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Chapter Hosts Japan Affiliate Members

by H. Steven Kennedy, Kennedy Strategic Consulting
In what has become a biannual tradition, the Chapter welcomed a group of 21 delegates from the Japan Affiliate to Boston as they passed through on their way to the ISPE Annual Meeting. This year’s activities were coordinated by Michael Lucey for the Japanese Affiliate and by H. Steven Kennedy on behalf of the Board of Directors.
Following a tour of the Cambridge biotech hub with Chapter volunteers as guides, visitors from the Japan Affiliate joined Chapter officers and board members for a family-style dinner in Boston.
The delegation arrived in Boston on Tuesday, November 3, and were taken to the Hyatt Regency Cambridge on the banks of the Charles. Bright and early the next day, Chapter tour guides Board Member Kevin Chronley and Young Professionals Committee Chair Chris Ciampa met the delegation and commenced the start of their 2-day tour. They started with a tour of Shire where hosts Lois Perry, head of the Lexington Manufacturing Site, Shawn Fitzpatrick, and Chapter Board Member Eric Felz showed off 400 Shire Way — Shire’s state-of-the-art, single-use manufacturing facility.
After the tour, the delegation headed back to Cambridge for lunch at Legal Sea Foods in Kendall Square. After lunch, they walked across the street to Biogen where host and former Board Member Tom Choyce conducted a tour of the bio2 production facility where Biogen is manufacturing three of their flagship products: Avonex®, Plegridy®, and Eloctate®. After the Biogen tour, the group boarded their bus and were given a tour of the Cambridge biohub by Kevin and Chris as they made their way back to the hotel. Later that evening, the Chapter Board of Directors hosted a reception and dinner for the visitors at Maggiano’s Little Italy in Park Plaza where everyone shared an array of Italian specialties served family style.    
The next morning, the delegation traveled to Waltham for a tour of the AstraZeneca Research Campus where they were greeted by hosts Paul Joyce, Director Engineering & Site Services; Stephen Shea, Associate Director Facilities & Lab Operations; and Ken Sutton, Director Facilities Management. Escorting them for the Chapter was Chapter President, H. Steven Kennedy and Immediate Past President Chris Opolski. After an excellent lunch, they headed to Connecticut to visit Pfizer Groton. Here they were met by their hosts, Chapter Board Member Darren Wolter and International Board of Directors Vice Chair Michael Arnold, who gave them a tour of their new PCMM - Pharmaceutical Continuous Manufacturing Module. After refreshments, the delegation continued on their journey to the Annual Meeting where they attended the Chapter’s Annual Meeting reception at the Hard Rock Café in downtown Philadelphia on Sunday evening.  
The delegation has written the Chapter to tell us they appreciate our hospitality and the time spent with the Chapter was the best part of their trip. They have extended an invitation to the Chapter to send a delegation to Japan to attend their 25th Annual Meeting in the spring of 2017. The Chapter will be coordinating a group to visit our “sister” Chapter, so if you are interested in making the trip, keep an eye out for details over the coming year.
The Chapter would like to thank the tour organizers, our hosts at Shire, Biogen, AstraZeneca and Pfizer, and the Chapter volunteers who acted as guides during the two-day tour for making this a great experience for our colleagues from Japan.


Annual Meeting 2015 – A Renewed and Vibrant ISPE

by Jack Campion, The Hart Companies, with photos by Chris Opolski, SPEC Process Engineering, and Brian Hagopian, Clear Water Consulting

There was a new "vibe" at the 2015 Annual Meeting of the ISPE. Both the organization and the industry that its members serve are feeling healthy, strong and growing. Chapter officers and Members traveled to Philadelphia on November 8-11 to learn, share and celebrate. We were joined by thousands of professionals from across the globe in a great conclave themed "New Paradigms for Manufacturing Excellence."

Philadelphia provided a photogenic backdrop for this year's ISPE Annual Meeting.

