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01:00pm - 04:00pm EDT - October 31, 2021
Avril J. Vermunt, Session Leader, Senior Director, Head of MSAT, Adverum Biotechnology; Maneesh Ghildyal, Vice President & Global Head Projects & Engineering, Biocon Ltd; Withoon Danwiboon, M.D., Managing Director, The Government Pharmaceutical Organization (GPO); Wendy Summers, Vice President, Pharmaceutical Operations and Technology, Locus Biosciences, Inc.; Masahiro Kondo, Senior Director, Takeda Pharmaceutical Company Limited; Mario Miele, Vice President Facilities and Engineering, ElevateBio; John Wichelt, Vice President Client Pharmaceutical Services, Grand River Aseptic Manufacturing
Track: Plenary Session

FOYA Category Winner Presentations|

Get an in-depth look at the latest, state-of-the-art developments being implemented, the winning projects, and see how excellence was delivered through agility, collaboration, and innovative thinking. Featured presentations include the 2021 Facility of the Year Awards Program Winners.

Facility Integration - Takeda Pharmaceuticals International AG

Project: NINLARO The Grange Castle Factory P2 Facility

Operational Excellence - ElevateBio

Project: ElevateBio BaseCamp

Project Execution - Janssen Sciences Ireland

Project: BioCork2 – Large Scale Fed Batch Facility

Process Intelligence and Innovation - Takeda Pharmaceuticals International AG

Project: Packaging Building and Automatic Line Clearance

Social Impact - Government Pharmaceutical Organization

Project: Thailand Self Sufficient for Pandemic Vaccines; Influenza and COVID-19

Operational Agility: COVID-19 Impact - Gilead Sciences, Inc.

Project: Gilead Sciences, Inc., Center for Innovative Drug Research (CIDR)

Operational Agility: COVID-19 Impact - Grand River Aseptic Manufacturing

Project: Grand River Aseptic Manufacturing Large-Scale Fill-Finish Facility

Honorable Mention - Biocon Biologics Limited

Project: Biocon Biologics Manufacturing (B3) Project

Honorable Mention - Locus Biosciences

Project: Commercial Phage Production Facility Upfit

Honorable Mention - Raymond G. Perelman Center for Cellular and Molecular Therapeutics

Project:  Raymond G. Perelman Center for Cellular and Molecular Therapeutics
Sunday
01:05pm - 01:20pm EDT - October 31, 2021
Mario Miele, Vice President Facilities and Engineering, ElevateBio
ElevateBio’s BaseCamp Facility is our Center of Innovation and enables our unique business model that provides integrated research and process development expertise, with flexible manufacturing capacity, thereby reducing time and cost required to take new therapies to market. Integration of ElevateBio’s founding vision into the facility design, building a team of industry experts, incorporation of digital platforms and a drive to deliver life changing therapies to patients in need all contributed to successful project execution.
Sunday
01:20pm - 01:35pm EDT - October 31, 2021
Withoon Danwiboon, M.D., Managing Director, The Government Pharmaceutical Organization (GPO)
This presentation is a brief summary of GPO’s self-sufficiency and sustainability for vaccine production in Thailand. The presentation covers a success story of an establishment of an egg-based vaccine production process along with the manufacturing facility construction, and vaccine distribution in Thailand.
Sunday
01:35pm - 01:50pm EDT - October 31, 2021
Wendy Summers, Vice President, Pharmaceutical Operations and Technology, Locus Biosciences, Inc.
A discussion on the build of the Locus Biosciences viral vector manufacturing facility and the rationale that went into the design. The presentation will focus down on the use of novel approaches used to contain viral vectors, prevent contamination, and ensure the safety of associates working in the facility.
Sunday
01:50pm - 02:05pm EDT - October 31, 2021
Maneesh Ghildyal, Vice President & Global Head Projects & Engineering, Biocon Ltd
This presentation will focus on successful completion of this fast-track project with more than 3 Million hours without a Lost Time Incident, with optimized and reduced production cost per unit translating to positive societal impact on patient population with focus on environment and sustainability throughout every aspect of the design.
Sunday
02:05pm - 02:20pm EDT - October 31, 2021
Masahiro Kondo, Senior Director, Takeda Pharmaceutical Company Limited
Takeda is accelerating automation and digital innovation to deliver high quality pharmaceutical products to patients. We will introduce our highly automated end-to-end packaging system and also several cutting edges of digital technologies used at this new packaging building, including automatic line clearance which Takeda implemented as the first pharmaceutical company in a commercial packaging facility.
Sunday
03:10pm - 03:25pm EDT - October 31, 2021
John Wichelt, Vice President Client Pharmaceutical Services, Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing set about on an ambitious new large-scale fill-finish facility with no idea that a global health crisis was coming down the tracks. Strategic site selection and flexible equipment choices prepared the CDMO to respond to the COVID-19 pandemic under the federal government’s Operation Warp Speed. To support the goal of increasing domestic fill-finish capacity, GRAM partnered with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacture of its SARS-CoV-2 vaccine.
08:30am - 11:15am EDT - November 1, 2021
Niranjan S. Kulkarni, PhD, Session Leader, Senior Director, Consulting Services | Associate, CRB; Thomas B. Hartman, President and CEO, ISPE; Joanne R. Barrick, RPh, Sr. Director TS/MS Validation, Eli Lilly and Company; Robin Kumoluyi, VP & Chief Quality Officer, Janssen Pharmaceuticals Johnson & Johnson Corporation; Lou W. Kennedy, CEO and Owner, Nephron Pharmaceuticals; Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations, FDA/ORA; Deusdedit Mubangizi, Unit Head Prequalification Unit (PQT) Regulation & Prequalification Department, World Health Organization; Kristen M. Farrell, CI/CT, Vice President, Cure SMA NE Chapter

