ISPE-CaSA Technology Conference 2017
 

AGENDA


 
No location
 
03/13/2017
4:00 pm - 8:00 pmLevel 4 - Ballrooms A, B, & CExhibitor Registration & Set Up [More Info]
4:00 pm - 8:00 pmRCC Front Entrance Salisbury Street or Loading Dock off of Lenoir Street.Exhibitor Entrance [More Info]
4:30 pm - 7:00 pmLevel 4 - Ballrooms A, B, & CPlease check if you plan on attending
Exhibitor Reception & Student Poster Display ( Judging starts at 6pm) [More Info]
5:00 pm - 8:00 pmCatalentTalk and Tours - Catalent (Additional Cost) [More Info]
5:00 pm - 8:00 pmMedicagoTalk and Tours - Medicago (Additional Cost) [More Info]
 
03/14/2017
7:00 am - 8:30 amLevel 4 - Ballrooms A, B, & CExhibitor Set-Up
7:00 am - 8:30 amRCC Front Entrance Salisbury Street or Loading Dock off of Lenoir Street.Exhibitor Entrance for Set-Up
7:00 am - 8:30 amLevel 4 - Ballroom LobbyExhibitor Registration
7:30 am - 9:30 amLevel 4 - Ballroom LobbyContinental Breakfast
8:00 am - 5:00 pmLevel 3 - RCC LobbyAttendee Registration
8:30 am - 5:00 pmLevel 4 - Ballrooms A, B, & CExhibit Hall Open
9:00 am - 10:00 amRoom 206NC BIOMANUFACTURING & PROCESS DEVELOPMENT
Allogeneic Cell Therapy Vaccines for the treatment of Cancers [More Info]
Jeff Hutchins, Ph.D., Chief Scientific Officer and Senior Vice President of Preclinical Development, Heat Biologic
9:00 am - 10:00 amRoom 301AIP COP
Revolutionary Medication Management [More Info]
Ali Abdulhay, Full Stack Engineer and COO, Digidose LLC
9:30 am - 9:45 amRoom 302 A, B, & CGeneral Session Kick-Off
10:00 am - 10:45 amSpecific to Session EDUCATIONAL SESSIONS I
10:00 am - 10:45 amRoom 206NC BIOMANUFACTURING & PROCESS DEVELOPMENT
Allogeneic CAR-T Cell Therapy Manufacturing [More Info]
Kim Nguyen, Director, Process Development, Precision Biosciences
10:00 am - 10:45 amRoom 301A
IP COP

