by Mark Levanites, Sequence Quality and Compliance Services, Chair Product Show Committee with photos by Alastair Battson Photography
What started as an incredible year in New England with a Patriot Super Bowl championship, wrapped up on October 7 at Gillette Stadium with the best ISPE Boston Area Chapter Product Show to date. Spurred by the beautiful fall weather and a full day of exciting activities, a record number of area professionals travelled to Gillette Stadium to attend our biggest Product Show ever.
The Plenary Session opened with Chapter President H. Steven Kennedy who welcomed attendees and reported that the Chapter is financially sound, continues to be the largest ISPE Chapter in the world and has an array of exciting programs and initiatives planned for the upcoming year. He concluded by presenting the 2015 Chapter Awards recognizing the outstanding efforts and accomplishments of Chapter volunteers. Award winners included:
|Chapter Award winners (clockwise, beginning at top left) Brian Hagopian, Chris Blackwell, Dan Mardirosian and Samir Gondalia accept their plaques from Chapter President H. Steven Kennedy.|
Following Steve's opening comments was special guest speaker, ISPE President & CEO John Bournas, who gave an insightful speech on the ISPE Blueprint for the Future. He laid out the Society's exciting strategy and direction for the next four years as well as providing a sneak preview of the upcoming Annual Meeting next month in Philadelphia.
Next up was the much-anticipated keynote address delivered by Andrew D. Skibo, Head of Global Biologics Operations & Global Engineering at Medimmune/AstraZeneca, and current Chairman of the ISPE Board of Directors. His talk focused on the Pharma Industry Outlook and the role of ISPE in helping to build necessary flexibility and agility back into the industry and was both insightful and well received. In case you missed them, all three Plenary Session presentations were recorded and are now available on the Product Show website at
|ISPE President & CEO John Bournas (l) and ISPE International Board of Directors Chair Andrew Skibo (r) addressed members during the Plenary Session.|
Once the doors officially opened at noon, 2650 attendees (a new record high) began to filter in to visit with the 377 exhibitors on the Show floor. This year we added space between the tables and more booths and both attendees and exhibitors were happy with the new layout. Other changes included the new electronic registration/lead retrieval system and updates to the Show Guide mobile app. The new Show Guide app got rave reviews - especially since it made it a lot easier to find all the free food we added this year!
|Exhibitors loved the Show's added amenities including the automated lead retrieval system, updated Show Guide mobile app and roomier exhibit space.|
A full slate of training sessions was offered throughout the day and this year, for the first time, the four flagship sessions were all conveniently located in the plenary session area and held one after the other with a 30-minute break in between. This meant attendees could attend all the sessions and still be able to visit the exhibits. Topics covered were: "Keeping Up with Single-Use: An Introduction to Single-Use Manufacturing Systems" led by Geoffrey Hodge; "Implementing Innovative Technologies" led by Jorg Thommes; "Oral Solid Dosage Baseline Guide Preview" led by Jack Chu; and "Bioprocessing Intensification: Strategies for handling High-Titer Mammalian-Based Bioprocess Systems" led by John Romero. All four sessions were very well attended but if you were not able to catch them all, you can view them on the Product Show website at http://productshow.ispeboston.org/attendees/educational-sessions/ .
|Educational sessions, conveniently located adjacent to the exhibit area, drew a record turnout this year.|
Throughout the afternoon on the Innovation Stage, eight exhibitors showcased their latest breakthrough technologies and techniques, including Parker dominick hunter, PTI Inspection Systems, Pressure Biosciences, Harrington Pure/E&S Technologies, ILC Dover, Clark-Reliance, Cimetrics and King Gage Engineering. Meanwhile, the Student Development Program attracted over 160 students with two sessions: "How to Network Successfully" led by Laura Poisson, Senior Vice President of Business Development and Client Services at ClearRock, Inc., and "An Introduction to Quality Systems" led by Theresa McCarthy, Pharmaceutical Sciences Audit Inspection Compliance Effectiveness Manager at Pfizer, and Byron Mattingly, Director of Systems Quality Engineering at Pathfinder Software. There were plenty of opportunities to learn something new at every level.
