Quarterly Newsletter
Jul 2018                                                                                                            Issue #11

This edition includes a focus on the increasing contribution of women, who comprised 42% of the industry* but represent 20% of management teams at biotech companies and 10% of biotech boards. Some examples of women who have led the way include:

- Dr. Janet Woodcock, now Director for the Center for Drug Evaluation and Research (CDER) has been instrumental in rolling out a new approach to drug safety evaluations.

- Emma Walmsley, the first woman in history to be named CEO of a top 10 pharmaceutical company at GlaxoSmithKline.

- Heather Bresch, who joined Mylan as a clerk in 1992 to CEO in 2012 to be the first woman to ever head a Fortune 500 pharmaceutical company. Since then, she has led the company with a S$5.3 billion acquisition of Abbott Laboratories.

ISPE's Women in Pharma® (WIP) is a community that provides women in the pharmaceutical industry a forum for connecting and collaborating on technical and career advancement topics. We are delighted to present our first event in conjunction with the ISPE Singapore annual conference and encourage all to attend!

Best Regards,
your ISPE Singapore Affiliate

*U.S. Bureau of Labor Statistics, 2017
Guest Editorial
Frances Zipp
President & CEO, Lachman Consultant Services USA, and current ISPE Executive Board Member

The field of pharmaceutical manufacturing traditionally skews male. According to a study by the Healthcare Businesswomen's Association and Booz Allen Hamilton, women hold only 17 percent of senior management positions at life science companies. This has not increased in the last 5 years, suggesting that companies continue to struggle to accelerate advancement and retention of senior executive women.
 
With this background in mind, current and ex-Board members of ISPE formed the "Women in Pharma" group in 2016, with the initial roundtable held at the 2016 Annual Meeting in Atlanta. The first panel discussion was chaired by me and Charlotte Enghave Fruergaard, PhD, Partner, Process Technology Consulting, NNE Pharmaplan, Denmark, and a Past Chair of ISPE.
 
The panel consisted of leading female executives from industry as well as FDA, representing major multinational brand pharmaceutical companies as well as medium sized private companies, consulting groups, brand and generics companies, all in positions of responsibility within the manufacturing operations sphere.
 
It was very well attended (and not only by women!), the discussions during the breakout sections were very engaging and spirited, and everyone left the room eager to continue the discussions and networking.
 
Two years later, the initiative has grown to a complete track at the Annual Meetings and other international conferences, and has become a year-round networking community as a Community of Practice on the ISPE website. At the 2017 Annual Meeting in San Diego, the Women in Pharma Networking Community held six complimentary topic-focused dinners covering a variety of topics that provided priceless connections and insights.
 
I am pleased to be a speaker and track leader at this year's ISPE Singapore Affiliate meeting, "From Manufacturing to Patients", being held August 29-31, 2018, at Suntec Singapore.
 
Please join me and other executive women at the Women in Pharma Panel Session, being held at 6:30 pm on August 30, day 1 of the ISPE Singapore conference. We look forward to continued networking and connections!

FEATURED Article
Factors to Consider for a Cleaning and Disinfection Program

An effective cleaning and disinfection program is critical to controlling the bioburden in a cleanroom. Cleaning and disinfection procedures are important elements in the overall cleanroom contamination control program, which is essential to ensuring that drug products meet current standards of safety, purity and efficacy. But what are the factors to consider when designing an effective cleaning and disinfection program?
The following are the important factors to consider.
  1. Disinfectant Technologies
  2. Rotation Strategy and Frequency of Use  
  3. Rinsing and Residue Removal
  4. Compatibility with cleanroom substrates  
Controlling bioburden in pharmaceutical, biotech, and medical device cleanrooms is dependent on various factors. These factors include the cleanroom design, environmental conditions, personnel hygiene, gowning, personnel practices / behavior, and commitment to adhere strictly to contamination control procedures. More importantly, selection of suitable products and implementation of robust procedures are critical to ensuring the success of the contamination control program.

Read the full article here!

Richard Chai
Technical Service Manager
STERIS Corporation

Thanks to our sponsors:


Events Calendar
Technical Tuesday
M+W Office, 16 International Business Park
Introduction to Cyber Security for Pharmaceutical Manufacturing
17 Jul 2018 | 6.00-7.00pm  
Surface Decontamination - Real Case Study
31 Jul 2018 | 6.00-7.00pm
(sign up here)
Best Practices on Technology Transfer 
14 Aug 2018 | 6.00-7.00pm
(sign up here)


Supporting Event: IChemE Pharmaceutical Special Interest Group - Adapting single use/stainless hybrid system for flexible biologics manufacturing.
25 Jul 2018, 6.30-8.30pm
National University of Singapore
Registration is Complimentary, but you must register to attend. Register HERE

ISPE Singapore Conference &  Exhibition
29-31 Aug 2018
Suntec Convention & Exhibition Centre
Check out this year's programme with new tracks dedicated to GAMP/Data Integrity, Aseptic & Sterile Operations, Process Validation, Logistics & Distribution and more! PLUS: Join us for the first 'ISPE Women in Pharma' event in Singapore!
Maximise networking and learning with more regulators, industry case studies, subject matter experts and exhibitors than ever. Limited exhibit spaces & sponsorship available, 
for details  www.ispesingapore.org

Student Poster Competition 2018
30 Aug 2018 | 2pm-6.30pm
Suntec Convention & Exhibition Centre
Join our ISPE Singapore Student Poster competition and stand to win great prizes, like an all-expense trip to the USA.