Monday
08:30am - 08:45am EDT - November 1, 2021
Thomas B. Hartman, President and CEO, ISPE; Joanne R. Barrick, RPh, Sr. Director TS/MS Validation, Eli Lilly and Company
Welcome and Opening Remarks|
Monday
08:50am - 09:20am EDT - November 1, 2021
Robin Kumoluyi, VP & Chief Quality Officer, Janssen Pharmaceuticals Johnson & Johnson Corporation
From the early days of the COVID-19 pandemic, Johnson & Johnson, as the world’s largest and most broadly-based healthcare company, has played a pivotal role on a global stage. J&J has adapted new ways of working and forged a unique path to continue to transform as a leader during this unprecedented time. In this keynote address, we will explore reflections, lessons-learned and examples of how the COVID-19 pandemic was a catalyst for new collaboration and innovation at J&J to enable continued success today and for the future.
Monday
09:20am - 09:50am EDT - November 1, 2021
Lou W. Kennedy, CEO and Owner, Nephron Pharmaceuticals

As one of the fastest-growing and most dynamic companies in its industry, the Nephron Pharmaceuticals Corporation story is one of resilience and growth – through vertical integration and on-shoring PPE, Nephron has not only realized the importance of domestic manufacturing, but is actively taking the steps to create a real, and lasting solution. Nephron has turned within, utilizing cutting edge workforce development to create opportunities in technology, innovation and automation as we continue the construction of three new state of the art facilities, including a vaccination production wing, a Nephron Nitrile glove plant, and a COC syringe facility.
Monday
09:50am - 10:15am EDT - November 1, 2021
Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations, FDA/ORA
Regulators quickly adapted business operations for inspections, investigations, and sampling work to provide the necessary oversight of regulated industry. This presentation will describe how agility, collaboration and innovation were key to conducting regulatory work and enabling market access.
Monday
10:15am - 10:40am EDT - November 1, 2021
Deusdedit Mubangizi, Unit Head Prequalification Unit (PQT) Regulation & Prequalification Department, World Health Organization
The global number of confirmed COVID-19 cases and deaths reported to WHO has passed over 220 million cases and 4.5 million deaths. Getting vaccinated, maintaining physical distancing, cleaning hands, avoiding crowded and closed spaces, and wearing a mask are ‘anti-lockdown measures’. However, without the unpresidential embracement by world leaders, pharma industry, regulators and society to seek tools to assist in mitigating transmission and save lifes these numbers could have been higher. During the past 18 months while the world was fighting the pandemic, national medicines regulators have enabled manufacturing capacity by adopting regulatory flexibility to ensure continuous sustainability of product delivery, not to mention the significant acceleration to normal development timelines of product through clinical trials until product roll out. The world saw agility and the ability of pharma, together with regulators, working tiredly to identify and approve new candidates for treatment and prevention of the disease, while collaborating on a platform of sharing, talking, consulting and discussing best practices, best treatment and best collaborating tools to detect, respond and treat the covid-19 disease.
Monday
10:40am - 11:05am EDT - November 1, 2021
Kristen M. Farrell, CI/CT, Vice President, Cure SMA NE Chapter

Monday
11:05am - 11:15am EDT - November 1, 2021
Niranjan Kulkarni, PhD, Director, Operations Improvement, CRB

01:00pm - 02:30pm EDT - November 1, 2021
James P. Grunwald, Session Leader, Senior Vice President Business Development, DPS Group; Frank Maggiore, Vice President, Account Management, Apprentice.io; Andrea Sardella, PhD, Pharma Inspection Product Development, Stevanato Group S.P.A.; John Robert Parraga, Director, Process Automation, ECSSolutions; John C. Spohn, CPIP, Principal Project Engineer, Castle Hill Technologies, Inc.
Track: Agile Innovation Life Sciences Development & Manufacturing

