Early Bird Pricing Ends July 15!
Are you a life science professional in charge of ensuring your firm is compliant with GMPs throughout the Pharmaceutical Quality System? Are you up-to-speed in 21 CFR Part 211 regulatory expectations and compliance trends? Did you know FDA renewed their interest in Quality Metrics by asking for public comments suggesting an FDA guideline is moving forward? Would you like to understand GMP statistics and data trending to use risk and deviation tool? Are you still having issues with Data Integrity? If your answer is yes, don’t walk – run to this event to keep you up-to-the-minute with GMP regulations and compliance trends, best in class procedures/documentation and the innovative technology platforms to get you there.
Over 50 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe
Quality Risk Management
- Develop a Custom Risk Analysis Tool
- Use Product and Process Knowledge – CQAs & CPPs
- Track Data and Monitor Outputs
- Rank Risk and Filter for Risk Identification
- Map Post-Market Events to Risk Analysis
- Use Statistics as a Risk Management Tool
Change Control & Program Management
- Conduct Meaningful Impact Assessments
- Create Procedures, SOPs, Forms and Checklists
- Present Your Program to an Inspector
- Centralize Processes in a Global Organization
- Validate and Document Automatic Software Upgrades
- Integrate Risk Management into Processes
FDA Inspection Readiness
- Build an Audit Team Based on Fitness-of-Use
- Integrate Risk Management into Audit Programs
- Conduct a Data Integrity Audit Enterprise-Wide
- Inspection Readiness Conduct a Mock Inspection
- Build Your Custom Audit Checklist
- Bridge Communication Between Quality and Operations
Quality Metrics Reporting Program
- Measure Manufacturing Process Performance – Process Capability/Performance Indices, Lot Acceptance Rate (LAR), Right-First-Time Rate, Lot Release Cycle Time
- Evaluate PQS Effectiveness – CAPA, Repeat Deviation Rate, Change Control, Equipment Effectiveness and Unplanned Maintenance
- Optimize GMP Laboratory Performance – Adherence to Lead Time, Right-First-Time Rate, IOOSR, Calibration Timeliness
- Ensure Supply Chain Robustness – On Time In Full (OTIF), Fill Rate, Disposition On Time, Days of Inventory On-Hand
21 CFR Part 211
- Container and Closure Systems – Receipt and Storage, Testing and Approval, Approved Components, Retesting, etc.
- Production and Control Processes – Written Procedures, Deviations, Calculation of Yield, Equipment Identification, Sampling and Testing, Contamination Control
- Laboratory Controls – Testing and Release, Stability Testing, Special Requirements
- Records and Reports – Equipment Cleaning, Master and Batch Records, Record Review, Lab and Distribution Records, Complaint Files
Statistics and Data Trending in Validation and Manufacturing
- Accelerate Development of a Robust Control Strategy — Statistics in Process Development
- Link Knowledge Across the Lifecycle & Optimize Sampling Plans to Demonstrate Process Performance – Statistics in PPQ: No More an Isolated Event
- Design a CPV/OPV Program that Benefits the Patient and the Manufacturer
- Tips & How to Avoid Common Mistakes Across the Lifecycle
Who Should Attend
- Validation
- QA/QC
- Engineering
- C&Q
- Regulatory and Compliance
- Facility Management
- Manufacturing
- Laboratory
This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation, and engineering professionals in the life science environment.
