5 Points For Devising An Effective Pharma 4.0 Program Proposal

By Davide Smaldone

In general, innovation can be tricky; the potential risks are evident and easily measurable while the benefits are sometimes only qualitative and rarely quantifiable. Pharma 4.0 technologies are no exception to this general rule. If a company is implementing Pharma 4.0 technologies for the first time, it may be difficult to estimate the possible benefits of the project, considering:

1. Not all the potential benefits are clear before implementation.
2. Potential benefits are clear, but their impact on the product/process can’t be precisely estimated.
3. Benchmarks on the market are rare and information limited.

All those points further make it difficult to establish a strong business case for Pharma 4.0 projects. That’s why many programs start with multiple proofs of concept with a limited number of technologies selected based on elements such as the digital maturity level of the company, its business needs, and its current infrastructure.

The ones that do present a positive net present value bear a percentage of risk related to the assumptions made during the business-case creation. Benefits could have been overestimated, some activities necessary to the project’s execution might have been overlooked, or the effort necessary to implement the project not correctly estimated.

Still, despite a Pharma 4.0 program being a risky endeavor, those early movers will be able to gain significant competitive advantages — if the initiative succeeds. Therefore, it’s important that potential opportunities are caught and exploited as early as possible.

Getting upper management buy in to a Pharma 4.0 initiative is not always easy and might become particularly hard when a key decision maker is adverse to risk. So, what elements should be leveraged to devise a well-structured Pharma 4.0 program proposal? Here are five points to remember:

1. FOCUS ON WHAT YOU NEED: Not all companies need a Pharma 4.0 transformation program. Starting a 4.0 project always should be tied to solving actual business needs. In too many cases, companies try to push 4.0 projects top-down, even where clear needs are not present. These projects will most certainly fail since no one will take ownership of the initiative or fight to make it succeed. The best place to start a Pharma 4.0 program is your current project portfolio. If you have a company idea management application, look there for ideas that were collected, deemed useful, and then discarded because no traditional applications and/or tools were available to implement them. Or, look at the projects that have been discarded along the project management funnel for the same reason. These represent concrete needs for the company that could not be satisfied due to lack of a suitable technology. All of these examples are good starting points since they identify proven business needs. Focus on two to five initiatives as the first projects of your 4.0 program. Give precedence to relatively simple projects that will demonstrate the viability and positive impact of 4.0 technologies. If you are not able to identify any initiatives, this might indicate that a Pharma 4.0 program is not needed for your organization.

2. FOCUS ON BUILDING SYNERGIES: Once you have identified a set of possible initiatives, try to identify what synergies could be built among them. The use of Big Data, for example, could be both a way of answering a specific need of the company as well as the basis for additional projects that will require enhanced data analytics. Another example is augmented reality, which could be used to gather information on process execution or maintenance activities. Such information could be fed back into the plant data pool and used to identify new correlations and areas of improvement. Keeping Pharma 4.0 efforts localized, furthermore, will contribute to develop a 4.0 culture that will foster innovation and allow new opportunities to be identified.

3. BE AGILE, WHEN POSSIBLE: The use of agile methodologies has been increasing for the last five to 10 years in most industries, and they are now making their way into the pharmaceutical industry. Agile focuses on breaking down bigger software implementation projects into smaller packages that are implemented in sequential waves. Doing so allows the users to benefit from the new application’s functionalities even as it is being developed, starting with a few features and then progressively adding new ones until the project’s completion. This approach has proven to be very effective and quickly delivers value to business stakeholders. The main problem of using agile methodologies in the biopharmaceutical industry is related to validation. Incremental implementation waves may create the need for revalidating the application after new functionalities are delivered, therefore increasing the effort both on the technical and the business sides. Agile enables you to reap the benefits of the new technology early on in the implementation process, thereby supporting the business case and detecting initiatives that are not worth pursuing before the whole project is finished. Consequently, you are able to focus your efforts — and budget — on other more-promising projects.

4. CHOOSE YOUR CHAMPIONS: People are the driving force that lies behind any project or program, and a Pharma 4.0 initiative is no exception to this rule. Choose your Pharma 4.0 champions wisely. These people will be the ones in charge of driving change within their function or organizations. They will be responsible for representing the functional side of the problem and steering the technical team in the right direction as each problem gets analyzed and solved. Pharma 4.0 champions will work as ambassadors with other people within the company, highlighting the advantage of the new technologies and stimulating idea generation for additional initiatives. If possible, 4. 0 champions should be allocated full time to the program and be representative of the different functions the program will impact. Usually participants from production, QC, and QA are a good starting point, but the right mix and composition is highly dependent on the initiatives included in the program.

5. GOVERNANCE, GOVERNANCE, GOVERNANCE: Especially if the Pharma 4.0 program will involve more than one production site, it will be very important to develop a strong and reliable program governance that will allow the program manager to:

a. monitor the progress of the different initiatives

b. anticipate problems and proactively act to prevent them

c. detect conflicts and take the needed action to solve them

d. collect ideas for new initiatives that are generated by the project teams.

Communication plays an important role in program governance as well. It will have to be directed both inward toward project and program members and the Pharma 4.0 steering committee, but also outward toward the overall organization in order to reach people who are not directly involved in the 4.0 program and might not Be aware of its nature, objectives, and/or results.

It’s imperative to spread the word and generate new opportunities to be fed into the program as it progresses. A strong governance is the backbone of a good Pharma 4.0 proposal and should be carefully thought out.

DAVIDE SMALDONE is corporate demand manager at Italian pharma The Menarini Group.