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The Parenteral Drug Association presents the...

2017 PDA Modern Biopharmaceutical Processing Conference November 28-29, 2017 | Singapore Hilton Singapore Exhibition: November 28-29

#PDASingapore

Image supplied courtesy of Pall Corporation

From Facility Design to Product Distribution pda.org/2017BiopharmSingapore This preliminary agenda is current as of August 28, 2017 RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS


2017 PDA MODERN BIOPHARMACEUTICAL PROCESSING CONFERENCE – GENERAL INFORMATION

Connecting People, Science and Regulation®

PROGRAM PLANNING COMMITTEE

WELCOME! Dear Colleagues,

Sudhir Goudar, MS Novartis

Wayne Lee, PhD, MBA Pall Corporation

Hongyang Li, MS Novartis

Anthony Morandi AstraZeneca

Arleen Paulino Amgen Inc.

David Spaulding SeerPharma

Andiyanto Sutandar, PhD HGP Asia Pte. Ltd.

Georg Roessling, PhD PDA

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Dinesh Khokal, PhD Amgen Inc.

The Program Planning Committee and the PDA Singapore Chapter invite you to participate at the 2017 PDA Modern Biopharmaceutical Processing Conference, November 28-29, 2017, at the Hilton Singapore. The goal of the Conference is to address all relevant aspects which need to be considered when manufacturing modern biopharmaceuticals. The Conference will address: • The latest development in regulations; • Technology transfers and upscaling from research to manufacturing site; • Processing, especially in single use systems; • Continuous manufacturing approaches; and • Challenges of temperature-controlled distribution of biopharmaceuticals in the global supply chain. Sessions will include a case study of a new Singapore facility for biopharmaceuticals manufacturing, details on experiences with process, regulatory agencies and businessrelated advantages and a technology update session will show new trends in technologies for the pharmaceutical industry. There will be plenty of time for discussion and questions during the panel discussions as well as networking opportunities with your peers. There will also be an exhibition presenting equipment and services. We look forward to welcoming you to beautiful Singapore! Respectfully, The 2017 PDA Modern Biopharmaceutical Processing Conference Program Planning Committee and the PDA Singapore Chapter

Molly O’Neill Moir, CMP PDA


November 28-29, 2017 | Hilton Singapore | Singapore Exhibition: November 28-29

GENERAL INFORMATION, REGISTRATION

#PDASingapore

FOUR WAYS TO REGISTER 1. Click pda.org/2017BiopharmSingapore 2. Fax +1 (301) 986-1093 3. Mail PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA 4. Phone +1 (301) 656-5900 ext. 115

VENUE Hilton Singapore 581 Orchard Road Singapore 238883 Republic of Singapore Phone: +65-67-372-233 Rate: Single: S$280 + applicable taxes; Double: S$300 +applicable taxes.

WHO SHOULD ATTEND Manager; Leader; Supervisor; Branch Chief | Director | Scientist; Researcher | Engineer Speciality Area/Areas of Interest Biotech | Process Validation | Quality | Technology Transfer | Data Integrity | Regulatory Affairs | Facilities and Engineering | Manufacturing | Research

CONFERENCE REGISTRATION HOURS Tuesday, November 28: 7:30 a.m. – 5:30 p.m. Wednesday, November 29: 7:30 a.m. – 2:15 p.m.

DRESS/ATTIRE Business casual attire is recommended for all events. The temperature in the meeting rooms tends to be cool, so a jacket or sweater is advised for your comfort.

SPECIAL REQUIREMENTS For information regarding special needs accommodations, please inquire at the Registration Desk. PDA is committed to make all events accessible to all individuals.