Faculty
AGENDA
12:00 ET
Exhibitor Showroom and Virtual Platform Open House
1:15 ET
Chairman's Opening Remarks
1:30 - 2:15 ET
Laboratory GMPs – A System of Voluntary Compliance Pharmaceutical Laboratory - An FDA Perspective
Gayle Lawson, RPh, Pre-Approval Manager, Office of Pharmaceutical Operations, U.S. FDA (Invited)
2:15 - 3:00 ET
Qualification of Reference Standards
Manju Joshi, Biologist, CBER, U.S. FDA (Invited)
3:00 ET
Exhibitor Showroom and Afternoon Stretch
3:30 - 4:00 ET
Lifecycle Management Concepts to Analytical Procedures - A Compendial Perspective
Amanda Guiraldelli, Ph.D., Scientific Affairs Manager, U.S. Pharmacopeia
3:30 - 4:00 ET
Stability Hall of Shame – Regulations, Guidelines, and Expectations vs. 483’s Warning Letters and Worse
Junghae Scott, Principal, J Scott Consulting
4:00 - 4:30 ET
Creating a Quality Culture - Reduce Human Error and Minimize Risk
Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc.
4:00 - 4:30 ET
Modernization of ICH Q1 Standards
Tina Dean, Global Stability Manager, Eli Lilly and Company
4:30 - 5:00 ET
Regulatory Distinctions in Application and Validation of Bioanalytical Methods – These May Not Mean What You Think They Mean….
Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts
4:30 - 5:00 ET
Stability Metrics - Calendars, Clocks, and Scoreboards
John O'Neill, PSDG Facilitator, Editor, StabilityHub.com
5:00 ET
Networking Welcome Reception
7:15 ET
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 ET
Develop a Compliant Test Method Validation (TMV) for Standard Operating Procedures (SOP) and Master Plan
David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences
7:55 - 8:35 ET
Conduct a Gap Analysis in the QC Laboratory
Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)
7:55 - 8:35 ET
Validation of the Stability-Indicating Profile of a Biological Product – Biologics are Durer’s Rhino
Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts
8:45 - 10:15 ET
Develop a Customized Roadmap for Analytical Procedure Lifecycle
John Long, Ph.D., Director, Bioanalytical Method Development and Validation, Aldevron
8:45 - 10:15 ET
Tips to Reduce and Handle Out of Specification (OOS) / Out of Trend (OOT) Test Results
Junghae Scott, Principal, J Scott Consulting
8:45 - 10:15 ET
Focus Sessions: LIMS – Device & Combination Products – Forced Degradation/Extractables & Leachables
Sheba Zaman, Head of Product Specialists &Training Services, Novatek International; Chris Latoz, Stability Manager, Hollister Incorporated; Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
8:45 - 10:15 ET
Focus Sessions: Stability Planning – Regulations – CRO’s
Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts
10:15 - 10:45 ET
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 ET
System Suitability Tests (SST) and Method Performance Monitoring
Horacio N. Pappa, CQE, Ph.D., Director – General Chapters, Global Science and Standards Division, U.S. Pharmacopeia
10:45 - 11:25 ET
Identifying Error By Conducting an Effective Laboratory Investigation
Robert J. Wherry, Principal, White Birch Consulting Services
10:45 - 11:25 ET
Stability Chambers Selection, Validation, and Calibration
Stefan Cazzonelli, Sales and Marketing Manager, Parameter
11:35 - !2:15 ET
Using Risk-based Tools in the Analytical Procedure Lifecycle to Develop and Validate Test Methods
Jane Weitzel, Industry Expert
10:45 - 11:25 ET
Stability Chambers Selection, Validation, and Calibration
Chris Latoz, Stability Manager, Hollister Incorporated
11:35 - 12:15 ET
Managing Method Changes and Revalidation
Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)
11:35 - 12:15 ET
Documentation Requirements for OOS Investigations
Gary Ritchie, Consultant, CAI
11:35 - 12:15 ET
Chamber Monitoring, Responding to Excursions, Best Maintenance Practices
Chris Latoz, Stability Manager, Hollister Incorporated
12:15 ET
Exhibitor Showroom and Grab & Go Lunch
12:45 - 1:25 ET
Using the Risk-based Tools from the Analytical Procedure Life Cycle to Develop and Validate Test Methods
Jane Weitzel, Industry Expert
12:45 - 1:25 ET
Retesting and Resampling - How Much is Enough
To Be Announced
12:45 - 1:25 ET
Stability Deviations and Out of’s Investigations (OOS/OOT)
Gary Ritchie, Consultant, CAI
1:35 -3:05 ET
Successful Execution of Analytical Method Transfer
Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)
1:35 -3:05 ET
Validate and Qualify Analytical Instruments to Confirm They Are Fit for Use - Insight form 3 USP Stimuli Articles
Jane Weitzel, Industry Expert and USP Council of Experts & Chair of the 2025 General Chapters-Measurement and Data Quality, US Pharmacopeia
1:35 -3:05 ET
Focus Sessions: LIMS – Protocols – Sample Handling
3:05 ET
Exhibitor Showroom and Afternoon Stretch
3:30 - 5:00 ET
Validation and Development of Stability Indicating Methods
To Be Announced
3:30 - 5:00 ET
Conducting a Mock Audit - How to Prepare and Handle FDA Inspections
Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc.