The Career Fair, a show within a show, was expanded this year to 39 hiring companies eager to meet with potential new employees. We partnered with Career Builder to help source talent and over 650 of the Show's attendees visited the Fair this year. Many of the visitors - 150 to be exact - took advantage of our complimentary professional photographer to get a new headshot. Feedback on the Career Fair was overwhelmingly positive all around, so if you are a hiring company, contact us and be sure to sign up early for next year's Fair.
Forty hiring companies and professional head shots drew over 650 visitors to the Career Fair.
We are really excited that our Champions for Charity pavilion was a huge success. Over 175 visitors donated over $2000 to the National Kidney Foundation and had the opportunity to have their photo taken with New England Patriots alumni Steve Grogan and Joe Andruzzi, Pats cheerleaders and the 2015 Vince Lombardi trophy. Their donations will go toward supporting our team of walkers, the ISPE Nephronators, participating in the Boston Kidney Walk on October 25.
|Pats Cheerleader Dance Team members Kayla Brunson (l) and Brittany Dickie (r) join (l to r) Andrew Skibo, Chair of the ISPE International Board of Directors; Steve Grogan, Pats Quarterback 1975-90; John Bournas, ISPE President & CEO; Mike Arnold, Treasurer of the ISPE International Board of Directors; H. Steven Kennedy, ISPE Boston Area Chapter President; Joe Andruzzi, Pats Offensive Guard, 2000-04; and the Vince Lombardi Trophy awarded to the New England Patriots for winning Super Bowl XLIX.|
And if that wasn't enough, the Young Professionals held a Networking Social Hour where students and YPs met and mingled with music provided by "industry" band Wolfpack. Later, when the exhibitor floor closed at 6:30pm, 800 attendees and exhibitors flooded into Gillette's new Optum Field Lounge in the stadium end zone to unwind, enjoy some more great food, listen to the jams of Keytar Bear, and grab a picture and autograph from Super Bowl hero, New England Patriot Malcolm Butler. A great end to a tremendous day!
|Eight hundred After-Party attendees got an exciting, up close & personal view of the end zone from the brand new Optum Field Lounge.|
The ISPE Boston Area Chapter is pleased that this event continues to be offered free of charge, supported in full by our generous exhibitors. This includes free parking, free admission, free food, free soft drinks, free educational seminars and free After-Party autographs. The Product Show is our Chapter's flagship event and the revenue generated funds the Chapter, allowing us to provide many worthwhile benefits for our membership. So, on behalf of the Chapter, thanks to all of our exhibitors for your continued support. We look forward to your participation next year and encourage you to pre-register. To make it easy, you can pre-register and pay your deposit online on our Product Show website at http://productshow.ispeboston.org/reserve-space/ . Doing so will allow you to pick your booth location early once registration opens.
|Lucky member David Saxner shares a photo with After-Party special guest Malcolm Butler while Mass Maritime students happily wait their turn.|
Next year will be the 25th anniversary of the Product Show - our silver jubilee! It goes without saying that a Show like ours does not happen without a lot of help from many people. Our volunteers are the backbone of this organization and we are grateful for their help in making the Show a continuing success. The Product Show Committee is already hard at work planning how to top this year's extravaganza and we are always looking for enthusiastic, imaginative and fun people to help us design and run this event. If that is you and you would like to join us, please contact the Product Show Committee at email@example.com .