CONTACT INFORMATION Conference and Exhibition/ Support Inquiries Molly O’Neill Moir, CMP Vice President, Programs & Meetings Tel: (301) 656-5900 ext. 132 Email: moir@pda.org Registration Customer Care Tel: +1 (301) 656-5900 ext. 115 Email: registration@pda.org

Content/Agenda Inquiries Georg Roessling Senior Consultant, Business Development Email: roessling@pda.org

NETWORK, COLLECT INTELLIGENCE, AND FORGE KEY RELATIONSHIPS The 2017 PDA Modern Biopharmaceutical Processing Conference offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility and help you connect with industry leaders. This Conference will bring together leaders from biotech, process validation, quality, technology transfer, data integrity, regulatory affairs, facilities and engineering, manufacturing and research. Good foot traffic is one thing; good leads are another. At this Conference, you will have access to attendees from a variety of companies – making this a must-attend meeting. In addition, high-profile sponsorships are available for lanyards, notepads, audience-response systems, tote bags, pens, refreshment breaks, lunch and the Networking Reception. We’ll create a customized sponsorship package to fit your needs and budget. For more information about exhibit and support opportunities, please contact: Molly O’Neill Moir, CMP Vice President, Programs & Meetings Tel: (301) 656-5900 ext. 132 Email: moir@pda.org

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2017 PDA MODERN BIOPHARMACEUTICAL PROCESSING CONFERENCE – GENERAL INFORMATION

2017 PDA Modern Biopharmaceutical Processing Conference


2017 PDA MODERN BIOPHARMACEUTICAL PROCESSING CONFERENCE – AGENDA

Connecting People, Science and Regulation®

TUESDAY, NOVEMBER 28 7:30 a.m. – 5:30 p.m. Registration Open 7:30 a.m. – 8:30 a.m. Continental Breakfast 8:30 a.m. – 8:45 a.m. Welcome and Opening Remarks Richard M. Johnson, President and CEO, PDA 8:45 a.m. – 10:45 a.m. P1: Opening Plenary: Regulatory Updates Moderator: Richard M. Johnson, President and CEO, PDA Session Description: The pharmaceutical industry is a regulated industry; therefore, assessors and inspectors of health authorities are important partners of the industry. This session will highlight the latest regulations and regulators will share their observations from inspections. 8:45 a.m. – 9:15 a.m. Health Authority Perspective: Singapore Health Sciences Authority Boon Hoe Meow, Deputy Director (Overseas Audit)/Senior GMP Auditor, Health Sciences Authority (Singapore) (Invited) 9:15 a.m. – 9:45 a.m. Health Authority Perspective: U.S. FDA Alicia M. Mozzachio, MS, Senior Advisor for International Activities, CDER, FDA (Invited) 9:45 a.m. – 10:15 a.m. Health Authority Perspective Sia Chong Hock, former Head and Current Senior Consultant, Singapore Inspectorate and Chair, Association of Southeast Asian Nations Pharmaceutical Product Working Group (ASEAN PPWG) GMP Workgroup (Invited) Industry Perspective on API Regulations Stephan Rönninger, PhD, Dr.-Ing., Director International Quality External Affairs, Amgen Inc. 10:15 a.m. – 10:45 a.m. Questions and Answers/Discussion 10:30 a.m. – 7:00 p.m. Exhibit Area Open 10:45 a.m. – 11:15 a.m. Refreshment Break in Exhibit Area 11:15 a.m. – 12:30 p.m. P2: Facility Design, Single-Use Systems, and Cleaning Requirements Moderator: Wayne Lee, PhD, MBA, Director, Biopharmaceuticals, Asia-Pac, Pall Corporation Session Description: This session discusses the different facility concepts for single-use processes. Based on PDA Technical Report No. 66, the relevant aspects from project initiation to execution will be addressed. In addition, maintenance, cleaning, and disinfection for modern single-use system environments will be highlighted. 11:15 a.m. – 11:45 a.m. Facility Concepts on Single-Use Systems: PDA Update on Technical Report No. 66 Morten Munk, Global Technology Partner, NNE 11:45 a.m. – 12:15 p.m. Facilities: Cleaning and Disinfection: How Much is Needed? Jim Polarine Jr., MA, Senior Technical Service Manager, STERIS Corporation 12:15 p.m. – 12:30 p.m. Questions and Answers/Discussion

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November 28-29, 2017 | Hilton Singapore | Singapore Exhibition: November 28-29

TUESDAY, NOVEMBER 28 (CONTINUED)