3:30 - 5:00 ET
Applying Stability Statistics - Staples, Best Practices, and Innovations
Laura Pack, Senior Director, Quality Control & Statistics, Rezolute, Inc.; Lori McCaig, Director, Stability Program Strategy, Seagen, Inc.
5:00 ET
Close of Day Two
7:15 ET
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 ET
Analytical Method Development Using QbD
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
7:55 - 8:35 ET
AIQ Examples - From Analytical Balances to More Complex Custom-designed Computerized Instruments
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
7:55 - 8:35 ET
PSDG Morning Opener – Virtual Facility Tour, Explore the Stability Landscape & Test Your Conference Knowledge
John O'Neill, PSDG Facilitator, Editor, StabilityHub.com; Alcami (Invited); PPD (Alternate)
8:45 - 10:15 ET
Assay Transfer, Qualification, Validation – Are We Living in a ‘Land of Confusion?
Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River Laboratories
8:45 - 10:15 ET
QC Lab Data Integrity Programs - Development, Implementation and Maintenance
David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences
8:45 - 10:15 ET
Stability Focus Topics Wider View: Planning – Regs – CROs – LIMS – Protocols – Sample Handling
10:15 - 10:45 ET
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 ET
Continued Method Performance Verification - Control and Reduce Variation and Risk
To Be Announced
10:45 - 11:25 ET
Data Integrity Process Mapping - Identify and Mitigate Data Gaps
Matthew LaPierre, Data Integrity Specialist, Jackson Scott Consulting
10:45 - 11:25 ET
Stability Function Mapping - Parallels, Intersections, and Dependencies
Walter Routh, Stabilitarian, AbbVie
11:35 - 12:15 ET
System Suitability Tests (SST) and Method Performance Monitoring
Horacio N. Pappa, CQE, Ph.D., Director – General Chapters, Global Science and Standards Division, U.S. Pharmacopeia (Invited)
11:35 - 12:15 ET
Laboratory Records and Notebooks - Compare Notebooks, Worksheets, and Records for Accuracy
Robert J. Wherry, Principal, White Birch Consulting Services
11:35 - 12:15 ET
Setting and Evaluating the Performance of Specifications
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
12:15 ET
Exhibitor Showroom and Grab & Go Lunch
12:45 - 1:25 ET
Using Statistics and Data Trending to Understand Variation
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
12:45 - 1:25 ET
cGMP Training for the QC Scientist - Best Practice and Tips for the QC Scientist
Elizabeth Brockson, MPH - VPH, Associate Director, Global Quality Control, CAI
12:45 - 1:25 ET
Elements of Sample Control-Compliance, Inventory, and Tracking
Sheba Zaman, Head of Product Specialists &Training Services, Novatek International
1:35 - 2:15 ET
Developing Robust HPLC and TOC Methods and Avoiding Common Issues
Michael Lund, Program Manger, Hyde Analytical Laboratory
1:35 - 2:15 ET
Measurements Systems Capability Analysis
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
1:35 - 2:15 ET
Telling the Stability Story – Reporting for Product Teams, Management, and Regulatory Stakeholders
Lori McCaig, Director, Stability Program Strategy, Seagen, Inc.
