Agenda

09:00
OPENING REMARKS FROM ISPE SINGAPORE

Joseph Micsko, President, ISPE Singapore Affiliate

09:10
GOVERNMENT ADDRESS:
HARNESSING THE FULL POTENTIAL OF PHARMA 4.0

Melissa Guan, Head, Healthcare, Economic Development Board, Singapore

09:30
LEADERSHIP KEYNOTE ADDRESS:
DRIVING INNOVATION FOR AFFORDABILITY AND ACCESS OF MEDICINES

Dr. Christiane Hamacher, CEO, Biocon Biologics Limited, India

10:00
PANEL DISCUSSION:
ASIA’S ROLE IN DELIVERING AFFORDABLE QUALITY HEALTHCARE

Moderator:
Pierre Winnepenninck, ISPE Singapore Conference Chair, Singapore

Panellists:
Chai Chong Meng, Director of Manufacturing Operations, Lonza Biologics, Singapore
Dr. Christiane Hamacher, CEO, Biocon Biologics, India
Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Switzerland
Vladimir Orlov, Deputy Head of Scientific, Methodology & Training Dept, FSI State Institute of Drugs and Good Practices, Russia

10:45
Opening of ISPE Singapore Exhibition and Morning Refreshments

Track A (AM): PHARMA 4.0

Chairman: Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, Singapore

11:30
TRANSFORMATION OF THE PHARMA VALUE CHAIN WITH INDUSTRY 4.0

Kartik Kulbhushan, Global Head and Vice President for Operations Strategy and Transformation, Dr. Reddy’s Laboratories, India

12:00
COLLABORATION AND ALLIANCE THROUGH “OPEN INNOVATION”

Dr. Toru J Seo, Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office, Pfizer Inc., Japan

12:30
HOW CAN AUTOMATION AND DIGITAL DATA IMPROVE SPEED TO MARKET?

  • What makes a great data set for a data scientist or process engineer?
  • Where are the challenges for data users with automation design?
  • What attributes of automation design make for seamless analytics?

Jacqueline Hora, Digital and Data Consultant, Zenith Technologies, Ireland

13:00
Lunch in the Exhibition Hall

14:15
MACHINE LEARNING IN PHARMACEUTICAL PROCESS DEVELOPMENT: WHERE ARE WE UP TO IN PHARMA 4.0?

  • Comparison of current AL and ML approaches with well-established alternative techniques in the process industries: Advanced Process Control (APC) and Multi-Variate Analysis
  • Case studies on the application of ML for process control and optimization

David Lovett, Managing Director, Perceptive Engineering Ltd., United Kingdom

14:45
CASE STUDY: DATA INTEGRITY IN PHARMA 4.0

  • Why is data integrity important?
  • Data Integrity in Industry 4.0: How to stay relevant in the new age?
  • Overview of ALCOA principles
  • Data Integrity Framework: How to integrate/implement data integrity into business functions?
  • Leading vs. lagging indicators of data integrity

Danee Zainal, Head of Manufacturing, Alcon, Indonesia

Track A (AM): PHARMA 4.0

Chairman: Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, Singapore

15:15
PANEL DISCUSSION:
PHARMA 4.0 – ADDRESSING OPPORTUNITIES AND CHALLENGES

Moderator:
Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, Singapore

Panellists:
Dr. Toru J Seo, Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office, Pfizer Inc., Japan
Kartik Kulbhushan, Global Head and Vice President for Operations Strategy and Transformation, Dr. Reddy’s Laboratories, India
James Weidner, Executive Director of Process Development, Amgen, Singapore
Dr. Xiaoping Cao, Vice President and Head of CMC and Supply Chain, Cerecin, Singapore

15:45
Afternoon Refreshments

Track A (PM): DATA INTEGRITY AND GAMP 

Chairman: Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, Singapore

16:25
MEETING DATA INTEGRITY REQUIREMENTS IN ASEAN

  • Implementing a robust data integrity program within Zydus Cadila
  • Compliance with ASEAN GMP
  • Progress and challenges of data integrity in Myanmar

Chandrakant Bhandare, Head of Quality, Zydus Cadila Myanmar, Myanmar

16:55
AUDITING FOR DATA INTEGRITY: EXPECTATIONS OF REGULATORS AND EXPERIENCE OF QA AUDITS

  • Requirements for data integrity audit
  • Expectations of regulators and GLP inspectors, and role of QA in ensuring compliance

