Engineering Pharmaceutical Innovation

In This Issue Page 1 ▪ President’s Address Page 2 ▪ Outgoing President’s Message ▪ 2007-08 Board of Directors Page 3 ▪ 2007 Annual Golf Tournament ▪ “The Industrialization of Drug Discovery” Page 4 ▪ “The End of Validation As We Know It” Page 5 ▪ Welcome New Members Page 6 ▪ BioPharma 2008 Page 7 ▪ New England Chapter Sponsorship Opportunities Page 8 ▪ NE ISPE Call for Articles!

ISPE New England Chapter 77 Rumford Avenue, Suite 3B Waltham, MA 02453 As of 11/16/07 411 Waverley Oaks Road, Suite 331B Waltham, MA 02452

Fall, 2007

President’s Address Dear New England Chapter Members, I am honored to have been elected President of the New England Chapter of the ISPE for the 2007-2008 year. Thank you and I look forward to serving you to the best of my ability. First, I would like to thank the immediate past President, Mark Sitcoske, the members of last year’s board and the rest of the chapter volunteers for their hard work in continuing to make the chapter a success. As always, we are looking to improve our services to our membership. After reaching the territory agreement with the Boston Chapter last year, we have restructured our programs to better serve our area. We will now have chapter meetings and networking events in all of our four main regions: • • • •

Eastern: Eastern Connecticut and Rhode Island Central: Central Connecticut Western: Western Connecticut and Southeastern New York Northwestern: Albany, New York and Western Massachusetts

Please keep a lookout on our website www.ispe.org/newengland for our Upcoming Events. This year, we are expanding our successful brew pub networking events. For the past two years, we have had the October networking event in Providence, RI. This year, we are expanding this idea to all four of our regions. We also continue to expand our Student Chapters and student services. Our newest Student Chapter was chartered at the University of Massachusetts Dartmouth. Congratulations to everyone involved! We are also planning to hold another “student night” this year where our student chapter members get a dedicated tour of a facility in our area. Finally, I would like to encourage you to get involved with the Chapter. Volunteers bring energy and new ideas to the organization and, I believe, get much more out of ISPE than passive members. If you are interested in getting involved, please contact our volunteer coordinator, Gene Lambert, at [email protected]. Positions are available in the following committees: Programs, Owner, Vendor, Communications, Student Chapter and Membership. Once again, thank you and I look forward to another great year!

Chapter Manager Eileen Healy Phone: 866-505-ISPE (4773) Email: [email protected] www.ispe.org/newengland

Best Regards, Tulsa Scott President, ISPE New England Chapter

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Engineering Pharmaceutical Innovation

Fall, 2007

Lasting Impressions! Dear New England Chapter Members, My year long goals of Increased Membership, Better Membership Participation, and Great Volunteer Support have been realized. We rank among the top 3 of all ISPE Chapters for membership growth and retention. We have had record turnouts for our programs, and our new slate of board members shows an increase to 16 members. In addition to these benefits for the chapter we have made some historic strides to put the Chapter on sound footing moving forward. We reached an agreement with the Boston Chapter on our respective territories which will end some of the confusion that has occurred. We have also changed chapter managers to CAMI with Eileen Healy as our new Chapter Manager. This move will be a very positive move and will bring a level of professionalism and experience for our Chapter. This move alone will ensure the Chapter continued strong growth. As a volunteer you don’t go into it with the hope of getting a pat on the back, you do it to give back to your industry and to try to make the industry and your personal level of knowledge and experience better. My motto has been and will always be “if the industry grows I will grow”. I urge you to become active with your Chapter as I have been and it will pay dividends for your career for many years to come. Thank you for the opportunity to serve you this year. My best personal regards, Mark Sitcoske Past President ISPE New England Chapter

ISPE New England Chapter 2007-2008 Board of Directors Congratulations to the newly-elected Board! President Tulsa Scott Commissioning Agents Vice President Tony Rao Stantec Treasurer Marc Estra, PE Bristol-Myers Squibb Co Secretary Peter Fox Cascade Controls Directors David Barkin JCJ Architecture

Eugene Lambert Wunderlich-Malec Engineering Inc.

