Member Spotlight: Jean François Duliere

During this period, I’ve experienced many highlights! Among them, the ISPE France Affiliate has offered our members opportunities to tour facilities; these events have been successful. With the support of board members and industry stakeholders we have created Special Interest Groups linked with current industry situations. These include:

Jean-François Duliere

Regulatory Advisor

ISPE

• French GAMP to assess new items regarding IT Systems. This group meets by phone four times per year and twice face-to-face. They are working on all IT regulatory points coming out every year from industry or from regulators’ findings.
• Serialization Working Group, which was working for two years prior to European Directive (FMD) implementation. The group has published an article for PE Magazine and a Q&A regarding serialization implementation.
• Special interest group to address the Medical Device UDI implementation. This group is still ongoing as the task is large, and the due dates have been postponed by EMA to 2021.
• We established several working groups around regulatory document comments. These documents, with the participation of ex-regulators, are very beneficial; we have received good input and some participants have shared ways to read the documents and understand them. These include:
  • Annex 1 Europe GMP’s
  • Annex 2 PIC/S GMP’s
  • Data integrity for PIC/S

Because our membership has remained stable for several years, we continually work to find new topics of interest for the pharmaceutical industry in our country. Currently, the highest interest is around practical aspects of serialization and UDI for DM.

We sent out invitations to many events, and attendees discovered their interest in ISPE and became members. This reduced the profitability of the events but increased the membership, which is also an objective for our association.

The Europe Conference in Lyon for Biotechnologies has been a success as well, with the largest presence of French people attending a Conference.

Drug shortages prevention is a particularly important topic in France. We are working to share information with the French National Academia of Pharmacy, which quotes our reports and information when they prepare reports for the government. In addition, we are sharing innovative practices around the world to supply drug products to hospitals.

We currently have a challenge regarding the continuity plan in France -- it’s difficult to find volunteers now since in the past few years, new members have joined the Board to take responsibilities. I anticipate moving out of the chair position in some months, becoming a past chair to support younger colleagues. Our board has several Young Professionals who assist us with our work; they are starting to volunteer and are helping us provide lunchtime webinars to the French Young Professional group.

You’ve been very active with ISPE (thank you!). Can you share some of the roles and responsibilities (in addition to Chair of the France Affiliate) you’ve held within ISPE? What are some of the successes you’ve experienced with these roles and responsibilities?

I chaired the Europe Affiliates Council in 2012-2013. During the same period, I was invited to become a member of the Europe Leadership Forum under Chairman Udo Vetter. The activities during this time were interesting and difficult, as Europe was not doing very well. ISPE requested that the Europe Office PCO recreate its business model, with high objectives:

• Transfer of all Europe Office activities to ISPE’s Home Office in the US. We had to convince 12 Affiliates this was the best way to move forward and that we would continue to have the same service and support, but more remotely.
• Create a Program Committee to launch an Annual Europe Conference; 350 people attended the first Europe Annual Conference, held in 2014 in Frankfurt. The objective was to create a new momentum for ISPE in Europe and to have more regulators involved in our events.
• Once the Europe Annual Conference became a highly beneficial event for industry members, we started to move this Conference to main European cities, experiencing higher attendance each year.

These changes were successful, thanks to all the Europe Affiliates’ involvement and their Chairs’ leadership.

I am also grateful to the Europe Affiliates for recognizing me with the “Max Seales Yonker” Award in 2013. Unfortunately, I was in the hospital at the time and Nancy Berg delivered the award at the ISPE Frankfort Europe Annual Conference. High emotions and big thanks to all my European colleagues.

As VP of European Operations, Thomas Zimmer brought momentum, as well as much support, to Europe.

At last year’s ISPE 2019 Annual Meeting & Expo in Las Vegas, The Program Committee for the Annual Europe Conference in Dublin received the “Committee of the Year” Award. This was a great moment for all our colleagues involved in this Committee, with support from the ISPE staff.

I have been also involved in several committees in Europe:

• The European Leadership Team (ELT) - working with Thomas Zimmer, this group is working on strategy plans for activities in Europe.
• RQHC EMEA - I have been chairing this group, which includes 45 invited members, for three years. We have several regulators from Italy, Germany; MHRA; WHO South Africa, and I thank each of them for their support. This group meets once a month to discuss several topics regarding regulatory awareness, and at each meeting, one participant - very often a regulator - addresses one point and gives their view on subjects that include:
  • Drug shortages
  • Anti-Microbio Resistance Industry and its responsibilities
  • Brexit (has been a frequent topic)
  • Covid-19 and regulatory flexibilities (MHRA)

This group is involved as well in providing topics for the Europe Annual Conference program.

• As chair of the regional RQHC focus group I am part of RSC and global RQHC.
• I have been involved in and have chaired several Comment Lead teams. The most important was in 2018 and was the first draft of Annex 1 Europe GMP’s(PIC/S)/2019; then Annex 2 PIC/S for ATMP’s 2020 second draft for comments from the European Commission.

Participating in these activities for Europe, all of which are highly interesting, required time availability. My former employer was helpful and generously allowed me time to work on these when my day-to-day work was done.

You live in Paris and have worked for a long time – more than 20 years – in pharmaceutical manufacturing in France. Despite the challenges the coronavirus has created for our industry, how are things going with the pharmaceutical industry in France? Growth, trends, etc.?

The pharmaceutical industry in France is moving from having numerous brand companies to more and more Contract Manufacturing Organizations (CMO) or Contract Development & Manufacturing Organizations (CDMO). Thanks to some tax incentives for R&D, we have a Clinical Studies sector which is very active, and many start-up companies in the field of ATMP’s. Nevertheless, we still have some big pharma production campuses: Sanofi, Sanofi Pasteur, Novo Nordisk, Lilly, and Boehringer Ingelheim for animal health.

We can expect that the Covid-19 crisis will allow some funding to relocate some API production in Europe and in France. The technologies are available to make API at an acceptable cost and compliant with the European environmental standards.

Congratulations on your appointment as an ISPE European Regulatory Advisor. That’s great news! Do you have anything you’d like to share with the ISPE Community regarding this exciting, well-deserved honor?

First, I would like to thank ISPE for this honor and for recognizing regulatory activities in Europe. It is a big challenge to support European activities by helping involve more regulators at our Conferences. We are extremely disappointed that Covid-19 necessitated us to postpone the 2020 Madrid Conference. A panel discussion with regulators was planned for this event, and 15 have accepted to participate in this panel. In addition, many regulators agreed to be involved in tracks. We were expecting attendance of 20 regulators from Europe and most parts of the world. We plan to organize this panel in a virtual way after the Covid-19 crisis ends.

Anything else you’d like to share?

What are my reasons for being so involved with ISPE? This is a great organization, one which gives you visibility, enhances your knowledge through communication with your peers, and one which, when you come to a new field of knowledge you will find help and support.

I am now retired from the active production field. Having worked in the pharmaceutical industry as a production manager, or in engineering as part of building design initiatives, my first objective has always been to support my teams by increasing their knowledge, providing training on new ideas, and creating new processes moving away from the easiest roads. All this has been possible because the companies for whom I was working gave me time and freedom to support these activities.

My last point is the most important -- working within multidisciplinary teams with different skills and areas of expertise, mixing engineers, pharmacists, and technicians together -- all of this allows us to create great things to serve patients around the globe.