New This Year! Compelling Keynote Presentations Spanning the Product Lifecycle

Education to Move Your Company Forward

Explore, strategize, develop tools, and determine how to navigate organizational and regulatory complexities to advance patient therapies.

Education Details by Track          Expand all

End to End Supply Chain Management Track

Track Director: Niranjan Kulkarni, PhD, Operations Specialist, CRB
Co-Director: Neal Gordon, Director, Director MRL Logistics, Global Clinical Supplies, Merck, Sharp & Dohme Corporation

From clinical trials to commercialization – Managing supply chains through innovative solutions and technology 

Featured Session- Artificial Intelligence: Taking the Mystery Out of Supply Chain Planning
Sunday, 29 October 1300 - 1400

Education Level: Advanced

We will discuss the use of learning driven analytical methodologies and disciplines to enhance the effectiveness of drug distribution across the value chain, from demand planning and feedstock management, to manufacturing scheduling, supply chain optimization, and point-of-demand inventory management. The methodology proposes a development and implementation of a framework that enables acquisition, filtering, and organization of data related to drug needs temporally and spatially, production capacities and schedules, stochastic understanding of system breakdowns, time-driven history of distribution capacities and schedules, and understanding of sickness with respect to historical trends, geographic locations, and changing environment.

  • Leader: Dennis Stamm, Partner, Dir. Industrial Engineering Services, InnovaNet Group, USA
    Artificial Intelligence: Taking the Mystery Out of Supply Chain Planning
  • Tariq Ismail, CEO, MineStream, LLC, USA

Leverage Expiry Date Material Planning to Reduce Waste
Sunday, 29 October 1415 - 1515

Education Level: Foundational
The identification and management of viable inventory is a very labor intensive process. The goal is to consider lead time and treatment durations when considering what material to access from inventory to package and or distribute to site. This presentation will provide an overview of the challenge and the approach Merck took to develop and enable this capability. This presentation will illustrate a MRP algorithm which considers material unusable in the appropriate timeframe so that the system can be leveraged to accurately plan quantities and timelines for Clinical Finished Goods and Drug Product at all nodes in the network.

  • Leader: Randa Atiyeh, Associate Director, Project Management (Clinical Supplies), Merck & Co Inc, USA
    Shelf Life Planning for Clinical Trials- a System Solution
  • Jean-Michel Carpet, Specialist Master, Deloitte Consulting LLP, USA
    Shelf Life Planning for Clinical Trials- a System Solution

Connecting the Dots: Sales, Inventory, Order, Make, Deliver- Drive the Supply Chain!
Monday, 30 October 1100 - 1230

Education Level: Advanced
A major challenge to CMOs and Pharma/BioTech companies is the reliability of forecasts and fixing production schedules. This is particularly the case for smaller organizations whose market intelligence, forecasting, inventory management and S&OP process are immature, resulting in write-offs, shortage of supply, late changes to production schedules, excess inventory, etc. With the advent of serialization and other high quality data sources, we potentially have an opportunity to fix this.

This session will explore this issue and potential solutions from a number of perspectives including:

  • Contract Manufacturers
  • Small Specialty Pharma Company
  • Solution providers
  • Consultants

In particular, it will encourage a more collaborative planning, and the use of data drawn from wholesalers, IMS, serialization, etc. to build effective dynamic demand forecasts and to use these in a collaborative way to schedule production at CMO's and others.

The session format will be presentations followed by a panel Q&A.

  • Leader: Nicholas Davies, M.Sc. B.Sc., Managing Partner, Co-Chair Operations, Management COP, Verta Life Sciences, USA
    Connecting the Dots- Drive the Supply Chain
  • Scott Aladeen, Vice President, Avara Pharmaceutical Services, Inc., USA
  • Robert DiVasto, PE, Senior Vice President, Manufacturing and Supply, Zavante Therapeutics, Inc., USA
    Speciality Pharma Viewpoint
  • Keith Harrison, Sr. Director, Supply Chain Planning, Neurocrine Biosciences, USA
    New Product Launch Viewpoint
  • Stephanie Roede, President, Life Science IT, Inc., USA
    Data Sources and How to Use Them to Drive the Supply Chain

Advances in Deterministic Parenteral Container Closure Integrity
Monday, 30 October 1100 - 1230

Education Level: Intermediate
This session will outline the challenges facing parenteral container closure integrity (CCI) and recent developments in certain methods listed in USP 1207. The session will provide an informative background on the principles of CCI, the pathways for validating CCI on different package formats, and a broad introduction of technologies available for testing packaging. The panel will specifically explain the theory and capability behind next generation deterministic CCI solutions aimed at inspecting the integrity of a wide class of parenteral product and container formats. High voltage leak detection, vacuum decay, headspace analysis and other technologies included in USP 1207 as deterministic test methodologies will be reviewed. The session will cover practical implementation and present hard data in the use of various CCI testing technologies. The session will shift from a presentation to an open panel session. The panel discussion and audience questions will aim to address the complex and unique challenges of implementing deterministic CCI test solutions.

  • Leader: Oliver Stauffer, CEO-VP Inspection Technologies, PTI Inspection Systems, USA
    Deterministic Container Closure Integrity
  • Olivia Henderson, PhD, Principal Engineer, Amgen Inc, USA
    Challenges in CCI
  • Edwin Martinez, Senior Engineering Manager, Baxter International Inc., USA
    On-line Technologies
  • Brandon Zurawlow, Associate Director, Container Qualification & CCIT, Whitehouse Laboratories, USA
    CCI Method Development

Efficient and Agile Supply Chains for Investigational Products
Monday, 30 October 1345 - 1515

Education Level: Intermediate/Advanced
This session will explore two topics that are relevant to efficient and responsive supply chains for investigational medicines. We will explore opportunities at both ends of the supply chain: at the beginning with up-front planning to drive value, and at the end with reconciliation of unused inventory at the conclusion of the clinical trial.

Effective Demand Modeling and Forecasting with Complex Protocols

Done well, demand modeling and supplies forecasting is an integral part of a successful clinical study. Well thought out plans help to ensure that the supply chain is fit for purpose, and responsive to patient needs. However, with study designs growing more complex and the increasing prevalence of expensive BioPharm medicines in development pipelines, there is a need to take planning and data analysis to the next level.

This session will explore how non-traditional approaches to data analysis and modeling opened up significant opportunities for one Sponsor company. Specifically, how different approaches enabled the Supplies Management team to better assess the needs of the study and to influence design parameters in a way that ultimately generated significant cost savings and supply optimization.

As a result of this session, the audience will learn directly from a subject matter expert about the approaches taken and how similar efforts can generate significant value for other Pharma sponsors.

Industry Trends and Best Practices on IP Returns and Reconciliation

The topic of Investigational Product (IP) returns and reconciliation continues to get a lot of attention in the industry. Many companies have expressed unease in this space as IP reconciliation continues to come under scrutiny by regulators. Add to that the wide diversity in approaches taken, and the complex and evolving expectations and it is no wonder that it is a prevalent topic among clinical supply professionals.

This session is intended to provide an update on the progress that is being made to identify and share best practices across the industry. This will include an overview of the workshop outcomes from the 2017 Global Clinical Supplies Group annual meeting along with a progress update on the industry task team working on a good practice guide for returns and reconciliation of IP.

  • Leader: Greg Hottell, Director, Clinical Interface Group Lead, GlaxoSmithKline, USA
    Industry Trends and Best Practices on IP Returns and Reconciliation
  • Linda Nichols, Clinical Supply Strategy Manager, GlaxoSmithKline, USA
    Effective Demand Modeling and Forecasting with Complex Protocols

The PRA-Takeda Strategic Partnership: Is it the Wave of the Future?
Monday, 30 October 1615 - 1745

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?

Serialization: Holistic Approaches, Current, & Predicted Trends
Monday, 30 October 1615 - 1745

Education Level: Intermediate
The impact of serialization to our industry is significant in terms of the disruption to our operations and the capital investment required to enable serialization. As companies prepare for serialization, it is useful to understand the current and future trends in serialization. It will not avoid the requirement to comply with the many different mandates, but it may help either verify or adjust an existing strategy for serialization. Serialization requires previously separate supply chain operation activities to become more integrated. This reorganization can be painful in the short term but synergies across multiple platforms and processes will also be explored to yield longer term process improvements.

  • Leader: Alfred Penfold, BSc MBA, Senior Project Manager, PM Group, United Kingdom
    Serialization:Holistic Approaches, Current and Predicted Trends
  • Padraic Duffy, Project Manager, Hyde Engineering + Consulting Europe Ltd, Ireland

Innovative Techniques to Improve Supply Chain Flexibility and Responsiveness
Tuesday, 31 October 1045 - 1215

Education Level: Intermediate
This session will focus on the business excellence tools and techniques presented in the ISPE's Operations Management Good Practice Guide which can be used to design, manage, and improve a multi-product end-to-end supply chain or individual manufacturing operation. The session will demonstrate how the techniques can be employed using real world examples and case studies of multi-product supply chains.

Some topics covered will include:

  • Statistical segmentation used to analyze demand and supply most effectively to maximize customer service, optimize inventory, and balance the batch requirements of production with lean pull techniques
  • Benefits of postponement (delay) of final product differentiation in a supply chain strategy
  • Allocating demand across manufacturing sites based on site capacity
  • Value visualization across supply chain to design strategies to minimize supply chain disruptions
  • Use of simulation to test how a change in an operation will perform, before implementing it in the live system, e.g., what-if changes to safety stocks, changes in manufacturing frequency, lean pull replenishment, delay of country specific labeling

Direct to Patient: Strategies, Processes, and Lessons Learned
Tuesday, 31 October 1600 - 1715

Education Level: Intermediate/Advanced

Considerations for Shipping Temperature Controlled Investigational Products
Wednesday, 1 November 0830 - 0945

Education Level: Intermediate
The rising percentage of investigational products requiring temperature controlled shipping creates challenges that must be considered in supply chain planning. GxP considers Good Practice guidelines and is designed to ensure product safety and integrity, including during distribution (GDP). This session will address core considerations to ensure a successful supply chain with focus on maintaining the integrity of investigational products during transport, such as:

  • Packaging options and innovations
  • Temperature Monitoring and GPS
  • Route assessment (timelines, controlled storage availability, etc.)
  • Protocol license approvals and import permits
  • Avoidance of Import delays by establishing open communication between shipper, courier, importer of record, broker and consignee

Quality Management and GxP compliance programs must be in place with logistics providers, which include global SOP's relevant to maintaining product integrity, training, risk management, etc.

