The MIT Consortium on Adventitious Agent Contamination in Biomanufacturing aims to:
1) Provide a collaborative environment for companies to share experiences with virus contaminations.
2) Identify and benchmark against best practices to mitigate contamination risks.
3) Sponsor research to better understand contamination and develop detection/prevention methods.
The consortium will anonymously collect contamination data from member companies and conduct a risk analysis to guide industry standards that enhance patient safety and regulatory compliance.
Presentation given by Dr. Iddo Dror and Zelalem Lema of ILRI during a Humidtropics Capacity Development Workshop on Innovation Platforms, held in Nairobi, Kenya, in April-May 2014.
Presentation given by Dr. Iddo Dror and Zelalem Lema of ILRI during a Humidtropics Capacity Development Workshop on Innovation Platforms, held in Nairobi, Kenya, in April-May 2014.
Wyższa Szkoła Europejska im. ks. J. Tischnera w Krakowie.
Konferencja "Zarządzanie projektami JUTRO".
Prezentacja dr. inż. Przemysława Domańskiego.
Więcej informacji na http://www.wse.krakow.pl/pl/aktualnosci/2133-zarzadzanie-projektami-jutro-zdjecia
Managing Change: How to achieve effective, large-scale, long-term change in a UK University setting. CDE workshop conducted on 7 February 2012 by Professor Stephen Brown (De Montfort University, CDE Visiting Fellow).
The lively session was attended by managers, senior managers and policy makers from within and beyond the University of London. The workshop aimed to help attendees to develop effective strategies for achieving large scale lasting change within their institutions, and examined the implications of different levels of stakeholder engagement for the success of sustainable institutional change and demonstrate how to employ a participatory design approach derived from the experiences of the JISC Curriculum Design and Delivery Programme. These slides are best considered alongside the accompanying workplan/report from the session, found here: http://cdelondon.wordpress.com/2011/11/16/cde-workshop-managing-change/.
An overview of the Industry Consortium on Adventitious Agent Contamination in Biomanufacturing - Administered by the Center for Biomedical Innovation at Massachusetts Institute of Technology
Episode 20 : PROJECT MANAGEMENT CONTEXT
Project phase and the Project Life Cycle
Project Stakeholders
Organizational Influences
Key General Management Skills
Social-Economic-Environmental Influences
SAJJAD KHUDHUR ABBAS
Chemical Engineering , Al-Muthanna University, Iraq
Oil & Gas Safety and Health Professional – OSHACADEMY
Trainer of Trainers (TOT) - Canadian Center of Human
Development
Lessons Learned from the application of Outcome Mapping to an IDRC EcoHealth ...ILRI
Presented by Tohtubtiang, K., Asse, R., Wisartsakul, W., and Gilbert , J. at the 1st Pan Asia-Africa Monitoring and Evaluation Forum, Bangkok, Thailand, 26-28 November 2012
The Executive Report entitled “The Building Blocks of Agility as a Team’s Competence in Project Management” is a preliminary result and a synthesis of key findings of the PM Agility Global Survey 2014, a worldwide research program conducted at Massachusetts Institute of Technology (MIT), Consortium for Engineering Program Excellence (CEPE). The research program had collaboration from different institutions around the globe and also the partnership with researchers from University of São Paulo, São Carlos School of Engineering.
This Global Survey successfully collected experiences and insights from more than 800 highly experienced professionals from 76 countries. We are very thankful for all participants around the world that collaborated to this study. More information at http://econforto.mit.edu.
Ideas, methods and tools for OSS Compliance assessment, OW2online, June 2020OW2
Presentation by Boris Baldassari, Consultant, Castalia Solutions.
Abstract: While Open Source Software has become mainstream, the understanding of its key principles, from ethics and collaboration to governance and community management, is gaining more interest and attention. There is a comprehensive volume of studies and reports backing up our individual and collective experience, yet we still cannot reliably measure these characteristics, and even less clearly define or assess them.
