Single-Use Technology (SUT) Symposium

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1 ISPE San Diego Chapter Invites you to a Full Day Class Single-Use Technology (SUT) Symposium 7:30 am - 6:00 pm Sponsored by: Caltrol Inc. Charter Medical, Ltd Commissioning Agents, Inc. CRB Enterey Life Sciences Consulting Horizon Controls Group ILC Dover NNE PSC Partners PharmEquipment SaniSure Additional Sponsorships Available Location: Genentech / Roche, 4040 Avenida De La Plata, Oceanside, CA Host and Single Use Expert: Program Managers: Juliana Ipuz, Account Manager, West Coast, Charter Medical, Ltd. Oliver Molina, Global Manufacturing Science and Technology Consultant, Enterey Life Sciences Consulting Margaret Stava, cgmp Equipment Manufacturer's Representative, PSC Partners PharmEquipment Michelle Wong, Global Manufacturing Science and Technology Consultant, Enterey Life Sciences Consulting

2 ISPE San Diego Chapter Single-Use Technology (SUT) Symposium Schedule: 7:30-8:00 am Registration and Networking 8:00-8:15 am Introductions with Overview of Agenda 8:15-9:15 am ROI Modeling Ken Hamilton, PhD, Director of Process Engineering, Genentech / Roche 9:15-10:00 am A Case Study of Single-Use System Development for Multi-Product Clinical / Commercial Facilities Sperry Brown, Sr. Manager, Process Development Pilot Plant, Amgen 10:00-10:15 am Break 10:15-11:15 am Integrating Exciting Single-Use Technologies into Flexible Facilities Peter Walters, Process Engineer, CRB Chris Miles, Process Engineer, CRB 11:15 am - Noon Advantages and Risks of Ballroom Manufacturing: Ideas for Addressing the Challenges Jim Green, Sr. Manager, Strategic Projects, E&T Americas, Bayer Noon - 1:00 pm Lunch and Networking 1:00-1:45 pm Benefits and Challenges of Single-Use in CAR-T Manufacturing Jimmy Glenn, PhD, Sr. Engineer, Product Sciences, Kite Pharma, a Gilead Company 1:45-2:45 pm Freezing: Controlled Freeze-Thaw Processes: Potential for Improved Product Yield and Quality Scott Farrar, CTO/Thermal Scientist, Farrar Scientific 2:45-3:00 pm Break 3:00-3:45 pm Single-Use Processes - Benchmarking Industry Best Practices: Cell Banking in Bags vs. Vials Dominic Clarke, PhD, Global Product Manager, Charter Medical 3:45-4:30 pm Bag Fill Processes and Environment: Why Outsourcing Your Bulk Liquids Preparation Makes Sense Becky Moore, Sr. Manager Product Management, Cell Culture & Cell Therapy, ThermoFisher 4:30-4:45 pm Wrap Up and Overview 4:45-6:00 pm Happy Hour Networking Reception with BBQ Dinner and Drinks

3 Registration Instructions ISPE San Diego Chapter To Register and Receive an immediate receipt, use our on-line registration: ISPE LA, SD, SF Members: If you are an ISPE Member in California, please do not set up a new account, you should already be in our system. Please Rob Fleming for assistance with your username and/or password. ISPE Members of other Chapters: You will not be in our system unless you have previously set up an account. Please follow instructions for Non Members below. To update your account to a Member account, please forward your confirmation from ISPE or ISPE Membership Card to Rob Fleming. We need your Chapter name, your ISPE Member number and expiration date. You can get your Membership card once logged onto the ISPE website (see bottom left side of the screen). Non Members: If you do not have an account on our system, you can set one up on the site using letters (not numbers) as your username. Registrations can also be faxed. Complete the form and fax to If paying by check, please mail your check made payable to: ISPE SAN DIEGO CHAPTER, 5319 University Dr., Suite 641, Irvine, CA (949) ISPE San Diego Chapter Tax ID# Registration Fees: ISPE Members $250 Non Members $315 *Genentech Employees $50 Per Person *Gilead Employees $50 Per Person Students $50 Sponsors Food or Drink Sponsors $500 (includes table and one attendee) SOLD OUT $500 (includes one attendee and a sign next to food or drinks indicating you are the sponsor - sorry, table tops are sold out) * Note: Special rates for Genentech and Gilead Employees does not extend to contractors working for either company. Registration or Online Questions? Contact Rob Fleming: rob.fleming@yahoo.com Any other Questions, Contact Kimberly Syre: ksyre@cox.net Name Badges will be given at the event. Cancellations must be received via to: ksyre@cox.net by January 15, 2018 for refund. After the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may attend in your place. If the alternate is not a member, they will need to pay the additional amount for non-members. Name badges will be given at the on-site registration desk.

4 Single-Use Technology (SUT) Symposium Registration Form REGISTRATION RATES $250 $315 $50 $50 ISPE Members Non-Members Genentech or Gilead Employees (does not apply to contractors) Students Sponsors (includes table and one attendee) SOLD OUT Food Sponsors (includes 1 attendee & a sign next to breakfast and lunch tables indicating you are sponsoring) 3 Available Happy Hour Sponsors (includes 1 attendee & a sign next to food and drinks indicating you are sponsoring) 4 Available Please supply the name and addresses of your attendee: 1. CREDIT CARD PAYMENT - Please Indicate Type of Credit Card VISA MASTERCARD AMERICAN EXPRESS Name on Card Signature: Credit Card #: Exp Date: YOUR CONTACT INFORMATION: First and Last Name: Title: Company: Address: City: State: Zip: Phone: Fax:

5 DRIVING DIRECTIONS: Genentech / Roche 4040 Avenida De La Plata, Oceanside, CA From Downtown San Diego Take Interstate I-5 North. Exit at Hwy. CA-78 East. Exit at El Camino Real, Turn Left/North (over the freeway). Make a right on Oceanside Blvd. Make a left on Corporate Centre Drive. Turn Right onto Avenida De La Plata. Genentech will be on the Left side. From Los Angeles Area Take Interstate I-405 South toward Long Beach. Merge onto I-5 South. Merge onto CA-78 East. Exit at College Blvd. Use Left 2 lanes to Turn Left onto College Blvd. Use Left 2 Lanes to Turn Left onto Oceanside Blvd. Turn Right onto Avenida Del Oro. Turn Left onto Avenida De La Plata. Genentech will be on the Right side. Note: Gilead (across the street at 4049 Avenida De La Plata) will host overflow parking. Please be sure to look up directions from your own starting point.

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