  • Leader: Michael Sweeney, Senior Director, Patient Centric Logistics, World Courier Management Inc., USA
  • Robert Montague, Head of Global Supply Chain Logistics, GlaxoSmithKline, USA
    Temperature Monitoring Yesterday, Today and Tomorrow
  • Kathryn Oliver, Regional Quality Manager (North America), World Courier Inc, USA
    Quality and Compliance Considerations for Shipping Temp Controlled Investigational Products

Future Utilization of Electronic Labels for Clinical Trials
Wednesday, 1 November 0945 - 1045

Education Level: Foundational
This session will focus on the opportunities and benefits of transitioning to electronic labels as well as providing an update on industry progress.

  • Leader: Rocco Barone, Associate Director, Operations, Merck & Co Inc, USA
    Future Utilization of Electronic Labels for Clinical Trials
  • Neal Gordon, PhD, Director, MRL Logistics, Global Clinical Supplies, Merck & Co., Inc., USA
  • Michael Sweeney, Senior Director, Patient Centric Logistics, World Courier Management Inc., USA

Facilities and Equipment Track

Track Director: Michelle M. Gonzalez, Engineering Director (Retired) AMGEN, Inc., BioPharm Engineering Consultant
Co-Director: Steven Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc. 

Meeting unique requirements for the facility design and production

WORKSHOP: Asset Management Triggers to Promote Design for Reliability (DfR)
Sunday, 29 October 1300 - 1515

Education Level: Intermediate
Asset Management has introduced a few key concepts which require a shift from focusing on initial investment to optimizing the life-cycle cost. The basis for such decisions are rooted in a risk-based and science-based approach to specifying the requirements of the asset throughout its useful life. The risk-based approach drives prioritization and optimization; whereas, the science-based approach honors the Subject Matter Experts (SME's) experience a to drive decisions.

Shifting the Project Management Office (PMO) from a mindset of initial cost, scope, and schedule to a focus on Total Cost of Ownership (TCO) requires a catalyst for change. The workshop Presenters will share their experience with introducing a Design for Reliability (DfR) Program. The design and concept stages become the most significant triggers for DfR and the mechanism for the timely application of each DfR tool.

This workshop will provide Participants an opportunity to map out their DfR Program and toolkit and the insight to properly apply the stage gates as triggers in their own capital project process. The Participants will leave having customized a DfR structure to significantly improve the Total Cost of Ownership (TCO) and Life-Cycle Cost (LCC) of their capital projects.

  • Leader: Marie Getsug, PMP, CMRP, CPIP, CRL, Program Manager, Asset Management Consultancy, Jacobs Engineering Group, Inc. - Building & Infrastructure (B&I) Consultancy, USA
    Asset Management Triggers Promote Design for Reliability
  • Leader: George Williams, Director, Asset Management, B. Braun Medical US, USA

Advanced Modeling & Simulation to Improve Efficiencies in Animal Research Lab and Facilities
Sunday, 29 October 1300 - 1400

Education Level: Intermediate
The session's objective is to present the advantages of utilizing advanced modeling techniques, simulation studies and animation to enhance the operations and efficiencies in Laboratory Animal Research Facilities. Whether planning a new facility or renovating an existing one, these techniques can help inform and improve the design decisions during the planning process. Relevant case studies will demonstrate how this data-driven approach can also reduce operating and design costs.

The attendees will see the benefits of incorporating modeling and simulations to enhance the design and improve efficiencies of Laboratory Animal Research (LAR) Facilities.

Combining simulations and animation, the audience will see the benefits of virtual four-dimensional analysis and demonstrations of operations within a LAR facility.

Combined with Building Information Modeling, the audience will see how Operations Improvement Modeling can enhance mechanical systems design, energy analysis, CFD analysis, and commissioning and validation efforts.

Sterile Manufacturing Facilities: Regulatory and Manufacturing Philosophy, Process Equipment Considerations, HVAC, and Barrier and Isolator Technology
Monday, 30 October 1100 - 1230

Education Level: Intermediate
This workshop will review and address the design foundations and fundamentals that have changed in the revised ISPE Sterile Manufacturing Facilities Baseline Guide, Third Edition. Four separate sections will cover the major revisions to the guide allowing attendees to understand and apply updates relative to new and legacy facility design and operation. Specific topics covered will be: Regulatory and Manufacturing Philosophy, Process Equipment Considerations, HVAC, and Barrier and Isolator Technology.

  • Leader: Gordon Leichter, PhD, Sales Manager, Belimed, Inc., USA
    Using The Revised ISPE Baseline Guide for Sterile Manufacturing Facilities
  • Jason Collins, AIA, Dir. Process Architecture, IPS, USA
  • Norman Goldschmidt, President, Genesis Engineers Inc, USA
  • Patrick Poisson, Executive Vice President, Technical Operations, United Therapeutics Corporation, USA

Managing Risk in a Live Facility Renovation
Monday, 30 October 1100 - 1230

Education Level: Intermediate
This Case Study session is for those who are interested in increasing the life span of existing facilities. It will focus on the approach to design, scheduling and in-progress execution with particular attention to managing the risks of extensive construction in an existing operating facility.

The program will include 3 speakers, who will discuss the project planning and execution from an Owner's perspective, the project schedule, its organization and the tools used to develop that schedule 'live', and the master plan and project implementation.

The session's Learning Objectives focus on risks of construction in a live operating facility. This includes the identification, the design to manage and scheduling to control / limit risk.

The group will also discuss the collaborative development of the design and schedule to accomplish more in less time and support production growth while keeping the existing facility up and running.

Facility of the Year Project Presentations I
Monday, 30 October 1100 - 1230

Education Level: Intermediate to Executive
The FOYA Education Sessions provide attendees with an in depth look at the latest, state-of-the-art developments in facility design and construction implemented by 2017 Facility of the Year Category Award winning companies. Learn how excellence was delivered via innovating thinking from the company representative themselves.

  • Leader: Dave DiProspero, Director of Pharmaceutical Process Technology, CRB, USA
    FOYA Award Session Intro
  • Ciaran Corcoran, PhD, Site Director, Abbott Ireland, Ireland
    Abbott- Operational Excellence- A New Quality Approach
  • Alexander Haig, Director of Engineering, Cook Pharmica, LLC, USA
    Cook Pharmica- Flexible Filling Line Project Journey
  • Myung Kim, Associate Vice President, CannonDesign, USA
    Novartis- Penn Center for Advanced Cellular Therapies
  • Daniel Post, Associate Director, Engineering, Bristol-Myers Squibb, USA
    Bristol Myers Squibb- Biologics Development Building/Clinical Manufacturing Building

Pharmaceutical Water and Energy Savings: Green for Your Wallet and the Environment
Monday, 30 October 1100 - 1230

Education Level: Intermediate
Water costs are rising at increasingly high rates. Many areas around the world are experiencing water scarcity issues, and these areas are expected to increase in coming years. Given the importance of water in the manufacture of pharmaceutical products, the pharmaceutical industry must implement water conservation programs for economic and social reasons.

This session will review technologies and techniques that can be applied to pharmaceutical water and process systems to reduce water and energy consumption. The session will include discussions on emerging water conservation technologies. Case studies will be presented that demonstrate savings. Also, to be highlighted are some innovative cases of water reclamation from other industries leading to lessons we can apply in pharmaceutical facilities. Throughout the discussion awareness of potential pitfalls, limitations, and warnings will be highlighted and shown.

The session will conclude with an exploration of pathways to achieving "zero water discharge" at a pharmaceutical manufacturing facility.

Amgen Singapore Next Generation Manufacturing
Monday, 30 October 1345 - 1515

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.

  • Leader: Robert Bader, Senior Manager Technology Pharma Bio, Jacobs Engineering Group Inc, USA
    Amgen Singapore Next Generation Manufacturing
  • Robert Forbes, RA, Process Architect, Jacobs Engineering Group Inc, USA
  • Michael Greening, Executive Director Capital Projects, Amgen Singapore, Singapore

Integrated Project Delivery
Monday, 30 October 1345 - 1515

Education Level: Intermediate
The design and construction of Pharmaceutical and Biotech Facilities is driven by speed to market, cost of goods and quality of product. An integrated project delivery approach where the client, engineer and constructor are aligned during FEL and committed to "design-in" proven modular construction components and systems improves the potential for consistently delivering quality assets faster with lower levels of on-site activity.

This conference team representing Merck, Jacobs Engineering Group and SBB-Daldrop LLC will discuss how their partnership in FEL on multiple international projects has been successful in realizing significant advantages in aligning schedule, cost and quality parameters. Andrew Dell, Project Design Manager from Merck will talk about how technique advancements of 3D deliverables including Virtual Reality in FEL have improved client/team engagement and alignment. Curt Biehn, Process Architect and SME from Jacobs will discuss interactive design techniques resulting in enhanced discipline coordination. Mike Sullivan, Director at SBB-Daldrop LLC will discuss how integration of modular turn-key suppliers in FEL helps optimize design solutions and supports accelerated start-up.

This session will provide a better understanding of how collaboration from project start using enhanced design and construction techniques can improve performance and repeatability of project delivery.

