Reset

Advanced Filters
08:30am - 10:15am Eastern - February 1, 2022
Jeffrey A. Biskup, PE, Session Leader, CEO and Chairman of the Board, CRB; Thomas B. Hartman, President and CEO, ISPE; Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland; Louis S. Schmukler, President, Global Product Development & Supply, Bristol-Myers Squibb; James Stephanou, Vice President Global Engineering Solutions, Merck; Matthew Hepburn, M.D., Senior Advisor To the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy, Executive Office of the President

The opening session will take a high-level look ahead at global pharmaceutical manufacturing and related regulatory systems. We will discuss how COVID has impacted our business and the applications of future manufacturing operations and the facilities required to adequately produce product that is safe, cost effective and meets the needs of the patients we serve. Key industry leaders will share their perspectives and their insights into how they see the industry changing as we move forward from COVID.


Tuesday
08:30am - 08:35am Eastern - February 1, 2022
Thomas B. Hartman, President and CEO, ISPE

Tuesday
08:35am - 08:40am Eastern - February 1, 2022
Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland

Tuesday
08:40am - 08:45am Eastern - February 1, 2022
Jeffrey A. Biskup, PE, CEO and Chairman of the Board, CRB

Tuesday
08:45am - 09:15am Eastern - February 1, 2022
Louis S. Schmukler, President, Global Product Development & Supply, Bristol-Myers Squibb

Tuesday
09:15am - 09:45am Eastern - February 1, 2022
James Stephanou, Vice President Global Engineering Solutions, Merck

Tuesday
09:45am - 10:15am Eastern - February 1, 2022
Matthew Hepburn, M.D., Senior Advisor To the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy, Executive Office of the President

11:00am - 01:00pm Eastern - February 1, 2022
Michael Martin, Session Leader, CEO, CAI; Yury Yohana Gomez, Global Strategy Leader, WW Manufacturing & Supply Chain, Microsoft; Mr. Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Julien Janda, Head of Process & Technology, GMS Global Engineering, Takeda Pharmaceutical International AG; Shanshan Liu, Director, No Deviation Pte Ltd
Track: Concurrent Session

Historically, industrial manufacturing has advanced from mechanization to mass production and then to automation/computerization. The next phase of manufacturing (referred to as Industry 4.0) involves integration of equipment and communication systems. The pharmaceutical industry is undergoing these same transformations (with the most recent phase referred to as Pharma 4.0). This session will explore aspects of Pharma 4.0 including IoT based technology and analytics, robotics in pharma manufacturing, a data mindset. This will include: The vision to integrate data and to easily visualize and analyze data providing insights across sites The future of pharmaceutical manufacturing with robots and cobots. The fundamental mindset shift to achieve a data driven decision.


Tuesday
11:00am - 11:30am Eastern - February 1, 2022
Yury Yohana Gomez, Global Strategy Leader, WW Manufacturing & Supply Chain, Microsoft
With the dynamic changes in both the pharma regulatory landscape and government policies, many leading pharma organizations are now more than ever under increased pressure to reimagine their internal operations to deliver consistent quality outcomes, minimize operational costs and accelerate scientific innovation for existing and unmet medical conditions. Intelligent automation delivers on the possibilities to truly reimagine process design and quality control through advanced manufacturing solutions leveraging cutting edge technology including IOT, digital twins, control towers, and AI/ML enabled cloud while empowering pharma companies and operators with real time data and insights to make better decisions & drive competitive advantage. This presentation will discuss insights on how to develop a multi-horizon roadmap to capture the full value that data, analytics and simulations can unlock to address pharma manufacturing most pressing challenges.
Tuesday
11:30am - 12:00pm Eastern - February 1, 2022
Mr. Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Julien Janda, Head of Process & Technology, GMS Global Engineering, Takeda Pharmaceutical International AG
The ISPE DACH founded in 2019 the Special Interest Group for Future Robotics in Oral Solid Dosage and Aseptic Processing. The SIG Future Robotics is working on different new application Robotics could be used. The presentation would introduce new field on Robotics for the pharmaceutical manufacturing as well as what regulatory and safety requirements are needed.
Tuesday
12:00pm - 12:30pm Eastern - February 1, 2022
Shanshan Liu, Director, No Deviation Pte Ltd
The fundamental mindset shift to achieve a data driven decision. The presentation will follow the data flow and demonstrate the pharma application of data collection, data analysis, data presentation, use of data and data integrity. The demonstration will be supported with industry case studies which will cover the product lifecycle from development, validation, production, maintenance to distribution. Also develop a new perspective of the existing data and the valuable database; learn how the data could be utilised to drive the decision making; be encouraged to initiate an organisation wide discussion on how to enable the transformation into a data era.
Tuesday
12:30pm - 01:00pm Eastern - February 1, 2022
Michael Martin, CEO, CAI

