Upcoming Events:

NewAge Industries-AdvantaPure

Boston Area Chapter Current Year Events List

Event
ISPE Educational Programs Planning Meeting
Date: 6 January 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 11 January 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 12 January 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE New Year's Social
Date: 14 January 2016

Pre-Registration is now closed.  Walk-ins accepted onsite.

Start the New Year off by joining Boston ISPE for a night of Ping Pong and Baseball!! There will be prizes awarded for the Ping Pong tournament (sign up early).  The batting cage at Fenway Park is available for all to take a few swings. Sign up now and show off your skills on the table and in the cage!

Light fare and cash bar will be provided.

Thursday, January 14, 2016
6:00 – 9:00pm
Blazing Paddles
85 Lansdowne Street, Boston, MA 02215

Thank you to our Sponsors:
Albireo Energy, LLC (formerly GxP Automation)
A/Z Corporation
Boston Analytical
DPS
JENSEN HUGHES
TRIA

50/50 Raffle benefitting The ALS Foundation

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ISPE Build A Bio
Date: 21 January 2016

PRESENTATION

Peter Cramer and Jeffrey Odum: http://www.ispeboston.org/files/ispe_build_a_bio_-_cramer_and_odum.pdf


EVENT INFORMATION:
Join ISPE Boston Chapter at the UMass Lowell for an eventful Town Hall discussion covering the ins and outs of manufacturing strategies. The program will include a networking reception including appetizers.  As an added bonus, representatives from UMass Lowell are hosting a tour of the Emerging Technologies and Innovation Center. This is an ISPE MEMBER ONLY tour.  Tour participation is limited, so register now!

PROGRAM SUMMARY:
As companies develop both short and long-term manufacturing strategies, operational efficiency and utilization become very critical to optimizing cost-of-goods, manpower planning, and supply chain management.  The approach that companies may take includes new technology and delivery platforms that are “outside the box” from the traditional project models of the past four decades.  During this session we will discuss the key decisions needed to be made in implementing new technologies in a full single use or a hybrid production facility. Our goal is to get feedback from the audience on the needs of the industry and how advances in technology are changing the way new facilities are being designed and built in the future. We will also discuss the implications and risks associated with choosing new technologies versus current industry standards.

TOUR:
The ISPE Boston Area Chapter is also glad to present a rare opportunity to join a tour of UMass Lowell’s Core Research Facilities in the Saab ETIC and Olney Science Center by CRF Staff.

Membership has its privileges!
This tour is open only to ISPE Members and will fill up fast! So register early!

Please check-in before 5:00 and you will be given your tour group schedule.  Tours start at 5:15 PM.|

SPEAKERS: 
Peter Cramer, Vice President of Life Science Facility Design, M+W Group
Peter Cramer, Vice President of Life Science Facility Design for M+W Group, has over 25 years of professional experience in the process architectural field.  Mr. Cramer serves as lead process architect on numerous projects serving the life science industry including vaccine, biotech, API, drug development, packaging and laboratory facilities and pilot plants to name a few.  Past clients have included Pfizer, Wyeth, Baxter, Vertex, Amylin, and Crucell.  Mr. Cramer holds a Master’s of Science degree in Civil Engineering degree from Northeastern University and a Bachelor of Architecture from the University of Miami.  Peter has LEED® AP accreditation and is affiliated with the American Institute of Architects and ISPE. Mr. Cramer is a frequent panelist and speaker for Seminars and Symposiums across the country. 

Jeffrey Odum, CPIP, SME, Director of Operations, Biotech Lead, IPS
Mr. Odum has over 25 years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, pharmaceutical, and chemical industries.  He is currently the Director of Operations and Biotech Sector Lead at IPS, leading the RTP Office in Morrisville, NC.  A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over 60 articles on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities.  He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to facility design, bioprocess, project management and GMP compliance.   Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the Biotechnology Community of Practice, a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management as well as commissioning and qualification, and is a member of ISPE's technical training faculty.   He has led training efforts in 15 countries, as well as in the US.  He is also a Teaching Fellow in NC State University’s BTEC graduate program in biomanufacturing and a guest Instructor for the North Carolina Community College System BioNetwork Program.