  • Leader: Curt Biehn, Design Manager, Jacobs Engineering Group Inc, USA
    Integrated Project Delivery
  • Andrew Dell, MS Engineering, Project Design Manager, Global Engineering, Merck & Co Inc, USA
  • Lawrence Pranzo, Architect, Global Engineering, Merck & Co Inc, USA
  • Michael Sullivan, Director, SBB Daldrop, LLC, USA

Facility of the Year Project Presentations II
Monday, 30 October 1345 - 1515

Education Level: Intermediate to Executive
The FOYA Education Sessions provide attendees with an in depth look at the latest, state-of-the-art developments in facility design and construction implemented by 2017 Facility of the Year Category Award winning companies. Learn how excellence was delivered via innovating thinking from the company representative themselves.

  • Leader: Dave DiProspero, Director of Pharmaceutical Process Technology, CRB, USA
    FOYA Award Session Intro
  • Ahmad Almaya, PhD, Director, Eli Lilly & Co, USA
    Eli Lilly and Company- Continous Direct Compression Manufacturings Kits
  • Lou Kennedy, CEO and Owner, Nephron Pharmaceuticals, USA
    Nephron Pharmacueticals- Nephron SC Project
  • Alan MacNeice, CPIP, Executive Director and Site Leader, Jazz Pharmaceuticals, Ireland
    Jazz Pharmacueuticals- Project Rock
  • Carlos Monserrate, PE, Senior Process Engineer, Eli Lilly & Co, USA
    Eli Lilly and Company - Continous Direct Compression Manufacturings Kits 2 & 3
  • Timothy Pletcher, PE, Associate Senior Consultant Engineer, Eli Lilly & Co, USA
    Eli Lilly and Company - Continous Direct Compression Manufacturings Kits 2 & 3
  • Christopher Sweeney, Senior General Manager, Pt Kalbio Global Medika, Indonesia
    Kalbio Global Medika- Biotech Facility

Compliant and Sustainable Facilities- The Future of Pharma
Monday, 30 October 1345 - 1515

Education Level: Intermediate

Part 1:
Sustainability is fundamental to future pharmaceutical facilities and a low carbon future. Manufacturing facilities are historically energy intensive and in many cases the production volume has very little impact and the energy cost of running the facility.

The subject for the session will present results of 4 years of R&D leading to a solution for safe & dynamic cleanroom control to deliver both sustainability and GMP control.

We will explore the benefits of dynamic simulation & modelling to maximise the engineering solutions of the facilities anywhere in the world.

In this session, the participants will take away thoughts and solution proposals for developing future sustainable Pharmaceutical Facilities.

Part 2:
It is common practice to establish local programs to reduce the energy demand or water usage for a production facility or site. But do we have the understanding of when, where and how the different environmental impacts that are related to the production facility/site occur? It could come as a surprise that local environment programs may have a lower effect on the global environment impact of a production facility. The presentation covers a case study for a modular biopharmaceutical facility utilizing single-use technology located in Asia.

Genentech Oceanside: A Flexible CHO Manufacturing Facility
Monday, 30 October 1615 - 1745

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.

  • Leader: Eric Fallon, PhD, Senior Director, Head of Global Biologics Manufacturing Sciences and Technology, Genentech Inc, USA
    A Flexible CHO Manufacturing Facility
  • Elizabeth Danbe, Senior Engineer, Genentech, USA
  • Christian Kaempfen, Project Director, Genentech Inc, USA

Understanding the Architectural, HVAC and Risk Management Considerations for OSD Facilities of the Future
Monday, 30 October 1615 - 1745

Education Level: Intermediate
This session will cover the application and use of the new ISPE OSD Baseline Guide, Volume 2, 3rd Edition, which was released in Nov 2016. The session will focus on two main chapters of the Guide: Architectural and HVAC. It will cover the key issue of Levels of Protection in an OSD Facility and will address the Risk Based elements associated with modern facility layout and HVAC design. The session will draw materials directly from the Baseline Guide and show the application of such, with input from owner representatives.

The Baseline Guide Revision is the culmination of a multi-year rewrite effort undertaken by a wide and diverse international team of owners, suppliers, vendors and academia, all focused on providing updated guidance for the OSD Factory of the Future. This new edition considers both current and new processing technologies to help meet international regulatory requirements, pursue industry best practices and their implementation in effective OSD facilities. The guide provides the user with a starting point from which to guide the user into technically sound and compliant solutions while offering the flexibility to meet their own specific facility and project needs.

  • Leader: Dave DiProspero, Director of Pharmaceutical Process Technology, CRB, USA
    Intro to Understanding the Considerations for OSD Facilities of the Future
  • Jack Chu, PE, Senior Consultant- Special Products, Commissioning Agents, Merck & Co., Inc (Retired), USA
  • Norman Goldschmidt, President, Genesis Engineers Inc, USA
    Risk Based HVAC and Considerations in Oral Solid Dosage
  • Terry Jacobs, AIA, Partner, JacobsWyper Architects, USA
    Understanding the Architectural, HVAC and Risk Management Considerations for OSD Facilities of the Future
  • Robert Matje, CPIP, PE, Principal, RemTech, LLC, USA
  • George Ruiz, BEChE, Director, OSD/API/Packing & Devices Team, Global Engineering Technical Services, AstraZeneca, USA

Project Delivery - Impact of Project Driver and Regional Conditions
Monday, 30 October 1615 - 1745

Education Level: Executive
Industry driver for this session: The technology breadth that can be used in the biopharma manufacturing, the technology change potential that is foreseen in future, and the globalization of the manufacturing footprints is having a large impact on selecting the delivery approach and facility type/technology to be implemented. That is, the delivery/facility type and model will vary based on the project drivers - standard stick built, use of pre-fabricated components, partial and full modular, hybrid, etcetera are all options with trade-offs and selecting the best one is specific to the project.

Understanding the range of the current options available and the trade-offs associated with each (flexibility, schedule, cost, labor location, other) is a key to selecting the best method early.

This session will highlight the options and provide guidance on the benefits/tradeoffs of each to aid project teams in selecting the best option for their project. Information will be summarized into simple reference guide for the attendees. They will walk away with a good reference guide to aid in their decisions selecting the best facility type and delivery model for their projects.

Increasing Operational Efficiency in Existing Facilities
Monday, 30 October 1615 - 1745

Education Level: Advanced
Existing facilities face pressure to produce more product with the same equipment set. Many can be streamlined with limited investment to increase production. Determining where to implement changes needs to be carefully weighed and considered to maximize the return on investment. Common debottlenecking targets are process operations, utilities, CIP/SIP and automation.

This session will begin by reviewing the tools used to identify process restrictions and the methods for weighing improvements for go/no-go scenarios. We will then walk through examples to decrease the turnaround time from process operations to CIP/SIP and return to a process ready state, followed by a question and answer session.

By the end, participants will be able to identify limitations in their facility as well as recognize the value of tools and technologies to increase capacity.

  • Leader: Michael Byron, Senior Project Manager, Seiberling Associates Inc, USA
  • Scott Klemme, Process Engineer, Genentech Inc, USA
  • Steve Welsch, Project Manager, Seiberling Associates Inc, USA

Lab/Office/WH Project Delivery- Methods and Practices
Tuesday, 31 October 1045 - 1215

Education Level: Intermediate
The challenge of balancing cost, quality and schedule when driving an accelerated project delivery can be quite the dilemma. This case study will address the challenges and some possible approaches for project owners, designers, and contractors to consider when faced with what seems to be an unrealistic deliverable. You will hear from the owner, general contractor and design team, each accountable for project delivery with their respective firms. They will walk you through the project and discuss the key factors that contributed to the successful delivery of a 208k sf lab/office/warehouse T.I. in 10 months from demo to occupancy. Participants will learn techniques and skills that were applied through people, process and technology as part of this project delivery.

  • Leader: Eric Hanson, Director, Biologics Support Operations, Gilead Sciences, Inc., USA
    Lab/Office/WH Project Delivery- Methods and Practices
  • Mark Davis, Principal, DGA planning|architecture|interiors, USA
  • Brad Kraus, Project Manager, DPR Construction, USA
  • Jeff Wegner, PE, Mechanical Engineer, CRB - Carlsbad, CA, USA

The First 100 Days of a Capital Expansion Project
Tuesday, 31 October 1045 - 1215

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!

A New Biomanufacturing Paradigm: Off-the-Shelf-Facility
Tuesday, 31 October 1045 - 1215

Education Level: Advanced
The biopharmaceutical industry requires increased investment control, additional flexibility and greater reproducibility. The introduction of the first pre-engineered manufacturing solution for biopharma, KUBio, has changed conventional thinking about investment and design of manufacturing facilities.

KUBio is a turn-key solution, its design focusing on single-use manufacturing and optimizing the facility function around manufacturing efficiency, speed to market and reproducibility.

The three presentations in this session will look into the added value brought by a pre-engineered, complete solution like KUBio, the challenges related to the design and delivery of a complete turn-key manufacturing solution, and the real-life experience by JHL Biotech in Wuhan (China,) where the first KUBio became operational in 2016.

“Don’t Let it Out!” A Practical Approach to Containment in Sterile Manufacturing Facilities
Tuesday, 31 October 1045 - 1215

Education Level: Intermediate
Sponsored by Women in Pharma

Looking for practical approach to containment? Many case study presentations have been created in the past which show a single approach to containment for an individual product in a given facility. But, where does one begin? What is the difference between containment for live virus organisms vs. potent products? When it comes to containment there seems to be a lack of information regarding a systematic approach for both equipment and facility design.

This three-part session will address appropriate containment solutions for Live Organisms, Potent Chemical and Highly Sensitizing materials in Sterile Manufacturing Facilities. Part I will define the different material types requiring containment and also discuss the principles of primary and secondary containment. The second part of the session will review applicable regulatory requirements for different markets and discuss the available guidance documents and standards. The third part of the session will discuss practical strategies for primary and secondary containment utilizing case studies and applied solutions. Strategies will include examples of both procedural and engineered solutions as required for each material type during different steps of manufacturing.

