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After a Brutal Winter, the Sun Shines for the Spring Golf Outing

by Dan Kenny, Northeast Engineering

The Boston Area Chapter hosted the Second Annual Spring Golf Outing on May 11th at Ledgemont Country Club in Seekonk, MA and we couldn't have asked for a better day. With the sun shining and the temps in the 80°s, ISPE Members and guests from all over New England got together for a great day of golf and networking. As expected, the course was in amazing shape and the staff at Ledgemont bent over backwards to accommodate our every need.

Looking to improve on the buzz and success of last year's Spring Golf Outing, the Social Committee was able to do just that. With a full field this year, the day started with a hearty lunch buffet to make sure that no one went out on the course hungry. Once on the course, Past Presidents Dan Ramsey and Jim Grunwald set the pace by crushing the ball all over the course and making it difficult for others to keep up. While out on the course, the cheers of amazing shots and loud sighs of "almost-ins" were heard from the first hole to the last. As the last groups made it into the clubhouse, the stories got better and better and the laughs got louder and louder over a beverage on the back deck overlooking the gorgeous landscape of the course.


Chapter Members from all over New England enjoyed a great day of golf and networking.

Once the last groups reached the clubhouse, everyone made their way to the dining room where a fantastic buffet with a full carving station awaited the golfers and guests. After dinner was served, the awards took center stage. Awards were handed out for first, second and third place foursomes, longest drive (men/women), straightest drive (men/women), and closest to the pin (men/women). There was also a putting contest held along with a number of amazing raffle prizes. Congratulations to all the winners!

Winning Foursomes 

  • First - JC Cannistraro (Roland Oreste, Mike Johnson, Chris Kilday, Tom McCabe)
  • Second - RW Sullivan (Paul Sullivan, Dan Paquette, Mike Shreve, Bruce Durkee)
  • Third - Commissioning Agents (Jim Grunwald, Jerry Nadeau, Dan Ramsey, Geoff Wilkinson Jr.) 

Longest Drive 

  • Chris DePaula
  • Tiffany Hubanks 

Straightest Drive 

  • Dan Paquette
  • Suzanne Stuhler 

Closest to the Pin 

  • Dan Paquette
  • Tiffany Hubanks

To end the event, there was a 50/50 raffle, with proceeds going to the Jimmy Fund which solely supports Boston's Dana-Farber Cancer Institute, raising funds for adult and pediatric cancer care and research to improve the chances of survival for cancer patients around the world.

Beautiful weather greeted Chapter Members and guests at Ledgemont Country Club in Seekonk.

The Social Committee would like to thank everyone who attended and helped make the tournament a big success. And we would like to extend a special thank you to all of the sponsors who made this event possible. Your support is greatly appreciated! 

  • A/Z Corporation
  • Commissioning Agents
  • Crosspoint Engineering
  • JC Cannistraro
  • Jenson Hughes
  • New England Labs
  • Northeast Engineering
  • Sentrol
  • Siemens
  • Structure Tone
  • Superior Controls


“A Better Way to Deliver Fast-Track Projects” Draws Record Turnout at Biogen

by Cheryl Huie, DPS Engineering, and Jack Campion, The Hart Companies, with photos by Joyce Chiu, Shire

The educational program held on May 21st provided Chapter Members with some terrific insights into a topic most of us have experienced - Fast Track Projects. Meeting manager Cheryl Huie of DPS assembled an all-star panel consisting of representatives from operating companies, an engineering firm and a construction firm. Together they represented the cross-section of key project stakeholders. Panelists included: Rich Quinby, Biogen Associate Director of Global Project Engineering (Owner); Tony Mejido, Sanofi Capex Procurement Director North America (Procurement); Jim Busam, Gilbane Vice President National Client Team (Construction Manager); Cory Siddons, DPS Senior Project Manager (Designer); and Eric Felz, Shire Associate Director of C&Q (Commissioning & Validation). Jack Campion of The Hart Companies served as moderator.


Attendees and speakers had a chance to "meet and mingle" during
the networking reception.

Prior to the presentation, the group held a series of round tables which addressed questions such as: "How does a fast-track project differ from a non-fast-track one?", "What are the biggest concerns about delivering a fast-track project?", and "What can be done to minimize the impact if they occur?" What followed was a clear consensus on a few universal points, which was shared with the audience in an interactive format that allowed the audience to participate.


Panelists from operating companies, and engineering and construction firms represented a cross-section of key project stakeholders.

Some of the main points included:

  • Having the right people at the table - Always having the right stakeholders/decision-makers in the room for key discussions; "front-loading" the project with information from all stakeholders; and having the owner's commitment - at a sufficiently high level - to apply the internal resources to make the project happen.