2:25 - 3:05 ET
Improper Use of Statistics -- The Misuse, Misinterpretation and Bias of Analytical Assay Data
Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River Laboratories
2:25 - 3:05 ET
Manufacturing and Shipping Challenges to Stability – Developing a Stability Shelf Life Budget
Lori McCaig, Director, Stability Program Strategy, Seagen, Inc.; Laura Pack, Senior Director, Quality Control & Statistics, Rezolute, Inc.
3:05 ET
Exhibitor Showroom and Afternoon Stretch
3:30 - 4:15 ET
Data Integrity Compliance - Create Your Custom QC Lab Audit Checklist
Matthew LaPierre, Data Integrity Specialist, Jackson Scott Consulting
3:30 - 4:15 ET
Developing a Stability Budget – Manufacturing and Shipping Challenges to Stability
Walter Routh, Stabilitarian, AbbVie
4:15 ET
Close of Day Three
Early Bird Pricing Ends May 13!
The time has never been greater to stay up-to-speed with current regulatory thinking. Join KENX for Laboratory University and stay up to date with the latest developments and regulations in Analytical Procedures & Methods Validation, Stability Testing & Program Management, and FDA Inspections of Quality Control Laboratories.
Between FDA’s interest in releasing guidance’s the last few years on Analytical Procedures & Methods Validation, Bioanalytical Methods Validation and a flurry of global regulations on data integrity, it is critical for you and your company to receive the training you need and avoid regulatory action. FDA, ICH and USP all recognize Analytical Development and Validation as top priority in the drug development process and each have respective guidance, albeit interpretation is left to industry. Not only does this event take a deep dive into how companies comply with regulations, but also showcases how leading companies develop methods, validate procedures, and generate data and information that lead to critical business decisions.
Stability testing is critical to the efficacy of drug substances. ICH, FDA and WHO stability guidance’s have been around for quite some time and are strictly enforced, however, industry still has challenges to overcome and seeks more direction. Learn best practices to evaluate your program and ensure your organization has an advanced, compliant processes that exceed the expectations of regulators. Laboratory University takes participants through a best practice journey through the development, validation, transfer of analytical methods, stability testing and program management .
Analytical Procedures & Methods Validation
• Develop a Customized Roadmap for Analytical Procedure Lifecycle Management
• Risk Based Tools for Development and Validation of Test Methods
• Managing Method Changes and Revalidation
• Successful Execution of Analytical Method Transfer
• Validation and Development of Stability Indicating Methods
• Develop an SOP and Master Plan for Method Validation
Stability Testing & Program Management
• Stability Chambers Selection, Validation, and Calibration
• Stone Cold – Biologics, Tissue, Cell and Gene Therapy Stability Practices
• Program Development, Implementation and Management
• Staples of and Best Practices in Applying Stability Statistics
• Elements of Sample Control-Compliance, Inventory, and Tracking
• How Much Does a Stability Study Cost? Developing a Stability Financial Budget