REGISTRATION FEES:

Before 1/14/2016: 
Member $50.00
Young Professional Members $20.00 
Non-Member $95.00
ISPE Student Members: Free to attend

After 1/14/2016: 
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00
ISPE Student Members: Free to attend

MEETING MANAGERS:
Mark Braatz, 
FW Webb
John Sheridan, PMA Consultants LLC

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ISPE RE-SHOWING: Build A Bio
Date: 28 January 2016

Pre-Registration is now closed.  Walk-ins accepted on site.

RE-SHOWING OF 1/21 PROGRAM AT


Crowne Plaza Hotel Providence - Warwick

801 Greenwich Street, Warwick, RI 02886

AND AT

WPI Biomanufacturing Education and Training Center at Gateway Park

50 Prescott Street, Worcester, MA 01605

EVENT INFORMATION:
Attend a re-showing at the Crowne Plaza Providence in Warwick, RI or at the WPI BETC at Gateway Park in Worcester, MA.  The programs will both feature a networking reception including refreshments and appetizers.  

PROGRAM SUMMARY:
As companies develop both short and long-term manufacturing strategies, operational efficiency and utilization become very critical to optimizing cost-of-goods, manpower planning, and supply chain management.  The approach that companies may take includes new technology and delivery platforms that are “outside the box” from the traditional project models of the past four decades.  This pre-recorded session will discuss the key decisions needed to be made in implementing new technologies in a full single use or a hybrid production facility. In the live session, our goal was to get feedback from the audience on the needs of the industry and how advances in technology are changing the way new facilities are being designed and built in the future. We will also discuss the implications and risks associated with choosing new technologies versus current industry standards. 

SPEAKERS: 

Peter Cramer, Vice President of Life Science Facility Design, M+W Group
Peter Cramer, Vice President of Life Science Facility Design for M+W Group, has over 25 years of professional experience in the process architectural field.  Mr. Cramer serves as lead process architect on numerous projects serving the life science industry including vaccine, biotech, API, drug development, packaging and laboratory facilities and pilot plants to name a few.  Past clients have included Pfizer, Wyeth, Baxter, Vertex, Amylin, and Crucell.  Mr. Cramer holds a Master’s of Science degree in Civil Engineering degree from Northeastern University and a Bachelor of Architecture from the University of Miami.  Peter has LEED® AP accreditation and is affiliated with the American Institute of Architects and ISPE. Mr. Cramer is a frequent panelist and speaker for Seminars and Symposiums across the country.

Jeffrey Odum, CPIP, SME, Director of Operations, Biotech Lead, IPS
Mr. Odum has over 25 years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, pharmaceutical, and chemical industries.  He is currently the Director of Operations and Biotech Sector Lead at IPS, leading the RTP Office in Morrisville, NC.  A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over 60 articles on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities.  He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to facility design, bioprocess, project management and GMP compliance.   Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the Biotechnology Community of Practice, a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management as well as commissioning and qualification, and is a member of ISPE's technical training faculty.   He has led training efforts in 15 countries, as well as in the US.  He is also a Teaching Fellow in NC State University’s BTEC graduate program in biomanufacturing and a guest Instructor for the North Carolina Community College System BioNetwork Program.

REGISTRATION FEES:
Member: FREE
Young Professional Members: FREE
Non-Member: FREE
ISPE Student Members: FREE

MEETING MANAGERS:
Mark Braatz, FW Webb      
John Sheridan, PMA Consultants LLC

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ISPE Student Career Workshop
Date: 30 January 2016

Pre-Registration is now closed.  Walk-ins accepted on site.

If you will be graduating in 2016-2019, come to a workshop specifically designed to help you to hone your skills and improve your chances of getting that internship, co-op, or full time position in the Life Science Industry.

ISPE Boston has assembled a group of industry experts to help you:

Take Inventory of Yourself
Why you are unique

Get the Interview
Resume building
Effective cover letters

Get the Job
First Impressions
Interviewing Tips
What employers look for

Build Your Network
Why networks are important
Where do I begin?

Build Your Career Path
Short and long term planning

Learn from Industry Pros
Young Professionals
Seasoned Veterans
Entrepreneurs

COST/REGISTRATION

Free for ISPE Student Members. Including materials, lunch, and refreshments

Not an ISPE member? Join and attend.

Join ISPE here www.ispe.org/join-or-renew

WHEN

Saturday, January 30, 2016

10:00 AM – 5:00 PM

Doors open at 9:30AM

 

WHERE

Northeastern University

Egan Hall

Raytheon Amphitheater

End of Forsyth Street

Boston, MA 02120

Here is a map of Northeastern University

What to Bring

Your Questions!

