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Happy New Year!
President's Message
By Tom Golden, Unbound Consulting
Happy New Year! Hello, I'm Tom Golden, your ISPE LA Chapter President from
September 2014 until August 2015.
I am looking forward to our Chapter events and serving the Chapter with the
goals of increasing our membership's Life Sciences knowledge as well as
increasing our overall membership.
Here's a quick biography. I grew up in Wilmington, DE, the son of a steam fitter. I have a Bachelor of
Science in Mechanical Engineering (BSME) from the University of Delaware, an MBA in International
Business from St Joseph's University, an Executive MBA. I also have a post graduate of an Independent
Study with a residency in Dublin, Ireland that focused on Global Strategies of Pharmaceutical and
Healthcare Marketing from St. Joseph's University.
My roots are with General Electric's Nuclear and Aerospace Divisions. I am a Field Engineer graduate
from San Jose, CA where I was introduced to Life Sciences Industry in 1992 working on Puerto Rico's Eli
Lilly PR3 Project.
Through my vast job tasks and attendance at ISPE meetings, I have met a spectrum of Life Sciences
Individuals that have motivated me to expand my horizons in this industry.
I have broadened my knowledge of the industry from working with the following companies: Warner
Lambert, Wyeth, Sanofi Pasteur, Shein, Merck, and Human Genome Sciences.
In 1998 I worked at Alza in Palo Alto and Mountain View. The following year, the same year I met my wife
Susan, I worked at Baxter in Thousand Oaks. Since this period I have work at Alpha Therapeutics in Los
Angeles, Genetics institute in Andover, MA, Amgen in Thousand Oaks and Fremont, Aventis in Kankakee,
Il, Taiwan Vaccines in Tapia and Kaesong Taiwain, TEVA pharmaceuticals in Irvine, Novo Nordisk in
Haywood, Irvine Pharmaceuticals/Avrio in Irvine, Neutrogena in LA, as well as Baxter in Los Angeles.
My personal hobbies include baseball, fishing, and golf. The reason I moved to California, other than for
my wife, is to have five baseball teams, increasing my chances of winning the World Series (go Giants!).
I have zero sick days since I have been in this industry, trying to duplicate Cal Ripken's record.
Congratulations to the MVP members Clayton Kershaw (CY Young) of the LA Dodgers and Mike Trout of
the LA Angels.
Please attend our ISPE LA Chapter events to increase your industry knowledge. Also I give my
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Save These Dates!
All ISPE California
Events Featured in
Emails
2015 Working
Calendar
(subject to change)
21 January 2015
ISPE LA Chapter
Particle Monitoring
Systems for
Pharmaceutical
Manufacturing Guidance
at Grifols
28 January 2015
ISPE San Francisco
Chapter CEO Night at
South San Francisco
Conference Center
30 January 2015
ISPE San Diego and LA
Chapter Joint Temecula
Winery Tour
26 February 2015
ISPE San Diego
Chapter Electrical
Utilities and Water
Infrastructure
10 February 2015
ISPE San Francisco
Chapter Commuter
Conference
Obsolescence of
Automation Systems at
Boehringer Ingelheim
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congratulations to all the ISPE LA Chapter Members who are MVPs to me.
Sincerely,
Tom Golden
ISPE LA President
See Business Card Ad
See Business Card Ad See Business Card Ad
Join us for our next meeting
Particle Monitoring Systems
for Pharmaceutical Manufacturing Guidance
Wednesday, January 21, 2015
3:30 6:30 pm
Speaker:
Peter Maguire, Application Sales Manager, Lighthouse Worldwide Solutions
Program Manager:
Merritt Postma, Regional Sales Manager, IMA Life North America Inc.
Richard Ramirez, Director Facilities Engineering & Maintenance, Grifols Biologicals Inc.
Location:
Grifols Biologicals Inc.
