Agenda - Wednesday 19th March - Main Conference Day One

Key Sessions

Tracy Ryan

Saving Sophie: The Mom, the Scientist & Their Journey to Cure Cancer

NKore BioTherapeutics

Cynthia Lam

Utilizing a regulated targeted integration expression system as both a diagnostic tool for difficult to express molecules and as a method to improve specific productivity without affecting cell growth in CHO cell lines

Genentech

Jesse Richter

Successful Global Launch with a Risk-based Approach to Tech Transfer

AstraZeneca

Wenqin Ni

Comparability Studies to Support Manufacturing Process Change, Enhancing Product Quality and Accelerating Timeline to Commercial Launch

Pfizer

Lakshman Prakash Balajepalli

Selecting CDMO’s for Successful Translation from Lab to Clinic

Cedars Sinai Biomanufacturing Center, USA

Wednesday 19th March - Main Conference Day OneWednesday, 19 March 2025 - PT (Pacific Time, GMT-08:00)

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Plenary Keynote Sessions

9:00am - 9:10am

Welcome to BPI West - Chair's Opening of Conference

Vilas Shukla, Ph.D - Director, Large Molecule Global Engineering Projects, Johnson & Johnson Innovative Medicine

9:10am - 9:50am

Saving Sophie: The Mom, the Scientist & Their Journey to Cure Cancer

Sharing the incredible story of Sophie Ryan who was diagnosed with a brain tumor at 8 ½ months old
After 7 years of chemotherapy and 11 surgeries, Sophie’s mom Tracy partnered with Dr. Anahid Jewett fromUCLA to launch NKore BioTherapeutics. Sophie was the first child to receive their company’s non-toxic cancerimmunotherapy, NK101.
Sophie is now the healthiest she has ever been, her tumor is crumbling due to only two infusions of the treatment,and NKore is on a path to helping patients with many forms of cancer, and other immune related illnesses.

Tracy Ryan - Co-Founder & Chief Communications Officer, NKore BioTherapeutics

9:50am - 10:30am

A Practical Roadmap for Digitalization in Biopharma Manufacturing

Insights and best practices for successful implementation
Achieving scalable optimization
Ensuring user adoption

Ramila Peiris - Global Head of Process Data Management, ML and AI Platform, MSAT, Sanofi

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Manufacturing Strategy & Digital Transformation

11:15am - 11:20am

Chairperson's Remarks: Manufacturing Strategy & Bioprocessing 4.0

Vilas Shukla, Ph.D - Director, Large Molecule Global Engineering Projects, Johnson & Johnson Innovative Medicine

11:20am - 11:50am

Streamline Biologics Process Characterization and Control Strategy Development

Accelerated clinical process development and CMC timeline
Downstream process characterization workflow and case study
Approach on Tier 1 and Tier 2 process characterization to enable PPQ and BLA
Control strategy platform development for robust manufacturing
Modelling consideration on future process characterization

Lihua Yang,PhD - Senior Principal Research Scientist, AbbVie

11:50am - 12:20pm

Comparability Studies to Support Manufacturing Process Change, Enhancing Product Quality and Accelerating Timeline to Commercial Launch

Wenqin Ni - Senior Principal Scientist, Pfizer

12:20pm - 12:50pm

Transforming Protein Biologics with High-Throughput Signal Peptide Engineering

Signal peptides have an important role in modulating protein biogenesis, and they can significantly impact the
efficacy, stability, and yield of therapeutic proteins.
Every protein in the secretory pathway has a unique pool of high-performing signal peptides. Latest
technological advances allow analyzing them in thousands to find the best performing signal peptide-protein
combination.
Examples presented will show how engineering of signal peptides lead up to 5X in expression without
compromising protein quality.

Tero-Pekka Alastalo, MD, PhD - CEO, Avenue Biosciences

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Manufacturing Strategy & Digital Transformation

1:55pm - 2:00pm

Chairperson's Remarks: Manufacturing Strategy & Bioprocessing 4.0

2:00pm - 3:00pm

PANEL DISCUSSION: Navigating the Ever-Changing CDMO Landscape

How CDMOs have evolved in the last 5 years and what to expect in the coming years;
Geopolitical uncertainty and its impact on outsourced manufacturing;
Collaboration to understand the changing needs of pharma and biotech.

Vadim Klyushnichenko - VP Bio/Pharmaceutical Development & Quality, Calibr-Skaggs Institute for Innovative Medicines
Lihua Yang,PhD - Senior Principal Research Scientist, AbbVie
Andrew Harmon - Associate Manager, Management & Strategy Consulting, Sia Partners
Kevin Zen, PhD - Senior Director, IGM Biosciences, Inc.
Lori Ball - Chief Executive Officer, Astoriom

3:00pm - 3:30pm

Streamlining and Fast-Tracking Mammalian Tech Transfer to Ensure High Quality Commercial Supply

The general trend towards external manufacturing sites for mammalian-derived biopharmaceuticals requires a seamless and efficient tech transfer concept.
This concept needs to ensure fast scale up and market supply while maintaining high quality standards and reliable processes.
With Lonza’s strong track record in tech transfers, this session will focus on key strategies and success factors to overcome common challenges during late stage tech transfers.
We will also share how to maintain a high standardization within a global mammalian manufacturing network, how to leverage the Lonza expertise across the globe, and how to create a streamlined road to success within each individual site.

Tillmann Schnierda - Director, Commercial Development, Mammalian, Lonza

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Manufacturing Strategy & Digital Transformation

4:30pm - 5:00pm

Successful Global Launch with a Risk-based Approach to Tech Transfer

Jesse Richter - Executive Director, Tech Transfer and Validation - Global Technical Operations, Biopharmaceuticals, AstraZeneca

5:00pm - 5:30pm

Tech Talk: Amplifying Your Licensing Message in a Digital World

Noman Khan - Associate Director External Engagement, University of Utah
Abdul Mukati - CEO and Founder, Master Inbox

5:30pm - 7:00pm

Networking Drinks in Exhibit Hall

Wednesday 19th March - Main Conference Day OneWednesday, 19 March 2025 - PT (Pacific Time, GMT-08:00)

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