Stream One Chair

Alison Moore

Alison Moore

Chief Technical Officer

Codexis

Stream Two Co-Chair

Jack Garvey

Jack Garvey

Chief Executive Officer/Managing Partner

Compliance Architects LLC

Stream Three Co-Chair

Justin Couch

Justin Couch

Life Sciences Supply Chain Managing Director

Accenture

1:00pm - 4:00pm

4:00pm - 4:55pm

Welcome Day Panel: The Five Biggest Things Facing Our Shared Biomanufacturing Future

Alison Moore

Alison Moore

Chief Technical Officer

Codexis

Kawa Chiu

Kawa Chiu

Chief Technical Officer

Abdera Therapeutics

Rainer Müller

Rainer Müller

Senior Vice President Global Technical Development

BioNTech

Alex Cooke

Alex Cooke

CEO

Phase 3

Dr. David Chang, PhD

Dr. David Chang, PhD

Chief Executive Officer

TBMC

  • Discussing the most important new technologies in biomanufacturing today, with a special emphasis on what we want to do as our industry matures
  • Debating how talent and workforce development in our industry is changing, and what we should do about it
  • Listing the current factors affecting speed of development and efficient manufacturing. How do we continue to improve in a changing business landscape with special reference to IRA and the BIOSECURE Acts?
  • Understanding the current Regulatory environment with an eye for how things are going to evolve into the future
  • How can we improve the access of biologic medicines?
5:00pm - 5:55pm

Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development

Alison Moore

Alison Moore

Chief Technical Officer

Codexis

Brian Riley

Brian Riley

Chief Manufacturing Officer

Beam Therapeutics

Harish Santhanam

Harish Santhanam

Vice President Cell Therapy Technical Operations

BMS

John Tomtishen

John Tomtishen

Senior Vice President Operations & GM

Cellares

Christine Sheaffer

Christine Sheaffer

Vice President Manufacturing & Supply

Spark Therapeutics

  • Science outpacing Industrialization of Technology: Reviewing next generation cell and gene therapy platforms/technologies, gene editing technologies to unlock new possibilities.
  • Manufacturing to Scale: Scaling up to meet demand, comparability challenges, production capacity, AI tools and AAV production will drive speed to market/approval
  • Regulatory Evolution: evolving regulatory frameworks and innovative products necessitate industry and local and global regulatory collaboration to define efficient pathways to approval
  • Economic/Global Expansion: expanding access to ATMP’s in new regions, reducing cost of goods via production efficiency, expanding global infrastructure to facilitate access to new patients
6:00pm

6:30pm

7:30am - 8:15am

8:15am - 8:20am

Opening Remarks and Important Announcements

8:20am - 8:30am

Chair’s Welcome Address

Alison Moore

Alison Moore

Chief Technical Officer

Codexis

8:30am - 9:05am

Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances

Sanat Chattopadhyay

Sanat Chattopadhyay

Executive Vice President, President Merck Manufacturing Division

Merck

  • Realizing the promise of this unprecedented era of medical innovation
  • Meeting the challenges of new modalities across process, analytical, quality, regulatory and digital
  • Adapting to emerging technologies and managing risks while improving productivity and speed-to-market
  • Fostering active industry partnerships, including with CMOs and regulators, to ensure transformative patient benefit
9:05am - 9:40am

FUTURE READY: Addressing Current Challenges in Biomanufacturing with Reliability, Efficiency, Agility, Data & (High) Yields

Jerry Murry

Jerry Murry

Senior Vice President, Process Development

Amgen

The biopharmaceutical sector is currently producing vast amounts of data, a trend set to amplify with new tech like smart sensors, PAT, and process automation. This presentation will highlight the significance of a holistic digital strategy, incorporating AI, machine learning, predictive modeling, and data visualization, to spearhead the evolution of biomanufacturing. Emphasizing enhanced efficiency and innovation, this strategy will enable the efficient manufacture of complex biologic molecules with reliability of supply, agility, and differentiation. By leveraging these advanced technologies, biomanufacturing can achieve high throughput, ensuring metric tons of life-saving medicines to patients in need around the globe.