  • Leader: Jason Collins, AIA, Dir. Process Architecture, IPS, USA
    “Don’t Let it Out!” A Practical Approach to Containment in Sterile Manufacturing Facilities
  • Vincent Cebular, MBA, BS. Chem. E., Senior Vice President, Compliance Services, IPS, USA
  • Christa Myers, Senior Pharmaceutical Engineering Specialist, CRB, USA

How to Execute the World's Largest Biotech Project
Tuesday, 31 October 1600 - 1715

Education Level: Intermediate
How do you execute one of the largest biotech projects in the world? How do you get it setup right? For successful and smooth execution?

Same could apply to an elephant. How do you eat an elephant?

The key here is to break it down into manageable/eatable sizes = Work Packages

Mr. Lohr will first introduce Novo Nordisk, the new API site in Clayton and how the new facility will look when fully build in 2020.

Mr. Petersen will then describe how the project is structured into Work Packages with Work Package Description for each sub component. How all schedules, cost, risk etc. is broken down according to the same structure to enable efficient execution of 50 sub-projects instead of one large project. The session also describes how all the Work Packages are coordinated via Interface Agreements and how some Work Packages have a more central and overall coordinating role!

In addition, the session will describe how the Project Management governance structure has been established and how the project team has been trained to all follow the same Project Management infrastructure (build on the principles known from PMI).

Surplus Equipment Disposition: Managing Surplus Assets
Tuesday, 31 October 1600 - 1630

Education Level: Foundational
Surplus Equipment Disposition- Learn best practices for how to manage surplus assets for your company! This would include how to make reusable equipment available within your company, getting the most value from the sale of equipment, and ways to give back to your community thru donation. This session will include specific examples of how Eli Lilly and Company and ELANCO is able to save significant dollars by reutilizing its own surplus prior to purchasing new equipment. It will also include methods of how to sale and donate equipment and supplies no longer needed. Equipment discussed will range from small office supplies, R & D equipment, to large packaging and manufacturing equipment. Attendees and companies are sure to walk away with new ideas and methods on how they can redeploy, sale, and donate their own surplus.

Oligonucleotide Synthesis Manufacturing Facility Solution
Tuesday, 31 October 1645 - 1715

Education Level: Intermediate
Anti-sense oligonucleotide (ASO) manufacturing is a relatively novel and growing manufacturing platform to treat diseases in various therapeutic areas. Biogen recently designed and constructed a new cGPM oligonucleotide manufacturing facility to support clinical and small scale commercial manufacturing for our growing portfolio of ASO compounds via renovation of an existing warehouse area. This fast track project was completed in 15 months from start of basic design to completion of commissioning and qualification. This presentation will highlight the technical solutions and innovative design approaches of this new facility to safely and efficiently manufacture a range of ASO compounds.

  • Leader: Paul Richards, Principal- Process Engineer, Biogen, USA
    Oligonucleotide Synthesis Manufacturing Facility
  • Brendan Nichols, Process Engineer, CRB, USA

WORKSHOP: Risk, Reliability, Performance, Compliance and ASTM E2500
Wednesday, 1 November 0830 - 1045

Education Level: Advanced
ASTM E2500 has been in use for 10 years. Have we realized its full potential to reduce quality risks, reduce project delivery time and risks, improve operational performance and reliability, and satisfy regulatory expectations? Using a combination of lectures, case studies and a round table discussion panel, participants will be able to explore, understand, and apply principles and practices to meet all these objectives. Projects large and small have benefited greatly by applying ASTM E2500 standard to its full extent, but misconceptions and concerns remain throughout industry. This session will put those concerns to rest while demonstrating significant benefits.

  • Leader: Robert Chew, PE, President/CEO, Commissioning Agents, Inc., USA
    Science and Risk-Based C&Q: Reducing Costs;Maximizing Results
  • Franco Casinelli, Qualification & Commissioning Sr manager, Janssen Pharmaceutical (Johnson & Johnson), Italy
    Case Study Risk Managed Qualification Xi'an China
  • Jodi Dey, BS, MT, Director Risk Management & Compliance, Pfizer Inc, USA
    Global Regulatory Compliance
  • Hazem Eleskandarani, PE, Global Director, C&Q - E&PS, Johnson & Johnson, USA
    A Risk-Based Approach to Commissioning and Qualification
  • Gert Moelgaard, Senior Consultant, Moelgaard Consulting, Denmark
    ASTM E2500 Verification Standard 10 Years After- Background and Impact
  • Steven Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc, USA
    C&Q Baseline Guide 5 Revision

Featured Session- Adaptive Mobile BioPharma Production Suite: Case Study
Wednesday, 1 November 0830 - 0930

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.

  • Leader: Jeff Serle, Senior Vice President, Germfree Laboratories, Inc., USA
  • Donald Masters, PhD, President and CEO, Artificial Cell Technologies, Inc., USA
    Adaptive Mobile BioPharma Production Suite: Case Study

WORKSHOP: Pharmaceutical Water Sampling
Wednesday, 1 November 0830 - 1045

Education Level: Intermediate
Whether used as an ingredient, cleaner, or something else, water is the most widely and universally used material in the pharmaceutical industry. Water sampling and testing is critical to demonstrate that the water meets its established quality attributes and is suitable for its intended purpose. Testing also demonstrates that the water distribution systems are operating under a state of control. Water sampling plays a critically important role and improper sampling may lead to falsely placing products on hold or worse; releasing product manufactured with water that is unsuitable.

This interactive session will help engineers and quality system professionals understand how to properly design pharmaceutical water sampling systems and reduce the potential false positive or negative sampling results from water sampling. The session will cover:

  • When to sample on-line, in-line, or at-line
  • When samples must be removed from a system
  • Sample valve designs
  • Sampling techniques
  • Sampling for various purposes
    • Process Control
    • Quality Control
    • Diagnostics
    • Method Validation
  • Establishing correlation between laboratory and on-line instrument measurements
  • Reducing the number of samples that need to be taken
  • Reducing sampling frequency
  • Using Quality Risk Management to adjust sampling frequencies
Sample valves from various manufacturers and of different designs will be used to illustrate pros and cons and provide a practical "show and tell" and provide attendees with a more thorough understanding of different sample valve designs.

  • Leader: Brian Hagopian, CPIP, Chemist and President, Clear Water Consulting, Inc., USA
    Pharmaceutical Water Sampling Workshop

Information Systems Track

Track Director: Eric Staib, Executive Director, Quality Assurance, PRA Health Sciences
Co-Director: Sam Brooks, Principal Consultant, Brooks Information Integrity Innovations 

Driving innovation with integrity in life-science information/GAMP®

WORKSHOP: Unifying System Validation and Data Lifecycles to Support Data Integrity
Sunday, 29 October 1300 - 1515

Education Level: Foundational/Intermediate
The publication of the ISPE GAMP Records and Data Integrity Guide (due approx. April 2017) introduces a number of new paradigms from regulators that are essential for data integrity, such as data lifecycle and data flows, and to amalgamate these new concepts with existing GAMP systems validation approaches. Data integrity is now a regulatory requirement across all areas of a regulated company, and is not simply some obscure IT responsibility.

For the 'hard core' GAMP community, many of whom have been involved in validation for a decade or more, this merging of validation and data integrity approaches builds comfortably on their existing foundation knowledge; however for Young Professionals and industry members new to the validation realm, this can seem an overly complex undertaking.

This interactive workshop session is designed to give attendees the opportunity to assess different system types, evaluate the records generated by the systems, map the data flows and data lifecycle for those records, and then build a validation approach for the systems based on their records and GxP impact.

At the conclusion of this education session, participants will:

  • understand how to assess systems and records
  • recognize that data in a system is only one part of the data lifecycle
  • understand how to tailor the validation approach based on the risks inherent in the system type and the criticality of the records generated and/or stored within that system.

    For more information, check out Charlie's blog post on iSPEAK:

  • Leader: Charlie Wakeham, Regional Informatics CSV Consultant, Waters Corporation, Australia
    WORKSHOP:Unifying System Validation and Data Life Cycles
  • Karen Ashworth, Director, Karen Ashworth Consulting Ltd, United Kingdom
  • Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation, USA
  • Arthur Perez, PhD, Retired, Novartis Pharmaceuticals, USA
  • Lorrie Vuolo-Schuessler, Manager, Computer Systems Quality Assurance, GlaxoSmithKline, USA

Current Perspectives on Data Integrity and cGMP Compliance
Monday, 30 October 1100 - 1230

Education Level: Intermediate
Data Integrity continues to be one of the hottest and highest priority regulatory and compliance topics impacting the life science industry. If the data associated with a drug product is not accurate or reliable, companies cannot ensure product quality and patient safety. Data integrity is a global regulatory and compliance expectation, as seen by the increased rigor and guidance's by global regulatory agencies. Non-compliance has resulted in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, and Application Integrity Policy Invocations/ legal actions. This session will provide an update on current trends in data integrity and cGMP compliance, including critical thinking and overcoming biases, as well as a review of current cGMP issues and trends impacting our industry. Participants will learn how critical thinking approaches can help identify and understand data integrity risks. They will also learn how current cGMP issues and trends can also contribute to data integrity issues and concerns. This session is the first of two sessions focused on data integrity and compliance.

  • Leader: Michael Rutherford, Executive Director, Computer Systems Quality and Data Integrity, Syneos Health, USA
    Introduction to the Data Integrity Sessions at the Annual Meeting and Current Thoughts
  • Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA
    Critical Thinking and Overcoming our Biases
  • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
    Current cGMP Issues

Practical Approaches to Data Integrity
Monday, 30 October 1345 - 1515

Education Level: Advanced
There has been a succession of regulatory guidances released over the last two years concerning data integrity and records management. The guidance has focused on governance, ALCOA+, segregation of duties and expectations for computerized systems controls.

The guidances have generally been high-level, and even the new ISPE GAMP Guide to Records and Data Integrity (due for publication Q2 2017) which builds on the regulatory guidances applies the concepts generically across the regulated industries.

