ISPE Presents Awards & a New Board Chair Takes the Helm

Day 3 Recap: 2019 ISPE Annual Meeting & Expo

The Membership and Awards Breakfast on Tuesday 29 October at the 2019 ISPE Annual Meeting & Expo saw a number of ISPE members honored with awards, a report on the state of the Society, and new ISPE International Board members taking their places, including the new Chair, Frances Zipp.

James E. Breen, Jr., PE, 2018-19 International Board Chair, and Vice President, Lead Biologics Expansion at Janssen Pharmaceuticals, opened the meeting with a video about the ISPE 2020-2022 Strategic Plan.

“I feel that development of this Plan was one of the most important initiatives for the International Board of Directors this year, and is a great source of pride for me personally as Chair,” Breen said. “We put a great deal of thought into codifying the key strategies for ensuring ISPE’s continued leadership in supporting the development, manufacture, and delivery of quality medicines to patients, and we believe the Strategic Plan provides an effective road map to get us there.”  

Breen introduced the 2020 Board Officers: Fran Zipp, Chair; Tom Hartman, Vice Chair; Joanne Barrick, Treasurer; Jörg Zimmermann, Secretary; and Jim Breen, Past Chair. Directors are Vivianne Arencibia, Gunter Baumgartner, Scott Billman, Chris Chen, Ylva Ek, Lou Kennedy, Stephen Mahoney, Christine M.V. Moore, Alice Redmond, Caroline Rocks, and LeAnna Marcum (Young Professionals Representative).

Breen thanked the outgoing members of the Board for their service: Tim Howard (past chair), Tony Crincoli, Flemming Dahl, Kelly Keen, and Mike Rutherford.

General Meeting Highlights

Breen called the ISPE 2019 Annual General Meeting to order. Tim Howard, ISPE Foundation Chair, gave an update on the ISPE Foundation. The Foundation’s mission is education, training, and research. Short-term initiatives are building the workforce of the future, empowering women and increasing diversity, and global knowledge exchange. 

The Foundation was established in 2017, and in 2018 began fundraising and supported travel grants for Annual Meeting attendance; this year, the Foundation formalized training for the development committee and supported additional travel grants. Future initiatives will include fund raising, expanding grants, and funding Workforce of the Future programs. 

Revenues for the Society rose again this year, Breen said in presenting a financial report of the Society. He noted that “the Society is very solid financially,” adding that investments are being made now “to set up the Society for the future.” He challenged attendees to get involved, saying that “it is great to see the energy and engagement in ISPE.”

Breen passed the Chair gavel to Fran Zipp, the 2020 Board Chair. She thanked Breen for his contributions to ISPE.  “I love teamwork, precision, and speed,” Zipp said, noting there is a link between these and her two passions: Porsches and ISPE. Both involve “a great team of ‘high performance’ professionals.” She said it was an honor to “take the wheel” of ISPE’s board. About her recent move into the “driver’s seat” of ISPE as Chair, Zipp noted that an individual “is in reality just one member of a much larger and more important team.” 

ISPE’s team is all of its members from around the world, and it is a team “that in order to be effective and successful, must consistently operate ‘on all cylinders.’” To do so takes “constant dedication, maximum effort, and sustained involvement. It’s that way with Porsche and I believe it to be the same way with all of us, who together form ISPE.”

Just as the average Porsche 911’s over 28,250 parts all contribute, so does each ISPE member contribute to the whole Society. “Everyone is essential and valuable to the success of our organization,” Zipp said. “Working together—in synch—we learn, we grow, we prosper.”

Another commonality between Porsches and ISPE that Zipp noted was that women created the first Porsche 917 race cars in the early 1970s, working as a team and women are still an important part of Porsche’s success today. The same is true for the pharma industry and for ISPE.

“Women in pharma are just as essential and important to our industry’s advancements and successes. We’ve taken on every role and met every challenge, becoming important contributors and leaders at every level. We have done this with the support of every member—men and women working as equals.” In this way, Zipp noted, women have “taken the wheel” in the industry. 

Zipp noted the great importance of ISPE and its members in her own career growth. “I grew up in ISPE,” she said. “When I started in the industry, I was in the lab. When I was asked to move to an operations role, I turned to ISPE for assistance. The Baseline documents became my bible.” 

“The networking groups became my family—they accepted my ignorance, they did not judge, and I had a safe place to learn. That is what ISPE is for our members.”

She encouraged attendees to become involved. “Join a team, participate in the development of a document, lead a training—you will get more than you give!”

Just as Porsche doesn’t define its brand of the future—it is the Porsche brand that defines the company’s focus—so it is with ISPE, Zipp said. Challenging people to do more and greater things is ISPE’s way, just as it is Porsche’s way.

In line with the new Strategic Plan, Zipp outlined some actions that are ahead:

• Engaging members at all career stages, providing them with exceptional networking and knowledge platforms.
• Improving and expanding the relevance, impact, and efficiency of ISPE’s operating and volunteer models.
• Strengthening engagement with stakeholders in prioritized target geographic markets through groups such as Women in Pharma®, Workforce of the Future, and Young Professionals. 
• Working with Affiliates and Chapters to strengthen understanding of the roles and benefits of these and commitment to the same goals. Zipp is hoping to attend many Chapter and Affiliate meetings during her year as Chair. 