2410 Lillyvale Ave., Los Angeles, CA 90032
This presentation will cover the regulations and guidelines regarding monitoring of critical
pharmaceutical manufacturing environments with emphasis on aseptic manufacturing. Topics such as
Risk Assessment for sample location selection and proper installation techniques will be covered.
Register today by clicking on the link below:
http://www.atdevents.net/register.php
Click here to download the event flyer
18 February 2015
ISPE LA Chapter
Program Energy
Efficiency, Title 24
at SCE Energy
Educational Center in
Irwindale
12 March 2015
ISPE San Francisco
Chapter Vendor Night
and Student Poster
Contest at South San
Francisco Conference
Center
18 March 2015
ISPE LA Chapter
Program TBD
19 March 2015
ISPE San Diego
Chapter Who's Coming,
Who's Going in San
Diego
2 April 2015
ISPE San Diego
Chapter Networking
Bowling Event
8 April 2015
ISPE LA Chapter
Program at Keck
Graduate Institute
23 April 2015
ISPE San Francisco
Chapter Joint Lunch
Meeting with DBIA
(DesignBuild Institute of
America) at Marriott SF
Union Square
1 May 2015
ISPE San Diego
Spring Golf Tournament
La Costa
23 May 2015
ISPE San Francisco
Chapter The Relay
7 May 2015
ISPE LA Chapter
Vendor Night
at The Loft in Long
Beach
19 May 2015
ISPE San Francisco
Chapter
Commuter Conference
Project Execution and
Delivery
18 June 2015
ISPE San Francisco
Chapter Facility Tour for
Members Only
24 June 2015
ISPE LA Chapter Joint
Meeting with LCI
25 June 2015
ISPE San Diego
Chapter CEO Night
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President Tom Golden (on the right) waking
early in the morning for the 5K walk/run.
ISPE Membership Who We are
A report from the Chapter's Membership Chair
by Margaret Stava of Laboratory Equipment Co.
ISPE provides professional development and networking opportunities for everyone with an interest in
supporting and growing the pharma and biotechnology industries. Our Members are top influencers
within their respective areas of expertise. ISPE provides tremendous value through various professional
development opportunities that include ongoing education and training programs (including online
classes), the ability to stay current on the latest industry trends on a worldwide basis, working with the
FDA to develop Baseline® Pharmaceutical Engineering Guides, articles, career opportunities and ISPE
Communities of Practice (COPs.)
The ISPE Greater Los Angeles Area Chapter was founded in 1995 and is made up of biotechnology,
pharmaceutical, generic drug, contract manufacturing companies and Student Chapters at local
universities, as well as supporting industry professionals from architectural, engineering and construction
firms, government agencies, universities, equipment manufacturers, and suppliers. Individual functions
within these companies include production/manufacturing, project/facility maintenance engineering,
QA/QC, process development, microbiology, regulatory affairs, research, training, materials management,
purchasing, and corporate and product management.
Our Chapter offers affordable, very highquality programs so that our Members can remain at the top of
their game while meeting others in our industry. We also have fun!
We look forward to an exciting 2015.
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In November the Chapter celebrated their 20 year anniversary honoring Past Presidents. The evening
started with each guest being greeted with a celebratory glass of champagne.
A Lifetime Achievement Award given to Paul Crissman of Biotechnical Solutions who was one of the
Chapter's first Presidents and who has been involved
with the Chapter since its inception. Paul is currently
the Chapter's Program Chair delivering some popular
technical programs and well received industry
updates. The award was given to Paul by David Sisto
of Purity Systems, the Chapter's first President.
Former President John Clapham of PSC Biotech
surprised the group of Past Presidents with a plaque
with all Past Presidents listed and lots of empty spots
for future Presidents.
The event was held in honor of Ken Balmer of Cal
Chem Corp, who passed away several years ago.
Ken was chiefly responsible for starting the LA
Chapter.