Dr. Labhu Sanghani, Director of Global Quality Assurance, Jai Research Foundation (JRF Global), India

17:25
PANEL DISCUSSION:
ENSURING DATA AND PRODUCT QUALITY FOR PATIENT SAFETY

Moderator:
Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, Singapore

Panellists:
Dr. Labhu Sanghani, Director of Global Quality Assurance, Jai Research Foundation (JRF Global), India
Jennifer Cheung, Head of External Relations Asia Pacific & Global Compliance Business Solutions, Genentech, United States
Holger Linnertz, Head of Software Development Factory, Mettler-Toledo (S) Pte Ltd., Switzerland

18:00
PHARMANITE NETWORKING

19:00
Close of Conference

TRACK B1 (AM): PROJECT MANAGEMENT

Chairman: Pierre Winnepenninck, ISPE Singapore Conference Chair, Singapore

11:30
PROJECT MANAGEMENT CONTINUOUS IMPROVEMENT: LESSONS LEARNED PROCESS

Hazem Eleskandarani, Project Director, Engineering & Property Services, Johnson & Johnson, United States

12:00
GMP COMPLIANCE PROJECT – FROM THE CLIENT PROSPECTIVE

A look at how the use of project management principles; with a focus on communication management, stakeholder engagement and scope definition; turned a complicated, fast track HVAC upgrade project for a pharmaceutical packaging facility from an organization working in silos; with unclear project milestones; and an undefined communication pathway; into a cohesive project team with the tools to deliver a successful qualification of the facility and allowing for the resumption of supply chain of critical medicines for the region.

Simone Hurly, Automation Engineer, MSD, South Africa
Morgan O’Brien, Business Development Manager, No Deviation Pte Ltd, Singapore

12:30
AMGEN’S CASE STUDY: OPTIMISING PROCESS IMPROVEMENT WITHIN DESIGN SPACE CAPABILITIES

 James Weidner, Executive Director of Process Development, Amgen, Singapore

13:00
Women in Pharma Lunch Panel

14:15
OPERATIONAL EXCELLENCE AND LEAN SIX SIGMA FOR PHARMA PLANT DESIGN

  • Enablers of incorporating Operational Excellence and Lean into Plant Design Phase in Project Management
  • Physical vs. cultural factors
  • Common flaws in assumption based on product volume/product mix/capital investment approved/budget
  • How can we overcome this to ensure that when the site goes into full operational phase, the processes are lean and meeting operational excellence KPI such as good throughput time, with an optimized work force?
  • Proposal

Teo Szu Hui, Site Facility Lead, Novartis, Singapore

14:45
THE IMPORTANCE OF CULTURE IN PROJECT AND PORTFOLIO MANAGEMENT DURING MERGERS AND ACQUISITIONS

  • Brief introduction of speaker’s experience in Roche’s buyout of Genentech in 2009 and Celonic’s acquisition of Glycotope in Heidelberg, Germany
  • Experiences, lessons learned and risks at different levels

Kelly Keen, Vice President Project Management, Head of PMO, Celonic, Switzerland

15:15
PANEL DISCUSSION:
PHARMA OUTSOURCING AND PROJECT MANAGEMENT   

Moderator:
Pierre Winnepenninck, ISPE Singapore Conference Chair, Singapore

Panellists:
Hazem Eleskandarani, Project Director, Engineering & Property Services, Johnson & Johnson, United States
Simone Hurly,
Automation Engineer, MSD, South Africa
James Weidner, Executive Director of Process Development, Amgen, Singapore
Teo Szu Hui, Site Facility Lead, Novartis, Singapore
Kelly Keen, Vice President Project Management, Head of PMO, Celonic, Switzerland

15:45
Afternoon Refreshments

Track B2 (PM):
ENVIRONMENT, HEALTH AND SAFETY (EHS)

Chairman: Thomas Terranova, Managing Director, Terra Asia Consulting, Singapore

16:25
BUILDING A PHARMACEUTICAL SAFETY CULTURE

  • How is EHS in pharma different from other industries?
  • Factors to consider for a well-designed and comprehensive EHS program, and a contingency plan
  • How to strengthen quality culture in your pharma business?

