A Decade Strong — Celebrating 10 Years of BMWS

November 9th

Welcome Day Chair

Sybil Danby

VP, Business Development and Strategy

ASIMOV

2:30 pm

Registration

3:30 pm - 4:20 pm WELCOME DAY SPECIAL CONTENT

Scaling the Future: Innovation, Operations, and Execution in New Modalities & CGT

Moderator

Sybil Danby

VP, Business Development and Strategy

ASIMOV

Susan Abu-Absi

Chief Operating Officer

Aura Biosciences

Lise Munsie

VP, Process Development

BlueRock Therapeutics

Ian Gaudet

Vice President, Technical Development

Kyverna Therapeutics

Senthil Ramaswamy

Head of Global Operations, Cell and Gene

Lonza

Session Details Arrow Icon
  • Operational Readiness & Scale-up: Translating breakthrough modalities into reliable, efficient manufacturing
  • Process & Technology Enablement: Implementing scalable, robust, and flexible manufacturing approaches for CGT and other advanced modalities
  • Talent Retention and Development: Attracting, retaining, and upskilling teams in cell, gene and other advanced modality operations
  • Leadership in Emerging Modalities: Preparing teams to manage technical challenges and rapid growth in next-generation therapies
4:30 pm - 5:20 pm WELCOME DAY SPECIAL CONTENT

Leading Through Complexity: Leadership, Talent, and Delivery in Biomanufacturing

Moderator

Alison Moore

President and Chief Executive Officer

Codexis

Ganesh Vedantham

SVP Global Manufacturing

BioMarin

Harish Santhanam

Vice President, Cell Therapy Technical Operations

Bristol Myers Squibb

Nihal Tugcu

Head of Global CMC - Vaccines R&D

Sanofi

Session Details Arrow Icon
  • How biomanufacturing leaders are adapting organizational structures, decision-making, and operating models to manage growing complexity across modalities, technologies, and global networks
  • Building the leadership capabilities, technical talent, and cross-functional collaboration needed to support faster execution and more agile operations
  • Balancing speed, innovation, and operational discipline as manufacturing organizations navigate increasing portfolio complexity and external partnerships
  • How leading organizations are strengthening culture, accountability, and execution to improve performance in a rapidly evolving manufacturing environment
5:30 pm - 6:20 pm WELCOME DAY SPECIAL CONTENT

Advancing Biomanufacturing: What’s Working, What’s Changing, and What’s Next

Moderator

Sybil Danby

VP, Business Development and Strategy

ASIMOV

Jerry Murry

Senior Vice President, Process Development

Amgen

Jose Torres-Vorshirm

SVP Global Technical Operations

BioNTech

Nuno Fontes

President WuXi Biologics USA & SVP, Head of Global CMC

WuXi Biologics

Session Details Arrow Icon
  • Programs & Culture: How are current programs fostering curiosity, accountability, and continuous improvement? What approaches drive measurable results across sites and modalities?
  • Technology & Data: Where are AI, digital twins, and predictive analytics delivering value in manufacturing and quality systems? Which tools provide actionable insights without overloading teams?
  • Supply Chain & Network Resilience: What strategies are strengthening agility, traceability, and risk mitigation across global biologics networks, and building long-term resilience against disruption?
  • Regulatory Alignment & Innovation: How can organizations navigate differing regional regulatory requirements while supporting innovation in cell, gene, and next-generation therapies?
  • Leadership & Talent Development: How are senior leaders preparing the next generation of biomanufacturing leaders to navigate complexity, integrate cross-functional teams, and drive performance?
6:20 pm

Welcome Drinks Reception

7:00 pm

Executive dinner

November 10th

Stream 1 Chair

Aine Hanly

Senior Vice President, Chief Quality Officer

Amgen

Stream 2 Co-Chair

Ryan Guerriero

VP, Technical Operations

Project Farma

Stream 3 Co-Chair

Alex Gerrish

Account Executive

Körber Pharma Software

7:15 am - 8:30 am

registration & breakfast

8:00 am - 8:10 am

Opening Remarks & Important Announcements

Aine Hanly

Senior Vice President, Chief Quality Officer

Amgen

8:10 am - 8:30 am

Welcome Address

Yatin Gokarn

SVP, Head of Product Development & Clinical Supply

Alexion Pharmaceuticals

8:30 am - 9:05 am KEYNOTE

From Molecule to Medicine: Driving AI-powered Pharmaceutical Manufacturing for a More Productive and Sustainable Future