Thank you to our speakers (below):
Timothy Culbreth, North American COO, PolyPeptide
Laboratories, Inc. presented "Current State and
Challenges in the Pharmaceutical Industry Impacts,
Activities and Actions to Keep You Prepared"
Emilio Rivera, Vice President of Engineering and
Oversees Facilities Operations, Corporate
Engineering, Capital Projects, and Global Real
Estate, Amgen Inc. and Member ISPE International
Leadership Forum presented "Perspectives On Next
Generation Biomanufacturing"
The event are subsidized by the following sponsors.
Thank you for your support:
Cornerstone Flooring
DPR Construction
Hyde Engineering + Consulting
The Program Managers (above) for the event were:
Paul Crissman, Biotechnical Solutions
Richard Ramirez, Director Facilities Engineering & Maintenance, Grifols Biologicals Inc.
Photos from October Meeting
Improving Robustness and Streamlining Project Delivery
Through Science and RiskBased Commissioning and Qualification
by Kimberly Syre, Chapter Manager
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In October the Chapter had a technical program featuring the following speakers:
Phil Bowles, Director Engineering, Amgen Inc.
Robert Chew, President, Commissioning Agents Inc.
Rick Kramer, President, CPFS
Thank you to Dona Tseng and Chester Zalaya from Baxter for hosting this meeting and to Paul Crissman
of Biotechnical Solutions for organizing the technical session.
Member Company Updates
by Margaret Stava of Laboratory Equipment Company
Actavis plc and Allergan, Inc. announced oi November that they have entered into a definitive
agreement under which Actavis will acquire Allergan for a combination of $129.22 in cash and
0.3683 Actavis shares for each share of Allergan common stock. Based on the closing price
of Actavis shares on November 14, 2014, the transaction is valued at approximately $66 billion,
or $219 per Allergan share. The combination will create one of the top 10 global pharmaceutical
companies by sales revenue, with combined annual pro forma revenues of more than $23 billion
anticipated in 2015. The transaction has been unanimously approved by the Boards of Directors
of Actavis and Allergan, and is supported by the management teams of both companies.
Kite Pharma, Inc., a clinicalstage biopharmaceutical company focused on developing engineered
autologous T cell therapy (eACT™) products for the treatment of cancer will presentations
information on KTEC19, the Company's most advanced product candidate at the 56th American
Society of Hematology (ASH) Annual Meeting in San Francisco, California, December 69, 2014.
KTEC19 is an antiCD19 chimeric antigen receptor (CAR) T cell therapy that involves genetically
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modifying a patient's T cells to express a CAR designed to target CD19, a protein expressed on
the cell surface of B cell lymphomas and leukemias. One of the presentations will be "Curative
Potential of Cell Transfer Therapy for Cancer." Kite also announced December 1, 2014 that it has
filed a registration statement on Form S1 with the U.S. Securities and Exchange Commission
(SEC) relating to a proposed followon public offering of shares of its common stock. All shares of
common stock to be sold in the offering will be offered by Kite.
Capricor Therapeutics, Inc., a biotechnology company focused on developing novel therapeutics
for the treatment of cardiovascular diseases, announced at the American Heart Association's
Annual Scientific Sessions November 17 2014, the oneyear results of the Phase
I ALLSTAR (Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration) clinical trial, which
indicate that intracoronary injection of allogeneic cardiospherederived stem cells (CAP1002) to
achieve myocardial regeneration in patients with leftventricular dysfunction who have had an
anterior myocardial infarction appears to be safe, with no deaths, no acute myocarditis and no
major adverse cardiac events.
Amgen and British drugmaker AstraZeneca announced that their Phase III trial of psoriasis drug
brodalumab met its primary endpoints when compared with both Stelara (ustekinumab) and a
placebo at week 12 when tested on more than 1,800 patients with moderatetosevere
psoriasis.C3 Jian, Inc., a private company focused on developing proprietary drugs with an initial
focus on improving oral healthcare closed their Series D financing raising total proceeds of $60.5
million. 3Jian has successfully completed the initial Phase 2 Clinical Trial for its novel drug,
C16G2. The Company's drug targets the specific elimination of Streptococcus mutans, the acid
producing bacterium associated with dental caries or tooth decay.