Business Cards

Dress is Business Casual

 

Want more information? Contact us at office@ispeboston.org or call 781-647-4773

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ISPE Product Show Committee Meeting
Date: 1 February 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 3 February 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professional's Retro Social
Date: 4 February 2016

Pre-Registration is now closed.  Walk-ins accepted on site. 

Come join the ISPE Boston Area Chapter Young Professionals at Roller World for an evening of socializing, roller skating, and food! Come reminisce when roller skating birthday parties were the envy all of your friends and request your favorite 90s songs! Registration includes food and skate rentals and admission to this private event to show off your skating skills!

Thursday, February 4, 2016
7:00 PM - 9:00 PM

Roller World
425r Broadway
Saugus, MA 01906

Registration Fees by 1/27:
Member: $25
Non-Member: $35
Student Member: FREE

Registration Fees after 1/27:
Member: $30
Non-Member: $40
Student Member: FREE

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ISPE Board of Directors Meeting
Date: 9 February 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Dancing Through Traffic: Facility Expansions in Operating Plants
Date: 18 February 2016

EVENT INFORMATION: 
Attend the live program at Genzyme in Cambridge, MA, or a simulcast presentation at the Crowne Plaza Providence in Warwick, RI, or a simulcast presentation at the WPI BETC at Gateway Park in Worcester, MA.  The programs at each location will feature a networking reception including refreshments and appetizers.

PROGRAM SUMMARY: 
When companies determine their current GMP facilities cannot support current or future manufacturing requirements, they need to choose whether to renovate, expand, or relocate. Often the decision to retrofit and remediate is the least costly option but most challenging because it must occur in tight quarters with minimal disruption to ongoing processes. Successful execution of these projects require a different approach than the fundamental or classic approach to planning and design. Our speakers will provide direction and strategies that are well-suited to these types of projects.

Specifically, this evening's program will:

*  Methodically presents a different approach to planning and implementation to mitigate product risks and business vulnerability
*  Addresses these key Owner concerns: Limiting production interruptions, developing a high-confidence schedule, proving no adverse effects to process under modification, to product concurrently in-process or to regulatory filings
*  Discusses considerations in all phases of the project lifecycle: Design, Planning, Execution, Return-to-Service
*  Suggests a dramatic shift in the approach to the planning and implementation of retrofit or remediation projects
*  Illustrates with case studies and leaves attendees with actionable information.

WHO SHOULD ATTEND: 

This presentation is intended for industry professionals seeking to gain a better understanding of the challenges of performing facility projects in operating GMP facilities.

SPEAKERS: 
Richard Kotosky, PE, CPIP, Senior Project Manager, Hargrove Life Sciences
Rick is a Senior Project Manager with Hargrove Life Sciences New England Operations with over thirty years of experience. He has held design engineering and project management positions with consulting A/E firms and has also worked directly for manufacturers of biologics, MAbs, vaccines, and medical devices. His operational experience includes roles from Senior Process Engineer to Senior Director of Facilities Operations and he has successfully managed retrofit projects and coordinated full plant maintenance and repair shutdowns in FDA licensed facilities that date back to the early 1900s. Rick is an active member of ISPE and earned his Certified Pharmaceutical Industry Professional™ credential in 2013. He holds a BS in Chemical Engineering from MIT and an MBA from Boston University. 

John Spohn, CPIP, Senior Project Manager, Hargrove Life Sciences
John is a Senior Project Manager with Hargrove Life Sciences New England Operations.   John has provided owner’s representative services and managed mission-critical projects in biotechnology, pharmaceutical and other industries.  He has over thirty years’ experience in the design and implementation of automated processes, systems and equipment.  John is an active member of the ISPE and earned its Certified Pharmaceutical Industry Professional™ credential in 2011.  He serves on the Boston Area Chapter Board of Directors and Educational Program Committee, managing educational presentations and authoring articles and presentations on topics of interest to the Pharmaceutical Engineering community.  John is co-author of the Pharmaceutical Engineering 2013 Article of the Year:  “Automating a Manual Cleaning Program In a Multi-Product Biopharmaceutical Manufacturing Operation”.  He holds a BS in Mechanical Engineering from Rensselaer Polytechnic Institute.