The "learning" took the form of numerous educational sessions that stretched over 3 days. Broad subject matter categories included Facilities and Equipment; Product Development and Production Systems; Supply Chain Management; Regulatory Compliance and Quality Systems; and Information Systems.

Sessions were led by several Boston Area Chapter Members. Pietro Perrone (EMD Millipore) led a session called "Single-Use Technology: The Advances of a Flexible Technology in a Structured Environment" featuring case studies of risk management associated with SUTs, including extractables and leachables, and reduction of operator errors. Jim Vogel (BioProcess Institute) led a panel called "Single-Use Standardization Update" that included Pietro.

Other members were also featured as speakers and panelists: Chapter Past President Andre Walker spoke on "Emerging Standards and Practices in Continued Process Verification." Andre Gill participated in "Critical Utilities Maintenance Program and Operational Optimization." David Krantz (Shire) and Rob Snow (Genzyme) both presented in a session covering the convergence of continuous processing and single-use technologies. David's talk was "upstream," describing a single-use perfusion bioreactor application. Rob tackled "Chromatography Column Sterilization Needs and Challenges for Continuous Operation." In all it was a great display of the expertise and technical leadership embodied in the Boston Area Chapter membership!

New this year was the "Innovation Forum." This series covered topics such as new strategies to turn piles of data into usable information and assure data integrity; the challenges of implementing new technologies in China; and new thought processes for efficient capital appropriation decisions. "The Future of Pharma" session went beyond the limits of standard topic categories. Ideas discussed included the development of medicines in outer space, the "internet of things," using "Big Data" tools, and the "Maker" movement.

The Forum challenged notions that ideas like those above don't apply or are tangential to pharma manufacturing. Conclusion from the sessions: Not for long! Next year's Forum could have speakers with a different perspective from "unrelated" industries such as aerospace or from companies such as Google.

Plenary sessions featured outstanding speakers and panelists. Notably, John Cox, EVP of Operations and Technology for Biogen, emphasized the need to "transform" biologics manufacturing in order to meet the coming challenge presented by a huge biopharma drug pipeline. A highlight was the introduction of Dr. Theodora (Dora) Kourti, ISPE's new SVP of Global Regulatory Affairs. She has a distinguished and truly global background in industry and academia and will serve as a resource to facilitate the Society's many technical initiatives.

The "sharing" took place in many forums including the vendor exhibition with numerous Chapter Members promoting their companies prominently. Chapter Manager Amy Poole, along with the Chapter officers led by Chapter President H. Steven Kennedy, participated in the Joint Affiliate Council - a roundtable of Chapter and Affiliate representatives from around the world. Separately the North America/South America Affiliate Council met to discuss collaborations and exchange ideas and best practices. As a result, the Boston Area Chapter leaders are exploring collaborations with the New Jersey Chapter and the Australia Affiliate for truly global education sessions. Separately, we met with the Brazil Affiliate to exchange ideas for event topics and volunteer management - a truly intercontinental learning experience!

Last but not least, "celebrations" included the annual Boston Area Chapter reception held at the nearby Hard Rock Café. About 75 attendees, including our colleagues from the Japan Affiliate, enjoyed the classic rock visuals, sounds, food, drink and each other's company. Boston Area Chapter Members also were out in force at the Society's Tuesday Night Party at the Reading Terminal Market. A highlight of the week occurred at the Annual Awards Breakfast where recent Northeastern grad and Chapter Member Sydney Shaw took the top prize in the international poster contest graduate category. A grand moment for the Chapter!

The Chapter's Sunday evening reception provided a warm welcome to Phillie for Chapter Members and guests.


The Tuesday Night Party provided a great way to unwind after three days of meetings and educational sessions.


Boston Area Chapter members share their congratulations (and a few laughs) with International Poster Contest winner Sydney Shaw (center) at Annual Meeting.

The 2015 Annual Meeting was a delight to attend for so many reasons. Great learning, great connections and a positive "long view" of our important and prosperous industry. See you there next year!


