Conference Overview

The 2019 ISPE Annual Meeting & Expo will focus modernization, globalization, and transformation in pharmaceutical science and manufacturing. This signature event draws pharmaceutical and biopharmaceutical professionals at all levels of the industry from young professionals to the most senior executives in drug manufacturing, supply chain, devices, equipment and services, and global regulatory agencies.

Submit Proposal

Call for Proposals Timeline

  • Call for proposals opens
  • Deadline for submissions
  • Committee review begins
  • Submitters notified of status

Guidelines

Abstract submissions may be proposed for any of the following:

  • 90-Minute Session
  • 2-Hour Workshop
  • Individual Oral Presentation
  • Poster Presentation

All presentations must be free of commercial intent Incomplete proposals will not be considered

By submitting a proposal, you acknowledge that, if your proposal is accepted, your organization will support your attendance at the conference(s). Accepted Annual Meeting leaders and speakers are responsible for their own travel and accommodations. Leaders and speakers giving a full presentation receive complimentary conference registration for the day on which their session is scheduled. Interested leaders and speakers may purchase full conference registration at a discounted rate. Session leaders who are not giving a full presentation, co-leaders, co-presenters, poster presenters, and panel only participants are eligible for discounted rate on education registration.

Before 30 June 30 June – 17 Sep After 17 Sep
$1,465 $1,595 $1,725

Requested Topics

Facilities and Equipment

Track Directors:
Steven Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc.
Brian Pochini, Principal Engineer, Sanofi

Transformation and Modernization of Harmonized and Efficient Facilities and Equipment
This track is designed to meet the needs of attendees challenged to provide modern and efficient facilities used to support the development, manufacturing, testing, and storage of pharmaceutical industry products meeting quality standards. A manufacturing transformation is in progress by applying harmonized approaches to both innovative design solutions and project delivery strategies. Each product lifecycle component and the nature of the product provide unique challenges in facility design, equipment selection, and providing quality pharmaceutical product to improve patient health. The emphasis of the topics presented by the F&E Track, for the most part, has been arranged to provide Owners/ Users, those very special individuals whose experiences, wants and needs are invaluable in modernizing, harmonizing, and transforming the pharmaceutical facilities of the future.

  • Transforming legacy facilities for new products and processes
  • Harmonized approaches to both facilities design and project delivery to provide efficiency
  • Consideration of reliability and sustainability impacts
  • Application of QRM to the C&Q process to insure facilities and equipment fit for their intended purpose
  • Harmonized QRM impacts when integrating GAMP (PCS) and ASTM E2500
  • How to handle Regulatory implications in new facilities

Communities of Practice/Special Interest Groups:
Commissioning & Qualification, Containment, Critical Utilities, HVAC/Sustainable Facilities, Project Management, Oral Solid Dosage, Sterile Products Processing, Biotechnology, GAMP®

Information Systems

Track Directors:
George Bass, CSV and Data Integrity Consultant, GGB Services
Christian Wölbeling, Senior Director Global Accounts, Werum IT Solutions

Transformational Technologies: Quality Innovation and Digitalization
The Digitalization of the pharmaceutical industry results in disruptive changes in Information Systems (IS) design, qualification, and lifecycle management. The new digital ICH Q10 Pharmaceutical Quality Systems / PQS enablers Digital Maturity and Data Integrity by Design need new design concepts. The PQS Digitalization Element Information Systems has a key role in the Digitalization of the Smart Factory. This includes the end-to-end ICH based pharmaceutical lifecycle management from Development, Clinical, Tech Transfer, Scale Up to Commercial Manufacturing streamlining the manufacturing supply chain.

  • Digitalization Strategies, Concepts, and Cultural Implications
  • Practical Experiences in Data Integrity by Design
  • Practical Experiences in achieving Digital Maturity
  • Clinical/R&D Systems Digitalization
  • Technologies & Devices in Biotech and Cell & Gene Therapeutic Applications
  • Digital Health
  • IT Cyber Security and Regulatory Compliance
  • Cloud Systems design, qualification, validation & lifecycle management
  • Pharma 4.0 Operating Model design concepts
  • Changes in infrastructure design, qualification, validation and lifecycle management
  • Digitalization of Quality Systems and Processes

Communities of Practice/Special Interest Groups:
GAMP®, Data Integrity SIG, Blockchain SIG, Cloud SIG, Agile SIG, Pharma 4.0 SIG, PAT & Lifecycle Control Strategy, Emerging Technologies

Innovation in Pharmaceutical Manufacturing

Track Director:
Michael O’Brien, Owner, NextGenTech Pharma Consulting LLC

New Frontiers in Medicine – Innovative Technologies and Applications
The Innovation Forum will focus on emerging and evolving technologies that are helping drive a revolution in medicinal therapies, analytical techniques, manufacturing paradigms, medical devices as well as novel methods to deliver the next generation of drugs to patients. The intent of this track is to highlight the global Pharmaceutical industry’s challenges, recent innovations, opportunities and success stories relative to the discovery and adoption of emerging technologies for pharmaceutical applications. This forum seeks to highlight innovations in small molecule, biopharmaceutical (large molecule) as well as whole cell and tissue engineering. Regulatory perspectives on the key challenges and opportunities for the adoption of these technologies will also be in scope for the IF sessions.