Jim Stout Amgen, Inc.

Tanya Bottaro Steris Corp.

Tom Mueller University of Rhode Island

Kenneth White Pfizer Inc

Matthew Dorf Freudenberg Building Systems

Steven Neveu, PE Notch Mechanical Constructors

Dale Farrell Hart Design Group

Russell Parry CM Services East, LLC

Ann Williams Applied Engineering Controls – AEC

Megan Gebhardt Pfizer, Inc.

Jim Rich Alexion, Inc.

Gary Knight Commissioning Agents, Inc.

Jonathan Savona Accuspec Inc

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Jonathan Woods MannKind Corp. Immediate Past President Mark Sitcoske High Purity New England

ISPE New England Chapter Newsletter

Fall, 2007

What’s been going on with the New England Chapter? NE ISPE’s 2007 Golf Tournament is a Hole-in-One! A great time was had by all at the 17th Annual New England ISPE Golf Tournament with a first ever Hole in One. Robert McDonough, Biokinetics, Inc. hit his winner on the par 3, 185 yard hole. Bob’s hole in one was recorded and he will win private jet service. Congratulations, Bob! This year, with the help of many people, we sold out the tournament and enjoyed a beautiful day at the Sterling Country Club in Sterling, MA. We would like to take the time to recognize Dale Farrell and Russ Parry for their unselfish efforts to make this year’s tournament a great success. Please mark your calendar now for our 18th Annual Golf Tournament, July 15th 2008! Hole in One!!

Another beautiful day at Sterling Country Club

“The Industrialization of Drug Discovery” Presentation and Tour at Bristol-Myers Squibb On May 24, 2007 the ISPE New England Chapter held a meeting with a tour at the Bristol-Myers Squibb Wallingford, CT facility. The topic of the presentation was “The Industrialization of Drug Discovery”. Dr. James Myslik, PhD. presented to the group and then led the attendees on a tour of the Bristol-Myers Squibb High Throughput Screening and Compound Storage areas of the facility.

a more finely tuned, logistics-based organizational culture similar to a productionscale operation. Drug discovery can and is learning from the experiences of other industries that have optimized their operations. The automotive industry and silicon chip producers are excellent examples of a versatile approach to manufacturing that relies on modular robotic systems, high-speed parallel processing, and a highly integrated control system. Adopting this approach, and adapting it to meet the specific demands of drug discovery and development, will result in a drug discovery “factory” that can produce quality, novel drug candidates on a unprecedented scale.

Advances in drug discovery technology have led to significant progress in accelerating drug target identification, lead generation, lead optimization, and the development of clinical drug candidates. Some of these advances are realized through the industrialization of the “art” of drug discovery. The growth in the fields of computer hardware and software, automation technology, complex data management systems and miniaturization strategies has been facilitating this paradigm at Bristol-Myers Squibb research centers. The robots, analyzers, and other instrumentation must be capable of operating 24 hours/day for weeks at a time, with minimal, scheduled off-line time for maintenance and repairs. Flexibility and responsiveness must be built into the initial design and construction of the process and the systems should be able to quickly accommodate novel assay formats and new technologies.

Dr. James Myslik is Associate Director of Discovery Automation at Bristol-Myers Squibb’s R&D division. His department automates drug discovery processes, develops novel scientific apparatus and maintains large-scale robot equipment utilized within Drug Discovery. Jim has a PhD. in Chemistry from Princeton University where he trained as an Xray crystallographer under Prof. C.E. Schutt. He was a founding scientist of 3-Dimensional Pharmaceuticals, Inc., a structure-based drug design company now part of Johnson & Johnson, and has worked at Bristol-Myers Squibb since 2000.

