Part 1: PDA Europ. Annual Meeting '18

Pharmaceutical Industry Highlights - Past, Present, Future

Outstanding! This is my one-word summary for the PDA European Annual Meeting 2018 last week in Berlin. In this first article you read about the pleanary session on Pharmaceutical Industry Highlights - Past, Present, Future. Get snapshots of topics presented in Berlin.

Future Opportunities and Directions for Pharmaceutical Manufacturing - A Global View

Axel Glatz started with a great presentation and his view into today’s pharma manufacturing. New technologies are knocking on our doors. Pfizer made the first experience with continuous manufacturing, NIR real-time release, Raman ID testing, lean manufacturing and connected tools.

The high volatility of manufacturing is critical!

One of the big challenges is the high volatility of manufacturing. Analyzing the volatility is crucial, critical and difficult. Alex Glatz gave great insight into the analyzed data of this manufacturing site in Freiburg. And the problems do not end at the site. The shipping and transports between sites are critical, too.

The solution for Pfizer is the IMEx (Integrated Manufacturing Excellence) approach. The first experience was disappointing but you have to learn from it.

These 3 pillars are the base for IMEx:

1. Operating system
2. Leadership system
3. Cultural system

Axel Glatz focused on the operating and leadership system because cultural system and developments is a topic of its own. 

?Isolated tools will never cure our systems!“

The Process-Centric Team is the key team in the operating system. It enables the people in manufacturing to improve processes. It develops standards for processes and visualizes progress to the management board and the leadership cascade. The Process-Centric Team is the turning wheel for the process is reporting at shift change and communicate progress and the current state of the process.

A dedicated knowledge management is important to realize a sustainable system and to transfer knowledge to other sites. Leveraging knowledge is crucial for a global roll-out. You should be long-term focused to reach the goal - it is a long challenging way to reach first goals.

?You get so many questions, information and new views going this way of operational excellence!“ said Axel Glatz in his great start to the conference.

Reducing Complexity in Pharma

?Reducing Complexity in Pharma“ was the title of the second presentation on Tueday, June 26, 2018. Marc Philipp, Accenture, focused on general financial numbers of the pharmaceutical industry in a disapointing presentation. He showed some examples from customers: A ratio of 0.8 policies per employee was one of them, Marc Philipp stated. But is this a representative number?

?For every employee an SOP!?“

Ask yourself: What is your number in your company?

Unfortunately, he focused only on big pharma but didn’t talk about small and mid-size companies.

Markus Hayek, also Accunture, focuses on simplification as a solution. He has huge experience in the car industry. ?Avoid complexity the customer is not willing to pay for - manage necessary complexity rigorously,“ he said. But in pharma, the customer is paying for other aspects than car buyers and the regulatory complexity is significant higher and different to automotive. Nevertheless a good question was: ?Is it necessary to increase complexity to introduce new colors or shapes of medicinal drugs?“

But, no word about drug safety and efficacy, the regulatory framework and market authorization challenges. A lot of buzzwords, less usable information. PDA had a good idea to bring the topic of simplification on the podium. But the performance could have been better. What a pity!

The Patient's perspective: Past, Present & Future of Diagnosis and Therapy

?The worst thing is to have the control.“

This was not a quote on quality control, but a statement Jette Christensen made in her talk from the patients view. And the perspective of patients is important for our daily work. Jette Christensen a well-known and very active PDA member talked about herself as a patient.

She talked very openly about her chronical diseases she is suffering. It is important for all of us, to see the patient at the center of our profession. In the first line, it is not the profitability or the financial number that is the motivation for us to go to work every day. No - to help patients to survive and increase life quality is the driver and the motivation for most of us.

Jette talked about treatment progress in the last 50 years - and it was a fascinating journey from the sixties until today. From museum equipment to modern manufacturing.

The worst thing of chronical diseases is: ?to have the control“ she said. "I have to be aware all the time" Thank you so much for this great and touching talk - we should hear more about such patient stories.

Links to the posts:

https://www.dhirubhai.net/feed/update/urn:li:activity:6417273834705035264

https://www.dhirubhai.net/feed/update/urn:li:activity:6417278003763507200

https://www.dhirubhai.net/feed/update/urn:li:activity:6417283537862434816

https://www.dhirubhai.net/feed/update/urn:li:activity:6417295686324219904

https://www.dhirubhai.net/feed/update/urn:li:activity:6417302172630806528

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