug, Biologics – interaction need coordination by Agency to discuss challenges and collaboration with out side Group.

Developers of Targeted therapies: Orphan Drugs, Biomarkers – expedited review to promote innovations, fast track breakthrough therapies. Opportunities of Scientist to engage discussion with FDA

 – ALL hands on Deck Approach at FDA – making products available, i.e. SCLC (small cell lung cancer)

Since 2005 – 25 Guidance Reports, i.e., Orphan Drugs and on Companion Diagnostics to be developed in tandem with drug development.

Companion Diagnostics – 3 month review, enforcement and direction – in the framework

FDA — needs to keep up with development in the Diagnostics and in the disease ares.

Illumina – Assays using SNIPS – FDA assesses a shared curated DB on mutation, reduce the review time significantly

FDA – NGS – reference libraries, Genomics Reference and Storage of genomics data

Tools and Capabilities  – support regulatory and science, statistical methods of analysis — implemented for Breast Cancer — signaled the way of new Partnerships and New Clinical Trials formats and methods in its development.

New diagnostics – AMP Program Alzheimer’s Disease, rheumatoid arthritis (RA), inflammatory bowel syndrome (IBS)

What Science is needed for the Regulators to effectively HELP spar innovation.

Pharmacogenomics, Pharmacogenetics — MAPPING the Human Genome and all other areas of “OMICS” – moving from Lab to bedside — requires expertise in Disease prevention, Difference in patients life, Standard medical practice

  • Biology and Pathways
  • Biomarkers
  • New diagnostics
  • Increased communication Universities, new paradigms models and continual effort of SHARING and coordination of shared resources

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

@HarvardPMConf

#PMConf

@SachsAssociates

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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.
R1
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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