3D Printing in Pharmaceuticals - Patient-Specific Care With Shortened Supply Chain [More Info]
Peter Denmark, Director of Sales - Americas - MCAD, Envisiontec
10:00 am - 10:45 amRoom 301BMANUFACTURING OPERATIONS
Engineering Human Competency – The First Step Toward Operational Excellence [More Info]
Shane Kelly, Maintenance Systems Manager, Shire
Richard Tree, Vice President, Commissioning Agents, Inc.
10:00 am - 10:45 amRoom 302 A, B, & CWOMEN IN PHARMA
Women Influencing the Industry: A Local Perspective on Developing Your Journey [More Info]
Addie Anderson, StrengthsFinder Coach; Lead Process Engineer & Project Manager, Associate, CRB
Susan Beckert, External Manufacturing Operations Director for DDS and Devices, Merck
Jennifer Lauria Clark, Executive Director of Strategic Development, Commissioning Agents, Inc.
Heather Denny, President and CEO, McDonald York Building Company
Megan Crum, Plant Engineer, Maintenance, Biogen
Cathy Middleberg, Pfizer
Christa Myers, Senior Pharmaceutical Engineering Specialist, CRB
10:00 am - 10:45 amRoom 303DEVICES & EQUIPMENT - CLEANING
Strategies for Cleaning and Cleaning Validation that Minimize Downtime for Product Changeovers [More Info]
John Hyde, Founder / Principal Consultant, Hyde Engineering + Consulting
10:00 am - 10:45 amRoom 304FACILITY OF THE FUTURE
Rapid Compounding of Drug Substances into Semisolid Matrices - One Patient at a Time [More Info]
Rick Lawless, Associate Director, Strategic Programs, NC State BTEC
Edison Hudson, CEO and Co-Founder; CTO & Founder, Panacea BioMatx, Inc.; Panaceutics, Inc.
10:00 am - 10:45 amRoom 306CFDA
Using stastical analysis in place of re-qualification testing for CTUs [More Info]
Gavin Wendel, Senior Validation Specialist, Pfizer
10:00 am - 10:45 amRoom 402STUDENT/YOUNG PROFESSIONAL CAREER DEVELOPMENT
Traveling Down your Career Path - Lessons Learned Along the Way [More Info]
11:00 am - 11:45 amSpecific to Session EDUCATIONAL SESSIONS II
11:00 am - 11:45 amRoom 206NC BIOMANUFACTURING & PROCESS DEVELOPMENT
Nanoparticle and Microparticle Manufacturing Using the PRINT® Platform: Enabling Novel Products in the Life Sciences and Beyond [More Info]
Derek Schorzman, Executive Director, Manufacturing Sciences, Liquidia Technologies, Inc.
11:00 am - 11:45 amRoom 301AIP COP/CROs
Delivering Superior Service to Clinical Sites and Patients [More Info]
Greg Hottell, Director, GSK
11:00 am - 11:45 amRoom 301BENGINEERING
Enhancing Compliance through Innovative Approaches to Commissioning & Qualification / Validation (CQV) of Automation, Facilities, Utilities, & Equipment Systems used in Biologics Manufacturing [More Info]
Brian Urban, Associate Director, Quality Systems & Enterprise Management, Biogen
Robert Smith, Sr. Manager, Automation, Biogen
Tolga Musa, Associate Director, Process Engineering, Biogen
11:00 am - 11:45 amRoom 302 A, B, & CWOMEN IN PHARMA
Women Influencing the Industry: A Local Perspective on Developing Your Journey [More Info]
Addie Anderson, StrengthsFinder Coach; Lead Process Engineer & Project Manager, Associate, CRB
Susan Beckert, External Manufacturing Operations Director for DDS and Devices, Merck
Jennifer Lauria Clark, Executive Director of Strategic Development, Commissioning Agents, Inc.
Megan Crum, Plant Engineer, Maintenance, Biogen
Heather Denny, President and CEO, McDonald York Building Company
Cathy Middleberg, Pfizer
Christa Myers, Senior Pharmaceutical Engineering Specialist, CRB
11:00 am - 11:45 amRoom 303DEVICES & EQUIPMENT - CLEANING
Feasibility Testing, Cycle Development and Validation Guidance of VHP Low Temperature Surface Terminal Sterilization for Pharmaceutical Packaging Process [More Info]
Juha Mattila, Senior Product Manager, STERIS FINN-AQUA
11:00 am - 11:45 amRoom 304FACILITY OF THE FUTURE
Seeing the Future – A Review of the ISPE 2016 Facility of the Future Conference [More Info]
Jim McGlade, Science Market Leader, BHDP Architecture
Robert Chew, President/CEO, CAI
Phil McDuff, VP, Global Engineering, Biogen
11:00 am - 11:45 amRoom 306CSERIALIZATION
Lifecycle Approach to Serialization Process Qualification [More Info]
Wendy Haines PHD, Project Manager, Mangan Biopharm
John R. Hodge IV, Project Manager, Mangan Biopharm
11:00 am - 11:45 amRoom 402STUDENT/YOUNG PROFESSIONAL CAREER DEVELOPMENT
Enhancing Your ISPE Experience [More Info]
Ken Ewan, Leadership Coach, KME Leadership, LLC
11:30 am - 1:00 pmLevel 4 - Ballroom LobbyLUNCH - Attendees and Exhibitors (11:30am-1:00pm) [More Info]
1:10 pm - 2:00 pmRoom 302 A, B, & CGENERAL SESSION
General Session - Keynote Address [More Info]
Nick Valvano, President Emeritus, The V Foundation for Cancer Research
Randy Karsten, Managing Director, Strategic and Corporate Sponsorships, The V Foundation for Cancer Research
3:00 pm - 3:45 pmSpecific to Session EDUCATIONAL SESSIONS III
3:00 pm - 3:45 pmRoom 301AIP COP
Investigational Products and the Academic Health Care System – A Dynamic Integration [More Info]
Gregory Westby, Clinical Compounding Pharmacist, Duke University Health System
3:00 pm - 3:45 pmRoom 301BENGINEERING
How to structure the execution of the World Largest Biotech Project [More Info]
Carsten Nicolai Petersen, Director, NNE
Gary Lohr, Project Director – Site Support and Deputy Site Head, Novo Nordisk
3:00 pm - 3:45 pmRoom 303INFORMATION MANAGEMENT SYSTEMS
Data Security in the Cloud for Life Sciences [More Info]
Jeff Miller, IS Department Manager, Avid Solutions, Inc.
3:00 pm - 3:45 pmRoom 304FACILITY OF THE FUTURE
SESSION CHANGE: Continuous Discharge Centrifugation: A Solution to the Challenges of High Cell Density Mammalian Cell Culture Clarification [More Info]
Ardarion Richardson, Process Engineer III, Process Engineering, Biogen
Joshua Walker, Senior Engineer I, Technical Development , Biogen
3:00 pm - 3:45 pmRoom 306CBIOTECH
From College to the Real World: How Our Senior Projects Prepared Us for Biotech Facility Design [More Info]
Kevin Ventura, Process Engineer, CRB
Bryan Raborn, Process Engineer, CRB
Allan Bream, Lead Biopharmaceutical Specialist, CRB
3:00 pm - 3:45 pmRoom 307DEVICES AND EQUIPMENT - CLEANING
Optimizing Plant Performance with Unique Mixproof Valves [More Info]
Roger J. Ashton, Valve Systems Specialist, Equipment Division, Sanitary, Alfa Laval Inc.
David Summers, ESE Commercial Manager – Valves, Equipment Division, Sanitary, Alfa Laval Inc.
3:00 pm - 3:45 pmRoom 402STUDENT/YOUNG PROFESSIONAL CAREER DEVELOPMENT
Data Integrity 101 [More Info]
Marisol Patino, Process Engineer, Sartorius Stedim Biotech
5:00 pm - 7:00 pmLevel 4 - Ballroom LobbyEvening Reception