  • "Before we go fast, we have to start slow" - For fast-track projects, planning is significantly more important. Decisions and financial commitments need to be locked down and made early in order to make tight schedules. If the project is not properly planned, rework, returns, and modifications to physical assets become very costly. Especially if changes are made in late-stage design, the cost in terms of re-engineering and extra time for approvals can significantly impact both the project schedule and the bottom line.

  • Prequalification of vendors, suppliers, contractors, etc., as well as engaging Commissioning & Qualification during planning will also have a positive impact on the timeline.

  • The Right Tools - Managing fast track projects can be challenging. Having tools such as Project Execution Plans, Collaboration Tools, Integrated Project Schedules, and BIM will help to guide the project through to success.

  • Stakeholder engagement was emphasized - as embodied by the makeup of the panel itself - and the importance of each stakeholder's understanding of her/his role.
A topic of wide interest and an interactive format prompted a healthy exchange between the panel and the audience.

During the presentation, there was a healthy exchange of thoughts between the panel and the audience. The interweaving thread throughout the program was the importance of creating a "culture of collaboration." In the end, all agreed that approaching the project as a unified team was the safest way to deliver a fast track project.

The Chapter would like to thank the panelists; and Biogen, which provided a terrific venue for the program at its headquarters in Weston, MA.


Panelists Provide Insight on Tech Transfer During June Program at Genzyme

by Jonathan Ly, Barry-Wehmiller Design Group, and Norline Crossdale-Walker, Genzyme, with photos by Joyce Chiu, Shire

The ISPE Boston Area Chapter educational program entitled "Tech Transfer: From Process Development to Product Manufacturing" was held on Thursday, June 18th at Genzyme Center in Cambridge. The program was planned and coordinated by Meeting Managers Jonathan Ly (Barry-Wehmiller Design Group), Zeke Johnston (AMAG Pharmaceuticals), Norline Crossdale-Walker (Genzyme), and Howard Sneider (CRB Consulting).

Following the traditional networking reception, the evening began with opening remarks by Boston Area Chapter President Christopher Opolski. The moderator for the event, Bhavi Mittal (Senior Scientist, Formulation Sciences - Takeda Pharmaceuticals), was introduced by Jonathan. He began the program with a comprehensive overview of the importance of technology transfer in the pharmaceutical industry. He described the industry's shift toward the outsourcing model in manufacturing, which has brought about new technical challenges as well as business practices that the guest speakers discussed at the event.


The atrium at Genzyme Center provides a striking welcome for Chapter Members.

Gary Mills (Associate Director, Drug Product Development - Momenta Pharmaceuticals) came to us with over 27 years of experience in tech transfer and the utilization of contract manufacturing organizations (CMOs) in the commercialization of drug products. He presented on strategies and tips in selecting CMOs and building relationships from the contract sponsor point of view. Gary revealed two levels of due diligence within the scope of evaluating the status and capabilities of CMOs. His presentation spelled out qualities and attributes that process/product owners often overlook.

Claudia Buser (Director, Cell Banking Development - Genzyme) followed Bhavi's introduction. As an expert in cell culture process development with over 20 years of experience, Claudia presented on high level approaches to Phase III bioprocess development. She touched on concepts in process characterization, scale down model qualification, and establishment of design space. Moving forward with these concepts, Claudia described the governance structure of an internal tech transfer that often applied to external cases as well. She offered an excellent perspective on the requirements for a successful tech transfer from the process development point of view.


Moderator Bhavi Mittal and speakers (l to r) Claudia Buser, Gary Mills and Joe Cobb provided a comprehensive snapshot of the concepts behind successful tech transfers.

Joe Cobb (Director, Pharmaceutical Development - Metrics Contract Services/Mayne Pharma US) spoke as a representative from the CMO side of the business. Joe utilized his 22 years of contract manufacturing experience to provide case studies and narratives from tech transfer projects that he had been involved with in the past. He provided informative insight on the issues CMOs would face and some of the lessons learned from those experiences.

After the last presentation, the three speakers joined Bhavi for an open panel discussion on tech transfer topics that were presented, as well as for Q&As. The audience participation was outstanding, with questions on how Quality by Design (QbD) played a role in the tech transfer.


Educational programs are collaborative efforts between the Chapter's Educational Program Committee and industry experts, in this case, Meeting Managers (l to r) Jonathan Ly, Howard Sneider, Zeke Johnston and Norline Crossdale-Walker and the program's moderator and guest speakers.