REGISTRATION FEES:

Before 2/11/2016: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE
Warwick Location: FREE
WPI BETC Location: FREE 

After 6/11/2015: 
Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
Warwick Location: FREE 
WPI BETC Location: FREE

**Non-members may only attend one program as a non-member**

 

 

MEETING MANAGERS:
Norline Crossdale-Walker, Genzyme
Joseph Kifer, RDK Engineers
Heather Longden, Waters
David Novak, OSDV Engineers, Inc.
Rose Mary Su, Acentech

Thank you to our Sponsor:  

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ISPE Educational Programs Planning Meeting
Date: 2 March 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Ski Trip
Date: 4 March 2016

Join ISPE for the Chapter's Annual Ski Trip on March 4, 2016 at Waterville Valley.  Space is Limited, so Don't Delay!

Price Includes: Bus ride up and back, full day adult lift ticket, lunch voucher, buffet dinner, and a lot of fun with fellow ISPE members!

Note: Books of 4 Tickets are available for $310.  If you would like to purchase a Book, please fill out the flyer and email or fax it to office@ispeboston.org or 781-647-7222.

Bus Departures: 6:00 AM: from Newton Marriott - Rt. 128 6:40 AM: from Chateau Restaurant - Andover, MA 7:40 AM: from LL Bean, Concord - NH.

Bus Returns: 4:30 PM from the hill to all Departure Sites (Concord, Andover, Newton)

Thanks to our Ski Trip Sponsors: 

Albireo Energy
A/Z Corporation
Boston Analytical
Commissioning Agents Inc.
Commodore Builders
DPS
JENSEN HUGHES
Reflex Lighting 
RW Sullivan
Sentrol
Superior Controls
TRIA

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ISPE Product Show Committee Meeting
Date: 7 March 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 8 March 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Learning Through Doing: The Interplay of Pilot Plant, Product, and Process
Date: 24 March 2016

EVENT INFORMATION: 
Attend the live program at Shire in Lexington, MA.  This program will feature a networking reception including appetizers.  As an added bonus, Shire is hosting a tour of the Shire’s Pilot Plant Facility. This is an ISPE MEMBER ONLY tour.  Tour participation is limited, so register now!  There is also a Young Professional's Pre-Meeting available.

PROGRAM SUMMARY: 
The Pilot Plant plays an instrumental role both in material supply for preclinical and clinical development purposes as well as scale-up of technology and operations.  The ultimate goal is developing a solid process that can be successfully transferred to a commercial manufacturing site.  In the developing age of customizable, specialized biotechnology therapies, how will Pilot Plants adapt to new technology and what niche will the Pilot Plant play in the future product development lifecycle?  

This educational event will include a presentation and panel discussion of Pilot Plant leaders from notable local biotechnology companies.  The current and future role of the pilot plant in the product development lifecycle will be examined.  The group will first present and comment on benchmarking data collected across their companies.  The group will then discuss agility and adaptability of their pilot plants in regards to the current and future pipeline and technologies. 

WHO SHOULD ATTEND: 
This presentation is intended for industry professionals involved in technology transfer, scale-up of manufacturing processes, process development and manufacturing.

TOUR:
The ISPE Boston Area Chapter is also glad to present a rare opportunity to tour Shire’s 200 Shire Way Pilot Plant in Lexington.  Highlights of the tour will include disposable technology and novel purification equipment.

Membership has its privileges!
This tour is open only to ISPE Members and will fill up fast! So register early!
Please check-in at Fortis Lecture Hall at 200 Shire Way, Lexington and you will be given your tour group schedule.  Tours start at 4:30PM and the last tour leaves at 5:15PM.

YOUNG PROFESSIONAL’S PRE-MEETING:
Join the YP’s for a pre-meeting session from 4:30PM -5:30PM.

MODERATOR:
Brad Ebel, Manager, Pilot Plant Operations, Shire
Brad Ebel has been active in the biopharmaceutical industry for over 15 years and has been focusing on the disposable industry for over 12 years. He is the Manager of Upstream and Media production in Shire’s Pilot Plant Operation (PPO) Group. While at Shire, he has designed and developed two fully disposable perfusion based cell culture operation facilities; responsible for supporting process development activities up too supplying material for toxicology studies.  Previous to Shire, Brad worked for two different manufacturing companies in Colorado where he was active in process development, MFG and media production groups. While in Colorado he helped developed and commission a stainless steel MFG/PD lab from “dirt” to operation in 6 months. In addition, he was able to develop a MFG process in an ISO 7 (100ft2) laboratoryand later transferred the process to an ISO5-8 (7200+ft2) facility that he helped design, oversaw construction and was an active member of the team responsible for commissioning it into a cGMP facility.  Brad holds his B.S. in Chemistry for Westminster College.

