Guiding Principles for the Development of Highly Innovative Biopharmaceuticals – an Overview from a Program Management Perspective
From the very beginning of the COVID-19 pandemic, biopharmaceutical development companies have been at the forefront of developing effective therapies to prevent and treat SARS-CoV-2 infections. The development and approval of vaccines against the SARS-CoV-2 virus were of critical importance and supported by global and national initiatives including substantial public funding. As a result, also innovative therapeutic approaches entered into clinical development – with great success – in particular the application of mRNA technology in the field of vaccines.
SARS-COV-2 MRNA VACCINES – AN EXAMPLE OF HIGHLY INNOVATIVE BIOPHARMACEUTICALS
In close alignment with regulators, vaccine development for SARS-CoV-2 could follow an accelerated timeline (Figure 1, Krammer 2020). Because of knowledge gained from the initial development of vaccines for SARS-CoV and MERS-CoV, the discovery phase was omitted. Existing processes were adopted, and Phase 1/2 trials were started. Phase 3 trials were initiated after the interim analysis of Phase 1/2 results, with several clinical trial stages running in parallel. In the meantime, vaccine producers could start the large-scale production of vaccine candidates, at risk.
EXHIBIT 1 | Traditional and accelerated vaccine-development pipelines.
PRODUCT APPROVALS IN RECORD TIME
As of August 2022, a total of 6 SARS-CoV-2 vaccines have been approved in the EU. 4 out of these 6 vaccines had been developed and approved in approximately 10-13 months (Exhibit 2). In contrast to other development programs, these extremely fast development timelines raise basic questions:
What are the success factors of these biopharmaceutical development companies to develop products in record time?
What are the key learnings for biopharmaceutical development programs to accelerate the development and approval?
What are major impediments within an organization or from the outside that could slow down or even make a development program fail?
EXHIBIT 2 | Overview of approved SARS-CoV-2 vaccines in the EU and estimated timelines till approval.
CHARACTERISTICS AND CHALLENGES OF INNOVATION MANAGEMENT
In general, innovations significantly differ from other projects which involve repetitive routine decisions. Innovations specifically raise novel challenges for their management and confront a company with several barriers throughout the innovation process. Consequently, innovations require another type of management in comparison to repetitive routine decisions (Hauschildt, 2010).
Innovations are related to a high degree of novelty and uncertainty.
Innovations are based on knowledge which has to be complemented by new knowledge to decrease their complexity and risk of failure.
Due to their newness, innovations have to be established within a market for commercialization as well as in the company during the innovation process.
Especially innovations with a high degree of newness, such as radical innovations, impose these managerial challenges on innovation management (Leifer, 2000).
PROGRAM MANAGEMENT AS FACILITATOR FOR HIGHLY INNOVATIVE BIOPHARMACEUTICALS
The development of innovative biopharmaceuticals poses unique challenges to development companies and teams working on such a program. Each company, technology, and product has specific features that influence the path of the development program such as the maturity of technology, funding, or resources assigned to the program. But, there are several guiding principles that teams developing innovative therapies can follow right from the program start:
Assemble and develop a high-performing and committed program team that embraces change.
Prepare an integrated development strategy that fundamentally reflects the science of the product and of all required development activities (to be discussed with regulatory authorities).
Prepare a robust program plan that is aligned within the organization and that includes agile planning elements.
Set up a clear and lean program governance and decision-making process.
Continuously assess and manage risks and handle issues - be prepared for surprises.
Empower the program team to keep the program on track and to remove roadblocks.
Use effective program management tools that provide clear guidance to the program team and that transparently report relevant information to all stakeholders.
In summary, the successful development of innovative medicines requires a company culture and organizational framework that enables program teams to effectively drive innovative development programs. Besides the support from the company’s Senior Management, Program Management plays a pivotal role as a facilitator of innovative biopharmaceutical development programs and deliverer of critical program goals.
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EMA (2022): Authorised COVID-19 vaccines, retrieved from website in Aug 2022.
Firgens, M. (2012): The Management of Ideas in the Front End of Innovation – a Case Study About the Creation of Innovation in the Pharmaceutical Industry, Master Thesis - Master of Business Administration in General Management.
Hauschildt, J.; Salomo, S. (2010): Innovationsmanagement, 5th edition, München.
Krammer, F. (2020): SARS-CoV-2 vaccines in development. Nature 586, 516–527.
Leifer, R. (2000): Radical Innovation: How Mature Companies Can Outsmart Upstarts, 1st edition, Boston.
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