11:00am - 01:00pm Eastern - February 1, 2022
Tara Tibbs, Session Leader, Sr Director Engineering API/DP, Eli Lilly & Co; Scott Keetch, Vice President Strategic Program Management Lead - BioTech, Bayer; Robert K. Allen, Executive Technical Director |Advanced Technologies & Life Sciences, Fluor Life Sciences; Jon Van Pelt, Vice President/General Manager - BioProcess Single Use and Enterprise, Cytiva; James Weidner, Executive Director, Engineering, Amgen
Track: Concurrent Session

Bio Manufacturing of the Future requires cost effective, scalable solutions that can be implemented quicker than the traditional stainless steel facilities of yesterday. This session explores aspects of bio manufacturing that challenge the status quo and push the boundaries of bio manufacturing as we know it. From continuous methodologies to disposable technologies, we explore the industries response to the bio manufacturing capacity challenge.


Tuesday
11:00am - 11:45am Eastern - February 1, 2022
Scott Keetch, Vice President Strategic Program Management Lead - BioTech, Bayer; Robert K. Allen, Executive Technical Director |Advanced Technologies & Life Sciences, Fluor Life Sciences; Jon Van Pelt, Vice President/General Manager - BioProcess Single Use and Enterprise, Cytiva

This presentation will address the ability to leverage single use technology for the rapid deployment of launch facilities independent of modality by the implementation of common platforms for process equipment, automation, instrumentation, modular cleanrooms and supporting utilities. Topics to be covered include construction strategies and design concepts for worldwide use; validation approaches allowing for optimized value; automation and data handling approaches for repeat use; and the incorporation of Cytiva formally GEHC FlexFactory(TM). Attendees will understand the importance of standardization and the value of being able to repeat a design that can be used globally; construct validation programs that address planned duplication of process and utility systems globally; understand how to reduce the time to market by utilizing standardized, modular design versus traditional stick-built construction; and the facility accommodating a wide range of SUT equipment types and sizes to maximize process flexibility to support multi-product modality.


Tuesday
11:45am - 12:30pm Eastern - February 1, 2022
James Weidner, Executive Director, Engineering, Amgen

Building new facilities can take years. We want to run the plants for decades. Supply plans changes after completing the facilities’ designs result in changes for processes to be run in the facilities. Flexibility to address potential future company needs requires facility reconfigurability. In this presentation, reconfigurable design options will cover how facilities might have capabilities for a combination of: high titer monoclonal antibody production with perfusion cell culture, low titer monoclonal antibody production with fed batch cell culture, mRNA processing, semi-continuous purification, and batch purification. We will also discuss best practice to advance Digital 4.0 with lessons learned, as many companies are advancing digital strategies for new and existing facilities. Finally, environmentally sustainable designs and designs for Employee Wellness are key to make the world a better place and attract talent: Sometimes there is synergy in the programs. In a few instances the two scorings compete against each other a little. We will discuss some recent lessons.