Soft Skills Educational Program: What Your Professors Never Taught You

by Jillian Willard, Genzyme, with photos by Joyce Chiu, Shire

A group of industry professionals gathered on a rainy Thursday night at Genzyme in Framingham to listen to a discussion of a number of different soft skills topics. First up was "How to Avoid Death by PowerPoint," presented by the Boston Area Chapter Educational Committee's own Michael Levesque and Howard Sneider. The dynamic duo discussed the many ways good presentations can go bad and how to avoid common pitfalls through better planning and structure. Howard encouraged participants to develop and concentrate on a message and bring all the elements of a presentation together to focus on that message, while Mike highlighted how bad PowerPoint etiquette can tank a presentation and distract from that message.

(l to r) Presenters and Education Program Committee Co-Chairs Michael Levesque and Howard Sneider with Meeting Manager Thomas Vaughan.

Following Mike and Howard, WPI Professor Sharon Wulf presented "Managing Multi-Generational Staff." Sharon discussed the four different generations in today's workforce: Generation Y, Generation X, the Baby Boomers and the Silent Generation, and the key generational differences and similarities. Participants learned how to use this knowledge to build effective teams and effectively mentor others by sharing life experiences, values, and perspectives.

Presenter and WPI Professor Sharon Wulf receives accolades from Past President Andre Walker.

The night concluded with a discussion of leadership skills lead by industry veteran Robert Wherry, who taught us that everything we need to know about leadership can be learned from The Beatles. Who would have thought The Beatles would ever be featured so prominently in an ISPE educational event?! Robert showed the attendees just how The Beatles provide an effective illustration of key leadership skills such as managing work (and stress!), teams and organizations, as well as how they relate to the biotech and pharmaceutical industries.


Pfizer Andover Hosts Plant Tour and Discussion of Industrial Wireless Networks

by Howard Sneider, CRB with photos by the author and Karima Erriahi, Thermo Fisher Scientific

The last educational program of 2015, "An Industrial Wireless Network: What It Is and How It's Done," took place on Thursday, December 10, at Pfizer's Andover manufacturing facility. The 60 attendees joined an opening reception in the atrium outside of F1300 where they enjoyed conversation and appetizers. While the reception was going on, representatives from Pfizer guided attendees through suites A and B to observe some of the equipment used in processing Prevnar13. This included fermenters, a centrifuge, filtration equipment and UF/DF equipment. The tour guide explained how the automation system controls and records asset, batch and material tracking. The tour also passed through the first floor of suites C and D where an array of process support equipment, including the base of the NPCW and WFI tanks, as well as the WFI pumps, was visible. The guide then demonstrated how whiteboards located in the corridor outside of central parts storage are used to communicate production status, safety metrics, quality review and other operational metrics to the facility staff in huddles at the start of each shift.

Attendees enjoyed the networking reception while waiting their turn to tour Pfizer's Andover manufacturing facility.

Following the reception and tour, Kristen Scharf of New England Controls opened the program by discussing the different types of wireless networks likely to be used in manufacturing environments and the difference between these networks and the networks used in consumer electronics. She emphasized that the goal of industrial wireless networks is to facilitate improving processes and assets. To that end, wireless is being used everywhere to make big improvements. The application examples she described ranged from installing automation to getting people out of hazardous areas, to monitoring assets to prevent downtime, to improving efficiency of processes and environmental and safety monitoring.

Presentations by Kristen Scharf and Erik Westberg combined for a timely and comprehensive overview of wireless networks used in manufacturing.

Kristen next described some of the particular aspects and challenges of field networks including the use of wireless networks for backhaul, RFID tracking, mobile workstation environments, and security cameras. She also discussed how wireless field networks provide pervasive wireless and analytics. As data volume and complexity increase over time, and trends indicate they will, the access wireless devices provide will become more important. Two examples that Kristen focused on were vibration monitoring and steam trap ultrasonic measurement.