Concurrent Session: New Approaches to Process Agility and Reliability|Over the past decade the adoption of Pharma 4.0 technologies and the challenges of accelerating new therapies while meeting  regulatory and business expectations for process robustness and reliability have driven new approaches in the industry. The sector’s accelerated response to the COVID pandemic was both enabled and sped up by these foundational innovations. This session will look at some of these responses and share the broader use of agile automation and data analytics to deliver more capable and reliable operations. The session includes a novel parenteral PAT case study that illustrates how the convergence of analytical and process technologies is delivering real value and ensuring a reliable supply of medicines to patients.
Monday
01:05pm - 01:25pm EDT - November 1, 2021
Frank Maggiore, Vice President, Account Management, Apprentice.io
Unlike traditional systems, intelligent, Pharma 4.0-driven platforms are flexible, ergonomic and easy to deploy. These dynamic platforms leverage artificial intelligence, machine learning, augmented reality to connect people, processes and environments to help organizations connect the dots between what they have, how they use it and what they will need soon. As a result, procedures are streamlined, better predictions can be made, and automated processes are triggered. For these reasons, we saw rapid adoption of intelligent, Pharma 4.0 systems within the life sciences industry during the COVID pandemic. This presentation will discuss the significance of this trend and how it allowed organizations to improve reliability, scale faster and increase their speed to market.
Monday
01:25pm - 01:45pm EDT - November 1, 2021
Andrea Sardella, PhD, Pharma Inspection Product Development, Stevanato Group S.P.A.
From defect detection to contaminant characterization to improve the detection rate and reduce false rejects in lyophilized products inspection. Recent developments of led light sources in the mid-infrared in conjunction with new higher sensitivity NIR sensors have allowed developing a multispectral imaging system suited to the inspection of lyophilized products without the drawback of previous systems, based on halogen lamps and highly light-demanding dispersive optics systems. We will present a new approach based on solid-state lighting devices and high throughput optical systems that operate at production rate. The high dimensionality data output has been elaborated using multivariate analysis to demonstrate the advantages in terms of detection accuracy, even in the case of few examples. Contaminants are characterized based on their spectral fingerprint providing relevant information as PAT tool and inherently reducing the false reject due to the product’s texture and topography variability.
Monday
01:45pm - 02:05pm EDT - November 1, 2021
John C. Spohn, CPIP, Principal Project Engineer, Castle Hill Technologies, Inc.; John Robert Parraga, Director, Process Automation, ECSSolutions
The speed with which vaccines for COVID were developed, tested, produced, and delivered is a stunning achievement fueled by unprecedented collaboration within industry and with regulators. It has also brought into stark relief a new challenge: Manufacturing activities must meet or exceed the nimbleness evidenced by these recent development and regulatory activities. Truly agile GxP manufacturing is no longer an aspiration but an urgent need. This presentation will focus on several hurdles for agile GxP manufacturing that stem from the growing dependence on single-use systems: mobile, self-controlled ‘islands of automation’. We will address key stakeholder concerns about making the integration or reconfiguration of unit operations more systematic, efficient, and predictable as well as restoring comprehensive EBRs and real time release. Attendees will also hear how to relieve operators of repetitive manual data entry and to mitigate the need for staff to train, utilize, and administer the user interfaces and platforms of each island. The presentation will also discuss potential relief from certain routine commissioning tasks. Surmounting these hurdles are keys to the faster and more confident stand-ups, scale-ups and tech transfers vital to providing therapies for urgent needs.
01:00pm - 02:30pm EDT - November 1, 2021
Mr. Klaus Ullherr, Leader/Speaker, Senior Product Manager, Syntegon Technology GmbH; Ute Schleyer, PhD, Project Manager Site Development, Vetter Pharma-Fertigung GmbH & Co.; Laura Moody, PhD, Product Manager, Syntegon Pharma Technology; Thomas O’Sullivan, Director of Aseptic Technology, IPS
Track: Process Development and Manufacturing