Tuesday
12:30pm - 01:00pm Eastern - February 1, 2022
Tara Tibbs, Sr Director Engineering API/DP, Eli Lilly & Co

02:00pm - 03:30pm Eastern - February 1, 2022
Brian K. Vaughn, Session Leader, Chair, North America/South America Affiliate Council, CRB; Ryan S. McDonough, PE, Senior Vice President Project Operations, DPS; Emily Thompson, PE, US Director New Process Technology, DPS Group; Benjamin M. Beneski, Executive Director, Manufacturing Plant Manager, Allogene Therapeutics; Jeff Wegner, PE, Mechanical Engineer, CRB
Track: Concurrent Session

New facilities for the GMP manufacture of cell and gene therapies are starting to come online. This session includes presentations on two recently constructed facilities that represent the latest industry best practices in design, construction, and flexible, sustainable operation. Speed of construction is a common thread, along with innovative facility designs intended to accommodate future conditions. Join us for an informative session and the opportunity to interact with industry leaders in this segment.


Tuesday
02:00pm - 02:30pm Eastern - February 1, 2022
Ryan S. McDonough, PE, Senior Vice President Project Operations, DPS; Emily Thompson, PE, US Director New Process Technology, DPS Group

As interest in the Advanced Therapy Medicinal Product (ATMP) and cell and gene therapy market continues to grow at a rapid pace, novel processes are demanding facility and technology infrastructures unlike any that have previously existed. ATMPs could transform health for many patients, and all of us involved in the field, including those of us specializing in facility design, have a role to play in helping this new era of medicine to reach its potential. This presentation will be centered around industry trends and challenges facing the ATMP industry and how the industry is working together to achieve our end goal - to get products to patients, faster. Case studies will be presented to address potential challenges designing facilities predicated on maximum flexibility, logistics optimization and technologies that reduce overhead costs, allow pipeline expandability and produce higher quality therapeutics.


Tuesday
02:30pm - 03:00pm Eastern - February 1, 2022
Benjamin M. Beneski, Executive Director, Manufacturing Plant Manager, Allogene Therapeutics; Jeff Wegner, PE, Mechanical Engineer, CRB
This presentation will describe the facility design, construction, and startup of Cell Forge 1, Allogene Therapeutics’ state-of-the-art manufacturing facility in Newark, CA. Cell Forge 1 was designed to be scalable and flexible to produce our allogeneic, off-the-shelf, CART cell therapies faster, more reliably, and at greater scale. In addition to process-driven design criteria, significant effort went towards sustainability in design, resulting in a facility that reduces energy usage and integrates renewable energy sources. We’ll share experiences from our facility construction process, including site selection and the challenges of managing facility construction and startup during the global pandemic.
Tuesday
03:00pm - 03:30pm Eastern - February 1, 2022
Brian K. Vaughn, Chair, North America/South America Affiliate Council, CRB

02:00pm - 03:30pm Eastern - February 1, 2022
Mr. Austin G. Lock, Session Leader, Technical Director, Group Head of Technology, PM Group; Jonathan Souquet, PhD, Global Head of Process Development and Clinical Manufacturing, Merck KGaA; Jordaan Kemp, Director of Architecture and Process Architect SME, PM Group; Jessica Hays, Project Manager, Strategic Projects, Bayer
Track: Concurrent Session

It can be argued that the pharmaceutical industry is changing at its fastest rate in decades, driven in part by the requirement to manufacture new process modalities, as well as the need to deliver new facilities in a quicker and more cost effective manner. Speed to market and accelerating first-in-human has never been as important. Companies are having to respond to challenges such as increased development complexity, demand volatility, and CoG challenges as a result of increasing competition, pricing pressures and profitability.  Furthermore, growing demand for more flexible and sustainable facilities, together with the advancement of new processing and Pharma 4.0 technologies, such as digitization and robotics, requires that Site Master Planning needs to advance accordingly. This session will hear about how two major pharma companies have responded to the above challenging industrial landscape. Merck KGaA will explain how they have introduced a fully continuous bioprocessing platform into a new dedicated bioprocessing centre that facilitates end-to-end convergence of Discovery, CMC Innovation, Development, and Clinical and Commercial supply. Additionally, Bayer will explain how they have adopted a Site Master Planning of the Future approach to accommodate new process modalities, delivery methods, and Pharma 4.0 technologies.


