The predominate focus of an early stage life sciences on their path to commercialization is on two fronts. The first is on the scientific, technical, and regulatory areas of drug development and the other is on capital raising and investments to keep the strategic vision and purpose of the company alive. The focus does not dissipate for many years and it continues through the stage when the therapeutic candidate is accepted for regulatory review by one or more health agencies. Interspersed though these critical and dynamic stages as the therapeutic candidate transitions along to the final stages of clinical development are decisions pertaining to the organizational structure of the supply chain, operations, and quality functions. These functions will play a vital part in not only enabling the company to cross-functionally support their first drug candidate but drive sustainable strategies, goals, and objectives that can be value differentiators for the company over its lifespan.
Proactively developing a strong organizational foundation or backbone for these business functions that has the capability to scale as the company matures is a critical piece of the complex ecosystem of an organization that does not get the full attention and investment it deserves. Unfortunately, it takes a lot of iterations and resources to get the foundation built and developed, leading to immediate negative opportunity costs when the company is at its early stages of the commercial product lifecycle. This paradigm requires an immediate correction since the risks to a pre-commercial company success is high. Supply Chain, Operations, and Quality are the back-office engines of the company and the sooner it focuses, funds, creates, and scales these vital functions throughout the drug development process, the better position the pre-commercial company will be when transitioning into a commercial one.
In the early stages of formation, the company needs to proactively establish a departmental strategic roadmap or playbook that lays out the infrastructure requirements at each stage to ensure, at a minimum, that resources are available to achieve objectives. As the path to commercialization approval becomes clearer as the therapeutic candidate meets its objectives, the organization needs to build the operational and quality infrastructure at a larger scale than what was in place to support Phase I through Phase III. Due to the uncertainty of success and the dynamic nature of these early stages, investments in infrastructure, such as policies, processes, systems, partnerships, capacity, and redundancy, may not be robust but minimally conducive to achieve the desired goal.
As an example, in the Discovery Phase and Phase I respectively, automated Operation and Quality systems, such as ERP and QMS, may be too large of an investment due to the size of therapeutic candidates in the portfolio and the size and scope of the clinical trials. Paper-based or minimal system investments and integrations is usually how companies support these phases. For Phase II and Phase III, a greater emphasis on automation (e.g. ERP, LIMS, QMS, etc.), partnerships, and network redundancy and resiliency (e.g. internal/external manufacturing, multiple raw material suppliers) may be required since volumes, stakeholders, and complexity begin to increase. There is no universal approach as to what will be required in each stage since each therapeutic candidate has different characteristics, each company’s capital position will be different, and each company’s investment strategy will be different. Despite the variations, there are proven tools and methodologies that can support the identification, design, and acceleration of a company’s immature back office infrastructure to one that will be capable and agile to support their commercialization requirements.
Playbooks are tools that contain all the pieces that a company needs to be successful to accelerate their path to commercialization. It’s a documented list of the proactive plans a company will initiate in order to meet it objectives. For the fundamental departments of Supply Chain, Operations, and Quality, there are three critical sets of playbooks that have proven to be critical in transitioning from pre-commercial to commercial, allowing the organization to align on common strategy, standard processes, structures, information and data flow, and enabling systems.
1. Back Office ERP for Pre-Commercial Organizations
Readying the organization for the scale and transactional volume that comes with commercialization could be overwhelming. A robust fit-for-purpose ERP selection, implementation, or SaaS solution playbook for ERP within the Life Sciences industry alleviates many concerns. An ERP that has predetermined solutions specific to the industry, with preselected out of the box, preconfigured routines, and basic yet applicable process enabled technologies can fit the needs that will be immediate upon commercialization. Examples of these include inventory management (e.g. location visibility, expiration dating), demand and supply planning tools, order management, and financial and accounting capabilities. Not only does this solution allow the organization to move and meet the pressing deadlines of commercialization, but it will get the organization ready to scale and grow, while avoiding ongoing switches from one platform to another. Selecting the right fit for purpose ERP and applying a playbook to keep processes standard and data structured in a simplified way will allow evolution and migration to the right scale ERP for the business.
Long gone are the days of multi-year ERP implementations. Leveraging a playbook and accelerators will significantly reduce the timeline and allow the organization to tackle the traditional longer polls in the tent, such as data cleansing and transformation, testing and validation, and change management. It will ensure the organization is ready to meet the deadlines to go commercial by following standard practices and leveraging templates, tools and accelerators.
2. LIMS on the Path to Commercialization
Similar to a back-office ERP, a fit-for purpose LIMS selection playbook will alleviate a large amount of concerns for a company transitioning into the commercial space. Efficiency solutions in sample and inventory management, instrumentation, reporting and certification, and tracking will enhance the quality oversight and assurance the company will need to meet quality and regulatory standards. It will also streamline decision making and reduce cycle times for batch releases, providing a competitive advantage in providing critical therapeutics to wholesalers when they are needed.
3. Going Digital in a Pre-Commercial Company
Starting a digital footprint immediately upon commercialization should be seen as an opportunity rather than a daunting task. Avoiding the opportunity to set up processes digitally first will prove to be more costly in the long turn. Going digital is not an easy task but leveraging a fit-for-purpose playbook can help a pre-commercial organization focus their time, money, and energy in enabling the right processes digitally, tapping into proven templates, process guides, and selecting the right technology providers in the market. Accelerating the selection and execution while keeping processes simple will prove to be an invaluable decision. Starting digital will allow the organization to scale processes over time and sustain them as new products, whether via R&D or acquisitions, join the commercialized portfolio. Digital has many applications in Supply Chain, Operations, and Quality, including network modeling and simulation via digital twins, predictive analytics, product tracking and traceability, and data collecting and reporting.
The pre-commercial life sciences market is crowded with a multitude of organizations making a furious sprint towards successful commercialization. Focusing resources and investments on the company’s science and technology competencies in the early drug development stages to ensure critical milestones are met is paramount; however, as the success of a therapeutic candidate becomes clearer as it transitions through the development stages, it’s never too early to begin developing a roadmap or playbook for the design and implementation of the supply chain, operations, and quality functions. The sooner these areas are identified, addressed, and funded, the better the organization will be at meeting the inevitable challenges on the path to commercialization. Leveraging the three key playbooks is a smart but pragmatic methodology that could make a difference between success or failure.