This presentation session will provide detailed information on the practical implementation of data integrity controls on three specific systems/topics and concurrently generate interest in the forthcoming ISPE GAMP "Practical Guide" planned for publication in 2018.

At the conclusion of this education session, participants will:

  • understand that different systems and realms require different approaches
  • implement the quick wins in their own organizations
  • analyze their data as part of detecting data integrity issues
  • strategize their data integrity approach

The ART of Efficient and Effective Computer Systems Validation
Monday, 30 October 1345 - 1515

Education Level: Foundational
Explore the ART of computer systems validation in a more efficient and effective means while creating less work and meeting your compliance objectives. Understand the basics and become familiar with more advanced concepts.

There are many known efficiency tricks when it comes to CSV. We will explore in depth the idea of a scalable SDLC, the application of risk-based validation, and the ability to leverage what your vendor may have already done.

We have also all heard of risk-based validation, but do you know when and where to apply it? Learn the secrets that only industry experts and consultants know. A little extra time spent up front can save precious dollars and unexpected delays to system implementation.

  • Leader: Eric Staib, Executive Director of Quality Assurance, PRA Health Sciences, USA
    The ART of Efficient and Effective Computer Systems Validation

Validation of Computerized eClinical Systems and Data
Monday, 30 October 1615 - 1745

Education Level: Foundational/Intermediate
Risk-based Quality Management (RBQM) is a key theme introduced into the new ICH E6 Integrated Addendum and it has an impact on the full range of activities surrounding the planning, conduct and evaluation of clinical trials. Application of RBQM principles is intended to be holistic in nature, affecting not only organizational processes, but also computerized systems and the data flowing through processes and systems. In facing the challenge of designing or changing validated processes in conjunction with qualified computerized systems to comply with this approach, the layer model for eClinical platforms proposed in the new GPG Good eClinical Practice Guide can be a powerful tool to aid implementation. The session will focus on the processes, systems and the data flowing along those processes within organizations throughout the entire life cycle of a clinical trial and the challenges and opportunities associated with it.

  • Leader: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
  • Leader: Eric Staib, Executive Director of Quality Assurance, PRA Health Sciences, USA
  • Frank Henrichmann, Director Technology Quality Management, PAREXEL International, Germany
    Sponsors, CROs and all the Rest
  • Philip Rath, PhD, Vice President, Palleos Healthcare GmbH, Germany

Data Integrity Concepts: A Broader Approach
Tuesday, 31 October 1045 - 1215

Education Level: Foundational/Intermediate
The scope of Data Integrity related risks and issues is quite broad and can impact a variety of areas across the data life cycle and business process. This session provides an opportunity to understand how key quality principles and processes, including system validation, risk management, supplier quality, and cybersecurity innovations are the foundation of data integrity assurance for cloud based systems. Techniques for evaluating cloud providers, specifying requirements, and implementing the correct client-side controls will be discussed as part of a case study of a cloud-based manufacturing execution system implementation. The session will also provide an overview from a sponsor's perspective on data integrity risks and mitigation strategies associated with clinical studies, from outsourcing to CROs and vendors to electronic source data created at clinical sites and in ePRO systems. Finally, innovations in information governance will be discussed to help demonstrate how it can be a competitive advantage for data integrity. Through the review of recent regulatory actions, participants will understand the direct relationship between recent trends and information governance and identify opportunities and strategies to reduce risks and improve data integrity in their own organizations.

Requirements for Demonstrating Compliance with the EU's General Data Protection Regulation
Tuesday, 31 October 1600 - 1630

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.

  • Leader: Bikash Chatterjee, President and CSO, Pharmatech Associates, USA
    Requirements for Demonstrating Compliance with the GDPR

Paperless Manufacturing
Tuesday, 31 October 1600 - 1630

Education Level: Intermediate
Digitalization in the Pharma Industry shows what bringing the worlds of automation and digitalization together to provide true and advanced paperless manufacturing facility. The presentation will outline how to achieve integrated operations excellence using MES as a core concept to create a Paperless Manufacturing facility.

  • Leader: Pamela Docherty, Life Sciences Industry Manager, Siemens Industry, Inc, USA
    Paperless Manufacturing
  • Todd Lybrook, PMP, US Director, Siemens, USA

Asset Information Lifecycle Modelling
Tuesday, 31 October 1645 - 1715

Education Level: Intermediate
The information that forms the records of an operating facility are increasingly being recognized as a vital part of a facility. This 'digital asset' reflects the value of data that mirrors the physical assets. The genesis of this digital asset (engineering data) is created and collected from various disparate sources. This information is also consumed by a variety of disparate functions. To facilitate the efficient creation, manipulation and consumption of engineering information it is important to define a master data model for the whole asset lifecycle. The identification of the information requirements to each of the asset lifecycle phases, processes and technologies produces a master data model that forms part of an organizations information governance strategy.

This governance provides contractual clarity to stakeholders involved in producing data such as vendors and suppliers. It supports project execution strategies such as BIM and Lean. A master data model is key for integration projects across business function and lifecycle phases. It is a significant element in an engineering information gathering and remediation exercise for existing facilities.

  • Leader: Jeremy Freeman, Associate Director/Sector Business Development Director, PM Group, Ireland
  • Colum Lynch, Information Management Strategist, PM Group, Ireland
    Asset Lifecycle Definition of Engineering Information to Support Operation, Maintenance and Projects

Featured Session- Cloud Concepts: Cyber Security and Blockchain
Wednesday, 1 November 0945 - 1045

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.

Innovation Forum

Track Director: Michael O'Brien, PhD, Vice President Technology & Innovation, Pfizer Inc.
Regulatory Track Director: Sau (Larry) Lee, PhD, Associate Director for Science, FDA/CDER/OPQ
Co-Director: Anne Kantardjieff, PhD, Director, Early Stage Process Development, Biologics Process Development, Alexion Pharmaceuticals 

Navigating the current landscape of pharmaceutical research, development and manufacturing for successful innovation

Featured Session: Application of 3D Printing Technology in Dosage Form Design and Drug Delivery
Sunday, 29 October 1415 - 1515

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.

Accelerating Innovation for Traditional and Novel Therapeutics Manufacturing
Monday, 30 October 1100 - 1230

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.

Emerging Methods, Equipment, and Technologies
Monday, 30 October 1345 - 1515

Education Level: Advanced
The advances in sensor technology, as well as computer science is leading to innovation, rapid development and deployment in the measurement and control systems available to Pharmaceutical manufacturing. The significant advances in, and deployment of Artificial Intelligence, or Machine Learning and the associated algorithms is particularly striking. Re-thinking the archaic microbial assessment systems presently in use for sterile facilities, will be proposed.

The rapidly advancing use of imaging technology, to understand compositional as well as structural attributes on material will be discussed, for both powder mixtures and products. Of particular importance, the advances in Raman imaging and processing algorithms to analyze complex mixtures that form culture media for bio product fermentations.

The combination of sensors with the enormous capability of Artificial Intelligence systems in processing large data blocks very quickly, will be illustrated by application of 100% inspection systems for tablets and capsules, which FDA Emerging Technology team described as "2001 Space Odyssey" come to pass, will be described.

A new approach to environmental monitoring in sterile manufacturing areas will be discussed. The potential significant improvement is sterility assurance, as well as the large reduction in costs and the big potential improvement in "green" operations will be described.

The Combination Development Process
Monday, 30 October 1615 - 1745

Education Level: Intermediate
Advances in our understanding of a wide range of diseases have resulted in new therapies, and new ways of administering those therapies. These include targeted application of a combination of drugs and/or biological products with medical devices to minimize adverse events, while maximizing treatment response and positive user experiences. These combination products, containing two or more different types of health authority-regulated constituents, bring added complexity in the product development process and life cycle management. They are the subject of a number of recently issued FDA regulations, including Request for Designation, Human Factors, Post Market Safety Reporting and Final Guidance on Good Manufacturing Practices. They are also the subject of evolving regulations globally beyond the US. This session will review the combination product development process in the context of these regulations, comparing and contrasting the drug and device development processes and integration of the two. In this session participants will benefit from best-practice and lessons learned, with FDA-, Pharm-centric, and Device-centric organizational perspectives and case studies.

Innovative Trends and Applications in PAT
Tuesday, 31 October 1045 - 1215

Education Level: Advanced
The use of Process Analytical Technologies (PAT) during the development phase and subsequent production of complex biopharmaceutical molecules has been considered as an enabler of Quality by Design (QbD). PAT applications can be leveraged during process development and to facilitate enhanced process monitoring and control of commercial manufacturing leading to improved process understanding and process outcomes. This session will include 3 speakers from across the biomanufacturing industry who will share applications of innovative PAT solutions to optimize the production and purification of complex biopharmaceutical products.

Innovative, Cross Industry Strategic Partnerships
Tuesday, 31 October 1600 - 1715

Education Level: Foundational to Advanced
As an industry, we are all working towards the common goal of making medicines and effective treatments readily available to patients around the globe. Never before has innovation through collaboration between drug manufacturers, academia, technology providers, and many other stakeholders, been so critical to meeting this goal. This session will provide an overview of two cross industry strategic projects, and will highlight the project drivers, challenges, and the innovative facility designs resulting from their collaborative efforts.

WORKSHOP: Emerging Therapeutic Modalities & Medical Devices
Wednesday, 1 November 0830 - 1045

Education Level: Advanced
ADCs "Antibody Drug Conjugates" are a new and promising generation of the cure of cancer. The workshop will address the GMP and occupational protection requirements during manufacturing from the warhead to the sterile fill finished ADC. The workshop will cover the occupational exposure requirements for the warhead and the ADC as well as the GMP cleaning and cross contamination requirements. ADCs are extremely potent products as never seen before in the Bio- pharmaceutical production. Presentations from Abzena about warhead manufacturing and their challenges and from Althea about Conjugation and Sterile Fill Finish. Requirements for GMP and Occupational safety will be presented from SKAN. An interactive panel discussion will round up the workshop.