9:45am - 10:20am

From Batch to Brilliance: Continuous Manufacturing in J.POD® Facilities

  • Just – Evotec Biologics is transforming biomanufacturing with a fully integrated, continuous manufacturing platform from discovery to cGMP production
  • Advanced technologies reduce costs, improve speed to market, and maintain top-tier quality from the clinical to the commercial stage
  • Our modular state-of-the art J.POD facilities are fully flexible in response to demand fluctuations and can be deployed globally to support expanded access to biotherapeutics
  • We are partnering with leading biotech, pharma, biosimilar players, and governments to drive these advancements as the fastest growing CTDMO
9:45am - 10:20am

Data Doesn’t Lie – Digital Manufacturing ROI

Matt Lowe

Matt Lowe

Chief Strategy Officer

MasterControl, Inc.

Attendees will see actual customer metrics and leave with a better understanding of:

  • Why digitizing production records and connecting to other systems is needed to remain competitive
  • The areas where digital systems have significant impact and how that translates to the bottom line
  • How digital systems can improve the work experience for operators
  • How to clearly demonstrate the ROI of a digital system
9:45am - 10:20am

Speed to Market: The Power of Centralized Data and the Promise of AI

Ken Forman

Ken Forman

Lead Product Manager, Manufacturing

IDBS

  • At IDBS, we recognize the critical importance of effective data management and the transformative potential of AI in the BioPharma industry. Our goal is to empower our customers to unlock data for faster and smarter decision-making. We invite you to join us for our presentation, “Speed to Market: The Power of Centralized Data and the Promise of AI,” to learn more and where we will discuss:
    • Centralizing data from various systems, teams and locations to minimize business, quality and technical risk
    • Harmonizing data to enhance collaboration, scalability and data integrity
    • Leveraging advanced analytics and AI to gain rapid, data-driven insights
10:25am - 12:05pm

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 

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.

12:10pm - 12:45pm

Leading a Technical Organization Through Uncertainty

Greg Guyer

Greg Guyer

Executive Vice President & Chief Technical Officer

BioMarin Pharmaceutical Inc.

  • Discuss drivers of uncertainty
  • How to manage Launch Demand through multiple scenarios
  • How to effectively navigate your organization through significant change
  • How to engage the organization through People
12:10pm - 12:45pm

Proactivity – the Future of Quality

Anthony Mire-Sluis

Anthony Mire-Sluis

Senior Vice President Head of Global Quality

AstraZeneca

  • Using Human and Organizational Performance (HOP) in designing quality into the end to end supply processes and how to implement effectively
  • Adopting risk-based approaches to identify and mitigate potential issues, maintaining a focus on critical processes and regulatory compliance
  • Fostering a culture of continuous improvement, leveraging digital tools to optimize processes and enhance overall quality management
  • Establish a proactive approach to regulatory compliance and production effectiveness using appropriate problem solving and conducting regular self-assessments
12:10pm - 12:45pm

A Vision for the Future: Intellia’s Journey in in Vivo Genome Editing

Eliana Clark

Eliana Clark

Chief Technical Officer

Intellia Therapeutics

  • An overview of Intellia’s journey to revolutionizing the treatment of diseases through potentially curative genome editing treatments
  • Next generation platforms that will change how we work and succeed
  • Our current and future capabilities by geography, people and technology
  • Exploring how Intellia’s has developed platform manufacturing processes and analytics
12:45pm - 1:45pm

12:45pm - 1:45pm

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.

Scaling Smart: Strategies for Sustainable Growth in Biotech Startups

Patricia Turney

Patricia Turney

Chief Technical Officer

Acelyrin

Quality and Compliance Considerations: Comparing and Contrasting Large Versus Small Biotechs

Gilbert Salud

Gilbert Salud

Vice President Quality

Arcus Biosciences

Application of AI in Quality: Approaches, Challenges, and Case Studies

Anthony Morandi

Anthony Morandi

Vice President, Head of Operations Central Quality

AstraZeneca

Digitalizing the QbD Continuum

Michael Boychyn

Michael Boychyn

Executive Director, Head of Manufacturing Process and Analytical Science, Biologics Global Technical Operations

AstraZeneca

Commercial Process Readiness for Cell & Gene Therapies

Amy Gamber

Amy Gamber

Vice President Manufacturing

Atara Bio

The Future of Regulatory Intelligence: AI and the Signal Ocean

Sarah Barkow

Sarah Barkow

Director of the GxP External Engagement

Bristol-Myers-Squibb

Karin Ann Payne

Karin Ann Payne

Vice President Corporate Quality

Bristol-Myers-Squibb

Cell Therapies: Overcoming Challenges to Drive Large-Scale Manufacturing

Katie Chaddock

Katie Chaddock

Site Head of Commercial Manufacturing

Orca Bio

Gene Therapy: Navigating CMC in the Midst of Rapid Clinical Development

Christopher Campbell

Christopher Campbell

Senior Vice President CMC Development

Sarepta

Inspectional (FDA and ROW) Considerations for ATMP

Mike Nuzzolo

Mike Nuzzolo

Head of Quality Operations

Spark Therapeutics

1:45pm - 2:20pm

Emerging Trends Impacting Technical Development and Manufacturing

Jamie Moore

Jamie Moore

Senior Vice President Global Head of Technical Development

Gilead

  • Geopolitical
  • ESG, Chemical and Regulatory Concerns
  • Technical Challenges
1:45pm - 2:20pm

