11:00am Chair Introduction

Mark Roache, Vice President, Cell and Gene Therapies, Quality Executive Partners (QxP)

11:05am Presentation: Biopharmaceutical Manufacturing Workforce Development in the Age of Gene and Cell Therapy

• A growing community of education, training, and workforce development professionals are keenly focused on the training needs surrounding emerging technologies such as gene therapy, cell-based therapies, gene editing, and regenerative medicine.
• As the sector continues to grow, we anticipate unique training needs across the landscape of academic cGMP facilities, healthcare professionals, startup companies, vendors, biomanufacturers, and the patient.
• This session will explore some of these unique needs as well as exploring how broad communication, collaboration, and partnership is critical to ensuring tomorrow’s workforce is ready to drive this next wave of technology innovation and adoption.

John Balachunas, Workforce Director, NIIMBL

11:20am Presentation: Operational Readiness

• Capitalize on the industry’s best practices for an early launch or capital project completion
• Enable a higher % in product batch release, a batch record error reduction, and/or higher operational equipment effectiveness (OEE) for your plant
• Optimum time to execute this approach is no later than at the start of basis of design (BD) during the concept phase, but precursor discussions are needed beforehand

Glenn Lumpkin, Director of Technical Services, CAI

11:35am Presentation: Addressing the Wave: Meeting Workforce Demands for Advanced Biopharmaceutical Manufacturing

• Global biopharma struggles to maintain a skilled and trained workforce, often poaching from one another, leaving perpetual gaps
• Educational institutions and training providers offer limited capacity, and cannot keep pace with industry’s demands…we need more workforce development capacity
• Innovative responses include development of novel hands-on training in vector manufacturing, rapid ‘bootcamp’ training to fill hundreds of positions in response to the pandemic, train-the-trainer, and curricula sharing to quickly address the oncoming wave

Jenny Ligon, Associate Director, Workforce Development, National Center for Therapeutics Manufacturing, Texas AM

11:50am Presentation: Training Tomorrow’s CGT Associates Today

• Recognizing skills missing when new staff join the industry
• New technology we are embracing and how to develop training programs
• Partnering with academia to better prepare the next generation

Ram Sharma, Associate Director, Manufacturing Development, Minaris Regenerative Medicine

12:05pm Closing Panel with Q&A

All session participants