2020 ISPE Biopharmaceutical Manufacturing · in manufacturing, facilities, and analytics important...

2020 ISPE

Biopharmaceutical ManufacturingVIRTUAL CONFERENCE

1–2 June

Connect with us #ISPEBio20 ISPE.org/Bio20 | 2

2020 ISPE

Bi pharmaceutical Manufacturing VIRTUAL CONFERENCE

Program AgendaMonday 1 June 2020Monday 0900–1030Opening Plenary Session—Challenges and Opportunities in the Manufacturing of New Treatment ModalitiesSession Leader: Joseph Famulare, Conference Chair, Vice President Global Compliance and External Collaboration, Genentech, A Member of the Roche Group

Session Description: This year, the 2020 ISPE Biopharmaceutical Manufacturing Conference will focus on advances in manufacturing, facilities, and analytics important to bring new therapies to patients. Now more than ever, manufacturing is on the critical path as many new treatments in the area of personalized medicines and individualized batch production present the challenge to bring these medicines through rapid development, reliable manufacturing, and availability to patients a pace with the advances clinical research is bringing to address unmet needs. At the same time, biosimilars are advancing with the opportunity to provide more access to medicines. In this opening session, we will hear an important regulatory perspective from FDA on gene therapy drug development and a reflection from industry on 10 years of Biosimilars.

0900–0905 Welcome and Opening Remarks Thomas Hartman, Incoming CEO and President, ISPE

0905–0915 Conference OverviewJoseph Famulare, Conference Chair; Vice President Global Compliance and External Collaboration, Genentech, A Member of the Roche Group

0915–0920 Boston Chapter WelcomeEric Felz, Associate Director Validation, Takeda Pharmaceutical Company

0920–0950 Reflecting on a Decade with the Biologics Price Competition and Innovation ActCarol Lynch, President US, Sandoz

0950–1020 Gene Therapy: Efficient Drug DevelopmentWilson Bryan, MD, Director, Office of Tissues and Advanced Therapies, CBER, FDA

1020–1030 Question and Answer/Discussion

1030–1830 Virtual Exhibit Hall and Virtual Posters

1030–1045 Break


2020 ISPE


Program AgendaMonday 1 June 2020 continuedMonday 1045–1215 Concurrent Sessions

Planning, Building and Operating Cell and Gene Therapy Facilities (Part I)Session Leader: Andre Walker, CPIP, Principal, Walker BioPharm Consulting

Pharma 4.0: What it is, What it isn’t, and How to implement itSession Leader: Eric Felz, Associate Director Validation, Takeda Pharmaceutical Company

Session Description: Many cell and gene therapy facilities are in different phases of planning, construction, and expansion. Learn from experts in engineering and manufacturing about how these facilities are progressing. This two-session track will explore various designs as we move from lab scale to higher volume production; control for single use to allow for multiple manufacturing trains. These sessions will examine going from manual to automated processing to meet the demand and the various technologies and layouts being utilized to supply patient needs and meet regulatory GMP requirements.

Session Description: Trying to figure out what pharma 4.0 is and what it means to your business? This session will clarify what Pharma 4.0 is and offer practical aspects of how it has been implemented in the plant and what it means to your workforce.

1045–1110Building Flexibility for Multiple Cell Therapy ProcessesDaniel Swanson, Senior Project Engineer, IPS

1110–1135Enabling Viral Vector Manufacturing in a Traditional Biopharmaceutical Pilot PlantEdward Stevens, Manager of Capital Projects, Biopharmaceutical Pilot Plant, GlaxoSmithKline

1135–1200Leveraging Operational Simulations for Gene Therapy FacilitiesNiranjan Kulkarni, PhD, Director, Operations Improvement, CRB

1200–1215Question and Answer/Discussion

1045–1110Why Pharma 4.0? Did We Advance?Christian Woelbeling, Senior Director Global Accounts, Werum IT Solutions

1110–1135Enabling Automation and Pharma 4.0 in Cell TherapyShin Kawamata, Director of R&D Centre for Cell Therapy, Foundation for Biomedical Research and Innovation (FBRI) David Margetts, CEO, Factorytalk, Co. Ltd.

1135–1200Pharma 4.0 Meets Operator 4.0: Facing Knowledge Challenges of Manufacturing in the 4.0 EraPatrick Boyle, President, SkillPad Canada Inc.


1215–1245 Lunch Break


2020 ISPE



Planning, Building and Operating Cell and Gene Therapy Facilities (Part II)Session Leader: Andre Walker, CPIP, Principal, Walker BioPharm Consulting

Application of ICH Q12 Principles in Modern CMC SubmissionsSession Leader: Terrance Ocheltree, PhD, President, PharmTree Consultants

Session Description: Many cell and gene therapy facilities are in different phases of planning, construction, and expansion. Learn from experts in engineering and manufacturing about how these facilities are progressing. This two-session track will explore various designs as we move from lab scale to higher volume production; control for single use to allow for multiple manufacturing trains. These sessions will examine going from manual to automated processing to meet the demand and the various technologies and layouts being utilized to supply patient needs and meet regulatory GMP requirements.

