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Boston Area Chapter Current Year Events List

Event
ISPE Product Show Committee Meeting
Date: 5 January 2015

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 January 2015

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: 13 January 2015

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 The Future is NOW for Continuous Manufacturing
Date: 15 January 2015

http://www.ispeboston.org/files/cattaneo_presentation.pdf 

http://www.ispeboston.org/files/mihlbachler_presentation_for_printing.pdf  

PROGRAM SUMMARY:

If your initial reaction is:  Impossible!  Can’t be done!  Not with MY process!  You may be surprised to learn that continuous manufacturing is much closer than you think.  As our industry evolves and matures, we continue investigating ways to produce biopharmaceutical products more efficiently. Come and learn from three cutting edge speakers working on different areas of this same complex issue as the Chapter presents a “future trends” program to kick off the 2015 educational program year!

Following up on the Lean and Six Sigma concepts covered during the Chapter’s December educational program, continuous manufacturing can offer process efficiencies that appeared unimaginable just a short time ago.  This program focuses on the science and technology behind different strategies sucessfully used to continuously manufacture products.

Salvatore Mascia will speak about how integrated continuous manufacturing (ICM) has been implemented at the first ever ICM pilot plant, developed by Novartis and MIT’s Center for Continuous Manufacturing to convert raw materials into finished products on a continuous basis. 

Maurizio Cattaneo will speak about how to leverage the science behind the design of experiments (DOE) and quality by design (QbD) concepts to create efficiencies in monoclonal antibody production which have increased yields ten-fold by using continuous manufacturing techniques. 

Kathleen Mihlbachler will speak about the use of multi-column continuous (MCC) chromatography for the effective separation of chiral (mirror image) compounds on a continuous basis and how this approach can be integrated into a more complex manufacturing strategy. 

SPEAKERS:

Salvatore Mascia, Ph.D., Founder and CEO, CONTINUUS Pharmaceuticals
Salvatore Mascia is the Founder & CEO of CONTINUUS Pharmaceuticals. He was the former Strategic Project Manager at the Novartis-MIT Center for Continuous Manufacturing, where he led the integration of the first end-to-end continuous manufacturing process for pharmaceuticals. At the end of the project, he was presented with the “Leadership Award” that recognized his leadership role at the Center. Dr. Mascia gained experience in strategic management and fund raising in addition to leadership skills via various roles of responsibility within the entrepreneurial ecosystem.  Among those, he co-founded “Professional Italians in Boston” in 2009, and served as President of the “Cambridge University Technology and Enterprise Club” in 2006/07.  He also ran a pharmacy business for 2 years.  Dr. Mascia completed a post-doc at MIT in Chemical Engineering and holds a PhD in Chemical Engineering from the University of Cambridge, UK and a BS and MS in Pharmacy (summa cum laude) from University of Perugia, Italy.

Maurizio Cattaneo, Ph.D., CEO, BioVolutions, Inc.
Dr. Cattaneo obtained his Bachelor of Applied Sciences Degree in Chemical Engineering from the University of Toronto and his MS and Ph.D. from McGill University. Dr. Cattaneo was a Research Officer at the National Research Council of Canada where he specialized in the development of human monoclonal antibodies by phage display. Most recently, Dr. Cattaneo spent one year at MIT developing single use systems for manufacturing monoclonal antibodies by cell culture. Dr. Cattaneo holds 6 patents in the field of bioprocess and biotechnology. Dr. Cattaneo is now CEO of BioVolutions, Inc. a local CMO offering diagnostic and therapeutic monoclonal antibodies made by Continuous Manufacturing. Dr. Cattaneo attained his Certified Pharmaceutical Industry Professional (CPIP) credential in 2013.

Kathleen Mihlbachler, Ph.D., Director of Global Separation Development, LEWA Process Technologies
Dr. Mihlbachler has worked in the field of process chromatography for more than 15 years. Currently, she is the Global Director of Separations Development at LEWA Process Technologies. She is responsible for the development of separation technologies for synthetic and biological molecules, in particular for continuous processing. Prior to this appointment, Dr. Mihlbachler worked as an external consultant for LEWA-NIKKISO since 2012 where she supported the technical transfer of process chromatographic technology and consulted in customer projects. Previously, Dr. Mihlbachler was involved as a Sr. Researcher at BMS, Eli Lilly and Pfizer in the development, scale-up and manufacturing of purification/separation processes for chiral and non-chiral compounds, peptides and proteins, in particular to implement continuous processes. From 2011 to 2013, Dr. Mihlbachler taught undergraduate courses for chemical and biomedical students at New Jersey Institute of Technology.

REGISTRATION FEES:

Before 1/8/2015: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 

After 1/8/2015: 

Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 

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

 

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ISPE New Year's Social
Date: 22 January 2015

ISPE Boston Area Chapter and I2SL New England Joint Event:

New Year's NETWORKING Social

Thursday, January 22, 2015
Flat Top Johnny’s 1 Kendall Square Cambridge, MA, 02139
6:00 - 9:00 PM

Come join ISPE Boston Area Chapter and I2SL New England and celebrate the New Year with Friends and Colleagues! Light fare and cash bar will be provided.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. This is a great opportunity to meet other people from the industry. Add your personal interests to your badge to facilitate more networking. If you do not indicate an interest, one will be assigned to you!

Registration Fee:

$10 for Members of ISPE or I2SL
$20 for Non Members

 

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ISPE Young Professionals Committee Meeting
Date: 28 January 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 2 February 2015

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 February 2015

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 Student Career Workshop
Date: 7 February 2015

If you will be graduating in 2015-2018, 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, February 7, 2015

10:00 AM – 5:00 PM

Doors open at 9:30AM

 

WHERE

Northeastern University

Alumni Center

Pavilion Room (6th fl)

716 Columbus Ave

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 Board of Directors Meeting
Date: 10 February 2015

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 Myth Busting Biopharm Facility Designs through Leading Edge Concepts
Date: 19 February 2015

PRESENTATIONS:

William Jacobsen: http://www.ispeboston.org/files/jacobsen_presentation.pdf

Doyle Johnson: http://www.ispeboston.org/files/johnson_presentation.pdf

Mike St. Louis: http://www.ispeboston.org/files/st.louis_presentation.pdf

EVENT INFORMATION:

Attend the live program at Genzyme Center in Cambridge, MA or a simulcast presentation at the Crowne Plaza Providence in Warwick, RI or at the WPI BETC at Gateway Park in Worcester, MA. The programs at all three locations will include a networking reception including appetizers.