PANELISTS:
Bill Brazier, Senior Manager, Process Development Pilot Plant, Amgen Rhode Island
Bill has 25 years of biotechnology experience in the areas of Manufacturing, Engineering and Process Development. He began his biotech career at Genentech in Manufacturing with roles that included operations, manufacturing technical support, facility and equipment design and start up. After 10 years he transferred to Immunex in Seattle for a role in Process Development responsible for the design, start up and engineering support of the Process Development Facility in Bothell, WA. In 2002 Immunex was acquired by Amgen and he took on roles in global Process Development and Corporate Engineering responsible for developing corporate standards for equipment design. In 2011 he transferred to Amgen Rhode Island for the position of Sr. Manager of the Pilot Plant.

Shaun Grier, Associate Director, Pilot Plant Operations, Shire
Shaun Grier has over 14 years of experience in Process Development, Clinical Manufacturing, and Pilot Plant Operations.   He currently is the Associate Director of downstream processing in Pilot Plant Operations at Shire Pharmaceuticals where he leads a group of downstream specialists responsible for the material production and scale-up of early stage therapeutic candidates.  In addition, his group also supports process development and manufacturing. 

Prior to taking a role in the Pilot Plant, he spent 5 years in Process Development at Shire as a process development engineer where he contributed to the development of several early stage purification processes.  He also has led the technology transfer efforts for several processes to internal and external manufacturing along with regulatory file authoring.   Before joining Shire in 2006, Shaun held positions in clinical manufacturing and Pilot Operations at Wyeth Biopharma.  Shaun holds a B.S in Biology and Chemistry from Fitchburg University and a M.S in Biotechnology Management from the University of Maryland University College.

Christof Schulz, Principal Scientist and Senior Group Leader of Scale-up Laboratory, AbbVie Bioresearch Center
Christof Schulz has over 15 years of experience in the Biotech industry. After obtaining his Ph.D. in Biochemical Engineering, Dr. Schulz worked as a Postdoctoral Scientist in Bioprocess Research and Development at Eli Lilly and Company in Indianapolis, IN. In 2003, Dr. Schulz joined the Abbott Bioresearch Center (now AbbVie Bioresearch Center) in Worcester, MA as a Scientist in Process Sciences. At Abbott and AbbVie, he has been holding positions with increasing responsibility, currently as Principal Scientist and Senior Group Leader of the Process Sciences Scale-up Laboratory.

Dave Sullivan, Director – Bioprocess R&D, Pfizer
David Sullivan is a Director in Pfizer’s Bioprocess R&D Organization responsible for leading the Non-GMP Pilot Plant and development lab support organization.  Pfizer’s Bioprocessing Pilot Plants, located in Andover, MA and Chesterfield, MO, support both early and late stage biologic and vaccine process development.  The primary outputs of the organization include regulatory toxicology and development study drug substance, 100L-1000L process characterization / scale up studies, and implementation of advanced manufacturing processes and process analytical technologies.

David has held a number of diverse roles within the large scale commercial/clinical manufacturing and process development since joining Pfizer in 2004.  Prior to Pfizer, he spent 4 years at Bayer Healthcare as a member of their nucleic acid and infectious disease diagnostics unit.  David received a B.S. from Worcester Polytechnic Institute and an M.S. from Tufts University.

Kelly Wiltberger, Associate Director Manufacturing, Biogen
Kelly currently oversees Biogen’s single-use Flexible Volume Manufacturing (FVM) facility in RTP, NC following over a decade leading the pilot scale teams in various capacities. She collaboratively designed and started up the upstream and downstream RTP pilot scale labs. She managed Pilot Scale Cell Culture Development across three separate sites, successfully integrating the San Diego site into RTP and Cambridge in 2011. She was the RTP Technical Development department site lead, spearheaded the initiative to align equipment and procedures between the RTP and Cambridge labs, and was instrumental in implementing the disposable bioreactor technology now used in FVM. Kelly has played key roles in the development of Advanced Process Control (APC) technology and the N-1 perfusion platform, both of which have recently been successfully implemented into large scale manufacturing processes. Under her leadership, the Pilot Scale group worked extensively on bioreactor characterization and process understanding, collaborating both internally and externally to improve scale-up capabilities and modeling of manufacturing processes.

