Open Innovation’s Role in Development and Go-to-Market Strategies

By Dr. Bethany Valente, founder and managing partner of Tempo7 LLC

Biotech and biopharma-based businesses face many challenges as they work to improve timelines for products, therapies, or drug development. One major challenge includes developing a deep understanding of national innovation systems and regulations and working within them to expedite approvals.

The industry struggles with gaining access to hidden knowledge to help them advance scientific or regulatory processes related to new developments. Additionally, it can be difficult to achieve patient equity, which ensures that patients of all backgrounds and socioeconomic statuses have access to research and development stages.

Having the right systems in place can solve these complex challenges: “The internet of medical things,” hospital and clinic devices, wearables, and implantables all collect data and could potentially detect an oncoming stroke or another medical issue. These are important insights that could change the medical community forever.

How Can Data Best Be Used?

Naturally, this raises the following questions: How can researchers access the wealth of patient data available from medtech devices and use it ethically in R&D practices? And how can researchers utilize qualitative data to ensure improved access at a faster rate to those positively impacted by a therapy?

The answers lie in open innovation, which requires decentralizing innovation to move R&D forward. For many researchers, open innovation cuts costs, expedites time to market, increases product and treatment differentiation, and increases overall revenue.

The biopharma industry largely focuses on patients, and open innovation allows it to explore improvements to patient equity. The customer’s problems are the focus of development efforts. Patients are the center of the development process, but they usually only participate in the clinical trials and commercialization stage due to certain regulations.

Partnering with a medtech company to get approval is one way that researchers can engage patients in the early stages of R&D, such as earlier access to patient interviews and critical insights into the effectiveness of particular therapies. When executive leadership, R&D leadership, and additional innovation leaders engage in partnerships or other open innovation strategies (such as collaborating with patients), they offer the necessary diversity in the participants being researched to arrive at a solution that incorporates patient equity.

Comprehensive Innovation Strategies and Open Innovation

“Open innovation,” according to the theory’s creator Henry Chesbrough, happens when the organization creates, develops, builds, markets, distributes, services, finances, and supports these ideas both internally and externally. If the organization examines each process and learns how to innovate in each one of them, it will successfully embrace an open innovation strategy, gain efficiencies, and limit risk.

A recent example of a comprehensive approach to open innovation strategy is the Pfizer COVID-19 vaccine. Pfizer issued its five-point plan, which embraced open innovation in all areas of development, and provided open access tools with the scientific community, access to its clinical trial, and regulatory expertise to support smaller biotech companies in development efforts. It also fostered communication and alliances with regulatory agencies to facilitate a rapid response team.

The result? Pfizer developed the first FDA-approved vaccine to market by utilizing the Illumina genomic sequence of the virus within 48 hours to begin research, partnering with BioNTech to access the hidden knowledge of mRNA technology to develop the vaccine, and leveraging the U.S. national innovation system (Operation Warp Speed) to gain needed funding for its research.

Integral Strategies for Sustained Success

Companies may face difficult hurdles while trying to bring a drug or therapy to market on their own. Here are four strategies for innovation leaders to consider in order to achieve their goals:

  1. Invest time in creating an open innovation strategy and company culture.

Looking back on Pfizer’s success story, it is clear that the company had a five-step plan that it could enact quickly. Also, its executive team identified what Pfizer’s core competencies were and where it needed assistance. The plan worked because it was concise and easy to understand.

  1. Evaluate challenging development pipeline projects.

Is the project stuck because it needs new knowledge applied to the project? Is it too high-risk for the company to take on by itself, or does it need funding to get the project to market? These are all opportunities to understand competencies and search for partners with additional expertise. Remember, this can occur at all points in business processes.

  1. Prioritize the patient equity perspective.

Look creatively at partnerships to learn how to include the patient in the early stages of R&D. For example, AstraZeneca partnered with PatientsLikeMe for its lupus development process. It was able to improve its informed consent process and took multiple patient recommendations throughout the development process in new ways. Something as small as improving an informed consent process might be the difference in whether a patient chooses to participate in a trial.

  1. Evaluate your ecosystem for opportunities.

Are you holding your intellectual property so close to the point that it’s prohibiting new developments? Are you willing to work with other innovators who can help you consider the total patient experience and speed to market? Understanding how you are partnering with other companies will assist you in developing better solutions.

At first glance, the idea of open innovation can seem daunting. It’s hard for companies to let go of their “best-kept secrets,” but holding onto these secrets may be preventing groundbreaking innovation. Instead of forging ahead on your own with a new drug or therapy, consider partnerships and how they add value to the entire patient experience. Isn’t that the most beneficial outcome for all parties involved?

Dr. Bethany Valente

About the author

Dr. Bethany Valente is the founder and managing partner of Tempo7 LLC, an innovation strategy consulting firm that develops strategic initiatives and uncovers growth opportunities through the Open Innovation Opportunity Program. Tempo7, LLC, helps biotechnology, pharmaceutical, CROs, and legal professionals to become industry leaders in today’s global, dynamic marketplace. She is currently co-authoring an academic article on the topic of national culture, national innovation systems, and open innovation strategy.