Industrial Pharmacy
In 2008, pharmaceutical companies in the UK spent over £4
billion on pharmaceutical research and development - that's an
investment of going on for £11 million every day. The
medicines that are available for doctors to prescribe are made, and
most of them were discovered, by pharmaceutical companies.
As well as providing new medicines for many diseases, the
pharmaceutical industry makes a substantial contribution to the
British economy, providing income, employment and major
investments. Earnings from the exports of medicines exceeded
imports by £4.3 billion in 2006 and the industry has been a net
earner for Britain throughout all of the past 30 years.
The industry in the UK employs around 68,000 people, including
26,000 highly-trained scientists and doctors. In addition, the
industry generates about another 250,000 jobs in related
industries.
The pharmaceutical industry carries out more research by far
than any other industry sector in the UK, bringing major health
benefits to patients in Britain and all over the world.
There's a huge range of areas in which to pursue a pharmacy
career.
Research and Development
Research and Development (R&D) covers the initial search for
a molecule to treat the disease, through to having a product ready
to market.
The scientific endeavour to find new leads in innovative
medicines has never been more efficient nor as fast. The
process is exciting and stimulating despite often taking
years. It can be frustrating at times, but when that one compound
that might eventually make it out on to the market is discovered,
the satisfaction is unbelievable.
Most of this work is carried out by scientists, mainly
biologists and chemists, with a variety of specialist
qualifications in, for example:
Drug metabolism and
pharmacokinetics
Scientists working in DMPK will be part of a working team
including chemists, pharmacologists and other biological
scientists.
The early stage research determines the pharmacokinetic and
pharmacodynamic characteristics of compounds from target
identification, through lead identification and finally selection
of the candidate drug. The selected compound will be tested for
toxicity to cells and to animals and assays for the compound in
biological fluids will be developed to allow its absorption,
distribution, metabolism and excretion (ADME) profile to be
determined.
Predicting the likely characteristics of a molecule in the way
it is absorbed, distributed, metabolised and excreted is vital to
prevent a lot of time and money being spent on compounds which are
likely to be toxic in man. Hence accurate computer modelling of the
likely properties of a compound is increasingly important.
Biochemists will contribute to the understanding of how the
compound will be broken down within the body. A successful medicine
will need to reach the right part of the body to act, and will need
to remain in the body for long enough that doses do not have to be
taken too frequently.
When dealing with compounds that have been selected for
development, scientists working in DMPK look in depth into the
proposed compound, to confirm the earlier data, and also to support
regulatory submissions. The data generated can also go on to help
explain toxicological or efficacy problems and aid planning of
drug-drug interaction and phase 1 clinical trials.
Scientists working in DMPK will be part of a working team
including
Regulatory Affairs
The satisfaction of knowing that, because of your work, a
medicine couldn't be any better is huge. And the variety of
challenges makes it unique.
Regulatory Affairs is the real safeguard of the pharmaceutical
industry. Given the large amounts of legislation which make sure
that a new treatment is as effective and free of risk as possible,
a career here allows you to help drive the development process
forward, so that a medicine reaches the market quickly. And by
offering advice that could help reduce misuse and dangerous side
effects, you can be as much of a lifesaver as the medicine
itself.
Involvement begins as soon as a new drug is discovered and
continues long after the finished product reaches the shelves of
the local chemist. There are stringent testing requirements set by
governments worldwide at every stage of this process, which must be
met by comprehensive and accurate information on top of convincing
analysis and results. So before the documentation required by the
regulatory bodies (sometimes up to 50,000 pages) can be submitted,
it's down to the people in regulatory affairs to keep track of the
changes in legislation and to make sure that the right tests have
been done, at the right times, with the right interpretation of
results.
All medicines on sale in the UK have been granted a Product
Licence, either through the UK Medicines and Healthcare Regulatory
Agency (MHRA), or via the European Medicines Evaluation Agency
(EMEA) which grants a licence for the whole of the EU.
Even when a licence to sell a new treatment has been granted,
the work doesn't end there. It's a huge responsibility to make sure
that the medicine's packaging is accurate and lets the patient know
about potential drawbacks as well as the benefits they can expect.
And, once it's on sale, adverse events must be monitored, and
variations to the licence applied for.
A real advantage of a career in this area is that you get a
holistic view of a drug's development. And by liaising with so many
different people, from drug development teams through to people in
marketing and legal affairs, as well as external health
authorities, you serve as a lynch pin - holding the whole operation
together.