So mark your calendars for October 5, 2016 at Gillette Stadium and watch this space through the coming year to learn what we have planned. Thank you for your support and see you at the Product Show in 2016!
by Janet Tice, GMP Piping, with photos by Alastair Battson Photography
Well on its way to becoming an annual tradition, Chapter President H. Steven Kennedy presented this year's Annual Chapter Awards during the Product Show Plenary Session. The awards were introduced in 2013 as a way to honor the exceptional contributions of the Chapter's volunteers.
|Chapter Award winners (clockwise, beginning at top left) Brian Hagopian, Chris Blackwell, Dan Mardirosian and Samir Gondalia accept their plaques from Chapter President H. Steven Kennedy.|
Volunteer of the Year Award
recognizes Chapter Members who have demonstrated an exceptional level of dedication to the Chapter's goals and who, through their dedicated effort and involvement over the past year, have enabled the Chapter to accomplish these goals. This year's winners are
of Hargrove Controls + Automation and
of WPI's Biomanufacturing Education and Training Center for their efforts on the Geographic Outreach (GO) Committee.
The Outstanding Achievement Award is awarded to a Chapter Member, group of Members or committee that has accomplished a specific task or completed a discrete project during the past year that has significantly contributed to the Chapter's success. This year's winner is Samir Gondalia of Pfizer for leading the development of the Product Show mobile app.
The Student Chapter of the Year Award is presented to a Student Chapter that has distinguished itself during the previous year by bringing significant value to its Student Members and participating in Boston Area Chapter student-related activities to the greatest extent possible. This year's winner is Northeastern University .
Named for the Chapter's founder, the Hank Moes Achievement Award is presented to a Chapter Member in recognition of a comprehensive body of work and specific accomplishments that are widely recognized as truly extraordinary and of positive and lasting impact on ISPE, the Boston Area Chapter and the life sciences/biopharmaceutical industry. The award is presented to Brian Hagopian of Clear Water Consulting for his many years of service to the Society and the Chapter in a broad range of roles including Chapter President; and for his outstanding contributions in several areas, including the Product Show, student development and the CPIP program.
The Chapter would like to extend its thanks and congratulations to this year's winners and to all the volunteers whose efforts ensure the Chapter's success.
by Dan Kenny, Northeast Engineering, with photos by Joyce Chiu, Shire, and Brian Hagopian, Clear Water Consulting
With its prime location on the waterfront in Charlestown, Pier 6 provides a perfect spot for the Chapter's summertime thank you to volunteers.
With the summer coming to an end, the Chapter hosted our annual Summer Social at Pier 6 on August 27. This is the second consecutive year we have held this event at Pier 6, as its great location in the Charlestown Navy Yard and roomy outdoor space make it a perfect choice for a summer get together. This year we also used the event to thank our many Chapter volunteers who were invited to attend at no charge and turned out in force.
|Volunteers (l to r) Howard Sneider, Dan Kenny & Eva Price enjoy the Chapter's recognition for their many contributions.|
Members in attendance were welcomed with a gorgeous view, superb weather and an awesome spread of food. The turnout was excellent: a diverse gathering of long-time Members, Young Professionals and new Members alike. The event gave Members the opportunity to meet incoming Chapter President H. Steven Kennedy, who began his term in early August and took a few moments to thank the Chapter's many volunteers. After all, the Chapter depends on the dedicated efforts of our many hard working volunteers for its success. This past year over 100 Members gave their time and expertise in many different ways, from running educational events to manning the information booth at the Product Show. In addition, Steve thanked Immediate Past President Chris Opolski and retiring Board Members Tulsa Scott, James Stout and Jillian Willard for their valuable contributions to the Chapter.
Past President Sylvia Beaulieu (r) joins Eva Price (l) and fellow members for the evening's celebration.
A special thank you to our event sponsors: Albireo Energy (formerly GxP Automation), Boston Analytical, Commissioning Agents, Festo Corporation, New England Lab, Northeast Engineering, Sentrol, Superior Controls and The Richmond Group who helped make the evening's event a success. And to Past President Jim Grunwald, Eva Price and the Social Committee for their hard work coordinating this and all of the Chapter's social events.
|Outgoing President Chris Opolski displays his "silver gavel award" for Past Presidents Rick Pierro (l) and Dave Novak (r).|
At the end of the evening it was clear that all who attended had had a great time and were looking forward to the next networking get together, the Fall Social at the Baseball Tavern in Boston on October 20.
|Long time volunteers Joyce Chiu and Jared Marshall have earned the Chapter's thank you with years of dedicated service.|
by Brian Hagopian, Clear Water Consulting, with photo by Shauna Barnum-Gouette, Boston Analytical
The Boston Area Chapter held its "first ever in the history of the world" joint educational program with the New England Chapter of the Parenteral Drug Association (PDA) on September 16. Turnout was record-breaking with over 150 in attendance. The program was re-aired in video format for Chapter Members in our Providence and Worcester "hubs" a week later, at the Crowne Plaza Hotel in Warwick and WPI's Biomanufacturing Education and Training Center in Worcester, with accompanying networking reception at each location.