Pam Cheng

Executive Vice President, Global Operations & IT, Chief Sustainability Officer

AstraZeneca

Session Details Arrow Icon
  • Exploring how AI, digital technologies, and data are helping manufacturers deliver greater value while reducing environmental impact
  • Examining the role of green chemistry, advanced manufacturing technologies, and new approaches to scaling increasingly complex therapies
  • Addressing how to build a more resilient, efficient, and patient-focused future for the development, production, and delivery of medicines
9:05 am - 9:40 am KEYNOTE

Evolving Quality from Reactive Oversight to Predictive Intelligence

Aine Hanly

Senior Vice President, Chief Quality Officer

Amgen

Session Details Arrow Icon

As biomanufacturing grows, how can Quality keep pace and help prevent problems before they occur?

Jackie Elbonne will share how Amgen is evolving Quality from reactive oversight to predictive intelligence; connecting data, technology, people, and culture to spot risk earlier, guide action, and support reliable supply for patients.

9:50 am - 10:25 am Workshops
STREAM 1 WORKSHOP

From Pharma Mindset to Manufacturing Innovation: Creating Value in a Dual-Role CDMO Model

Athelney J Woolnough

Director, Business Development and Key Account Management

Boehringer Ingelheim

Philip Nelson

Director, Head of Process Technology and Process Transfers

Boehringer Ingelheim

Session Details Arrow Icon
  • Trust as the foundation: Biopharma customers need a CDMO that can deliver reliable supply while adapting to changing demand and timelines
  • Pharma mindset: Regulatory and product-lifecycle expertise helps move programs from R&D to patients without compromising quality or compliance
  • Innovation and continuous improvement: adaptable multiproduct facilities and targeted process enhancements lead to flexible manufacturing solutions
  • Customer value: Combining pharma-grade execution with a service mindset turns manufacturing complexity into confidence and capacity into long-term value
STREAM 2 WORKSHOP

Automating Your Way to Regulatory Confidence: A Comparability Case Study

Isabel Tian, Ph.D.

Senior Director of Scientific Affairs

Cellares

Session Details Arrow Icon

Process changes are inevitable in cell therapy, and comparability is where many programs lose time and regulatory confidence. This case study shows how comparability data generated on the Cellares Cell Shuttle supported successful IND amendment clearance, and what made that data persuasive to regulators.
Attendees will also learn:

  • How to apply phase-appropriate comparability approaches based on clinical experience and product knowledge
  • How automation reduces variability, strengthens process understanding, and enables scalable, lifecycle-ready manufacturing
STREAM 3 WORKSHOP

Scaling Smarter: Intelligent Planning for Biomanufacturing Growth

Scott Barnard

Managing Director USA

BlueCrux

James Ward

Lab Digital Transformation Lead

BlueCrux

Session Details Arrow Icon

As biotech companies grow, planning complexity increases across labs, manufacturing, external partners, and commercial operations, with systems and processes quickly becoming outdated. Organizations that scale successfully are rethinking how planning connects people, processes, and data across the value chain, creating the foundation for smarter decisions and more agile operations.

What you’ll learn:

  • What scalable planning looks like in modern biotech organizations
  • The role of lab, manufacturing, and partner planning in supporting growth
  • Lessons from advanced therapies and patient-centric supply chains
  • Priorities for building a more connected and resilient operating model
10:25 am - 12:10 pm Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 10:30 am – 10:50 am: Meeting Slot 1/Networking
  • 10:55 am – 11:15 am: Meeting Slot 2/Networking
  • 11:20 am – 11:40 am: Meeting Slot 3/Networking
  • 11:45 am – 12:05 pm: Meeting Slot 4/Networking
12:15 pm - 12:50 pm Case Studies
Stream One - Strategic Manufacturing

Technical Product Health by Design: The Device Was Selected on Time — and Still Too Late

Sebastian Stening

VP, Global Head Device, Packaging & Distribution MSAT

Roche

Stream Two - Quality

If We All Want Quality Excellence, Why Are We So Far Away?