Kristen concluded her presentation with a discussion of the Industrial Internet of Things (IIoT). This emerging technology allows pervasive data sensing to be analyzed in real time and provides real-time control recommendations. Wireless systems have enabled IIoT by lowering the cost of installing the sensors required for this technology.

Next up was Erik Westberg of Pfizer whose presentation described the design, implementation, and validation of the wireless Ethernet network used in Pfizer's Andover manufacturing suites. He began with an overview of the control system network layers, components and functionality, then explained that the decision to explore wireless was based on production requirements and challenges with the in-place wired connections. One benefit to implementing the selected system was that the validated programming could be reused with the new hardware. After implementing the change, risk assessments on security, throughput, and robustness were conducted. Once Pfizer had determined that the wireless system performed as well as the wired predecessor, there were additional challenges that needed to be met. These included wireless signal overlap, malfunctions caused by duplicate addressing, and loss of data caused by dropped connections.

A question-and-answer session followed each presentation. The audience had many excellent questions for each presenter, attesting to the high level of interest in the subject matter. The Chapter would like to thank each of our speakers for their wonderful presentations, the staff at Pfizer who coordinated the event and tour, event sponsor Acentech, and everyone who helped make this event a great success!


“Orangutan Skies” at Aeronaut Brewing in Somerville

by Brian Kennedy, Genzyme, with photos by Christopher Ciampa, Thermo Fisher Scientific

On December 3rd, the Boston Area Chapter Young Professionals hosted a social event at Aeronaut Brewing in Somerville. This is the second time the Chapter has hosted a networking event at a Boston-area microbrewery after a very successful event at Night Shift Brewery last year in Everett. This year followed suit with nearly 30 people, representing some 22 companies and universities, turning out for an engaging evening of barbeque-style food, networking, and craft beer.

Chapter YPs hosted a networking social, brewery tour and craft beer tasting at Aeronaut Brewing in Somerville. Orangutan Skies, anyone?

Aeronaut Brewing was started in 2013 by a group of MIT graduates who began brewing craft beers in a Somerville backyard. In the summer of 2014 they opened their current location on Tyler Street, creating Somerville's first craft brewery in more than a century. Co-owner Ben Holmes provided ISPE Members with tours of the in-house laboratory as well as the large-scale brewing area as he guided us through the process of making beer. He provided a great overview of the purpose of each of the vessels as well as the precautions and practices they adopted to successfully manufacture in an aseptic manner. The similarities to the biotech industry were stark, both in the lab-scale culture of yeast lines and in the large-scale production of the beer.

Attendees got the chance to try several of the 8 tasty and uniquely-named craft beers that Aeronaut currently offers on tap, with the "Orangutan Skies" and "Saison of the Western Ghats" being two of the more popular selections. The fare for the evening included jerk chicken, Texas BBQ beef, and mac ‘n' cheese from Redbones BBQ in Davis Square.

The event at Aeronaut was a big success, filled with opportunities to meet new people, build connections, and learn a bit about how craft beer is made. Given the popularity of this and the previous brewery event, we look forward to holding similar events at other Boston-area microbreweries in the future!


2016 Shaping Up as Another Great Year for the YPs

by Christopher Ciampa, Thermo Fisher Scientific

Hello everyone! Now that 2015 has come to a close, I wanted to provide a look at what we have to offer for 2016. 2015 was an amazing year for the Young Professionals and we look forward to serving the Chapter again this year! Our December social and tour at Aeronaut Brewery in Somerville was a big success as you can see from the accompanying article and we have a full schedule of equally great social and educational events for you to look forward to in the upcoming 12 months.

Currently we are in the process of planning the social and educational events for the winter and spring seasons. While we used to host the popular Medieval Manor Social in February each year, we just discovered Medieval Manor closed their doors on December 31, so we are looking at a roller skate themed event at Roller World in Saugus instead. The timing will be around the first week of February and the theme will be "90s Throwback Thursday." Since most millennials grew up in the 90s, the theme should be perfect!