Promoting Quality Excellence and Cultivating a Culture of Proactive Operations

Søren Thuesen Pedersen

Søren Thuesen Pedersen

Senior Director, External Affairs Regulatory Policy and Intelligence

Novo Nordisk

Martin Müller

Martin Müller

Director Technology Development - AMSAT - Technology Innovation

Novo Nordisk

  • Implementing strategies to motivate teams to prioritize quality, fostering a culture centered around excellence
  • Exploring seamless methods to integrate stringent quality standards into manufacturing processes
  • Implementing robust monitoring and control measures to ensure quality standards are upheld throughout operations
  • Employing strategies to empower workforce members to take ownership of quality control measures
1:45pm - 2:20pm

The New Wave of Cancer Treatment Through Targeted Radiotherapeutics

Kawa Chiu

Kawa Chiu

Chief Technical Officer

Abdera Therapeutics

  • The New Frontier of Targeted Radiotherapeutics: We stand at a pivotal moment where precision medicine meets radiation oncology, creating new opportunities for patient care
  • Biologics: The Missing Link in Target Delivery of Radiotherapeutics: Drawing from our preclinical data at Abdera, discuss how biologics are uniquely suited for targeted radiotherapeutics, offering distinct advantages over other approaches
  • From Lab to Patient: Making Novel Medicines Available: Sharing insights from our journey brining a novel molecule to the clinic, offering practical solutions to the challenges of CMC development and scale-up of targeted radiotherapeutics
2:25pm - 3:00pm

Panel: Agile Manufacturing: Technical Strategies for Operational Flexibility

Adam Pfeiffer

Adam Pfeiffer

Vice President of Strategy

Project Farma

Greg Gara

Greg Gara

Senior Vice President

Project Farma

John Tomtishen

John Tomtishen

Senior Vice President Operations & GM

Cellares

John Lee

John Lee

Global Head of Cell & Gene Therapy

SK Pharmteco

  • How to decide when to scale internal manufacturing
  • Advantages of flexible, phase-appropriate facility builds
  • Operational readiness and a successful facility startup
2:25pm - 3:00pm

Revolutionizing RNAi Therapeutics Manufacturing with Enzymes

Stefan Lutz, PhD

Stefan Lutz, PhD

Senior Vice President of Research

Codexis

  • Provide an overview of the opportunity for enzymatic synthesis to transform RNAi therapeutics as a class of medicines
  • Introduce Codexis’ unmatched capabilities in biocatalysis, ligation and sequential enzymatic synthesis
  • Showcase market-leading data from recent customer case studies demonstrating the potential of Codexis’ Enzyme Catalyzed Oligonucleotide (ECO) Synthesis™ manufacturing platform to enable enzymatic RNA manufacturing
  • Highlight next steps for Codexis and the ECO Synthesis™ platform as it moves up the value chain to provide siRNA manufacturing from pre-clinical scale through to eventual GMP capabilities
2:25pm - 3:00pm

KojoX™ – Transforming the CDMO Industry with a Patient-Centric Approach Fueled by Innovation

John Stewart

John Stewart

Vice President, KojoX™ Strategy

FUJIFILM Diosynth Biotechnologies

  • FUJIFILM Diosynth Biotechnologies is making a multibillion-dollar investment to expand global cell culture capacity, including 30+ 20,000 L bioreactors in Denmark and the USA, with further expansions in the UK and Texas
  • These expansions aim to meet clinical and commercial demand, with capacity volumes of up to 5,000 L
  • The KojoX strategy drives global alignment, improving agility to handle demand fluctuations while enhancing cost efficiency
  • A single Quality Management System (QMS) and harmonized documentation across similar, validated equipment at nearly identical sites ensure streamlined operations
  • This strategy enhances delivery speed and ensures patients access medicines quickly and efficiently
3:05pm - 4:15pm

3:05 pm – 3:25 pm: Meeting Slot 5/Networking 

3:30 pm – 3:50 pm: Meeting Slot 6/Networking 

3:55 pm – 4:15 pm: Meeting Slot 7/Networking 

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.