PROGRAM SUMMARY:
The emerging trends in our highly regulated industry require a unique approach and broad experience base to optimize facility designs and implement process improvements in a validated environment. This event brings three industry experts together to provide diverse perspectives on trends, techniques and strategies to implement world-class facility operations. There is a revolution within the Biotech and Pharmaceutical Industries where sharing best practices will enhance standards to address emerging issues such as process complexity, adoption of new technologies, and contamination risks. This collaborative event brings these unique perspectives together, covering:

Facilities Optimization Design Perspectives
The first presentation will illustrate areas where facility design is impacted by the number of products in the pipeline, operational ease, operating costs, and the impact of yield changes. Facility Design Optimization is often overlooked or not fully addressed when developing a facility for a specific process. Designing an optimal facility  requires the input from all stakeholders and incorporating critical input ensuring compliance and consideration for process, risk(s), compliance and operations into account.

Biotech Facility Best Practices
The second presentation focuses on Biotech manufacturing facilities with complex and technical cleaning requirements. Real World examples  of FDA requirements, Quality Practices and Consultant Advice in the Biopharm industry that have contributed to high costs, poor facility hygiene and increased operator and building hazards. There is Best Practice that keeps patients and operators safe and complies with cGMPs will be shared. These Best Practices will be coveredin this presentation, where common myths will be busted.

Facility Optimization Considerations
The closing presentation will provide broad range of consideration exploring Facilities Optimization from the Facilities Management and Facilities Engineering viewpoint. We hear a lot about design, construction and optimization of layout, utilities, capacity and processing areas of new facilities. This presentation looks at a wide range of optimization considerations, including; maintenance programs, calibration and maintenance intervals, capital budgets and resources, facility and utility robustness, process optimization, and evaluations techniques for these categories. Considerations to maximize capital budgets and thoughts on optimal facilities team composition to successfully operate these complex facilities – what? This sentence is missing a closing.

Please join these industry experts and our distinguished panel to learn more about these topics and participate in a Q&A session at this ISPE Boston educational event.

SPEAKERS:

William Jacobsen, Chief Technology Officer, Dovetail Integrated Systems
Mr. Jacobsen has responsibility for leading initiatives focused on optimization and standardization of manufacturing operations. Mr. Jacobsen has extensive experience in biotechnology process development, manufacturing and operations and is considered a subject matter expert for single use systems. He has played key roles in the design, start-up, validation and operation of cell culture facilities at numerous Boston based Biologics companies. These facilities ranged from pilot to full-scale manufacturing. As a consultant, Mr. Jacobsen led the $20M facility expansion at a newly formed CMO based on single use systems. Mr. Jacobsen received his BS in in-vitro cell Biology from the State University of New York at Plattsburgh.

Doyle Johnson, Life Sciences Industry Leader, Hargrove Life Sciences, LLC
Doyle has over thirty years of domestic and international experience in in the chemical, pharmaceutical and biotech industries. His expertise and knowledge includes hands-on operations and project management, technical and business management, process engineering, customer relations and regulatory requirements. Experiences include managing projects up to $120MM total installed cost. Doyle has experience from the owner’s side (Genzyme, MassBiologics) as well as the contractor’s side (CDI/Herzog-Hart, and Hargrove Life Sciences, LLC). As testament to his leadership and expertise, Doyle served on the Board of Directors for the International Society for  Pharmaceutical Engineering (ISPE) and the Engineering and Construction Contracting Association (ECC). Doyle has particular skills in Site Remediation, having been part of the Site Leadership Team at Genzyme during their FDA Consent Decree period. He has managed the operation of two large facilities in Boston – the MassBiologics Laboratories and Genzyme Framingham.

Mike St. Louis,Vice President of Operations, CPS Group
Mike St.. Louis has 22 years of experience in construction and operation of high technology facilities serving the Semiconductor, Pharmaceutical and Biotechnology industry. He previously worked at Olympus Biotech (formerly Stryker) and prior to that Project Manager for Kinetic Systems, Inc. In that time his experience  included roles as a Project Engineer, Project Manager, Manager of Capital Projects, Facilities Engineering Manager and Director of Plant Services, participating in the design, construction, commissioning, qualification and operation of process utility systems. Mr. St. Louis holds a BS degree in Construction Management from Boise State University, and Associate degrees in Architectural Engineering and Building Technology from Vermont Technical College. He has been a long time ISPE member.

REGISTRATION FEES:

Before 2/12/2015: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: Free to attend
Warwick Location: FREE
WPI BETC Location: FREE 

After 2/12/2015: 

Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 
WPI BETC Location: Free

 

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

 

MEETING MANAGERS:

Maurizio Cattaneo, BioVolutions
Terry Butler, Hallam-ICS
Nonjaros Chomcharn, Lyne Labs
Sean Brown, Barry Wehmiller

To view the meeting flyer click here: http://www.ispeboston.org/files/ispe_february_19%2C_2015_flyer.pdf

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ISPE Young Professionals Medieval Manor Social
Date: 25 February 2015

Pre-registration is now closed for this event.  Walk-in registration is available on-site.

Come join the ISPE Boston Area Chapter Young Professionals at the Medieval Manor for a bawdy but lighthearted interactive romp through the dark ages! Enjoy one-of-a kind entertainment as you feast on six courses without a fork, knife, or spoon (vegetarian meals are available). Beer and Red/White wine will also be provided with the dinner. If you need a vegetarian meal, please contact the office at 781-647-4773 or office@ispeboston.org.

REGISTRATION FEES:

Member: $20
Non-Member: $30

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ISPE Young Professionals Committee Meeting
Date: 26 February 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 2 March 2015

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 March 2015

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: 6 March 2015

Join ISPE for the Chapter's Annual Ski Trip on March 6, 2015 at Waterville Valley.  Space is Limited, so Don't Delay!