#PDASingapore

12:30 p.m. – 1:30 p.m. Networking Luncheon 1:30 p.m. – 3:15 p.m. P3: Single-Use Systems Moderator: Anthony Morandi, Head of Operations Quality Global Strategy and Transformation, AstraZeneca Session Description: Single-use systems play a significant role in the manufacturing of biopharmaceuticals. This session addresses challenges when working with single-use systems, especially handling extractables and leachables, particles, and leak testing. The latest requirements from regulations will be considered as well. 1:30 p.m. – 2:00 p.m. Single-use Particulates Risk Management Patrick Evrard, Senior Director SLS, Single Use Technologies, Pall Corporation 2:00 p.m. – 2:30 p.m. Extractables and Leachables Piet Christiaens, PhD, Scientific Director, Toxikon Europe 2:30 p.m. – 3:00 p.m. Case study: Development of a Helium-based Supplier Integrity Testing Method for Single-use Systems (SUS) Integrated into a Global Container Closure Integrity (CCI) Strategy Carole Langlois, MBA, Senior Product Manager, Sartorius Stedim Biotech 3:00 p.m. – 3:15 p.m. Questions and Answers/Discussion 3:15 p.m. – 3:45 p.m. Refreshment Break in Exhibit Area 3:45 p.m. – 5:45 p.m. P4: Continuous Processing Moderator: Arleen Paulino, Vice President, Singapore Site Operations, Amgen Inc. Session Description: Continuous processing is the hot topic in pharmaceutical manufacturing. This session will give an overview of current best practice for continuous processing of biopharmaceutical products. Focus will be on the use of single-use systems and the unit operations: cell culture perfusion, chromatography, viral clearance, and filtration processes will be considered in a continuous processing approach. 3:45 p.m. – 4:15 p.m. Continuous Bioprocessing Using Single-Use Systems Parrish M. Galliher, MS, Chief Technology Officer, Upstream, GE Healthcare Life Sciences 4:15 p.m. – 4:45 p.m Continuous Processing Optimization with Smarter Tools Barbara Paldus, PhD, Vice President/General Manager, Finesse, a part of Thermo Fisher Scientific 4:45 p.m. – 5:15 p.m. Continuous Processing of Biopharmaceuticals: Virus Clearance Laura Holtmann, MS, Research Associate, Bayer/INVITE GmbH 5:15 p.m. – 5:45 p.m. Use of Process Analytics in Continuous Primary Manufacturing Martin W. Hermanto, PhD, Chemometrician, GlaxoSmithKline 5:45 p.m. – 6:00 p.m. Questions and Answers/Discussion 6:00 p.m. – 7:00 p.m. Networking Reception in Exhibit Area

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2017 PDA MODERN BIOPHARMACEUTICAL PROCESSING CONFERENCE – AGENDA

2017 PDA Modern Biopharmaceutical Processing Conference


2017 PDA MODERN BIOPHARMACEUTICAL PROCESSING CONFERENCE – AGENDA

Connecting People, Science and Regulation®

WEDNESDAY, NOVEMBER 29 7:30 a.m. – 2:15 p.m. Registration Open 8:00 a.m. – 9:00 a.m. Continental Breakfast 8:00a.m. – 8:45 a.m. Breakfast Session: Biotechnology Update Moderator: Georg Roessling, PhD, Senior Consultant, Business Development, PDA Session Description: This session gives suppliers of machines and processing and testing equipment as well as service providers an opportunity to share their latest technologies and services. 8:00 a.m. – 8:15 a.m. DHL Leonora Lim, Vice President, Life Sciences and Healthcare, Asia Pacific, DHL 8:15 a.m. – 8:30 a.m. Bosch Pharmatec Ralf Kretzschmar, General Manager, Bosch Pharmatec 8:30 a.m. – 8:45 a.m. From Theory to Practice: Scale Up and Transfer Chervee Ho, Director of Key Account Management, Asia Pacific, Vetter Pharma-Fertigung 9:00 a.m. – 10:45 a.m. P5: Advancing Manufacturing Operations: Amgen Case Study Moderator: Andiyanto Sutandar, PhD, Technical Director, HGP Asia Pte. Ltd. Session Description: The session will be introduced with a presentation on risk-based approaches for continuous manufacturing. Amgen has built a facility that recently went into operation. This presentation will cover differences, advantages, and challenges between traditional and single-use manufacturing plants. A panel discussion will follow addressing facility, continuous processing, closed systems, and regulatory aspects of such systems and a representative from Amgen will share their experiences. 9:00 a.m. – 9:30 a.m. Risk-based Approach for Continuous Manufacturing Wayne Lee, PhD, MBA, Director, Biopharmaceuticals, Asia-Pac, Pall Corporation 9:30 a.m. – 10:15 a.m. Case Study: Modern Biopharmaceutical Facility Arleen Paulino, Vice President, Singapore Site Operations, Amgen Inc. 10:15 a.m. – 10:45 a.m. Panel Discussion: Facility, Closed Systems, Continuous Processing, and Regulatory Requirements 10:30 a.m. – 2:00 p.m. Exhibit Area Open 10:45 a.m. – 11:15 a.m. Refreshment Break in Exhibit Area