People who work in Regulatory Affairs
Because being able to understand and construct scientific
arguments is such a crucial part of any regulatory role, a
background in science is a prerequisite. Occasionally people join
the industry straight from school and work their way up from an
administrative role, but the vast majority of new recruits come
from university. A PhD can be useful, in terms of the experience
and authority it gives you when arguing or defending a point, but
it's by no means essential.
There are lots of different roles and plenty of variety across
the different sectors of the industry. Typically graduates might
enter into a role as a Regulatory Affairs
Officer/Scientist/Executive. This could be in any number of areas
such as clinical research (obtaining permission to carry out
clinical trials), manufacturing or sales and marketing. You can
then move into different specialist fields should you choose.
To begin with, the work you do is often designed to familiarise
you with your company's product range and legislation. It could
involve preparing documentation for licence renewals (looking at
the market to see if changes need to be made to regulatory
information about the medicine) or helping with the information for
the Summary of Product Characteristics. You'll be expected to pick
things up quickly and shouldn't be scared of responsibility. But
with the training that's widely on offer, both internally and
externally, you can develop your skills at a rate to match
everything that's demanded of you.
If you're the sort of person who's interested in science this
could be the area for you. To be successful you'll need a host of
different skills, none more important than the ability to
communicate both face to face and on paper. Tact and diplomacy are
also essential when challenging ideas and methods to argue a
case.
Analytical Chemistry
Analytical chemists work at every stage of development of a
medicine
Analytical chemists work at every stage of development of a
medicine, from identifying the structure of a compound that has
been made for the first time, to checking the purity of a batch of
medicine that is about to be released for sale.
Every batch of the compound that is made at all stages of
development of the medicine must be checked for purity. A
range of analytical techniques will be used, one of the most common
is high pressure liquid chromatography (HPLC) linked to a mass
spectrometer (MS). By linking the two machines it makes it
easier to identify any impurity in the compound that is being
tested.
Tests are carried out on the actual chemical compound that is
the active medicine (the active pharmaceutical ingredient - API)
and on the medicine once it has been formed into the dosage form -
such as a tablet, capsule or ointment.
Imaging
Imaging is rapidly becoming an essential tool for research and
development of new medicines.
Imaging techniques include magnetic resonance imaging (MRI),
positron emission tomography (PET), single photon emission
tomography (SPECT), ultrasound and optical imaging. Such techniques
can often be used in animals as well as humans, so information from
clinical studies can be directly translated to validate animal
models of disease and, vice versa, animal imaging can provide
insight into the human condition and treatment effects. Imaging is
important for the reduction, refinement and replacement (the 3 Rs)
of techniques in animal research.
MRI produces 3-dimensional images of all body systems
non-invasively. It can be used to understand disease processes,
monitor the progress of a disease and its response to treatment at
an early stage. MRI is especially useful for investigating brain
function in psychiatric and neurological disease. PET images
chemical processes in human organs using radioactive tracers and
ligands that bind to receptors in the brain, heart and lungs,
providing information on changes at a molecular level. Hence
quantitative data can be gathered on the distribution and impact of
a new medicine, in an animal study or a clinical trial.
The data are processed using specialist computer systems and
software to provide quantitative measurements. Thus the deployment
of the imaging technology and the acquisition of the image data are
often only the first stage of a complex analytical process.
As well as providing early data on responses to treatment,
imaging can speed up drug development. With around £550 million
spent on every medicine that reaches the market, substantial
savings can be made if the timescale can be reduced. Developing
techniques to help identify potential medicines that are
not going to prove effective is just as valuable as
supporting active compounds. Imaging can provide more sensitive
methods to measure compound activity: by using each subject as
their own control, the resulting increase in statistical and
scientific power means group sizes and trial times can be reduced
compared with conventional methods. Imaging can therefore save huge
amounts of money if the compound can be rejected at an early stage
before large, multicentre trials are initiated.
Those working in medical imaging, therefore, have backgrounds in
biological, medical, computing or physical science, obtaining
further training usually in specialist academic imaging
laboratories as part of their MSc, MRes or PhD studies. Industrial
placements during first degrees, and CASE award PhD studentships
can provide insight into how the pharmaceutical industry makes use
of these techniques, either at in-house Centres or through external
academic collaborations.
Statistics
Pharmaceutical statisticians are closely involved with all
stages of drug production.
The Pharmaceutical industry is continually trying to develop new
medications for conditions that currently have no known cure.