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

Note: Books of 4 Tickets are available for $265.  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: 7:00 PM: to all Departure Sites (Concord, Andover, Newton)

Thanks to our Ski Trip Sponsors: 

A/Z Corporation
Bard, Rao + Athanas Consulting Engineers
Commissioning Agents Inc.
GxP Automation 
Perkins + Will
Superior Controls
T & M Associates
UltraFiltronics

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ISPE Board of Directors Meeting
Date: 10 March 2015

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 Risky Business: How Quality Systems and Risk Blend
Date: 19 March 2015

PRESENTATION:

Edmund Mrak: http://www.ispeboston.org/files/mrak_presentation.pdf

EVENT INFORMATION:
Attend the live program at Shire Human Genetic Therapies in Lexington, MA or a simulcast presentation at the Crowne Plaza Providence in Warwick, RI or at the WPI BETC at Gateway Park in Worcester, MA.  The programs at all locations will feature a networking reception including appetizers.

PROGRAM SUMMARY:
Have you ever wondered about how risk approaches integrate across different quality systems?  What does the FDA think of risk assessments?  Do they just justify not doing work or are they a tool to quantify the risk associated with decisions and focus work on the most impactful portions of the business.  How should risk be viewed, especially when looking across different quality systems? Is risk in a silo or do we integrate risk across different quality systems?  Why is risk in change control so different than deviations?  Come ready to hear some thoughts from an FDA speaker and then bring questions for our panel of and FDA speaker and industry expert.

SPEAKERS:
Edmund Mrak, Drug Specialist, New England District of Food and Drug Administration and member of FDA’s Pharmaceutical Inspectorate

He conducts domestic and foreign drug manufacturing quality inspections and pre-approval inspections on the majority of prescription drug manufacturers and other complex or high risk pharmaceutical operations including biotechnology and aseptic processes.  Mr. Mrak has been with the FDA for over seven years and joined FDA with over ten years of prior experience in the pharmaceutical industry where he led the manufacture of solid oral, liquid, and sterile drug products. Training includes extensive topics from FDA and a BS in Biology and MS in Teaching Biology, both from the State University of New York at Plattsburgh, NY, USA.

Xach Kibbie, Senior Risk Program Manager, Quality Risk Management Department, Shire
He has 15 years of industry experience, performing risk assessments on production equipment and control systems, business continuity, embedding risk into validation master plans, and tech transfer efforts.  Recently, he was responsible for the global design and leadership at a consent decree site to successfully implement risk operationally in all areas.  Xach has also lead efforts in validation program management, tech transfer, and operations strategy.  Xach has a bachelors from Lesley and is currently attending the MIT Sloan Executive Certificate Program, where he holds a certificate in Business Continuity and Crisis Management.

REGISTRATION FEES:

Before 3/12/2015: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: Free to attend
Warwick Location: FREE
WPI BETC Location: FREE 

After 3/12/2015: 

Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 
WPI BETC Location: Free

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

 

MEETING MANAGERS:

Eric Felz, Shire
Mike Foshey, UMass Dartmouth
Nagmeh Salimi, Northeastern University

 

Thank you to our Sponsor:  

RCM Technologies

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ISPE Young Professionals Committee Meeting
Date: 25 March 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 1 April 2015

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 April 2015

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 April 2015

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 2015 Student Poster Contest
Date: 16 April 2015

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

ISPE Boston Area Chapter
ANNUAL STUDENT POSTER CONTEST
on Thursday, April 16, 2015

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 Philadelphia, PA. on November 8-11, 2015. 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 9, 2015 at noon

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ISPE Downstream Processing, How it is Done and How to do it Faster & Better
Date: 16 April 2015

PRESENTATIONS:

Stuart Green: http://www.ispeboston.org/files/green_presentation.pdf

Dr. Kathleen Mihlbachler: http://www.ispeboston.org/files/mihlbachler_presentation.pdf

EVENT INFORMATION:
Join ISPE at WPI’s Gateway Park for this dual track event that has something for everyone. Attend the live program or a simulcast presentation at the Crowne Plaza Providence in Warwick, RI. The programs at both locations will feature a networking reception including appetizers. Tours of the BETC facility will be offered during the reception hour or cheer on the Student Poster Contestants during the final phase of judging.

TRACK 1: Downstream Processing Techniques and Single Use Applications
This interactive presentation will introduce participants to the unit operations typically carried out to purify a cell culture product.  Understanding what the contaminants are and how they can be removed is the first step in understanding how the downstream process should be designed. This discussion will provide insight as to how virus inactivation and removal, chromatography and UF/DF are achieved and best arranged in a process. In addition, the opportunities and merits of single use options for downstream processing will be discussed.

SPEAKER: Stuart Green, VP of Process Engineering for Pall Corporation’s Life Science Division of North America
Stuart has worked in the biotechnology field since the early 90s after completing his degree at University of the Sciences in Philadelphia. After spending time at various start-ups in PA, Stuart settled in at Centocor for approximately 9 years working in process sciences and eventually became manager of a GMP pilot plant. After leaving Centocor, Stuart was Director of Manufacturing for ImClone systems for 5 years prior to joining Pall as VP of process Engineering in early 2014.

TRACK 2: Integrated Continuous Downstream Processing – an Enabling Approach that will Break the Bottleneck
This presentation is for seasoned professionals who are familiar with the purification process and want to learn about the newest technologies.

Over the last decade, the expression levels have tremendously increased for the upstream fermentations; thus, the downstream processes (DSP) became the “bottleneck” in manufacturing process of bio-pharmaceutical, especially for monoclonal antibodies. Additionally, biosimilars/biobetters are introduced to the market which demands new downstream approaches that are cost and time effective by retaining the properties of the biomolecules. Consequently, different integrated DSP and/or multi-column continuous chromatographic technologies are investigated that showed promising results in reducing manufacturing costs. However, up to today there has not been a reported case at the production scale. What are the remaining barriers when implementing the approaches into the downstream processing? This presentation will outline the integrated continuous downstream process by focusing on the continuous chromatography and highlight major barriers and how to overcome them in the GMP environment.