The program focused on "Process Validation Lifecycle Approaches: A Return to Science" and featured two distinguished speakers: Hal Baseman, COO of Valsource, and Rusty Morrison, Principal Consultant at CAI Consulting, who led us through thought provoking presentations that touched on topics as diverse as the pressures faced by regulators by the US Department of Public Health, to challenging the "3 batch" rule, and the science behind taking a risk-based approach to establish how many batches are actually required.
|PDA New England Chapter President Jonathan Morse (second from left) and ISPE Boston Area Chapter President H. Steven Kennedy (far right) share the limelight with presenters Hal Baseman (far left) and Rusty Morrison.|
Hal opened the session by providing some history and background on the link between quality issues and drug shortages in the past, reviewed the evolution of the concept of process validation, and stressed the importance of identifying potential sources of variation and establishing controls during the process development stage of a product.
Rusty followed with a discussion of how manufacturing history and process knowledge can be leveraged to identify risks and establish levels of confidence in a particular process. Each process is different and risk analysis tools can be employed to arrive at the correct number of batches required. Rusty indicated that the number of batches should not be used as a way to check if a process is under control but rather as proof that the process is under control.
Both speakers cited the complimentary missions of ISPE and PDA and cited references to materials published by each society on this topic. The audience came away with the clear message that process validation is an ongoing process and data generated during manufacturing should be reviewed continuously and integrated to establish the robustness (or lack thereof) of a process.
With over 150 professionals in attendance, the program clearly demonstrated the advantages of pooling knowledge and collaborating. With all the positive feedback generated by the event, this type of collaborative program will surely be repeated. Congratulations to meeting managers Laurie Masiello and Mary Griffin from PDA and Brian Hagopian and Mallory Duquesne from ISPE for the success of this "first of its kind" educational program.
by Dan Kenny, Northeast Engineering
A beautiful autumn evening greeted attendees at the Chapter's Annual Fall Social held at the Baseball Tavern near Fenway Park on October 20. The Social Committee scheduled the event to coincide with the ISPE Fall Classroom Training being held in the Fenway area October 19-23 and the turnout was great. The event enabled Chapter Members to network and socialize with ISPE trainees from all over the world in addition to their peers from the Boston area. The Baseball Tavern was a great host for the group and the spread they put out did not disappoint.
|The Chapter hosted an international group of ISPE members at the Baseball Tavern for this year's Fall Social.|
In keeping with Chapter tradition, the social had an altruistic side as well, as it featured a raffle designed to raise money for the National Kidney Foundation and the Chapter's ISPE Nephronators taking part in the Boston Kidney Walk the following Sunday. Fourty-two people entered the raffle for a chance to win a beautiful necklace donated by Kings Jewelers of Cohasset and added their donations to the almost $7000 already raised by the Chapter for the NKF. Thanks to all who gave so generously for this important cause.
|President Steve Kennedy presented the raffle prize to lucky winner & new Chapter member Kyle Roberts of CAI.|
Lastly, a special thanks to the Social Committee for organizing another great networking event. Including the ISPE trainees made it unique and gave Chapter Members a chance to show they know how to party!