Tuesday
02:00pm - 02:30pm Eastern - February 1, 2022
Jonathan Souquet, PhD, Global Head of Process Development and Clinical Manufacturing, Merck KGaA

Tuesday
02:30pm - 03:00pm Eastern - February 1, 2022
Jessica Hays, Project Manager, Strategic Projects, Bayer; Jordaan Kemp, Director of Architecture and Process Architect SME, PM Group

A comprehensive outlook on some of the most relevant Pharmaceutical developments in the world that are configuring a new understanding on the role of master plans. In a time of faster project delivery, evolution of process modalities, products and production processes, growing demands for more flexible processes and facilities and a shift in company objectives, the traditional modernist planning model might be transitioning to a new stage and this is the hypothesis and starting point of the presentation. We will look at the following key areas that affects how we plan and arrange our site masterplans for clients: modular design solutions; flexibility; adaptable modules; the drivers for pre-investments to assist speed to market; impact of the various modalities on support functions and designing for adaptability; impact of robotics and the integration of cobots; digitization and next generation technological developments; designing a sustainable future; well building design and creating great working environment. Our new generation of masterplanning methodology is testing renewed strategies to understand and plan sites, and by also using the intersection of the digital and physical, to display information and communicate within client organizations to help plan their futures.


Tuesday
03:00pm - 03:30pm Eastern - February 1, 2022
Mr. Austin G. Lock, Technical Director, Group Head of Technology, PM Group

04:15pm - 05:45pm Eastern - February 1, 2022
Tara Tibbs, Session Leader, Sr Director Engineering API/DP, Eli Lilly & Co; John Chiminski, Chair & CEO, Catalent Pharma Solutions; Myrta W. Atiles, MS, Director of Process Development, Amgen Manufacturing Ltd; Kenneth A. Whitehead, Vice President of Global Manufacturing Services, Eli Lilly And Company; Joydeep Ganguly, Senior Vice President, Corporate Operations, Gilead Sciences Inc; Tom Ross, President and CEO, Grand River Aseptic Mfg Inc
Track: Plenary Session

The pandemic has had significant impact to industries around the world and the Pharma Industry has been no exception.  Early on, the Pharma Industry responded with unprecedented speed to bring treatments to patients through collaborations, leveraging expertise and creative solutions.  Today, we continue to navigate the pandemic with resilience and continued partnership.  This session covers a few of these collaborations and extraordinary responses COVID-19 Pandemic.


Tuesday
04:15pm - 04:45pm Eastern - February 1, 2022
John Chiminski, Chair & CEO, Catalent Pharma Solutions

Catalent, Inc. continues to play a strong partnership role, along with other CDMOs, in fighting the pandemic. The company’s expertise in implementing advanced pharmaceutical technologies uniquely positioned it to support biopharmaceutical companies seeking to manufacture COVID-19 vaccines and therapies. In 2021, Catalent produced over 1 billion COVID vaccines, while simultaneously manufacturing all of its other life-saving and -enhancing drugs for its customers and their patients. In this session, Catalent Chair and CEO John Chiminski will discuss key success factors, including how strong collaborations with both customers and supply chain partners, a strong focus on employee safety, and a shared purpose to defeat the pandemic, allowed the company to accelerate planned facilities expansions to help deliver vaccines in record time.


