Member Spotlight – Teresa Minero

Teresa Minero

Founder & CEO

LifeBee - Digitalizing Life Sciences

The ISPE Italy Affiliate was established in 1992 and you have been an ISPE Member since 1996! Can you discuss some of the highlights of your long-lasting involvement with the Society?

My path towards working in pharma started in 1993, after having worked many years as a Consultant for digitalization projects in automotive and food plants in Italy and around Europe. One day my boss called me to his office and declared that “we have decided to provide consulting and digitalization services for the pharma sector, it shouldn’t be so different from food, where you have gained experience. Your goal is to start this new business”. I immediately realized that there were substantial differences between pharma and food (!), that it would be a huge challenge, but at the same time a huge opportunity for the company and for my career. I had a lot to learn and there were no internet search engines available at that time: finding the right knowledge was key and, at the same time, a very difficult task. Fortunately, a new association had just been founded in Milan, called “Affiliata Italiana” of ISPE. I found a new professional nest in it - experts, colleagues, customers, mentors, friends, and also competitors – and each of them taught me something new. Undoubtedly, it was hard work, but the incredible ISPE network has been essential for a successful working life in pharma. After collaborating with multinational consulting organizations, founding my own company in 2004, with a continued focus on Life Sciences, was a natural progression. When I have the opportunity to speak to students and recent graduates, I share my experience and lessons learned, knowing the value these can provide. First: remain consistent in your thirst for knowledge, study, and always accept changes - even more, embrace the change. Second: no one knows everything, but in the ISPE network you will always find someone who knows something you don’t and is willing to share. Therein lies the great value of ISPE to me.

Can you share some of the experiences you have had working with the Italy Affiliate and its Board, being the Vice-Chair for one mandate and then the Chair for other two?

I have always been an active member of ISPE Italy, participating in meetings, working groups, and events; in the last few years, I have chaired many ISPE local conferences, especially on Operational Excellence and Digitalization.

In 2014, after 20 years of ISPE Membership, I decided it was time to give back and dedicate more time as an ISPE Volunteer and I put myself forward as a candidate in the vote for the Italian Board. To my surprise, I gained many votes and began serving as Vice-Chair. During the first two years of my mandate, I learned how ISPE works as a local and global organization and I started to meet, in-person, HQ and international colleagues. In 2016 I was re-elected, and this time was honored by becoming the Chair, a role that I upheld for four years until the end of my run in 2020. In the six years serving the Italian Board, I focused my tenure mainly on membership and collaboration with external entities such as other associations, tradeshows, universities, and the Italian Regulatory Body called AIFA. I’m very proud to say that during my three mandates, membership increased from 331 members at the end of 2013 to 539 at the end of 2019 and that we now have multiple collaborations in place including the Italian Regulatory Authorities, 40+ of whom are members of our Affiliate. One of the key tools that have been very beneficial in reaching our targets has been the creation of the ISPE Italy Affiliate Strategic Plan. The plan is agreed upon at the beginning of each mandate and is a useful tool in clearly setting up goals and then objectively measuring them. Each Board Member defines his/her goals in accordance with the other members, and the activities he/she is committed to delivering during their mandate. Simple, but transparent and forward thinking.

You’ve been very active with ISPE (thank you!). Can you share some of the roles and responsibilities (in addition to Chair of the Italy Affiliate) you’ve held within ISPE? What are some of the successes you’ve experienced while managing these roles and responsibilities? For example, you have been and are involved in ISPE EAC and ELT, but also in Women in Pharma, Student Chapters, and many other initiatives. Can you discuss some of these with our readers?

In 2017 I was nominated the Vice-Chair, and then in 2018 the Chair of the European Affiliate Council (EAC), a team composed of staff and all the Chairs and Vice-Chairs from the region. I am also currently acting as a member of the European Leadership Team (ELT). These roles have been very important for my ISPE experience. In such a position you can share your experiences and best practices and proactively act on criticalities among all the European Affiliates. As a result, you are confident you are adding value while serving ISPE. At the very least, you are trying to improve the daily life of the Affiliate Board Members in your region as much as you can, supporting them and reminding them they are not alone. What follows is an example of an EAC activity that proved to me that Councils of Affiliates belonging to the same region are very useful: in May 2018 the European Legislation on Data Privacy GDPR came into force. We supported European Affiliates in understanding how to comply with the new rules in the best possible, most harmonized way and to facilitate the link with our HQ staff based in the United States. At that time, we were all interpreting the adoption of the new rule in our own ways based on our own backgrounds and cultures. Moreover, the exchange of privacy-sensitive personal data (like that of the list of ISPE Members, mandatory for our association) between EU and the US was more than troublesome and required a lot of effort from both ISPE HQ and Affiliates. I would like to mention that I created an annual Award dedicated to Women in Pharma® at a national level, a classic volunteer activity for which I am very proud. I also sponsored the establishment of our first ISPE Student Chapter at the University of Pavia, which has been very interesting and has enabled me to delve into student life once again. Students are undoubtedly our future, and spending time with them provides a clear need that it’s time to give back by providing them the knowledge that we have been bestowed by our mentors and working friends in all our life. All my working life has been spent on Digitalization and consequently, I’m very much involved in the ISPE Special Interest Group Pharma 4.0™, participating in the Steering Committee and initiating the Sub-Working Group “Management Communication Strategy”. I am also very proud to have been elected, in late 2020, to serve on the ISPE International Board of Directors, where in addition to other responsibilities I provide a direct connection to the Pharma 4.0™ initiative. My deep passion for Pharma 4.0™ is too long to be described here: maybe we can do it in another interview?