In an attempt to build up confidence and foster maturity in this area, this talk will look at the various existing models and metrics related to OSS compliance and governance, and build upon them to propose methods and tools for their evaluation and analysis. We will discuss the requirements and essential questions to ask, offer guidelines for implementation and suggest efficient ways to present results.
An approach to implementing Web 2.0 using Communities of Practice. Describes the process and deliverables involved in establishing a Community of Practice.
Describes how to initiate and plan a Community of Practice to meet strategic objectives. Describes metrics for CoPs. Lists common Web 2.0 features for CoPs.
Lean at Cisco: Lessons Learned from Lean Product Development and Lean StartupKen Power
Slide deck from my talk on Lean at Cisco: Lessons Learned from Lean Product Development and Lean Startup.
The 3 lessons I talk about are:
1. Reduce Batch Sizes and Manage WIP Limits
2. Customer Development
3. Learn to see Waste
I gave this talk at the Clayton Hotel on June 21 2012, at a Lean Startup Event organized by Enterprise Ireland and ITAG.
Ensuring Learning from Start to FinishIUCN Forests
How KNOWFOR partners use design, monitoring, evaluation and learning (DMEL) for understanding knowledge uptake. A joint product from CIFOR, IUCN and PROFOR as part of KNOWFOR with support from DFID.
Wyższa Szkoła Europejska im. ks. J. Tischnera w Krakowie.
Konferencja "Zarządzanie projektami JUTRO".
Prezentacja dr. inż. Przemysława Domańskiego.
Więcej informacji na http://www.wse.krakow.pl/pl/aktualnosci/2133-zarzadzanie-projektami-jutro-zdjecia
Managing Change: How to achieve effective, large-scale, long-term change in a UK University setting. CDE workshop conducted on 7 February 2012 by Professor Stephen Brown (De Montfort University, CDE Visiting Fellow).
The lively session was attended by managers, senior managers and policy makers from within and beyond the University of London. The workshop aimed to help attendees to develop effective strategies for achieving large scale lasting change within their institutions, and examined the implications of different levels of stakeholder engagement for the success of sustainable institutional change and demonstrate how to employ a participatory design approach derived from the experiences of the JISC Curriculum Design and Delivery Programme. These slides are best considered alongside the accompanying workplan/report from the session, found here: http://cdelondon.wordpress.com/2011/11/16/cde-workshop-managing-change/.
An overview of the Industry Consortium on Adventitious Agent Contamination in Biomanufacturing - Administered by the Center for Biomedical Innovation at Massachusetts Institute of Technology
Episode 20 : PROJECT MANAGEMENT CONTEXT
Project phase and the Project Life Cycle
Project Stakeholders
Organizational Influences
Key General Management Skills
Social-Economic-Environmental Influences
SAJJAD KHUDHUR ABBAS
Chemical Engineering , Al-Muthanna University, Iraq
Oil & Gas Safety and Health Professional – OSHACADEMY
Trainer of Trainers (TOT) - Canadian Center of Human
Development
Lessons Learned from the application of Outcome Mapping to an IDRC EcoHealth ...ILRI
Presented by Tohtubtiang, K., Asse, R., Wisartsakul, W., and Gilbert , J. at the 1st Pan Asia-Africa Monitoring and Evaluation Forum, Bangkok, Thailand, 26-28 November 2012
The Executive Report entitled “The Building Blocks of Agility as a Team’s Competence in Project Management” is a preliminary result and a synthesis of key findings of the PM Agility Global Survey 2014, a worldwide research program conducted at Massachusetts Institute of Technology (MIT), Consortium for Engineering Program Excellence (CEPE). The research program had collaboration from different institutions around the globe and also the partnership with researchers from University of São Paulo, São Carlos School of Engineering.
This Global Survey successfully collected experiences and insights from more than 800 highly experienced professionals from 76 countries. We are very thankful for all participants around the world that collaborated to this study. More information at http://econforto.mit.edu.
Ideas, methods and tools for OSS Compliance assessment, OW2online, June 2020OW2
Presentation by Boris Baldassari, Consultant, Castalia Solutions.
