10/13/2015

1

24th Annual Product Show

State of the Chapter

H. Steven KennedyPresident, ISPE Boston Area Chapter7 October 2015

10/13/2015

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What’s New This Year?

• Contract Extension with Gillette Through 2021

• Preregister to Exhibit for 2016 Today

• Please Complete the New Survey

• New Website and 9 New Videos

What’s New This Year?

• Contract Extension Through 2021

• Preregister To Exhibit for 2016 Today

• Please Complete the New Survey

• New Website and 9 New Videos

• New Registration and Lead Retrieval System

• Mobile Show Guide App

10/13/2015

3

EDUCATIONAL SESSIONS

12:30 pm – 1:30 pm 

Keeping Up with Single‐Use: An Introduction To Single‐Use Manufacturing Systems Including A Survey of Technology, New Developments and Economic and Operational Issues

Geoffrey Hodge

Bioprocess Technology Leader 

Co‐Founder Xcellerex 

SVP Operations | Unum Therapeutics

EDUCATIONAL SESSIONS

2:00 pm – 3:00 pm 

Implementing Innovative Technologies

Jorg Thommes

Senior VP Operations Technology & Innovation

Biogen

10/13/2015

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EDUCATIONAL SESSIONS

3:30 pm – 4:30 pm 

Oral Solid Dosage Baseline Guide Preview

Jack Chu 

Associate Director of Engineering, MMD Operations 

Merck & Co., Inc.

EDUCATIONAL SESSIONS

5:00 pm – 6:00 pm 

Bioprocessing Intensification: Strategies for Handling High‐Titer Mammalian‐Based Bioprocess Systems

John Romero 

Associate Director

Operations Technology & Innovation

Biogen

10/13/2015

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VENDOR SHOWCASES ON THE INNOVATION STAGE

12:30 pm – 1:00 pm 

Parker domnick hunterBest Practices for Developing Single‐Use TFF Steps for Biopharmaceuticals

1:00 pm – 1:30 pm PTI Inspection SystemsThe Path to Container Closure Integrity

1:30 pm – 2:00 pm Pressure BioSciences, Inc.Protein Sample Preparation Using High Pressure

VENDOR SHOWCASES ON THE INNOVATION STAGE

2:00 pm – 2:30 pmHarrington Pure / E&S TechnologiesPOINT‐OF‐USE WFI/ PW Systems2:30 pm – 3:00 pmILC Dover LPSingle Use Powder Transfer Solutions

3:00 pm – 3:30 pm Clark‐Reliance CorporationCleanability You Can See

10/13/2015

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VENDOR SHOWCASES ON THE INNOVATION STAGE

3:30 pm – 4:00 pmCimetrics, Inc.Application of Quality Risk Management for Manufacturing Systems through Periodic Review

4:00 pm – 4:30 pm King Gage EngineeringMulti‐Variate Flow Measurement and Control with Alicat Scientific

STUDENT DEVELOPMENT PROGRAM

2:00 pm – 3:00 pm 

How to Network Successfully at the Product Show

Laura Poisson 

Senior Vice President of Business 

Development and Client Services

ClearRock, Inc.

10/13/2015

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STUDENT DEVELOPMENT PROGRAM

3:30 pm – 4:30 pm 

Quality Systems – What Are They And How Can They Give Me An Edge?

Theresa McCarthy 

Pharmaceutical Sciences Audit Inspection

Compliance Effectiveness Manager 

Pfizer

CAREER FAIR

Open 12 – 5 pm in the Northwest Lounge

10/13/2015

8

2015 Boston Kidney Walk

October 25, 2015

Canal Park, Cambridge

CHAMPIONS FOR CHARITY1:00 pm – 5:00 pm

West Clubhouse, Club Level, Northwest Lounge

Champions for Charity Event 

Featuring Patriots Alumni Steve Grogan, Joe Andruzzi &

Patriots Cheerleaders & the Vince Lombardi Trophy.

10/13/2015

9

YOUNG PROFESSIONALS/STUDENT NETWORKING  HOUR

5:00 pm – 6:00 pm

East Clubhouse, Club Level, Southeast Lounge

(Vendor Showcase Area)

Featuring live music by “Wolfpack”

AFTER PARTY6:30 pm – 9:30 pm

Optum Field Lounge

(Take the South End‐Zone Ramp to the Field Level)

Featuring Patriots Super Bowl hero Malcolm Butler and entertainment by 

Boston icon, Keytar Bear

10/13/2015

10

Significant Accomplishments Over the Past Year

• Membership • Events• Recent Events

• Golf Outing

• Summer Social and Volunteer Appreciation

• YP Boat Cruise

• Joint ISPE‐PDA Educational Event

• Geographic Outreach• Succession Planning• Finance Committee• Scholarship

Chapter Initiatives

• Cleaning Up Policies, Bylaws, and Charter

• Industry Advisory Board

• Geographic Outreach Committee

• Student Development– Mentor Program

• Young Professionals

• Communications Committee– Modernizing our Email marketing

– Update of the website to allow for content streaming and usability

10/13/2015

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Events

• Education• Classroom Training

• November Soft Skills

• The Chapter Education Calendar is Planned Out to March of 2017

• Social• Fall Social

• Boston Kidney Walk  ‐ October 25th

• Chapter Social at the Annual Meeting  ‐ Sunday, November 8th, Hard Rock Café Philadelphia

• Winter Social

• Spring Golf Outing

• Summer Social and Volunteer Appreciation

• Summer Golf Outing

Chapter Awards

10/13/2015

12

STUDENT POSTER COMPETITIONWINNERS

Sydney Shaw Northeastern University

Graduate Winner

Dan Ezra Aurian‐BlajeniUMASS Amherst

Undergraduate Winner

STUDENT CHAPTER OF THE YEAR AWARD

10/13/2015

13

VOLUNTEERS OF THE YEAR AWARD

Chris Blackwell Dan Mardirosian

OUTSTANDING ACHIEVEMENT AWARD

Samir Gondalia

10/13/2015

14

HANK MOES AWARD

Brian Hagopian 

ISPE 2016‐2019 BLUEPRINT FOR THE FUTURE

John E. BournasPresident & CEO, ISPE

10/13/2015

15

ISPE: PHARMA INDUSTRY OUTLOOK

Andrew D. Skibo

Head of Global Biologics Operations & Engineering, MedImmune/AstraZeneca

10/13/2015

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24th Annual Product Show