  • Bioprinting
  • Expanding chemical space for drug discovery explorations
  • Adoption of Artificial Intelligence (AI) by pharma and biotech
  • New Antibiotics Discoveries
  • Serialization and Supply Chain Security
  • Bio-pharmaceutical monoclonal antibodies: Manufacturing and Formulation Innovations
  • Biomanufacturing: Advances in single-use systems and continuous/closed processing
  • Advances in robotics and 3D printing in the Pharmaceutical industry
  • Novel trends in drug delivery

Communities of Practice/Special Interest Groups:
Facilities and Equipment, Information Systems, Product Development & Production Systems, Biological Engineering

Process Development & Manufacturing

Track Directors:
Lisa Graham, Vice President of Analytics Engineering, Seeq Corporation
Sarah Mancini, Director, Global API Technology, Zoetis

Transforming Process Development and Manufacturing Paradigms
The track will explore technologies and business strategies that can change the process development and manufacturing paradigms to have a transformative impact on the industry. Examples include integration of manufacturing equipment, continuous manufacturing, compatibility of API with drug product, single-use technology, knowledge management, integrated data analytics and other technologies and methodologies.

  • Continuous Manufacturing
  • Compatibility of API with Drug Product
  • Strategies to Ensure Process Capability/Product Robustness
  • Process Control and Integrated Data Analytics in Manufacturing
  • Data Science Solutions in Process Development
  • Technology Transfer: Pilot to Launch

Communities of Practice/Special Interest Groups:
Biotechnology, Disposables, Oral Solid Dosage, PAT & Lifecycle Control Strategy, Sterile Products Processing, Pharma 4.0, Regulatory, Information Systems, Knowledge Management

Quality Systems & Regulatory

Track Directors:
Timothy Watson, Executive Director and Team Leader, CMC Advisory Office, Pfizer Inc.
Sarah Pope Miksinski, Senior Director, Global Regulatory Affairs, AstraZeneca

Harmonization. We’re All In!
This track will focus on globalization of regulatory and quality issues and the opportunities for harmonization and implementation of new initiatives and guidelines. This includes issues related to GMP, expanding ICH topics and implementation in new member regions, and accelerated access to new medicines and nest generation therapies. This session will also explore the challenges, consequences, and opportunities presented by global regulatory convergence (or divergence) for maintenance of lifecycle, innovative improvements, product quality, supply and introduction of novel manufacturing techniques, etc.

  • Clinical Relevance
  • ICH Q12, 13, 14 updates and implantation examples/ cases studies
  • Drug device combinations
  • Big data and artificial intelligence
  • Facility and utility impact on quality
  • Global Regulatory Harmonization- ICH case studies
  • Accelerated development programs
  • GMP, CMC aspects of Continuous Improvement
  • Inspection challenges with novel and breakthrough therapies
  • Process Validation
  • Continuous Manufacturing and other emerging technologies
  • Quality and regulatory implications for continuous manufacturing
  • Regulatory aspects of analytical methods development
  • Technology Transfer
  • Quality & regulatory challenges for novel therapies

Communities of Practice/Special Interest Groups:
Product Quality Lifecycle Implementation (PQLI), Process Validation, Quality Metrics, Commissioning & Qualifications, Sterile Products Processing, Biotech

Supply Chain Management

Track Directors:
Rodney Neal, Strategic Program Manager, Werum IT Solutions
Oliver Stauffer, CEO, PTI Inspection Systems

Global Supply Chain: Driving Transformation in Pharmaceuticals
A convergence of factors is causing the pharmaceutical industry to evaluate and implement new supply chain strategies, technologies and practices. Market dynamics include a desire to use low cost manufacturing clusters, logistics complexity, demand shift to emerging markets and remote collaboration by brand owners with CMOs and CDMO / CROs. The End to End Supply Chain track equips a new generation of supply chain professionals with tools to effectively transform the industry to meet the challenges.

  • Supply Chain transformations required by personalized medicine; e.g. Cell & Gene Therapy
  • Harmonizing supply chains across market diversity; first market to emerging markets
  • Mitigating risks in increasingly complex supply chains; e.g. regulatory differences, natural disasters, inefficient or unpredictable logistics, ocean shipment vs air freight, data security, etc.
  • Realizing the promise of technology (e.g. Internet of Things) to increase performance of supply chains; e.g. GPS, condition management, loss management, chain of custody, timely sharing of information, “smart” containers, block chain, etc.
  • Serialization as an anti-counterfeiting initiative is the first wave of supply chain transformation; e.g. GPS location, cold chain assurance, real time data collection, universal sharing of information, etc.

Communities of Practice/Special Interest Groups:
Product Development & Production Systems (API, Biotech, Process Development, Investigational Products, Operations Management, Packaging, Serialization SIG, Pharma 4.0, GAMP® Cloud SIG

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