Wan Mohd Nazeem Wan Asharuddin, Senior EHS Manager, Biocon Sdn. Bhd, Malaysia

16:50
EFFECTIVE CONTRACTOR SAFETY MANAGEMENT

  • Critical success factors and minimum requirements required to lead safety
  • Overview of how different elements can be applied to influence perceptionof safety within workforce
  • Overview of the Full Range leadership model, and practical application of the Model to safety

Craig Docherty, CEO/Founder, Fusion Safety Management, Australia

17:10
IMPROVING SAFETY IN THE NEXT-GENERATION BIOMANUFACTURING PLANT – IS THERE A DIFFERENCE?

  • Perspective of safety in the Next-Generation Biomanufacturing Plant
  • Four critical pillars for proven safety success

Anna Koay, Director of EHSS, Amgen, Singapore

17:30
TEN MOST COMMON OCCUPATIONAL HEALTH AND SAFETY AUDIT FINDINGS FROM HIGH-POTENCY API FACILITIES IN THE DEVELOPING WORLD

  • Overview of emerging markets for manufacturing HPAPIs
  • Most common occupational health and safety audit findings

Dean Calhoun, President/CEO, Affygility Solutions, United States

18:00
PHARMANITE NETWORKING

19:00
Close of Conference

TRACK C (AM): ASEPTIC OPERATIONS

11:30
STRATEGIES TO KEEP PARENTERAL DRUG PRODUCTS FREE FROM PARTICULATE MATTER CONTAMINATION

  • Introduction to visible particles’ contamination in parenteral drugs
  • Adverse effects caused by visible particles
  • Sources of visible particles
  • Detection and identification of visible particles
  • Strategies of effective control of visible particles’ contamination

Farooq Mustafa Chaudhry, Associate Director, Quality Operations & Biotech, Macter International Ltd., Pakistan

12:00
ASEPTIC PROCESS SAMPLING RISK MITIGATION

  • Complexity and risks of traditional sampling methods
  • Key drivers for aseptic process sampling
  • Regulatory recommendations and corresponding needs
  • Key considerations for optimizing sampling plan and best sampling options

Li Jun Sim, Technology Manager, Biologics Lead, Merck Life Sciences, Singapore

12:30
DESIGNING A CONTAMINATION CONTROL STRATEGY IN AN ASEPTIC FACILITY

Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia

13:00
Women in Pharma Lunch Panel

14:15
MOIST HEAT STERILIZATORS: FROM STERILIZATION THEORY TO NO DEVIATION DESIGN

Moist heat sterilization as technology is based on a theory, the principles of which are shortly refreshed from the industry point of view. Production of aseptic drugs is object of a detailed European legislation, the core of which is contained in Annex 1 to Eudralex Vol. 4. Rather obviously, sterilizers themselves can’t comply with pharma production rules, but their design and construction must consider all of them in order to prevent any deviation from them. This has also to be the object of a proper documentation.

Dr. Chem. Eng, Vittorio Mascherpa, Senior R&D Consultant, Fegedari Group, Italy

14:45
BEYOND THE DATING GAME: SERIOUS SUPPLIER RELATIONSHIPS IN THE ADOPTION OF SINGLE-USE TECHNOLOGIES

  • Drivers for rapid emergence and adoption of single-use technologies
  • Challenges in the evolving relationship between component suppliers and pharmaceutical manufacturers, as they shift away from traditional stainless steel systems
  • Guidelines for vendor selection, and re-defining the rules of engagement for ongoing interaction

Stephen Doherty, Global Director, Business Development, Garlock Hygienic Technologies, United Kingdom

TRACK C (PM):
MANUFACTURING FOR CELL AND GENE THERAPY

Chairman: Ief Leroy, Managing Partner, VILS, Belgium

15:15
CELL AND GENE THERAPY: OVERCOMING CONSTRAINTS IN SCALABILITY, SUSTAINABILITY AND COST OF GOODS

Andy Rayner, Pharma Sector Director and CTO, PM Group, United States

15:45
Afternoon Refreshments

TRACK C (PM):
MANUFACTURING FOR CELL AND GENE THERAPY

Chairman: Ief Leroy, Managing Partner, VILS, Belgium

16:25
SCALING UP THE CELL THERAPY MANUFACTURING PROCESS

  • Overview of flowchart for the cell therapy manufacturing process
  • Current manufacturing models for stem cell therapies, and regulatory challenges
  • Advancements in bioprocessing tech for stem cell therapy manufacturing