For drug discovery to meet the demands of the 21st century, to produce safe, high quality, and targeted new drugs that address unmet market needs and are tailored to the growing knowledge base of human genetic variation, a restructuring of the drug discovery process has been evolving. This change represents a shift from scientific inquiry of a research facility, to

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ISPE New England Chapter Newsletter

Fall, 2007

“The End of Validation As We Know It” A Science and Risk Based Approach to Commissioning and Qualification On June 19, 2007, the first ever joint program by the New England Chapter of ISPE and the Boston Chapter of ISPE was held at the Beechwood Hotel and Conference Center in Worcester, MA. The program featured keynote speaker Dave Petko, who is currently assigned to the construction of Johnson & Johnson’s combination products plants for its Cordis affiliate in Europe. During the meeting you could hear a pin drop as the industry received cutting edge information about the coming changes regarding validation and commissioning. This joint program was sold out, with many staying until 9:30pm. Mr. Petko will be making some return appearances in New England to provide more information regarding the new ASTM 2500 standard. The program, hosted by both Chapters, was managed by David MacDonald of Avecia Biotechnology and Mark Sitcoske of High Purity New England, Inc.

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Mark Sitcoske, Dave Petko, David MacDonald

ISPE New England Chapter Newsletter

Fall, 2007

WELCOME NEW MEMBERS! Mr. Eric K. Anderson

Mr. Nathan Dulac

Mrs. Cheryl A. Hayward, PMP

Val Eng Technologist Wyeth BioPharma

Process Engineer II Genzyme

Manager Amgen, Inc.

Dr. Stephen M. Antonelli

Mr. Paul M. Favreau

Kurt Hogan

Manager, Pharmaceutical Development Microbia, Inc.

Mr. John Bender

Analyst Community College of Rhode Island

Dr. Peter J. Bonk

Instru. & Cal. Supervisor Mylan Technologies Inc

Ms. Christine J. Feulner

Student Worcester Polytechnic Institute

Ms. Mary E. Fisher

Asst. Director Process R&D Rhodes Technologies

Clinical Supplies Coordinator Boehringer Ingelheim Pharmaceuticals Inc

Mr. Jeffrey G. Brimmer

Mr. Michael C. Frank

Validation Analyst MannKind Corporation

Validation Specialist Commissioning Agents

Dr. Ralf M. Bueschges Boehringer Ingelheim Pharmaceuticals, Inc.

Mr. John P. Clark

Facilities Engineer Rhodes Technologies

Dr. Thomas P. Garcia Research Fellow Pfizer Inc.

Wyeth BioPharma

Mr. Louis E. Horton Project Engineer Wyeth

Ms. Niloufar Khyamian

Student University of New Hampshire

Eric S. Langer Managing Partner BioPlan Associates, Inc.

Mr. Jeffrey H. Mason

Manufacturing Manager Lonza Biologics

Andy Matthiesen

Ms. Maninder K. Gill

Graduate Student University of New Hampshire

Executive Director American Red Cross

Mr. Jason McKinley

Peter Day

Mr. Earnest P. Grenier

Clinical Supply Project Manager Pfizer

APECS Engineering Corporation

Product Manager Massachusetts Biologic Laboratories

Dr. Jin Montclare

Mr. Giovanni A. De Dona Product Manager Mettler-Toledo Thornton

Mr. David M. Haynes

Assoc. Dir. Facility Mgmt. Regeneron Pharmaceuticals, Inc.

Mr. Antone J. DeBettencourt

Professor Polytechnic University

Ms. Shelly M. Moore

Senior Quality Engineer Covidien

Senior Associate Scientist Pfizer Inc

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ISPE New England Chapter Newsletter

Fall, 2007

WELCOME NEW MEMBERS! CONT’D Mr. Daniel C. Ostravage

Quality Assurance Associate Mannkind Corporation

Mr. F. Manny Rodrigues Principal CRC Consulting, LLC

Mr. Martin D. Ruse

Senior Product Manager ITT

Mr. John C. Scheidel, P.E.

VP, Critical Environments Division Controlled Environment Structures Inc.

Sudheer Solipuram

Mr. Marc F. St Germain

Project Manager Water Consulting Specialists Inc.

