Data-Driven Decision-Making Throughout the Pharma Life Cycle

Over half of the industry’s recently approved drugs originated from startup companies located around the world. A lot of these businesses will stumble and fail because they do not follow one fundamental guideline for success: all decision-making within the company, whether related to a drug product, advanced manufacturing technology, or marketing/business development issues, must be driven by data and science. A disconnect remains between science, manufacturability, and marketability as new product concepts are introduced and developed. Science and data are just as crucial for marketing, business development, and commercial operations, and the same data-driven methods should be employed across the entire company.

The Importance of Data in Decision-Making

What everyone must remember is that, without facts to back them up, statements are simply opinions, beliefs, and/or perceptions and may not actually be connected to the reality of the situation.

When company leaders base decisions on appropriate information using established science backed by supporting data, they avoid taking the company in the wrong direction and increase the probability of success. Decisions based on science and data can eliminate political influences that can drive decisions in directions that are best for certain individuals rather than the company as a whole. 

Whether a firm is in the drug development or contract service space, it is essential to stop and gather the necessary information that will support effective, informed, and unbiased fact-based decisions. Often, the right data can reveal imp-ortant issues that had previously escaped notice. This approach also prevents unsupported, incorrect ideas from being perpetuated, increases confidence, and results in optimized products or services.

Criticality of Current Data

However, not all data is equally valuable. The data must be current and valid at the time the decision is made. Too often companies perform initial due diligence when developing their first product to garner their first funding, but then fail to continue collecting data. Situations, technology, and markets constantly evolve, and those initial data sets are often no longer relevant.

One of the worst attitudes a company can have is to think that they know the business well enough not to need new data. That often leads to decisions being made on “gut feelings” that send a firm beyond the point of no return, where unnecessary money and time get spent and wasted. 

Four Inflection Points

For most startup companies, there are four key inflection points when current data should be gathered to inform critical decisions: concept and startup, business development, corporate development, and the final transaction. 

During startup, companies must be aware of the competitive landscape and the best funding strategy to attract investors. Once they receive their first funds, they need information to help them establish an effective company –– what people to hire, what operating systems to implement, and so on. 

In the next stage, they need to build their businesses by making the right connections. CDMOs want connections that lead to contracts with their first clients, while drug developers need to build relationships with hospitals and doctors that can facilitate clinical trials. 

During the corporate development phase, companies require knowledge about competitors and firms that would make good partners. Since the market is constantly changing, this evaluation must be an ongoing process. Establishing appropriate systems to track and monitor internal and external activities related to business development, marketing, and management can be very helpful. With this approach, it is possible to identify early on if the company is going off track and the reasons, allowing for the implementation of a course correction before the point of no return. 

Indeed, risk assessments are crucial to success and should be conducted on an ongoing basis to ensure the company is going in the right direction and taking the right approaches. Having this type of information at hand is also essential when small companies are looking to find a private equity or larger company buyer. 

Start with the Executive Team

Emphasizing the use of science and data for decision-making across all company activities must be driven from the top down. The leadership team must have an awareness of where the company is, where it is trying to go, and how it might get there. Each member of the leadership team needs an understanding of any potential unconscious biases so that facts can be built out to overcome them. 

Overall, decision-makers need to truly understand their business and the company, starting with its vision and mission. Conducting a business assessment is equally important: how big is the market and which part is the company targeting and why? Controversial conversations need to take place and the right questions must be asked from both sides of an argument to ensure that the right data — and not just more data supporting an existing thesis — will be gathered. The executive team must be willing to evaluate whether the business concept is really as good as initially thought or if there are disrupting factors that could influence the business going forward.

Gathering Data

There are vast quantities of data available for use in decision-making about every aspect of a company’s operations. Regulatory authorities provide a wealth of information, as do numerous other external and internal sources, including customers, regulatory compliance, laboratory, manufacturing scheduling, and other management systems. Supporting data can also be collected by bringing experts from each department within a company together to assess how existing processes and systems are perceived by different groups. Gaps in communication and data sharing can be identified and readily fixed, thus eliminating inefficiencies.

We partner with our clients, including contract service providers, venture capital/private equity firms, and drug product companies, to generate market and business intelligence data, business strategies, and business plans; coach leaders and their teams; and even develop board and investor presentation materials.

Neutral Advisors

A neutral third party can play an important role in identifying problem areas and what data is needed to address them. They can also raise important issues and make suggestions that people invested in projects are unable to. 

AKDYS was founded to serve as this type of neutral third party. We partner with our clients, including contract service providers, venture capital/private equity firms, and drug product companies, to generate market and business intelligence data, business strategies, and business plans; coach leaders and their teams; and even develop board and investor presentation materials. We passionately support our clients to transform their ideas into successful realities.

We offer support at all four inflection points from concept and startup to the point of transaction. We can help with product/service market intelligence research; competitor, benchmark, and supply chain analyses; and the development of funding, business planning, and marketing strategies. 

AKDYS also provides market insight training and executive leadership mentoring, ongoing business and intelligence marketing support, and advice on business contracts and setting targets and budgets. We can help assess product, customer, and/or service portfolio mixes and values, define key differentiators, identify critical risks, and advise on internal and external growth strategies. 

When companies are ready for the transaction process, we can provide advice on an appropriate exit strategy and timing, help develop management presentations, prepare the executive management team for interactions with buyers, and support due diligence efforts. Bringing in AKDYS as a neutral advisor helps ensure that decision making is truly data-driven and free of undesirable political influences so that the right data is used to make the right decisions at the right time. 

Stephan Kutzer, Ph.D.

Dr. Stephan Kutzer is co-founder and principal of AKDYS LLC, a data led pharma and biotech boutique advising firm, supporting its clients throughout their product and services life cycle. Dr. Kutzer has over 25 years of experience in the pharmaceutical and biotech industry, building and managing successful CDMO/CMO service enterprises. Prior to AKDYS, Dr. Kutzer was CEO of Alcami and COO of Lonza’s Pharma and Biotech division. Dr. Kutzer earned a master’s degree in chemical engineering and a Doctorate (Ph.D.) in engineering sciences from the Technical University of Munich, Germany.