A New Place for Information - 2018 Nov/Dec ISPE Briefs
Welcome to ISPE Briefs, a new column about happenings at ISPE—chapters and affiliates, conferences, and more.
New Technologies & Molecules
Ready for the Future of Biologics Manufacturing? For a deep dive into what’s coming in the next decade, the 2018 ISPE Biopharmaceutical Manufacturing Conference, 10–12 December, Huntington Beach, California, will help attendees explore, strategize, develop tools, and determine how to navigate the evolving technical and regulatory complexities of biopharma’s exciting future, according to conference chair Andre L. Walker, Principal, Andre Walker Consulting.
“As novel therapies emerge from the clinic and provide dramatic improvement in disease treatment, the biopharmaceutical professional of today must be prepared to design, build, operate, and support the new and different facilities and processes required to meet demand,” Walker said. In other words, “This won’t be your parents’ biopharma plant.”
Speakers from Kite, Biogen, Alnylam, bluebird bio, MedImmune, Genentech, Immunogen, and more are scheduled to present. Global industry leaders and regulators will be on hand. And as part of “From Lab to GMP Production,” an interactive half-day workshop led by experts in this emerging field, attendees will collaborate to design a facility and equipment layout that supports a new cell therapy treatment.
Attendees tour the new Late-Stage Development and Launch Facility at F. Hoffmann La-Roche AG.
The ISPE D/A/CH (Germany, Austria, and Switzerland) Affiliate’s Young Professionals and Students Group sponsored Future Leaders’ Days on 21–22 June at F. Hoffmann-La Roche AG headquarters in Basel, Switzerland. Presentations by companies including Ho man-La Roche, Bayer AG, Werum IT Solutions, Boehringer Ingelheim, Novartis, and CRB Group GmbH focused on engineering career paths as well as technical topics such as project management and execution, digitalization, Pharma 4.0, and biopharmaceuticals. Attendees toured the new Late Stage Development and Launch Facility in Kaiseraugst, participated in a Q&A session, networked with presenters and fellow attendees, and met with the ISPE D/A/CH Board at an evening social event.
Plenary panel participants (from left): Vincent Loret, Site Director, GlaxoSmithKline, Singapore; Chong Meng Chai, Head of Mammalian Manufacturing, Lonza Biologics, Singapore; Dr. Jincai Li, Vice President, Drug Substance Manufacturing (MFG1), WuXi Biologics, China; and Conference Chair Pierre Winnepenninckx, CEO and Founder, No Deviation Pte, Ltd. (moderator).
The ISPE Singapore Conference and Exhibition, 29–31 August, drew over 1,000 participants, a record attendance for the 18 years of the conference. Participants included delegations from Indonesia, Thailand, and Vietnam. Over 65 speakers shared thought leadership, best practices, and real-life experiences. The event featured the region’s ¬ first Women in Pharma® session, which was held in conjunction with the conference.
International speakers included Tim Howard, ISPE Board of Directors Chair (2017–2018); Dr. Christine Moore, Global Head and Executive Director, GRACS CMC Policy, Merck, Sharp & Dohme Corporation, US; Christian Wölbeling, ISPE Pharma 4.0 and Co-Chair GAMP® MES Special Interest Groups, Senior Director Global Accounts, Werum IT Solutions, Germany; and Hazem Eleskandarani, Global Director, Commissioning & Qualification, Engineering & Property Services, Johnson & Johnson, US.
Keynote speaker Ferry Soetikno, Chief Executive Officer, Dexa Group, Indonesia, presented on “Ensuring the Supply of Quality Medications Beyond Domestic Markets.” The plenary panel discussion on “Driving a Quality Culture through Leadership” generated lively debate; other popular sessions included process and technology transfer, digitization, quality culture, process and cleaning validation, and ICH Q12.
The Regulatory A airs track brought together regional and global regulators including Boon Meow Hoe, Chairman (2018–2019), PIC/S; Vladimir Orlov, Deputy Head of Scientific, Methodology & Training Department of FSI, State Institute of Drugs and Good Practices, Russia; and regional authorities from Thailand and Singapore.
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Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los Angeles, one in Boston, and one in In-dianapolis.
The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.