The World Health Organization (WHO) defined health in its broader sense in its 1948 constitution as “a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity”; a substantial fraction of the waste in healthcare expenditure results from not knowing what works for particular patients in specific therapeutic indications
The aspect of increasing regulatory requirements, the growing complexity of small molecules for progressively 'personal' (focused patient groups) and, thus, smaller volume active ingredients is driving costs up — whereas society needs lower price solutions. A true dilemma of epic proportions.
The pharmaceutical innovators being served by contract development and manufacturing organisations (CDMOs) such as Sai Life Sciences are facing significant cost pressures — combined with a need to accelerate supply — and are undergoing dramatic changes in their operating environment. Contributing factors include geopolitical upheavals, more alliances and partnerships, full transparency expectations, an increased emphasis on innovative technologies, convergence between the medical technology and pharmaceutical industries and a proliferation of regulatory changes.
This has added to the complexity of the life sciences supply chain, escalating the importance of ensuring that all products are manufactured, distributed and delivered in a safe, cost-effective and timely manner.
Compliance is therefore as much about the spirit — and not just the letter — of the law. Indeed, regulators and life sciences supply and development companies have the same interests at heart — patient safety and products that effectively treat the therapeutic need. The life sciences industry is also experiencing dynamic shifts in consumer attitudes, such as expecting earlier access to new products. There is also a move towards greater patient engagement, both in determining the effectiveness of a particular therapeutic pathway and its impact on patient adherence, and in obtaining information on patient reported outcomes.
During the past decade, India has emerged as an important player in the global pharmaceutical supply chain. The country has one of the highest numbers of FDA, MHRA and WHO-GMP approved manufacturing facilities outside of the US. However, several mainly generic firms are facing a credibility crisis as they attempt to address global regulator’s concerns regarding non-compliance in their manufacturing, data management and quality and control practices. Such issues of non-compliance have been penalised by import bans and the erosion of trust and business.
This comes at a time when the hybrid model using external suppliers can help to innovate and generate considerable flexibility, agility and the cost savings required by society. Only people — the right people — who collaborate and learn together to meet this serious challenge can have a chance at designing a novel solution that helps to resolve all these dynamics. Increasingly, there is a need for an ethics-driven culture mediated through effective leadership, communication and governance that permeates behaviours, values and beliefs, and influences how work gets done within a company.
For pharma and the CDMO world alike, it means recalibrating what their collaboration means and redesigning ways of working, particularly in terms of transparency (knowing the end-goal and ground reality), requirements, planning in more detail and aligning resources and capacities accordingly to meet these goals.
There is no silver bullet solution here, but rather a portfolio of areas of expertise that need upgrading and integrating to reduce timelines and increase the reliability of outputs, data generation and subsequent regulatory filings. And this is just on the CMC side of things… as the clinical side is outside the scope of this article.
For a CDMO such as Sai Life Sciences, the stakes have gone up and each department in the company needs a revamp, including sourcing and supply chain, PR&D and AR&D, process engineering, technical transfer, quality assurance, documentation and manufacturing; equipment upgrades and redesigns must accommodate very sensitive processes and quality control have to apply very advanced methods using often sensitive reference standards.
This requires closer links with supporting and enabling departments such as IT, HR and finance. Software and communication systems in particular have become indispensable but, at the same time, require firewalls to protect against hackers of all kind. No small feat for any company, not to mention driving the need to upgrade people, train them and learn together to help innovators deliver new medicines faster that are right first time.
Recruiting, retaining, training and developing the right people will become a critical skill that CDMOs will have to improve and implement quickly to keep up with industry requirements. It is increasingly rare that candidates fit every stated job requirement and expectation; rather, the search is on for energetic, passionate people who are keen to learn and apply new ideas to solve the challenges ahead.
The issues facing today’s industry can only be solved by well-trained, motivated personnel working in a co-ordinated transparent fashion with clients. The need to supply more cost-effective drug therapies will not go away.
Customers and regulators alike are invited to invest time in training their CDMOs and sharing best practice — even at a cultural level. Leaders in the CDMO environment themselves need to be open to improving performance regardless of where the advice comes from. Sai Life Sciences has embarked on its biggest training design effort yet, covering critical areas such as people processes, communication, execution, training and simplification. Inspired by the example set in the aerospace industry, in terms of precision, perfection and training the best and the brightest, we aspire to create and train a team that is able to meet the demands of global innovators.