ISPE Awards

Breen, Zipp, and John Bournas, CEO and President of ISPE, presented the 2019 ISPE International Honor Awards.

Before presenting the 2019 awards, Bournas noted the addition of “a new component in our ISPE constellation,” the newly established ISPE Affiliate of Mexico. 

“I am honored to be able to announce the recipients of the 2019 International Honor Awards that are bestowed on ISPE groups and members who have contributed remarkable service to the Association and the industry,” Bournas said. The ISPE International Honor Awards Committee reviews nominations and administers the awards process. “Thank you to ISPE Board Member Gunter Baumgartner and his Committee for doing a great job in identifying today’s honorees.”

Hackathon 

The first award was presented to the winning team in the Student and YP Hackathon. This is the first Hackathon held during an ISPE Annual Meeting & Expo, and Bournas noted that this will now be an annual competition. “This event brings together some of the brightest, most inquisitive young ISPE members from across the globe for a weekend of networking, collaboration, education, and innovation. ISPE is proud to help shape our future industry leaders.” 

Team 4 was the winning team. Members of the team were Sarah-Catherine Dannelly, YP, GEMU Valves, Inc.; Kathrine Parga, Graduate Student, Keck Graduate Institute; Phuong (Sophie) Le, Graduate Student, University of Minnesota; Matthew Ong, Undergraduate Student, National University of Singapore;  Elice Kitchen-McKinley, Undergraduate Student, North Carolina State University; and Yemisi Mohammed, Graduate Student, North Carolina Central University. Each will receive a one-year membership to ISPE and all 37 Hackathon participants will receive a certificate to note their participation.

Affiliate and Chapter Excellence

The next award, for Affiliate and Chapter Excellence, is a new one. ISPE’s 39 Affiliates and Chapters “are instrumental in extending the Membership experience locally,” Bournas said. The first award to recognize excellence in Affiliated and Chapters went to the Delaware Valley Chapter. Chapter President Eleanor Small accepted the award for the Chapter.

Delaware Valley has done outstanding work this year, particularly in the areas of membership development and community affairs, Bournas noted. “DVC has one of the highest ISPE Chapter membership retention rates at 78%.” Through efforts to improve new member rates, DVC reversed a trend of slightly declining membership and brought the total membership up to nearly 900 members. DVC actively supports Young Professionals and worked closely with ISPE YP International to support the 2019 ISPE Hackathon. “This Affiliate does a phenomenal job driving participation and promoting ISPE in the region,” Bournas said.

Committee of the Year

ISPE has more than 75 committees, councils, Communities of Practice, and other teams supporting the Society’s mission, and delivering value to the membership. The 2019 Committee of the Year award recipient was the 2019 ISPE European Annual Conference Programme Committee. The award was accepted by Committee Chair Jean-François Duliere and by Eamon Judge, accepting on behalf of Co-Chair John Lynch. 

This Committee was nominated for its efforts to develop, plan, and execute a very successful EU Annual meeting in Dublin, Ireland in April 2019. The Dublin conference exceeded expectations with over 700 attendees, which made it the largest ISPE event to date in Europe. 

Article of the Year Award

The 2018 Roger F. Sherwood Article of the Year award was given to Continuous Manufacturing in Biotech Processes: Challenges for Implementation  by Robert Dream, PE, CPIP; Christoph Herwig, PhD; and Emilie Pelletier. Now in its 25th year, the award showcases the best content in Pharmaceutical Engineering, increases industry recognition, and highlights ISPE’s reputation as a global knowledge leader.

The winning article was selected from a field of 37 articles published in Pharmaceutical Engineering during 2018 by a panel of Pharmaceutical Engineering Committee (PEC) judges. Articles were assessed on the following criteria: usefulness to ISPE readers; how the articles improve the knowledge of key topics; and clarity/ease of reading.

Company of the Year

CRB, the Company of the Year, “has had strong participation through support of membership, attendance at ISPE conferences, among others,” Bournas noted. The award was accepted by Jeff Biskup, President and CEO. 

CRB won the ISPE Company of the Year as it has had consistent membership growth, demonstrating annual increases in membership over the past six years. “CRB leadership has instilled a culture supportive of ISPE and its mission, allowing employees to attend conferences and volunteer as leaders of committees and conferences. CRB understands the value and impact of ISPE, and demonstrates this by encouraging employees to participate as industry leaders.”
 
Since 2016, CRB has provided support to ISPE conferences such as Facilities of the Future, Aseptic, Europe Annual Meeting, and Europe Biopharma, among others. Their support also includes outreach beyond common demographics as it encourages overall attendance to signature ISPE educational events. Bournas also noted that CRB has been a part of 16 FOYA winners and is a previous winner of the ISPE Company of the Year.  

