Key Sessions

Janani Swamy

KEYNOTE ADDRESS: Digital Transformation - Keys to Achieving Breakthrough Transformation of Manufacturing & Supply Operations

Sanofi

David Roush, Ph.D.

KEYNOTE ADDRESS: Innovative strategies and technologies to drive sustainability of Biologics Process Development

Merck

Janani Swamy

KEYNOTE ADDRESS: Digital Transformation - Keys to Achieving Breakthrough Transformation of Manufacturing & Supply Operations

Sanofi

David Roush, Ph.D.

KEYNOTE ADDRESS: Innovative strategies and technologies to drive sustainability of Biologics Process Development

Merck

Day 3Wednesday, 20 September 2023 - ET (Eastern Time, GMT-05:00)

7:30am - 8:00am

Coffee and Registration

Showing 3 of 3 Streams

Well Characterized Biologics & Biological Assays

Analytical & Quality

BWB Main Stage

8:00am - 8:10am

Chairperson's Remarks

Vilas B Shukla, Ph.D. - PMP Senior Principal Engineer, Biologics Project Engineering, AbbVie Operations

8:10am - 8:50am

KEYNOTE ADDRESS: Digital Transformation - Keys to Achieving Breakthrough Transformation of Manufacturing & Supply Operations

Janani Swamy - Head of Operational Excellence and Digital Transformation, Sanofi

8:50am - 9:30am

KEYNOTE ADDRESS: Innovative strategies and technologies to drive sustainability of Biologics Process Development

David Roush, Ph.D. - Distinguished Scientist, Merck
Sri Madabhushi - Principal Scientist, Merck & Co., Inc.

8:00am - 8:10am

Chairperson's Remarks

Vilas B Shukla, Ph.D. - PMP Senior Principal Engineer, Biologics Project Engineering, AbbVie Operations

8:10am - 8:50am

KEYNOTE ADDRESS: Digital Transformation - Keys to Achieving Breakthrough Transformation of Manufacturing & Supply Operations

Janani Swamy - Head of Operational Excellence and Digital Transformation, Sanofi

8:50am - 9:30am

KEYNOTE ADDRESS: Innovative strategies and technologies to drive sustainability of Biologics Process Development

David Roush, Ph.D. - Distinguished Scientist, Merck
Sri Madabhushi - Principal Scientist, Merck & Co., Inc.

9:20am - 9:30am

Chairpersons Opening Remarks

Willis Thomas - HR Business Partner, PQE

Showing 2 of 2 Streams

Break

BWB Main Stage

9:30am - 10:30am

Morning Break

9:30am - 9:40am

High-volume Fluid Transfer

Michael Francis - Product Manager, CPC - Colder Products Company

9:40am - 9:50am

Integrated Sensors for Smart Biopharma Peristatic Pump Systems

Aaron Schneider - Product Manager, Avantor

9:50am - 10:10am

C1 Gene Expression Platform: Rapid, High Yield and Lower Cost Way to Develop and Manufacture Biologics

Joseph Hazelton - Chief Business Officer, Dyadic

10:15am - 10:30am

Innovation Start Up Showcase

Lynne Frick - CEO & Co-Founder, BioGuides LLC & BioInnovation Group
Gregg Nyberg - Chief Technology Officer, Landmark Bio
Sarah Yuan - Chief Technical Operations Officer, Sigilon Therapeutics
Dmitry Gumerov - Director, CMC Pharmaceutical Sciences and Technology, Visterra Inc
Carrie Mason - Associate Director Biologics R&D a PAT/Automation, Lonza
Joseph Shultz - Vice President & Technical Head of Biologics and Vaccines, Resilience
Jason Criscione - CSO and Member, Board of Directors, jc@enquyst.com
Mandana Manzari Honu - Head of Business Development, Kaleidoscope
Caroline Johnson - Application Scientist, Cell X Technologies, Inc
Marcie Black - CEO and Co-Founder, Advanced Silicon Group
Irene Rombel - Co-Founder and CEO, BioCurie

Showing 3 of 3 Streams

Well Characterized Biologics & Biological Assays

Analytical & Quality

BWB Main Stage

10:30am - 11:00am

ORSI and Extramural Research at FDA

Tina Morrison, Ph.D. - Director, Office of Regulatory Science and Innovation, FDA

11:00am - 11:30am

Connecting the dots - How to connect primary and working reference standards when your therapeutic is a cellular (CAR T) product

