2016 ISPE Annual Meeting & Expo

The Membership and Awards Breakfast at the 2016 ISPE Annual Meeting & Expo honored ISPE groups and members who have demonstrated remarkable dedication and service to the organization during the past year.

Outgoing Chair Joseph Famulare opened the ceremony and called the annual general meeting to order. He began by thanking outgoing directors Jeffrey Biskup and Jennifer Lauria-Clark for their service, introducing the new 2016–2017 board, and acknowledging the past chairs in attendance.

Famulare next reviewed the 2015 audit result, which he said showed ISPE gaining strength and steadily rebuilding its revenues. “We’ve done good work to balance the budget and stabilize the operation. We’re improving both our current revenue streams and actively seeking new ones. We continue to build value and grow the organization.”

ISPE continues to be the global leader in the drug shortages arena, he said, and the organization’s quality metrics initiative leads the way with data-driven approaches. In addition, he said, “our international presence continues to be strong.”

Honors and Awards

Following Famulare’s remarks, John Bournas, ISPE CEO and President, announced the 2016 honors and awards.

The International Student Poster Competition Awards recognizes outstanding achievement from undergraduate and graduate student members. These research projects are adjudicated at the Affiliate and Chapter level, with the top selections invited to the Annual Meeting for the final presentation and adjudication.

  • 2016 undergraduate winner is Param Bhatter from the University of California—San Diego
  • 2016 graduate winner is Sara Sukenik from the University of California—Davis

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 ISPE supporter 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.

  • 2016 Joseph X. Phillips Professional Achievement Award recipient is Mike Rutherford.

Involved with ISPE and GAMP® leadership since 2003, Rutherford currently serves as the Chair of the GAMP Global Steering Committee, is past Chair of the GAMP Americas Steering Committee, and has sponsored numerous GAMP Special Interest Groups.

He has played a pivotal role in GAMP’s push for improvements in the industry’s approach to data integrity. Because of his leadership across the industry, he has touched hundreds of companies and countless professionals in his quest to put data integrity at the forefront of the conversation.

Rutherfords’s diligent pursuit of regulatory involvement has raised the quality of ISPE’s data integrity programs, and the connection that he has facilitated between industry professionals and regulatory experts has significantly improved the industry’s understanding of the issues and the best approaches for mitigating data Integrity complications.

In addition, he is highly regarded for his expertise and professionalism, along with a strong sense of community that fosters support and camaraderie among fellow volunteers.

When presented with his award, Rutherford professed himself “totally shocked.” He thanked the GAMP organization, whom he called “an awesome group of individuals. The effort they’ve put in has taken hold and influenced industry.”

The Richard B. Purdy Distinguished Achievement Award honors an ISPE Member who has made significant, long-term contributions to the Society. It is named after one of the Society’s founders and most accomplished presidents.

  • 2016 Richard B. Purdy Distinguished Achievement Award recipient is Bruce S. Davis.

An ISPE member since 1991, Davis’s expertise has been a critical part of the development and delivery of many ISPE products. He has served on countless committees and was a member of the Board of Directors for 9 years, serving as Board Chair from 2007–2008. He is a key training instructor for ISPE and has delivered training courses in the US, Europe, Asia, and the Middle East.

Davis served on the Guidance Documents Committee for many years and participates on many document development teams. Most of all, Davis is a professional with high integrity and very kind and generous to all that he works with.

When presented with his award, Davis said that his career in ISPE started when someone asked him to “go and give a talk.” Committee seats and eventually the Board of Directors followed. “It grows you, ISPE,” he said.

The Max Seales Yonker Member of the Year Award honors the ISPE Member who has made the most significant contribution to the Society during the past year. It honors a dynamic lady who was an active member, Society leader, and a relentless contributor to ISPE and the industry.

When her ISPE and her family lost Max to cancer in 2005, it seemed only fitting that her memory be honored with an award that recognizes that same commitment to service. Maxine Yonkers’s memory reminds us that we are all patients, and that we do vital work to advance the development, production, and delivery of a safe and reliable drug supply.

  • 2016 Max Seales Yonker Member of the Year Award is presented to Maurice Parlane.