Dr. Steve Oh, Institute Scientist / Professor, A*STAR, Singapore

16:55
LION TCR’S STRATEGY FOR T CELL THERAPY MANUFACTURING

Dr. Victor Li, Co-founder and Chairman, Lion TCR, Founder and CEO, BioSyngen, Singapore

17:25
CGMP CONSIDERATIONS FOR THE DESIGN AND OPERATION OF CELL THERAPY FACILITIES

Francesca McBride, Director of Regulatory Compliance, Jacobs Engineering, United States

18:00
PHARMANITE NETWORKING

19:00
Close of Conference

Track D (AM): QUALITY AND COMPLIANCE

Chairman: Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Switzerland

09:00
CMC REGULATORY COMPLIANCE FOR BIOLOGICS

Dr. Gang Wang, Vice President, Quality, WuXi Biologics, China

09:30
ENSURING QUALITY COMPLIANCE IN TECH TRANSFER

Michelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesia

10:00
DEVELOPING KPIS TO MEASURE REGULATORY CONVERGENCE OF ASIA-PACIFIC ECONOMIC COOPERATION (APEC)

  • Evolution of regulatory harmonization, convergence and cooperation: The ICH experience
  • Best practices and feasible processes for APEC economies’ convergence
  • Proposed KPIs to measure APEC regulatory convergence and cooperation
    • Certificate of pharmaceutical product (CPP)
    • The pharmaceutical inspection co-operation scheme (PIC/S) membership
    • Managing multiple sites in one license
    • Risk-based reliance evaluation system
  • Capacity building

Dr. Sannie Chong, Head of Asia Pacific Tech Regulatory Policy – Singapore Technical Operation, Roche, Singapore

10:30
Morning Tea

 11:00
MANUFACTURING AND QC LABS GMP STANDALONE SIMPLE EQUIPMENT COMPLIANCE PROCESS

Mansoor Mohammad, Director, Quality Assurance, Data Integrity and Quality Management System, Samsung Biologics, South Korea

11:30
BREAKTHROUGH IDEAS IN QUALITY

  • Use of a Design Thinking approach to transform an over-engineered process
  • Case Study on DMS/Change Management: Low Risk Discrepancies; Redesign Technical Change Management Pilot
  • Case Study on Governance and Quality Oversight: Retirement of top-down monitoring systems through implementation of DR&S / Tableau

Dr. Susanna Nagel, Quality Site Head, Roche, Singapore

12:00
CHALLENGES AND ACHIEVEMENTS WITH DRUG REGULATION IN THE GCC REGION

  • How has regulatory compliance evolved in the Middle East?
  • Overview of regulatory approval pathway in the MENA region
  • How does GCC’s approval system compare with SFDA, USFDA and the EU?

Dr. Syed Abid Hassan, Head Regulatory Compliance; Team Leader – Variation Management Committee, Jamjoom Pharmaceuticals Company, Saudi Arabia

12:30
Lunch

Track D (PM): QUALITY AND COMPLIANCE

Chairman: Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Singapore

13:45
SUPPLIER QUALITY MANAGEMENT FOR PHARMA

  • Risk assessment application in supplier management
  • Third party deviation handling
  • Auditor qualification

Ting-Yuan Tan, QA Senior Specialist, ASQ Certified Quality Auditor, JHL Biotechnology, Taiwan

14:15
BUILDING AN INTEGRATED QUALITY SYSTEM IN PHARMA COMMERCIAL MANUFACTURING

  • Compliance with ICH Q10 regulatory
  • Approach in implementing an effective QMS
  • Implication of industry trends and tech for QMS

Dinar Wahyuni, Quality Assurance Executive, Strides Pharma, Singapore

14:15
COMPARATIVE REVIEW OF QUALITY COMPLIANCE FOR PHARMA MANUFACTURING AND DISTRIBUTION

  • Review of how GMPs have evolved
  • Continuous improvement in quality risk management: A need for a Holistic Approach
  • Role of tech in balancing GxP compliance and productivity