4:20pm - 4:55pm

Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche

Tongtong Wang

Tongtong Wang

Senior Vice President, Global Head Technical Development

Roche

  • Making the business case that true end-to-end integration and alignment should begin with the molecule, product, process, and technical development work that will feed into the manufacturing and supply chain operations
  • Highlighting examples where including innovative technical solutions in the larger technical operations planning and execution to create more value for patients and society
  • Offering ways to break down silos and allow broader collaborations internally and externally
4:55pm - 5:30pm

Accelerating the Pace of Progress for Innovative Biologic Products

Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research (CBER)

FDA

  • Highlight the importance of manufacturing technologies for innovative biologic products
  • Discuss efforts to expedite development of products for small populations through increased use of accelerated approval
  • Review efforts toward global regulatory convergence
  • Summarize internal changes and external initiatives at FDA in support of expeditious product development
5:30pm - 5:35pm

Chair’s Closing Remarks

Alison Moore

Alison Moore

Chief Technical Officer

Codexis

5:35pm

6:30pm

7:30am - 8:20am

7:45am - 8:20am

The Coming Patient Treatment Crisis

Fabian Gerlinghaus

Fabian Gerlinghaus

Co-Founder & CEO

Cellares

  • As many as 20% of patients eligible for approved cell therapies are dying on the waitlist due to manual manufacturing bottlenecks
  • Cell therapies are being approved as earlier lines of treatment, and promising clinical trial data for new indications, such as autoimmune diseases, is resulting in a massive increase in the eligible patient population
  • The creation of cell therapy manufacturing capacity to treat the total global patient demand for these life-saving medicines is a medical and commercial imperative
8:25am - 8:35am

Chair’s Opening Remarks

Alison Moore

Alison Moore

Chief Technical Officer

Codexis

8:35am - 9:10am

Authentic Leadership

Mike McDermott

Mike McDermott

Executive Vice President, Chief Global Supply Officer

Pfizer

  • Physical Health: Leveraging the biology of sleep, nutrition, and exercise
  • Emotional Health: Understanding and strengthening our internal world to avoid burnout
  • Authentic Self-Leadership: Leading based on personal core values and aligning personal and professional life
  • Purpose & Values: A people-centric approach to leadership
  • Diversity, Equity, and Inclusion: Emphasizing diverse teams and embracing differences for optimal performance and outcomes
9:10am - 9:45am

Peak Performance Leadership

Pascal Bécotte

Pascal Bécotte

Managing Director

Russell Reynolds

Laurent Rossi

Laurent Rossi

Former Chief Executive Officer

Alpine (F1) and Google Executive

  • A live interview with the former Alpine Formula 1 CEO on Peak Performance Leadership
  • The 2024 TechOps Leadership Accelerator Program Highlights and Key Learnings
  • 2025 TechOps Leadership Accelerator Program Launch
9:50am - 10:25am

Advancing Cell Therapy Industrialization: Key Focus Areas

Thomas Potgieter

Thomas Potgieter

Senior Vice President, Cell Therapy Development & Operations

Bristol Myers Squibb

  • Identifying critical challenges in CMC for cell therapies and strategizing solutions for overcoming them
  • Exploring how deeper insights into cells, their critical quality attributes, and control mechanisms can enhance safety, efficacy, and manufacturing efficiency
  • Discussing strategies for manufacturing autologous, allogeneic, and next-generation autologous therapies
  • Outlining a roadmap for developing an innovative, flexible, and modular platform to facilitate true industrialization of cell therapy in the near future
  • Examining partnering models that integrate innovation engines with global supply networks to translate concepts into tangible solutions
9:50am - 10:25am

Validating a Gene Therapy Innovation Center (GTIC)

John H. Adams, Jr.

John H. Adams, Jr.

Senior Director, Validation

Spark Therapeutics

  • What is a Gene Therapy Innovation Center?
  • Validation Planning: From careful vendor selection to developing a pragmatic validation plan and strategy
  • Identifying and deploying Digital Tools to support the GTIC and support Pharma 4.0
  • Using a Validation Lifecycle Management System (eValRoche), a first step towards a paperless plant
9:50am - 10:25am

Enhancing the Timely Introduction of Novel Therapies

John Pinion

John Pinion

Executive Vice President Translational Sciences, Chief Quality Operations Officer

Ultragenyx

  • Analyzing the link between CMC development speed and clinical progress, with a focus on rare and ultra-rare diseases
  • Balancing accelerated timelines with quality control and regulatory compliance
  • Organizing teams and processes to achieve fast, efficient development while maintaining regulatory standards
  • Defining key criteria and strategic approaches for selecting and advancing novel therapies
  • Optimizing time from early development through to clinical stages for timely and effective therapy delivery
10:25am - 11:15am

10:30 am – 10:50 am: Meeting Slot 8/Networking

10:55 am – 11:15 am: Meeting Slot 9/Networking

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.

