Life Sciences CIO


If you ask most people in an organization what they think of their IT department, more often than not, the response will be something like “they suck”. This perception is particularly apparent in most Pharmaceutical or Biotech companies due to heavy and strict regulations that prevent agility and speed in technology decision-making and progress. Resource availability (both budget and employees) in small to mid-sized Life Sciences companies are even more constrained, which further escalates the difficulty for IT to help create efficiency and deliver IT value to the organization. Small start-up companies have the advantage in IT to have a relatively blank slate in building their IT infrastructure. With the introduction of cloud and Software as a Service (SaaS) solutions, these small start-ups with little to no application architecture can start lean and grow in parallel to the rest of the organization. However, small to mid-sized companies typically have an existing infrastructure that is not only inundated with technical debt and outdated technology, but also has to fight the complete lack of trust in IT, making an IT transformation an extremely difficult battle.

Nevertheless, if you understand the problem and the root causes well enough, there is a path to make IT “not suck” and become an innovative function within the company.



A few nuances make a pharmaceutical or biotech company different to support from an IT perspective. It is critical to understand these nuances to ensure that IT becomes more than just a back office function that performs infrastructure or helpdesk services.

Pharma Differentiator Description IT Implication
Speed to Market The need to perform a very complex and long drug development process to discover, test and get approval to sell as quickly as possible, to maximize the possible lifespan before the patent expires and the product goes generic. It takes a massive amount of investment to bring a product to FDA approval (~ 7 years) and resources. From thousands of possible compounds or molecules, there may be one good idea that proves worthwhile in the years to come. IT needs to act quickly while still abiding to good IT practices and more importantly, regulations that often come with implementing and controlling a validated system.
Importance of Intellectual Property Efficient collaboration between external parties becomes extremely important for managing expectations, sharing relevant information quickly, and taking action, all while ensuring tight compliance to regulations and laws and protecting our intellectual property. IT needs to have a strong handle on data governance and policies to ensure that proper IT controls are in place to prevent the loss of intellectual property. Proper user training is also extremely important.
Partnerships Managing Investors expectations and strategic partnerships with other pharma companies, research institutes, study sites and regulatory bodies become critical. Collaboration tools are important because they enable efficient communication. Policies must be in place to not only prevent loss of intellectual property, but also ensure that no information is stored that can later be used for a legal investigation.
Dynamic Business Strategies Company strategies and imperatives can shift at any time. A new business development opportunity can quickly add merger and acquisition efforts. A new product could launch a shift to commercialization efforts. An FDA audit can shift attention to producing documentation and data. IT must be ready to shift resources quickly and have proper architecture and documentation of their infrastructure and applications at all times. This is not only required by law, but also helps with agility and speed.
Strict & Heavy Regulations Life sciences companies must adhere to and follow GxP practices to ensure that any computerized system is developed, validated and operated appropriately for the intended use of the system. Excellent working knowledge in GxP systems and risk areas in the function is critically important, in addition to the normal technical knowledge needed to support a system. Strong processes and controls must be defined, followed and audited.



An IT organization’s definition of success is directly correlated to its ability to add value to corporate results – in other words, IT wants to add competitive advantage to the organization. An MBA student will tell you that there are three ways for an organization to create a competitive advantage in a market:

  1. Cost Leadership– winning through becoming the lowest cost producer in its market
  2. Differentiation– winning by being the only player with a unique product that consumers want to buy, and therefore, by demanding a premium price
  3. Focus– winning by combining cost leadership and some differentiation, but for a narrow and specific target

Unless you are in the business of making, selling or distributing generic drugs, a pharmaceutical or biotech company is typically in the business of winning through fulfilling the unmet needs of patients (a.k.a. differentiation).

So how does a pharmaceutical company create value and whencan it profit?

Due to the relatively long time it takes to take a differentiated product from concept to commercial viability in a highly regulated industry (approximately 7 years) andthe short window a company has to reap the profits before the product’s patent expires and goes generic, a company’s success is largely based on two drivers:

  1. Throughput– how many viable product candidates can be created or acquired in a company’s product pipeline
  2. Efficiency– how quickly a candidate product can get to market to maximize the longevity if its patent life

As a company slowly moves through the steps of the value chain, it takes on new IT challenges, which require an evolution of IT capabilities. The evolution does not only involve the technology, but also the skillsets of employees, process maturity model and IT organizational model & culture.

Evolving the IT organization is an ongoing struggle of balancing operational day-to-day responsibilities, implementing new projects and technology to support the organization’s needs and maturation, and the organizational transformations that need to take place to prepare for the future.

A successful IT organization is one which can consistently add to whatever competitive advantage is needed at the time, but also manage the balance of those three pillars of evolution.



