Heroes Make Us Strong

Of all the definitions of a hero, this one from Joseph Campbell is my favorite. You met one such hero at our 2016 Annual Meeting, when I introduced you to Gavin Pierson. His mother Nicole was a keynote speaker who shared her family’s journey in their fight to save Gavin, who was suffering from a rapidly growing teratoma, a type of brain tumor. Gavin was in remission when you met him and I’m happy to say he still is—and is about to get his brown belt in karate!

As she ended her presentation, Nicole called you heroes for the work you do in advancing medicine to improve patient outcomes. I said you were heroes not only for creating medicines that save lives, but for finding ways and improvements to reliably manufacture high-quality medicines, when many attempts fail after years of hard work.

Some notable examples of these efforts include discovery and approval of pediatric CAR T-cell therapy—a treatment that genetically engineers a patient’s immune cells to target and destroy cancer cells (see article), advancing biotechnology and biosimilars, and alliances with technology firms. These efforts are being applied toward the achievement of a single goal: the improvement of patient care.

What A Difference A Year Makes

Over the past 13 months I’ve had the opportunity to work closely with many of you who are discovering new medicines. On behalf of the International Board of Directors and ISPE staff, I offer my sincerest thanks to you, our members and volunteers, for finding time in your busy schedules to volunteer with ISPE and lend your continued support. It’s simply amazing. You are my heroes.

When you accept the role of Chair, you know you have a fixed period of time to help move things forward. You know that you must foster stability, maintain continuity, and support ISPE’s relationship with its community. You also want to grow the organization, ensure an effective infrastructure, and prepare it to meet future demand.

In my first column for this magazine, I wrote that I would focus on four primary areas: transparency, business diversity, collaboration, and strengthening our core. In this, my final column, I would like to discuss the outcome of that focus.

TRANSPARENCY As Chair, I shared 21 messages with you: seven via my "View from the Chair" editorial in this magazine, and 14 via "Chairman’s Chatter" on the ISPE Blog. These communications covered global celebrations, society successes, ISPE core values, Young Professionals, Board activities, organizational decisions, plus highlights of conferences and other events.

BUSINESS DIVERSITY The Board has been busy looking at how we can diversify ISPE activities to better serve you and our mission. I asked some Board members to share their thoughts on our accomplishments.

Tom Hartman, Board Director, and Vice President of GMP Operations, Biopharm CMC, GlaxoSmithKline

• "The Business Development Team was established in January 2017 with a remit to identify and assess new ISPE focus areas with the intention of increasing membership, member value, and further industry engagement. Multiple initiatives were evaluated using a tool developed by the team that weighs potential benefits against effort and member needs. From these evaluations, the concept of the ISPE Foundation emerged. The idea was approved by the Board and is currently being developed. Information about the foundation will be shared in San Diego at the 2017 Annual Meeting & Expo."

Fran Zipp, Board Director, and President and CEO, Lachman Consultant Services

• "ISPE Women in Pharma (WIP) provides women in the manufacturing sector of the pharmaceutical industry a community of mentors, resources, and educational sessions for career success and work-life balance. WIP held its inaugural session at the 2016 ISPE Annual Meeting & Expo in Atlanta, Georgia, with nine panelists from industry and FDA and about 70 attendees. It has since grown remarkably, with well over 120 attendees at the 2017 Women in Pharma breakfast at the ISPE/FDA/PQRI Quality Manufacturing Conference. Since 2016 WIP has received $5 donations for ISPE Women in Pharma buttons; proceeds have been awarded to the University of Georgia Department of Pharmaceutical and Biomedical Sciences to women pursuing degrees in the field. Monies are earmarked for ISPE student memberships, registration fees for ISPE events, purchase of an ISPE Guidance Document, or attendance at an ISPE training course."

Antonio Moreira, Board Director, and Vice Provost for Academic Affairs, University of Maryland, Baltimore County

• "The Academic Outreach Subcommittee of the Business Development Committee recently joined forces with the WIP Academic Subcommittee to foster initiatives to recruit and retain student memberships in ISPE, including specific efforts aimed at reaching female students and faculty, followed by conversion to YP membership.
• "During the past summer, the Academic Committee interviewed YP and Student Activity Committee leaders in the Boston Area, Carolina–South Atlantic, New Jersey, and San Francisco Bay Area Chapters. From these interviews, we are compiling information on activities and processes that produce a strong and sustained student chapter. These best practices will serve as the foundation for establishing three new student chapters at universities, which have yet to be selected. This pilot exercise will guide the development of a package of information to be made available to all chapters and affiliates."