Abstract: While Open Source Software has become mainstream, the understanding of its key principles, from ethics and collaboration to governance and community management, is gaining more interest and attention. There is a comprehensive volume of studies and reports backing up our individual and collective experience, yet we still cannot reliably measure these characteristics, and even less clearly define or assess them.
In an attempt to build up confidence and foster maturity in this area, this talk will look at the various existing models and metrics related to OSS compliance and governance, and build upon them to propose methods and tools for their evaluation and analysis. We will discuss the requirements and essential questions to ask, offer guidelines for implementation and suggest efficient ways to present results.
An approach to implementing Web 2.0 using Communities of Practice. Describes the process and deliverables involved in establishing a Community of Practice.
Describes how to initiate and plan a Community of Practice to meet strategic objectives. Describes metrics for CoPs. Lists common Web 2.0 features for CoPs.
Lean at Cisco: Lessons Learned from Lean Product Development and Lean StartupKen Power
Slide deck from my talk on Lean at Cisco: Lessons Learned from Lean Product Development and Lean Startup.
The 3 lessons I talk about are:
1. Reduce Batch Sizes and Manage WIP Limits
2. Customer Development
3. Learn to see Waste
I gave this talk at the Clayton Hotel on June 21 2012, at a Lean Startup Event organized by Enterprise Ireland and ITAG.
Ensuring Learning from Start to FinishIUCN Forests
How KNOWFOR partners use design, monitoring, evaluation and learning (DMEL) for understanding knowledge uptake. A joint product from CIFOR, IUCN and PROFOR as part of KNOWFOR with support from DFID.
Essentials of Automations: Optimizing FME Workflows with ParametersSafe Software
Are you looking to streamline your workflows and boost your projects’ efficiency? Do you find yourself searching for ways to add flexibility and control over your FME workflows? If so, you’re in the right place.
Join us for an insightful dive into the world of FME parameters, a critical element in optimizing workflow efficiency. This webinar marks the beginning of our three-part “Essentials of Automation” series. This first webinar is designed to equip you with the knowledge and skills to utilize parameters effectively: enhancing the flexibility, maintainability, and user control of your FME projects.
Here’s what you’ll gain:
- Essentials of FME Parameters: Understand the pivotal role of parameters, including Reader/Writer, Transformer, User, and FME Flow categories. Discover how they are the key to unlocking automation and optimization within your workflows.
- Practical Applications in FME Form: Delve into key user parameter types including choice, connections, and file URLs. Allow users to control how a workflow runs, making your workflows more reusable. Learn to import values and deliver the best user experience for your workflows while enhancing accuracy.
- Optimization Strategies in FME Flow: Explore the creation and strategic deployment of parameters in FME Flow, including the use of deployment and geometry parameters, to maximize workflow efficiency.
- Pro Tips for Success: Gain insights on parameterizing connections and leveraging new features like Conditional Visibility for clarity and simplicity.
We’ll wrap up with a glimpse into future webinars, followed by a Q&A session to address your specific questions surrounding this topic.
Don’t miss this opportunity to elevate your FME expertise and drive your projects to new heights of efficiency.
GraphRAG is All You need? LLM & Knowledge GraphGuy Korland
Guy Korland, CEO and Co-founder of FalkorDB, will review two articles on the integration of language models with knowledge graphs.
1. Unifying Large Language Models and Knowledge Graphs: A Roadmap.
https://arxiv.org/abs/2306.08302
2. Microsoft Research's GraphRAG paper and a review paper on various uses of knowledge graphs:
https://www.microsoft.com/en-us/research/blog/graphrag-unlocking-llm-discovery-on-narrative-private-data/
Builder.ai Founder Sachin Dev Duggal's Strategic Approach to Create an Innova...Ramesh Iyer
In today's fast-changing business world, Companies that adapt and embrace new ideas often need help to keep up with the competition. However, fostering a culture of innovation takes much work. It takes vision, leadership and willingness to take risks in the right proportion. Sachin Dev Duggal, co-founder of Builder.ai, has perfected the art of this balance, creating a company culture where creativity and growth are nurtured at each stage.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
JMeter webinar - integration with InfluxDB and GrafanaRTTS
Watch this recorded webinar about real-time monitoring of application performance. See how to integrate Apache JMeter, the open-source leader in performance testing, with InfluxDB, the open-source time-series database, and Grafana, the open-source analytics and visualization application.
