About NSMF
The Vision
The current medicines R&D process needs revision.
Despite heavy investment, the pharmaceutical industry is facing declining productivity measured by the number of new innovative medicines approved and being available to patients over the past decade. The pharmaceutical industry has picked the low-hanging fruits and the era of the blockbusters is over.
Research on the human genome has revealed a profound diversity. Humans are as different inside the body as we are in our appearance. This is also the case for the enzyme systems responsible for metabolism and effect of medicines.
This is a blow to the "silver bullet" or one-fits-all concept for treatment of many chronic, progressive disorders. We must realise that the population of patients with a certain disease does not represent a normal distrubution but reflects a group of sub-populations.
The future therefore calls for individualised medicine to ensure maximum efficacy and safety for the individual.
This will have a profound impact on the medicines R&D process and chance the paradigm for medical practice.
The knowledge from the genome research and other groundbreaking technologies will
- Decrease the need for use of animal testing by use of in-vitro and in-silico tests instead
- Enable identification of non-responders in clinical phase 2 efficacy trials
- Enable identification of persons liable to experience rere but severe side effects
This points should lead to leaner R&D programmes.
The changing paradigm for medical practice should lead to a more focused medical practice with better diagnosis based on clinical/genetical/metabolical parameters before commencement of treatment. This also calls for a closer follow-up in medical practice. Further medical counselling based on the individual's genetic profile for the prevention of disease will be possible.
The benefit for the patients as well as for society will be massive in terms of both quality and cost.
This huge endeavour cannot be lifted by the pharmaceutical industry alone.
Achievement of this calls for collaboration of all parties involved in medicines R&D, academia, health care professional including hospitals, regulatory authorities, industry (big and small pharma, biotech, technology), patient organization and public funding bodies.
- A public-private partnership for the benefit of the individual:
Currently both the European Commission's 6th Framework Programme and the EUREKA network have expressed a strong interest and encouragement of the concepts described above as a means to counter the fragmented nature of the European research systems and to enhance the competitiveness of the European pharmaceutical industry and health care systems.
NSMF proposes to coordinate R&D efforts and bring all stakeholders together to
- Reengineer the current drug research & development processes utilising contemporary scientific knowledge by removing bottlenecks and deloping new tools (streamlining)
- Re-evaluate the entire process and create a new efficient flow of knowledge generation and management without compromising safety based on the scientific advances within the genome research and other groundbreaking technologies (fresh approach).
Streamlining is the first step. Experiences from this will form valuable input to development of the fresh approach.
What can you do? Join the Section on Medicines Development
Members of the Section on Medicines Development are automatically personal members of the European Federation of Biotechnology. As a Personal member – EFB Membership is Free!
Many dedicated, hard-working and unpaid volunteers continue to promote the safe and sustainable use of biotechnology in Europe and beyond as well as servicing over 4000 personal members for free. But we need the moral and financial backing of a large number of academic and industrial institutions. We hope you feel a responsibility to support our community of biotechnologists from Europe and beyond.
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