The industry also seeks to improve existing medications to provide
safer or more efficacious therapies. All of this research and
development work involves carefully designed experiments and
clinical trials. These are governed by the regulatory
authorities who also stipulate that trials of various kinds must be
carried out. The pharmaceutical statistician designs the
experiments and trials, analyses the data and interprets the
results so that health care professionals can have the necessary
information at their fingertips when they need it.
Statisticians (and statistical programmers) in the
pharmaceutical industry are certainly not just "number crunchers";
instead, they are key players in all areas of drug development,
from initial research and development right through to
manufacturing of pharmaceutical products. They spend a lot of time
working with people from different disciplines, including doctors,
scientists, production managers and marketing teams. They work in
many different geographical locations, including working with
worldwide government agencies, all round the world.
People who work in statistics
Pharmaceutical statisticians carry out a wide range of
activities. These often begin with the design of scientifically
sound experiments, followed by helping to design collection methods
for the data.
The statistician then has primary responsibility for the
analysis of the collected data which they have to do throughout all
stages of a drug's development. The final task is ensuring the
correct interpretations of the data analyses, writing summaries for
formal documentation, and presenting the results to senior managers
and regulatory authorities as necessary.
Development of a new or improved drug typically passes through
many stages, from laboratory work through to trials in humans
(clinical trials) and finally to manufacturing and marketing.
Pharmaceutical statisticians are closely involved with all stages
of drug production.
The pharmaceutical industry has come to realise how important
statisticians are. As a result, other opportunities are arising all
the time. For example, statisticians are supporting areas such as
pharmacology and, more recently, they have been instrumental in
cost-effectiveness modelling.
Process
Chemistry
Process chemists improve the method used for making the active
chemical compound to enable it to be made reliably in kilogram
quantities.
A compound that shows very good activity for treatment of a
particular disease might be selected for further development.
Once a candidate molecule has been selected for development,
process chemists scale up and improve the synthetic route to
produce the compound on a much larger scale - several kilograms at
a time. The compound will be used in further tests, for example to
check that it isn't likely to be harmful.
Alternative synthetic routes will be investigated until a safe,
efficient and reliable method is found.
Animal
Technology
In the early stages of a medicine's development, research
involving animals is vital.
The in-life phase of studies provides scientists with essential
information to help understand how the chemical compound works and
to estimate the safe amount to be given to humans.
Throughout this time the welfare of the animals involved is
paramount. Regulated by the Institute of Animal Technology, animal
technicians have a clearly defined set of values. They must be
convinced that there is a proper purpose to the studies - the
alleviation of human or animal suffering. Thus there must be a
balance between the desire to care for animals and the acceptance
of their use for pharmaceutical research.
Animal technicians can work with a wide range of professionals,
including experts in drug metabolism and pharmacokinetics,
toxicologists, pathologists, pharmacologists, formulation experts,
statisticians and veterinarians. Each will have a particular role
to play in the conduct of studies using animals or the evaluation
of samples taken to determine the safety of the medicine on test.
Regulation is very important, so animal technicians will also
liaise with Home Office inspectors and health and safety
professionals.
Many animal technicians are primarily involved in caring for
animals, providing them with a safe and enriched environment. Some
are also involved in the conduct of studies. This may involve the
administration of medicines and the collection and recording of
data that's critical to supporting the development programme.
People who work in Animal Technology
The people who work in this area of the industry are
characterised by a desire to work with and look after animals.
Basically, they're the foundation of the animal care system.
The great thing about this area of pharmaceuticals is that you
can begin a career fairly early. As long as you've GCSEs or
equivalent (especially in English, Maths and Science subjects) and
would like to continue your studies further, you can begin working.
Animal technology is a practical subject and so initial on-the-job
training will focus on giving you the practical skills you need to
do the job.
As part of an Apprenticeship with a pharmaceutical company,
you're able to study for qualifications such as BTECs or NVQs.
The following qualifications are awarded by the Institute of
Animal Technology:
- First Certificate in Animal Technology (Level 2)
- National Diploma in Animal Technology (Level 2)
- National Certificate in Animal Technology (Level 3)
- Fellowship Diploma
- Degree in Animal Technology (currently under discussion with
Middlesex University)
Most companies will encourage and support you throughout this
time by providing day release and financial assistance with fees
and travel. You could then go on to study for a degree.
Genetics
Understanding the role that genes play in disease is one of the
fastest growing areas of science.
The Human Genome Project (HGP) has created the field of genomics
- understanding, and using, genetic information. The knowledge,
resources and technologies arising from the HGP enables us to
understand how our genes contribute to human health and disease.