SPEAKER: Dr. Kathleen Mihlbachler, Global Director of Separations Development, LEWA Process Technologies, Devens, MA
Dr. Mihlbachler has worked in the field of process chromatography for almost 20 years. Currently, she is the Global Director of Separations Development at LEWA Process Technologies. She is responsible for the development of separation technologies for synthetic and biological molecules, in particular for continuous processing. Prior to this appointment Dr. Mihlbachler worked as an external consultant for LEWA-NIKKISO where she supported the technical transfer of process chromatographic technology and consulted in customer projects. Previously, Dr. Mihlbachler was involved as a Sr. Researcher at BMS, Eli Lilly and Pfizer in the development, scale-up and manufacturing of purification/separation processes for chiral and non-chiral compounds, peptides and proteins, in particular to implement continuous processes. From 2011 to 2013, Dr. Mihlbachler taught undergraduate courses for chemical and biomedical students at New Jersey Institute of Technology. 

REGISTRATION FEES:

Before 4/9/2015: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: Free to attend
Warwick Location: FREE

After 4/9/2015: 

Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 

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

 

MEETING MANAGERS:
Dan Mardirosian, Worcester Polytechnic Institute
Christopher Ciampa, Thermo Fisher

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ISPE Plant Tour and Program at EMD Millipore
Date: 17 April 2015

Registration for this event is now closed

ANNOUNCING A PLANT TOUR AT
EMD MILLIPORE, DANVERS, MASS
FRIDAY APRIL 17TH, 1:30 – 4:00 PM 

Come to see, first hand how an industry leader develops and manufactures products that support the life science industry including:

Analytical Instrumentation for Life Sciences

Mobius Single Use Assemblies for bio-production processes

Capacity is limited

Sign up now to secure your spot!

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ISPE Brainstorming Session For 2016 Educational Programming
Date: 29 April 2015

Pre-Registration is now closed.  Registration is available on-site.

The Boston Area Chapter of ISPE is holding a Brainstorming Session to plan educational content for the 2016 programming season. This is an ideal opportunity to share your ideas and help us plan programs of interest to you for the upcoming year. If you have ideas for programs, speakers, or locations, please join us to share your thoughts. A pre-session networking reception, with light dinner, will let you unwind with fellow industry professionals. Then we will focus on your ideas and suggestions. All ideas will be collated and presented to the membership via electronic survey before being finalized for the next programming season. The Committee is meeting in July to coordinate volunteers to help develop these programs. Please consider volunteering for the Educational Programs Committee to make these programs come to life!

Attendance is free (we want your ideas!), so please come and help us plan and brainstorm! All you have to do is RSVP today via the website or the form below. If you have ideas but are unable to attend, please send your ideas to the office at office@ispeboston.org.

SCHEDULE:

5:30 - 6:30 pm Networking Reception with light dinner served
6:30 - 8:30 pm Brainstorming Session

COST: Free

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ISPE Pizza, Networking and Bowling
Date: 30 April 2015

Pre-Registration is now closed.  Registration is available on-site.

Back by Popular Demand! Come join the ISPE Boston Area Chapter Young Professionals at The Flatbread Company in Davis Square for an evening of pizza, 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). Bowling shoes will be provided and a cash bar will be available.

Space is limited, so get your tickets before it’s too late! 

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

Registration  by 4/23

ISPE Member $25
ISPE Student Members Free
Non-member $35

Registration after 4/23

ISPE Member $30
ISPE Student Member Free
Non-member $40

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ISPE Product Show Committee Meeting
Date: 4 May 2015

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 May 2015

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 Spring Golf Tournament
Date: 11 May 2015

SCHEDULE:

11:30 AM - 12:45 PM Registration and Buffet Lunch 
1:00 PM -Shotgun Start – Scramble Format 
5:30 PM - Reception/Cocktails/Buffet Dinner

COST:

$700 Foursome/$175 Player
Lunch, Dinner and Golf are included for each player

LOCATION:

Ledgemont Country Club, Seekonk, MA 02271

Please contact the office at (781) 647-4773 if you have any questions about this event.

To sponsor this event or sign up for a foursome click here.

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ISPE Board of Directors Meeting
Date: 12 May 2015

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: A Better Way to Deliver Fast Track Projects
Date: 21 May 2015

MEETING HANDOUT: http://www.ispeboston.org/files/ispe_may_21_handout.pdf

PANEL PRESENTATION: http://www.ispeboston.org/files/ispe_fast_track_projects_presentation.pdf

Join us in Biogen Weston
133 Boston Post Road, Weston, MA

PROGRAM SUMMARY:
In today’s competitive marketplace, speed to market is more critical than ever for ensuring the successful launch of new drug products. In response, fast-tracking the development of retrofit or greenfield facilities —from concept through commissioning—has increasingly become the norm. These projects require particularly close collaboration between all project contributors, relentless adherence to schedule, and constant communication. So what is the best way to deliver a fast track project?  We held a series of round table discussions with industry experts each representing key stakeholders in the process.  They will share their experiences and offer solid insight and recommendations for producing a successful fast-track project.  Come and hear our panel members reveal their formula for success…the results might surprise you.

STAKEHOLDER PANELISTS:
Owner: Richard Quinby, LEED AP, Associate Director, Global Project Engineering, Biogen
Rich is responsible for all capital infrastructure projects on the Cambridge campus of Biogen. He is a chemical engineer with over 25 years of experience in the pharmaceutical and biotechnology industry. Rich has worked both on the owner’s side and as a consultant. He has a diverse background in project management, construction management, process engineering, controls engineering, commissioning, and validation.

Procurement: Tony Mejido, North America Capex Procurement Director, Sanofi
Tony is responsible for all capex procurement projects across 20 Sanofi sites in North America and Puerto Rico. His primary focus is on the execution of large capex projects for Genzyme and Sanofi sites in Toronto and Swiftwater, PA with responsibilities to negotiate agreements using several project delivery models, including EPCM, design/build and CM at risk. Tony has over 30 years of sourcing experience that includes category management, supply chain management, and supplier relationship management.