Michael Sadick, Ph.D. - Senior Director, Precision Biosciences

11:30am - 12:00pm

De-risking the Development of Tomorrow’s Medicines with Advancing Analytical Characterization Capabilities

Jason Barker - Director of Analytical Development, Analytical Method Transfer, and Formulation Development, FUJIFILM Diosynth Biotechnologies

10:30am - 11:00am

Implementation of Multi-Attribute Methods

Da Ren, Ph.D. - Founder and CEO, BioTherapeutics Solutions

11:00am - 11:30am

Benefits of Multi-Attribute Methods in QC Laboratory Setting

Jonathan Bones, Ph.D. - Principal Investigator, NIBRT Characterization and Comparability Laboratory, National Institute for Bioprocessing Research & Training (NIBRT)

11:30am - 12:00pm

Deliver Products to Patients Faster with a Purpose-Built, No-Code MES Solution

Matt Lowe - Chief Strategy Officer, MasterControl

10:30am - 11:50am

Innovation Start Up Showcase

Lynne Frick - CEO & Co-Founder, BioGuides LLC & BioInnovation Group
Gregg Nyberg - Chief Technology Officer, Landmark Bio
Sarah Yuan - Chief Technical Operations Officer, Sigilon Therapeutics
Dmitry Gumerov - Director, CMC Pharmaceutical Sciences and Technology, Visterra Inc
Carrie Mason - Associate Director Biologics R&D a PAT/Automation, Lonza
Joseph Shultz - Vice President & Technical Head of Biologics and Vaccines, Resilience
Jason Criscione - CSO and Member, Board of Directors, jc@enquyst.com
Mandana Manzari Honu - Head of Business Development, Kaleidoscope
Caroline Johnson - Application Scientist, Cell X Technologies, Inc
Marcie Black - CEO and Co-Founder, Advanced Silicon Group
Irene Rombel - Co-Founder and CEO, BioCurie

11:50am - 11:55am

Break

11:55am - 12:00pm

[11:55-12:15] Characterization and Quantification of Adeno-associated Virus Fill States Using Analytical Ultracentrifugation - KBI Biopharma

N. Karl Maluf - Director of the Biophysical Characterization Core, KBI Biopharma

Showing 2 of 2 Streams

Break

BWB Main Stage

12:00pm - 1:25pm

Luncheon in the Poster/Exhibit Hall

12:00pm - 12:15pm

Characterization and Quantification of Adeno-associated Virus Fill States Using Analytical Ultracentrifugation - KBI Biopharma

N. Karl Maluf - Director of the Biophysical Characterization Core, KBI Biopharma

12:15pm - 12:35pm

Enhanced Bioprocess Efficiency for Biologics Production using OmniBRx Dynamic-Bed Reactor Technology

Jiten Pant - CEO and CSO, OmniBRx Biotechnologies Inc

12:35pm - 12:55pm

Functional Assays at the Single Cell Level

Robin Krueger, PhD - Vice President, Arralyze LPKF

12:55pm - 1:05pm

An Improved Method for the Characterization of Ultrafiltration (UF) Membranes for Bioprocessing

Thomas Lazzara, PhD - Director, Research & Development, Meissner

1:05pm - 1:25pm

Leveraging Continuous Manufacturing to Expand Global Access to Biotherapeutics

Ben Castro - SVP, Manufacturing Operations, Just – Evotec Biologics

Showing 3 of 3 Streams

Well Characterized Biologics & Biological Assays

Analytical & Quality

BWB Main Stage

1:25pm - 1:30pm

Chairperson’s Remarks

1:30pm - 2:00pm

Phase Appropriate DP Development and Characterization in Relation to Human Clinical Trials

Bruce Kerwin, Ph.D. - Principal and Member of Coriolis Scientific Advisory Committee, Kerwin Biopharma Consulting LLC

2:00pm - 2:30pm

Update on Method Qualification Vs. Phase Appropriate Method Validations

Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC

2:30pm - 3:00pm

Doubling Process Productivity and Speeding Up Process Development with Mechanistic Modeling for Chromatography

Per Lidén - General Manager, Cytiva

1:25pm - 1:30pm

Chairperson’s Remarks

1:30pm - 2:00pm

SEC in tandem with MS: A Powerful Tool to Understand HCP Risk

Younghoon Oh - Scientist, Janssen R&D

2:00pm - 2:30pm

Pros and Cons of Mass Spec for HCP Analysis

Kevin Van Cott - Associate Professor, University of Nebraska-Lincoln

2:30pm - 3:00pm

Scientific Track Presentation

1:25pm - 1:30pm

Chair Opening Remarks

Jared Auclair, PhD - Vice Provost Research Economic Development, Director of Bioinnovation, College of Science at Northeastern University