Anders Vinther

Founder & CEO

Quality Business Administration

Stream Three - Innovation

Advancing the Next Generation of CAR T Cell Therapy: Progress and Opportunities

Ben Beneski

Chief Technical Officer

Allogene

Session Details Arrow Icon
  • Building on the success of initial autologous CAR T approvals, the field is expanding into new modalities – including allogeneic and in vivo CAR T – and into new therapeutic areas beyond hematologic cancers, such as autoimmune disease
  • Allogeneic CAR T is a platform built for real life: treating patients where and when they need it, with cells designed to safely do the job
  • Manufacturing and operational excellence, grounded in proven biologics approaches, are critical to successfully advancing next-generation therapies
  • An evolving regulatory landscape offers an opportunity to help shape the path forward for CAR T cell therapy development
12:50 pm - 1:50 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

Two Functions, One Radar: Building Trust, Transparency, and Shared Risk Ownership Between CMC and Quality

Ella Hwang

Vice President, Technical Operations and Supply Chain

Abcuro

Yuyi Shen

Vice President, Technical Operations and Supply Chain

Abcuro

AI Powered Process and Product Development – Capabilities and Skills Needed to leverage AI

Raghavan Venkat

SVP, Biopharmaceutical Development

AstraZeneca

Driving the Next Phase of CAR-T Manufacturing Efficiency: Balancing Cost, Capacity and Patient Access

Miranda Neville

Chief Technology Officer

Autolus

Mid-Phase Biologics Tech Transfer: Onshoring Strategies, Operational Pitfalls, and Lessons Learned

Richard Richieri

Chief Operations Officer

Avid Bioservices

Building Better Medicine: Resilience, Growth, and Virginia's Manufacturing Ecosystem

Jennifer Reynolds, PhD, MBA,

Director of Life Sciences

Virginia Economic Development Partnership

AI in Cell Therapy Supply Planning: Capabilities and Limitations

Praful Sanas

Senior Director, Cell Therapy Supply Chain Planning Capability Owner

Bristol Myers Squibb

Running a Value Stream Without FG Inventory; Unique Challenges in Car-T

Lon Geraghty

Sr. Director, Business Excellence

Bristol Myers Squibb

From AI Hype to AI Impact: Deploying AI in Small to Mid-size Biotech

Opeyemi Tayo Balogun

Executive Director

Disc Medicine

One Quality Product, Many Regulatory Realities: Can Global Harmonization Close the Gap?

Paresma Patel

Director, Regulatory CMC Policy & Advocacy

Gilead

From Raw Materials to Batch Release: Where AI Is Actually Working in Biomanufacturing

Reza Farahani

Co-founder & CEO

Katalyze AI

Using Prior CMC Knowledge to Advance Cell and Gene Therapies

Bryan Silvey

Senior Director, Head of Quality Compliance, GCP, and Risk Mgmt.

Kyverna Therapeutics, Inc.

The CDMO Balancing Act: Rethinking Selection in a Complex Environment

Brian Greven

General Manager

LOTTE Biologics

Rig for Variability: Submarine Lessons for Running a Reliable Cell Therapy Supply

Hans Nowak

Senior Vice President, Manufacturing Operations

Ossium Health

What Does it Really Take to Go From Early Data into Phase 3 Quickly?

Aparna Deora

Vice President BTx Portfolio and Strategy

Pfizer

Manufacturing, Analytical and Facility Readiness for PPQs

Jeffrey Pawar

Vice President, Technical Operations

Rocket Pharmaceuticals, Inc.

Driving Operational Excellence, Quality and Cost in Biomanufacturing

Rakesh Kakkar

Vice President, Head of Manufacturing & Supply, Vaccines, US

Sanofi

When Should NGS Replace, Complement, or Confirm Traditional Biosafety Testing?

Mike Pipis

Head of Sales, Biosafety Labs (NAM)

SGS Vitrology

Mahdi Roohnikan, PhD

Business Development Manager, Biosafety Labs

SGS Vitrology

Turning Data into Strategic Decisions: Breaking Silos Between Operations, Quality, and Supply Chain

Sheila Iyer

VP of Supply Chain

Teva

1:55 pm - 2:30 pm Case Studies
Stream One - Strategic Manufacturing

Scaling CAR T Manufacturing to Deliver Successfully for Patients

Laura Alquist

Global Head of Technical Operations

Kite Pharma

Session Details Arrow Icon
  • Strategies for scaling technical operations to support commercial cell therapy manufacturing
  • Ensuring process consistency, product quality, and operational reliability across complex manufacturing networks
  • Lessons learned from transitioning cell therapies from clinical development to commercial execution
  • The role of automation, digital infrastructure, and cross-functional coordination in improving scalability and patient access
Stream Two - Quality