10:40am - 11:15am

Quality Evolution in Biomanufacturing – Key Indicators, Emerging Trends, and Practical Takeaways

Mike Nuzzolo

Mike Nuzzolo

Head of Quality Operations

Spark Therapeutics

Karin Ann Payne

Karin Ann Payne

Vice President Corporate Quality

Bristol-Myers-Squibb

Lisa Winstead

Lisa Winstead

Site Quality Head-Senior Director

Resilience

11:20am - 11:55am

Addressing Cell Therapy Challenges for Rare Diseases

Robert Beall

Robert Beall

Vice President Cell and Gene Therapy Center of Excellence

ProPharma

  • Solutions for Low Accrual
  • Effective Business / Strategic Decisions
  • Resolving Low Efficacy
11:20am - 11:55am

Panel: Digital Change for Future-Proof Biomanufacturing: How Biopharmas and CDMOs Redefine Operations

Mike Cody

Mike Cody

Director of Digital Life Science

Zaether

Brad Lambert

Brad Lambert

President, MILRAE; former VP of Global IT AGC Biologics

Former AGC Biologics

Steven Barash

Steven Barash

Vice President of Strategy & Product Management

L7 Informatics

  • Data Ecosystem for the Future: We’ll look at how AI and data-centric architectures are setting the stage for future innovations and predictive capabilities
  • Scale Out and Up Across Manufacturing Networks: We’ll discuss strategies for standardizing and integrating digital processes across multi-site and decentralized networks
  • Accelerate Technology Transfers and New Product Introductions: We’ll examine how digital solutions are transforming tech transfer and expediting the launch of new products, including how global contract development manufacturing organizations (CDMOs), are accelerating knowledge transfer and reducing time-to-market by up to 40%
  • Enable Composable Architectures: We will discuss how composable architecture addresses the limitations of monolithic systems, ensuring flexibility, scalability, and better data-driven decision-making
11:20am - 11:55am

Using Innovation to Accelerate and Optimize Your Drug Manufacturing Scale-Up Strategy

Joe Goodman

Joe Goodman

Global Vice President of Customer Transformation

Honeywell Life Sciences

As the number of novel drug approvals increases year on year, in parallel with the market share of large molecules, we will discuss how drug manufacturers can now start their journey to achieving:

  • Faster scale-up and transfer from ‘Development to Manufacturing’
  • Faster batch release with reduction in cycle time through review by exception
  • Proactive quality response with reduction in ‘Defects Per Million Opportunities’
  • Quality By Design through Continuous Process Verification, Process Characterization, and the ultimate achievement of ‘golden batch’ conditions
12:00pm - 12:35pm

How to Reset the Pharma Trajectory: From Profit to Patient-Centric

Andy Ramelmeier

Andy Ramelmeier

Chief Technology Officer

Adverum Biotechnologies

  • Reputation Decline: Once respected, the pharmaceutical industry’s reputation has fallen due to perceptions of profit-seeking, off-label marketing, overcharging, and data concealment
  • Impact of Poor Reputation: A damaged reputation hinders hiring top talent, recruiting patients for trials, ensuring medication adherence, and acceptance of health interventions like vaccines. The current unsustainable pricing model also makes therapies unaffordable and caps out payers
  • Proposed Solutions:
    1. Enhance collaborations to reduce effort, regulatory burdens, and costs (e.g., Biophorum, NIMMBL, BIO)
    2. Stop issuing process patents that only block competitors
    3. Operate transparently to build patient trust beyond being Nasdaq or Dow-listed entities
    4. Use science and medicine to develop cures and create affordable access mechanisms
  • Emphasis on Curative Therapies: The author highlights the need to expand on developing gene therapy products for eye diseases. A case study on a potential cure for wet age-related macular degeneration shows the importance of manageable Cost of Goods and a viable CMC strategy for product launch
  • Ensuring Long-term Survival: Despite some companies’ reluctance, the author argues that Pharma’s long-term survival depends on prioritizing patient-centric approaches and delivering cures
12:00pm - 12:35pm