ISPE Singapore Go-Kart Challenge 2018
21 Sep 2018 | 6.30pm-9pm
KF1 Karting Circuit
Formula 1 blues? Get into top gear at our annual race!

Recent Developments in Biopharmaceutical Manufacturing (featured event)
4 Oct 2018 | 9.30am-4.30pm
Genting Hotel, Jurong
Sponsored by ZETA & BWT Pharma & Biotech GmbH

Thirsty Thursday with ISPE!
4 Oct 2018 | 6.30pm-8.30pm
Twenty15@Big Box, Jurong
Unwind, meet old and make new friends conveniently in Jurong East! Finger food & first round on the house, thereafter 1 for 1 Happy Hour. Bring a friend from or if you're full time staff from bio/pharma manufacturing facility, enjoy bonus drinks!
Click here to register

Process Validation (PV) Workshop: Life Cycle Management & Risk Based Approaches (save the date)
18-19 Oct 2018| 9.00am-5.30pm
Genting Hotel, Jurong
Gain regulatory updates and practical implementation for your validation programme at this 1 day workshop. Recommended for participants who are familiar with basic concepts of validation and quality risk management prior to attending this course. 
Day 1: Principles of PV and basics, with exercises
Day 2: Practical application
RECOMMENDED: Attend Day 2 if you attended the 1 day workshop in 2017!

ISPE Singapore Soccer Tournament
15 Nov 2018 | 7-9pm
GOLAZO Futsal Singapore
Sign up individually or with a team!

Contact us if you'd like to include your
event here. (Postings are vetted according to ISPE guidelines on commercial content and subject to approval by the committee.)
Events in the Region
ISPE Thailand Annual Meeting
16-17 Jul 2018, Bangkok, Thailand
Announcements
We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?
A S$50 voucher will be given for each one featured in the next issue. Please write in to ispesingaffiliate@gmail.com

FEATURED Event
Recent Developments in Biopharmaceutical Manufacturing
(sponsored by ZETA Biopharma GmbH and BWT Pharma & Biotech GmbH)
4 Oct 2018 | 9.30am - 4.30pm 
Genting Hotel, Jurong

Summary

Biopharmaceuticals are getting more complex and manufacturing techniques must take cognizance of such complexity. A high performing and well-designed production plant is crucial for a satisfactory product yield and quality.
ISPE Singapore - in combination with ZETA Biopharma GmbH and BWT - is proud to present a full-day seminar on Recent Developments in Biopharmaceutical Manufacturing. ZETA's insight into plant design and engineering as well as BWT's leadership in clean utilities will provide a holistic approach in planning plants of the future. (read more here)
 
Learning Objective

To gain insights into recent innovations in both technology and regulatory guidelines that have implications for manufacturing.
 
Key Takeaways
  • The importance of an accurate bioreactor characterisation with focus on the kLa value
  • How to leverage single-use and stainless steel technologies in an optimal bioreactor design
  • An assessment of the new WFI requirements from EP9.1 / EMA Q&A documents
  • Cold WFI Generation as a possible solution from a membrane-based WFI generator
                                                              

FREE before 20 Sept 2018 |  SGD 25 after 20 Sept 2018


Recent Events
Technical Tuesdays
17 Apr: Sterilization - Process vs Load
24 Apr: Surface Decontamination with H2O2
22 May: Single Use/Hybrid System Pros & Cons
12 Jun: Cold Chain Management
19 Jun: Pharmaceutical Water Systems

New for this year, our regular Technical Tuesday sessions are steadily gaining regular attendees, with more topics in the pipeline. Thanks to all who have attended, including our Subject Matter Experts and team, who have generously volunteered their personal time and energy to make this happen! 
 

ISPE Singapore Quiz Night 2018
25 Apr 2018

Over 60 joined an enjoyable and competitive battle of trivia and industry brain-teasers. Congratulations to the Team Repassa on their well-deserved win! Special thanks to committee members and our sponsors for their support: No Deviation, PM Group, Repassa & STERIS
 

YGEN Challenge
9 Jun 2018

The Student Chapter's annual event was attended by over 90 for inspiring and informative industry and career talks. Well done on a fantastic event, where speakers and students alike gained fresh insights! Thanks to all for lending their time and support to make this a resounding success!


Sponsored by: Goro Goro, I'm Kim Korean BBQ, No deviation, Repassa, Steris, Swensens
Student Chapter Industry Visit to Abbott
25 Jun 2018

Thanks to Abbott for hosting our students and a highly informative morning.
 
An Evening with Kelly Keen, ISPE: APAC Strategy & Global Drug 
Shortages
28 Jun 2018

ISPE Singapore welcomed a flying visit by Kelly, a former Singapore Affiliate VP and Portfolio Manager/Business Process Manager, Genentech/Roche, USA
Your feedback and suggestions are most welcome as we strive to provide you with membership and industry news updates.
Contact Us
ISPE Singapore Affiliate
Ph +65 6826 1105