Session Description: This session brings together industry and regulatory agency representatives to discuss case studies involving the implementation of ICH Q12 principles in regulatory submissions to facilitate post-approval CMC changes in an efficient and predictable manner.

1245–1310ATMP Facility Scale-up to Production using Isolator TechnologyMichael Hennessy, Head of Global Sales, ProSys Group

1310–1335The Impact of Innovation on Building the Facilities of the FutureJohn Khoury, Principal Engineer, ProjectFarmaAlexis Melendez, Director of Engineering and Facilities, Kite Pharma, Inc.


1245–1300FDA Perspective on the Implementation of ICH Q12Terrance Ocheltree, PhD, President, PharmTree Consultants

1300–1325ICH Q12 and Beyond: The Journey Towards Regulatory Convergence in Product Life Cycle ManagementNina Cauchon, PhD, Director, Regulatory Affairs—CMC, Amgen

1325–1350Application of ICH Q12, Established Conditions, and a Product Life Cycle Management Document to the Analytical Aspects of the 2019 FDA Q12 Pilot ProgramMichael Cohen, PhD, Research Fellow—Global CMC, Pfizer Inc.

1350–1415Extended Panel Q&A/Discussion:Nina Cauchon, PhD, AmgenMichael Cohen, PhD, Pfizer Inc.Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Product Supply Quality, Novo Nordisk

1415–1430 Break


2020 ISPE



Cell and Gene Therapy CMC and Manufacturing: Ensuring the Analysis, Production, and QualitySession Leader: Robert Dream, PE, CPIP, Managing Director, HDR Company LLC

Technology Advancements for Drug Product ManufacturingSession Leader: Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.

Session Description: Robust and cost-effective characterization and manufacturing presents a core challenge in the commercialization of gene and cell therapies with pressure mounting on CMC, analytical and manufacturing teams to keep up with accelerated development times and cost pressures. Gene and Cell Therapy CMC and Manufacturing examines the critical challenges facing the production, characterization and quality control of gene and cell therapies, with dedicated presentations on rapid CMC development, comparability assessment, product and process characterization, upstream and downstream bioprocessing and considerations for personalized and large-scale manufacturing.

Session Description: This session will discuss technology advances related to the manufacturing of biologic drug products of different dosage forms. Technologies and case studies to be discussed include low temperature sealing of container closures and continuous aseptic spray freeze-drying.

1430–1455Transformation from R&D to ManufacturingJames Warren, PhD, Vice President, Pharmaceutical Development, Ultragenyx

1455–1520Re-thinking Comparability Assessments for Individualized TherapeuticsKathy Francissen, PhD, Senior Director, Pharma Technical Regulatory, Genentech, A Member of the Roche Group

1520–1545Virtual Inspections: Navigating the New ParadigmMonica M. Commerford, PhD, Manager of Regulatory Affairs, Brammer Bio


1430–1455Dynamic Challenge Sealing Performance for Biologic Container Systems at Low TemperatureQingyu Zeng, PhD, Fellow, Technical Director, West Pharmaceutical Services, Inc.

1455–1520Single-Use Technology for Final Fill: An OverviewLaura Moody, PhD, Product Manager—Primary Packaging, Pharma Liquid Packaging, North America, Syntegon Pharma Technology LLC

1520–1545Vial Visualization Using AIJoshua Stauffer, Staff Engineer, Merck & Co., Inc.


1600–1615 Break


2020 ISPE



Increased Automation and Digitalization in ManufacturingSession Leader: David Doleski, Compliance Head for Biologics, Sanofi

Practical Challenges with Quality System Management in Cell and Gene TherapiesSession Leader: Vivianne Arencibia, Independent Consultant, Arencibia Quality Compliance Associates

Session Description: Computer systems have continued to help manage complexity involved in biopharmaceutical manufacturing. Such systems have evolved in ways previously not anticipated. This session will explore some of the evolving uses of computer systems to allow a greater focus on product quality.

Session Description: This session will focus on the challenges with the establishment of quality oversight and systems from the initial patient interface through manufacturing and supply for cell and gene therapies. Experience with the application of cGMPs in the hospital setting will be discussed as well as the conflicting priorities when multiple companies are imposing different demands on the same institutions, notably as these controls are part of the approved applications. The efforts to harmonize standards globally, as well as the regulator experience in determining true compliance risks will be addressed.

