2020 ISPE Annual Meeting & Expo

Nov 2, 2020 ‐ Nov 6, 2020



Sessions

Opening Plenary Session Opening Plenary Session

Preview Available

Opening Plenary Session

Nov 2, 2020 9:00am ‐ Nov 2, 2020 11:00am
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/KEYNOTEMON

Opening Plenary Session |

Speaker(s): Speaker(s): Speaker(s):

Innovation Ecosystems Innovation Ecosystems

Preview Available

Innovation Ecosystems

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/SES203

Innovation Ecosystems | In a world of accelerating change, companies can no longer rely of top down strategies to adapt and innovate. Rather, the ability to harness the wisdom of the crowd is becoming central to drive incremental and disruptive innovations across discovery, development, manufacturing, and supply. Yet the best practices to harness the talents of the masses remain under-developed. This session will present different viewpoints on how to inspire and challenge, crowdsource and connect ideas, sponsor, and fund projects through progressive stages, and ultimately drive results from the innovators that permeate throughout modern corporations. As a result of the session, participants can expect to take away best practices for setting up their own innovation ecosystem, or better engaging and enhancing the ecosystem in which they already find themselves.

Session Leader(s): Speaker(s):

Pharma 4.0 Concepts & Cases Pharma 4.0 Concepts & Cases

Preview Available

Pharma 4.0 Concepts & Cases

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/SES202

Pharma 4.0 Concepts & Cases | The ISPE Pharma 4.0TM Operating Model was developed as a practical model for implementing a holistic approach for the digitalization of a pharmaceutical organization end-to-end. – While we are not there yet, some interesting case studies are available, showing the concepts are working and providing expected benefits. This session will overview how we can adjust our Pharmaceutical Quality Management System to embrace technology and increase data integrity, use our massive data stores for action by leveraging data analytics for Container System optimization and capping, and how facility management and building system support can increase productivity and reduce costs for pharmaceutical firms. For example, one core component of the Pharma 4.0TM Operating Model is the digitalization of the ICH Q10 Pharmaceutical Quality System (PQS), which is enabled by a Data Integrity by Design approach and a clear definition of Process Maps and Data Flows. Having this in place, data analytics will help to improve quality, performance and robustness of the processes and help to prevent drug shortages for the benefit of the patient.

Session Leader(s): Speaker(s):

Process Technology Process Technology

Preview Available

Process Technology

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/SES204

Process Technology | This session will focus on technologies associated with the future state of manufacturing. Critical to successful process scale-up is defining process capability and robustness including integration of data analytics, in silico modeling, and process control. The presentations in this session cover a wide variety of technologies from spray dried dispersion, to small-scale bioreactors to the use of single use technologies. The benefits of using these tools to evaluate the technologies and how this leads to successful scale-up and implementation will be presented.

Session Leader(s): Speaker(s):

The Importance of Quality Management Maturity

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/SES205

The Importance of Quality Management Maturity | FDA introduced interest in quality management system maturity and a rating system of maturity of manufacturing facilities in their 2019 Drug Shortages report. Experienced industry, FDA and academic speakers will present on 1) The background, status and content of ISPE’s industry-for-industry quality maturity framework. This framework has been developed over the past 3 years and evolved from ISPE’s research in response to FDA Quality Metrics draft guidances, and its work to issue the Cultural Excellence report. This program is scheduled to deliver its first module in assessment and potential improvement of CAPA maturity; 2) FDA’s journey to assessing quality management maturity; 3) An academic perspective on how to assess quality maturity

Session Leader(s):
  • Tami J. Frederick, Senior Director, Corporate Quality Systems & Cultural Excellence, Perrigo
Speaker(s):

Improving Vaccine Delivery to the Developing World

Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/SES206

Improving Vaccine Delivery to the Developing World | Current delivery of liquid injectable vaccines to the developing world is currently based on the multi-dose vial. Investigations have shown that the cost per delivered dose with multi-dose vials is significantly higher than the initial cost per dose at the factory; wastage through loss of unused doses, glass breakage product loss and temperature excursions all add to the final cost per dose. Blow/Fill/Seal (BFS) advanced aseptic technology has been investigated for the application of single dose vaccine packaging. Ongoing work has shown that the technology is viable for producing single dose primary packaging for Live Attenuated and inactive vaccines. The work includes container and device designs for oral and injectable vaccines, product stability studies, cost comparison between packing technologies, and developing world human factor studies to test the container design and function. This presentation will introduce participants to BFS technology and its application to cold chain products, single dose container designs for oral and injectable vaccines, and the challenges around filling adjuvants.

