By: Mark A Lane, PhD
As our world adapts to new COVID-19 realities, it appears that many innovations have been put on hold. But biopharmaceutical innovation isn’t among them.1 In fact, COVID-19 sparked a burst of innovation in the sector and in 2021 we’re now on track to possibly see the highest number of new drug approvals by the FDA since 2018 and perhaps of all time – but certainly beating 2020’s total of 53 – with many of them truly novel platform technologies and pioneering therapeutics.2
But while scientific innovation may be on the rise, the drug development process still remains a long and costly proposition. Drug development timelines have increased significantly over the decades, and the cost of bringing a drug to market has more than doubled in the past 10 years. Today it takes pharmaceutical companies far more than a decade at a cost of nearly $2.6 billion to bring a new drug from discovery to the market, according to a recent study by Tufts Center for the Study of Drug Development.3
Some reasons for these accelerated milestones included doing more activities in parallel (or taking a risk in starting the next trial before the first had finished, but safety had been established), leveraging data more effectively from previous research, and the FDA shortening the time it took to review. All of these learnings can now be applied to drug development moving forward.
Despite some clear success stories, pharmaceutical companies overall still have a long way to go to compress drug development cycle times and reduce costs. Now consider the complexities inherent in the current environment: the increasing prevalence of decentralized and virtual clinical trials, the price tags associated with novel therapies that some governments and commercial payers say they simply can’t afford, and the struggles for many companies to adequately scale-up manufacturing capabilities while ensuring safety and efficacy.
The question remains, how do we accelerate drug development by being more agile, transparent, and progressive enough to streamline outdated processes?
It all comes down to pinpointing areas for improvement throughout the drug development process. The time has come to acknowledge that the traditional drug development model is too complex and time-consuming and results in far more failures than successes. We typically think of innovation in drug development in terms of new science or technology, however, innovation can also mean new or improved processes to improve efficiency. Biopharmaceutical companies now have the opportunity to scale transformative approaches across their product portfolios and their organizations to maximize the probability of delivering new therapies to patients.
Efficient Drug Development Rests On 4 Transformative Approaches
Being more agile means adapting more quickly to changes and breaking down the silos that have slowed down development. Organizations should consider implementing new approaches, pharma technologies, process improvements, and operating models that facilitate functional team collaboration and empowerment and that bring new efficiencies to the product lifecycle. Drug development is often thought of as a sequential phase-driven process, where a product is taken methodically from discovery to preclinical through clinical development, and ultimately to market. In reality, drug development is not linear – rather it needs to involve collaboration between various functions and stakeholders from the outset in an integrated model that is designed to bring efficiencies and speed to processes.
So where do you begin? Here are 4 interlocking pillars to transform drug development processes.
- Develop an integrated product development plan, which can be considered an organizing construct for end-to-end decision making throughout the development lifecycle, but also a mechanism to bring together multi-disciplinary teams and stakeholders – including providers and patients.
- Establish a flexible, adaptive infrastructure by redesigning traditional development processes. This will allow for easier collaboration across partners, suppliers, and the health ecosystem and cross-functional teamwork within the company. This allows biopharma companies to break down traditional processes and avoid decision making in isolation.
- Play a more pivotal role in the health ecosystem by creating a transparent and collaborative working model across stakeholders, including regulators, payers, patient advocacy groups, and others.
- Determine how best to leverage data and technology to speed decision making and unlock the value of insights through automation, artificial intelligence (AI), and machine learning. While AI is beginning to prove its value in clinical trial design, in drug target identification and validation, in predictive modeling, and even in statistical analyses using next-generation sequencing data, the potential outside of clinical trials is at a nascent stage. But the structured and unstructured data collected throughout the clinical process holds great promise in pharmacovigilance, in ongoing clinical monitoring, and in helping to formulate market access strategies.
1. Develop the Integrated Product Development Plan
The transformation journey begins with the integrated product development plan, which is a roadmap for global development. It aligns goals and activities across R&D, brings together anticipated commercial and medical assumptions, and helps assimilate the strategies across cross-functional sub-teams – the ultimate decision makers and creators of the deliverables. The plan helps give teams a laser-like focus on the end goal and improve the odds of success.