In this webinar, we will review the benefits of leveraging InfluxDB and Grafana when executing load tests and demonstrate how these tools are used to visualize performance metrics.
Length: 30 minutes
Session Overview
-------------------------------------------
During this webinar, we will cover the following topics while demonstrating the integrations of JMeter, InfluxDB and Grafana:
- What out-of-the-box solutions are available for real-time monitoring JMeter tests?
- What are the benefits of integrating InfluxDB and Grafana into the load testing stack?
- Which features are provided by Grafana?
- Demonstration of InfluxDB and Grafana using a practice web application
To view the webinar recording, go to:
https://www.rttsweb.com/jmeter-integration-webinar
Neuro-symbolic is not enough, we need neuro-*semantic*Frank van Harmelen
Neuro-symbolic (NeSy) AI is on the rise. However, simply machine learning on just any symbolic structure is not sufficient to really harvest the gains of NeSy. These will only be gained when the symbolic structures have an actual semantics. I give an operational definition of semantics as “predictable inference”.
All of this illustrated with link prediction over knowledge graphs, but the argument is general.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Kubernetes & AI - Beauty and the Beast !?! @KCD Istanbul 2024Tobias Schneck
As AI technology is pushing into IT I was wondering myself, as an “infrastructure container kubernetes guy”, how get this fancy AI technology get managed from an infrastructure operational view? Is it possible to apply our lovely cloud native principals as well? What benefit’s both technologies could bring to each other?
Let me take this questions and provide you a short journey through existing deployment models and use cases for AI software. On practical examples, we discuss what cloud/on-premise strategy we may need for applying it to our own infrastructure to get it to work from an enterprise perspective. I want to give an overview about infrastructure requirements and technologies, what could be beneficial or limiting your AI use cases in an enterprise environment. An interactive Demo will give you some insides, what approaches I got already working for real.
Search and Society: Reimagining Information Access for Radical FuturesBhaskar Mitra
The field of Information retrieval (IR) is currently undergoing a transformative shift, at least partly due to the emerging applications of generative AI to information access. In this talk, we will deliberate on the sociotechnical implications of generative AI for information access. We will argue that there is both a critical necessity and an exciting opportunity for the IR community to re-center our research agendas on societal needs while dismantling the artificial separation between the work on fairness, accountability, transparency, and ethics in IR and the rest of IR research. Instead of adopting a reactionary strategy of trying to mitigate potential social harms from emerging technologies, the community should aim to proactively set the research agenda for the kinds of systems we should build inspired by diverse explicitly stated sociotechnical imaginaries. The sociotechnical imaginaries that underpin the design and development of information access technologies needs to be explicitly articulated, and we need to develop theories of change in context of these diverse perspectives. Our guiding future imaginaries must be informed by other academic fields, such as democratic theory and critical theory, and should be co-developed with social science scholars, legal scholars, civil rights and social justice activists, and artists, among others.