There are typically a few standard types of IT goals in a small to mid-sized pharmaceutical company that directly support a company’s competitive advantage:

  • Efficiency Goals– leveraging technology and business process transformation to make a business process more efficient. Examples:
    • Improve the efficiency of the drug discovery process by 30% by end of Q2 with a payback period of 2 years or a return on investment of 30%.
  • Quality Goals – improving the quality of a business process and minimize errors. Examples:
    • improve the quality of clinical trial data by 30% by end of Q3, by adding technology controls and effective user training for CRAs.
  • Effectiveness Goals – similar to quality goals, effectiveness goals improve a decision-making process, by improving the usability or quality of data. Examples:
    • increase the patient engagement metric by 25% by creating a single view of the customer which will improve the relevancy of targeted messaging.
  • Risk Management Goals– investing in risk mitigation, security or business continuity efforts to ensure the security of data and resources, avoiding risk of downtime or errors and ensuring uninterrupted business continuity. These goals can be similar to quality goals but are expressed in terms of avoiding potential costs or risks to the organization. Examples:
    • reduce the risk of security breaches with a potential cost avoidance of 25%.
    • ensure that business critical systems have a 99.999% uptime by end of Q1.
    • ensure that all IT general controls are satisfied with no deficiencies by end of Q2.



IT Departments in small to mid-sized Pharma companies face some unique challenges which make it more difficult for them to operate effectively and produce competitive advantage for an organization.

  • Prioritization & Resource Allocation– As a service function that serves the entire enterprise, IT is oftentimes facilitating corporate prioritization and governance.
  • Regulations– strict and heavy regulations in life sciences prevent the speed and agility that is expected of an IT function to innovate the organization. Producing a validated system adds a minimum of 30% to the cost and timeline of a project, and oftentimes it can add significantly more. For that reason, projects are oftentimes delayed and over budget.
  • Technical Debt – due to the implications of regulations, IT departments in life sciences are oftentimes burdened with massive technical debt. This goes beyond the typical company’s technical debt which can be solved with increasing resources or budget. They are so invested in their technology platforms, that it is extremely difficult to move to a newer system. This is beyond the typical challenges that occur with application portfolio modernization with difficulties of data migration or integrations.
  • Resource Capabilities– as the application portfolio and architecture grows and becomes more complex, so does the need for skilled support resources. Unfortunately, growing the IT organization with new headcount is not always an option. The paradigm often has to shift from having technical employees on staff to having management resources on staff who manage external staff augmentation or managed services vendors. With this comes a cultural change for business stakeholders who are used to the VIP, hands-on support that an employee can provide. All they have to do is walk down to the employees desk and ask to get something done vs. having to follow a structured process with escalation points and SLAs.



IT guiding principles help an IT organization understand how decision-making occurs in IT. This is not only important with the internal IT team, but also with external stakeholders when they do not understand why “IT sucks” or cannot deliver per expectations.

Guiding principles work best if they are not only written down and communicated across the organization, but can also be recited and explained by everyone in IT in day-to-day conversations. This is how trust is built with business stakeholders, because they understand from which decision-making paradigm IT is coming from. Just like it’s important for a spouse to understand your principles and morals so that you can operate efficiently and independently without constant conversations about how to approach a certain issue or situation, it’s also important for your customers to understand the same thing. They may not always agree, but at least there is an understanding.

There are many kinds of guiding principles that can be defined in an organization – team guiding principles, project guiding principles or imperatives, core values and more. But the most important principles that are generally most misunderstood between IT and business stakeholders, are technology architecture principles. Architecture principles guide how good technology investments are vetted, made and integrated. They also guide the IT team around how to implement and integrate technologies. When to insource a capability and when to outsource. When to custom develop and when to buy a standard off-the-shelf package. How to manage data and govern data decision-making.

The following are guiding principles that are especially useful in small to mid-sized pharmaceutical companies to manage team expectations in IT. These are typically seen as changes in IT organizational culture as it progresses in maturity and in building stakeholder trust. The following are some team core values that are especially relevant when managing the cultural shift:

  1. We focus on outcomes
  2. We value quality over speed
  3. We aim to be proactive vs. reactive
  4. We do our homework before making decisions
  5. We document everything
  6. We value teamwork and partnership
  7. We lean towards over-informing vs. under-informing

The next set of principles are technology architectural principles. They help in decision-making around which technologies to choose and what are the determining factors that are relevant in small to mid-sized pharmaceutical companies. The following are some examples of relevant ones:

  1. Opt for out-of-the-box functionality that meets the majority of business needs and minimize customization.
  2. Find established vendors and technologies that have specific experience in pharma and life sciences, specifically around GxP processes and templates.
  3. Favor pre-validated systems.
  4. Favor cloud-based systems over on-premise systems.
  5. Make technology selection decisions only after we understand the entire value chain that the technology supports.

Each organization should certainly create their own relevant principles based on their current technology architecture, maturity and goals. The important factor is that they exist.