Kelly holds a BS degree in Chemical Engineering from the University of Rochester as well as an MBA from UNC Chapel Hill and has been a co-author on numerous scientific publications.  


REGISTRATION FEES:

Before 3/17/2016: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE
Warwick Location: FREE
WPI BETC Location: FREE 

After 3/17/2016: 
Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
Warwick Location: FREE 
WPI BETC Location: FREE

**Non-members may only attend one program as a non-member**

MEETING MANAGERS:
Stacy Price, Shire
Eric Felz, Shire
Chris Ciampa, Thermo Fisher Scientific

Thank you to our Sponsor:  

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ISPE RE-SHOWING: Learning Through Doing: The Interplay of Pilot Plant, Product, and Process
Date: 31 March 2016

RE-SHOWING OF 3/24 PROGRAM AT

WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND AT

Tech Collective - Providence

166 Valley Street, Providence, RI 02909

EVENT INFORMATION:
Join us at the WPI BETC at Gateway Park in Worcester, MA or Tech Collective in Providence, RI for a re-showing of the program recorded at Shire, March 24, 2016. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location.  

PROGRAM SUMMARY:
The Pilot Plant plays an instrumental role both in material supply for preclinical and clinical development purposes as well as scale-up of technology and operations.  The ultimate goal is developing a solid process that can be successfully transferred to a commercial manufacturing site.  In the developing age of customizable, specialized biotechnology therapies, how will Pilot Plants adapt to new technology and what niche will the Pilot Plant play in the future product development lifecycle? 

This pre-recorded session will include a presentation and panel discussion of Pilot Plant leaders from notable local biotechnology companies.  The current and future role of the pilot plant in the product development lifecycle will be examined.  The group will first present and comment on benchmarking data collected across their companies.  The group will then discuss agility and adaptability of their pilot plants in regards to the current and future pipeline and technologies. 

WHO SHOULD ATTEND: 
This presentation is intended for industry professionals involved in technology transfer, scale-up of manufacturing processes, process development and manufacturing.

MODERATOR:
Brad Ebel, Manager, Pilot Plant Operations, Shire
Brad Ebel has been active in the biopharmaceutical industry for over 15 years and has been focusing on the disposable industry for over 12 years. He is the Manager of Upstream and Media production in Shire’s Pilot Plant Operation (PPO) Group. While at Shire, he has designed and developed two fully disposable perfusion based cell culture operation facilities; responsible for supporting process development activities up too supplying material for toxicology studies.  Previous to Shire, Brad worked for two different manufacturing companies in Colorado where he was active in process development, MFG and media production groups. While in Colorado he helped developed and commission a stainless steel MFG/PD lab from “dirt” to operation in 6 months. In addition, he was able to develop a MFG process in an ISO 7 (100ft2) laboratoryand later transferred the process to an ISO5-8 (7200+ft2) facility that he helped design, oversaw construction and was an active member of the team responsible for commissioning it into a cGMP facility.  Brad holds his B.S. in Chemistry for Westminster College.

PANELISTS:
Bill Brazier, Senior Manager, Process Development Pilot Plant, Amgen Rhode Island
Bill has 25 years of biotechnology experience in the areas of Manufacturing, Engineering and Process Development. He began his biotech career at Genentech in Manufacturing with roles that included operations, manufacturing technical support, facility and equipment design and start up. After 10 years he transferred to Immunex in Seattle for a role in Process Development responsible for the design, start up and engineering support of the Process Development Facility in Bothell, WA. In 2002 Immunex was acquired by Amgen and he took on roles in global Process Development and Corporate Engineering responsible for developing corporate standards for equipment design. In 2011 he transferred to Amgen Rhode Island for the position of Sr. Manager of the Pilot Plant.

Shaun Grier, Associate Director, Pilot Plant Operations, Shire
Shaun Grier has over 14 years of experience in Process Development, Clinical Manufacturing, and Pilot Plant Operations.   He currently is the Associate Director of downstream processing in Pilot Plant Operations at Shire Pharmaceuticals where he leads a group of downstream specialists responsible for the material production and scale-up of early stage therapeutic candidates.  In addition, his group also supports process development and manufacturing. 

Prior to taking a role in the Pilot Plant, he spent 5 years in Process Development at Shire as a process development engineer where he contributed to the development of several early stage purification processes.  He also has led the technology transfer efforts for several processes to internal and external manufacturing along with regulatory file authoring.   Before joining Shire in 2006, Shaun held positions in clinical manufacturing and Pilot Operations at Wyeth Biopharma.  Shaun holds a B.S in Biology and Chemistry from Fitchburg University and a M.S in Biotechnology Management from the University of Maryland University College.