Construction Manager: S. James Busam, Vice President, National Client Team, Gilbane Building Company
Jim has 40 years in the design and construction industry throughout the US and internationally. He has worked in many market segments, but his primary focus is on technical facilities from research to pilot plants to large scale manufacturing in biotechnology, pharmaceuticals, and microelectronics. Jim is highly experienced in negotiating and delivering in various contract forms, including lump sum, GMP, cost plus using design/build, CM, CM at risk, and general contracting contracts.

Designer: Cory Siddons, Senior Project Manager, DPS
Cory is an accomplished project manager with a focus on the biopharmaceutical manufacturing sector. He is responsible for leading multidisciplinary teams through design, procurement, construction, and C&Q activities. Cory’s prior experience as a bioprocess engineer includes process design, process equipment design, process simulation, and risk assessments for FDA/EMA regulated pharmaceutical/biologics manufacturers.

C&Q: Eric Felz, Associate Director of Validation, Shire
Eric is responsible for equipment, facility, and utility qualification for Shire’s Alewife and Lexington facilities. He is currently involved in updating the commissioning and qualification program at Shire facilitating the move to an ASTM E2500 based C&Q methodology. Eric is involved with the ISPE Community of Practice for commissioning and qualification as part of the owners’ team and the web team.

REGISTRATION FEES:
Before 5/14/2015: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: Free to attend

After 5/14/2015: 
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend

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

MEETING MANAGERS:
Cheryl Huie, DPS
Jack Campion, The Hart Companies

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ISPE Young Professionals Committee Meeting
Date: 27 May 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE RE-SHOWING: A Better Way to Deliver Fast Track Projects
Date: 28 May 2015

This Program has been canceled. If you have any questions, please contact the office at 781-647-4773 or office@ISPEBoston.org

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 appetizers.

PROGRAM SUMMARY:
In today’s competitive marketplace, speed to market is more critical than ever for ensuring the successful launch of new drug products. In response, fast-tracking the development of retrofit or greenfield facilities —from concept through commissioning—has increasingly become the norm. These projects require particularly close collaboration between all project contributors, relentless adherence to schedule, and constant communication. So what is the best way to deliver a fast track project?  We held a series of round table discussions with industry experts each representing key stakeholders in the process.  They will share their experiences and offer solid insight and recommendations for producing a successful fast-track project.  Come and hear our panel members reveal their formula for success…the results might surprise you.

STAKEHOLDER PANELISTS:
Owner: Richard Quinby, LEED AP, Associate Director, Global Project Engineering, Biogen
Rich is responsible for all capital infrastructure projects on the Cambridge campus of Biogen. He is a chemical engineer with over 25 years of experience in the pharmaceutical and biotechnology industry. Rich has worked both on the owner’s side and as a consultant. He has a diverse background in project management, construction management, process engineering, controls engineering, commissioning, and validation.

Procurement: Tony Mejido, North America Capex Procurement Director, Sanofi
Tony is responsible for all capex procurement projects across 20 Sanofi sites in North America and Puerto Rico. His primary focus is on the execution of large capex projects for Genzyme and Sanofi sites in Toronto and Swiftwater, PA with responsibilities to negotiate agreements using several project delivery models, including EPCM, design/build and CM at risk. Tony has over 30 years of sourcing experience that includes category management, supply chain management, and supplier relationship management.

Construction Manager: S. James Busam, Vice President, National Client Team, Gilbane Building Company
Jim has 40 years in the design and construction industry throughout the US and internationally. He has worked in many market segments, but his primary focus is on technical facilities from research to pilot plants to large scale manufacturing in biotechnology, pharmaceuticals, and microelectronics. Jim is highly experienced in negotiating and delivering in various contract forms, including lump sum, GMP, cost plus using design/build, CM, CM at risk, and general contracting contracts.

Designer: Cory Siddons, Senior Project Manager, DPS
Cory is an accomplished project manager with a focus on the biopharmaceutical manufacturing sector. He is responsible for leading multidisciplinary teams through design, procurement, construction, and C&Q activities. Cory’s prior experience as a bioprocess engineer includes process design, process equipment design, process simulation, and risk assessments for FDA/EMA regulated pharmaceutical/biologics manufacturers.

C&Q: Eric Felz, Associate Director of Validation, Shire
Eric is responsible for equipment, facility, and utility qualification for Shire’s Alewife and Lexington facilities. He is currently involved in updating the commissioning and qualification program at Shire facilitating the move to an ASTM E2500 based C&Q methodology. Eric is involved with the ISPE Community of Practice for commissioning and qualification as part of the owners’ team and the web team.

REGISTRATION FEES:
Warwick Location: FREE
WPI BETC Location: FREE

MEETING MANAGERS:
Cheryl Huie, DPS
Jack Campion, The Hart Companies

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ISPE Product Show Committee Meeting
Date: 1 June 2015

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 Young Professionals Annual Red Sox Game
Date: 2 June 2015

Join the ISPE Boston Area Chapter Young Professionals in cheering on the Boston Red Sox as they take on the Minnesota Twins! We will be convening at Who’s on First beforehand for ticket pickup, as well as some pre-game food and drinks. 

5:00 PM
Pre-Game Social at 
Who’s on First
19 Yawkey Way, Boston, MA 02215

7:10 PM
Red Sox vs. Minnesota Twins

Registration Fee: $20
Limit One Ticket per Person
This is a Members Only Event

Availability is limited, so register today!

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ISPE Educational Programs Planning Meeting
Date: 3 June 2015

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: 9 June 2015

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 Tech Transfer: From Process Development to Product Manufacturing
Date: 18 June 2015

PRESENTATIONS:

Bhavi Mittal, PhD: http://www.ispeboston.org/files/mittal_presentation.pdf 

Claudia Buser, PhD: http://www.ispeboston.org/files/buser_presentation.pdf

Gary Mills: http://www.ispeboston.org/files/mills_presentation.pdf

Joe Cobb, CPIP: http://www.ispeboston.org/files/cobb_presentation.pdf

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

PROGRAM SUMMARY: 
The research, development and manufacturing of drug products present many challenges for engineers and scientists. The path from process development to product manufacturing involves a multitude of disciplines with specific expertise. Each stage has unique technical, economic, and regulatory requirements.