In March, we will be hosting our first "roundtable" session. This will be good timing for an event geared toward graduating students who will soon be entering the industry. The topic is still to be determined but we will keep you posted. In April, we will host a dual-track educational program with the students at WPI. This time the topic will be "Science and Technology: What Will the Next Ten Years Bring?" In addition, the Chapter's Annual Student Poster Contest will be judged the same evening - with the posters on display during the networking reception - so plan to be there to show your support for the student participants!

April will bring a return to Sacco's Bowl Haven/The Flatbread Company in Davis Square for another bowling social. In June, we'll continue the momentum with our Annual Red Sox Social, and after a brief summer siesta, we'll be back in September with our annual harbor cruise. This year we're going to shake things up and do a joint event with the PDA - based on the success of the Chapter's joint educational program with the PDA in September, this should be another blockbuster. Given the success of the Kidney Walk this year, we are planning to participate again in 2016 and may branch out with other charitable events this year as well.

In terms of communication and social media, we now have grown our online presence significantly. There are now 3 ways to stay in touch with the YPs. The first is through email distribution (if you want to be added to the list, let me know). Second, we have both a LinkedIn and a Facebook YP page. Both the LinkedIn and Facebook groups are called ISPE Boston Area Chapter Young Professionals. In 2016 we will be using all of these means to communicate YP updates and push events.

As always, we want to hear from you! If you have any suggestions or would like to attend one of the regularly scheduled Young Professionals Committee (YPC) meetings, please don't hesitate to reach out to me ( christopher.ciampa@gmail.com ). Hope to see you at lots of our events this year!


Chapter Student Members Win International Poster Competition, Scholarships…

by Brian Hagopian, Clear Water Consulting, and Paige Kane, Pfizer, with photo by Brian Hagopian

The Boston Area Chapter is proud to congratulate D. Ezra Aurian-Blajeni and Sydney Shaw, winners of the Chapter's 2015 Student Poster Competition winners, both of whom competed in the international-level Poster Competition at the ISPE Annual Meeting in November. And extra-special congratulations to Sydney Shaw for winning the top award in the graduate category! This year's local Poster Competition is on April 20, giving you the chance to share your work, polish your presentation skills and compete for one of two $500 cash awards and more! Read Sydney's article below for an "up close and personal" look at her experience, then check out the program flyer for everything you need to know about entering the local competition:  http://www.ispeboston.org/boston_area_student_chapters_postercontest.html .

International Poster Contest winner Sydney Shaw happily accepts her plaque and congratulations from Joe Famulare, Chair of the ISPE International Board of Directors.

The Chapter Scholarship Committee has been busy this semester, sifting through applications and awarding $13K in scholarships as part of the Chapter's commitment to giving back and "investing in the future" of our industry. This brings our 2015 scholarship award total to more than $25K. Congratulations to the following Student Members (listed alphabetically):

Oluwatosin Adedokun, New Jersey Institute of Technology
John de la Parra, Northeastern University
Victoria Drake, University of Connecticut
Margaret Grace, Temple University
James Hughes, Tufts University
Diego Leonardo, Middlesex Community College
Anton Malin, Brown University
Steven Rodriguez, University of Connecticut
Brody Stara, University of Massachusetts Amherst
Ryan Sullivan, University of Massachusetts Amherst
Peter Trearchis, Tufts University

We want to welcome to the ISPE community our two newest Student Chapters: the University of Connecticut and the Community College of Rhode Island. This brings the number of Student Chapters up to an even "baker's dozen." Students from each of these institutions were highly motivated to start Student Chapters, with efforts on both campuses dating back to last year. Look for them to be active in the coming year and please extend a warm welcome when you see them at ISPE events!