An ISPE member since 1999, Parlane has held leadership roles in the Asia–Pacific Affiliate Council, Australasia Affiliate, Australasia–New Zealand Committee, Board Nominating Committee, and Membership Development Committee. He spoke at last year’s ISPE China Annual Meeting, representing the Process Validation Team that spoke with the Chinese FDA. This year he gave two presentations focused on process validation at the ISPE India Annual Meeting.

Passionate about education, Parlane helped deliver the three-day ISPE Process Validation Training course to a group in Singapore, and is working diligently to make this training available elsewhere in the Asia–Pacific Region. He is currently part of the ISPE PV Conference Planning Committee for the October conference and is a member of the ISPE Practical Implementation of the Life Cycle Approach to PV Good Practice Guide writing team. Parlane brings endless energy and enthusiasm to all of his ISPE roles, and mentors new ISPE Affiliate leaders as they rise through the ranks.

He was overcome with surprise at receiving the award. “I really don’t know what to say,” he exclaimed. “Thank you very much. This is a great Society—it really energizes me.”

The Company of the Year Award recognizes the outstanding leadership and support provided by a company as reflected by significant active participation in the Society’s committees, Communities of Practice (CoPs), programs and activities, as well as its support of employee participation in ISPE.

ISPE’s outstanding owner companies, suppliers, and service providers invest in the Society through employee involvement, sponsorship, and providing extraordinary leadership. This investment helps foster understanding and advancement of knowledge throughout the industry.

  • 2016 Company of the Year is Novo Nordisk.

Currently, 174 Novo Nordisk employees are ISPE members, a significant increase in the number of new members this year. Novo Nordisk members serve as key volunteers in many areas throughout the organization, including committee members, conference speakers, guidance document authors, and local Affiliate and Chapter Board members.

The Committee of the Year Award honors an ISPE committee, council, task team, or Communities of Practice (CoPs) Steering Committee for outstanding work in support of fellow Members and the industry. More than 75 committees, councils, Communities of Practice, and other teams support the Society’s mission, and deliver value to the Membership.

  • 2016 Committee of the Year is the GAMP® Global Steering Committee:

Chair: Michael L. Rutherford
Co-Chair: Chris Clark, BSc.
Secretary: Heather D. Watson
Past Chair: Winnie Cappucci
Past Chair: Arthur D. Perez, PhD

Committee Members:

  • Sam Brooks
  • Marcelo Decanio De Oliveira
  • Cristiano B. Ferrari
  • Hirokazu Hasegawa
  • Paige E. Kane, CPIP
  • Kevin C. Martin
  • Christopher J. Reid
  • David W. Selby, PhD
  • Eric J. Staib
  • Lorrie L. Vuolo-Schuessler
  • Guy A.S. Wingate, PhD
  • Siôn Wyn

GAMP is a truly global group, with steering committees in Europe, North America, Brazil, and Japan. In 2016, GAMP has supported conferences and education sessions around the globe. This year, the GAMP Community of Practice celebrates its 25th Anniversary, a significant milestone for this group.

GAMP has established itself as the definitive source of industry good practice for computerized system compliance and validation, and continues to deliver programs and products that advance ISPE’s mission and support the needs of our membership and industry.

The Affiliate and Chapter Excellence Award recognizes outstanding work of ISPE’s 38 international Affiliates and Chapters as reflected by membership development and services, management, industry and society support, and innovation.

This year’s Awards Committee had an unusually difficult job in selecting the best of the best in this category, so they opted to recognize two outstanding teams.

The Belgium Affiliate has done outstanding work this year, particularly in membership development and supporting young professionals. The Affiliate hosts membership recruitment and retention activities throughout the year and has the highest retention and recruitment rates in Europe. Their mission is to be an open community to discover and build young professionals’ future in the pharmaceutical industry. To further develop the future generation of leaders, the Affiliate has a Young Professionals (YP) Board, a YP is invited to participate in the monthly Board meeting and YPs participate in Board subcommittees.

The Turkey Affiliate has done a tremendous job in developing relationships with local regulatory agencies. The Affiliate met with the Turkish Medicines and Medical Devices Agency, and has been officially added to the agency’s distribution list. The Affiliate also develops students through outreach programs, career days, and scholarships, and supported the development of two pharmaceutical manufacturing curriculum’s at Istanbul University and Kadirga Vocational School. In 2015, the Affiliate celebrated its 10th Anniversary and was featured on a broadcast of Bloomberg News.