There is no cookie cutter approach to this plan – each will be unique – and if employed early in the program lifecycle, the integrated product development plan will provide a clear roadmap on how to scale knowledge and optimize decision making. The integrated product development plan is a way to have more transparency and alignment across functions so an organization is able to bring together a multi-disciplinary team to co-develop drug development strategies and plans and flag key risks and how those will impact timing and resources – as early in clinical development as possible.
Through the integrated product development plan, companies should outline the end goal and how the various puzzle pieces must fit together helps to ensure new therapies are brought to the market while avoiding costly delays, budget overruns, and failed or repeated studies. A global integrated product development plan is an essential tool for improving efficiency, shortening timelines, reducing costs, and improving the probability of regulatory approval and success in the marketplace. It should include major development milestones, decision points, and potential timelines for key activities and the overall program. In addition to providing a roadmap an integrated strategy can improve decision-making by ensuring all available data and perspectives across multiple functions are considered.
If the integrated product development plan provides the roadmap, then the target product profile (TPP) serves as the destination. Developing a target profile is a team activity that requires input not only from the various drug development functions, but also experts in regulatory and market intelligence who understand the competitive landscape and the changing expectations of patients, physicians, and payers.
While the TPP will evolve as development progresses, it can – and should – begin early in development with just a few basic components. A useful approach when developing a TPP is to define both minimally acceptable and best-case scenarios. The minimal version defines the attributes of the drug that absolutely must be achieved to ensure the drug is viable in the market and worth the investment required, while the best-case version is the success story which, if achieved, will generate significant return on investment.
2. Redesign Traditional Drug Business Development Through a More Flexible Model
With the integrated product development plan providing the roadmap, organizations must next address the potential operational speed bumps that will inevitably slow them down. Addressing those barriers become the next important pillar in redesigning the drug development operating model. Organizational breakdowns come down to four things:
- operating models that do not support agility and fast decision making (including models to support processes, collaboration, and governance)
- lack of technology enablement or automation of business processes
- Inability to optimally leverage data and analytics
- disconnects across functional teams that have potential to create knock-on effects on plans and timing.
Too often, the various activities, deliverables and associated decision-making involved in drug development – nonclinical, regulatory, CMC, toxicology, clinical, statistics, pharmacovigilance, market access, among others – are conducted and managed in functional siloes rather than in an integrated fashion. Functional leaders often insist on retaining decision rights regarding program resourcing and timelines for their specific deliverables thus limiting the ability to make cross-functional tradeoffs that would optimize the overall development program. A lack of integration and coordination of functional strategies and activities can adversely impact a development program. From cost overruns or delays to an inability to meet program timelines, the lack of team integration can derail plans.
In examining how best to support a more collaborative environment, organizations must first assess their operational model (employees, organization; e.g. governance), business processes and automation of processes, and data and performance measures. They must then correlate them with the right business processes, the selected available systems and the right performance measures. Finally, they need to eliminate the multiple layers of functional decision-making and functions developing their plans in a silo without considering the timing/deliverables/risks of other areas.
In an integrated approach, teams will be able to conduct activities in parallel to improve efficiencies and reduce timelines and costs. The integrated product development plan will outline strategies and key deliverables for regulatory, clinical, CMC, nonclinical, and commercial strategies, but the organization must have the proper infrastructure to facilitate collaboration – within its own walls and across its network of partners and suppliers.
3. Evaluate Your Place in the Health Ecosystem
It may seem obvious, but many biopharmaceutical companies don’t work with stakeholders early or often enough through the development process. Biopharmaceutical companies need to address how they will collaboratively and transparently work with the healthcare ecosystem, potentially carving out a new role that allows them to gain inputs all along the product lifecycle.
Aligning with the goals of all ecosystem stakeholders – healthcare organizations, regulators to shape and pilot new approaches, payers to initiate proactive conversations around evidence hurdles, and patients and advocacy groups to define endpoints that matter – helps companies to incorporate all-important considerations into the planning and decision making across their regulatory, clinical, CMC, nonclinical, and commercial strategies. Understanding the risks and potential roadblocks through the lens of stakeholders will also help organizations navigate more efficiently and reduce the barriers to market entry while accelerating the adoption of new approaches.