Photos from September Golf Tournament
by Kimberly Syre, Chapter Manager
This year's annual Golf Tournament was by far the best tournament the Chapter has ever offered. The
event was held this year at Coyote Hills Golf Course in Fullerton.
Some of the elements making the event more fun this year included an ice cream cart filled with unique all
natural flavors sponsored by Laboratory Equipment Company and a bloody mary bar sponsored by
Murray Company both conveniently stationed near the club house. On the course the players enjoyed
sponsored holes by the following companies:
Cannon Building served drinks and snacks
CRB served drinks and had fun games with prizes
LA Valves and Automation (LAVA) who created laminated golf bag/luggage tags
ProPharma Group who always has fun chipping games and snacks for the players
Other sponsors were:
Attention To Detail hole and snack sponsor
Doe & Ingalls (a division of Thermo Fisher Scientific) hole sponsor
DPR Construction dedicated hole sponsor
Matthew Atwong hole sponsor
Stonhard, Inc. dedicated hole sponsor
We would like to thank all of our sponsors and the players as well as Tom Golden for raffle prize
donations and Laboratory Equipment Company/Bahnson for golf towels.
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Photos from September Aseptic Processing Meeting
by Kimberly Syre, Chapter Manager
DPR Construction hosted a meeting in September on Aseptic Processing. The meeting was organized by
Justin Cantor of PSC Biotech and Merritt Postma of IMA Life North America Inc.
Speakers included:
Sterling Kline RA, Vice President of Design, IPS
Justin Cantor, Director, PSC Biotech
Frank DeMarco, Product Manager, Freeze Dryers, US, IMA Life
Elizabeth "Lisa" J. Dorn, PE, Associate CRB Consulting Engineers
Jessica Frantz, Field Marketing Mgr, Biotech Aseptic Transfer Technology, Sartorius Stedim
Richard Ramirez, Director of Facilities, Engineering and Maintenance, Grifols Biologicals Inc.
Thank you to our sponsors:
Bausch + Stroebel Machine Co Inc.
DPR Construction
SKAN US Inc.
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· Information Systems
· Product Development and Production Systems
· Regulatory Compliance and Quality Systems
Quality initiatives, case studies, benchmarking data and technical solutions for all educations levels are
encouraged.
If you have any questions, please contact Marianne Bock at mbock@ispe.org.
Welcome New Members from 2014
Lee Aptaker, SW Regional Manager, ABEC
Timur Atalay, Sr. Mechanical Engineer, Amway Corp
Aniqa Azad, Student, University of CaliforniaIrvine
Vikram Babu, University of CaliforniaIrvine
Stewart Bailey, Project Manager, Zenith Technologies
Eleonora Bellissimi, Grifols Diagnostic Solutions
Paul Bemis, Senior Manager, QA, Par Pharmaceuticals
Victorio Bracamontes, Engineer II, Baxter Healthcare Corporation
Edward Burton, Regional Leader Science & Technology, HOK
Ronald Bush, Director, Design Group Facility Solutions
Margaret Cai, Assoc Director, QA, Gilead Sciences, Inc.
Gilbert Cervantes, Senior Engineer, Validation, Par Pharmaceutical
Anju Chatterji, Grifols Diagnostic Solutions
Margaret Choi, Sr. Project Manager, Par Pharmaceuticals
Walter Cholawsky
Bianca Christensen, Student, University of CaliforniaIrvine
Phillip Curtis, Manager Planning & Scheduling, Baxter
Joseph DeGraff, Manager, Customer Projects, Siegfried Irvine
Rika DeVore, Baxter Healthcare Corporation
Kevin Dizon, Consultant
Tom Doan, Quality Systems Manager, Masimo Corp.