Concurrent Session: Fill Finish|This session will focus on technologies associated with the future state of Fill-Finish manufacturing. The presentations in this session cover a wide variety of technologies such as innovative processes using modern technologies and intelligent modular concepts, the development of an innovative cGMP-compliant and flexible production cell based on isolator technology and technological highlights to cover major challenges for the aseptic handling of viral vaccines under BSL2. Three different projects pushing the boundaries of Fill-Finish to show Agility, industry Collaboration and successful Innovation in new technologies.
Monday
01:05pm - 01:35pm EDT - November 1, 2021
Ute Schleyer, PhD, Project Manager Site Development, Vetter Pharma-Fertigung GmbH & Co.; Mr. Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
In the case of small commercial quantities, batch sizes vary between 500-3,000 units. The technical and economic challenge for high value drugs in smaller batch sizes is to maximize API-yield, flexibility and time-to-market. A new industry standard for fill/ finish technology is currently in the realization process. Its development started by linking Vetter’s know-how in process development for aseptic filling and clean room technology with the expertise of Syntegon Technology GmbH in system and plant technology. The objective is the development of an innovative, cGMP-compliant and flexible production cell based on isolator technology. This presentation will show the outline of the cooperation and the status quo of this newly developed fill/finish equipment with insights into the detailed design and technical innovations.
Monday
01:35pm - 02:05pm EDT - November 1, 2021
Thomas O’Sullivan, Director of Aseptic Technology, IPS; Laura Moody, PhD, Product Manager, Syntegon Pharma Technology
The design and implementation of a state-of-the art fill finish facility for viral vaccines faces numerous challenges. Besides the right facility design with focus on BSL2 aspects, this project had the challenge of a very short timeline (fast-track project) combined with facility space limitations. One major goal was to combine the flexibility to handle liquid and lyo products with fully-isolated equipment, to guarantee the highest degree of operator safety . Besides that, the presentation covers also insights into the background for handling of viral vaccines as well as the major hurdles from a project execution perspective.
01:00pm - 02:30pm EDT - November 1, 2021
Mr. Eric J. Staib, Leader/Speaker, Head of Quality, Validated Cloud; Alice Rystov, Session Leader; Meher Muttanapalli, Senior Quality Validation Manager, Johnson & Johnson; Brandi M. Stockton, Co-Founder and Principal Consultant, The Triality Group LLC
Track: Information Systems

Concurrent Session: Digital Innovation - Ensuring Quality and Regulatory Compliant Solutions|This digital innovation session allows attendees to discover how to cost effectively/efficiently validate and ensure the quality of their machine learning (ML) and software automation projects, while collecting and establishing the necessary evidence to withstand regulatory scrutiny. From a newly formed GAMP5 framework to computer systems/software assurance for automation, this session provides easily understandable and practical approaches behind the “mystery” of compliance for such novel digital technologies. Not only does the session give you tangible information to use in your next project, but it also breaks it down into the details you need. This includes ML as a sub-component of your overarching system(s), recommended risk-based life cycle deliverables, and right-sized scalable efforts to put your time and money where it matters most.
Monday
01:05pm - 01:25pm EDT - November 1, 2021
Meher Muttanapalli, Senior Quality Validation Manager, Johnson & Johnson
Adoption of the novel Computer Software Assurance (CSA) instead of traditional & heavily documented focused Computer System Validation resolves many challenges. CSA focuses on critical thinking and testing/assurance instead of documentation by streamlining the validation efforts based on the integral risks to the product quality, patient safety and data integrity. CSA allows for taking credit of the work/testing performed by software provider and puts the least burden on the manufacturer. Use of Limited Scripted/Unscripted Ad-Hoc testing approaches focuses on Testing and not scripting addressing the high critical risks and help mitigate the controls for a computerized system used in production and QMS.
Monday
01:25pm - 01:45pm EDT - November 1, 2021
Eric J. Staib, Head of Quality, Validated Cloud
This presentation will describe a life cycle framework for Machine Learning (ML) for use within life sciences in a GxP regulated environment. The life cycle of an ML sub-system or component to be embedded in a wider computerized system life cycle, and for most systems using these technologies many aspects of the traditional computerized system life cycle and the compliance and validation approach are still fully applicable (e.g. those related to specification and verification of user interface, reporting, security, access control, data integrity controls and data life cycle management).
Monday
01:45pm - 02:05pm EDT - November 1, 2021
Brandi M. Stockton, Co-Founder and Principal Consultant, The Triality Group LLC
There is an uncertainty in industry as to what documentation and/or deliverables that need to be created as part of the "machine learning life cycle". This presentation shall examine each phase of the AI/ML implementation process and provide recommendations, based upon recent regulatory guidance and the presenters own experience, as to what is required in terms of evidence, data, and deliverables to support an inspection and/or client audit.
01:00pm - 02:30pm EDT - November 1, 2021
Steven J. Wisniewski, Session Leader, Principal Consultant, CAI; Midhu Varghese, Associate Director, Commissioning & Qualification, AbbVie, Inc.; Joerg Block, PhD, GMP Compliance Engineering, Bayer AG PH-PS Engineering; David Macdonald, Principal Engineer, Hyde Engineering and Consulting
Track: Facilities and Equipment