Alon Vaisman

Project Engineer Malvern Instruments

Computer Validation Eng Propharma Group

Ms. Kimberly E. Vukovinsky

Mr. Alan P. Souza

Director, Statistics Pfizer Inc

Software Quality Manager United Automation

Why should your company exhibit at New England BioPharma 2008? New England BioPharma 2008 promises to be a valuable day for your company! The show will feature over 300 attendees, 4 educational tracks, and a keynote presentation by Dr. Paul McKenzie, Site Director, Bristol-Myers Squibb Co.

What do I get with my booth registration? The cost of one booth ($850 for returning vendors, $1000 for new vendors) includes one box lunch, one 6 foot table for your table top display, electricity, one chair, and one dinner ticket. There is no charge for Trade Show admission, educational seminar admission, or networking reception.

BioPharma 2008 Schedule 12:30pm 1:00pm 5:00pm 6:00pm

Trade Show Begins Education Tracks Begin Networking Reception Dinner

Reserve your booth today! Registration deadline is December 31, 2007. Click here for a registration form Send a completed vendor registration form with payment to: ISPE New England Chapter, 77 Rumford Avenue, Suite 3B, Waltham, MA 02453 **Booths will not be reserved until payment is received!** For more information contact Eileen Healy, 866-505-4773, [email protected] www.ispe.org/newengland

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ISPE New England Chapter Newsletter

Fall, 2007

Become a New England Chapter Sponsor for 2007-2008! Looking to get your company name in front of the New England Chapter for 2007-2008? Purchase a BioPharma 2008 booth ($1000/ booth, $150 discount for returning vendors) and sign on as a 2008 Golf Tournament Sponsor at the same time. Your company will be entitled to a free business card size ad, or a ½ price larger ad, in the 2007-2008 New England Chapter Newsletter! The 2008 tournament is scheduled for July 15, 2008 at Sterling Country Club, Sterling MA. Our Annual Golf Tournament is consistently a Sold Out Event! Don’t miss this opportunity! Golf Sponsorship Opportunities: Tee Sign $250 Continental Breakfast $500 Hole in One $500 Longest Drive Male $200 Longest Drive Female $200 Closest to Pin Male $200 Closest to Pin Female $200 First Place Team $600 2nd Place Team $400 3rd Place Team $200

If you are interested in taking advantage of this Sponsorship Package opportunity, please contact Eileen Healy, Chapter Manager at 866-505-4773, or [email protected].

Advertise in the ISPE New England Chapter Newsletter 2007-2008 Rates Business card (3 ½ x 2”) Quarter page (3 ½ x 5”) Half Page (7 x 5”) Full page (7 x 10”)

$150 $250 $400 $600

All ads must be camera ready. Newsletter staff reserves the right to approve, edit or decline any submission as may be necessary. Mail ads with check payable to ISPE NE Chapter to: ISPE NE Chapter 77 Rumford Avenue, Suite 3B Waltham, MA 02453

The ISPE New England Chapter Newsletter is published quarterly and distributed electronically to all NE ISPE Members.

Newsletter Schedule:

January, 2008 (ad deadline 1/4/2008) April, 2008 (ad deadline 4/4/2008) July, 2008 (ad deadline 7/7/2008 October, 2008 (ad deadline 10/3/2008) Questions? Email [email protected] or call 866-505-4773

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ISPE New England Chapter Newsletter

Fall, 2007

ISPE New England Chapter Call for Articles! The ISPE New England Chapter Communications Committee is currently seeking articles for future New England Chapter Newsletter editions. Articles may feature industry updates, technical reports, or hot topics in the industry. Do you have an article you’d like to share? Contact Ann Williams, Communications Chair, at [email protected], or Eileen Healy, Chapter Manager at [email protected], 866-505-4773.

Our Office is Moving! Please Note ISPE New England Chapter’s new address as of November 16th: 411 Waverley Oaks Road, Suite 331B Waltham, MA 02452 Please update your records. Our phone number and email address will remain the same.

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