Session Leader(s):
  • Tim Kram, General Manager-North America, Rommelag USA Inc
Speaker(s):

FOYA Category Winner Presentations

Nov 3, 2020 10:30am ‐ Nov 3, 2020 12:00pm
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/SES100A

FOYA Category Winner Presentations | Get an in-depth look at the latest, state-of-the-art developments being implemented by ISPE’s 2020 Facility of the Year Awards (FOYA) Category Winners. Hear from the project teams themselves as they share the technical story of their project and learn how excellence was delivered via innovative thinking.

Session Leader(s): Speaker(s):

FOYA Category Winner Presentations

Nov 3, 2020 12:30pm ‐ Nov 3, 2020 2:00pm
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/SES100B

FOYA Category Winner Presentations | Get an in-depth look at the latest, state-of-the-art developments being implemented by ISPE’s 2020 Facility of the Year Awards (FOYA) Category Winners. Hear from the project teams themselves as they share the technical story of their project and learn how excellence was delivered via innovative thinking.

Session Leader(s): Speaker(s):
  • Anthony Carter, Project Director, Capital Governance & Controls, Bristol-Myers Squibb
  • Jeroen Geens, PhD, Engineering Technical Director, New Platforms, Janssen Research & Development
  • Noel Heaney, General Manager, Biologics, Bristol Myers Squibb
  • Dean Morris, Program Director, Investment and Operations, Sanofi
  • Jeroen Geens, PhD, Engineering Technical Director, New Platforms, Janssen Research & Development
  • Noel Heaney, General Manager, Biologics, Bristol Myers Squibb
  • Matthew L. Depola, Sr. Director, Engineering and Facilities, United Therapeutics Corporation

Global Regulatory Town Hall - The Impact of a Pandemic on Harmonization and Convergence

Nov 4, 2020 9:00am ‐ Nov 4, 2020 11:00am
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/KEYNOTEWED

Global Regulatory Town Hall - The Impact of a Pandemic on Harmonization and Convergence|The impact of the current pandemic will have far-reaching effects on global regulations, inspections, and related efforts toward regulatory harmonization and convergence. The discussion during this year’s Town Hall will center around COVID-19-related implications for global regulatory alignment. The pandemic has shed new light on the need for developing internationally harmonized standards and standards convergence to facilitate greater coordination and oversight of medical products. The current environment has not only exacerbated existing weaknesses in the supply chain, but also has let to postponed inspections, increased scrutiny of products shipped internationally, and highlighted inconsistencies in the regulatory processes from agency to agency. Representatives from USFDA, MHRA, ANVISA, WHO, ANSM, PIC/S, and Health Canada have been invited to join the live discussion.

Session Leader(s): Speaker(s):
  • Abdelaali Sarakha, PhD, Senior GMP Inspector, Annex 1 Rapporteur, French Health Products Safety Agency (ANSM)
Session Leader(s): Moderator(s):
  • Timothy J. Watson, PhD, Executive Director & Team Leader, CMC Advisory Office, Pfizer Inc.
Panelist(s):
  • David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, MHRA
  • Lucinda F. Buhse, PhD, Acting Senior Advisor for OPQ, CDER/FDA
  • Rick Friedman, Deputy Director, Office of Manufacturing Quality, CDER/FDA
  • Abdelaali Sarakha, PhD, Senior GMP Inspector, Annex 1 Rapporteur, French Health Products Safety Agency (ANSM)
  • Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization
  • Gustavo Mendes Lima Santos, General Office of Medicines and Biological Products, GGMED, ANVISA

Agile Project Delivery for Cell & Gene Therapy Facilities

Nov 4, 2020 1:00pm ‐ Nov 4, 2020 2:30pm
Expiration Date: Nov 30, 2021

Identification: NA20CENOV1/SES207

Agile Project Delivery for Cell & Gene Therapy Facilities | Pharmaceutical companies are now investing heavily in R&D to develop cell and gene therapies targeting previously incurable diseases, with the FDA anticipating more than 200 investigational new drug applications per year. Commercial growth in this sector will require substantial investment in new research and manufacturing facilities, with an emphasis on speed to market, flexibility, cost, and innovation. This session will review best practices in developing an agile engineering project delivery model to support these goals, focusing on the unique project management challenges in delivering projects for the cell and gene therapy sector. We will also discuss how innovations in robotics, engineering design, and modular construction can be leveraged to accelerate delivery and improve safety, quality, and reliability.

Key learning objectives:
-Understand the unique design differences and challenges in delivering cell and gene therapy facilities
-Apply critical project management processes and tools to drive performance and target value delivery
-Leverage innovative technologies in design and construction

Session Leader(s): Speaker(s):
  • Scott Bertch, Exec. Director, Clinical Site Head, Tenaya Therapeutics
Print Certificate
Completed on: token-completed_on
Print Transcript
Please select the appropriate credit type:
/
test_id: 
credits: 
completed on: 
rendered in: 
* - Indicates answer is required.
token-content

token-speaker-name
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
/
/
token-index
token-content
token-index
token-content