Concurrent Session: QRM/CQV - Best Practices and Lessons Learned|This session will address the development of standardized templates, application of risk-based concepts, and examples of implementation by Bayer and Amgen.  In addition, the session will provide case studies demonstrating design with qualification in mind.  Join the discussion and hear more about best practices, industry use-cases, and utilizing a system of lean integrated CQV.
Monday
01:05pm - 01:25pm EDT - November 1, 2021
Midhu Varghese, Associate Director, Commissioning & Qualification, AbbVie, Inc.
With the recent release of the Commissioning and Qualification, Baseline Guide 5 v2, ISPE C&Q Steering team has shed light on the mystery of “how" by developing standardized templates across several process deliverable examples. Part 1 of this presentation will show User Requirements Specifications (URS), System Risk Assessments (SRA), Design Qualification (DQ), Acceptance and Release Summary Reports developed by the cross-company Task Team and explain the philosophy and concepts behind the content. The presentation will demonstrate application of the risk-based concepts and how scaling, based on complexity, impacts documentation activities. Example deliverables will be presented related to production equipment, packaging equipment and critical utilities.
Monday
01:25pm - 01:45pm EDT - November 1, 2021
Joerg Block, PhD, GMP Compliance Engineering, Bayer AG PH-PS Engineering
In part two of this presentation, Dr. Block will present examples showing application of C&Q Process deliverables to System Risk Assessment approaches being applied at his organization. Insight will be presented on how Bayer AG is moving forward with the establishment of QRM best practices with multiple risk assessment tools supporting the application of QRM in C&Q..
Monday
01:45pm - 02:05pm EDT - November 1, 2021
David Macdonald, Principal Engineer, Hyde Engineering and Consulting
2020-21 has demonstrated the importance of delivering new production capacity on an expedited timeline. Too often in the past, CQV testing has been the last dragging item on the critical path preventing the start of GMP manufacturing. The principals of ASTM E2500 have been with us for 15 years but rarely fully utilized. Using a system of lean integrated CQV based on the principals of E2500 and the revision of the C&Q baseline guide allows the reduction of testing, especially on site testing, and the removal of some CQV activities from the projects critical path. This is design with qualification in mind, with quality and validation integrated into the early phases of the project. This approach will be described and two case studies will be discussed - a large GT project and a smaller flexible CGT project. From these case studies participants will see the advantage of integrating QA and Validation into the project early allowing for the rational design of testing - once and in the best phase for the expedited delivery of the facility.
01:00pm - 02:30pm EDT - November 1, 2021
Christian Wölbeling, Leader/Speaker, Executive Industry Advisor, Körber Pharma Software GmbH; Drishya Nair, Manager, Life Sciences Consulting, Ernst & Young US LLP; Stephanie G. Garth, Vice President, Quality Assurance North America, The Binding Site; Jay Welsh, Partner & Supply Chain Leader, Ernst & Young US LLP
Track: Supply Chain, Operations, and Packaging Excellence (SCOPE)

Concurrent Session: Drug Shortages and Meeting Supply Chain Challenges|During the pandemic, supply chain issues and drug shortages were discovered across many industries, including biopharmaceuticals.  Drug shortages have the potential to be one of the most impactful supply chain challenges to the health of people throughout the world and are a topic of significant interest to manufacturers, regulators, policymakers, health care professionals, and, most importantly, patients.  The slow pace of post-approval changes can also impact the supply chain and has the potential to create drug shortages. While the purpose of post-approval changes is typically to improve the quality of the product by incorporating a new understanding of the drug or process, approval of these changes can take months or years. Using a Digitalization Toolbox beginning with Process Development and throughout the pharmaceutical lifecycle enables a flexible change management of the product through a robust Control Strategy.  The optimal toolbox includes software and analytical tools to address knowledge management, holistic process understanding and the process monitoring and quality control across the development steps; a Holistic Control Strategy approach. This session will cover these topics and discuss how experiences with the COVID-19 pandemic provided an opportunity to further reduce drug shortages and improve the time it takes for post-approval changes to be implemented.  Additionally, analytical models can help to maintain and manage complex supply chains from the start of development in order to shorten the time to patient.  Finally, the session will open the topic of Holistic Control Strategy approach to increase processing efficiency and control across drug development.
Monday
01:05pm - 01:20pm EDT - November 1, 2021
Christian Wölbeling, Executive Industry Advisor, Körber Pharma Software GmbH
Digitalization enables the continuous design, execution and lifecycle management of the ICH Control Strategy. Using the Digitalization Toolbox starting in Process Development and using it along the pharmaceutical lifecycle enables a flexible change management of the product but more importantly of the Control Strategy. Challenges are still in the knowledge management, holistic process understanding and the process monitoring and quality control across the development steps, calling this the Holistic Control Strategy approach. Analytical models will help to maintain and manage complex supply chains which are already starting in Process Development to shorten the time to patient. The ISPE Pharma 4.0™ Operating Model offers holistic concepts for digitalized Control Strategies.
Monday
01:20pm - 01:40pm EDT - November 1, 2021
Anders Vinther, PhD, Vice President Quality Kronos Bio & Co-lead 1VQ on PAC Initiative, QBA
Post-approval changes are inevitable and necessary throughout the life of a drug product—to implement new knowledge, maintain a state of control, and drive continual improvement. Many of these post-approval changes require regulatory agency approval by individual countries before implementation. Because of the global regulatory complexity, individual post-approval changes usually take years for full worldwide approval even when they reduce patient risk, improve compliance, or enhance the manufacturing process or test methods. This global complexity slows down continual improvement and innovation and can cause drug shortages and current good manufacturing practices compliance issues. A global problem needs a global solution. Chief Quality Officers from the largest pharma companies are speaking with “One Voice of Quality” and have defined how companies can demonstrate an effective Quality System for managing PACs both at a system and individual level. The solutions are based on ICH Q9, Q10, Q12 and driven by SCIENCE.
Monday
01:40pm - 02:15pm EDT - November 1, 2021
Jay Welsh, Partner & Supply Chain Leader, Ernst & Young US LLP; Stephanie G. Garth, Vice President, Quality Assurance North America, The Binding Site; Drishya Nair, Manager, Life Sciences Consulting, Ernst & Young US LLP
Following the issuance of the FDA Drug Shortages: Root Causes and Potential Solutions, there has been renewed activity by HAs globally as well as ISPE to the drug shortages issue, particularly with the need to respond to the COVID 19 pandemic. Access to critical medicines has been primary focus for Life Sciences companies especially since the pandemic and many solutions are being developed to solve the Supply Chain challenges during such global health emergency situations. Experts from the front line will present experiences and the steps involved in planning ahead including: a Business Continuity plan, summarizing actions for senior management to prepare proactively for potential drug shortages. Prioritization, risk assessment, mitigation options. Experiences and learnings from the COVID 19 pandemic supply chain pressures.
01:00pm - 02:30pm EDT - November 1, 2021
Gregory Rullo, Session Leader, Senior Director, Regulatory Affairs-CMC, AstraZeneca; Timothy J.N. Watson, PhD, Vice President – Head of CMC Regulatory Affairs, Gilead Sciences; Ciby Abraham, PhD, Senior Director and Group Manager, Project and Product Leadership, AstraZeneca; Rodrigo Palacios, Associate Director, Global Regulatory Policy, F. Hoffmann-La Roche AG
Track: Quality Systems and Regulatory