Building a Leading Quality Management Framework

Karin Ann Payne

Karin Ann Payne

Vice President Corporate Quality

Bristol-Myers-Squibb

  • Recognizing the pivotal role of quality assurance and quality control in driving key business objectives, ensuring they are strategically aligned
  • Upholding adherence to cGMPs, established policies, procedures, and industry standards to maintain regulatory compliance
  • Investing in personnel capabilities and knowledge to strengthen the effectiveness of the quality management system
  • Ensuring the efficiency and efficacy of global quality management systems across varied operational landscapes
  • Deploying advanced tools and techniques to enhance quality assurance and control practices
12:00pm - 12:35pm

Sanofi Manufacturing Modernization – The Best in Class Ambition

Koustuv Chatterjee

Koustuv Chatterjee

Senior Vice President, Head of External Manufacturing & Supply

Sanofi

  • Analyzing emerging trends and disruptions in the global biopharmaceutical landscape to navigate and capitalize on industry shifts
  • Crafting strategic initiatives that drive continuous improvement and achieve best-in-class operational excellence
  • Identifying key drivers of transformation and assessing their impact on manufacturing modernization efforts
  • Cultivating agile, cross-functional teams to seamlessly implement transformative strategies
  • Expertly managing change while proactively addressing and mitigating associated risks
  • Harnessing digital technologies and advanced data analytics to enhance operational efficiency and sustain competitive advantage
12:35pm - 1:35pm

12:35pm - 1:35pm

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.

Strategies to Evolve Global Supply Networks for New Modalities and Next Gen Manufacturing

Brad Matanin

Brad Matanin

Network Strategy Director, Biologics Global Supply Chain & Strategy

AstraZeneca

Achieving Speed to Clinic with a Diverse Biologics Portfolio; How to Accommodate Non-Standard mAb Formats from DNA to IND

Caitlin Masterman

Caitlin Masterman

Associate Director Biologics Technical Operations

Gilead

Inspection Readiness for Cell and Gene Therapy

Andrew Jones

Andrew Jones

VP Commercial Quality

Iovance

Modernizing the Pharma Quality System: What is It and Does It Drive Results?

Lisa Winstead

Lisa Winstead

Site Quality Head-Senior Director

Resilience

Navigating the CDMO/Client Relationship – Partnered for Success or Headed for Disaster

Karen Arneson

Karen Arneson

Director, External Manufacturing

Spark Therapeutics

Defining Supply Assurance: How Far Should Companies Investigate and Secure Their Supply Chains?

Praveen Prasanna

Praveen Prasanna

Sr. Director External Manufacturing

Verve Therapeutics

1:35pm - 2:10pm

Empowering A Culture of Operational Excellence For Sustainable Growth

Tina Self

Tina Self

Senior Vice President, Global Biologics Manufacturing & Berkeley Site Head

Bayer

  • Leading site-based teams that meet global standards at Bayer
  • Strategies for setting up a robust OpEx culture that drives consistent and reliable results
  • Empowering teams to have asset ownership and accountability
  • Remaining focused on your people while driving drive towards your organization’s goals
  • Case Studies: tool and techniques to instill a continuous improvement mindset
2:15pm - 3:10pm

Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing

Tim Moore

Tim Moore

Executive Vice President, Chief Technical Officer

Allogene

Pat Yang

Pat Yang

Vice Chairman & Co-Founder

Resilience

Michael Thien

Michael Thien

Senior Vice President & Head, Pharmaceutical Sciences Takeda R&D

Takeda

Hari Pujar

Hari Pujar

Chief Operating Officer & Operating Partner

Tessera Therapeutics & Flagship Pioneering

  • Assessing Changes in the CMC Ecosystem: Are We Overbuilding Capacity Again?
  • Uniting for Success: Strategies to Prevent Fragmentation and Foster Collaboration in Biomanufacturing
  • Pioneering New Ventures: Reasons to Establish a New Company Today and Anticipating Future Growth in the Business Ecosystem
  • Evaluating Production Platforms for Emerging Modalities: Which Platforms Will Best Serve the Future of Medicine?
  • Navigating the Future of Existing Platforms: Efficiently Addressing Market Needs for Established Therapies such as mAbs, ADCs, and mRNA-based Treatments
3:10pm - 3:25pm

Chair’s Closing Remarks

Alison Moore

Alison Moore

Chief Technical Officer

Codexis

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