ISPE Italy Affiliate Poised for Leadership

A country best known for its artists, food, and fashion designers, Italy is also home to a thriving pharmaceutical industry. Along the country roads that stretch from Milan to Bologna, Florence, deep into Rome and Naples, idyllic hillsides are dotted with the facilities of life sciences companies both big and small, as well as those of satellite industries like medical devices and packaging equipment. In fact, Italy is Europe’s second-largest producer of pharmaceutical products (Germany ranks first), exporting 73% of its pharmaceutical manufacturing industry production through some 200 production sites, and employing 65,000 people.1

• 1Farmindustria

• 2Farmindustria: Imprese del farmaco e ricerca

“It’s our best-kept national secret,” said Teresa Minero, Founder and CEO of LifeBee, a management and IT consulting firm for the life sciences industry, and President of ISPE Italy, a position she has held since May 2016, following a term as Vice President from 2014 to 2016. An ISPE member since 1992, she is also Vice Chair of ISPE’s European Leadership Council. “I believe that Italy has great potential to become a true European hub,” she explained. With reasonable production costs, state of the art production technology and highly qualified professionals—about 224,000 employees work in the pharmaceutical supply chain1—Minero thinks Italy may well become an even stronger player in Europe’s pharmaceutical manufacturing space.

Italy is Europe's second-largest producer of pharmaceutical products.

ISPE Italy has 400 members. Roughly half come from industry, regulatory agencies, and academia; the other half represent from satellite industries and services. “We are Italy’s largest and most popular international association dedicated to life sciences,” said Minero, “and our members come from across the spectrum: engineering, manufacturing, automation, IT, validation, and quality assurance, and also from laboratories, logistics, and regulatory agencies.” This broader definition is one that matters to Minero. She believes it will help boost membership and promote ISPE as an inclusive association that is about more than just engineering and pharma, as it used to be and sometimes (at least in Italy) still perceived to be. “Life sciences counts almost four times as many people working in it [than pharma],” she said, “and it is important we reach out to the entire supply chain: the sector is bound by similar regulations and guidelines, by similar opportunities and challenges, and, ultimately is devoted to the same customer, the patient.”

Based in Milan, Italy’s industrial capital, Minero concedes ISPE Italy has had its membership issues. “The economic downturn of the last couple of years has had an impact,” she said, “yet through our public relations activities, we are hoping to reignite interest and demonstrate value.” The Affiliate’s board has begun outreach efforts at the local level. “We’re more active in northern Italy simply because all our Board members, save one, are from the north,” she stated. The life sciences sector is most active in northern Italy, and in the center of Italy. “This, too, is a challenge, as it isn’t always possible to travel from one end of the country to the other, either for Board members or Affiliate members.”

Each Board member has been assigned one of the Affiliate’s 2016–2018 strategic objectives; these include development of local communities of practice on topics such as powder-handling safety, GAMP® data integrity, activities with other associations and European affiliates, and building a Young Professional (YP) community. The current Board has 10 members, seven of whom are women. Other executives include Vice President Guia Bertuzzi, Treasurer Corinna Carganico and Secretary Cristian Musazzi; remaining Board members are Fernanda Ferrazin, regulatory relations and ISPE RCC representative; Francesca Maienza, operational support; Alessandro Villa, local community of practice coordinator; Fabiana Stoppa, YP coordinator; Anna Lidia Vignoli, GAMP Italy relations; and Saverio Cornacchia, membership. ISPE Italy’s accomplishments were recognized in 2015 when it was named ISPE’s Affiliate of The Year. “We’re still beaming,” said Minero, “and it is an honor we promote when positioning ISPE at trade shows and other association events.”

Celebrating its twenty-fifth anniversary this year, the Affiliate has planned events both social and professional to highlight its member contributions, including the new Operations Management Good Practice Guide, which boasts two Italian leaders: Giuseppe Ravizzini of Recordati and Marzio Mercuri of Polpharma. The Board is planning and organizing events based in Milan, Bologna, and Rome on a variety of subjects, such as Industry 4.0 and operational excellence, data integrity, serialization and track & trace, elemental impurities, new information and communications technology trends in good practices, powder-handling safety, and nutraceuticals.

Promoting the ISPE Italy brand and its message of knowledge-sharing and collaboration ranks high on Minero’s list of objectives for 2017. In addition to “making room” for members outside of traditional pharma, “like Brazil and San Diego are doing on nutraceuticals,” Minero and the Board want the affiliate to be more present at other association conferences and trade shows, for example. “It felt great to deliver a speech as an ISPE representative last spring at the Paperless Lab Academy in Barcelona,” she recalled. Her presentation, “Paperless and Data Integrity: Different Paths, Same Goal,” was also an opportunity to promote ISPE, GAMP, and the benefits of membership. “We need to be more visible, to create and participate in working groups, write articles and make everybody aware of ISPE’s great body of knowledge,” said Minero. “If knowledge sharing and networking are our true values, we need to ‘live’ them,” she added.

On a personal and professional level, Minero tries to stay true to her values. She believes in the power and passion of groups, and the responsibility of sharing knowledge. “Our Board members are passionate about ISPE Italy—they always have been,” she said. “They want things to work well, and for us to create even stronger ties with members, both current and future.

“The view that the pharma industry needs to redeem its reputation is a matter of fact. The sciences sector has improved the quality of many lives, and it continues to achieve new and important goals, even if sometimes it is forgotten by media and social networks. We have to remind colleagues within the pharma industry, but especially to everybody outside it, that people are the end of our supply chain. Our children, our mothers, and our friends—they are affected by the work we do every day; their better health is what drives our professional community. This is our value, and the message we need to get across.”