Overall, the presentations provided a comprehensive and diversified snapshot of the concepts behind successful tech transfers in the pharmaceutical industry. Having a different speaker from each perspective of the industry and a large and exceptionally engaged audience combined to generate a great number of discussion points for the panel and stimulated open dialogue during the Q&A. This experience opens the doors to new ideas for future educational programming.

The Boston Area Chapter and Meeting Managers would like to thank the panelists, moderator and audience members for their valuable contributions to this program. And we would like to thank Genzyme for collaborating with us once again in providing an excellent venue for this event.


Keeping Up With the YPs…

by Chris Ciampa, Thermo Fisher Scientific, with photo by Karima Erriahi, Thermo Fisher Scientific

Hello all! It has been quite some time since we last checked in, as I was hibernating. Now that spring is in full effect, I am back with some great opportunities the YPs are hosting! But first let me bring you up to date, in case you missed our spring activities. YPs gathered in April at Sacco's Bowl Haven in Somerville for flatbread pizza and candlepin bowling (see companion article). And in early June, 50 Chapter Members had the opportunity to get out to the Fenway area for a meet up at "Who's on First" followed by a chance to see our beloved Red Sox take on the Minnesota Twins. Boston, fifth in the AL East at the time, won the game 1-0!


YPs cheered the Sox to a win over the Twins at Fenway in June.

During the summer months, YP events will enter a lull period as many folks will be traveling and planning their vacations. We are planning only one event during that time: a Pub crawl. Date and details are yet to be finalized, so please stay tuned!

The annual Boston Harbor cruise, our flagship YP event, is going to happen in early September. This is typically the biggest YP event of the year (other than the Product Show) and is a great opportunity for YPs and other Chapter Members to network and socialize. This is a fun event not to be missed - hope to see you there! And speaking of the Product Show, as always the YPs will be spearheading a number of activities designed just for us and our Student Members. Lastly, an educational session is being planned for late fall. It will focus on the "soft skills" needed to help YPs make their first big career move following their first entry level jobs. The date and details will be finalized in the coming months.

There is a lot happening with the YP organization at the international level, too. The Boston Area Chapter YPs participate in a monthly YP conference call for the purpose of sharing events best practices, etc. Our Chapter is known as one of the more active Chapters where YPs are concerned, with many fun events planned throughout the year. As Governor John Winthrop said when describing Boston in 1630: "as a city upon a hill, the eyes of all people are upon us," thus the Boston Area Chapter is a shining example in the ISPE organization! There is also a Community of Practice (COP) designed solely for YPs. Also, in the ISPEAK blog, a few YPs have had the opportunity to share their stories, including Boston Area Chapter YP Member Peter Trearchis from Pfizer. You can see the interview at  http://blog.ispe.org/?p=2225

As always, we want to hear from you! If you have any suggestions, or would like to attend one of the regularly scheduled YP committee meetings, please don't hesitate to reach out to me or Jared Marshall. Thank you for tuning in and see you at an event soon!


Young Professionals and Students Enjoy Bowling and Flatbread Pizza

by Christopher Ciampa, Thermo Fisher Scientific, and Lucas Wafer, Pfizer

On Thursday, April 30th, Boston Area Chapter Members gathered at Sacco Bowling/Flatbread Company in Davis Square. This venue has been a staple in the Somerville community ever since the Sacco family opened the bowling alley back in 1939. The venue is a mix of two companies: the Flatbread Company is known for delicious organic, nitrate-free pizzas and Sacco Bowling is the famous candlepin bowling alley. Flatbread's came into the picture around the late 1990s/early 2000s and offered pizza made with earth and fire (that is, in stone-based ovens). Flatbread's has since integrated its Somerville operations with Sacco Bowling to be able to offer the combination of pizza and bowling to the Somerville community.


Chapter President Chris Opolski and VP Steve Kennedy joined YPs and students
at Sacco's Bowl Haven in April.

The April event drew quite a crowd with approximately 40 attendees, including many Young Professionals, the Chapter President himself, Chris Opolski, and Chapter Vice President Steve Kennedy. Student Members were provided free access to the event as part of their student membership, which also includes free attendance at the Chapter's educational programs. A few ISPE members from New Hampshire even made the trek to the social!

The event started with a networking session from 6-7pm that included unlimited pizza and salad. Folks also had the opportunity to sample hand-crafted, local beers, as Flatbreads keeps an excellent selection on tap. Aftewards, YP members had the opportunity to test out their bowling skills. Folks had a blast playing candlepin, many of whom even got strikes and spares!

All in all, a great time was had by the Members that attended. This is an event we will be sure to host again in the following years since it was a hit!

Page last updated: 15 September 2015