Spotlight on

Pharma

Perhaps more than any other industry, the pharma & life-science sector relies on long-term, high-risk R&D. It also faces the additional challenge of innovating within a strictly regulated framework, sometimes under intense public scrutiny.

Medicines in some form have existed since the beginnings of human civilisation. In around 120 BC, King Mithridates VI developed a ‘remedy’ named ‘Mithridatium’, which contained dozens of compounds and was held as a panacea for most diseases until the 1700’s. In 1540 the manufacture of Mithridatium was subject to supervision under the ‘Apothecaries Wares, Drugs and Stuffs Act’ in England – one of the earliest attempts to regulate the medicines sector. The standards for the manufacture of Mithridatum became formally established in The London Pharmacopoeia in 1618.

In 1937, over 100 people died of diethylene glycol poisoning in the US, after it had been used as a solvent for an elixir without any safety testing. In 1938 the US introduced the Federal Food, Drug and Cosmetic Act. These early moves towards regulation were not enough to prevent one of the most tragic chapters in the history of medicine development: the thalidomide disaster of the late 1950’s, where thousands of babies were born with deformities.

Today, the pharmaceutical industry is very heavily regulated in the interests of public safety.

The basic goal - to find safe and effective medicines has remained unchanged over recent history. However, the challenges associated with meeting that goal are always evolving, as are the research tools available to do so.

The landscape is also changing. Targeted or precision medicines, matched to the patients most likely to benefit from them, are now becoming possible. This trend has been greatly assisted by advances in diagnostic testing technologies. Other game-changing strategies, such as the exploitation of targeted protein degradation (e.g. with proteolysis targeting chimeric drugs, or PROTACs) are also emerging to enable the development of more potent and selective treatments for cancer and other diseases.

The concept that ‘prevention is better than cure’, is an increasing principle of modern healthcare. We are seeing increasing examples of medicines being used to prevent disease, rather than just treating it (one example being Truvada, for pre-exposure prophylaxis (PrEP) for HIV). The rise of  so-called ‘superbugs’ (antibiotic-resistant microbes) is also a growing concern leading to the need for new innovation in the area of antibiotics.

Pharmaceutical companies spend up to 25% of their revenue on research and development (R&D), one of the highest R&D spends of any industry. However, it is important to remember that the sector does not comprise only ‘Big Pharma’. A huge amount of pharmaceutical innovation originates in smaller and medium-sized pharma and life-sciences companies, and also in universities and research organisations.

Read our Pharma Blogs

The brilliant dawn of AI drug discovery

The brilliant dawn of AI drug discovery

by Camille Terfve

Computer simulations are solving challenges previously thought uncrackable.

Updates to the Guidelines for Examination at the EPO

Updates to the Guidelines for Examination at the EPO

by Rebecca Brooks

The Guidelines for Examination at the EPO (which will be referred to as “the Guidelines” in this article) elaborate on the various articles/rules of the European Patent Convention and provide ...

Most opposed patents of 2023

Most opposed patents of 2023

by Katherine Green

Multiple sclerosis therapies are the subject of two of the most opposed patents of 2023. Novartis’ EP2959894 is notable from a patent attorney perspective not only because it’s the subject of 23 ...

Pharma trade marks: 2023 EU case law round up

Pharma trade marks: 2023 EU case law round up

by Emily Sullivan

As we enter 2024, we reflect on the lessons we have learned in 2023. The trade mark landscape has continued to evolve, and pharmaceutical trade marks are no exception. In this article, we take a ...

Antibiotic with novel mechanism offers new hope for treating resistant infections

Antibiotic with novel mechanism offers new hope for treating resistant infections

by Emily Lythell

This week saw the publication of a potential new class of antibiotics and their mechanism (Zampaloni et al., 2024, Pahil et al., 2024).

Synthetic probiotics: bacteria that link the gut to the brain

Synthetic probiotics: bacteria that link the gut to the brain

by Alice Jefferies

Optimising pharmacokinetics of a drug is a vital stage of the development process. Pharmacokinetics relates to a drug's journey through the body, and includes drug absorption, distribution, ...