Over the years, companies have strategically focused their development efforts and manufacturing capabilities based on the costs and risks required to support multiple product groups and manufacturing operations. As internal resources become strained, or as the desire to explore new opportunities arise, companies may turn to contract development and manufacturing sites for external support as an alternative to in-house investment. Engineering, science, quality and regulatory teams are vital in facilitating the technology transfer of the product and managing the contracted site.

At the same time, regulatory agencies are taking a greater interest in the use of contract research organizations (CROs), contract manufacturing organizations (CMOs), and the companies that are utilizing them. Agencies have identified the transfer of the process between different sites as an opportunity to focus on quality by design (QbD) elements early in the process.

This educational event will involve several brief presentations about drug product manufacturing from process development stages to external manufacturing. Afterwards, there will be a moderated Q&A session where questions can be answered by our experts. The panelists represent varying disciplines in the industry. We’ll hear about methodology for CMO selection, how to effectively partner with a CMO, and get tips from the CMO side on how to be a great sponsor company.

MODERATOR: 
Bhavi Mittal, PhD, Senior Scientist, Formulation Sciences, Millennium/Takeda Pharmaceuticals (Cambridge, MA)

Bhavishya Mittal is a Senior Scientist in the Formulation Sciences department at Takeda Pharmaceuticals International Company based in Cambridge, MA. Bhavi has a PhD in Materials Engineering from the Pennsylvania State University and a BS in Chemical Engineering from Regional Engineering College, Jalandhar (India). Bhavi has 12 years of industrial experience in formulation and process development of various solid oral dosages of small therapeutic molecules (oncology, inflammation, and CNS indications) aimed for NDA and ANDA filings. He is the author/co-author of 1 patent application, 10 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences. His research interests include formulation design, process engineering, scale-up and tech-transfer, and computational modeling of pharmaceutical unit operations for solid oral dosage manufacturing.

SPEAKERS: 
Claudia Buser, PhD, Director, Cell Banking Development, Genzyme (Framingham, MA) Claudia has been with Genzyme, now Sanofi, since 1995. She started as a process scientist, and has over 20 years of cell culture and process development experience. She has participated in the development and commercialization of several of Genzyme’s recombinant therapeutic proteins produced in perfusion culture. Currently, her main responsibilities include leading a small group focused on cell banking development and late-stage development and tech transfer for a pipeline therapeutic. Her group is developing high density cell banks to support Genzyme’s new continuous manufacturing platform. Her previous experience includes responsibility for production of GMP banks, and prior to that, late stage upstream development. Her responsibilities have included cell culture process development, scale-down and scale-up, technology transfer to manufacturing, and manufacturing support for commercial processes. Prior to joining Genzyme, Claudia worked at Wyeth Laboratories and also at Repligen Corporation. Claudia has a BS in Chemical Engineering and a PhD in Biochemical Engineering, both from MIT.

Gary Mills, Associate Director, Drug Product Development, Momenta Pharmaceuticals (Cambridge, MA) Over 27 years of experience in the design, development, technical transfer and commercialization of aseptic and purification processes associated with the production of biopharmaceuticals. To date have contributed to the successful commercialization of three biologics, two complex generics, one ultrasound imaging contrast agent and one reusable auto-injector device for prefilled syringes. Currently responsible for the oversight of parenteral drug product manufacturing at Momenta’s contract manufacturing organizations, including management of technology transfer, scale-up, process optimization and trouble-shooting, and validation activities. Prior to joining Momenta, Gary worked at MassBiologics, TKT and Genzyme. Gary has a BS in Chemical Engineering from UMass Lowell and a MS in Engineering Management from Northeastern University.

Joe Cobb, CPIP, Director, Pharmaceutical Development, Metrics Contract Services/Mayne Pharma US (Greenville, NC) Joe has worked at Metrics for 13 years starting as a Pharmaceutical Development Scientist and has been responsible for the execution of dozens of contract service projects ranging from early phase, first-in-human trials all the way to commercial process validation. He has 22 years in the industry, serving in similar roles previously for DSM/Patheon and Geneva (Sandoz) Pharmaceuticals. He has expertise in most areas of solid oral dosage form manufacturing including standard tablet/capsule dosage forms and a variety of modified-release or bioavailability enhancement technologies. He is a graduate of The Ohio State University and is one of 149 Certified Pharmaceutical Industry Professionals world-wide as awarded by ISPE/PCC.

REGISTRATION FEES:
Before 6/11/2015: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: Free to attend
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 to attend
Warwick Location: FREE 
WPI BETC Location: Free

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

MEETING MANAGERS:
Howard Sneider, CRB Consulting Engineers
Jonathan Ly, Barry-Wehmiller Design Group
Norline Crossdale-Walker, Genzyme
Zeke Johnston, AMAG Pharmaceuticals

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ISPE Product Show Committee Meeting
Date: 13 July 2015

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 Finance Committee Meeting
Date: 14 July 2015

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 Student Chapter Committee Strategic Planning Session
Date: 15 July 2015

Pre-Registration is Closed. Walk-ins will be Accepted onsite. If you have any questions please call the office at 781-647-4773.

We just finished year 3 of a multi-year plan to completely rebuild our student chapters from the ground up.  We’ve had some great successes and also learned several important lessons.  While we are building momentum at each student chapter, there is still much work to do.  The Boston Chapter has the overall plan for student chapter growth and success, but we also want to get your critically valuable input and feedback on how we can be more effective for you and your students.  We can use all the help we can get as we chart our course forward.  It is our hope that everyone will walk away with a clear understanding of the unified plan and everyone should know how they can help further the cause.

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ISPE Educational Programs 2016 Season Planning Meeting
Date: 23 July 2015

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

This summer, the Boston Area Chapter will receive valuable input on educational programs of interest to our Members through a survey which will be launched in June. The Educational Program Committee would like YOUR help to finalize the educational program content for the upcoming Chapter year using the survey results. Please join us on Thursday, July 23, 2015 as the 2016 educational season is developed.

