Jul 2 2018

Facts and Knowledge on the Pharmaceutical Industry: Only Medics, pharmaceutical industry articles.#Pharmaceutical #industry #articles

The Pharma Industry

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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

Pharmaceutical Companies

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.

Medicines Development

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.

Discovery Phase

The molecular modelling of a broad spectrum of candidate drugs followed by chemical and biological screening of the best products.

Pre-Clinical Phase

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

Phase I

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

Phase II

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

Phase III

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

Pivotal trials

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.

Phase IV

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.

Written by CREDIT

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