Xuan Doan, Validation Engineer II, Gilead Sciences, Inc
Valentin Doering, Senior PM, IPS Integrated Project Services
Luke Dorsett, Director, Engineering, Pharmavite, LLC
Scott Dunckley, Director, Manufacturing, Teva Pharmaceuticals
Gul Dusi, DPR Construction
Anne Ephraim, Director Regulatory Compliance, Pharm Sector, Johnson & Johnson
Chris Eskridge, Project Manager, Vertical Construction
Robert Figel
Sabrina Frazier, Doc Specialist, Endologix
John Gagel, Business Development Specialist, Evoqua Water Technologies LLC
Tatiana Galushkina, University of CaliforniaLos Angeles
Javier Garcia, Student, Moorpark College
Susan Ginsberg, Director, Manufacturing Technology, B. Braun Medical, Inc.
Veronica Gusti, Student, University of CaliforniaRiverside
Allison Hamoy, Student, University of California, Irvine
Louie Hernandez, Hathaway Dinwiddie Construction
Ryan Hernandez, Manufacturing Supervisor, Baxter Healthcare Corp
Sara Herrmann, Graduate Student, Keck Graduate Institute
Alex Ho, Student, University of CaliforniaIrvine
Donald Hodgson, President, HBT Labs
Mark Holt, Amgen Inc
Trinh Im
Ursula Johns, Burkert Fluid Control Systems
Lance Kasaback, Hathaway Dinwiddie Construction
Elizabeth Kelly, Associate Director, QA, Agensys
Dae Jin Kim, Engineer, Baxter Healthcare
Max Knipper, Automation Engineer, NNE Pharmaplan
Kazuya Koda, Specialist, Gilead Sciences, Inc.
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Dipakkumar Kothiya, Cosmetic Laboratories of America
Diego Laboy, Process Engineer, Par Pharmaceutical
Hyo Jin Lee, Graduate Student, Keck Graduate Institute
Kate Lee, Process Development Engineer, Genentech
Linna Li, Project Engineer, Par Pharmaceuticals
Ne Lin, Technical Service Engineer III, Impax Laboratories Inc
Carly Liu, Engineer II, Baxter Healthcare
Jaime Liu, Genentech Inc
Daniel Lucey, Hyde Engineering + Consulting
Jon Lundstrom, Principal, Lundstrom & Associates Architects
Jay Malmo, Keck Graduate Institute
Charles McCarthy, Impax Laboratories Inc
Geremy Mendelson, CDT, Stonhard
Jose Mendoza, Facility Maintenance Mechanic, Avrio Biopharmaceutical/Irvine Pharmaceutical Services
Peter Momjian, Sales Representative, SartoriusStedim North America
Arlene Monanr
Joel Jose Nario, University of CaliforniaIrvine
Rodney Pannell, Jr., Sr. Supervisor, Sr. Supervisor, Filling, Teva Parenteral Medicines
Bob Panza, Engineer, B Braun Medical
Soo Bin Park, Student, University of CaliforniaLos Angeles
Ruben Pedroza, MBA | EIT, BioSPEQ/Azzur Engineering
Michael Prantil, Solution Architect, Proconex / Valspec
Aniruddha Rajan, Genentech Inc
Greg Randall, Sr Validation Engineer, Baxter
Brian Reding, Process Engineer, Amphastar Pharmaceuticals
Parish Reed, The Fitting Source
Harry Reynolds, Project Director, Kinetics
Manik Sangvikar, Engg SpecialistControls, BBraun Medicals
Payman Sarhadi, Student, California State University
Jon Scott, University of California, Irvine
Priyadarshini Singha, University of CaliforniaIrvine
Anna Stozhkova, QA Assistant, RPharm
Christopher Tam, Associate Microbiologist, Medtronic / University of California Irvine
Karina Tang, Validation Engineer, PSC Biotech
Keith Teeuwen, Site Leader, PL Developments
Ya Thao, University of CaliforniaIrvine
Heather Todd, Grifols Diagnostic Solutions
Daniel Trivino, MES Adminstrator, B.Braun Medical
Nick Vulcan, P.E., Consultant
James Xu, Sr. Principal Engineer, Nutrilite
Marina Yanez, QA&QC Manager, IACI
Arnold Yap, Validation Engineer, Gilead Sciences
Dr. Seok Yim, Sr Engineer, Integrity Bio, Inc.