Christof Schulz, Principal Scientist and Senior Group Leader of Scale-up Laboratory, AbbVie Bioresearch Center
Christof Schulz has over 15 years of experience in the Biotech industry. After obtaining his Ph.D. in Biochemical Engineering, Dr. Schulz worked as a Postdoctoral Scientist in Bioprocess Research and Development at Eli Lilly and Company in Indianapolis, IN. In 2003, Dr. Schulz joined the Abbott Bioresearch Center (now AbbVie Bioresearch Center) in Worcester, MA as a Scientist in Process Sciences. At Abbott and AbbVie, he has been holding positions with increasing responsibility, currently as Principal Scientist and Senior Group Leader of the Process Sciences Scale-up Laboratory.

Dave Sullivan, Director – Bioprocess R&D, Pfizer
David Sullivan is a Director in Pfizer’s Bioprocess R&D Organization responsible for leading the Non-GMP Pilot Plant and development lab support organization.  Pfizer’s Bioprocessing Pilot Plants, located in Andover, MA and Chesterfield, MO, support both early and late stage biologic and vaccine process development.  The primary outputs of the organization include regulatory toxicology and development study drug substance, 100L-1000L process characterization / scale up studies, and implementation of advanced manufacturing processes and process analytical technologies.

David has held a number of diverse roles within the large scale commercial/clinical manufacturing and process development since joining Pfizer in 2004.  Prior to Pfizer, he spent 4 years at Bayer Healthcare as a member of their nucleic acid and infectious disease diagnostics unit.  David received a B.S. from Worcester Polytechnic Institute and an M.S. from Tufts University.

Kelly Wiltberger, Associate Director Manufacturing, Biogen
Kelly currently oversees Biogen’s single-use Flexible Volume Manufacturing (FVM) facility in RTP, NC following over a decade leading the pilot scale teams in various capacities. She collaboratively designed and started up the upstream and downstream RTP pilot scale labs. She managed Pilot Scale Cell Culture Development across three separate sites, successfully integrating the San Diego site into RTP and Cambridge in 2011. She was the RTP Technical Development department site lead, spearheaded the initiative to align equipment and procedures between the RTP and Cambridge labs, and was instrumental in implementing the disposable bioreactor technology now used in FVM. Kelly has played key roles in the development of Advanced Process Control (APC) technology and the N-1 perfusion platform, both of which have recently been successfully implemented into large scale manufacturing processes. Under her leadership, the Pilot Scale group worked extensively on bioreactor characterization and process understanding, collaborating both internally and externally to improve scale-up capabilities and modeling of manufacturing processes.

Kelly holds a BS degree in Chemical Engineering from the University of Rochester as well as an MBA from UNC Chapel Hill and has been a co-author on numerous scientific publications.  


REGISTRATION FEES:
Member: FREE
Young Professional Members: FREE 
Non-Member: FREE
ISPE Student Members: FREE

MEETING MANAGERS:
Stacy Price, Shire
Eric Felz, Shire

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ISPE Product Show Committee Meeting
Date: 4 April 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 6 April 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals: Pizza, Networking, and Bowling
Date: 7 April 2016

Back by Popular Demand! Come join the Young Professional's at The Flatbread Company in Davis Square for an evening of pizza, beer, socializing, and candlepin bowling at the famous Sacco’s Bowl Haven! Enjoy a variety of wood-fired, clay oven flatbread pizzas (vegetarian options will be offered), salad, and dessert. Bowling shoes will be provided and a cash bar will be available.

Space is limited to 50 attendees, so please get your tickets before it’s too late!

6:00pm: Pizza and Networking
7:00pm - 9:00pm: Bowling

Registration  by 3/31
ISPE Member: $25
ISPE Student Members: Free
Non-Member: $35

Registration after 3/31
ISPE Member: $30
ISPE Student Member: Free
Non-Member: $40

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ISPE Board of Directors Meeting
Date: 12 April 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE 2016 Student Poster Contest
Date: 20 April 2016

Want to Show Off Your Work and Win $500.00? Register to Compete in the:

ISPE Boston Area Chapter
ANNUAL STUDENT POSTER CONTEST
on Wednesday, April 20, 2016

Two winning student posters, one each from the graduate and undergraduate categories will receive a $500 cash prize and a FREE TRIP to compete at the International Student Poster Competition at ISPE’s Annual Meeting in Atlanta, GA. on September 18-21, 2016. Winners of the International competition receive cash awards and have the opportunity to publish their materials in ISPE's Pharmaceutical Engineering magazine, as well as other Chapter/Affiliate publications. 