1:30pm - 2:20pm

Panel Discussion: Future Talent Structures that Inspire Inclusion and Cultivate a Winning Culture – A Call to Action to Achieve Diversity and Inclusion Today

Karen Lewis - Chief People Officer, Apellis Pharmaceuticals
Kenn Turner - President and CEO, Massachusetts Life Sciences Center
Tamicka James - Senior Director and Head of Diversity and Inclusion, US Commercial, Medical, Government Affairs, Genentech
Erin Cowhig - Chief People Officer, Nimbus Therapeutics
Tricia McCall - Chief People Officer, Delix Therapeutics

2:20pm - 2:25pm

Break

2:25pm - 3:00pm

Imagine Our World: Creating Impact in the Biotechnology Industry

Azurii Collier - President & Board Chair, Women in Bio, Director, Portfolio Innovation, Abbvie

Showing 2 of 2 Streams

Break

BWB Main Stage

3:00pm - 4:00pm

Afternoon Break

3:00pm - 3:15pm

Imagine Our World: Creating Impact in the Biotechnology Industry

Azurii Collier - President & Board Chair, Women in Bio, Director, Portfolio Innovation, Abbvie

3:15pm - 3:20pm

Break

3:20pm - 3:40pm

Laboratory Challenges for Radiation Sterilization Validation and Dose Audit Testing of Bioprocessing Products

Jason Rogers - Principal Scientist, STERIS

3:40pm - 3:50pm

Tune into your Formulation: Rapid at/in-line Accurate Quantitation of Excipients and Protein Titer using High Precision Tunable Laser Spectroscopy (HPTLS™)

Bryan Hassell, PhD - Founder / Chief Technology Officer, Nirrin Technologies

3:50pm - 4:00pm

Harnessing the Power of the Mobius® Breez Microbioreactor to Address Cell Therapy Process Optimization Challenges

Kara Levine - Senior R&D Manager, Cell Therapy Applications, MilliporeSigma

Showing 3 of 3 Streams

Well Characterized Biologics & Biological Assays

Analytical & Quality

BWB Main Stage

4:00pm - 4:30pm

Analytical Standards in the Characterization of Biopharmaceuticals

Michael Tarlov - Chief, NIST

4:30pm - 5:00pm

NISTmAb and beyond: Standards support biotechnology and biomanufacturing innovation

John Schiel, Ph.D. - Research Chemist, IBBR, National Institute of Standards and Technology

5:00pm - 5:30pm

USP Biological Standards for Analytical Methods

John Kokai-Kun - Director, Biologics Industry Collaborations and Partnerships, United States Pharmacopeia (USP)

4:00pm - 4:30pm

Proteomics Supported Process Development for Bridging Host Cell Proteins Coverage Gap

Ujjwal Bhaskar, Ph.D. - Associate Director, Bristol Myers Squibb

4:30pm - 5:00pm

Characterization and Clearance of Host-Cell-Protein-Rich Aggregates in Monoclonal Antibody Bioprocessing

Chase Herman, Ph.D. - Investigator, GSK

5:00pm - 5:30pm

Raman technology to enable real-time upstream bioprocess monitoring and continuous control: From media preparation to cell culture expansion

Greg Voyta - Senior MSAT Engineer, Millipore Sigma

4:00pm - 4:20pm

Supply Chain Management

Joe Ivan - Head of Supply Chain Services, DS InPharmatics, a ProductLife Group Company

4:20pm - 4:30pm

Paving the way to Affordable and Accessible Advanced Therapies: Innovation in Bioprocess Technologies for ATMP Manufacturing

René Gantier, PhD - Senior Director R&D, Advanced Bioprocess Applications, Repligen

4:30pm - 4:35pm

Break

4:35pm - 5:25pm

Lessons in Diversity, Equity and Inclusion: For Teams and Individuals to Thrive

Chaunté Lowe - Motivational Olympic Medalist, American Record Holder, and TEDx Speaker, USA

5:30pm - 9:00pm

Party on Lawn D

Day 3Wednesday, 20 September 2023 - ET (Eastern Time, GMT-05:00)

Day 3Wednesday, 20 September 2023 - ET (Eastern Time, GMT-05:00)

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