5 Drug Discovery and Development Challenges and How to Solve Them
Importance of drug discovery and development
Drug discovery and development is a complex, and ever-evolving process that can take between 8-12 years and cost on average, over £1 billion. On top of this already astronomical amount, regulatory pressures on new drug approvals, and payor influence on drug pricing add extra costs that make establishing a reliable revenue increasingly challenging in the sector.
However, financial pressures aren’t the only hurdle scientists must overcome; a successful drug discovery strategy relies on understanding patient need, as well as current and future competition.
To navigate this complex landscape and successfully provide patients with life-saving medication, researchers must optimise and improve their processes wherever possible to ensure innovation continues at pace in a cost-effective, and sustainable manner.
In this Synergy article, we will explore 5 of the most critical challenges faced by the pharmaceutical industry and provide ways to strengthen organisational efficiency without causing costs to spiral.
1. An absence of people management expertise
Strong business and management skills are critical across any project; including those involved across drug discovery and development.
In industrial settings, a lack of business and management skills can lead to errors and delays in research and culminate in a high financial cost.
At the crucial early stages of drug development, scientists in the workplace should not only have a wide range of subject matter expertise, but additional experience in assisting with the planning and conducting of toxicological and pharmacokinetic studies in a Good Laboratory Practices (GLP) environment.
This means equipping scientists with a range of business and management skills to help limit risk, and maximise the potential of the wider team and the project itself.
Jared Auclair, Director of the Biopharmaceutical Analysis Laboratory (BATL) notes that industrial pharmacy is placing a growing onus on soft skills and company culture.
He describes 7 main business skills for scientists today, these are:
- Business Acumen
- Management Skills
- Critical Thinking and Problem Solving
Implementing development opportunities to build these skills can help improve business agility, minimise risk, and maximise the potential of every scientist.
Revising science modules to include business skills may be a good solution in the long term. According to Associate Dean of the University of Alabama and ex-virology researcher Jeffrey Engler, the students and postdocs he works with on his scientific business training course are “excited about combining research with teaching, mentoring and business”.
Meanwhile, the scientists that take the course report that the business skills “give them more confidence and a greater sense of purpose about their work”.
2. Simultaneous responsibility to identify novel hits, and enable traditionally intractable targets
As patent expirations rise, organisations across the pharmaceutical sector face a growing need to replace their key revenue generators with new drugs.
This competitive environment results in a joint focus between both identifying novel hits, and developing new ways to enable traditionally intractable targets. Accelerating the discovery and optimisation of high-quality disease-relevant starting points means evolving traditional screening systems and translational assays to minimise late-stage drug attrition.
While traditional outsourcing methods support with the workload involved across the drug discovery process, they can put IP at risk, as well as raise overall costs.
Technological advances such as AI software for hit identification can provide accurate, efficient support.
However, there remain barriers to successful digital implementation, an industry-led review sponsored by the UK government, reveals that data security, IP theft and cybersecurity remain key barriers to digital success.
3. Rising cost pressures
Cost efficiency is a core area of focus across the pharmaceutical industry, and yet is notoriously challenging to control.
With every new drug taking over a decade to develop, and merely 12% of drugs that enter clinical trials being ultimately approved for introduction, drug discovery and development can be an uncertain and expensive process.
Clinical trial delays over COVID have only amplified this situation, resulting in rising costs with no real financial return while drugs continue to wait for FDA approval and market introduction.
The current situation has resulted in a shift in priorities away from traditional outsourcing methods, towards insourcing teams to maximise laboratory space and equipment without excess cost.
Meanwhile, technology-enabled clinical trials are growing in popularity; these decentralised trials are powered by smart devices and enable research to continue without increasing patient risk over COVID.
Research from McKinsey reveals that before the pandemic, only 38% of pharma and CRO’s expected virtual trials to be a major component of their portfolios. In 2020, 100% of the same organisations described a commitment to virtual trials as a major component.
4. Hiring freezes
While necessary for budget management, headcount limitations can pose a challenge for time-sensitive projects where many scientists are required over an intense, but short time frame.
Mass investments in breakthrough therapies such as new oncological drugs can exacerbate research capacity, leading to organisations turning for additional support.
However, there are hurdles to overcome when collaborating with or purchasing support from an external provider.
While partnerships with academic research organisations can often come at a lower price, few academic institutes (especially in the US) are GLP compliant, meaning that data from these institutes cannot be presented to the FDA. Furthermore, these groups are often relatively small, and are not always equipped to deal with research co-ordination for drug development.
CROs are a popular option and ideally work as operational and strategic partners, alleviating pressure from internal teams.
However, holistic partnerships depend on both internal, and external team members proactively coordinating and communicating in separate, and busy research environments. CRO’s can also inadvertently increase the time it takes to make decisions, causing critical delays that damage relationships with investigators.
An external provider should be chosen based on their capability to accomplish high-quality work at a lower cost – rather than out of time pressure.
5. Medicine supply issues and shortages
Active pharmaceutical ingredients (API) shortages, and delays in the pharmaceutical supply chain have posed significant challenges to drug discovery and development.
Furthermore, prescription demand globally continues to fluctuate.
Research from the US shows that across 2020, patients with chronic diseases were likely to discontinue medication therapies, and that far fewer than normal new patients took medications that were vital to their care.
Meanwhile, in the UK an overall increased prescribing of several medications was observed in primary care – especially among treatments for chronic health conditions. However, while end-of-life prescribing faced a dramatic spike, medications that were previously high-volume such as contraceptives, travel-related vaccines, as well as medications for dementia and Parkinson’s declined.
In Europe, research conducted by the European Patients Forum reveals that 49% of patients faced treatment delay, and 12% experienced treatment discontinuation.
Further examinations from the World Health Organisation highlights a major disruption to non-communicable diseases (NCD) services. Medications for conditions such as hypertension, type 2 diabetes, cardiovascular, mental health and chronic respiratory diseases were most impacted.
These unprecedented changes across the drug supply chain create an increased need for agile support to allow for a rapid change of focus.
One solution to address all 5 key challenges in drug discovery and development
Synergy is an onsite scientific services supplier, providing pharmaceutical businesses with trained scientists that work within client facilities, under Synergy’s oversight.
A mobile team, embedded in your scientific project.
Challenge 1: An absence of people management expertise
Solution: Synergy provide organisations with skilled scientists onsite, that learn and develop at work through our continuous training provision. We help organisations create leaders and researchers with the key business and professional skills needed to drive widespread success.
Challenge 2: How to identify novel hits, and enable traditionally intractable targets
Solution: Synergy enable organisations to benefit from additional support around hit identification, expansion and lead optimisation – without taking projects off-site or risking IP.
Challenge 3: Rising cost pressures
Solution: Synergy helps organisations capitalise on their laboratory space, and equipment with insourced experts that integrate and work alongside current teams. Our trained experts are trained to employ speciality methods to reduce complexity across the research process - maximising efficiency and creating cost savings.
Challenge 4: Hiring Freeze
Solution: Due to being a scientific service, and not a temporary contracts provider, Synergy can help businesses overcome headcount restraints and accelerate innovation, discovery and development.
Challenge 5: Medicine supply issues and shortages
Solution: Synergy empower organisations with agile teams, enabling fast reactions to unprecedented changes in the drug supply chain. Managing the entire recruitment process at speed, Synergy enable organisations to rapidly scale with ease.
Find out more
Contact our team at firstname.lastname@example.org to find out how we can support you in accomplishing your business requirements.
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