Schedule 5:30 PM - 8:30 PM Dinner, planning the 2016 programming year, and brief committee meeting

Attendance and parking are free (we want your assistance) and food will be provided! 

ISPE Membership is required in order to participate in any Chapter Committee.  To become a member, click here and select the Boston Area Chapter.

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ISPE Educational Programs Planning Meeting
Date: 5 August 2015

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: 10 August 2015

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: 11 August 2015 - 12 August 2015

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 Summer Golf Tournament
Date: 17 August 2015

We are SOLD OUT.  Please contact the office if you have any questions.

SCHEDULE:

11:15AM - 12:30 PM – Registration, Lunch and Driving Range
12:30 PM – Shotgun Start – Scramble Format
6:00 PM – Reception/Cocktails/Dinner

LOCATION:

Kernwood Country Club, 1 Kernwood Street, Salem, MA 01970

Please contact the office at (781) 647-4773 if you have any questions about this event.

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ISPE Product Show Committee Meeting
Date: 24 August 2015

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 Summer Social and Volunteer Appreciation Night
Date: 27 August 2015

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

Come join the ISPE Boston Area Chapter for our Summer Social and Volunteer Appreciation Night! All are welcome to enjoy in a night of socializing and networking.

Thursday, August 27, 2015
6:00 – 9:00pm
Pier 6 Outdoor Patio
1 8th Street, Charlestown, MA 

Thank you to our Sponsors:
Boston Analytical
Commissioning Agents
Festo Corporation
GxP Automation is now Albireo Energy
New England Lab
Northeast Engineering
The Richmond Group
Sentrol, Inc.
Superior Controls

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ISPE Educational Programs Planning Meeting
Date: 2 September 2015

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 Boston Harbor Boat Cruise
Date: 3 September 2015

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

Come join the ISPE Boston Area Chapter for our kick-off event of the season! New and returning members, young and old professionals are all welcome to enjoy in a night of socializing and networking as we tour the Boston Harbor waters.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields.  This is a great opportunity to meet other people from different areas of these exciting and diverse industries and get involved with the ISPE Boston Area Chapter.

6:00 pm – Boarding Time
6:30 pm – Sailing Time
9:30 pm – Return Time

Massachusetts Bay Lines, Inc.
60 Rowes Wharf
Boston, MA 02110

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ISPE Board of Directors Meeting
Date: 8 September 2015

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: 14 September 2015

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 Process Validation Lifecycle Approach, A Return to Science
Date: 16 September 2015

EVENT INFORMATION:
Do we have a blockbuster September program for you! For the first time ever, the ISPE Boston Area Chapter and the PDA New England Chapter have pooled resources to present an incredibly strong educational event to kick off the program year! The topic is Process Validation and we’ve secured two excellent speakers who will help us decode and understand guidance documents written by the FDA, ICH, PDA, ISPE, and other industry sources on the topic. Don’t miss out on this one of a kind opportunity to meet, exchange ideas, and network with a much larger industry cross section than usually participates at these programs. Be sure to sign up now to secure your spot before the event sells out! 

PROGRAM SUMMARY:
The expectations for process validation and process control have changed and are continuing to change – for the better. More and more global health authorities and regulators are communicating their expectations for risk and science based justification for process control and validation approaches. A true life cycle approach to process validation requires gathering useful, scientific information as process and control strategies are developed, thus saving time and resources during later qualification and validation stages. The key is better understanding of the process, its sources of variation and their control, and the correlation between validation studies, sampling plans, process performance, product quality, and continued process verification. These coordinated presentations will use recent global guidance, PDA Technical Report 60, ISPE white papers and other industry publications and examples to explore global expectations and approaches for process validation, the background leading to these expectations and approaches, as well as current trends and future direction.

SPEAKERS: 

Rusty(Russell)Morrison is a Principal Consultant for CAI Consulting (a division of Commissioning Agents, Inc.), where he is responsible for the sales, marketing, and execution of qualification, process validation and technology transfer projects. He has directed multiple process validation efforts, including the complete process validation for the startup of a large cell culture monoclonal antibody manufacturing facility, and remedial process validation for a manufacturer of numerous small volume sterile parenteral products, including designing a continued process verification program. Mr. Morrison is a member of PDA and ISPE, and has served as a member of ISPE’s Process Validation Implementation Team. In addition, he is a past president and board member of the PDA New England Chapter. Prior to CAI, Mr. Morrison held management and engineering positions with Protein Sciences Corporation, INNCOM International, and Sonalysts, Inc., and served as a submarine officer in the United States Navy. He has a BS in chemical engineering with honors from the University of Minnesota, an MBA in Information Systems from Rensselaer Polytechnic Institute, and has received ISPE’s Certified Pharmaceutical Industry Professional (CPIP) credential.

Hal Baseman is Chief Operating Officer and a principal at ValSource LLC and ConcordiaValsource LLC. He has over 36 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several drug manufacturing and consulting firms. He is a the Chair of the Parenteral Drug Association (PDA) Board of Directors, former Chair of the PDA Science Advisory Board, former Co-Leader of the PDA Process Validation Interest Group, and co-leader of the PDA TR 60 task force, as well as a long-time member of the PDA Training Research Institute faculty. He is a frequent presenter on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.

 

REGISTRATION FEES:

Before 9/11/2015: 

Member $55.00  
Young Professional Members $20.00 
Non-Member $55.00
ISPE Student Members: Free to attend

After 9/11/2015: 

Member: $85.00
Young Professional Members $30.00 
Non-Member: $85.00
ISPE Student Members: Free to attend

MEETING MANAGERS:
Brian Hagopian, Clear Water Consulting, Inc.
Mallory Duquesne,
Independent Consultant
Chris Ciampa, Thermo Fisher Scientific
Dan Mardirosian, Worcester Polytechnic Institute

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ISPE RE-SHOWING: Process Validation Lifecycle Approach, A Return to Science
Date: 24 September 2015

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 appetizers.