Product Development and Production Systems Track

Track Director: Steven R. Miller, Director, AstraZeneca
Co-Director: Robert Perks, Vice President, Operations, Werum IT Solutions 

Developing agile and flexible production systems for the next decade

WORKSHOP: Maximizing Manufacturing Utilization through Facility Design
Sunday, 29 October 1300 - 1515

Education Level: Advanced
A flexible multiproduct Single Use Systems based manufacturing facility must adapt to a variety of changes in product capacity and process requirements. This workshop examines the facility and operational ramifications of a process that changes from a fed-batch to continuous operation necessary for a hypothetical process to increase the manufacturing capacity of an important product. Possible facility and operational changes are examined by the workshop participants to provide the necessary short and long term facility capabilities necessary to support the product's launch as well as the simultaneous development of other products in the company's pipeline within the facility.

Learning Objectives

1. Identify the interactive elements of a manufacturing enterprise to provide maximum flexibility for operating processes within a manufacturing facility.

2. Identify the best combination of Facility and Infrastructure control systems, particularly procedural and time sequencing control tools, to manage process changes.

3. Understand important operational and design features of a manufacturing facility required for flexibility and agility to accommodate process changes.

  • Leader: Jeffery Odum, CPIP, SME, Managing Partner, Strategic Mfg, NNE, USA
    MaximizingManufacturing Utilization throughFacility Design
  • Doug DeVeny, NCARB, Global Technical Lead, Architecture / HVAC, Genentech Inc, USA
  • Carrier Li, Engineering Director, Amgen Inc, USA
  • Mark Witcher, PhD, Operations Lead, Strategic Manufacturing Concept Group, NNE, USA

Agility in Biotechnology Process Development
Monday, 30 October 1100 - 1230

Education Level: Advanced
Does it seem like changes in the biopharmaceutical industry have rapidly accelerated in the past few years?! Attend this session to learn about the industry drivers that are inspiring this acceleration and how process development professionals are using technology innovations like continuous manufacturing and operational excellence to deliver facilities of the future and advance patient outcomes.

This session will include presentation of enabling technologies as well as implementation case studies. It will wrap up with a panel discussion on the challenges and benefits of being agile in our current dynamic environment.

  • Leader: Avril Vermunt, Bioprocess Hardware Applications, GE Healthcare Life Sciences, USA
    Agility in Biotechnology Process Development- Introduction
  • Zachary Bornholdt, PhD, Director, Antibody Discovery, Mapp Biopharmaceutical, Inc., USA
    Atypical Development Path of Filovirus Immunotherapeutics
  • Bahar Dahi, Process Engineer, Genentech (A Member of the Roche Group), USA
  • Bryan Dransart, Senior Research Scientist, Gilead Sciences Inc, USA
  • Thomas Woods, Manager, Downstream Lab and Pilot Plant, Genentech (A Member of the Roche Group), USA

Process Capabilities as They Apply to the Pharmaceutical and Biotech Industry
Monday, 30 October 1345 - 1515

Education Level: Foundational
Process Capability is a valuable concept and is a series of tools to assess and improve product and process robustness. The ISPE Process Capability workgroup published earlier this year one article on how process capabilities can be used to drive both process improvement and compliance. Two more articles are being published, one focused on the development of a process capability maturity model that is specific to the pharmaceutical and biotech industry and another one on the statistical considerations involved in the use of process capability indices. This body of work discusses the advantages, limitations and risks associated with the use of such tools and concepts. It also gives some useful insight as to what the key elements of a process capability program may look like. In this session, you will hear about the work done by the ISPE process capability work group. Importantly, you will also hear about how pharmaceutical and biotech companies implemented such programs in their respective companies.

Facility Design Using Standardized Single Use Assemblies
Monday, 30 October 1615 - 1745

Education Level: Advanced
The drive for standardisation continues and in the past 12 months, numerous suppliers have adopted the Standard Disposables Design (SDD) approach to standardising single use assemblies.

SDD is intended to be a global solution to the global problem of the reliance on custom assemblies, long lead times, high inventory levels and high costs of disposable assemblies. It consists of simple, easy to assemble assembly designs that end users can source via the internet from a network of global suppliers. Component parts have been carefully selected using feedback from end users and knowledge gained during designing facilities.

In this session, attendees will be hear from a leading expert from one of the major pharmaceutical companies explaining why standardisation is so important to the industry. This will be followed by a talk where you will be taken through a design process of using these assemblies, how the decisions came about in setting up SDD and how the SDD approach speeds up the design process using the SDD design tool. The third and final talk will be where you hear about the program from a supplier perspective, on how SDD helps solve some of their manufacturing and supply chain issues.

The session will be rounded up with a question and answer session.

Engineering and Design for Continuous Manufacturing: Lessons Learned from the Users
Tuesday, 31 October 1045 - 1215

Education Level: Advanced
Continuous Manufacturing has moved from a "trend" to reality. As a new form of processing for most pharmaceutical engineers it requires new skill sets to overcome its unique challenges compared to traditional batch processes.

This session pulls together three users with direct experience in this area to share their lessons learned designing and implementing such systems and then, most importantly, operating actual processes on their installed systems. The format will be a combination of case study and design overview so attendees will leave with a deeper understanding of what to expect and how to prepare for actually engineering continuous processes. It will become clear which design aspects drive value for the end user and which features are critical success factors. Attendees are expected to come with a basic knowledge of continuous processing, related unit operations and integration requirements.

All three speakers hold key positions within their organizations offering a unique perspective and insight into this area of technology, two from Europe and one from the US, representing pharmaceutical manufacturing, machine design, systems integration and process development.

Implementing Pharma 4.0: The Holistic Manufacturing Control Strategy
Tuesday, 31 October 1045 - 1215

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.

Continuous Bioprocessing: Current and Future State
Tuesday, 31 October 1600 - 1715

Education Level: Advanced
Continuous manufacturing is gaining significant momentum in the biopharmaceutical industries. In addition to already established continuous perfusion cell culture technologies, we now see an increasing interest in continuous downstream processing technologies. This enables establishing a fully integrated continuous bioprocessing platform, allowing significantly higher facility throughput at lower costs. In addition to this, continuous bioprocessing allows for improved process control and hence more consistent product quality control.

In this session, we will review the current state of continuous downstream processing, address process development approaches and regulatory challenges. The session will cover case studies with antibodies and will illustrate the scale-up capabilities showing examples that involve scale-up from gram scale to kilogram scale production.

Enabling Manufacturing Control Strategy
Tuesday, 31 October 1600 - 1715

Education Level: Foundational/Intermediate
The session will focus on two components of the Manufacturing Control Strategy - Quality and Process Understanding.

The two presentations will highlight optimal approaches to realizing Quality Assurance - using Lean methodologies including batch record flow and real time release, and the use of advanced Data Analytics to support sustainable process design and continuous improvement.

Manufacturing Enterprise Facility Design
Tuesday, 31 October 1600 - 1630

Education Level: Advanced
In order to achieve operational excellence, a critical first step is to develop manufacturing facility design concepts and approaches focused on a manufacturing enterprise model. In this model, the process, facility, and infrastructure elements align with the product and process attributes and the control strategy to ensure that risk is identified and addressed in early Stage 1 design activities. This framework evaluates the Customer's requirements based on a sequence that efficiently creates the design basis for the facility to achieve the complex requirements of the manufacturing process. The framework must be straightforward, flexible, and efficiently guide the design process, focusing on the product attributes and the process unit operations over the enterprise's complete operating lifecycle required for manufacturing the product(s).

This session will describe this enterprise model and provide details on developing the key design elements, their relationship to the development of manufacturing strategy and achieving facility optimization, and identify key tools utilized to develop the enterprise framework. It will include case studies to look at the implementation of new enabling technologies, the focus on risk mitigation as part of an overall QRM approach, and address the critical impact of lackluster early-stage risk identification of project economic and execution stability.

  • Leader: Jeffery Odum, CPIP, SME, Managing Partner, Strategic Mfg, NNE, USA
    Building Enterprise Solutions for Complex Requirements and Risks

The Manufacturability Concept of a Commercial Product
Tuesday, 31 October 1645 - 1715

Education Level: Advanced
Process changes via continuous improvement initiatives are viewed as innovation vehicles of commercial processes. Monitoring intensification programs combined with science-based product/process realization (QbD) can be used to gain deeper understanding and to ensure continued stability and capability of the manufacturing process.

Here we present an approach for extracting information on existing/historical end-to-end process data and the use of latent variable models to summarize different blocks of information (viz., starting material, process operation, product quality). The evidences collected form the process characterization study were used in a small-scale investigation where the starting material variability was propagated throughout the process flowsheet in small-scale models, through a step linkage procedure. Based on results optimized process conditions were identified within the filed range. These settings were further investigated to gauge the validity of the results and confirmed optimization opportunities in at-scale production.

  • Leader: José Menezes, PhD, CEO, 4Tune Engineering, Portugal
    Revisiting the Manufacturability Concept of a Commercial Product

Formulation Development for Auto Injectors and Challenges of Combination Products
Wednesday, 1 November 0830 - 0930

Education Level: Advanced
This session will address focused development activities geared towards meeting user requirements and complying with combination product regulations.

Lessons Learned from Implementing BPOG's Risk Based Deviation Management
Wednesday, 1 November 0945 - 1045

Education Level: Intermediate
This is an interactive session which challenges decades of perceived wisdom to Deviation Management. The redesign of the Deviation Management System is driven by the recognition that different types of non-conformances are best solved using different investigational techniques. Minor, or low risk "events" are generally symptoms of a larger systemic process issues. Rather than conducting a comprehensive root cause analysis on each individual instance these are more effectively addressed by trending for patterns and then utilizing Continuous Improvement methodologies to address the "common cause" issues which lead to the events. More significant issues, deviations, are more likely the result of "special causes" and are effectively investigated using traditional root cause analysis tools on an individual basis.