Rashid Yousufzai, Maintenance Manager, Grifols Biologicals Inc.
Chester Zelaya, Plant Manager, Baxter Healthcare
ISPE Los Angeles Board of Directors
President:
Tom Golden, UnboundConsulting tom.golden@unboundconsulting.com
Vice President:
Dona Tseng, Baxter Bioscience dona_tseng@baxter.com
Treasurer:
Tim Cannon, Cannon Building Services tcannon@cannonbuilding.com
Secretary, Marketing & Communications and Membership Chair:
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Margaret Stava, Laboratory Equipment Co. mmstava@gmail.com
Directors
Student Affairs Chair: Justin Cantor, PSC Biotech Corporation justincantor@rocketmail.com
Director: Miguel Cerezo, Amgen mcerezo@amgen.com
Director: Chris Deitz, Gilead Sciences cdeitz@gilead.com
YP Chair: Russell Early, PSC Biotech Corporation rearly@biotech.com
Director: Michael Gagne, Par Pharmaceutical, Michael.Gagne@parpharm.com
Exhibits/Professional Outreach: Randy George rgeorge001@socal.rr.com
Program Committee: Ron Mirian, B. Braun Medical Inc. Mehron.Mirian@bbraun.com
Director: Richard Ramirez, Grifols Biologicals Inc. richard.ramirez@grifols.com
Director: David Steinberg, Agensys, Inc. dsteinberg@agensys.com
Social Committee Chair: Libby Virtue, CRB libby.virtue@crbusa.com
Past President:
Stephania Armani, PhD, Saban Research USC stephania.armani@gmail.com
Active Past Presidents:
Advisory Council Chair: Matthew Atwong, Adventist Health/JLL matthewatwong@yahoo.com
Past President: John Clapham , PSC Biotech Corporation jclapham@biotech.com
Programs Chair: Paul Crissman, Biotechnical Solutions paul@biotechnicalsolutions.com
Past President: Stu Levenshus, M.D. Stainless Services stulevenshus@aol.com
Advisory Council Chair and Golf Committee: Scott Tiedge, Flotek scott@flotekca.com
Chapter Manager:
Kimberly Syre, Attention To Detail ksyre@cox.net
Volunteers Wanted!
If you are interested in joining the Chapter's Membership Committee or any other Chapter Committee,
please contact the Committee Chair (see above).
Host a Meeting or Facility Tour at Your Company
If you host a meeting at your company, your employees get free training. Contact our Program Committee
Chair, Paul Crissman to coordinate a meeting in 2015.
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Content Needed for Chapter Newsletter
We need your submissions! We are always accepting content for the Chapter newsletter. New items
should be of general interest to our Members. Items we are seeking are: technical articles, photos from
Chapter events, volunteers for the Committee to write overview of meetings, industry news (no company
promotions accepted) and other items you may find of interest.
Please submit your items to the Chapter's Communications Chair, Margaret Stava (mmstava@gmail.com).
Be sure to include your name and contact information in case we need to contact you.
All submissions will be reviewed by the Chapter's Board of Directors. We reserve the right to edit any
content and select entries of best interest to our Members while maintaining ISPE standards.
Advertising
If you are interested in advertising in our newsletter, please download the advertising form. Complete the
form and return it with your payment. We will also need a pdf of a business card sized ad and a jpg
company logo. Please email your logo and ad to Kimberly Syre (ksyre@cox.net).
Published by ISPE Greater Los Angeles Area Chapter