You live in Milan and are the Founder and CEO of LifeBee, a company that digitalizes Life Sciences, so you are very involved in the pharma industry. In spite of the challenges the coronavirus has created this year, how are things going with the pharmaceutical industry in Italy? Growth, trends, etc.?

From initial projections regarding the 2020 trends of the Italian pharmaceutical industry, the pandemic seems not to have impacted the positive growth of recent years, which have shown a continuous increase in the value of production, rate of employment, and most of all, export (that in 2019 reached 85%). This is a valuable amount considering that Italy holds a leadership position together with Germany in the European Community, with Italy reaching 34 billion euros from pharmaceutical production in 2019. As a matter of fact, pharmaceutical companies and the related ecosystem have assured operational continuity, in full consideration of safety conditions for personnel, therefore ensuring therapeutic continuity for patients and maintaining consistent employment levels for the sector. My company, being part of what is considered an “essential supplier” for the pharma industry, never stopped serving more than 70 customers in our territory and abroad with Consulting and Digitalization Services. I’m proud to share that, despite all the year’s challenges, we finalized 2020 with a 25% increase in revenue compared to 2019. The key factors have been organization, collaboration, and a sense of responsibility from all involved. Farmindustria, the national organization of pharmaceutical companies, has put dedicated task forces in place (implemented by all related companies) on crucial topics in response to the threat of the pandemic: work organization, production, distribution, research and management of clinical study in emergency conditions. AIFA, the Italian Regulatory Agency, has put forth extraordinary effort to accelerate the approval procedures of new medicines for coronavirus. Nor should we disregard the attitude of employees and operators of the entire pharmaceutical ecosystem who, during periods of strict lockdown, have ensured their presence and participation in order to maintain the high levels of continuity required for production and related services. “Heroes” as they have been called by the Farmindustria President, Massimo Scaccabarozzi.

From Milan, which has been hit hard by the coronavirus as has the entire region, we can see this resilience directly and have observed the evolution of the pandemic while working, (remotely as much as possible) towards all the active countermeasures.

Can you share a little about the award the Italy Affiliate created in honor of Graziella Molinari? What it represents, who is eligible, etc.

We dedicated our Women in Pharma Award to Graziella Molinari, a valuable figure who contributed to the development of ISPE Italian Affiliate. The award was created to celebrate the commitment, consistency, professionalism, and competence of a lovely, unforgettable woman working in our sector. Such qualities accompanied and distinguished Graziella’s work, as did her service as the Vice President of ISPE Italy and an active member for many years, until the very end.

Our Women in Pharma® award is dedicated to enhancing innovative projects and excellence: our goal is to encourage and stimulate the professionalism of women in Life Sciences by creating unique and unprecedented recognition. It is an invitation to all women to stand out in their careers and workplaces and to further their ideas with passion and determination. Not only that, but this award also aims to create a strong and credible reference model for younger women as they take their first steps into Life Sciences. It is an invitation to believe that you can always improve the environment in which you work and increase opportunities for everyone.

The ISPE Italy Women in Pharma® Graziella Molinari Award has been presented since 2019 and will be awarded in the following years to a woman who has distinguished herself for:

• Innovative projects to improve efficiency, quality, smart compliance
• Sustainability projects
• Promotion and recognition of Italian excellence abroad
• Special initiatives for knowledge sharing activities in the ISPE founding spirit

The 2020 Award added a category dedicated to Innovative Solutions that permitted continuity during the critical period of the pandemic. The award consists of a professional training course (technical, managerial, linguistic) of the winner’s choice, subject to approval by the Italian ISPE Board.

Anything else you’d like to share?

Nothing more than this: thank you ISPE and my sincere gratitude to all the amazing colleagues and friends I have gained!