2017 ISPE Annual Meeting Recorded Sessions

ISPE has teamed up with presenters from this year’s Annual Meeting & Expo to record 10 presentations that address a wide range of topics pertinent to global pharmaceutical professionals. This package is the ideal opportunity to gain valuable information from new technology, product development, case studies with in-depth knowledge, and best practices all without leaving your desk. These presentations will be sold as a package. PRODUCT FEATURES - 30-90 minute webinars from 10 Recorded Sessions - PowerPoint slides with synchronized audio - Downloadable presentation for notetaking - Unlimited playback for 90 days from receipt of login information.


Application of 3D Printing Technology in Dosage Form Design and Drug Delivery

Education Level: Advanced 

As 3D printing technology is becoming more accessible to pharmaceutical scientists and the first 3D printed drug product was approved by FDA in Aug, 2015, using 3D printing technology to develop pharmaceutical products has gained significant interests in pharmaceutical industry and academia. Pharmaceutical application of 3D printing has two potential directions to bring the pharmaceutical product development to uncharted areas, one is the manufacturing of drug delivery systems with sophisticated structures and the other one is personalized medicine. While application of 3D printing technology to produce pharmaceutical products involves many areas including materials sciences, building specialized 3D printers and so on, the design of dosage forms that will take the advantages of the 3D printing technology is pivotal in the application of 3D printing technology for pharmaceutical product development. In this symposium, the presentations will focus on the design of dosage forms that will be fabricated using 3D printers to achieve control release of pharmaceutical agents. The speakers will provide the theoretical aspects of design and the fabrication technology to realize the designs as well as material sciences aspect of constructing such system.

Speakers

  • Mr. Xiaoling Li, PhD, Professor- Associate Dean University of the Pacific Senping Cheng, PhD, Founder and CEO, Triastek, China
  • Jaedeok Yoo, PhD, Advanced Automation Researcher, GlaxoSmithKline

Accelerating Innovation for Traditional and Novel Therapeutics Manufacturing

Education Level: Executive

The Biomanufacturing industry has made tremendous progress over the past thirty years in increasing the available manufacturing capacity and number of new biologics available for treatments. Along the way, multiple innovations in feedstock, processes, equipment and regulations have facilitated the growth of this industry. However the current situation with increasing pressure on costs, quality and speed requires a bold new approach. With this in mind, a cross industry stakeholder consortium consisting of biomanufacturers, suppliers and academia, facilitated by The Biophorum Operations Group (BPOG) kicked off a major effort 2 years ago to agree on a Technology Development Strategy in order to address the challenges faced by this industry. This effort recently culminated in a freely downloadable Technology Roadmap. The key aspects of the Roadmap which the consortium hopes will lead to accelerated innovation will be presented during the session. The Technology Roadmap also identified the need in future for smaller, more flexible manufacturing facilities in order to address the need for personalized treatments for patients. Two case studies for personalized treatments involving traditional protein based therapies and novel autologous cell therapies will be presented during this session. Examples of how both traditional and novel treatments will leverage the Roadmap will be included.

Speakers

  • Rajesh Beri, PhD, Head–Mammalian Manufacturing Research and Technology, Lonza Biologics Inc.
  • Monica Hueg, Global Technology Partner, GMP and Compliance, NNE
  • Behzad Mahdavi, PhD, Vice President of Strategic Innovation and Alliances,
  • Lonza Henriette Schubert, Global Technology Partner, Facilities and Laboratories,NNE Amgen Singapore

Next Generation Manufacturing

Education Level: Advanced

This session describes the 10 year process Amgen went thru to evolve their biotechnology manufacturing platform from large scale stainless steel processing to a next generation all disposable single use manufacturing facility in Singapore. The session starts with a discussion of the status of Amgen's manufacturing platform in 2005. It then discusses the roadmap Amgen used to develop their next generation process as well as strategies employed for shrinking the footprint of the analytical labs, warehouse and offices. Concepts used to develop the next generation facility layout are then discussed including use of a combined process ballroom, single use solution prep area, CNC logistics corridor for media and buffer supply, and large volume moveable buffer and media bag holders. Options considered in developing the final layout are discussed. Finally, results are shared from recent Regulatory inspections by the EU and FDA.