Genetics is playing an increasingly important role in the
diagnosis, monitoring and treatment of diseases.
The ultimate goal is to use information on how genes cause or
contribute to disease, to develop new ways to treat, cure, or even
prevent the thousands of diseases that people suffer from. But
getting from the point at which a gene is identified in having a
role in a disease, to effective treatments is a long, and
challenging, task.
Gene therapy has been, and continues to be, considered for
diseases such as cystic fibrosis caused by a faulty gene.
Drug design has also been revolutionised, as researchers create
new classes of medicines based on information on protein structure
and function, rather than the 'trial-and-error' methods that were
used in the past. Drugs targeted to specific sites in the body, and
'personalised medicine' - use of medicines suited to your genes -
promise to have fewer side effects than many of today's
medicines.
So what type of person works in genetics in the pharmaceutical
industry?
- Molecular biologists identify sections of DNA that code for
proteins which may be targets for drug interaction; working out
their DNA sequences.
- Protein engineers create and modify sections of DNA/RNA to make
proteins of choice such as receptors or enzymes
- People work in cell culture, creating and growing cells with
modified DNA to use in test systems for drug/receptor interactions.
If tests show that a new compound works on isolated cells in
plastic containers, they will initiate work on more complex
systems
- Genomics researchers investigate sub-populations of people, to
identify specific sections of genes that may be implicated in
disease, or that may lead to side effects
- Computational Biologists and Bioinformaticians use
computational models to predict drug/receptor interactions; analyse
and interpret DNA sequences
Medicinal Chemistry
A chemist working in synthetic organic chemistry / medicinal
chemistry, makes new chemicals that, hopefully, will have the
required biological activity.
Synthetic organic chemists (also known as medicinal chemists)
make chemical compounds for biological testing.
The chemist uses their knowledge of chemistry, biochemistry and
physiology to design a molecule that is likely to work as a
treatment for a particular disease.
Compounds closely related to those which have been identified as
having useful activity are made on a small scale - possibly only
1-200mg at a time - for testing in biological screens. The results
of the tests are used to make further changes to the molecule to
improve the activity it has against the disease. This process is
known as lead optimisation.
Once activity has been optimised the compound will be made on a
larger scale for further tests. The medicinal chemist develops a
route to make the compound which uses well known reactions that can
be relied on to make the molecule in the small quantities needed;
once larger quantities of pure compound are required a new
synthetic route may have to be developed.
Quality
Control
Making sure that every medicine is of the highest standard
possible
Quality control includes sampling, setting specifications for
and testing of raw materials, intermediates and finished products.
All supplies that come into the factory have to be carefully
controlled. Raw materials must meet the specification set by the
company, and all batches are tested against this specification.
To safeguard the quality and efficacy of the medicines being
produced, teams of analytical chemists, microbiologists,
environmental scientists and safety experts work closely with
manufacturing colleagues to see that every medicine that's produced
is of the highest standard possible. They also check that the
bi-products of the process do not adversely affect the local
environment.
Quality
Assurance
Manufacturers have to have quality systems for the design,
manufacture, packaging, labelling and storage of medicines.
The medicine has to be made by a registered process to a very
tight specification to ensure that every batch is as pure as
possible and that it doesn't contain any unexpected impurities. To
achieve this, the process has to be documented at every stage and
all processes must be carried out in line with Standard Operating
Procedures (SOPs) that have been developed. This is the role of
Documentation Managers.
Pharmaceutical quality auditing plays a major role in quality
management. The auditor must possess a blend of technical and
personal skills in order to facilitate a common sense and flexible
approach to many different pharmaceutical manufacturing and control
situations. Trained Auditors perform audits of suppliers, and of
contract manufacturers and packaging operations. Inspections are
regularly carried out by Government agencies such as the American
Food and Drug Administration (FDA) and there are regular internal
company inspections. Trained auditors also ensure that systems are
being maintained.
A thorough knowledge of the legal and administrative provisions
of EU rules and directives and other regulatory requirements such
as FDA, are likely to be a priority requirements in quality
management.
Quality Assurance managers work closely with operations managers
to ensure that there is overall control of the manufacture and
packaging of the products.
GMP trainers are important roles within any organisation. They
often have to facilitate training at all levels of the organisation
from Senior Management to Operator/Shop Floor level. They manage
training programmes and competency assessments and need to be able
to prepare and deliver training presentations, making them
interactive and interesting.
Contact us
on 020 784 32410
Email: info@resourcing.uk.com