Concurrent Session: Path to a Global Quality Dossier - Part 1|Industry has observed vastly different and region-specific CMC submission requirements and quality standards which can cause delays in approval of new medicines to patients worldwide.  A related challenge is the differing global Post Approval Change requirements that can risk continuity of supply of medicines.  The ideal state is a global quality dossier that can be assessed by multiple regulators and provides for a single, approved dossier that is globally maintained.  This would allow faster access of medicines to patients around the world, reduce the risk of supply shortages, help resource constrained regulators to rely on each other’s expertise and provide less regulatory burden to industry.  ICH Quality guidelines provide a firm foundation, and ICH Q8-Q12 outline key principles that cover product development by incorporating principles of risk assessments, pharmaceutical quality systems, and lifecycle management. In this two-part session, key aspects of a potential path to a global quality dossier will be presented.  In part 1, presentations will focus on control strategy, a globally harmonized, risk-based quality overall summary and an update on Accumulus.
Monday
01:05pm - 01:30pm EDT - November 1, 2021
Timothy J.N. Watson, PhD, Vice President – Head of CMC Regulatory Affairs, Gilead Sciences
ICH guidelines introduced risk-based approaches and enhanced scientific understanding as an opportunity to encourage continuous process improvement for pharmaceutical manufacturing. Conceptually, Quality by Design (QbD) promised to improve confidence in quality through the lifecycle of pharmaceutical products. A primary incentive for industry is the prospect of global regulatory concordance for new applications and post approval changes. Unfortunately, during the last decade, the industry has experienced a proliferation of regulatory divergence regarding the interpretation of ICH guidelines (and control strategies) across geographic regions. Rather than truly harmonized regulatory expectations, localized interpretations of ICH guidance have resulted in different technical requirements and/ or control strategies posing significant challenges for a global industry. As a result, the increased complexity of manufacturing supply chains and the regulatory burden associated with maintaining compliance with these diverse regulatory expectations serves as a barrier to continual improvement and innovation. Divergence has become one of the newest risks to continued improvements (disincentive) and risks temporary drug shortages in some markets.
Monday
01:30pm - 02:00pm EDT - November 1, 2021
Ciby Abraham, PhD, Senior Director and Group Manager, Project and Product Leadership, AstraZeneca
Currently there are varying CMC submission requirements and quality standards for ICH and non-ICH countries that cause global delays to approval of new medicines to patients even though the quality of the product supplied is the same. Perhaps a greater challenge are differing global Post Approval Change requirements where supply of medicines can be interrupted. The quality of a drug should ensure safety, efficacy and consider patient risk-benefit. The Quality Overall Summary (QOS) provides an ideal opportunity to provide a comprehensive view of the control strategy and discuss patient risk-benefit. Unfortunately the QOS is not harmonized in the ICH regions and no Module 3 document provides a logical spot to discuss either the overall control strategy or patient risk-benefit.
Monday
02:00pm - 02:30pm EDT - November 1, 2021
Rodrigo Palacios, Associate Director, Global Regulatory Policy, F. Hoffmann-La Roche AG
The current approach to how sponsors and health authorities exchange data is inefficient and ripe for transformation. Existing regulatory filing processes are inconsistent across geographies, require significant manual effort, and use outdated technology that ultimately leads to delays in patient access to medications and higher drug development costs. A radical transformation is needed from a static transactional exchange between sponsors and regulators to a dynamic approach capable of exploiting the full range of data sources and digital tools. This presentation will explore how Accumulus Synergy is taking this aspiration from theory to practice via execution of use cases in partnership with regulators. Accumulus Synergy is working with the FDA’s Oncology Center of Excellence (OCE) and other global health authorities to design, develop, and deploy, a full-scale, cloud-based solution enabling collaborative review of structured data submissions by regulators. In addition, we will also discuss the long-term aspirations and regulatory design considerations and show how tangible progress is being made in the near term via use cases with regulators for parallel review and CMC Stability Data Automation, Usage and Exchange. These use cases intend to provide a proof of concept that can be scaled to all aspects of regulatory filings.
03:00pm - 04:30pm EDT - November 1, 2021
Clay Schaeffer, PE, Leader/Speaker, Principal Engineer / Automation, Biogen; Kenneth W. Pierce, B.Sc. Ph.D., Cleaning Validation Specialist, Engineer III, Hyde Engineering + Consulting Europe Ltd; Geraldine Murray, Associate Director, Strategic Services, Astellas Ireland Ltd; Tyler C. Underhill, Biologics & Cell / Gene Therapies SME, PM Group; Juerg Brechbuehler, Bio Future TechOps Program Engineer, Novartis; Javier Lozano, Head of Process Engineering, PM Group
Track: Agile Innovation Life Sciences Development & Manufacturing

