03/09/2021 | |||
8:30 am - 10:00 am | OPENING GENERAL SESSION & KEYNOTE ADDRESS "Leading Ladies in Industry - A Panel Discussion" [More Info] Wendy Haines, Associate Director of Technical and Scientific Services, PharmEng Technology Christine Vannais, Chief Operating Officer (COO), FujiFilm Diosynth Biotechnologies Sylvie St-Martin, VP, Quality Assurance, Medicago Kelli Collin, Vice President, Head of Quality, Shattuck Labs Monique Sprueill, Senior Manager, Strategy, Insights & Innovation, Enterprise Quality Strategy & Services, Johnson & Johnson | ||
10:00 am - 10:15 am | **Program Break** [More Info] | ||
10:15 am - 11:00 am |
EDUCATIONAL SESSIONS I
EDUCATIONAL SESSIONS I | ||
10:15 am - 11:00 am | Use of (AI) Artificial Intelligence and Advancements in Technology Virtually There: Replacing Physical Walk-Throughs with Virtual Environments for a Travel-Restricted World [More Info] Max Webber, Manager, Automation Engineering, NNE | ||
10:15 am - 11:00 am | Cell and Gene Therapy Considerations for Multi-Product Facilities for ATMP Manufacturing [More Info] Emily Thompson, Senior Process Specialist, Associate, CRB Michael Principato, Process Engineer, bluebird bio | ||
11:00 am - 11:15 am | **Program Break** [More Info] | ||
11:15 am - 12:00 pm |
EDUCATIONAL SESSIONS II
EDUCATIONAL SESSIONS II | ||
11:15 am - 12:00 pm | Cell and Gene Therapy Flexible Universal CAR-T Manufacturing in Isolators - Closing the Process from Upstream through Aseptic Filling [More Info] Les Edwards, VP Technology & Bus Dev, SKAN US Anthony Thatcher, US Head - Manufacturing Support and Technology, Cellectis | ||
11:15 am - 12:00 pm | Program Management in a Warp Speed Environment Expediting EPCMV for Warp Speed Projects in the Life Sciences Industry [More Info] Leigh Formanek, Director of Construction and Project Services; US Lean Leader, DPS Group Bruce Klopfenstein, Director of CQV, DPS Group | ||
12:00 pm - 12:15 pm | DAY 1 - CLOSING REMARKS DAY - CLOSING REMARKS [More Info] Alma Montemayor, Director of Project Development; ISPE-CaSA 2021 Technology Conference Chair, Flad Architects | ||
1:00 pm - 2:00 pm | Student/Emerging Leaders Career Development ISPE-CaSA Emerging Leaders Panel [More Info] Jennifer Lauria Clark, Executive Director of Strategic Development, Commissioning Agents, Inc. Mone't Johnson, Director of Operations, Mid-Atlantic Region, CAI Tanya Sharma, Partner, Assurea, LLC Melissa Luck, People and Organization Manager, Novartis Vidhi Bhanderi, Validation Specialist, PharmEng Technology | ||
03/10/2021 | |||
8:30 am - 10:00 am | KEYNOTE ADDRESS "The Board’s Point of View - A Panel Discussion" [More Info] Tolga Musa, Director of Manufacturing, Biogen Geoffrey Ramsay, Sr. Manager, Validation, Patheon, by ThermoFisher Scientific Jennifer Popovich, Director, Validation, Mayne Pharma Daniel Williams, Regional Project Director, Americas, GlaxoSmithKline Rich Stanfield, Vice President, North America; ISPE-CaSA President, Commissioning Agents, Inc. | ||
10:00 am - 10:15 am | **Program Break** [More Info] | ||
10:15 am - 11:00 am | EDUCATIONAL SESSIONS III EDUCATIONAL SESSIONS III | ||
10:15 am - 11:00 am | CDMO Drug Development Technology Transfer Best Practices Tech Transfer Program Management – Best Practices in the Era of COVID-19 [More Info] Charlie Maher, Project Director, Resilience, Inc. | ||
10:15 am - 11:00 am | Use of (AI) Artificial Intelligence and Advancements in Technology Digitize the Batch Records with Pharma 4.0 Technology that Works [More Info] Gilad Langer, Industry Practice Lead, Tulip Michelle Vuolo, Quality Practice Lead, Tulip | ||
11:00 am - 11:15 am | **Program Break** [More Info] | ||
11:15 am - 12:00 pm | EDUCATIONAL SESSIONS IV EDUCATIONAL SESSIONS IV | ||
11:15 am - 12:00 pm | Program Management in a Warp Speed Environment Efficiency Gains Through Cycle Time Reduction [More Info] Justin Blackwelder, Project Services Manager, PCI Rick Mineo, Operations Director - North America, Kneat | ||
11:15 am - 12:00 pm | Women in Pharma Applying Lean Execution Tools on a Fast-Track Project [More Info] Shannon Chase, Senior Project Manager, CRB Megan Arnold, Project Manager, CRB Daniela Gracey, Project Manager, CRB | ||
12:00 pm - 12:15 pm | DAY 2 - CLOSING REMARKS DAY 2 - CLOSING REMARKS [More Info] Alma Montemayor, Director of Project Development; ISPE-CaSA 2021 Technology Conference Chair, Flad Architects | ||
1:00 pm - 1:45 pm | How UPS Executed Unprecedented Delivery of Fragile COVID Vaccine [More Info] Darren Dasburg, CBO, CRISPR Biotechnologies Alma Montemayor, Director of Project Development; ISPE-CaSA 2021 Technology Conference Chair, Flad Architects |