FDA Inspections of Quality Control Laboratories
• Conduct a Gap Analysis in the QC Laboratory
• Tips to Reduce and Handle Out of Specification (OOS) / Out of Trend (OOT) Test Results
• Validation and Qualification of Analytical Instruments, Equipment and Software Platforms
• Development, Implementation and Management of a Data Integrity Program
• Laboratory Management – Critical Elements, Effective Strategies, and Essential Tips for Process Control
Who Should Attend
- Validation
- QA/QC
- Scientist
- Chemist
- Laboratory Management
- Regulatory Affairs
- Data Integrity
- Development and Manufacturing – (Bio)pharmaceutical, API and Medical Device
- QA/QC
- Stability Laboratories
- Raw Materials
- Laboratory Management
- Regulatory Affairs
- Formulation
Faculty
AGENDA
10:30 PT
Registration & Exhibitor Showroom and Virtual Platform Open House
11:30 PT
Lunch (Grab & Go)
12:00 - 12:15 PT
Chairman’s Opening Remarks
12:15-1:00 PT
Discovering how Covid-19 has Changed Biopharmaceutical Manufacturing Forever
Joel Gates, Senior Director of Operations, Azzur Cleanrooms on Demand
1:00 - 1:45 PT
Facilitating the Development of Gene Therapies
Peter Marks, Ph.D., Director of Center for Biologics Evaluation and Research U.S. Food and Drug Administration
1:45 - 2:15 PT
Exhibitor Showroom and Refreshment Break
2:15 - 2:45 PT
The Rapid Adoption of Intelligent Manufacturing and Pharma 4.0 During Covid-19
Jon Thompson,Principal Consultant, CAI
2:45 - 3:15 PT
4 Tips for Enhancing Trust with Contract Organizations for Increased Efficiency and long-lasting Relationships
Luiz Barberini, Head of External Manufacturing Operations, Bayer
3:15 - 3:45 PT
Regulatory Review of Cell & Gene Therapies – Understanding CBER’s Existing Framework and Looking Ahead to PDUFA and Other Changes
Kalah Auchincloss, EVP and Deputy General Counsel, Greenleaf Health, Inc.
3:45 - 4:00 PT
Afternoon Stretch and Coffee Refresh
4:00 - 4:30 PT
Examining Next Generation Biopharmaceutical Manufacturing
David W. Vincent, MPH, PhD, CEO,VTI Life Sciences
4:30 - 5:00 PT
Creating the Biopharma Workforce of the Future
Emily Moran,VP, Viral Vector Manufacturing The Center for Breakthrough Medicines
5:45 PT
Networking Welcome Reception
7:30 PT
Exhibitor Showroom Opens and Lite Breakfast
8:30 - 9:30 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Digital Tools in Bioprocess Design and Optimization
Maria Papathanasiou, Lecturer, Imperial College London
CELL & GENE
Strategies for Cell and Gene Therapy Translation from Bench to Bedside
Shirley Mei, Investigator – Regenerative Medicine Program The Ottawa Hospital Research Institute
BIOPROCESS EXCELLENCE
Reflecting on the Growing Momentum for Biosimilars in the US
Antonio Moreira, Vice Provost for Academic Affairs and Professor of Chemical, Biochemical and Environmental Engineering, University of Maryland, Baltimore County (UMBC)
9:40 - 10:30 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
The Road to Digital Transformation in Biopharma: Moving from Change Management to Enterprise Transformation for Bioprocessing 4.0
Rosalind Beasley,VP Digital Innovation, Dot Compliance Inc
CELL & GENE
Challenges & Solutions to Tracking of Off-the-Shelf Cell Therapies
Amanda Conerty, Senior Director of CMC, Artiva Biotherapeutics
BIOPROCESS EXCELLENCE
A Packaging Engineer – Luxury or Necessity?