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Getting New Drugs to Market

The process of getting a new drug all the way from the laboratory to the pharmacy shelf is lengthy (often 10-15 years) and expensive, with typical costs of well over £1 billion.

Before any initial compounds are even prepared, the research journey may have begun in a university laboratory, where researchers may have undertaken basic research to understand the processes behind a disease at a cellular or molecular level. Through better understanding of disease processes and pathways, targets for new treatments can be identified. Once a potential target has been identified, researchers can then try to devise a substance that acts on this target in a selective, efficacious and non-toxic manner.

Historically, researchers have sometimes looked to natural compounds from plants, fungi or marine animals to provide the basis for candidate drugs. Even today, some interesting new drugs are based on compounds from plants such as cannabis.

Increasingly however, scientists are using knowledge gained from the study of genetics and proteins to create new molecules. In recent years, the use of artificial intelligence to assist in the earliest phase of drug discovery has started to receive attention.

Once a promising new compound or biologic treatment is identified, the next stage involves carefully controlled clinical trials.

Many drugs do not make it through the clinical phase. The US medicines regulator, the FDA, estimates that whilst 70% of candidate drugs make it through phase 1 trials, only around a third of these pass through phase 2 successfully. Then, only 25-30% of these get through phase 3 trials and continue towards a marketing approval.

Given that drug development requires many years of careful research and clinical testing, while at the same time carrying a high degree of risk and cost, law-makers in many countries have recognised the need for extra IP protections to incentivise innovator pharma companies and to help recoup the enormous costs that are involved. These IP protections include the acceptability of ‘second medical use claims’ in patents, as well as different forms of regulatory exclusivity and patent term extensions.

Of course, efforts to innovate do not stop when a drug wins an initial approved for a given disease condition. Frequently, there is scope for further improvement: An improved formulation might improve an aspect of tolerability or patient compliance. With further trials a drug might be found to be useful against a broader segment of disease than was initially envisaged. Innovative improvements may also be found by combining two drugs – perhaps with a specific dosage and sequencing of administration that maximises the efficacy and/or tolerability against a given type of cancer.

The innovative pharma and life-sciences sector is making great strides forward to meet society’s medical challenges – but certainly, there is so much still to do.

Find out more about our expertise in the pharma and biologics space.

Open pages of Validating European patents outside Europe Special report 2023

Special Report

Validating European patents outside Europe - the Validation State system

This report examines the Validation State system, a newer feature of the European Patent (EP) system employing ‘Validation Agreements’ and looks at usage and awareness of the system. It aims to answer:

  1. Who is using the system to file applications?
  2. What is the awareness of the system?
  3. How do the economies of the Validation States compare against the EPO member states?
  4. How is the system used?
  5. What should applicants be aware of?
download here

Environmental Sustainability

Human and environmental health are two sides of the same coin. After all, air quality contributes to respiratory disease, global temperatures influence which areas are affected by infectious diseases, and increased levels of extreme weather disrupt continuity of healthcare. So, for good reason, pharma has environmental impact high on its agenda.

Aside from the moral imperatives, there are also well-established business reasons to reduce environmental impact. A strong link exists between environmental and financial performance. In part, this link is provided by an appreciation that improved environmental performance is typically achieved through reduction and elimination of wasteful activity. In turn, this can lead to reduced costs and potential increases in revenue. Consequently, sustainability is rapidly becoming a key driver for change in pharma and the supporting industries.

We know that the pharma sector is flexing its innovative might to address its environmental footprint. From more sustainable API formulations to greener manufacturing methods, and from more efficient R&D processes to better products and services for improved clinical outcomes, a revolution in sustainability is underway to meet the ambitious ESG targets set by the leading companies in the pharma sector.

planet earth
Forward Magazines Overlapping 8

Mewburn Ellis

FORWARD MAGAZINE

Mewburn Ellis Forward is a biannual publication that celebrates the best of innovation and exploration. Through its pages we hope to inform and entertain, but also to encourage discussion about the most compelling developments taking place in the scientific and entrepreneurial world. Along the way, we’ll engage with the IP challenges that international organisations face every day.