Max Seales Yonker Member of the Year Award

Bournas explained that “ISPE’s most significant awards are its ‘named’ awards,” honoring members who dedicated themselves to excellence and service to the industry and  ISPE. 

Max Seales Yonker was an active member, Society leader and a relentless contributor to ISPE and the industry. After her death from cancer in 2005, the award was created to honor her memory and those who have made the same commitment to serving the Society. The recipient of the 2019 award was Charlie C. Wakeham. 

Charlie Wakeham has been an active member and leader within the GAMP Community of Practice for more than 10 years, championing activities and serving as a global ambassador for GAMP and ISPE in several global regions, including the UK and the Asia Pacific. She is a co-leader of the GAMP Data Integrity Special Interest Group and a member of the GAMP Global Steering Committee. Wakeham has led or contributed to the development of numerous GAMP Good Practice Guides (GPGs), including the Testing Guides, the Operations Guide, the Records and Data Integrity Guide, and more recently the two Data Integrity GPGs on Key Concepts and Manufacturing Records released during the last year. Wakeham serves as a global champion of data integrity, and has had tremendous impact in the Asia Pacific region, presenting on data integrity and computer system validation to more than a thousand representatives of regulated companies each year.

Wakeham expressed her appreciation of her 20 years of membership and the opportunity to learn from subject matter experts and opinion leaders. She noted that her volunteer efforts have been paid back many times in what she has learned and friendships she has made.

Purdy Award

The Richard B. Purdy Distinguished Achievement Award is presented to members who have made significant, long-term contributions to the Society. It is named after one of the Society’s founders and most accomplished member Presidents. The 2019 award was presented to Christopher Reid.

Reid has been a dedicated member of ISPE and the GAMP Community of Practice for over 15 years. He served two terms as a Director on the ISPE International Board, where he made significant contributions to the strategic plan, including activities related to training, growth of the Young Professional initiative, membership retention, and regional relevance. He has also been a strong supporter and volunteer on the European Leadership Team, as well as the ISPE Foundation Board, serving as Secretary for the last two years. As GAMP Global Chair, he supported the launch of new GAMP affiliates in India and Turkey. He has also focused on growing the next group of GAMP leaders, identifying and challenging new individuals to step up and volunteer. Reid has served as the GAMP/Information Systems Track Chair for the European Annual Meeting, as well as several other larger conferences, for several years.

In accepting the award, Reid joked that he started at ISPE way back when he was younger, less gray, and skinnier, before he started going out drinking with the GAMPers.

Joseph X. Phillips Professional Achievement Award

The Joseph X. Phillips Professional Achievement Award is not given every year. It honors an ISPE member who has made a significant contribution to the industry, not just ISPE. The award is named in honor of Joe Phillips, longtime supporter of ISPE and a leader in establishing the Society as an “integrator” of industry and regulators, both during his years of service with the FDA and later when he became International Regulatory Affairs Advisor to ISPE.

This year’s recipient was Dennis Gross, whose contributions include work in the industry, academic, education, and government consultancy. He has been a member of ISPE since 1996 and served on the Delaware Valley Chapter Board of Directors in many capacities. He has held positions of increasing responsibility as Co-Chair of the R&D Subcommittee, Director-at-Large, Vice President for Student Advisory, and Secretary. He has also served as a member of the ISPE International Young Professionals Committee. Gross was a coauthor of the ISPE Oral Solid Dosage Baseline Guide (OSD BG) V3. He has also worked with the Center for Strategic & International Studies in Washington, DC, on policy issues and the development of site inspection protocols relating to the production of biological weapons of mass destruction and compliance with the International Treaty on such weapons.

Gross observed that he was probably the only one in the room who was not an engineer! He is a pharmacologist, but he said he was told to join ISPE because it would help him with his career. Gross felt that ISPE is extremely open and willing to help and forge connections. As an example of his commitment to the industry and ISPE, he noted that just the other day, he was speaking to middle schoolers about ISPE, encouraging them to consider pharma as a career, and to not fear STEM.

Facility of the Year (FOYA) Overall Winner Award

Tony Crincoli, Chair of the Facility of the Year (FOYA) Judging Team, presented the last award of the morning, the Facility of the Year Overall Winner Award, to Kantonsapotheke Zurich. The company was the category winner for operational excellence.

Kantonsapotheke is one of the leading centers of hospital pharmacies in Switzerland. Before Kantonsapotheke replaced and integrated two outdated hospital pharmacies for the Canton of Zürich hospital system, patients often had to wait a long time before receiving the medicine they needed. In addition to setting up a new pharmaceutical building, Kantonsapotheke also reorganized the organizational setup to ensure Lean structures and clear responsibilities, incorporated robotics to increase productivity, and redefined and reengineered all operational procedures and processing steps.

The new compounding pharmacy offers a broad spectrum of pharmaceutical services, including oral, dermal, and parenteral formulations, often with patient-specific recipes, using the latest technologies and most up-to-date pharmaceutical knowledge. All products are manufactured under industrial cGMP conditions, and the operators have achieved an astonishing 60- to 90-minute turnaround time from diagnostic test to patient delivery.