Brody Stara, YP Committee Chair, and Engineer at Amgen

• "2017 was a year of growth and organization for YPs. We put a new committee structure in place to serve membership around the world. We added YP regional leaders for North America and Europe, and held the YP Hackathon at the 2017 Europe Annual Conference in Barcelona. Europe’s YPs have also begun to hold regular conference calls to engage members and support local chapters."

COLLABORATION I am happy to report there has been good progress on this front. Throughout 2017 we identified partnerships with other organizations and fostered opportunities to share and promote knowledge with chapters and affiliates.

We’ve had successful business events with the Ireland Affiliate, Singapore Affiliate, and the Great Lakes Chapter; we also started an active conversation with the India Affiliate on opportunities for collaboration. Additionally, the ISPE Board approved the creation of ISPE Affiliates in China and Russia (Eurasia). Launch of the ISPE Eurasian Economic Union Affiliate is slated for October 2017.

We began discussions with the Parenteral Drug Association to work together on overlapping initiatives and identify other collaborative activities that align with ISPE strategy. We also met with the US Pharmacopeia regarding business prospects.

We continued to pursue our relationship with the FDA, providing input on several initiatives, including quality metrics. We also proposed quarterly strategy meetings to be facilitated by the ISPE Regulatory Steering Committee.

STRENGTHENING OUR CORE As robust and efficient business systems and processes are essential for success, this area received a great deal of the Board’s attention in 2017. We worked closely with ISPE staff to do the following: Update and approve Governance Documents, assess and implement new business process automation tools (accounting), redesign and launch a new website, restructure the organization, and establish an ISPE Regulatory Steering Committee and Voice of the Customer Committee—interviews and feedback.

Joanne Barrick, Board Director, and Advisor in Global Validation Support, Eli Lilly and Company

• "The Guidance Document Committee and document authoring teams have had an extremely productive year: Five new or updated Guidance Documents and two Concept Papers were issued. Over 8,000 Guidance Documents were sold through 31 July, with the GAMP® Records and Data Integrity Guide selling more than 700 copies in the first four months after publication. Guidance Document member authors are now being recognized on the ISPE website. ISPE staff has been bolstered with additional personnel to assist in editing draft documents and implement improvements focused on facilitating document development. ISPE has also invested in a new publisher platform, Tizra, which will improve delivery and searchability of ISPE publications."

Chris Reid, Board Director, and CEO, Integrity Solutions Ltd.

• "The Voice of the Customer Committee is charged with soliciting feedback from key ISPE stakeholders: industry leaders, ISPE volunteers, Board members, affiliates and chapters, young professionals, staff, and regulators. Their feedback is vital to ensure that we are meeting the needs of ISPE members, and will influence the way we operate, communicate, and move our strategy forward." Customer feedback has contributed to several of our business decisions in 2017.

A FINAL NOTE

When I first wrote this column 13 months ago, I indicated we would be faced with both opportunities and challenges. Challenges, I predicted, would arise from the complexity and competitiveness of our environment. I also said that ISPE must embrace these challenges head-on as we prepared for the future.

Embracing them made for a very busy year for our Board, staff, and volunteers! As a result, our business is better positioned to meet future demands, our membership continues to grow, and our finances remain strong and directionally correct. Our income continues to rise, as does our contribution to the reserve funds; supporting our 2017 investments in infrastructure and technology.

Although we’ve made significant progress this year, more remains to be done. By building on this year’s changes, we can concentrate on other important business opportunities.

In closing I would like to thank the Board members for their unwavering support, strategic input, and counsel. Their tireless efforts have made 2017 a year of tremendous effort and accomplishment.

To our 18,456 members I want to express my sincere gratitude for your intellect, personal time commitment, and passion for ISPE. As an organization, ISPE is the world’s largest, financially sound, highly respected, and professional nonprofit organization serving the pharmaceutical industry. You make us strong!

To Tim Howard, our incoming 2017–2018 Board Chair, I wish you great success in the coming year, and I pledge to you my continued support.

Thank you for the opportunity to be your leader for the past 13 months; I wish you all continued success in the years to come.