Dr. Nirmal Kumar, Head, Quality Assurance, Novugen Pharma, Malaysia

15:15
Afternoon Refreshments

15:45
DIGITAL- LET THE WATER EXPERTS MONITOR, MANAGE AND IMPROVE THE OPERATION OF YOUR COMPENDIAL WATER SYSTEMS

Ranj Rihal, Pharmaceutical and Cosmetics Business Development, Veolia Water Technologies, United Kingdom

16:15
PANEL DISCUSSION:
QUALITY, COMPLIANCE AND SUSTAINABILITY

Speakers of the day to be invited

Moderator:
Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Switzerland

Panellists:
Ting-Yuan Tan, QA Senior Specialist, ASQ Certified Quality Auditor, JHL Biotechnology, Taiwan
Danee Zainal, Head of Manufacturing, Alcon, Indonesia
Dr. Syed Abid Hassan, Head Regulatory Compliance; Team Leader – Variation Management Committee, Jamjoom Pharmaceuticals Company, Saudi Arabia
Dr. Nirmal Kumar, Head, Quality Assurance, Novugen Pharma, Malaysia

17:00
YOUNG PROFESSIONALS (YP) NETWORKING

18:00
Close of Conference

Track E  (AM): LEAN AND OPERATIONAL EXCELLENCE

Chairman: Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia

09:00
APPLIED OPERATIONAL EXCELLENCE IN PHARMACEUTICAL MANUFACTURING

Rodel Sibulo, Director Pharma Project Operations – Deputy General Director, Nanogen Pharmaceutical Biotechnology Joint Stock Company, Vietnam

09:30
LEAN PRINCIPLES FOR A STRONGER QUALITY MANAGEMENT SYSTEM

  • Identifying the requirements of customers and stakeholders
  • Value stream approach to identify and minimize waste and variations
  • Types of waste
  • Push system vs. Pull system
  • Continuous improvement culture and the role of employees

Srinivasa Rao Sambangi, Senior General Manager, Aurobindo Pharma, India

10:00
ROLE OF LEADERSHIP IN FOSTERING OPERATIONAL EXCELLENCE  AND CONTINUOUS IMPROVEMENT

Jose Luis Narvaez, Plant Director, United Laboratories Inc., Vietnam

10:30
Morning Tea

11:00
CASE STUDY: ACHIEVING OPERATIONAL EXCELLENCE IN PRODUCT CHANGEOVER

Paul Tan, Head of Manufacturing Excellence, Biologics, Takeda Pharmaceuticals, Singapore

11:30
CASE STUDY: HOW CAN SIX SIGMA IMPROVE BIG PHARMA

  • Application of Six Sigma in a Lean Production System
  • Application of Process Capability Indices in Pharma
  • Statistical Process Control – Where we went wrong and what to do about it?

Isa Hamzah, Asia-Pacific Integrated Manufacturing Excellence Deployment Leader, Pfizer, Singapore

12:00
ACHIEVING OPERATIONAL EXCELLENCE IN END-TO-END PHARMA SUPPLY CHAIN

  • Overview of Operational Excellence and Lean Management Principles
  • Hoshin-Kanri Policy Deployment
  • Success factors and Pitfalls of Operational Excellence execution

Arnel Cabungcal, Assistant Vice President – Manufacturing, United Laboratories Inc, Philippines

12:30
Lunch

Track E  (PM): LEAN AND OPERATIONAL EXCELLENCE

Chairman: Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia

13:45
CASE STUDY: OPERATIONAL EXCELLENCE IN PHARMA R&D

Stephen Shi, Lean Six Sigma Director, Fosun Pharma, China

14:15
HUMAN BEHAVIOURAL ROOT CAUSES AND CAPA 

  • Using real data and decision trees to practice behavioral root cause analysis, CAPA formulation and continuous improvement efforts

Harry Benson, Global Director, Human Performance Services, CAI, United States

14:45
CONTINUOUS ON-LINE MICROBIAL MONITORING FOR PHARMACEUTICAL WATERS

  • Overview of 7000RMS principle of operation
  • Industry’s drive for online rapid microbial detection
  • Examples of 7000RMS customer data