We're very excited to have just released a promotional video to highlight the benefits of belonging to ISPE. While it's geared toward students, it's a great commentary on the value that the ISPE network can deliver to all of our Members. Check it out at  https://vimeo.com/148636910 . We're sure you will be impressed!

The next big event for students is the Career Workshop on January 30 which is filled with practical "tricks of the trade" from industry experts designed to help students build resumes, make great first impressions, win interviews and land that dream job, internship or co-op position. The workshop's popularity has grown so much that we've had to expand to a bigger venue. Registration is open to ISPE Student Members and it's free to attend but we'd really appreciate it if everyone would register in advance so we can have enough food, drink, etc. for everyone. Here's the link:  http://www.ispeboston.org/eventcal/calendar.html?action=display_event&oid=600 . We're also planning a tour for students at Shire in March. Final details are being worked out now, so stay tuned.


Annual Meeting Poster Competition Provides Winning Experience

by Sydney Shaw, Genzyme, with photo by Katie Darby Photography

In April 2015, I was in the middle of wrapping up my master's degree in chemical engineering at Northeastern University and job searching at the same time. Although I made a rather late decision to participate in the Boston Area Chapter's Annual Poster Competition because of my impending thesis deadlines, the event was ultimately a great experience. It not only gave me a chance to practice presenting a part of my work to a non-academic audience but provided me with the opportunity to network with local ISPE Members in the process.

My poster was titled, "The effect of light, jasmonate, and tissue organization on the expression of the vindoline pathway genes in Catharanthus roseus." The work focused on comparing gene expression levels of certain genes in the alkaloid metabolic pathway of the flowering plant C. roseus (common name Madagascar periwinkle). Catharanthus alkaloids are used in medicinal applications, including chemotherapy treatments but they are very expensive and difficult to produce synthetically or in a cell culture system. My goal was to better understand the plant system's native metabolic regulation with the ultimate aim of being able to genetically manipulate the metabolism to upregulate production of these unique compounds. It was particularly fun to present my work at the competition because the judges showed genuine interest in my research and their questions led to engaging discussion with a more practical focus than what I was used to when presenting to an academic group.

International Poster Competition Winner Sydney Shaw of Northeastern (center) with local winner D. Ezra Aurian-Blajeni of UMass Amherst (far right) surrounded by Boston Area Chapter well-wishers (l to r) Jack Campion, Andre Walker, Chris Opolski, H. Steven Kennedy and Brian Hagopian.

In the seven months between winning the local poster competition and traveling to Philadelphia for the ISPE Annual Meeting, I had graduated from Northeastern and started a full-time position at Genzyme - giving me even more of a reason to take full advantage of the opportunity to attend. As a newcomer to the industry, it was almost overwhelming to walk through the exhibitor hall and talk to some of the vendors who supply or support every need imaginable in the manufacturing process. The educational sessions I attended also allowed me to see more of the industry than I experience in my day-to-day process engineer job - including discussions on quality control and applications of single-use bioprocess technologies.

For me, the biggest challenge of the poster competition process was planning how to emphasize the importance of the work, show my technical knowledge and cover the critical findings, all within the 5-minute time limit. At ISPE's Annual Meeting, I was happy with how my talk went but knew I had some stiff competition after spending time getting to know the other student participants. At the awards breakfast the next morning, I was genuinely surprised to be named the winner - but was also very excited to know that all my preparation had paid off.

If you are a student interested in getting more involved in ISPE, or if you want an interesting opportunity to present your research outside of the typical university setting, I would highly recommend participating in the Boston Area Chapter's Annual Poster Competition this spring. Judging will be taking place at WPI on April 20 so it's not too early to start thinking about your poster. It was a great experience for me and the Chapter is always eager to get more students actively involved.

Remember: winners in each category, undergrad and graduate, receive $500 and a trip to the ISPE Annual Meeting to participate in the international level competition. Since I'll be one of the judges this year, I'll plan to see you at WPI in April!


Page last updated: 2 March 2016