Beyond Compliance: How AI is Transforming Quality into a Strategic Business Partner

Rodrigo Muradas

Vice President, Global Head of R&D GMP Quality

Takeda

Session Details Arrow Icon
  • How quality organizations are evolving from reactive compliance to predictive, AI-driven risk management
  • Using AI and advanced analytics for real-time decision support, deviation detection, and quality event prediction
  • Human-AI collaboration in GxP environments – where automation adds value and where human judgment remains essential
  • What quality leaders need to prioritize over the next 24 months to stay ahead of the curve
2:35 pm - 3:10 pm Workshops
STREAM 1 WORKSHOP

Bringing Advanced Modalities to Commercial Scale: Strategy in Action

Jacob Greenwood

Vice President of Client Solutions

Project Farma

Jim Rice

VP, Client Engagement

Project Farma

Andrea Goddard

Chief Technical Officer

CatalYm GmbH

Jeffrey Pawar

Vice President, Technical Operations

Rocket Pharmaceuticals, Inc.

Session Details Arrow Icon
  • Translating technical ops strategy into GMP-ready execution
  • Accelerating capital projects and commissioning in multi-modality facilities
  • Managing cross-functional complexity in advanced therapy manufacturing
  • Practical takeaways for reducing time-to-market while maintaining compliance
STREAM 2 WORKSHOP

G-Rex: A Plastic Bottle and The Value of Simplicity

Andrew Scheffler

G-Rex Optimization Specialist

Scale Ready

Session Details Arrow Icon
  • Take the [linear] path of least resistance: A quick review of the technical and regulatory basis for qualifying reduced scale models. Hear our perspective on how and where to deploy them for maximum efficiency.
  • The robots are coming!: Robotic autonomation is coming to cell & gene therapy – and G-Rex is at the heart of this revolution. See how cell & gene therapy developers are deploying robots and why these robots love G-Rex!
  • Intelligent manufacturing with SMART biosensors: Passive resonance biosensors provide in-line, real-time, and non-invasive (contactless) insight with the simplicity you’ve grown to love. Get introduced to this novel process analytical technology recently integrated into G-Rex technology
STREAM 3 WORKSHOP

Balancing Speed, Quality and Cost Leveraging Ultra-Large Bioreactors in Global Networks

Nida Sayed Zubairy

Sr Scientist/Sr Manager

Boston Institute of Biotechnology, LLC

Session Details Arrow Icon

Leveraging ultra large bioreactors, global network designs and platform technologies to compress manufacturing timelines, maintain high standards and provide solutions to mitigate major financial risk during commercialization of biologics.

3:10 pm - 4:30 pm Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 3:15 pm – 3:35 pm: Meeting Slot 5/Networking
  • 3:40 pm – 4:00 pm: Meeting Slot 6/Networking
  • 4:05 pm – 4:25 pm: Meeting Slot 7/Networking
4:35 pm - 5:10 pm KEYNOTE

Automation That Works. Digital That Delivers. Lights-Out Next

Edgardo Hernandez

President, Global Manufacturing

Eli Lilly and Company

Session Details Arrow Icon
  • Cutting-edge science is a manufacturing advantage, not just an R&D one. How applying advanced process science on the floor improved robustness and set the foundation for everything else that followed.
  • Standardized platforms let you scale fast. Replicating proven designs across sites is an unlock that most networks underuse.
  • Automation earns the right to digital. End-to-end automation that genuinely works at the site level is the precondition for meaningful digital and AI.
  • Lights-out is a direction, and we’re charging at it deliberately. What the bold ambition for parenteral looks like, why it’s credible given the track record, and what it demands of leadership to get there.
5:10 pm - 5:25 pm
5:25 pm - 5:30 pm

Chair’s Closing Remarks

5:30 pm

Drinks Reception

6:00 pm

Executive dinner

November 11th

Stream 1 Chair

Ben Beneski

Chief Technical Officer

Allogene

Stream 2 Co-Chair

Jacob Greenwood

Vice President of Client Solutions

Project Farma

Stream 3 Co-Chair

Alex Gerrish

Account Executive

Körber Pharma Software

7:30 am - 8:20 am

registration & breakfast

7:45 am - 8:20 am breakfast workshops
Stream Two

The New Manufacturing Reality: Why Digital Strategies Must Evolve with the Industry

April V.