Speakers

  • Robert A. Bader, Senior Manager Technology Pharma Bio, Jacobs Engineering Group Inc.
  • Michael J. Greening, Executive Director Capital Projects, Amgen Singapore
  • Robert Forbes, RA, Process Architect, Jacobs Engineering Group Inc. Genentech

Oceanside: A Flexible CHO Manufacturing Facility

Education Level: Executive

Genentech/Roche faced the business challenge of supporting launch of a robust pipeline of new products while sustaining high demand for existing commercial products. This drove evaluation of their existing production network on how to best achieve a flexible overall solution to deliver the pipeline while ensuring supply to patients. As such Genentech/Roche designed and constructed a facility at their Oceanside CHO drug substance site, utilizing existing shell space to deploy more product launch capacity. The target facility capability was to enable drug substance production for two new product launches per year with minimal lead time and tech transfer cost for platform monoclonal antibody processes. This session explains how the Genentech team approached the task to design and construct this flexible facility, in particular covering how process, piping/ equipment, and automation aspects were devised. We will also address considerations for future capabilities of the facility in terms of capacity, higher product titers, and novel process requirements.

Speakers

  • Eric Fallon, PhD, Senior Director, Head of Global Biologics Manufacturing Sciences and Technology, Genentech Inc.
  • Elizabeth Clare Danbe, Senior Engineer, Genentech Inc.
  • Christian Kaempfen, Project Director, Genentech Inc.

The PRA-Takeda Strategic Partnership: Is It the Wave of the Future?

Education Level: Advanced

Agility and supply chain responsiveness has never been more important. This case study will examine the innovative partnership formed between Takeda and PRA late last year. This partnership is characterized by a flexible operating model that combines operational expertise, transferred from Takeda to PRA, with PRA's wide range of global capabilities. Speakers representing the clinical supply organizations of both companies will each provide their unique perspective on the benefits of the partnership to their organization. Participants will get a glimpse into what may be the future of externalization. They will be challenged to evaluate the status quo for supply chain delivery. Is this the wave of the future?

Speakers

  • Julie A. Jacobs, RPh, Director, Clinical Supply Strategy, PRA Health Sciences
  • Karyn Corti, RPh, Senior Director, Embedded Programs, PRA Health Sciences
  • Jodi B. Luce, Executive Director, Global Clinical Supply, Merck & Co Inc.
  • Beth Gardner, Senior Director, Clinical Supply Strategy, Takeda Pharma America Inc.

The First 100 Days of a Capital Expansion Project

Education Level: Executive

This session will review the tasks and outline of events that occur in the first 100 days of a major capital expansion project. Everyone realizes that the first 100 days of a new capital program are critical to aligning processes, making decisions on methodology, and coordinating the use of best practices so that the project is driven to successful completion. This session will leave you with a detailed checklist of what you need to do in order to achieve capital project excellence!

Speakers

  • William J. Deckert, Senior Consultant, Commissioning Agents, Inc.
  • Robert E. Chew, PE, President/CEO, Commissioning Agents, Inc.
  • John P. Ward, Vice President Patheon, Part of Thermo Fisher Scientific - Needham
  • Roger J. Filannino, Manager of Technical Services, Commissioning Agents, Inc.

Implementing Pharma 4.0: The Holistic Manufacturing Control Strategy

Education Level: Advanced

Understand how the Holistic Production Control Strategy as the key element for production execution is created out of the Control Strategy in development. We need the interdisciplinary collaboration of the different departments (QA/QC, Process Development, Manufacturing Operations, Engineering, Automation and IT) to design a robust and flexible production execution environment. Based on Best Practice case studies the enablers, elements and challenges of the Production Control Strategy implementation are discussed. The workshop will show the new opportunities in creating a best practice based methodology to create the Holistic Production Control Strategy. A well-designed Production Control Strategy is enabling Right First Time, Data Integrity and high performance best practice based processes. Participants will discuss and learn how to approach a Production Control Strategy implementation and its benefits when it is designed in a cross divisional approach.

