Lessons learned at ISPE 2019 Europe Biotechnology Conference.
The landscape of the pharmaceutical industry is evolving very fast in today’s world. The evolution of biopharmaceuticals (large molecules) has become a main pillar next to the small molecules. The introduction of these biopharmaceuticals has a big impact on development, technologies, operations, production and analytical test methods. The changes due to these new products is a constantly evolving process that is also impacted by the growing digitalization of the industry.
This new level of medicines like cell therapies, gene therapies, personalised medicines will have a huge impact on the treatment of diseases.
On the other hand, there is the technical evolution, such as new sophisticated medical devices, including wearables, that are designed to have the ability to collect real-time data. Because of the interest of tech companies in healthcare industry these types of developments continue to have an accelerated growth. For example, Google founded the companies Calico and Alphabet that subsequently founded Verily Life Sciences. Recently Verily has partnered with GSK to form a new drug company, Galvani Bioelectronics.
All these new developments generated a lot of changes over the last 30 years. In the past, getting a production line up and running was easy. Today, there is more complexity due to evolving technologies, regulations, mindset & behaviour, deviation & CAPA handling. This complexity leads to a paradox in the driving forces:
All these new developments in medicines demands agility in a very constrained, highly regulated environment.
The pharmaceutical industry demands a high-quality standard, matching a cost, but prices are more and more under pressure.
For rigid organizations it’s not easy to manage millennials who want to move fast and are not scared to change jobs.
Long term investment in contrast to short term return.
To cope with all these changes, we need to strive to a collaborative culture.
Employees must be involved to help optimize and simplify the processes by using their knowledge and experience instead of just letting them perform tasks. Besides this, we need to understand why people behave in a certain way to change their behaviour. One of the most important behaviours is trust, especially for the younger generation, this in combination with freedom to operate, the feeling of having an impact and a well-defined growth path. In order to make this work it is very important to bring generations together, each generation bringing their own strengths. The combination of these strengths is of a high added value. One of the final goals is to reach compliance by responsibility.
This culture doesn’t stop by the employees but is also extended to the suppliers and regulators. Suppliers will need to understand that there is more needed than only a contract, a partnership must be in place, this way they can be fully integrated in the supply chain. For regulators, there must be a collaboration based on mutual trust.
How can we make our capabilities more advanced? To answer that question, we have to rethink the way we train people and how information is available for them. Everybody recognizes the fact that you must read a hundred SOP’s when you start a new job, when you finalized this task your status is ‘trained’. You can question yourself if that’s the fact? What do we need to do to increase our capabilities? Besides reading SOP’s, we need to investigate new technologies (augmented reality, portable devices, …) to make the information available at the moment the employee needs it. These new technologies can function as a second brain and will lead to employee connectivity. In other words, we will transfer additional intelligence to the employee.
If you want to innovate you have to reward innovators and that in all layers of the company. Do not underestimate the power of positive reinforcement. To make innovation possible you need leaders who can enable growth of others. In this case you don’t need to hire Mini-Me’s, instead you need diversity and inclusion. A collaborative culture in combination with advanced capabilities are a good breeding ground for innovation. It is also good to monitor innovations in other industries.
If you want to increase the speed to implement innovations, you better use prototypes. This will help you to refine your innovation before you deliver your final product.
Pitfalls for innovation are:
Failure to look ahead
Lack of focus
Getting stakeholders engaged early and frequently
How will we prepare our production plants for the future? Jakob Harttung from Sanofi described 5 pillars to build the factory of the future that will be digitally enabled.
Integrated industrialization: More sophisticated process technology that allows you to use advanced data analysis solutions to further improve the quality, yields and reliability.
Connected plant and equipment: Real time asset performance and data driven supply chain will lead to increased capacity and optimized plant cycle times
Smart quality: Use of inline sensors allows multiple measurements of various data and parameters. Thanks to these sensors all irregularities are spotted immediately and corrected, this to avoid any negative impact on the final product (striving to the golden batch).
Connected teams and operations: Technical solutions are present to augment operators with additional capabilities. For instance, the integrated industrialization model makes it possible to train operators even before the plant is build (digitized training). Paperless solution and electronic batch records that enhances easy review and in time release.
Real time data: Continuously monitoring of data allows a better understanding of the complexities of the process. Real time process control is possible via interactive screens that are linked to the data.
How are new technologies implemented?
First phase: there are lighthouse sites where they build a digital product with new operating routines
Second phase: the new technology is rolled out in the early adaptor’s sites
Third phase: there is the scale-out to the other sites
An interesting link was made to the ‘Tesla deep learning model’ on how Tesla is gathering data from the sensors present on all their cars to improve self-driving capabilities. Even if this functionality isn’t active the sensors are sending data. This way Tesla created a real-life testing environment that they use to improve the quality of future cars.
Lesson learned here is that if we want to guarantee reproducibility each time we produce a batch, we need to gather real-life data. This data is then analysed and based on those results the process is adjusted.
With this digital transformation we need to review the way we validate a process/equipment. Something to think about: why do we still perform manual actions and create a ton of paper to validate digitized systems?
The fast evolution in biopharmaceuticals in combination with the digital transformation will have a huge impact on the way we are working today. To cope with these future challenges in the pharmaceutical industry we really need to create a collaborative culture, we must increase the advanced capabilities of the employees by implementing new technologies and we have to embrace innovation. In other words, we have to invest in people and technology, one does not go without the other.
Besides all this we need to connect the plant, equipment and operations to the different teams so they can make their decisions based on real-life data to produce in a more qualitative and cost-efficient way.
Senior project manager @ pi