Jan Gates, President/Advisor Packaging Engineer, PackWise Consulting
10:30 - 11:00 PT
Exhibitor Showroom and Networking Refreshment Break
11:00 - 12:00 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Smart Manufacturing and Contamination Control Strategies for Bio-Pharmaceuticals as ATMPs
Richard Denk, Senior Consultant Aseptic Processing & Containment SKAN AG
CELL & GENE
Digital Transformation – A Key to the Success of Cell and Gene Therapies
Per Hammer, Head of Automation and Digital, Cell & Gene Therapy, Cytiva
BIOPROCESS EXCELLENCE
Creating an Agile Culture to Be Ready to Adapt to New Innovative Ways of Working
Brent Gendleman, Innovation Lead IT Advisory Services, Azzur Jordyne Blaise, Director of Diversity, Equity & Inclusion, Bluebird bio
12:00 - 1:00 PT
Exhibitor Showroom and Networking Luncheon
1:10 - 1:55 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Realizing the Paradigm Shift to a Smarter Manufacturing Process
Chor Sing Tan, Strategy Manager Growth Initiatives, Cytiva
CELL & GENE
Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
Emily Moran, VP, Viral Vector Manufacturing, The Center for Breakthrough Medicines
BIOPROCESS EXCELLENCE
Partnering for Success – Collaborations between Industry and Academia
Emily Hopewell,Director, Cell and Gene Therapy Manufacturing Indiana University
2:05 -2:55 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Leveraging Flexible Networks, Cutting-Edge Innovation in a Quality Culture
Ellyn Ludden, Principal Consultant, CAI Lisa Hawkins, Principal Consultant, CAI
CELL & GENE
Leveraging Platform Technologies for Gene Therapies
Mari Salmi, Director of Process Development Scientist, GenCure
SUPPLY CHAIN
Accelerating Innovation in Ultracold and Cryogenic Medicines Supply Chain Distribution
Eric Elbel, Senior Manager of Supply Chain Logistics, AVROBIO
2:55 - 3:25 PT
Exhibitor Showroom and Afternoon Stretch
3:25 - 4:10 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Unleashing the Value of Quality by Design Through Continuous Process Verification, Manufacturing Anomaly Capture & AI-enabled Proactive Quality Response
Stephen McCarthy, VP, Digital Innovation, Honeywell Sparta Systems
CELL & GENE
Regulatory Considerations for Expedited Programs
Kimberley Buytaert-Hoefen, Director of Regulatory Affairs, Azzur
BIOPROCESS EXCELLENCE
Implementing Modern QC Tests Strategies Today Instead of Tomorrow
Audrey Chang, Executive Director of Biologics Testing Solutions, Charles River
4:20 - 5:05 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Increasing Efficiencies in Bioprocess Development and Manufacturing through Digital Process Development
Mark Duerkop, CEO, Novasign GmbH
CELL & GENE
Advances and Trends in Aseptic Fill / Finish for Targeted Therapy Products
Keith Dodson, Vice President of Business Development Automated Systems of Tacoma (AST)
SUPPLY CHAIN
Improving the Supply Chain for the Biopharma Industry – What Covid-19 Vaccine Production is Teaching Us
Kelly Smeltzer, Sr Principal Consultant, CAI
5:05 PT
Close of Day Two
7:30 PT
Exhibitor Showroom Opens and Lite Breakfast
8:30 - 9:20 PT
Select Between Think Tank Sessions
SMART MANUFACTURING
BioProcessing - How AI and Machine Learning Are Changing the Manufacturing Landscape
CELL & GENE
Cost Management in Cell & Gene Therapies
SUPPLY CHAIN
Real-time Risk Management - Using Data and Technology to Enhance GDP Compliance and Supply Chain Security
9:30 - 10:20 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Continuous Process Improvement in Commercial Product LCM – Focusing on Perfusion Systems
Prasad Pathange, Director of MSAT BT DS Labs, Bayer
CELL & GENE
The What and When of GMP for Critical Material in Cell & Gene Therapies
Dominic Clarke, Chief Technical Officer, Cell & Gene Therapy, Discovery Life Sciences
BIOPROCESS EXCELLENCE
Underserved Patient Populations: Developing, Manufacturing and Supplying Age-Appropriate Medicines for Children
Daniel Schaufelberger, VP CMC, NGT BioPharma Consultants LLC and Adjunct Assistant Professor, Johns Hopkins University School of Medicine
10:20 - 10:50 PT
Exhibitor Showroom and Networking Refreshment Break
10:50 - 11:35 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Remote Inspections, Enforcement Trends and Enforcement Examples
Eric Good, Director of Compliance, ProPharma Group
CELL & GENE
Cell & Gene Therapy Beyond Oncology
Emily English, Senior Director for Regulatory Affairs & Quality, Cartesian Therapeutics
SUPPLY CHAIN
Automation and Visibility - Effectively Combining People, Processes and Technology to Deliver Supply Chain at Scale
M. Dave Malenfant, Director of Outreach & Partnerships, Center for Supply Chain Innovation Neeley School of Business
11:45 - 12:45 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
Priya Baraniak, Vice President, Corporate Development, OrganaBio
CELL & GENE
How R&D with Cloud Bioreactors can Accelerate Process Development
Kris Tyner, Senior Director, Bioprocessing, Culture Biosciences
SUPPLY CHAIN
Using Digital Twins to Improve the Biopharmaceutical Supply Chain
Amar Chahal, Senior Vice President – Global Marketing, Strategy and Corporate Development, Cold Chain Technologies, LLC; Alok Bhanot, Chief Technology Officer, Cloudleaf, Inc.