Speakers

  • Christian Woelbeling, Senior Director Global Accounts, Werum IT Solutions GmbH
  • Line Lundsberg-Nielsen, PhD, Global Technology Partner, NNE
  • Lorenz Binggeli, QM-IT B. Braun

Medical AG Requirements for Demonstrating Compliance with the EU’s General Data Protection Regulation

Education Level: Foundational

The GDPR is slated to go into effect May 25 of 2018 in the EU. There is no roll in period as this has been in discussion since 2012. This new regulation will replace the existing EU regulation (Directive 95/46) on Data Privacy and dramatically extends the definition of privacy considerations for anyone doing business in the EU. It will have a sweeping impact on how the Internet and data are utilized for global business. The punitive measures associated with non-compliance are significant with a maximum fine of 20 million Euro or 4% of a firm's annual turnover, which ever is higher. This presentation will discuss the key attributes of this new regulation and the required elements from an IT perspective and organizational perspective required to demonstrate compliance.

Speakers

  • Bikash K. Chatterjee, President and CSO, Pharmatech Associates

Cloud Concepts - Cyber Security and Blockchain

Education Level: Intermediate

The cloud is the future and the future is now. But is the cloud a safe place for pharmaceutical companies to operate? Or is it best to continue hosting and operating software technology solutions on an organizations own, on-premise infrastructure? This session will explore the pros and cons of cloud-based computing. Attendees will gain an understanding of what "the cloud" is and how it's both different, and similar, in comparison to software solutions that run on company owned servers. Data concerns will also be addressed and aspects of regulatory compliance will be explored and answers on how one can comply will provided. If already operating in the cloud, attendees will be gain insight on how they can assess their own company's cloud platform, and take proactive measures to resolve any vulnerabilities. This session will also explore the concept of a distributed ledger that is accepted as the truth by the majority of participants in a network that can change the way we manage, verify, and trust data. Eliminating a central authority (i.e., a database or centrally managed cloud environment) removes our reliance on a single system of record, as well as the vulnerability of being able to alter the truth. Blockchain is a foundational technology based on the concepts of distributed computing. Its primary use in industry to date has been through the bitcoin network, however, the application of Blockchain to healthcare and life sciences is actively being explored. The basics of how the blockchain functions and its potential impact on pharmaceutical manufacturing and data integrity as it relates to ALCOA+ will be discussed.

Speakers

  • Stephen R. Ferrell, CISA, CRISC, Senior Quality Director, IT Systems Compliance, Thermo Fisher Scientific
  • James Canterbury, Senior Manager, Ernst & Young LLP
  • Steven Thompson, ValGenesis, Inc. Adaptive Mobile BioPharma

Production Suite: Case Study

Education Level: Executive

This session will cover a case study of the selection, installation and operation of a flexible design and production platform that allows for clinical vaccine production. This unique cGMP mobile adaptive biopharma production platform was placed into operation in New Haven, CT in April 2016. Installation occurred in a matter of days and has been certified and operational since early May 2016. This true, Facility of the Future solution enabled critical preclinical stage vaccine development and clinical trial manufacturing to occur in house, with ACT's technology and expertise. Dr. Donald S. Masters will discuss the rationale for selecting their adaptive facility solution and the operation of this innovative facility. You will gain insight into how one company defined their facility needs, developed flexible design and production platform selection criteria and worked to implement an innovative approach to meet their critical R&D enablement needs.

Speakers

  • Jeff Serle, Senior Vice President, Germfree Laboratories, Inc.
  • Donald S. Masters, PhD, President and CEO, Artificial Cell Technologies, Inc.

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