Alleviating suffering and saving lives are at the very centre of the pharmaceutical industry. Over the years, we’ve been able to discover a growing number of new molecules that have led to the development of pioneering therapeutics for treating an extensive range of diseases. Those blockbuster drugs have been used by millions of patients across the world, improving their quality of life while also helping our industry to maintain healthy revenue streams to facilitate new research and development (R&D) programmes.
The landscape, however, has changed dramatically over the last decade and large pharmaceutical manufacturers have been struggling to cope with a number of growing challenges, such as increasingly complex clinical trial protocols required to develop new drugs for rare and complicated diseases. In response, we’ve witnessed the industry actively looking for innovative ways to overcome these challenges to continue serving its purpose of discovering novel treatments.
At ELRIG, we believe that opportunities to share the latest ground-breaking research and cutting-edge advances in laboratory technology can help realise these initiatives. That’s why we organise Drug Discovery, which in its 12th year, aims to provide valuable insights into disease biology and methods of identifying novel chemical and biological drug candidates.
What are the main drug discovery challenges?
Drug discovery has never been an easy path to walk on, with the resource-draining R&D process requiring 10-12 years and millions of pounds to complete and deliver a new treatment to patients. While we’re all painfully aware that this will always be the case, new challenging elements have been added to the equation. The need to develop more targeted medicines to treat rare and complex diseases, such as cancer, has triggered an increase in the use of large, protein-based molecules instead of small, chemically-manufactured, active-substance molecules. Large molecules, however, are more difficult to work with, requiring greater depth of knowledge and expertise, as well as the implementation of extensive biotechnological processes to identify and validate a new target.
Furthermore, many of the top-selling medicines have already or are about to come off patent, paving the way for producers of generic drugs to introduce more affordable versions. At the same time, competition in the pharmaceutical marketplace has reached a record high, with too many similar drugs available to treat the same conditions, marking the end of the big blockbusters era. Global regulatory bodies have also been introducing ever-stringent legislation, making it much harder for new drugs to receive approval. According to a recent review by researchers at the Brookings Institute in the U.S. and the Deerfield Institute in Switzerland, R&D spending has grown substantially between 1994 and 2013, however the number of drugs that receive approval by the U.S. Food and Drug Administration (FDA) for every billion dollars spent on R&D annually has been declining at a steady pace.
How have biologics changed the drug discovery scene?
In a previous ELRIG blog, we explored how drug discovery is a rapidly changing field that has seen huge leaps in scientific research and technological innovation in the last decade alone. A leading example is how we’ve developed an improved understanding of the underlying disease biology, which has enabled us to create biologic medicines to treat conditions that fall outside the primary care therapy areas. Having realized that these advanced therapeutics hold the key to addressing unmet patient needs, many large pharmaceutical companies have changed their strategic focus and realigned their R&D efforts to the extent that their discovery pipelines currently consist of 20 to 50 percent of biologic drugs.
In addition to greatly benefiting patients who suffer from rare diseases, biologics can also bring longer-lasting profits, mainly due to the challenges associated with developing biosimilar drugs. Those of us involved in the manufacture of biologics understand the level of expertise required to bring such a drug to market. As a result, companies with no or inadequate experience would need to go through a steep learning process and invest significant resources to develop a biosimilar drug. Even if they succeeded in that, adequate profitability would be questionable as, unlike generic medicines, biosimilars are highly similar and not identical to the original product, meaning that automatic substitution at the pharmacy level is not an option.
The role of emerging markets in drug discovery innovation
Over the last few years, the growth of emerging markets has served as a major revenue driver for large pharmaceutical manufacturers. Whereas until 2005 the U.S. and EU were the leading markets, Asia, Latin America, Russia, Middle-East and Africa have since emerged as key players. Growth has primarily been driven by patent expiry of primary care drugs in the U.S. and EU, and simultaneous increase in demand of these products in the emerging markets.
Further to presenting us with greater commercialisation opportunities, the emerging markets also provide room for innovation. China, in particular, has evolved into a large, well-educated talent pool, funded by substantial government and private capital. This has resulted in many large pharmaceutical companies establishing state-of-the-art research facilities in Shanghai to drive the next breakthrough drug discoveries.
So, has big pharma solved its problems?
In an ever-changing marketplace, large pharmaceutical companies will always come across new challenges that will threaten their short- and long-term viability. Practice has demonstrated that dedication to drug discovery innovation is the way forward, and contrary to what many critics believe, profitability is not the industry’s main purpose, rather the means to realising it.
As Dr Nessa Carey, Owner of Carey International Impact Training, noted during her presentation in ELRIG’s 2017 Drug Discovery conference, “The paradox is that we hold big pharma to a higher standard because what it does is so important. We expect it to be ‘purer’ than other forms of commerce because it’s about health.” But the truth is that we can continue to serve our noble cause only if we remain profitable so that we can fund the discovery of the next great therapeutics.
Drug Discovery 2018 will be held at ExCeL, London on the 9th – 10th October. Registration is now open.