Pre-Registration is required and you must be a member of the Boston Area Chapter of ISPE to participate.  Join ISPE at www.ispe.org/join-or-renew .

Cost:
Free

Location:
WPI’s Biomanufacturing Education and Training Center (BETC)
60 Prescott Street, Worcester, MA

Registration Deadline:
April 13, 2016 at noon

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ISPE Science, Technology, and Society
Date: 20 April 2016

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WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

Or Via Simulcast at:

TBD - Rhode Island


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ISPE Product Show Committee Meeting
Date: 2 May 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 4 May 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 10 May 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Single Use
Date: 19 May 2016

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ISPE RE-SHOWING: Single Use
Date: 26 May 2016

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ISPE Educational Programs Planning Meeting
Date: 1 June 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 6 June 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 14 June 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Data Integrity
Date: 16 June 2016

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ISPE RE-SHOWING: Accidental Project Manager
Date: 23 June 2016

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WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

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ISPE Educational Programs Planning Meeting
Date: 6 July 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 12 July 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs 2017 Season Planning Meeting
Date: 21 July 2016

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ISPE Product Show Committee Meeting
Date: 1 August 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 3 August 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Summer Golf Tournament
Date: 8 August 2016

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This year the Social Committee is bringing us to a great location for a golf tournament - Lake Winnipesaukee Golf Club. Lake Winnipesaukee Golf Club is a private, 18-hole Clive Clark championship course that offers the golf experience of a lifetime - again and again. A stunning 700 mountain acres shelter almost 7,000 yards of magic. From magnificent bent grass tees and fairways to elegant greens, an exquisite experience nurtured by state-of-the-art technologies and the game's premier staff professionals. 

Click here for a video tour of the club: http://www.lwgcnh.com/The-Club/Video-Tours.aspx

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ISPE Product Show Committee Meeting
Date: 15 August 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 16 August 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 17 August 2016

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 29 August 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 7 September 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 12 September 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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Accidental Project Manager
Date: 15 September 2016

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ISPE RE-SHOWING: Accidental Project Manager
Date: 22 September 2016

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WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND AT

TBD - Rhode Island

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ISPE Product Show Committee Meeting
Date: 26 September 2016

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Product Show and Educational Seminars
Date: 5 October 2016

Please note that this is the planned date for the 25th Annual Product Show!

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ISPE Educational Programs Planning Meeting
Date: 12 October 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Classroom Training
Date: 17 October 2016 - 20 October 2016

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ISPE Fall Social
Date: 27 October 2016

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ISPE Educational Programs Planning Meeting
Date: 2 November 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE QBD
Date: 10 November 2016

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ISPE RE-SHOWING: QBD
Date: 17 November 2016

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WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND AT

TBD - Rhode Island

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ISPE Educational Programs Planning Meeting
Date: 7 December 2016

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Joint with ISA
Date: 15 December 2016

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ISPE RE-SHOWING: Joint with ISA
Date: 22 December 2016

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WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND AT

TBD - Rhode Island

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ISPE CIP & SIP
Date: 19 January 2017

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ISPE RE-SHOWING: CIP & SIP
Date: 26 January 2017

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WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND AT

TBD - Rhode Island

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ISPE Water, Water, Everywhere
Date: 16 February 2017

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ISPE RE-SHOWING: Water
Date: 23 February 2017

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WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND AT

TBD - Rhode Island

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ISPE C&Q Baseline Guide Update
Date: 16 March 2017

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ISPE RE-SHOWING: C&Q Baseline Guide
Date: 23 March 2017

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WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND AT

TBD - Rhode Island

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ISPE Annual Product Show and Educational Seminars
Date: 4 October 2017

Please note that this is the planned date for the 26th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 26 September 2018

Please note that this is the planned date for the 27th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 18 September 2019

Please note that this is the planned date for the 28th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 16 September 2020

Please note that this is the planned date for the 29th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 15 September 2021

Please note that this is the planned date for the 30th Annual Product Show!

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Page last updated: 23 November 2015