One annual award— the Roger F. Sherwood Article of the Year Award, which recognizes writing that provides real value to the industry—was absent from this year’s proceedings. Bournas noted that due to the timing of the 2016 Annual Meeting, the award will be announced in January and recognized in the March/April issue of Pharmaceutical Engineering® Magazine.

Facility of the Year Awards

ISPE’s Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.

The program is about much more than just the science and technology of the facilities, however. It recognizes the shared commitment and dedication of individuals working for different companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.

Awards are considered in the following categories:

  • Equipment innovation
  • Facility integration
  • Facility of the future (beginning 2017)
  • Operational excellence
  • Process innovation
  • Project execution
  • Sustainability

Category winners, honorable mentions, and the overall Facility of the Year Award winners are chosen by a team of judges consisting of prominent industry leaders with extensive global experience.

Jim Breen, Vice President, Worldwide Engineering and Technical Operations in Johnson & Johnson’s Supply Chain group and 2016 FOYA Judging Committee Chair, took the stage to announce the 2016 Facility of the Year overall winner, beginning with a video of the six category winners and three honorable mention winners.

  • 2016 FOYA Overall Winner is Genentech, for their large-scale cell culture biologics drug substance plant 2 (CCP2) located in Vacaville, California.

This project, focused on an upgrade to the original CCP2 facility put into an “idle but keep warm” status in 2010, combined with a fast-track return-to-service (RTS) project. The RTS project and its fast-track timing was driven by a need to support product supply to patients of two significant oncology products whose market demand has tripled in recent years.

Revamping the existing CCP2 facility to support new process technology in lieu of building anew resulted in significant savings in capital ($50 million). The project was completed two months ahead of schedule, ensuring patient product supply.

Chris Schreil, Senior Principal Engineer/Project Advisor and project team lead accepted the award.

Passing the Torch

Following the awards ceremony, Joe Famulare symbolically handed the chairman’s gavel to Mike Arnold, who accepted it with a smile. The new ISPE International Board of Directors Chair announced: “We have a lot of good stuff to do.”

Looking ahead, Arnold said, “I see both opportunities and challenges. Opportunities abound; two are leveraging our Affiliates and Chapters, and our Young Professionals. Challenges are a complex and competitive environment. We have to be flexible and forward thinking to address these challenges. I’m convinced that the answers to these challenges are in this room.”

The new Chair also identified four areas of focus:

Transparency:  Ensure appropriate level of transparency between Affiliates and Chapters and the organization. I’ll help by doing two things: The “Chairman’s Chatter” articles on ISPE website, and the “Message from the Chair” column in Pharmaceutical Engineering® Magazine. “That’s me communicating to you on behalf of the Board of Directors,” he said.

Diversity:  Look for new opportunities to engage and establish effective partnerships with academia and other not-for-profits with common industry goals and objectives. “We want to leverage existing ISPE expertise and structure to enhance our global effectiveness,” he explained.

Collaboration:  Leverage Chapters and Affiliates more effectively to share knowledge and expertise globally, and leverage the skills and insights of Young Professionals to develop current and future strategies. “I want to be sure we get their intellect, involvement, and experience,” Arnold added.

Strengthening Our Core:  Identify opportunities to enhance efficiencies in the development and execution of our conferences, technical documents, and member services. “I want to make this more efficient going forward,” he said.

In addition, Arnold announced four new board committees:

  • Voice of the Customer:  Take members’ pulse on issues, concerns, and level of customer satisfaction. Get information back from members—the customers—to allow us to be more effective. As part of this effort, the Board will also conduct annual self-assessments.
  • Business Development Committee:  Identify and assess opportunities for partnerships, collaborations, and new ISPE business focus areas.
  • Operations Review Committee:  Assess current high-level processes associated with business decisions, and ensure effective and sustainable processes are in place.
  • China Strategy:  Assess opportunities for developing ISPE business in China, and determine how best to leverage this market.

“Let me be clear,” Arnold said, “ISPE is alive and well. We are heading in the right direction. We have tremendous strengths and opportunities, and I want to take advantage of that. My commitment to you is that we will listen, facilitate sound business decisions, and be as transparent as possible.”

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2017 Annual Meeting & Expo, 29 October - 01 November, San Diego, California

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