Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, and extensive coverage of the basic science underlying each topic. Experienced Training Seminar instructors offer a mix of formal lectures, interactive discussions and activities to help attendees maximize their learning experiences. These immersive trainings will be of value to scientists from industry and academic research groups who are entering new fields – and to those working in supporting roles that will benefit from an in-depth briefing on a specific aspect of the industry.

TS5A: Intro to Gene Therapy and Viral Vectors

INSTRUCTORS:

Jerrod Denham, Principal, Dark Horse Consulting

Andrew Steinsapir, Consultant, Dark Horse Consulting

In the age of gene therapy, there is a significant demand for scientists trained in the “dark arts” of viral vector process development, production and analysis. This 1.5 day course has been specifically created for those looking for a solid understanding of the analysis, quality control and manufacture of AAV, lentiviral and retroviral-based therapies.

TOPICS TO BE DISCUSSED:

• Gain a thorough understanding of viral vector development

WHO SHOULD ATTEND:

Those working in AAV and lentivirus viral vector development, upstream and downstream process development, production and analytics

INSTRUCTOR BIOGRAPHY:

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.