Tuesday
04:45pm - 05:15pm Eastern - February 1, 2022
Myrta W. Atiles, MS, Director of Process Development, Amgen Manufacturing Ltd; Kenneth A. Whitehead, Vice President of Global Manufacturing Services, Eli Lilly And Company

In the first quarter of 2020, As the US and the World faced an emerging pandemic, Lilly quickly leveraged its expertise in developing anti-body Therapies as potential treatments. When faced with a key challenge of capacity and speed, Lilly approached a competitor instead of the traditional contract manufacturing options to help ensure success. Amgen brought capability and responsiveness that allowed an unprecedented response and resulted in treatments available to patients in less than a year. Lilly and Amgen will discuss what allowed this partnership to be successful and deliver solutions for patients.


Tuesday
05:15pm - 05:45pm Eastern - February 1, 2022
Joydeep Ganguly, Senior Vice President, Corporate Operations, Gilead Sciences Inc; Tom Ross, President and CEO, Grand River Aseptic Mfg Inc

Tuesday
07:15pm - 08:30pm Eastern - February 1, 2022
James A. Breen Jr., PE, Session Leader, Vice President, Lead Biologics Expansion, Janssen Pharmaceuticals; Matthew Hepburn, M.D., Panelist, Senior Advisor To the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy, Executive Office of the President; Patrick J. Poisson, Panelist, Executive Vice President, Technical Operations, United Therapeutics Corporation; Felix Velez, Panelist, VP Engineering & Property Services, Johnson & Johnson; Thomas Warf, Panelist, Director, Manufacturing, Facilities and Engineering, DHHS/OS/ASPR/BARDA; Ylva Ek, Panelist, Chief Quality Officer, KeyPlants AB
Track: Plenary Session

Hear from government authorities and industry experts on the lessons learned through the pandemic and the innovative development opportunities as a result.  The panel will discuss these topics and more with questions from attendees in this town hall style session.


Wednesday
07:00am - 08:30am Eastern - February 2, 2022
Tanya Sharma, Session Leader, Partner, Assurea; Steering Committee, Women in Pharma, Assurea, LLC; Ms. Vivianne J. Arencibia, Panelist, Vice President, Global Quality Systems and Compliance, Moderna; Lindsey E. Daniel, PE, Panelist, Product Operations Program Manager, Takeda; Yury Yohana Gomez, Panelist, Global Strategy Leader, WW Manufacturing & Supply Chain, Microsoft; Shanshan Liu, Panelist, Director, No Deviation Pte Ltd

Biotech is adapting and evolving to have more automation, digitalization, and we need to be ready for the new challenges while continuing to break barriers in our industry. How can we use innovative technology for both personal and professional growth? What types of technologies are smart facilities using for learning? How has virtual reality transformed how we learn?

Join this think tank during the Women in Pharma® breakfast and be part of innovative group discussions to transfer new and emerging knowledge to everyone. Facilitators will encourage creative and innovative design thinking (No prior knowledge required, just creative flow) and participants will be able to contribute and share ideas on different ways, types, and areas to use innovative technology for both personal and professional growth. Ideas from each group will be submitted and shared with the Women in Pharma® community of practice. Top Ideas will be selected as part of the Think Tank pilot and participants can support idea development teams.


08:45am - 10:30am Eastern - February 2, 2022
Lindsey E. Daniel, PE, Session Leader, Product Operations Program Manager, Takeda; Sau (Larry) Lee, PhD, Deputy Director of Science Chair, Emerging Technology Program, Office of Pharmaceutical Quality/CDER/FDA; David Estape, PhD, Technology Manager Biotechnology, CRB Group; Oliver Hennig, PhD, Senior Vice President Operations, BioNTech SE
Track: Plenary Session

This session provides insights from industry experts in meeting the extraordinary challenges of pharmaceutical production and development in the COVID age.  Hear about their experiences implementing new and emerging technologies and how these lessons learned can benefit future opportunities.