It's not too early to start looking forward to our next networking get together: the Holiday Social in January 2016. See you there!
by Christopher Ciampa, Thermo Fisher Scientific, with photos by Karima Erriahi, Thermo Fisher Scientific
On Sunday, October 25, the Boston Area Chapter took part in a two-mile walk organized as a fundraiser by the National Kidney Foundation. The event took place at Canal Park, which is connected to the Cambridgeside Galleria area in Cambridge. In addition to fundraising, the Walk strives to raise awareness, educate the public and promote organ donation.
|YP Committee Chair & Kidney Walk coordinator Chris Ciampa (r) with Chapter members (l to r) Tom Struble and Jared Marshall.|
The name of our team was the "ISPE Nephronators" which combined a play on words from the Terminator movie franchise with "nephros," the Greek word for "kidney." Over 20 Chapter Members signed up to walk and some folks even brought their families with them! This event had special meaning for the Chapter since the wife of Past President and Chapter Founder Richard Priester has developed kidney disease. Luckily, her story is positive as she will be receiving a transplant on December 1, however, not everyone suffering from the disease has as fortunate an outcome.
|Congratulations to the "ISPE Nephronators" and Chapter members who raised over $8500 for the National Kidney Foundation!|
The two-mile walk started at 10:30am and wound around the Cambridge area, beginning at Canal Park, continuing through the Lechmere area, looping around near the Museum of Science and eventually returning to Canal Park. As of that day, the Chapter ranked fifth for top team donations, with total donations of over $8,500! The Nephronators had a goal of $3,000 and was able to beat that goal by over 150 percent! Great job, everyone!
Still want to donate, but missed the walk? Donations are still being accepted! D onations can be submitted via check, made out to “The National Kidney Foundation” and mailed to National Kidney Foundation, Attn: Boston Kidney Walk , 85 Astor Avenue, Suite 2, Norwood, MA 02062. Put Team ISPE Nephronators in the Memo line! The Kidney Walk website will also continue accepting donations via credit card until January 25, 2016 at http://donate.kidney.org/site/TR/Walk/NewEngland?pg=entry&fr_id=7592 .
by Chris Ciampa, Thermo Fisher Scientific, with photos by Joyce Chiu, Shire, and Alastair Battson Photography
Happy fall! The crisp New England air is now upon us - you can already smell the aroma of wood burning. As I wrote this, the Product Show was in full swing and as you may have read elsewhere in this newsletter, it was a very successful event! See below for a Product Show recap from the YP perspective plus comments on other recent events. After that we'll let you know what to expect for the next few months.
Our Annual Boston Harbor Cruise took place during the first week in September on a balmy summer night perfect for sailing the local waters. Sponsored by the YPs, the Harbor Cruise welcomes all Chapter Members and their guests, which numbered close to 50 people this year. Next year, we plan to schedule the event closer to the end of September so that our returning student chapter members can attend. Also, given the success of the joint ISPE/PDA educational event in September, we are looking into partnering with another local organization (such as the PDA) for a YP social event in 2016, which may just be the Harbor Cruise!
|The Boston skyline provided a magical backdrop for this year's harbor cruise.|
As always, the Product Show was a great event with lots of special activities for Young Professionals. This year's YP Networking Hour took place an hour before the Product Show ended and attracted a record turnout - a mix of students and young working professionals - with food, drink, a gift card raffle and live entertainment. We collected contact information so the attendees can be invited to join the Young Professionals Committee and become even more active in the future.
This year's Product Show Career Fair grew by leaps and bounds over prior years, with a grand total of 39 hiring companies on hand to chat with potential applicants. Both YPs and students took advantage of the opportunity to talk informally with hiring managers & learn what the industry has to offer new grads and YPs moving up the career ladder.
|YPs joined students & others at this year's highly successful Career Fair.|
On October 25, the Chapter took part in the 2015 Boston Kidney Walk presented by the National Kidney Foundation and the YPs played a lead role in that effort. Our team was called the "ISPE Nephronators" and we had a sizeable group participating. A "Champions for Charity" booth at the Product Show as well as a raffle at the Fall Social were used to raise awareness and donations for the event. All in all, the Chapter raised over $8,500 for the NKF and its efforts to eradicate kidney disease and promote organ donation. NKF is still taking donations, so help our team continue to raise funds by clicking here to donate .