12:45 - 1:15 PT
Exhibitor Showroom and Grab and Go Lunch
1:15 - 2:30 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Data Integrity and Biopharmaceutical Manufacturing
Dominic Mancini, Vice President, Operations, OrganaBio, LLC Marc Diament, CEO & Founder, Integral Biometrics Roque Redondo, Senior Technical Consultant, PharmEng Technology
BIOPROCESSING EXCELLENCE
Diversity in Clinical Research
Jordyne Blaise, Vice President, Diversity, Equity and Community Engagement, Circuit Clinical
SUPPLY CHAIN
Improve Supply Chain Visibility, Shipment ETA’s and Workflow Automation with Location Intelligence
Bart Coppelmans, Global Head of Industry Solutions for Supply Chain & Logistics, HERE Technologies
2:30 PT
Afternoon Stretch and Coffee Break
2:45 - 3:30 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Enabling Successful Process Validation in Biopharmaceutical Manufacturing
Rahul Rajan Kaushik, VP, Protein/Antibody Process Development & Manufacturing, Fibrogen
CELL & GENE
Discover an Allogeneic MSC Source for the Regenerative Medicine Supply Chain
Jessica Snyder, Bioprocessing Application Scientist, RoosterBio
SUPPLY CHAIN
How the Covid Vaccine Distribution Challenge was Overcome?
Amar Chahal, Senior Vice President – Global Marketing, Strategy and Corporate Development, Cold Chain Technologies, LLC
3:30 PT
Afternoon Stretch and Coffee Break
3:40 - 4:25 PT
Select Between Knowledge Exchange Sessions
SMART MANUFACTURING
Cloud Does Not Bite! How to Enhance the Pharma, Biotech and Life Science Industry by Implementing Modern IT Solutions with a Compliant Regulatory Control Framework
Agata Mizera, Cybersecurity Senior Manager in Risk Advisory in Deloitte
CELL & GENE
How Analytics Enables Manufacturing Automation, Process Robustness and Delivers Patient Access to Life-Saving Cell-Based Therapies
To be Announced
SUPPLY CHAIN
Supply Chain Resiliency – Manage Through Disruption
Dominic Mancini, Vice President, Operations,, OrganaBio
4:25 PT
Close of Conference
Early Bird Pricing Ends April 29!
More than ever before, the past 24 months has outlined the need for rapid, scalable and cost-effective vaccine, diagnostic, and therapeutic development. It also showcased the importance of flexibility and the need for the biopharmaceutical manufacturing industry to adapt to changing market demands. Additionally, we’ve recognized the importance of the supply chain as it applies to pharma and biopharma companies, particularly as all industries across the globe are experiencing difficulties across the supply chain.
- Hear from industry experts in biopharma manufacturing with their personal case studies and use-case stories
- Understand how Smart Manufacturing is taking over the Biopharmaceutical Manufacturing Industry
- Examine the role AI, Machine Learning, Data Analytics will continue to change the Biopharma Manufacturing process
- Receive the opportunity to collaborate with your peers across the industry
- Understand the importance of flexible manufacturing and the future of the workforce to biopharma manufacturing
Testimonials
“This is the first time I am attending a Virtual Conference, Love how interactive it is and also the Whova app is great.”