Concurrent Session: Increasing Facility Flexibility through Improving Turnarounds and New Product Introduction|The timelines involved in the introduction of new therapies often requires the creation of additional capacity while avoiding significant new capital investments.  Maximising the productivity of existing assets is key to that response and the ability to reduce the time taken to complete cleaning and turnarounds can add real value.  Similarly  faster product introduction can be enabled through standardisation of quickly adaptable and adoptable single use process components and their associated automation systems.  The three presentations in this session will share real world examples of companies delivering on those objectives and realising significant value.
Monday
03:05pm - 03:25pm EDT - November 1, 2021
Kenneth W. Pierce, B.Sc. Ph.D., Cleaning Validation Specialist, Engineer III, Hyde Engineering + Consulting Europe Ltd; Geraldine Murray, Associate Director, Strategic Services, Astellas Ireland Ltd
Manufacturing paradigms continually change and supply stability and sustainability have become significant issues during the Covid-19 crisis. How can we support supply without increasing demand on finite resources, or increasing our ecological resource footprint? What if you are at 90+% of the designed manufacturing capacity? Can you demonstrate continuing viability without capital investment? Are your utility systems running at capacity? This co-presentation with Astellas, Dublin, Ireland will look at aging/established facilities environmental responsibility and efficiency. Their best version of Pharm4.0 is delivered by people, SME knowledge, and their empowerment to challenge the norms of operation. We showcase a methodology for dismantling and rebuilding cleaning programmes without requiring engineering support that can release your production capacity. We examine two different drivers; one supply maintenance (API), and one supply increase (Biotech), both with an environmental twist. We show how human intuition, experience and knowledge was empowered to leverage continually generated, but inadequately utilised, data.
Monday
03:25pm - 03:45pm EDT - November 1, 2021
Tyler C. Underhill, Biologics & Cell / Gene Therapies SME, PM Group; Juerg Brechbuehler, Bio Future TechOps Program Engineer, Novartis
It is widely accepted that standardisation of Single Use (SU) designs would be beneficial to the industry, providing simpler, faster and lower cost solutions. However, as SU technology become more widely adopted, suppliers may struggle to keep up with demand. A widely adopted SU Standardisation approach is needed to alleviate SU supply issues. This would not only benefit the biopharma industry by helping to ensure production but ultimately, it would help patients as well. This presentation will consider current practices in designing Single Use processes and facilities, and will examine where standardisation may be appropriate. It will present an analysis of the benefits an industry wide standardisation will bring to both end users and SU vendors, and highlight the advantages and challenges that standardisation may bring. Focusing on the areas where standardisation has the greatest potential impact, the speakers will look to a potential future scenario where vendors compete on product attributes rather than dimensions and end users enjoy greater supply-chain security, and shorter leadtimes.
Monday
03:45pm - 04:05pm EDT - November 1, 2021
Clay Schaeffer, PE, Principal Engineer / Automation, Biogen
As the biopharma industry moves towards more agile production environments, process equipment automation systems will require tools that align with the inherent flexibility of single-use technology (SUT). SUT enhances a manufacturer’s ability to modify operations to meet the needs of today’s dynamic industry, however, integrating flexible platforms into the plant infrastructure requires extended timelines and increased costs due to custom development and validation of data interfaces. The BioPhorum Plug and Play workgroup has been working since 2017 to leverage established and emerging communications standards to move from the current state of unique and custom software interfaces to a configurable, standardized approach that enables rapid integration of intelligent process skids into a facility’s existing manufacturing system. This seminar will discuss the fundamentals of Plug and Play technology, how Plug and Play is being developed by BioPhorum in collaboration with other industry groups, and the progress made to date.
03:00pm - 04:30pm EDT - November 1, 2021
Mr. Paul T. Lopolito, Leader/Speaker, Technical Services Senior Manager, Steris Corporation; Z.A.M. Shabeer Thahir, MEng, Session Leader, Process Validation Engineer, Patheon UK Ltd - Part of Thermo Fisher Scientific; Mohamed Shaker, Scientist, Cytiva; Amanda Culliton, Senior Project Manager, Cytiva; Daniel A. UpDyke, P.E., Life Sciences Market Development Manager, Rockwell Automation; Sachin Misra, Pharmaceuticals & Biotech Industry Principal, Kalypso
Track: Process Development and Manufacturing