Search and Society: Reimagining Information Access for Radical Futures
Pda2012 talk
1. The MIT Consortium on Adventitious
Agent Contamination in
Biomanufacturing
A Center For Biomedical Innovation Initiative
2. Consortium Goals
●Provide collaborative environment for companies to
share experiences
●A forum for companies to network, develop
collaborations and synergize
●To identify and benchmark against best industry
practices
●To sponsor collaborative research activities and
initiatives
●To promote generation and application of new
technologies
●To make public a summary of consortium findings and
recommendations 2
3. Consortium Activities
Consortium
Operations & Purposes Participants
Activities
•To evaluate, revise and approve CAACB strategic
Steering Committee Representatives of
plans
Meetings Member Companies
•To identify, recommend and prioritize future projects
•To evaluate and recommend potential future projects
Representatives of
Consortium Task to the Steering Committee
Member Companies
Force Meetings •To assist in analysis of project findings and/or
technology advances in relevant fields
•To learn of advances in selected technology areas
Consortium •To contribute to the understanding of anonymous data Delegates of
Workshops & collected from CAACB projects Member Companies,
Symposia •To exchange ideas, experience and knowhow of Invited MIT faculty
industry practices
•To report progress and future plans of CAACB to
Delegates of Member
Consortium General consortium body
Companies, Invited
Meetings •To highlight technology advances and policy changes
guests
relevant to mission of CAACB
Consortium
•Forum to promote CAACB mission Public
Sponsored Meetings
3
4. Key Components of Consortium
Consortium Operations & Management Fee-based Membership
● MIT CAACB Team ● Full Members
● Program Director: Dr. Stacy Springs
● Manufacture Biologics
● Lead Investigators: Michael Wiebe and James
Leung ● Steering Committee
● MIT Faculty Investigator: Anthony J. Sinskey representation
● MIT Faculty & Staff: As Needed Per Consortium ● Active participants in all
Projects
consortium projects including data
● Steering Committee contribution, results interpretation
● One individual from each member company and report generation
● Advisory Board ● Associate Members
● Kurt Brorson, FDA (CDER) ● Do not manufacture Biologics (e.g.
● Marshall Dinowitz, Consultant Service Providers & Technology
● Jim Gombold, Charles River Laboratories Companies)
● Bill Lucas, WuXi AppTec ● Active participants in projects
● Ray Nims, Consultant focusing on technologies and
● Carol Marcus-Sekura, Consultant methods assessments &
● Anton Steuer, BioReliance development, roles to be defined
● Hannelore Willkommen, Consultant
● Ruth Wolff, Consultant
4
5. Outline
● Consortium Mission & Goals
● Consortium Organization
● Organization
● Deliverables
● Protection of Confidential Information
● Consortium Activities
● Projects & Meetings
● Schedule for 2011/2012
● Benefits of Joining
● Update of CAACB Inaugural Project
● Virus Contaminations In Biomanufacturing
● How to Join
5
6. Consortium Goals
1. To provide a safe and collaborative environment for companies to share their
experiences, lessons learned and the operational approaches to control and
mitigate the risk of adventitious agent contamination in biomanufacturing.
2. To provide a forum for companies to network, develop collaborations and
synergize their activities to reduce adventitious agent contaminations risk.
3. To identify best industry practices currently utilized by biomanufacturing
companies.
4. To provide opportunities for companies to benchmark their own adventitious
agent control and risk mitigation strategies against best industry practices.
5. To sponsor collaborative research activities and initiatives that promote a
better understanding of how to address adventitious agent contamination.
6. To promote the generation and application of new technologies to detect and
identify adventitious agents; and to mitigate the risk of contamination.
7. To make public a summary of consortium findings and recommendations.
6
7. Key Components of Consortium
Consortium Operations & Management Fee-based Membership
● MIT CAACB Team ● Full Members
● Program Director: Dr. Stacy Springs
● Manufacture Biologics
● Lead Investigators: Michael Wiebe and James Leung
● MIT Faculty Investigator: Anthony J. Sinskey
● Steering Committee
● MIT Faculty & Staff: As Needed Per Consortium
representation
Projects ● Active participants in all
● Steering Committee consortium projects including data
contribution, results interpretation
● One individual from each member company
and report generation
● Advisory Board
● Associate Members
● Kurt Brorson, FDA (CDER)
● Marshall Dinowitz, Consultant ● Do not manufacture Biologics (e.g.