CSV Manager, Meitheal Pharmaceuticals, Inc.
“Great presentations, speakers, and interaction by both onsite and remote participants. Whova has been the best virtual conference platform I’ve experienced over the past few years.”
-ISO IT CSV and SQA Manager, AmerisourceBergen
BIO-SUPPLY CHAIN DISTRIBUTION & PROGRAM MANAGEMENT
- Accelerating Innovation in Ultracold and Cryogenic Medicines Supply Chain Distribution
- Improving the Supply Chain for the Biopharma Industry – What Covid-19 Vaccine Production is Teaching Us
- Automation and Visibility: Effectively Combining People, Processes and Technology to Deliver Supply Chain at Scale
- Accelerating Innovation Across Your E2E Supply Chain to Drive Efficiency and Improve Speed to Market
- Using Digital Twins to Improve the Biopharmaceutical Supply Chain
- Real-time Risk Management: Using Data and Technology to Enhance GDP Compliance and Supply Chain Security
- How the Covid Vaccine Distribution Challenge was Overcome
- Supply Chain Resiliency – Manage Through Disruption
- Improve Supply Chain Visibility, Shipment ETA’s and Workflow Automation with Location Intelligence
CELL & GENE THERAPY – STRATEGIES FOR RAPID ADVANCEMENT AND COST MANAGEMENT
- Strategies for Cell and Gene Therapy Translation from Bench to Bedside
- Challenges & Solutions to Tracking of Off-the-Shelf Cell Therapies
- Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
- Leveraging Platform Technologies for Gene Therapies
- Advances and Trends in Aseptic Fill / Finish for Targeted Therapy Products
- The What and When of GMP for Critical Material in Cell & Gene Therapies
- Optimizing Transfection Process in Suspension Cells to Reduce Dramatically the Cost of Goods of AAV Gene Therapy
- How Can Analytics Enable Manufacturing Automation, Process Robustness, and Deliver Patient Access to Life-Saving Cell-Based Therapies?
- An Allogeneic MSC Source Accelerated the First Cell Therapy for Covid-19 Associated Lung Fibrosis
- Gene Editing and Emerging Technologies
SMART MANUFACTURING AND BIOPROCESSING EXCELLENCE
- Digital Tools in Bioprocess Design and Optimization
- The Road to Digital Transformation in Biopharma: Moving from Change Management to Enterprise Transformation for Bioprocessing 4.0
- Smart Manufacturing and Contamination Control Strategies for Bio-Pharmaceuticals as ATMPs
- Realizing the Paradigm Shift to a Smarter Manufacturing Process
- Leveraging Flexible Networks, Cutting-Edge Innovation in a Quality Culture
- Unleashing the Value of Quality by Design Through Continuous Process Verification, Manufacturing Anomaly Capture & AI-enabled Proactive Quality Response
- Increasing Efficiencies in Bioprocess Development and Manufacturing through Digital Process Development
- Using Process Analytical Technology (PAT) Tools in Biopharmaceutical & Pharmaceutical Manufacturing
- Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
- Data Integrity and Biopharmaceutical Manufacturing
- Enabling Successful Process Validation in Biopharmaceutical Manufacturing
Who Should Attend:
Attendees will come from biopharmaceutical companies, pharma, biotech companies, medtech companies and their peripherals across the globe and will bring together all those individuals involved with the manufacturing process.
VPs/Directors/Managers & Heads of:
- Manufacturing
- Engineering
- R&D / Research & Development
- Process Improvement
- Quality
- Supply Chain
- Operations
- Innovation
- Plant/Site/Facilities
- Quality
- Strategy
- Business Development
- Technology
- IT/Information Technology
- AI
- Data & Analytics
Titles will include:
- Chief Engineering Officer
- Chief Manufacturing Officer
- Chief Scientific Officer
- Chief Innovation Officer
- Chief Technology Officer
- Chief Operations Officer
- Chief Quality Officer
- Chief Data Analytics Officer
