2. Process
Annual Forward Look report involves:
• Continuous tracking of new medicines
• Systematic research and analysis of clinical and
epidemiological data (including Scotland
specific data)*
• Expert advice from NHS Scotland clinicians
• Intelligence from Pharmaceutical Industry*
* includes CIC data
3. Process
NHS Scotland Intelligence gathering
Pharmaceutical
Industry Filtration and selection of
medicines within relevant time
Standard horizon (next financial year)
Sources
Cancer Steering
Group Filtration and selection of
high impact medicines (financial
Clinical experts and service)
Product monographs
Sponsor
(estimated uptake
pharmaceutical & net budget impact at years 1 & 5)
company
Key NHS
Forward Look report
personnel
4. Stages in the Discovery and
Development of a New Medicine.
Marketing approval
REGULATIONS Final patent Investigational new drug application or Marketing
product launch.
application Clinical Trial application. application.
↓ ↓ ↓ ↓
B 0 1 2 3 4 5 6 7 8 9 10 11
TIME (Years) A
S
I Post-
C Discovery Research Development Research Regulatory Marketing
PHASES OF Review Development
DRUG R Phase Phase Phase Phase
DEVELOPMENT E Synthesis biological testing & ←I→ ← II → ←-------------III ------------------- ----------------------→ ← IV →
S pharmacological screening 50-100
E Volunteers 200-400 Patients 3000 + Patients
A
R Clinical Phases
C
H
Long-term animal testing
Safety and pharmacokinetic studies
Chemical development
Pharmaceutical development
ATTRITION
RATES
5000+ 8 - 15 4-8 2-3 1 1
0 £350 m
COST
5. 7 issues for 2020 from
Pharma industry
• Instances of chronic disease are increasing, placing even
greater pressure on already stretched healthcare budgets
• Healthcare policy-makers and payers are increasingly
mandating what doctors can prescribe
• A growing number of healthcare payers are measuring
the pharmacoeconomic performance of different
medicines. A widespread use of electronic medical
records will give them the data they need to insist on
outcomes-based pricing
PWC pharma 2020 July 2011
6. Pharma 2020
• Boundaries between different forms of healthcare
are blurring, as clinical advances render previously
fatal diseases chronic and the self-medication sector
expands
• Demand for medicines is growing more rapidly in the
emerging economies than the industrialized
economies
• Governments are beginning to focus on prevention
rather than treatment, although they have not yet
invested very much in pre-emptive measures; and
• Regulators are becoming more cautious about
approving truly innovative medicines.
PWC Pharma 2020
7. More Pharmaceutical
industry challenges
• Patent cliff ($140 billion)
• Problems with the pipeline
– Paradigm shift?
– The biology of disease
• Financial constraints in Europe and
US
8. So is there any good news?
• Biologics
– Cancer
– Rheumatoid Arthritis
– Crohn’s disease
– Psoriasis
• On the horizon -Polyclonal antibodies, oral tx,
• Personalised medicine
10. So is there any good news?
• Biologics
– Cancer
– Rheumatoid Arthritis
– Crohn’s disease
– Psoriasis
• Personalised medicine
• Vaccines – Cervical Ca
• Outcomes data – linking Rx to outcomes
• Medicines for children (licensed)
11. Hazards of predicting the future
• “As we know, there are known knowns. There are
things we know we know. We also know there are
known unknowns. That is to say we know there
are some things we do not know –but there are
also unknown unknowns. The ones we don’t know
we don’t know”.
Donald Rumsfeld
US Secretary of Defence
February 2002
12. 3 nominations for 2020
• Personalised medicine
• Oral biologic therapy (tofacitinib)
• Real world outcomes data
Notes de l'éditeur
So what are the messages? Chronic diseases still a growing area Europe and US may be challenging grow other markets The standards for regulators may not be enough to guarantee use and even then the regulators are more cautious. Do I agree? Yes to chronic disease issues and more disease are not becoming chronic –like cancer Yes to outcomes- but that could be exciting Takes strength to deal with prevention when we are stuck with high burden and I don’t think we think strength At the moment when we look at european governments Definitely emerging markets may influence the areas for R+D and that’s a new paradigm for the west I don’t know if regulators are more cautious – they may be but they are also very concious of this
The patent cliff describes a time staring in 2009 peaking in 2011 and tailing off in 2013 when almost all leading blockbuster drugs will lose their patent. This will result in a massive decline in sales for global pharma companies. The cliff is estimated at $140 billion over a five year period $125 billion for the top ten products. In reality all medicines have lots of patents and companies have strategies to protect them, the result will Be more of a patent slope than patent cliff Pipeline in USA peaked in 1995 50 new drugs now about 25 a year. Recent UK government document estimates 20 new medicines/year
What are biologics. These are treatments designed to stimulate or restore the body’s Immune system ability to fight disease or infection – some of them will also protect the body from the side effects of other medicines This therapy involves the use of substances known as biologic response modifiers (BRMs). The body normally produces these in small amount to combat disease or infection now pharma can make thses in large amounts. Examples. Monoclonal antibodies, interleukins, interferons, colony stimulating factors You will know them as the anti –tnfs used in RA, Crohn’s and Psoriasis or Oncology medicines, G-csf, rituximab etc. These are biological products –proteins actually so as you will know proteins cannot be taken orally as they will be Destroyed in the aid of the stomach-so to date they have all been parenteral formulations ORAL and polyclonal antibodies
What are biologics. These are treatments designed to stimulate or restore the body’s Immune system ability to fight disease or infection – some of them will also protect the body from the side effects of other medicines This therapy involves the use of substances known as biologic response modifiers (BRMs). The body normally produces these in small amount to combat disease or infection now pharma can make thses in large amounts. Examples. Monoclonal antibodies, interleukins, interferons, colony stimulating factors You will know them as the anti –tnfs used in RA, Crohn’s and Psoriasis or Oncology medicines, G-csf, rituximab etc. These are biological products –proteins actually so as you will know proteins cannot be taken orally as they will be Destroyed in the aid of the stomach-so to date they have all been parenteral formulations ORAL and polyclonal antibodies