● Jim Gombold, Charles River Laboratories
Service Providers & Technology
Companies)
● Bill Lucas, WuXi AppTec
● Ray Nims, Consultant ● Active participants in projects
● Carol Marcus-Sekura, Consultant
focusing on technologies and
methods assessments &
● Anton Steuer, BioReliance
development, roles to be defined
● Hannelore Willkommen, Consultant
● Ruth Wolff, Consultant
7
8. Consortium Organization & Deliverables
General
Member
General
(Data Contributor) Steering Advisory
Member Board
General Committee
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
(Data Contributor)
Deliverables Available to
CAACB Members
MIT CBI/CAACB Team
Data Management Anonymous Project Reports:
Project Project Data Data Analysis &
Data Recommendations
Collection Data Analysis: Web Resource
& Coding Trend & Risk Center
CAACB
Analysis, etc. Workshop Technology
Associate Proceedings Research Proposals
Member
Associate
Member
Associate
Member
Associate
Member
Associate
Member
Associate
Member
Public Reports Public Presentations
Summary of Findings Summary of Findings
8
9. Consortium Information Flow
& Confidentiality Space
General
Consortium Information Domain
Member
General
(Data Contributor) Steering Advisory
Member Board
General Committee
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
(Data Contributor)
Deliverables Available to
CAACB Members
MIT CBI/CAACB Team
Data Management Anonymous Project Reports:
Project Project Data Data Analysis &
Data Recommendations
Collection Data Analysis: Web Resource
& Coding Trend & Risk Center
CAACB
Analysis, etc. Workshop Technology
Associate Proceedings Research Proposals
Member
Associate
Preview, Review
Member
Associate Authorize by Steering
Member
Associate Committee
Member
Associate
Member
Associate
Member
Public Reports Public Presentations
9 Summary of Findings Summary of Findings
10. Company Specific Information:
MIT-Member NDA Confidentiality Space
General
Member
General
(Data Contributor) Steering Advisory
Member Board
General Committee
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
(Data Contributor)
Deliverables Available to
CAACB Members
MIT CBI/CAACB Team
Data Protected by
Project
Data Management Anonymous
Project Data
Project Reports:
Data Analysis &
Individual NDAs between
Data
Collection
Recommendations
Data Analysis: Web Resource
Companies and&MIT
& Coding Trend Risk Center
CAACB
Analysis, etc. Workshop Technology
Associate Proceedings Research Proposals
Member
Associate
Member
Associate
Member
Associate
Member
Associate
Member
Associate
Member
Public Reports Public Presentations
Summary of Findings Summary of Findings
10
11. Company Specific Information:
Confidentiality Protection
General
Member
General
(Data Contributor) Steering Advisory
Member Board
General Committee
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
(Data Contributor)
Deliverables Available to
CAACB Members
MIT CBI/CAACB Team
Data Management Anonymous Project Reports:
Project Project Data Data Analysis &
Data Recommendations
Collection Data Analysis: Web Resource
& Coding Trend & Risk Center
CAACB
Analysis, etc. Workshop Technology
Associate Proceedings Research Proposals
Member
Associate
Member
Associate
Member
Associate Confidentiality
Member
Associate Barrier & Filter
Member
Associate
Member
Public Reports Public Presentations
Summary of Findings Summary of Findings
11
12. Confidential Information Is Protected
General
Consortium Information Domain
Member
General
(Data Contributor) Steering Advisory
Member Board
General Committee
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
General
(Data Contributor)
Member
(Data Contributor)
Deliverables Available to
CAACB Members
MIT CBI/CAACB Team
Data Management Anonymous Project Reports:
Project Project Data Data Analysis &
Data Recommendations
Collection Data Analysis: Web Resource
& Coding Trend & Risk Center
CAACB
Analysis, etc. Workshop Technology
Associate Proceedings Research Proposals
Member
Associate
Preview, Review
Member
Associate Authorize by Steering
Member
Associate Confidentiality Committee
Member
Associate Barrier & Filter
Member
Associate
Member
Public Reports Public Presentations
12 Summary of Findings Summary of Findings