Given the trend toward longer development timetables and unforeseen regulatory delays, understanding how and when stakeholders should be engaged is key to avoiding roadblocks and improving the odds of success.
One area where biopharma companies are making great progress is in their collaboration with health authorities. In an analysis of pharma product launches that were targeted for 2018 onward, a survey found that 40% delayed launch because of regulatory challenges.4 While there are a number of factors for regulatory delays, companies shouldn’t be blindsided by feedback from regulatory agencies. Companies must engage as early and transparently as possible with regulatory agencies to understand their perspectives and discuss and explore potential concerns.
Agencies can become supportive resources for sponsors and researchers. Research shows that organizations that work in collaboration with regulators are more successful. In fact, there is an 84% success rate of marketing authorization applications for companies that complied with clinical trial design recommendations from regulatory agencies compared with 43% of non-compliant programs.5
4. Determine How Best to Leverage Data and Technology
Finally, for organizations pursuing transformative approaches, technology enablement can be a crucial differentiator. Automation, AI, and machine learning are revolutionizing how biopharmaceutical companies are supporting all phases of the development process and turning data into knowledge. From identifying drug targets to designing adaptive clinical trials, precision medicine to the use of advanced statistical methodologies for the development, validation and control of processes to manufacture all types of drugs, we’re at the threshold of AI informing our decisions.
But while these technologies hold the promise of accelerating knowledge, they also incrementally increase the value and usage of data on a wider scale – in creating substantial efficiencies that are just not possible through human effort alone. These technologies are also helping us mine data – both structured and unstructured – to support a number of use cases across pharmacovigilance, regulatory information management, and market access strategies where the ability to analyze a vast amount of data is crucial.
For example, using data mining tools based on natural language processing (NLP) for CMC documents and guidelines offers great potential for health authorities as well as pharmaceutical companies. Such tools offer the opportunity to automatically extract information from health authority guidelines and import that directly into regulatory intelligence systems.
The historical limitations of data have been attributed to technology locked in silos across multiple functional groups and organizations. But with cloud-based systems, organizations now have access to capabilities that allow them to better manage workflow, securely exchange data, and facilitate drug development processes across collaborators and partners. Those capabilities open the door to unlocking data insights and better informing the decisions companies make.
Streamline Processes: The Key to Accelerating Pharmaceutical Drug Development
It’s clear that pharmaceutical companies must update their infrastructures, drug development ways of working and reliance on technology to automate and speed those processes, and appropriately leverage data to make more-informed decisions. But a new way of working really rests on giving up the siloed approach and developing a more collaborative and transparent way of working. Establishing your destination – or your TPP – in combination with the key pillars outlined will guide the drug development program and ensure the team, senior leadership, and key stakeholders across the ecosystem remain aligned and focused on the end goal.
A well-designed integrated drug development process, bringing together the key activities to support a well-defined goal, maximizes the probability of delivering new therapies to patients. A bench-to-bedside holistic and cross-functional approach helps avoid pitfalls that can delay, or perhaps even kill, a program. It also helps to reduce timelines and development costs, improve the probability of commercial success and, crucially, bring life-saving or life-changing products to patients in need.
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1 Fierce Pharma Special Report https://www.fiercepharma.com/special-reports/innovation-hold-during-pandemic-fda-says-no-27-approvals-first-half-2021
2 Nature BioBusiness Briefs https://www.nature.com/articles/d41573-021-00175-8.epdf?no_publisher_access=1&r3_referer=nature
3 Tufts Center for the Study of Drug Development, https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html
4 McKinsey https://www.mckinsey.com/industries/life-sciences/our-insights/ready-for-launch-reshaping-pharmas-strategy-in-the-next-normal 5 Hofer MP, Jakobsson C, Zafiropoulos N, Vamvakas S, Vetter T, Regnstrom J, et al. Impact of scientific advice from the European Medicines Agency. Nature Reviews Drug Discovery 2015;14:302-3; https://www.nature.com/articles/nrd4621