 Akash Trivedi, Product Manager, METTLER-TOLEDO (S) PTE LTD., United States

15:15
Afternoon Refreshments

15:45
RISK MANAGEMENT AND ENDOTOXIN CONTROL IN BIOPHARMACEUTICAL MANUFACTURING

  • Review of the dynamic nature of lipopolysaccharide fine structures and how these structures are associated with gram negative bacteria survival strategies
  • Process deviations and root cause recommendations that may facilitate investigations to alert or action level excursions
  • Tools used to track and/or trend critical systems that enable a state of environmental control

John Dubczak, General Manager, Operations Management, Charles River Laboratories, Microbial Solution, United States

16:15
PANEL DISCUSSION:
CREATING AND MANAGING AN OPERATIONAL EXCELLENCE MANAGEMENT SYSTEM

Moderator:
Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia

Panellists:
Rodel Sibulo, Director Pharma Project Operations – Deputy General Director, Nanogen Pharmaceutical Biotechnology Joint Stock Company, Vietnam
Srinivasa Rao Sambangi, Senior General Manager, Aurobindo Pharma, India
Arnel Cabungcal, Assistant Vice President – Manufacturing, United Laboratories Inc, Philippines

17:00
YOUNG PROFESSIONALS (YP) NETWORKING

18:00
Close of Conference

TRACK F (AM): CLEANING AND VALIDATION

Chairman: Maurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia

09:00
STATISTICAL APPROACHES IN PRODUCT VALIDATION

  • Introduction to equivalence testing, and surrounding regulatory frameworks
  • Importance of equivalence testing
  • Where is equivalence needed: product transfers and method validations
  • Examples of equivalence testing

Christian Cater, Head of Operational Excellence, Roche, Singapore

09:30
UNDERSTANDING THE CLEANING PHENOMENA IN API PLANTS TO ENABLE CLEANING BY DESIGN

  • Measurement of relevant material properties of APIs such as solubility, strength of surface bonding
  • Flow rig to observe tokens under cleaning conditions
  • Evaluation of analytical technologies such as UV-Vis and Fluorescence for wash liquor monitoring
  • Inspection technologies such as borescope and associated image analysis

Murugappan Karthick, Research Scientist, Institute of Chemical and Engineering Sciences, A*STAR, Singapore

10:00
CLEANING VALIDATION FOR COSMETIC PRODUCTS

  • Overview of cleaning validation protocol for cosmetic products
  • How much variation is acceptable in products and processes?
  • New techniques in designing cleaning process

Lathalu Krishnamoorthy, Quality Control and Assurance Manager, ICM Pharma, Singapore

10:30
Morning Tea

11:00
CONTAMINATION CONTROL IN GMP CLEANROOMS

  • Regulatory expectations related to contamination control
  • Causes of contamination in cleanroom
  • Effective strategies in bioburden control, cleaning and disinfection

Richard Chai, Technical Service Manager, STERIS Corporation, Singapore

11:30
SELECTING THE RIGHT STERILE CONNECTOR FOR YOUR SINGLE-USE SYSTEM

  • Overview of current market for sterile connectors
  • Key characteristics to look at when selecting sterile connector

Raymond Dallago, Director of Sales, SaniSure, United States

12:00
PANEL DISCUSSION:

EMERGING CLEANING TECHNOLOGIES AND INNOVATIONS

Moderator:
Maurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia

Panellists:
Christian Cater, Head of Operational Excellence, Roche, Singapore
Murugappan Karthick, Research Scientist, Institute of Chemical and Engineering Sciences, A*STAR, Singapore
Lathalu Krishnamoorthy, Quality Control and Assurance Manager, ICM Pharma, Singapore
Richard Chai, Technical Service Manager, STERIS Corporation, Singapore

12:30
Lunch

TRACK  G (PM): TECH TRANSFER

Chairman: Liu Shan Shan, ISPE Singapore Vice President, Singapore

13:45
PRODUCT TRANSFER CASE STUDY ON PTS ANTI-CANCER DRUG: WORLD’S FIRST TARGETED CHEMO-ABLATION

  • Experience sharing from Gongwin on tech transfer success with CMO partner
  • Current landscape for local production and tech transfer in Taiwan, China and the US
  • Key factors to consider ensuring successful tech transfers, and how to address roadblocks

Wu Tai Jung, Director of Production Technology Division, GONGWIN Biopharm, Taiwan

14:15
SUN PHARMA’S EXPERIENCE IN TECH TRANSFER FOR BIOLOGICS

  • Critical steps for a successful tech transfer process
  • Risk management in the tech transfer of biologics
  • Overcoming challenges of biologics process transfer