|Chapter founder Tom Moss supported the ISPE Nephronators and the National Kidney Foundation with a donation at the Product Show's "Champions for Charity" pavilion.|
On November 12, there will be a dual track educational program held at Genzyme in Framingham with a focus on "soft" skills. The two-part program is geared for both Young Professionals/Students and also more seasoned members and has been designed to facilitate networking opportunities. The speaker for the YP event is Larry Elle who will discuss "Making Your First Job Change." His talk is intended to help young professionals understand what is needed to move beyond the entry level and take that first step up the industry career ladder. This will be a great opportunity for students and YPs to network with other Members. Who knows? They may even create connections leading to that first job change!
Last December the YPs tried a new type of event: a tour at a local microbrewery. Given the success of that event, we have decided to host another one during the first week of December and we are targeting Aeronaut Brewery in Somerville. The event will include a brewery tour as well as appetizers, networking, and of course a great craft beer selection. Keep an eye out for more information - this is one event you don't want to miss!
As you may have heard, a Chapter-wide Mentoring Program is currently in the works. This program will be designed to connect like-minded Young Professionals/students with seasoned Members in a year-long partnership that will help mentees achieve their career objectives. Details on the program are on the Chapter Bulletin Board section of the newsletter and is also posted on the Chapter website at http://www.ispeboston.org/mentoringdescription.html .
As always, we want to hear from you! If you have any suggestions or would like to attend one of the regularly scheduled YP meetings, please don't hesitate to reach out to me at firstname.lastname@example.org . Thank you for tuning in and I hope you all enjoy the rest of your fall season!
by Brian Hagopian, Clear Water Consulting, and Paige Kane, Pfizer with photos by Alastair Battson Photography
September was a busy month for our Student Chapters as many held organizational and recruiting meetings in advance of the Product Show, a wildly successful event for students. Funded buses transported about 200 students to the Show, one our signature events, where two "student specific" educational programs, the Career Fair and the student/YP social, made for a really exciting day.
The Product Show featured two "top tier" educational programs specifically for students this year. First, Laura Poisson from ClearRock Inc., a Boston-based executive coaching and outplacement firm, helped students understand how to network at the Product Show and touched on topics including elevator speeches, making good first impressions and body language. Laura's presentation was well received by those in attendance. Our second presentation featured Theresa McCarthy from Pfizer and Byron Mattingly from Pathfinder Software who provided an excellent introduction to Quality Systems, something that students typically don't study in college. Theresa and Byron are both deeply involved with the American Society for Quality (ASQ) and we were thrilled to have them speak to our students. Copies of these presentatios are available on the Product Show website, here: http://productshow.ispeboston.org/attendees/student-development-program/ .
|Students turned out in force for the Networking Workshop, then practiced their skills at the Career Fair.|
The Northeastern Student Chapter was highlighted during Chapter President H. Steven Kennedy's opening remarks as winner of the highly coveted "Student Chapter of the Year" award for their significant efforts and accomplishments over the last twelve months. There was a lot of buzz on campus with students and faculty after the Show about the best location to prominently display the ISPE award plaque. Congratulations to everyone at Northeastern!
Our two Student Poster Competition winners, D. Ezra Aurian-Blajeni (undergraduate winner) and Sydney Shaw (graduate winner) had the chance to display their posters and practice their presentations in advance of the upcoming competition at the ISPE Annual Meeting.
The Student Development Committee has been working on a promotional video to show students the benefits of joining ISPE. Interviews were filmed during the Product Show and we expect to have the video completed by Christmas. Thanks to the following Chapter leaders for their participation:
And lastly, the Chapter's current scholarship application period closed November 1. Awards of up to $2000 are available so hopefully you have submitted your online application for an excellent chance to receive funding to help with your education. And if you missed the November deadline, go ahead and submit your application now - it will be considered for the next round June 1. Full details and a link to the online application can be found on the Chapter website at https://scholarships.ispeboston.org/scholarships/ .
Page last updated: 6 January 2016