13. Consortium Projects with Confidential Information –
Deliverables and Access by CAACB Participants
Research resource
Research Raw data Full research Research summary
Anonymous with processed data,
tools: e.g. data collected from reports to include reports: major
data pool - interpretation from
collection Participating all methods, data findings and
annotated CAACB forum (MIT
instrument, qu Members & analyses, findings, recommendations
and collated Team & Industry
estionnaire Partners recommendations without data details
Members)
Access Available to:
Full Members Full Members
Full Members Full Members
contributing data participating in project
CAACB Research &
ALL: Internal &
Ops Team with MIT
Associate External of CAACB
Associate NDA coverage ONLY
Members Associate Members Associate Members
Members
contributing data
13
14. Consortium Activities
Consortium
Operations & Purposes Participants
Activities
•To evaluate, revise and approve CAACB strategic
Steering Committee Representatives of
plans
Meetings Member Companies
•To identify, recommend and prioritize future projects
•To evaluate and recommend potential future projects
Representatives of
Consortium Task to the Steering Committee
Member Companies
Force Meetings •To assist in analysis of project findings and/or
technology advances in relevant fields
•To learn of advances in selected technology areas
Consortium •To contribute to the understanding of anonymous data Delegates of
Workshops & collected from CAACB projects Member Companies,
Symposia •To exchange ideas, experience and knowhow of Invited MIT faculty
industry practices
•To report progress and future plans of CAACB to
Delegates of Member
Consortium General consortium body
Companies, Invited
Meetings •To highlight technology advances and policy changes
guests
relevant to mission of CAACB
Consortium
•Forum to promote CAACB mission Public
Sponsored Meetings
14
15. Consortium Activities & Participations
MIT External
Associat Non-
Full Faculty/ Experts
Consortium Operations & Activities e member
Members Staff by by
Members Entities
Invitation Invitation
Steering Committee Meetings ✔
Consortium Task Force Meetings ✔ ✔
Consortium Workshops &
Symposia ✔ ✔ ✔
Consortium General Meetings ✔ ✔ ✔ ✔
Consortium Sponsored Meetings ✔ ✔ ✔ ✔ ✔
15
16. Consortium Schedule 2012
●Jan. – June 2012
● Workshop on Media Treatment for Viral Inactivation
● Steering Committee Meeting
●July – Sept. 2012
● CAACB General Meeting
● Symposium on New Virus Testing & Identification
Technologies
16
17. Consortium Benefits to Member Companies
1. Learning from industry-wide experience and solutions, as compared to only learning
from your company’s experience
2. Benchmarking your adventitious agent contamination strategy against best industry
practice
3. Networking and establishing collaborations with individuals in other companies, to
address similar adventitious agent issues and solutions
4. Learning first-hand how others have addressed adventitious agent contaminations,
decontaminated facilities and implemented corrective and preventive actions.
5. Learning of cutting edge technologies that can be applied to virus testing and
contamination risk reduction, and providing guidance to technology providers as to when
new technology applications are ready for implementation.
6. Identification of best strategies to obtain regulatory approval for testing and process
changes.
7. Sharing best approaches to making risk-based management decisions for
implementation of improvements (or corrective actions) to mitigate low risk, high impact
events.
8. Promotion of higher industry standards through consortium recommendations to
implement scientifically reasonable and beneficial testing and process improvements,
without being compelled to implement low value and potentially burdensome changes.
17
18. Overview of Inaugural Project
Project: The Collection and Analysis of
Virus Contamination Data in
Biomanufacturing
18
19. Premise
The confidential collection of industry-wide
viral contamination data and a subsequent
risk analysis assessment would be a highly
valuable “lessons learned” exercise for
industry, and could guide companies in best
practices to mitigate the risks that lead to
these events.