Suyamburam Sathasivam, Senior General Manager and Head of External Manufacturing Biologics, Sun Pharma, Dubai

14:45
NAVIGATING REGULATORY AND COMPLIANCE ISSUES SURROUNDING TECH TRANSFER

Dr. Harleen Kaur, Senior Research Scientist-I, Aurobindo Biologics, India

15:15
Afternoon Refreshments

15:45
BEST PRACTICES FOR EFFECTIVE TECH TRANSFER- FROM R&D TO CLINICAL TO COMMERCIAL

Moderator: Liu Shan Shan, ISPE Singapore Vice President, Singapore

Panellists:
Wu Tai Jung, Director of Production Technology Division, GONGWIN Biopharm, Taiwan
Suyamburam Sathasivam, Senior General Manager and Head of External Manufacturing Biologics, Sun Pharma, Dubai
Dr. Harleen Kaur, Senior Research Scientist-I, Aurobindo Biologics, India
Ruchir Umalkar, Deputy General Manager – Process Development and Technical Services, Mylan, India

16:15
Combined Q&A session

17:00
YOUNG PROFESSIONALS (YP) NETWORKING

18:00
Close of Conference

Workshop 1 : 13:00 – 17:00
Hands-On Implementation of Risk-Based Qualification following the New ISPE Baseline Guide

Workshop Speakers:

Pierre Winnepenninck
ISPE Singapore Conference Chair,
Singapore

Hazem Eleskandarani
Project Director, Engineering & Property Services
Johnson & Johnson, United States

Workshop 2: 13:00 – 17:00
Root Cause Analysis and CAPA

Workshop Speaker:

spk-maurice-parlane

Maurice Parlane
ISPE PV Chapter Lead, Director, ISPE Australasia & Director
Centre for Biopharmaceutical Excellence, Australia

Women in Pharma Brainstorming Lunch & Talk

  • All are welcome! Entry with a Women in Pharma pin (available at ISPE, CAI & No deviation booths; donations of US$ 10 / US$ 15 and above; all proceeds go to ISPE Foundation)
  • Engage in lively discussion and insights with facilitators drawn from industry leaders.
  • A talk will follow lunch (topic and speaker details to come)

1st time! Happy Hour & Young Professionals (YP) Networking

23 August 2019, 5.30pm till late, Paulaner Brauhaus

All are welcome to join this informal gathering, after our annual conference winds down.

Whether you’re a young or seasoned professional, this is a great opportunity to engage with friends and peers over an ice cold beer. Show your ISPE entry pass and the first drink is on us!

NEW! ISPE Singapore Hackathon – calling Students & Young Professionals*!

21 – 22 August 2019 9am-7pm

*Students may be Undergraduates or Post-graduate; Young Professionals (YPs) are members with up to 5 years’ industry experience.

Singapore and regional affiliates have held Poster Competitions for individual entrants, with the overall winner sponsored to present their poster at the USA Annual meeting. Last year, our regional winner from Philippines, Cy M. Rodriguez took the global award in the Undergraduate category!

This year, ISPE Singapore is proud to host the first Hackathon, for students and young professionals (YPs)!

All participants will receive a real-world, industry-relevant case study prior to the beginning of the Hackathon. Industry professionals will judge the presentations. Teams will be tasked with developing a solution to their respective challenge and present it to judges on 22 August.

Winners will be announced later that day at Pharmanite.

Teams compete for a Team Prize, while the Best Performer Prize will be awarded to an individual, to participate in the Hackathon at the USA Annual meeting in Las Vegas. This takes place from 26-27 October and culminates with the Annual Member Brunch and Award Ceremony on 29 October 2019.

FAQs:

  • Eligibility Criteria
    • Young Professional with 1 – 5 years experience in the life sciences industry
    • Undergraduate student with internship/work experience in the life sciences industry
    • All participants must be current or sign up as ISPE members by 21st August 2019
  • The overall Best Performer must be available to join the Annual Meeting Hackathon in Las Vegas from 25-29 October 2019. If not, the next runner-up will be granted travel and accommodation to compete.
  • The Team Prize will be awarded and shared amongst the winning team.
  • Individuals will be assigned to a team, comprising a mix of students and YPs