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November 28-29, 2017 | Hilton Singapore | Singapore Exhibition: November 28-29

WEDNESDAY, NOVEMBER 29 (CONTINUED)

#PDASingapore

11:15 a.m. – 1:00 p.m. P6: Technology Transfer Moderator: Sudhir Goudar, MS, Executive Director-Senior Compliance Officer, Group Compliance and Audit, Novartis Session Description: Technology transfers from development to the manufacturing site is very important. Because of the complexity, early planning with a competent project team is most crucial to avoid delays in product launch. In this session, the most relevant points are summarized and highlighted in two case studies covering the technologies, processes, regulations, people, and their culture. 11:15 a.m. – 11:45 a.m. Technology Transfer while Scaling Up Gary Khoo, PhD, Head of Manufacturing, Shire 11:45 a.m. – 12:15 p.m. Industry Case Study: New Product Launch in Singapore Immaculada Gomez, Tech Transfer Lead, MS&T, Novartis NTO Solids, Singapore Maud Grachet, Product Steward, MS&T, Novartis NTO Solids, Singapore 12:15 p.m. – 12:45 p.m. Questions and Answers/Discussion 12:45 p.m. – 2:00 p.m. Networking Luncheon 2:00 p.m. – 4:00 p.m. P7: Good Distribution Practice: Temperature-Controlled Distribution of Biopharmaceuticals Moderator: David Spaulding, Partner and Training Manager, SeerPharma Session Description: In the global environment, APIs and pharmaceutical products can have an extended supply chain. APIs are transported to the fill-finish site, filled containers are brought to the labelling and packaging site; and, later on to the wholesaler, clinic, or patient. Mechanical stress and temperature excursion might have an impact on product quality; therefore, it has to be ensured that through the whole supply chain the transported goods are in a state of control. This session will address such issues from a practical point of view. 2:00 p.m. – 2:30 p.m. Controlled Freeze and Thaw Process for Monoclonal Antibody Solutions Mike Marciniak, MS, Senior Product Manager, Freeze-Thaw Technologies, Sartorius 2:30 p.m. – 3:00 p.m. Temperature Control and Monitoring of Pharmaceuticals in the Supply Chain Elizabeth Darragh, Vice President, Global Marketing Communications, Sensitech Inc. 3:00 p.m. – 3:30 p.m. Distribution of Biopharmaceuticals: Challenges of Transportation of Temperature Controlled Products Leonora Lim, Vice President, Life Sciences and Healthcare, Asia Pacific, DHL 3:30 p.m. – 4:00 p.m. Questions and Answers/Discussion 4:00 p.m. Closing Remarks Georg Roessling, PhD, Senior Consultant, Business Development, PDA

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2017 PDA MODERN BIOPHARMACEUTICAL PROCESSING CONFERENCE – AGENDA

2017 PDA Modern Biopharmaceutical Processing Conference


2017 PDA Modern Biopharmaceutical Processing Conference

Four easy ways to register – Click: www.pda.org/2017BiopharmSingapore Fax: +1 (301) 986-1093 (USA) Mail: PDA Global Headquarters 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA Call: +1 (301) 656-5900 ext 115

November 28-29, 2017 Hilton Singapore, Orchard Road, Singapore Exhibition: November 28-29

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CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by September 29, 2017, your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. If you are preregistering as a subsitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). REFUNDS for CONFERENCE: If your written request is received on or before September 29, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900. PLEASE NOTE THAT PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ON-SITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. RECORDING/PHOTO RELEASE: By registering for this event, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA conferences.

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2017 PDA Modern Biopharmaceutical Processing Brochure