1615–1640BioPhorum Plug and Play: Developing and Utilizing Standards to Enable Reduced Project Delivery Time Bruce Kane, P.E. Global Life Science Technical Consultant, Rockwell Automation

1640–1705How Digital is Transforming Quality Assurance Operations: A Focus on Real and Right Time ReleaseMichael Shanno, Head of Digital and IT Biologics Quality, Sanofi

1705–1730The Digital Twin: Integrated Engineering the Key to Cost Effective DigitalizationMartin Mayer, Business Development, ZETA GmbH


1615–1640FDA Perspective on GMPs for Cell and Gene TherapiesEkaterina Allen, PhD, RAC, Regulatory Project Manager and CMC Facilities Reviewer, CBER, FDA

1640–1705Quality Considerations for Cell and Gene TherapyLuciana Mansolelli, Head Quality Strategic Planning, Cell and Gene Technical Development and Manufacturing, Novartis

1705–1730Challenges for GMPs for ATMPs: European PerspectiveLina Ertle, Head of External Relations EMEA and Japan, Roche


1745–1830 Virtual Networking Session for Attendees, Speakers, and Exhibitors


2020 ISPE


Program AgendaTuesday 2 June 2020 Tuesday 0900–1030

Plenary Session—Regulatory Updates on Biotechnological and Biological ProductsSession Leader: Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.

Session Description: Regulatory expectations related to biotechnology and biological products are continually evolving both within mature and emerging regulatory agencies. This session will provide a snapshot of recent regulatory changes across the global. Invited speakers will discuss the quickly evolving regulatory landscape in China, emerging regulatory expectations for drug device combination products in Europe, and changes to biologics regulations within the US.

0900–0930Inspectional Trends for Biotech Products and Drug SubstancesFDA Speaker Invited

0930–1000Update on Sterile Products and Change ManagementRichard Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing and Product Quality, CDER, FDA

1000–1030Regulatory Requirement Differences Between China and US for Biologics and BiosimilarsLawrence Hill, CEO and Vice President Global Clinical Development, Gan and Lee USA

1030–1700 Virtual Exhibit Hall and Virtual Posters

1030–1045 Break


2020 ISPE


Program AgendaTuesday 2 June 2020 continuedTuesday 1045–1215 Concurrent Sessions

Automation, Robotics and Digitalization in Biopharmaceutical QC LabsSession Leader: Georg Singewald, Vice President, Global Quality Control, Genentech, A Member of the Roche Group

Single Use Technology StrategiesSession Leader: Darren Dasburg, PE, CEO, TreeCo Inc.

Session Description: The goal of this session is to engage laboratory leaders, automation and informatics experts, regulators, and instrument/equipment/software vendors in rich discussions regarding the use of automation, robotics, and digital solutions to advance multiple dimensions of operational excellence in the pharma quality control laboratories.

Session Description: The approach to manufacture is never simple and now more and more hybridized. In this session experts share their latest findings and recommendations in SUT. Given the movement toward personalized medicine even if you are not a single use proponent, getting ready for the future is important to your business.

1045–1110Technology Solutions and Business Drivers for Moving from Manual to Automated Solutions in the Pharmaceutical QC LabJacqueline Larew, Senior Advisor-Global Quality, Eli Lilly and CompanyMark G. Schweitzer, Global AS&T and Scientific Initiatives, Novartis

1110–1135QC Today and QC in the FutureVinny Browning III, Executive Director Commercial Attributes Sciences, Amgen

1135–1155Case Study: Automation of Stability Data Reporting and Trend AnalysisJanine Kuratli, Manager Data Analytics, CSL Behring

1155–1215Case Study: Automated Technology Platform for Real-Time PCR-based Adventitious Agent DetectionSven M. Deutschmann, PhD, Head of Global ASAT Adventitious Agents Testing and Alternative Microbiological Methods, Global QC, Roche Diagnostics GmbH

1045–1115Going from N-1 to Purified Product in a Closed and Connected Single-use SolutionPietro Perrone, PE, Cytiva, Formerly GE Healthcare LifeHande Özgen, PhD, Scientist, Cytiva, Formerly GE Healthcare Life

1115–1145Single-use Versus Stainless Steel Biomanufacturing Facilities: Are Hybrid Facilities the Best of Both Worlds?Lindsay Smart, ZETA GmbH


1215–1245 Lunch Break


2020 ISPE


Program AgendaTuesday 2 June 2020 continuedTuesday 1245–1415

Preparing for the Workforce Needs in Biopharma ManufacturingSession Leader: Antonio Moreira, PhD, Vice Provost, University of Maryland, Baltimore County

Session Description: The new therapeutic modalities and associated manufacturing processes and technologies require a new workforce skillset. Process automation, process intensification, continuous manufacturing, and scale-out versus scale-up are examples of what are becoming new norms in manufacturing. The demand for a trained workforce is challenging many biopharma companies. This session will discuss approaches for meeting these challenges.

