$30 – $35

Project Execution Excellence - BioMarin New Gene Therapy Facility

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333 Market St

WellsFargo Event Center

Annex Building

San Francisco, CA 94105

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Description

As disruptive technologies become more prominent in the industry drug programs need to react with speed and flexibility to maintain a foot hold in the market place. Over time GMP manufacturing projects have continued to reduce in duration, with the current duration averaging 3 - 4 years from concept to operation. To be first to market in a competitive environment BioMarin successfully completed this same effort in 54 weeks.

At project kickoff the team had an existing storage warehouse, a draft layout, large process equipment identified a phase 1 production process and a single manufacturing employee. Simultaneously, the team successfully developed a GMP manufacturing process, executed scale up and tech transfer activities while designing, building, and qualifying the facility. This, all while facing technical challenges typical of scale up, gene therapy design considerations, fill finish technologies, coupled with strict local and federal regulations and the worst winter in the bay area in 10 + years.

The project has received an award for project execution from ISPE and is a current contender for the 2018 project of the year award.

Join us in learning how Biomarin, partnered with CRB engineers and Novo construction made the imposable project a reality without compromising on quality, schedule or cost.

Presenter: Carl Albertson, Director of Capital Projects, BioMarin

Carl Albertson has over 30 years of diversified experience in engineering and project management in the biotech, aseptic and pharmaceutical processing industry. His experience ranges through all phases of project design including design, construction, commissioning and qualification. He is currently a Director in the capital projects department at BioMarin in Novato, CA. BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions with focus on rare (orphan) genetic diseases. For the ISPE FOYA project, Carl was the overall project manager responsible for all facets of the project.

Presenter: Logan Kelley Senior Project Manager, BioMarin

Logan Kelley has spent the last 15 years developing physical assets for health care, higher education and pharmaceutical organizations. These assets range from office, lab and manufacturing space, cold environments, utility systems, process equipment, and structural improvements. His responsibilities encompass all phases of the project life cycle while managing all stakeholder and sponsor expectations from individual contributors to C-suite management. Logan specializes in fast track projects where the development of high performing teams is a key ingredient for success. Logan is currently a senior project manager at BioMarin and an active board member for the San Francisco chapter of the International Society of Pharmaceutical Engineers. At BioMarin he most recently led the development, design and construction of the company’s new gene therapy manufacturing facility.

Agenda:

- 6:00 PM Registration/Networking/Complimentary Food & Drinks
- 6:45 PM Announcements
- 7:30 PM Featured Speakers/Q&A
- 8:30 PM Adjourn

Sponsors:

Gold Sponsor

Silver Sponsor

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How can I contact the organizer with any questions?

You can contact the organizer at rsvp@wccpda.org until 1 day prior to the event

Is my registration fee or ticket transferrable?

Yes, you can update your reservation communicating changes to rsvp@wccpda.org until 1 day prior to the event

What is the dressing code?

Business casual

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Date and Time

Location

333 Market St

WellsFargo Event Center

Annex Building

San Francisco, CA 94105

View Map

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