PROGRAM SUMMARY:
The expectations for process validation and process control have changed and are continuing to change – for the better. More and more global health authorities and regulators are communicating their expectations for risk and science based justification for process control and validation approaches. A true life cycle approach to process validation requires gathering useful, scientific information as process and control strategies are developed, thus saving time and resources during later qualification and validation stages. The key is better understanding of the process, its sources of variation and their control, and the correlation between validation studies, sampling plans, process performance, product quality, and continued process verification. These coordinated presentations will use recent global guidance, PDA Technical Report 60, ISPE white papers and other industry publications and examples to explore global expectations and approaches for process validation, the background leading to these expectations and approaches, as well as current trends and future direction.

SPEAKERS:
Rusty (Russell) Morrison is a Principal Consultant for CAI Consulting (a division of Commissioning Agents, Inc.), where he is responsible for the sales, marketing, and execution of qualification, process validation and technology transfer projects. He has directed multiple process validation efforts, including the complete process validation for the startup of a large cell culture monoclonal antibody manufacturing facility, and remedial process validation for a manufacturer of numerous small volume sterile parenteral products, including designing a continued process verification program. Mr. Morrison is a member of PDA and ISPE, and has served as a member of ISPE’s Process Validation Implementation Team. In addition, he is a past president and board member of the PDA New England Chapter. Prior to CAI, Mr. Morrison held management and engineering positions with Protein Sciences Corporation, INNCOM International, and Sonalysts, Inc., and served as a submarine officer in the United States Navy. He has a BS in chemical engineering with honors from the University of Minnesota, an MBA in Information Systems from Rensselaer Polytechnic Institute, and has received ISPE’s Certified Pharmaceutical Industry Professional (CPIP) credential.

Hal Baseman is Chief Operating Officer and a principal at ValSource LLC and ConcordiaValsource LLC. He has over 36 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several drug manufacturing and consulting firms. He is a the Chair of the Parenteral Drug Association (PDA) Board of Directors, former Chair of the PDA Science Advisory Board, former Co-Leader of the PDA Process Validation Interest Group, and co-leader of the PDA TR 60 task force, as well as a long-time member of the PDA Training Research Institute faculty. He is a frequent presenter on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.

REGISTRATION FEES:
Warwick Location: FREE
WPI BETC Location: FREE

MEETING MANAGERS:
Brian Hagopian, Clear Water Consulting, Inc.
Mallory Duquesne, Independent Consultant
Chris Ciampa, Thermo Fisher Scientific
Dan Mardirosian, Worcester Polytechnic Institute

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ISPE Product Show Committee Meeting
Date: 28 September 2015

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: 7 October 2015

Register Today! Your FREE registration badge allows you to:

*  Connect with experts from 375+ companies
*  Get insights from educational sessions on the show floor
*  Attend the plenary session and hear from keynote speakers John Bournas, ISPE President & CEO, and Andy Skibo, Head of Global Biologics Operations & Global Engineering at MedImmune/AstraZeneca
*  Visit Champions for Charity, where you meet Patriots alumni Steve Grogan and Joe Andruzzi and also contribute to a great cause
*  Network and exchange ideas with peers at the After Party at the new Optum Field Lounge and meet New England Patriot Malcolm Butler

And if you preregister now and attend the show, you are automatically entered into a drawing to win 2 tickets (courtesy of Superior Controls) to the New England Patriots versus New York Jets game on Sunday, October 25th, along with lodging and dinner on Saturday night at Patriot Place.

Click Here to Register 

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ISPE Board of Directors Meeting
Date: 13 October 2015

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 Planning Meeting
Date: 15 October 2015

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: 19 October 2015 - 23 October 2015

Learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance.

Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

Courses

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ISPE Fall Social
Date: 20 October 2015

Save the Date!! More information is coming soon.

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ISPE Kidney Walk
Date: 25 October 2015

One in nine American adults has kidney disease and most don’t know it. With the increase in diabetes and high blood pressure – two major kidney disease risk factors – kidney disease is on the rise. The National Kidney Foundation (NKF) Kidney Walk is an inspiring community fundraiser that calls attention to the prevention of kidney disease and the need for organ donation.

This year, the ISPE Boston Area Chapter and The New England Patriots Charitable Foundation are joining together to sponsor a team of our Young Professionals that will participate in the 2015 Boston Kidney Walk on October 25th and we need your support.

If you are interested in participating on the ISPE team, contact the office at 781-647-4773 or office@ISPEBoston.org.

http://donate.kidney.org/site/TR/Walk/NewEngland?pg=entry&fr_id=7592

 

 

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ISPE Board Dinner with Japan Affiliate Delegation
Date: 4 November 2015

This is a Board Meeting. If you have any questions about this event please contact the office at 781-647-4773 or office@ISPEBoston.org.

 

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ISPE Educational Programs Planning Meeting
Date: 4 November 2015

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 Meeting
Date: 8 November 2015 - 11 November 2015

New Paradigms for Manufacturing Excellence

Join us in Philadelphia, Pennsylvania – one of North America’s leading pharmaceutical engineering centers!

Gain solutions-based approaches designed to create robust international supply networks, advance production quality and prevent drug shortages.

New Programs This Year!

Global Regulatory Town Hall - International and US FDA regulators weigh in on the biggest challenges facing the industry - harmonization - data integrity - quality risk management. Be there to lend your voice to the discussion.

Innovation Forum - Interactive sessions focus on unique projects, technologies and approaches that clearly demonstrate how companies have successfully adopted innovation as a benefit rather than as a risk. Does your organization foster a culture that supports innovation?

Choose from Six Dynamic Education Tracks

Facilities and Equipment Regulatory Compliance and Quality Systems
Product Development and Production Systems Information Systems
End-to-End Supply Chain Management Innovation Forum

70+ Education Sessions and Workshops

Register Early! Save before 11 October

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ISPE Boston Chapter Social Event at the Annual Meeting
Date: 8 November 2015

Save the Date!

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ISPE Soft Skill: Death by Powerpoint
Date: 12 November 2015

Save the Date!

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ISPE Board of Directors Meeting
Date: 17 November 2015

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 Planning Meeting
Date: 2 December 2015

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: 7 December 2015

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 December 2015

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 Information Systems
Date: 10 December 2015

Save the Date!

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Educational Program
Date: 21 January 2016

Save the Date!

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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 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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Page last updated: 26 June 2014