TS9C: Design of Experiments for Cell and Gene Therapies

THURSDAY, AUGUST 15 AND FRIDAY, AUGUST 16, 2019
DAY ONE: 1:30 – 5:00 PM | DAY TWO: 8:30 AM – 3:30 PM

Waterfront 2

INSTRUCTORS:

Jerrod Denham, Principal, Dark Horse Consulting

Andrew Steinsapir, Consultant, Dark Horse Consulting

Design of Experiment (DOE) is recognized as the most prominent tool for analyzing the effect of multiple factors on complex unit operations. Cell and gene therapy manufacturing processes contain many classic examples of such operations, and DOE is the best systematic approach for their optimization. This results in improved manufacturing yields, efficiency, cost, consistency and safety. This branch of applied statistics is intimidating, but once explained clearly, surprisingly intuitive and easy to use. This seminar will include specific, practical examples of the application of DOE to optimization cell culture, gene medication and downstream processing unit operations in cell and gene therapy. Attendees will leave with concrete methods and tools enabling them to address their own products’ manufacturing in a sophisticated but practical way.

WHAT YOU WILL LEARN:

Attendees will leave with concrete methods and tools enabling them to address their own products’ manufacturing in a sophisticated but practical way.

WHO SHOULD ATTEND:

Those working in cell and gene therapy process development looking to understand the principals and benefots of adopting a “Design of Experiments” approach

INSTRUCTOR BIOGRAPHIES:

Jerrod Denham, Principal, Dark Horse Consulting

Over the past two decades, Jerrod has led process engineering, development and manufacturing teams within several biotechnology companies developing cell and gene therapy products. At Dark Horse Consulting, he advises biotechnology companies on upstream and downstream process engineering, manufacturing and regulatory through all phases of manufacturing from pre-clinical to commercial. Utilizing his specialized skills in Lean Six Sigma, formalized root cause analysis, statistical data analysis, design of experiments, technology transfer and facility design, he has solved problems relating to CMC of both cell and gene therapy products.

Andrew Steinsapir, Consultant, Dark Horse Consulting

Andrew holds a Lean Six Sigma Green Belt and has proven himself a leader in upstream, downstream, and analytical process development of gene therapies. At Dark Horse Consulting, Andrew leads efforts in creating process models that integrate technical, economic, and process engineering information to evaluate equity investment opportunities, risk and returns, as well as construct a more informed process/technology design. Andrew also brings expertise in CMC, technology transfer, facility design, root cause analysis, Design of Experiments (DOE) and statistical analysis utilizing JMP software to advise cell and gene therapy companies on the most streamlined and robust methods to achieve their goals.

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.