Wednesday
08:45am - 09:25am Eastern - February 2, 2022
Sau (Larry) Lee, PhD, Deputy Director of Science Chair, Emerging Technology Program, Office of Pharmaceutical Quality/CDER/FDA

Wednesday
09:25am - 10:15am Eastern - February 2, 2022
David Estape, PhD, Technology Manager Biotechnology, CRB Group; Oliver Hennig, PhD, Senior Vice President Operations, BioNTech SE

mRNA is not just the basis of new COVID-19 vaccines. mRNA is also a versatile technology for the development and manufacturing of new medicinal product candidates such as cancer. As cancer is also a global health threat, BioNTech aspires to develop individualized cancer treatments. The manufacturing process behind mRNA-based cancer vaccine candidates is equivalent to mRNA-based the company’s COVID-19 vaccine. The vaccine manufacturing approaches mainly differs in the required quantity, e.g. a few microgram of mRNA for the individualized vaccine candidates compared to hundreds of kilograms for a pandemic supply. The new technology allowed not only developing a new COVID-19 vaccine in a record time but also to quickly ramp-up the manufacturing facilities to supply billions of doses. The presentation will reveal key elements that make mRNA such a powerful technology and that define the facility set-up of tomorrow already today, for both: individualized medicines as well as for large volume medical products such as vaccines against infectious diseases.


Wednesday
10:15am - 10:30am Eastern - February 2, 2022
Lindsey E. Daniel, PE, Product Operations Program Manager, Takeda

11:15am - 12:45pm Eastern - February 2, 2022
Mark A. Butler, Session Leader, President and Managing Director, IPS; Dr. Michael K. O'Brien, PhD, President & CEO, NGT BioPharma Consutlants; Mr. Dennis Powers, Vice President of Business Development & Design Consulting, G-CON Manufacturing; Doug DeVeny, NCARB, Global Technical Lead, Architecture / HVAC, Genentech Inc
Track: Concurrent Session

This session will explore novel ways to reduce project time lines and demonstrate how PODular manufacturing will increase facility flexibility to meet potential future changing business needs. The presentation is directly applicable to flexible manufacturing facilities and responsiveness of drug supply.  It will address key lead time challenges in traditional manufacturing and offer an option for manufacturing closer to the customer.


Wednesday
11:15am - 11:45am Eastern - February 2, 2022
Mr. Dennis Powers, Vice President of Business Development & Design Consulting, G-CON Manufacturing; Dr. Michael K. O'Brien, PhD, President & CEO, NGT BioPharma Consutlants
Supply chain end-to-end lead times are typically long, triggering decision-making prior to the actual customer demand signals. Demand can be highly variable and unpredictable, while the industry is often challenged with drug shortages. As political, regulatory, and market demand requirements evolve, one’s ability to respond appropriately and in a timely fashion is therefore undermined. Today’s manufacturing platforms and associated analytics are smaller, lighter, and significantly more modular versus their predecessors, enabling much smaller factory footprints, allowing for the realization of a transportable manufacturing platform and facilities concept. These flexible, transportable units can address variable demand through scale out (running the continuous process longer, or replication of the unit), and may be installed more quickly than traditional manufacturing site expansion. Consequently, when business needs change down the road, the manufacturing unit can be moved to another location. The potential financial, technical, and regulatory obstacles for the movability of a manufacturing environment will be addressed. Case studies will be presented that illustrate the benefits of mobility and the opportunities and challenges of operating a mobile facility.
Wednesday
11:45am - 12:15pm Eastern - February 2, 2022
Doug DeVeny, NCARB, Global Technical Lead, Architecture / HVAC, Genentech Inc
The presentation will explore many of the methodologies utilized and resulting design characteristics intended to achieve these goals over the lifecycle of the facility. A modular design approach, involving the creation and deployment of standard unit operation work cells, will be highlighted throughout the discussion, illustrating its impact on the facility configuration, construction techniques and project timelines, as well as the potential options and benefits expected to be realized on similar future next generation projects. In addition, progressive regulatory strategies, leveraging functionally-closed systems, have been integrated to reduce spatial segregations and area classifications, while minimizing the need for modifications to accommodate future process changes and technologies.
Wednesday
12:15pm - 12:45pm Eastern - February 2, 2022
Mark A. Butler, President and Managing Director, IPS