Concurrent Session: Tech Transfer|This session will focus on three critical areas for successful tech transfer. The first presentation will provide insight to working with and establishing the right team for positive collaboration with a CDMO. The second presentation dives into a specific process and walks through steps to avoid common pitfalls in designing and transferring a cleaning process for manufacturing. The final presentation unlocks the concerns around continuous product and data flow from discovery through manufacturing exposing potential savings in time and costs. Concurrent Session: Tech Transfer|Concurrent Session: Tech Transfer|Concurrent Session: Tech Transfer| The valuable information will help ensure successful tech transfer and can lead to accelerated project timelines, waste reduction, and improve profitability.
Monday
03:05pm - 03:25pm EDT - November 1, 2021
Amanda Culliton, Senior Project Manager, Cytiva; Mohamed Shaker, Scientist, Cytiva
A successful technology transfer to a CDMO is far more than just sending over your data and documents and hoping for the best – it’s “friending” another team that is going to help you achieve your goals and bring your product to market faster. In these days of international biomanufacturing at warp speeds, getting this relationship right from the beginning is more important than ever. Much like with your online friends, you’ll gain the most benefit by establishing a positive collaboration with your CDMO, ultimately resulting in accelerated timelines and process improvements. Join us for real-world examples of what to do, and what not to do, for a positive and successful tech transfer to a CDMO. After this presentation, you’ll know what to do to foster open communication and maintain a productive relationship between the two teams.
Monday
03:25pm - 03:45pm EDT - November 1, 2021
Mr. Paul T. Lopolito, Technical Services Senior Manager, Steris Corporation
Equipment cleaning concerns are often over-looked during design, startup, and commissioning of pharmaceutical facilities. This is often the case with newer technologies such as mRNA vaccines and cannabis derived products. Failures to link the manufacturing process to cleaning agent selection, physical properties of cleaning chemicals, storage and handling requirements, waste discharge restrictions, dispensing requirements, and material compatibility can lead to costly delays. Technical transfer teams and regulatory agencies expect laboratory testing to support cleaning agent selection, cycle development, critical parameter selection, and a continuous monitoring strategy. Current industry trends also demand a sustainable cleaning approach which considers water consumption, energy requirements, carry-over concerns of active ingredients, and personnel safety. The presentation will focus on some steps to avoid common pitfalls in designing a new cleaning process through laboratory testing as well as leveraging a master soil to take full advantage of factory acceptance testing and commissioning events of new equipment. This valuable insight enables engineering and commissioning teams to dedicate resources on their manufacturing process.
Monday
03:45pm - 04:05pm EDT - November 1, 2021
Daniel A. UpDyke, P.E., Life Sciences Market Development Manager, Rockwell Automation; Sachin Misra, Pharmaceuticals & Biotech Industry Principal, Kalypso
The Pharmaceutical industry sells a variety of products and therapeutic packages that include diagnostic tests, drugs, monitoring devices and mechanisms, as well as a wide range of services to support patients. In addition, due to constant merger and acquisition activity, companies often struggle with a cumbersome patchwork of system and tools. Extended value chains in the Pharmaceutical industry are becoming more global and complex in nature, making visibility of information and structured data across the value chain a vital issue for efficient tech transfer and rapid scale-up. With all of these challenges, there has been a major shift away from national to "regional" or "global" manufacturing & value chain structures with emerging economies, providing further opportunities for manufacturing and sourcing for the Pharmaceuticals industry. A continuous product and process data flow from Discovery to Internal or External Manufacturing can enable efficient and effective Tech Transfer and Scale-Up – unlocking significant timeline, cost and profitability improvements.