19
20. Impact of Virus Contaminations
● Potential Issue For Patient ● Requires Development Of
Safety Comprehensive Plan For
● Production Shutdown Corrective And Preventive
Actions
● Product Stock Out
● Manufacturing Plant
● Lost Product And Lost Sales Decontamination
● Expense Of The ● Encourages The Competition
Comprehensive Investigation
Required ● Complicates Partnerships
And Contractual Agreements
● Delay In Product Approval
● Exposes Company To
● Exposes Company To Intense Lawsuits
Regulatory Scrutiny
● Diverts Focus Of Company
● Changes Public Perception Of Leadership
Product Quality
20
21. Virus Contaminations: An Industry-Wide Issue
Virus Cell Year Company Reported By
EHDV CHO 1988 Bioferon GmbH Bioferon GmbH
MMV CHO 1993 Genentech Genentech
MMV CHO 1994 Genentech Genentech
Reovirus Human 1˚Kidney 1999 Abbott Labs FDA
Reovirus CHO ? ? BioReliance
Cache Valley CHO 1999 Amgen / CMO Amgen
Cache Valley CHO 2000 ? BioReliance
Vesivirus 2117 CHO 2003 Boehringer- Boehringer-
Ingelheim Ingelheim
Cache Valley CHO 2003 ? BioReliance
Cache Valley CHO 2004 ? BioReliance
Hu Adenovirus HEK 293 ? Eli Lilly Eli Lilly
MMV CHO 2006 Amgen Amgen
Vesivirus 2117 CHO 2008 Genzyme, Genzyme
Belgium
Vesivirus 2117 CHO 2008 Genzyme, USA Genzyme
Vesivirus 2117 CHO 2009 Genzyme, USA Genzyme
MMV CHO 2009 Merrimack Merrimack
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22. Virus Contaminations: Company’s Have Learned
Primarily From Their Contamination Event(s)
● Many companies have not publically disclosed virus contamination
events
● No obligation to disclose unless the contamination results in a “material
change” to the business
● Motivated by concerns for negative publicity.
● This is well known in the industry.
● Some companies do not notify regulatory authorities
● Companies that have disclosed rarely describe the event in sufficient
detail to be of significant value
lack of industry wide knowledge
● Companies are only really able to learn from their own contamination
events.
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23. Potential Value of Industry-wide
“Lessons Learned” Exercise
● Identification Of Industry Risks
● Which viruses have contaminated operations?
● What virus sources have been identified?
● What are the most likely process breaches?
● Which cell lines are most likely to be contaminated?
● Do some process designs have higher risk? (batch vs. perfusion)
● Identification of effective barriers
● Is there value in raw material testing?
● Has the elimination of animal derived raw materials lowered the frequency of
virus contamination?
● How effective are procedures used to inactivate virus in cell culture media before
use?
● Is there value in using molecular virus detection methods for in-process testing?
● Shared information could save industry millions of dollars and
prevent a potential patient safety catastrophe.
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24. Initial List of Information to Collect
● Virus Identification
● Method Of Virus Detection And Identification
● Cell Line Contaminated
● Extent Of Contamination
● Source Of Contamination All data will remain
● Process Breach Identification
● Frequency Of Contamination
confidential via
● Raw Material Treatment And Control System NDAs between
● Process Controls companies and MIT
● Methods Of Decontamination
● Corrective Actions
● Preventive Actions
● Lessons Learned
● Success Of Actions Taken
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25. Project Goals
1. Collect and analyze consortium member virus
contamination data (if member has experienced)
2. Compile processed data into a searchable
database with access for members while
maintaining confidentiality.
3. Uncover any new risk factors for contamination
4. Determine best industry practice to mitigate risk
5. Identify technology gaps for further R&D
6. Publish summary of key learnings from the
project.
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27. How to Join
●Written information to be sent for review and
discussion with colleagues and management
●Teleconference and/or company visit with
Consortium Staff
●Consortium agreement and membership fee
●Company representatives to steering committee
determined
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28. Contact Us
●Consortium Executive Director
Dr. Stacy Springs
email: ssprings@mit.edu
Tel: 1-617-253-3084
●Lead investigators
Dr. Michael Wiebe Dr. James Leung
email: quantumco@comcast.net email: leungjc@mit.edu
Tel: 1-650-365-7022 Tel: 1-781-333-8822
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