Senior Solutions Consultant

Körber Pharma Software

Session Details Arrow Icon

As the pharmaceutical manufacturing landscape continues to evolve, companies are rethinking how they approach digitalization. The assumptions that shaped MES strategies a decade ago don’t always align with the realities faced by today’s emerging and mid-sized manufacturers.

This session explores how expectations around MES and digital manufacturing have evolved, the increasing demand for actionable data, and the shift toward more flexible approaches to digital transformation. Attendees will gain insight into how manufacturers can build a digital foundation that meets their current needs while maintaining a path to future expansion.

8:25 am - 8:35 am

Chair’s Opening Remarks

Ben Beneski

Chief Technical Officer

Allogene

8:35 am - 9:10 am Fireside Chat

Fireside Chat: Inside a Changing FDA - Leadership, Onshoring and What’s Next for Biomanufacturing

Moderator

Ben Beneski

Chief Technical Officer

Allogene

Kalah Auchincloss

Co-Founder, President & Principal

Canal Row Advisors | Former FDA

Hilary Marston

Principal, Drug & Biological Therapies

Canal Row Advisors | Former FDA

9:10 am - 9:45 am KEYNOTE

Cyber Security Leadership Insights in BioPharma

Pascal Bécotte

Managing Director

Russell Reynolds

Angela Jung

Executive Director, Technology & Cyber Security

Russell Reynolds Associates

Sydney Klein

Global Chief Information Security Officer and Head of Enterprise IT

Bristol Myers Squibb

Session Details Arrow Icon
  • Industry Trends: Key trends shaping the BioPharma landscape and the leadership implications emerging across the industry.
  • Cyber Security in BioPharma: The growing relevance of cyber security and what it means for organizations and leaders today.
  • Leadership Perspective: A live discussion bringing real-world perspective on cyber security challenges, priorities, and leadership.
9:50 am - 10:25 am Case Studies
Stream One - Strategic Manufacturing

From Patient Need to Commercial Reality through Product Design and Drug Delivery

Yun Mao

Vice President and Head, Drug Product Development

Bristol Myers Squibb

Session Details Arrow Icon
  • How product development strategy must evolve to support scalable manufacturing and robust supply chains
  • Integrating development timelines with manufacturing readiness, especially for cell & gene therapies and next-gen biologics
  • Leveraging cross-functional data and real-world learnings to reduce risk and speed time-to-market
Stream Two - Quality

Quality at Scale: Leveraging Digital and A.I. into Global Risk Based QMS frameworks

Anthony Morandi

Senior Vice President, Quality

AstraZeneca

Session Details Arrow Icon
  • Scalable QMS structure integration into manufacturing operations to improve consistency, speed, and risk based decision-making across diverse global sites
  • Leveraging digital tools and data to strengthen visibility, oversight, and quality system alignment across business units
  • Compliant and effective implementation of A.I. in GxP processes and environments, principles and case studies
STREAM 3 CASE STUDY

Science, Manufacturing and Commercialization

Stephen Hill

Chief Operating Officer

Lyell Immunopharma

Session Details Arrow Icon
  • The cell therapy scientific and manufacturing journey at Lyell
  • CMC translation: science and manufacturing platforms
  • Manufacturing paradox – manufacturing with early positive clinical data
  • Managing change and commercialization
  • The need for leader resilience
10:25 am - 11:20 am Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 10:30 am – 10:50 am: Meeting Slot 8/Networking
  • 10:55 am – 11:15 am: Meeting Slot 9/Networking
10:35 am - 11:10 am FOCUS GROUP

Executive focus groups are informal moderated discussions among peers, held during networking breaks outside the summit agenda. No sign-up is required; delegates and speakers can join any group of interest.

TOPIC one

The Small Biotech Advantage: Agility, Innovation, and the Challenges of Scale

Session Details Arrow Icon
  • CTO perspectives on how small biotechs are structuring teams, decision-making, and execution models
  • How innovative ways of working are enabling speed, flexibility, and focus in lean organizations
  • The evolving role of CDMOs and external partners in enabling development and scale-up

Kawa Chiu

Former Chief Technical Officer

Abdera Therapeutics Inc.