We will explain the BPOG risk based Deviation Management Model and the case for change. Show how the model works in practice and the major benefits 16 companies have achieved by adopting it and describe a best practice implementation model forged from this experience. We will distinguish fact and fiction in the typical reasons cited for keeping the DMS model unchanged. In this session, participants will learn about track and trending for low risk deviations, will review applied tools, and health authority reactions.

  • Leader: Scott Fields, Senior Manager, Operational Excellence, Genentech (A Member of the Roche Group), USA
    Lessons Learned from Implementing BPOG's Risk-Based Deviation Management System
  • Jenny Stevens, CPIP, Head, Drug Product, Bayer, USA

Quality Systems and Regulatory Track

Track Director: Christine Moore, PhD, Global Head & Executive Director, GRACS CMC-Regulatory Policy & Compendial Affairs, Merck, Sharp & Dohme Corporation
Regulatory Track Director: Robert Iser, Director (Acting), Office of Process & Facilities, FDA/CDER/OPQ/OPF
Co-Director: Frank Montgomery, PhD, Global Head, Regulatory CMC, AstraZeneca 

Balancing regulatory opportunities and quality challenges

Featured Session- ICH Q12: Fostering Change and Innovation
Sunday, 29 October 1300 - 1400

Education Level: Advanced
A harmonized approach for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the biopharmaceutical sector, strengthening quality assurance and improving supply of medicinal products. ICH Q12 is intended to provide a framework to facilitate the management of post-approval CMC changes in a more predictable manner; to demonstrate how increased product and process knowledge can contribute to a reduction in the number of regulatory submissions; and provide tools and enablers for the biopharmaceutical industry to manage many CMC changes effectively under the Pharmaceutical Quality System (PQS) with less need for extensive regulatory oversight prior to implementation. In this featured session, Dr. Frank Montgomery, a member of the ICH Q12 Expert Working Group, will share an update on ICH Q12 and Dr. Mihalea Simianu will provide perspectives on how an effective PQS may facilitate the use of the post-approval concepts, tools and enablers that are part of ICH Q12.

Enabling Knowledge Excellence: Delivering Quality Innovation
Sunday, 29 October 1415 - 1515

Education Level: Intermediate
Matthew Neal, a Knowledge Management thought leader from LIQUENT will discuss the value of knowledge- from product and process knowledge to the "tribal" knowledge of how we do our work and how we learn from past experiences. In addition, preconceptions around the value of social media and other societal norms of how we share and use the knowledge we have will be explored. Mr. Neal will discuss how individual contributions can be harnessed to establish a collective corporate memory by outlining the key elements of an effective learning organization.

The session will then outline the Current State of Knowledge Management (KM) within the Industry. Paige Kane will share results from ISPE's recent Knowledge Management Industry Survey, a survey lead by the ISPE PQLI KM Task Team. This survey, the first of its kind in Biopharmaceutical industry, will benchmark against other industry sectors, establish the current state of KM capabilities provide insight on opportunities for achieving enhanced KM maturity.

The session will close with an Industry Panel Discussion consisting of PQLI KM team members to discuss the challenges and opportunities that exist for organization's investing in their knowledge assets.

  • Leader: Nuala Calnan, BSC. Eng, MBA, PhD, Regulatory Science Adjunct Research Fellow, Dublin Institute of Technology, Ireland
    Introduction to Enabling Knowledge Excellence
  • Leader: Paige Kane, CPIP, Regulatory Science Researcher, Dublin Institute of Technology, USA
    The Current State of Knowledge Management (KM) within the Bio/Pharmaceutical Industry
  • José Menezes, PhD, CEO, 4Tune Engineering, Portugal
  • Matthew Neal, MA, BA, Senior Director Product Management, Regulatory & Clinical Solutions, LIQUENT, a PAREXEL Company, USA
    Knowledge Management, Effective Learning, and Paying Attention

Future State: Globally Harmonized Process Validation
Monday, 30 October 1100 - 1230

Education Level: Intermediate
In 2011, the FDA published their "Guidance for Industry, Process Validation: General Principles and Practices". Since then Process Validation practices throughout the industry have been rapidly changing. Companies have been implementing the lifecycle approach and enhanced use of statistics but, the extent of implementation varies greatly across the industry. Other regulatory bodies have also redefined their process validations expectations. While there is significant alignment between regulators some differences exist. In this session, participants will hear both an industry and regulatory viewpoint on globally harmonized expectations including some possible opportunity areas to address perceived challenges. Additionally, the opportunity for harmonization of the role of statistics for process validation will be discussed. Specific elements required for successful harmonization will be explored.

  • Leader: Matthew McMenamin, Manager, Systems & Technology, GlaxoSmithKline, USA
  • Leader: Jennifer Walsh, Director Robustness & Validation, Bristol-Myers Squibb, USA
    ISPE Process Validation Team
  • Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Product Supply Quality, Novo Nordisk A/S, USA
    Global Harmonization/Convergence on Process Validation: Industry’s Perspectives
  • Grace McNally, Acting Branch Chief, Branch 3, FDA/CDER/OPQ/OPF/DIA, USA
    Considerations for Global Harmonization of Process Validation Requirements and Expectations: an FDA Perspective
  • Tara Scherder, Partner, SynoloStats, LLC, USA
    Harmonization of the Role and Application of Statistical Methods For Process Validation

Quality Systems Integration for Acquisitions/Mergers and Suppliers
Monday, 30 October 1345 - 1515

Education Level: Advanced
Does your firm have quality systems in need of updating perhaps after mergers or they have evolved over time and the company may have outgrown the current quality system? Have your quality systems evolved with multiple small revisions that have become cumbersome? If so you are encouraged to attend this session to learn how a firm went about a complete redesign of 5 major quality systems in about a month and implemented the new design within 6 months.

This session will benefit professionals and leaders responsible for quality systems. Participates will learn an effective and practical approaches to redesign major quality systems.

The team of speakers will include a Project Team Leader, System Owner and a Project Consultant. They will share a case study of how they went about the major clean sheet redesign of 5 quality systems aligned to industry best practice and harmonized procedures with parent and subsidiary companies.

The session will be an interactive discussion to allow the audience to share their experiences from quality system redesigns. In addition to sharing industry best practice the team will discuss best practices in change management and communication when making a major change in a quality system.

Measuring and Managing Quality from an Overall System Perspective
Monday, 30 October 1615 - 1745

Education Level: Advanced
The session will be focused on the outcomes of the FDA funded "Pharmaceutical Manufacturing Quality Metrics" Project conducted by the University of St. Gallen. The Analysis shown is based on the evaluation of data from around 350 pharmaceutical manufacturing plants and is structured along of a new model encompassing "Supplier Quality", "Operational Stability" and "Delivery Quality". Besides the Quality outcomes, the resources spent are also analyzed, taking into consideration QA/QC as well as maintenance headcounts and costs. On the one hand the three metrics from the revised FDA Quality Metrics Guidance are part of the analysis, on the other hand a more comprehensive evaluation is done also considering the most important enablers including Quality Engagement/Culture.

Session Structure:

  • Introduction of Pharmaceutical Production System Model (PPSM), and main conclusions from data Analysis
  • A closer look to Quality Culture
  • Aligning the findings with ICH

Delegates will leave the session with an understanding of Plants from an overall system perspective, as well as being able to analyze KPIs in the overall context and deriving conclusions for their own organizations.

  • Leader: Thomas Friedli, PhD, Director of Institute of Technology Management, University of St. Gallen (Switzerland), Switzerland
    Session Introduction and the St.Gallen Pharmaceutical Production System Model
    FDA Quality Metrics Research Report
  • Prabir Basu, PhD, President, Consultant, USA
    Aligning Quality Excellence with ICH Quality Systems Management
  • Nuala Calnan, BSC. Eng, MBA, PhD, Regulatory Science Adjunct Research Fellow, Dublin Institute of Technology, Ireland
    A Closer Look to Quality Culture

Quality Management System Considerations for Innovative Technologies and Product Life Cycle Management
Monday, 30 October 1615 - 1745

Education Level: Intermediate/Advanced
As the pharmaceutical industry is adopting new technologies in manufacturing, the pharmaceutical quality system needs to adapt its function to support the implementation of innovative techniques in the manufacturing environment such that quality control and oversight are built into processes and decision making. The session will provide an overview of the considerations for quality management systems to support innovation in pharmaceutical manufacturing throughout the lifecycle of the product, both from the industrial and regulatory perspectives. Examples of regulatory considerations will be provided for continuous manufacturing of solid oral dosage forms.

  • Leader: Yanxi Cain, PhD, Executive Director and Global Head of Quality Management Systems and Compliance, Merck & Co Inc, USA
    Quality Management System Considerations for Innovative Technologies and Product Life Cycle Management
  • Ahmad Almaya, PhD, Director, Eli Lilly & Co, USA
    Current Status and Technical Development Challenges with Continuous Manufacturing of Drug Products
  • Arwa El Hagrasy, PhD, Acting Quality Assessment Lead, FDA/CDER/OPQ/OPF, USA
    Quality Management System Considerations for Implementation of Continuous Manufacturing

Changes in Regulatory Landscape: Regulator Updates
Tuesday, 31 October 1045 - 1215

Education Level: Intermediate/Advanced
This session will provide updates from regulators across the globe regarding changes in how their agencies approach regulatory review and inspections. Areas anticipated to be covered include the recent FDA reorganization of ORA and changes in Russian inspectional approaches. Audience questions are encouraged.

Cultural, Operational and Quality Excellence- A Winning Formula to Deliver Quality Product on Time Every Time
Tuesday, 31 October 1045 - 1215

Gain insights into the current status of the FDA Quality Metrics program, hear firsthand the impact of robust quality Culture, help create the vision of strong and integrated cultures of quality and operational excellence.

Tuesday, 31 October 1330 - 1515

he Global Regulatory Town Hall provides attendees and regulators a forum for open discussion on topics relevant to the pharmaceutical industry and regulatory agencies, both domestic and international. This year's theme of "International Convergence" will bring Regulator perspectives and updates on key international convergence issues including ICH Q12 and mutual reliance and recognition of inspections, from FDA, Russia and ANVISA.

