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Developing new medicines

Our medicines save and transform the lives of millions in the UK and around the world every year, but developing them is a long and complicated process.

 

Did you know, on average, it can take around 12 years and more than £1bn to develop each new medicine?1,2 Moreover, for every 10-20 medicines identified in the laboratory, only one will ever reach patients - the others will fail along the way.2

We passionately believe that medicine development shouldn't be done alone - collaboration is essential. That's why we work with other innovators across the health landscape including academic scientists, patient organisations, governments, other bio-pharmaceutical companies and healthcare professionals, in the hope to discover 'Breakthroughs that change patients lives'.


Read more about the journey from 'Molecule to Medicine' below:

Pre-Discovery

- understanding the disease -

Average cost: undefined
Average time: undefined

The drug discovery process begins with observing how a disease changes biological processes in the body. Researchers home in on what might be causing the disease, typically with the goal of identifying proteins in the body that might be involved in the disease process. They then form a hypothesis that inhibiting or activating a specific protein might potentially help to treat the disease. Proteins are the most common drug targets because they play so many critical roles in the body, but drug targets can also include DNA or RNA. A good target is one whose activity can be both linked to the way the disease works and also modified by a drug.

During this phase, collaboration is key. Our scientists are involved in projects and strategic alliances with universities, charitable research organisations and other pharmaceutical companies, all working together to understand the disease and its causes. In 2017, we had 138 active research collaborations within the UK alone.3

We focus our efforts in core areas where we are best positioned to develop unique medicines for much needed therapies; chronic inflammatory and autoimmune diseases, vaccines, oncology, pain, cardiovascular and metabolic disease and rare diseases.

Discovery

- finding the molecule -

Average cost: £436 million2
Average time: 4.5 years1
5k - 10k candidates2

Scientists begin searching for a molecule that will work on a specific disease target such as a gene or protein. Through ‘rational drug design’ scientists can create a molecule from scratch using cutting-edge chemistry and biotechnology. Alternatively scientists can use ‘libraries’ of existing molecules, where thousands of potential candidates can be tested by automated systems.

Between 5,000 – 10,000 molecule combinations are screened in the hope of finding one or more promising candidates that show signs of potentially stopping or reversing a disease.2

Molecule Development

- testing the molecule -

Average cost: £97 million2
Average time: 1 year1
10 - 20 candidates2

This is a critical stage where the molecule is built into a compound with different combinations tested to find out which formulation makes the molecule work most effectively.

Once the most promising molecule combination has been identified it gets put through a series of rigorous tests, to determine that it works, that it works effectively, that it is stable and that it is reproducible.

The testing can be carried out in a number of ways, for example using computer simulations (in silico studies), cell-based tests (in vitro) and animal testing (in vivo studies) when absolutely necessary.

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Medicine Development

- making the medicine -

Average cost: ongoing
Average time: undefined

Our Pharmaceutical Sciences teams work to turn the experimental molecules into a safe, consistent and robust medicines in preparation for clinical trials.

At this stage of the process, scientists aim to design and develop the most effective delivery mechanism for the molecule. How will the medicine reach its intended target? What is the optimal dose? Will it be a tablet, capsule, inhaler, cream, gel or liquid? How do we mass produce?

Our site in Sandwich is able to perform every step in the complex process of producing a new medicine and is home to Pfizer’s only automated ‘pilot plant’ that manufactures medicines for use in our clinical trials worldwide.

In preparation for clinical trials, our Devices Centre of Excellence in Cambridge, UK develops medical devices for the delivery of medicines which cannot be taken orally, such as auto-injectors or injector pens.

Clinical Trials

- testing the medicine -

Average cost: £567 million2
Average time: 5.5 years1
1 - 10 candidates2

Medicines need to be tested to check they are safe, and are effective at treating or preventing the disease they were developed for, prior to applying for a license to make them available to the public.

There are four stages of testing medicines in human subjects:

Phase 1 – 20-100 health volunteers2
Phase 2 – 100 - 500 patients with the disease2
Phase 3 – 1,000 – 5,000 patients2
Phase 4 – Ongoing monitoring during the life span of the medicine4

Trials are often run in partnership with universities, hospitals, general practitioners and the government.

Information about clinical trials that Pfizer conducts is publicly available on www.clinicaltrials.gov and www.clinicaltrialsregister.eu

Licensing & Access

- regulation of medicines -

Average cost: £50 million2
Average time: 1.5 years1
1 medicine2

Results from clinical trials are submitted to regulatory agencies to obtain a licence prior to it being made available to patients. Licensing is needed to confirm the quality, efficacy and safety of a medicine. Whilst no medicine is risk free, a licence indicates all the proper checks have been carried out and the benefits of the medicine are believed to out weigh the risks.

In the UK licences are granted by The Medicines and Healthcare Products Regulatory Agency (MHRA) and The European Medicines Agency (EMA)

In order for medicines to be made available to UK patients through the NHS, after licensing, it is also necessary to gain market access and reimbursement for a medicine. This is achieved through health technology assessment (HTA) for reviewing clinical effectiveness and cost effectiveness of a medicine. In the UK, examples of HTA agencies are the National Institute for Health and Care Excellence (NICE), All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC).

The UK, is home to Pfizer’s Global Regulatory Affairs, where licensing submissions for 175 markets across the globe are managed.

Manufacturing

- producing the medicine -

Average cost: undefined
Average time: ongoing

Once a medicine is licensed and has UK market access approval, it can now be manufactured at scale in preparation for supply to the NHS.

At Pfizer we manufacture many of our own medicines, but also rely on third parties to manufacture and warehouse medicines within the UK. Our manufacturing follows European Good Manufacturing Processes (GMP) and has a dedicated team based in the UK to ensure Pfizer medicines are produced to the highest standards for UK patients.

Our Material Characterisation Team, based in Sandwich, UK, specialise in safety testing during the manufacturing process. This team ensures that suppliers and Pfizer's own manufacturing processes, across the globe, meet exacting standards.

Ireland is a leading manufacturing base for Pfizer, where many of our leading and newest medicines are manufactured for global export.

Supply

- transporting medicines -

Average cost: undefined
Average time: ongoing

Packaging and transporting medicines across the UK and around the world involves significant investment to maintain high quality supplies and to be able to respond to demand.

Our Global Supply site in Havant, UK, is home to highly sophisticated production lines. These provide state-of-the-art packaging of vaccines and specialist injectable products, often in highly secure refrigerated conditions. In 2018 the site packed in excess of 80 million doses, which were distributed to over 100 countries around the world.5

Temperature-controlled shipping containers are used so that medicines arrive at their destination in perfect condition – from large airline shippers containing thousands of doses, to a small container in a four-wheel drive, heading for a remote mountainous location.

As part of the supply process, Pfizer is committed to tackling counterfeit medicines to ensure patient safety is not put at risk. Our Counterfeit Lab in Sandwich, UK, uses spectrometry technologies to provide expert analysis of suspected counterfeit Pfizer medicines and helps identify the manufacturers and distributors of these illicit products. This facility supports not only the UK, but Europe, the Middle East and Africa.

 

References

  1. ABPI, March 2012, 'Time to Flourish Infographic'
  2. ABPI, May 2014, 'Innovation in Medicine Infographic'
  3. Pfizer data on file. July 2018.
  4. NHS UK June 2016, 'Clinical Trials'
  5. Pfizer data on file. March 2019
PP-PFE-GBR-1641 / May 2019