Andrea Goddard

Chief Technical Officer

CatalYm GmbH

Kevin Kerls

Vice President, General Manager

Lonza

11:25 am - 12:00 pm Workshops
STREAM 1 WORKSHOP

Industrializing Advanced Therapies: Building a Factory of the Future

Chris Murphy

CEO

ElevateBio Technologies, Inc.

Session Details Arrow Icon
  • Advanced therapies have shown clinical success, and the challenge now is to manufacture at scale. Taking them beyond the first handful of indications and into broader disease populations requires robust manufacturing systems that improve speed, quality, and cost together
  • ElevateBio, an advanced therapy CDMO and gene editing services partner, is designing its next facility as a ‘factory of the future,’ built around automation and digital execution from the start
  • End-to-end automation, digital execution systems, and advanced analytics across the full workflow will reduce the variability and cost that come with manual, program-specific processes
  • Chris Murphy, ElevateBio CEO, will cover how ElevateBio is rethinking plant design and operation, and what has to change for these medicines to reach patients at scale
STREAM 2 WORKSHOP

Your AI Strategy Has an Accountability Problem

Krystyna Riley

Chief Executive Officer

Havior

Session Details Arrow Icon
  • Why AI implementation doesn’t guarantee AI adoption
  • Identifying accountability gaps before they derail results
  • Recognizing the environments that accelerate or suppress adoption
  • Turning AI investments into measurable business impact
STREAM 3 WORKSHOP

Managing AI Suppliers: Ensuring Control Across Pharma AI Systems

Taylor Chartier

CEO

Modicus Prime

Session Details Arrow Icon
  • Address fragmented AI governance as adoption expands across functions, sites, and suppliers.
  • Establish consistent lifecycle controls based on Context of Use and risk.
  • Manage AI suppliers through clear responsibilities, assessment, evidence, and ongoing oversight.
  • Maintain inspection readiness through integrated assurance, monitoring, and change management.
  • Implement an AI Management System to provide enterprise-wide visibility and governance.
12:05 pm - 12:40 pm KEYNOTE

Antibody Data Bank - A Call to Action

Pat Yang

Chairman

Taiwan BioManufacturing Corp (TBMC)

Yatin Gokarn

SVP, Head of Product Development & Clinical Supply

Alexion Pharmaceuticals

12:40 pm - 12:45 pm

Chair’s Closing Remarks

Ben Beneski

Chief Technical Officer

Allogene

12:45 pm - 1:45 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

Quality as Enterprise Value: Insights from the Manufacturing Floor

Tom Velasco

Manufacturing Director

Amgen

From Risk Mitigation to Supply Resilience: Agile CMC Regulatory Pathways for Alternate Critical Biologic Raw Materials

Satarupa Das

Director, Product Champion (Global Technical Operations)

AstraZeneca

CMC Challenges of Platform Development in CGT

Elena Peletskya

Sr Director, Portfolio Technical Strategy

Bristol Myers Squibb

Challenges in Cell Therapy Manufacturing

Nidhi Shah

Senior Director, CAR-T Closed Manufacturing Operations

Bristol Myers Squibb

Better Questions, Earlier Signals: Where Is AI Helping Quality and Operations?

Cory Johnson

QA Director

Eli Lilly

Talent Strategies for the Future of Biomanufacturing: Retention, Engagement, and Building Capabilities

Callum Chapman

Executive Director

Gilead

Comparability in Cell Therapy: Balancing Innovation, Manufacturing Changes, and Regulatory

Amol Thote

Head, Process Development Team Leads

Kite Pharma

Bridging Commercial and Tech Ops: Lessons from First Cell Therapy Launches

Giselle Perez

Sr. Director, Product Sciences

Kyverna Therapeutics

Ready to Scale? Building the People, Processes & Systems for Growth

Sona Son

Vice President of Operations

Microbial Discovery Group

Commit, Flex or Defer: How to Make Capital/Automation Decisions Amid Portfolio Uncertainty

Rohit Harve

Partner

PA Consulting

Before the Agent Acts: Why Business AI Needs a Governed Intelligence Layer

Eris Crosswhite

Global Operations Pfizer Supply Head of Supply Chain

Pfizer Global Supply

Driving Performance and Agility with Single Use System Platforms: Real-World Implementation Insights

Joseph Panella

Head of Biologics Manufacturing, Mass BioCampus

Sanofi