1245–1315Biopharmaceutical Manufacturing Workforce Development in the Age of Gene TherapyJohn Balchunas, Workforce Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

1315–1345University Engagement SuccessesAntonio Moreira, PhD, Vice Provost, University of Maryland, Baltimore County Lindsey Silva, PhD, Senior Manager, Microbiology Global QC Technology, Genentech, A Member of the Roche GroupManfred Maeder, PhD, Global Head Device Development and Commercialization, Novartis


1415–1430 Break

Tuesday 1430–1530

Innovation in Technological Platforms in Biopharmaceutical ManufacturingSession Leader: Stephen Mahoney, JD, Senior Director, Global Quality and Compliance, Genentech, A Member of the Roche Group

Session Description: As described in the morning session, regulatory expectations continue to evolve given the complexities associated with new products and innovation. This session will provide an opportunity to hear more about this topic in the context of an innovative vaccine facility and related sterile manufacturing requirements.

1430–1500Process and Facility Innovation using PODs in Vaccine Manufacturing—Benefits and ChallengesMaria Hoffman, Executive Director, Supply Chain Management, Merck & Co., Inc.

1500–1530Innovations in Sterile Manufacturing—Regulatory ConsiderationsPatricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment, CDER, FDA

1530–1545 Break


2020 ISPE


Program AgendaTuesday 2 June 2020 continuedTuesday 1545–1700

Closing Plenary Session—Regulatory and Industry Insights and Lessons LearnedSession Leader: Darren Dasburg, PE, CEO, TreeCo Inc.

Session Description: Wrapping up the conference it is important to hear from regulatory leaders to help frame the strategy for the era ahead. Lessons learned from organizations around the world will give individuals the most current insights for those difficult discussion back at your home base.

1545–1615Facilitating Development of Advanced TherapiesRaj K. Puri, MD, Director, Division of Cellular and Gene Therapies, CBER, FDA

1615–1645Industry and Regulatory Fireside ChatRaj K. Puri, MD, PhD, Director, Division of Cellular and Gene Therapies, CBER, FDAPatricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment, CDER, FDA John Balchunas, Workforce Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) Lawrence Hill, CEO and Vice President Global Clinical Development, Gan and Lee USAMaria Hoffman, Executive Director, Supply Chain Management, Merck & Co., Inc.Zhihao (Peter) Qiu, PhD, Acting Director, Division of Biotechnology Manufacturing, CDER, FDA

1645–1700Closing Remarks

2020 ISPE


Exhibitor List


Bigfinite650 California Street, 7th floor, San Francisco, CA 94108 USAPhil [email protected]

Burkert Fluid Control Systems11425 Mt. Holly-Huntersville Road, Huntersville NC, 28078 USAAndrew [email protected]

The Baker Company175 Gatehouse Road, Sanford, MN 04073 USAGregory [email protected]

CAI2601 Fortune Circle East, Suite 301B, Indianapolis, IN 46241-5567 USAJennifer Lauria [email protected] 317-271-6082www.cagents.com

CRB1251 NW Briarcliff Pkwy, Suite 500, Kansas City, MO 64116 USALisa [email protected]

DPS Group959 Concord St. Suite 100, Framingham, MA 01701 USAAlexa [email protected] 508-861-3748www.dpsgroupglobal.com

IPS721 Arbor Way, Suite 100, Blue Bell, PA 19422 USAMark [email protected]

Mason-Grey400 Galleria Parkway Suite 1500, Atlanta GA 30339Joseph [email protected]

2020 ISPE


Exhibitor List


MilliporeSigma80 Ashby Road, Bedford, MA 01730 USA1-800-645-5476www.emdmillipore.com

ProPharma Group8717 W. 110th St, Suite 300Robert BeallBob.Beall@propharmagroup.com913-906-7179www.propharmagroup.com

Rapid Micro Biosystems1001 Pawtucket Blvd., Suite 280, Lowell, MA 01854 USACourtney Makolandracmakolandra@rapidmicrobio.com978-349-3661www.rapidmicrobio.com

SUEZ-Sievers Instruments6060 Spine Rd., Boulder, CO 80301 USABrittany Gleasonbrittany.gleason@suez.com800-255-6964www.sieversinstruments.com

Werum IT Solutions, Inc.5 Sylvan Way, Suite 200, Parsippany, NJ 07054Ryan Hamilton, Sales Manager and Business Consultant [email protected]

ZETA GmbHZetaplatz 1, Lieboch, Styria, AustriaLindsay [email protected]+4331369010-0www.zeta.com


2020 ISPE


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2020 ISPE Biopharmaceutical Manufacturing · in manufacturing, facilities, and analytics important...

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