The Pharma Industry
33 Blagrave Street
Keep connected join the Only Medics Network here.
Global pharmaceutical sales in 2010 topped $911bn, which equated to a growth of 2.90%.
In 2010, the FDA approved 88 new drugs and biologics.
The research-based pharmaceutical industry is one of the few remaining leading high technology industries in Europe, amounting to 17% of EU business R D investments, and about 3.5% of the total EU manufacturing value added
The pharmaceutical industry invested more than 16% of total sales back into research and development.
Approximately 633,100 individuals are employed within the pharmaceutical industry in Europe, including 113,400 in R D facilities.
On average, 17.0% of total health expenditure in Europe is currently spent on pharmaceuticals and other medical non durables.
Thanks to innovations in healthcare European citizens can expect to live up to 30 years longer than they did a century ago
Companies vary from large multi-nationals, small or medium sized organisations, Biotechnology, Medical Device, Generics or Niche companies to Clinical Research Organisations (CROs). CROs are Global organisations, service providers that undertake outsourced clinical trials for pharma companies to help get a compound on to the market. Their work includes specialist Phase I services, Pharmacokinetics/ Pharmacodynamics and Phase II IV Services.
Only 1 in every 5,000 products screened is approved as a new medicine and only 30% of approved and marketed drugs produce profits that cover their R D costs. Around 40 new medicines are approved each year and the average cost of developing a single drug, from initial discovery to approval is estimated at more than 400M. Most drugs fail to make it to market but still incur development costs. On average it takes more than 10 years to progress through ‘Phases’ from initial Discovery to product approval.
The molecular modelling of a broad spectrum of candidate drugs followed by chemical and biological screening of the best products.
Investigating a compound s safety and pharmacology prior to assessment in humans.
the likely effect on human biological systems
evidence of safety in pharmacological screening tests
formation of a multi-disciplinary project team to manage the development of the compound
toxicological and pharmacological screening
manufacture of small amounts of the drug for testing
market research to establish the need for a new medicine in the therapeutic area
10 to 18 months
Determining the pharmacokinetic properties, safety and toleration of the drug in healthy volunteers. Sometimes known as 1st into man studies.
safety profile in humans escalating from sub-pharmacological doses to test the safety profile
how the drug is absorbed, distributed, metabolised and excreted
food interactions, potential drug interactions
possible close ranges and formulations
clinical trials involving up to 100 healthy volunteers
manufacture of small amounts of the drug for testing and trials
development of appropriate dosage forms such as capsules or tablets for large scale patient trials
further toxological testing in parallel with clinical trials
Determining the safety profile and investigate evidence of efficacy and dose response in target patients.
First clinical studies in a small number of patients to demonstrate safety and first signs of efficacy.
Initial dose-ranging efficacy trials. More extensive than Phase IIa patient studies, IIb is used to establish dose and overall efficacy/safety properties. These studies also establish the initial benefits to risk ratio. The results of these trials are used to determine the study design and dosing for Phase III trials.
preliminary evidence of efficacy, safety and differentiation against gold standard treatments proof of concept
biomarkers providing initial evidence of efficacy
optimal dose and dosage regimen
clinical trials involving larger patient groups
interactions with Regulatory Agencies before starting clinical trials
complex statistical analysis and reporting data
further toxological testing and development of commercial dosage forms
further market research and medical value research
Proving safety and efficacy in large scale trials with determination of the risk/benefit profile to allow regulatory approval.
Phase III trials are often subdivided into:
Expanded, controlled and uncontrolled clinical trials intended to gather additional evidence of efficacy for specific indications being studied and to better understand safety and drug related adverse effects. Trials are usually multi-centred and collect substantial safety experience and efficacy information. They often include the Pivotal Trials which serve the basis for drug approval.
Studies conducted after the drug has been submitted for marketing approval. The purposes of these studies include differentiation from other treatments, exploring use in additional patient populations, seeking new indications for the study, or exploring AEs. Results of these studies may be used to supplement a pending application or complete earlier trials by providing additional safety data or they may test the approved drug for additional conditions for which it may prove useful.
proof that the drug works against the disease in the general population showing clear advantage over existing therapies
confirmation of optimal dose and how often it s given
further toxicology and Phase I studies
clinical trials involving 1000s of people in global studies
large-scale statistical analyses and reporting
global interactions with Regulatory Authorities
preparation and submission of the Regulatory Filing
manufacture of large amounts of expected drug formulation
knowledge transfer to Marketing and Manufacturing
A generic term for adequate and well-controlled Phase II and III trials which provide substantial evidence of effectiveness and safety upon which the drug is approved.
Commercially oriented trials conducted after the drug has been approved for marketing.
Post-Approval Studies (Post Marketing Surveillance)
Testing a marketed drug in new age groups or patient types.