Drug Shortages: A Focused Review
Tuesday, 31 October 1600 - 1715

Education Level: Executive
Drug shortages in the US and worldwide continue to be a problem for patients, caregivers, manufacturers and regulators. In 2017, ISPE and the PEW Charitable Trust published a report summarizing their research on the market forces, supply chain management and business continuity decisions and their relationships to drug shortages. This session will discuss the major outcomes of the PEW-ISPE research. Additionally, an FDA official has been invited to speak on the current landscape for drug shortages in the US.

Clinically Relevant Specifications for Drug Substance and Drug Product Impurities: The Why and How
Tuesday, 31 October 1600 - 1715

Education Level: Advanced
Currently, it is usual and customary to set drug substance/ drug product (DS/DP) specifications based on the variability observed in limited clinical batches without consideration of the actual impact on the patient. This practice could unintentionally reward poor manufacturing process with relatively wider specifications compared to good manufacturing and control that would lead to tighter specifications. In addition, this approach could unnecessarily reject batches that would have met patient's needs for safe and effective medicine. Hence, it may contribute to drug shortages and drive higher medicine cost.

The objective of this workshop session is to discuss the drawbacks of the current practice and the benefits to decouple the voice of the patient (safety and efficacy) from the voice of the process (statistical process control limits). The opportunity, challenges and future direction for clinically relevant specification (CRS) will be discussed with drug substance and drug product impurity specification as an embodiment. Regulatory and industry speakers will give presentations on this topic follow by panel discussion.

  • Leader: Daniel Peng, PhD, Director, Drug Product Manufacturing Science & Technology, Shire, USA
    Introduction to Clinically Relevant Specifications
  • Julia O'Neill, Principal, Tunnell Consulting, USA
    Defining Limits To Represent Patient Needs and Process Capabilities
  • Mahesh Ramanadham, LCDR, PharmD, Director (Acting), Division of Inspectional Assessment, FDA/CDER/OPQ/OPF/DIA, USA
    Patient Centric Assessment: FDA Perspective
  • Ann Subashi, Director, Global CMC, Pfizer Inc, USA
    Industry Case Studies: Clinically Relevant Specifications

WORKSHOP: Creating a Strong Quality Culture: A Stepwise Interactive Process
Wednesday, 1 November 0830 - 1045

Education Level: Advanced
Most managers in the pharmaceutical business are gifted with good analytical brains. We're really good at solving problems. We got into management because of these great analytical skills. And that is both our blessing and our curse.

The blessing, of course, is that we can solve a lot of problems quickly. The curse is that when the problem lies with the actions of more than a dozen people, those great analytical skills become powerless. They may even become a liability.

When the magnitude of the job expands to this level, it's not just a quantitative difference in the workload anymore. The manager's job changes qualitatively. The manager cannot be simply a good administrator. The manager has to transform into a leader. And this is the point where the career of many a manager stops.

This seminar describes how one facility built a strong quality culture from a mediocre one, while at the same time cutting costs. The amazing part? We did this with managers who were not charismatic leaders.

  • Leader: Norman Howe, PhD, Senior Partner, Validation & Compliance Institute, USA
    Engineering a Strong Quality Culture

Professional Development Sessions

Featured Session- Women in Pharma: Career Strategies for Early Career Professionals
Sunday, 29 October 1300 - 1400

Education Level: Foundational/Intermediate
Mentoring is a hot topic these days - do a quick Google Search of the word "mentoring" and you'll get a cool 85 million results. A narrowed down search of "mentoring an engineer" and you'll get about 3.7 million results, less than 5% percent of the first search. For even further clarification, try searching "mentoring a woman engineer" - a nice 438 thousand - about 0.5% of the number of results for "mentoring". How many of those 438 thousand search terms are relevant? Every article appears similar: it's important to mentor the younger generation, they need it to succeed, to become better co-workers, Gen Xer's should sacrifice time and energy to mentor the next generation, Millennials must ask someone to mentor them as soon as possible and all of their work problems will go away.

Our presentation is a case study of an actual give-and-take mentoring relationship between two very different women: one a Gen Xer and the other a Millennial, one an established professional and the other a young engineer. Our presentation includes examples of reading materials, topics of guidance, lessons learned and the joint successes the presenters have seen in both their personal and professional lives.

From College to the Real World- How Our Senior Projects Prepared Us for Biotech Facility Design
Sunday, 29 October 1415 - 1515

Education Level: Foundational
When finishing your final semester of Chemical Engineering, it can be difficult to envision how hours of Organic Chemistry problem sets, Thermodynamics tutoring and a Senior Design project will translate to the professional world. However, in your first three years of designing Biotech facilities, you'll learn that all those late-night study groups and hard work truly paid off.

As Young Professionals in the Biopharmaceutical industry, you're not only fortunate to have colleges and universities investing resources in state-of-the-art engineering education, you're graduating into a field that offers multiple technical and leadership opportunities. Asking good questions, finding a mentor and participating in professional organizations can prove to make all the difference.

You'll hear from two process engineers and their mentor as they compare the development and timeline of a Continuous Processing Senior Design project to an actual large scale biomanufacturing facility design.

Session Highlights:

  • Discuss the differences between college and the real world and how to navigate the challenges
  • Learn how to hone the right professional skills and how to accelerate your career by setting the right goals
  • Understand the importance enlisting the right mentors and seeking out leadership responsibilities

  • Leader: Christopher Humphrey, Associate, Core Team Leader, CRB, USA
    From College to the Real World:How Our Senior Projects Prepared Us for Biotech Facility Design
  • Morgan Malick, BS, Process Engineer, CRB, USA
  • Bryan Raborn, BS CE, Process Engineer, CRB, USA

Own Who You Are: Women in Pharma Accept Responsibility for Managing Your Career
Sunday, 29 October 1415 - 1515

Educational Level: Foundational to Executive
"We cannot become what we need by remaining where we are."
-John Maxwell

ISPE proudly continues the spotlight on "The Women in Pharma." Key industry leaders from young professionals to executives in the pharmaceutical and biotech industries will lead us in engaging roundtable discussions focusing on you. We will cover topics that recognize and discuss your technical abilities, continuing education, and other topics that will help you Own Who You Are as you progress through your journey of professional and personal growth.

Please join us in sharing your personal story and learning how our professional perspectives shaped the way we navigate our careers as Women in Pharma.

The Most Important Role of a Project Sponsor is...
Monday, 30 October 1100 - 1230

Education Level: Foundational/Intermediate
Although many people perform critical roles in a project's success, a Project Sponsor can single handily make or break a project. Session attendees will gain a complete understanding of the many roles and responsibilities of a Project Sponsor. In addition, attendees will also learn how these responsibilities can often be in conflict by means of an interactive case study exercise reminiscent of the Kobayashi Maru (for all you Star Trek fans). This exercise will help Project Managers and other team members to identify the common issues they experience when working with Project Sponsors.

Without giving away the answer to the session title, attendees will then explore the Project Sponsor's "reason for being" through an interactive Q&A exercise. Finally, the attendees will identify and prioritize the critical qualities that are essential for an effective Project Sponsor.

  • Leader: James McGlade, Director, Project Management, Longfellow Real Estate Partners, LLC, USA
    The Most Important Role of a Project Sponsor is...
  • Kenneth Ewan, Principal, KME Leadership LLC, USA
  • William Hill, Senior Program Manager, West Pharmaceutical Services, USA
  • Patricia Melton, PhD, Managing Director, Mime Solutions Ltd., United Kingdom

"Exciting conference with plenty to learn from all different facets of the industry!"
~2016 ISPE Annual Meeting & Expo Attendee

                                                                                                "Engagement opportunities were numerous and the social events facilitate these interactions."
                                                                                                ~2016 ISPE Annual Meeting & Expo Attendee

"ISPE is a great meeting. I usually go as an exhibitor but would also like the opportunity to attend educational sessions."
~2016 ISPE Annual Meeting & Expo Attendee


2017 ISPE Annual Meeting & Expo Daily Schedule

Saturday, 28 October 2017

0800 – 1700 Committee Meetings
1730 – 1900 Leadership Reception (Invitation Only)

Sunday, 29 October 2017

0700 – 1500 Exhibitor Move-In
0800 – 1530 Committee Meetings
1100 – 1245 Young Professionals/Student Brunch and Orientation
1300 – 1515 Education Sessions
1515 - 1530 Networking Break
1530 – 1700 Opening Keynote Session
1700 – 1830 Expo Hall Open
1700 – 1830 Welcome Reception in Expo Hall

Monday, 30 October 2017

0645 – 0800 5K Charity Run/Walk
0715 – 0815 New Member/First-time Attendee Orientation
0830 – 1000 Keynote Session
1000 – 1700 Committee Meetings
1000 – 1615 Expo Hall Open
1000 – 1100 Networking Break in Expo Hall
1100 – 1230 Education Sessions
1230 – 1345 Lunch and Networking in Expo Hall
1345 – 1515 Education Sessions
1515 – 1615 Networking Break in Expo Hall
1615 – 1745 Education Sessions
1800 Open Night for Sponsored Events and Exploring the City

Tuesday, 31 October 2017

0800 – 1000 Membership and Awards Breakfast
1000 – 1545 Committee Meetings
1000 – 1600 Expo Hall Open
1000 – 1045 Networking Break in Expo Hall
1045 – 1215 Education Sessions
1215 – 1330 Lunch and Networking in Expo Hall
1330 – 1515 Global Regulatory Town Hall
1515 – 1600 Networking Break in Expo Hall
1600 – 1800 Exhibitor Move-Out
1600 – 1715 Education Sessions
1900 – 2200 Tuesday Night Party

Wednesday 01 November 2017

0800 – 1600 Committee Meetings
0830 – 1045 Education Sessions
1100– 1800 Facility Tours