Category

LIFE SCIENCES

How to Make the Bio-Revolution a Reality: Building Bayer’s Cell & Gene Therapy Platform
LIFE SCIENCES, VIDEO, LIFE SCIENCES

How to Make the Bio-Revolution a Reality: Building Bayer’s Cell & Gene Therapy Platform

November 30, 2021

How Bayer AG built its Cell & Gene Therapy unit New business model joining best of Biotech and best of Pharma How to build a sustainable pipeline? How to manage complexity and keep focus? What are the “must haves”? what are the learnings on common threats of significant transformations? New ways of working accelerated by COVID-19 pandemic Wolfram Carius EVP, Cell and Gene Therapy Bayer AG Prof. Wolfram Carius is the EVP, Cell and Gene Therapy at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer,…

Continue reading
Fighting COVID-19 with Innovation – What We Have Achieved, What We Have Learned, and What Comes Next
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Fighting COVID-19 with Innovation – What We Have Achieved, What We Have Learned, and What Comes Next

November 30, 2021

Offering an overview of how our industry responded to the global pandemic Highlighting how our organization adapted our existing processes and programs to continue to work under extraordinary circumstances Discussing some of the key takeaways and lessons learned from the past year and a half Where do we go from here? How will AstraZeneca and the biopharmaceutical industry at large move forward from here? What are we doing today to pave the way to those objectives? Pam Cheng EVP, President Global Operations & IT AstraZeneca Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information…

Continue reading
The World of Tomorrow: Serving Patients Through Transformational Change
LIFE SCIENCES, VIDEO, LIFE SCIENCES

The World of Tomorrow: Serving Patients Through Transformational Change

November 30, 2021

How learnings from the global pandemic combined with the introduction of new technology will enable the patient-centric manufacturing of the future Highlighting what the industry should do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably and affordably Exploring how and where products will be made, and how those products will be delivered by adopting system-driven planning and automation capabilities, leveraging the power of data and advanced analytics Describing a patient-centric pipeline the industry needs in order to deliver transformative therapies for all humanity A glimpse of how the world will evolve as…

Continue reading
The Transformational Potential of the Advanced Manufacturing of Biologics
LIFE SCIENCES, VIDEO, LIFE SCIENCES

The Transformational Potential of the Advanced Manufacturing of Biologics

November 30, 2021

Describe the potential for advanced manufacturing Review case studies illustrating the potential of advantages advanced manufacturing Provide resources for product developers Peter Marks Director – Center for Biologics Evaluation and Research (CBER) Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director…

Continue reading
Panel: Looking Backwards, Looking Forwards —How Did the Last Two Years Change Us?
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Panel: Looking Backwards, Looking Forwards —How Did the Last Two Years Change Us?

November 30, 2021

How has working through a global pandemic impacted the way we do business? Taking stock of how we changed and why we changed. What are some of the net positives? What are some of the things where we do want to return to how things used to be? Reviewing where our organizations were five years ago and where we planned to be today, how much has COVID-19 changed the trajectory of our journeys? What are some of the lessons learned that we plan to take with us into the future? Is the community of biopharmaceutical manufacturers stronger for this experience?…

Continue reading
A Changing Biopharmaceutical Landscape: How Operations Must Be Front and Center to Enable Business Success
LIFE SCIENCES, VIDEO, LIFE SCIENCES

A Changing Biopharmaceutical Landscape: How Operations Must Be Front and Center to Enable Business Success

November 29, 2021

Discussing the changing landscape for our industry, from pricing to innovation How Operations leaders must prepare their organizations to succeed in this environment Offering a framework for balancing the need to execute in the short-term with the imperative to invest in innovation for the future Esteban Santos EVP, Operations Esteban Santos serves as executive vice president, Operations. Esteban is responsible for the Operations organization, which encompasses Manufacturing, Process Development, Quality, Engineering and Global Supply Chain. Prior to this role, Santos was senior vice president, Manufacturing, responsible for operations at Amgen’s commercial manufacturing locations in the U.S., Puerto Rico, Ireland, the…

Continue reading
Quality 4.0: Where Do I Start?
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Quality 4.0: Where Do I Start?

November 29, 2021

 Discussing the current Quality 4.0 environment and addressing the most common challenge of how to get started Applying what we’ve learned to help companies begin their quality and compliance digital initiatives by leveraging behavioral and predictive analytics Ensuring quick results and getting the most value out of your investments in Quality 4.0 initiatives Jaime Velez Co-founder Operations & Quality Systems Improvement Experts (OQSIE) For the last 15 years Jaime has supported more than one hundred consulting engagements with Life Science companies delivering significant productivity improvements in supply chain and quality systems. He started his consulting career at McKinsey &…

Continue reading
Chair’s Welcome Address and PMWS21 Opening Keynote – A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Chair’s Welcome Address and PMWS21 Opening Keynote – A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients

May 19, 2021

Highlighting what should the industry do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably and affordably Exploring how and where products will be made, and how those products will be delivered by adopting system-driven planning and automation capabilities, leveraging the power of data and advanced analytics Describing a patient-centric pipeline the industry needs in order to deliver transformative therapies for all humanity A glimpse of how the world will evolve as molecular complexity increases in the future for small molecules, blurring the boundaries between small and large molecules — Sanat Chattopadhyay EVP…

Continue reading
Day Two Chair’s Opening Remarks and Keynote: The Vertex Story: Serial Innovation in Manufacturing
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Day Two Chair’s Opening Remarks and Keynote: The Vertex Story: Serial Innovation in Manufacturing

May 19, 2021

Sharing Vertex’s track record for serial innovation in manufacturing to create transformative medicines for people with serious diseases and high unmet medical needs Highlighting Vertex’s success with small molecule continuous manufacturing in Cystic Fibrosis Transforming manufacturing in cell and genetic therapies for Sickle Cell Disease, Beta Thalassemia, and Type 1 Diabetes — E. Morrey Atkinson SVP and Head of Commercial Manufacturing and Supply Chain Vertex Pharmaceuticals As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current responsibilities include defining the commercial manufacturing and supply chain strategy needs, as well as, designing and building a global organization and supply…

Continue reading
Leading Global Supplies in Times of High Biologic Demands Now and After the Pandemic Crisis
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Leading Global Supplies in Times of High Biologic Demands Now and After the Pandemic Crisis

May 19, 2021

Strong wave of innovation and new Biologic therapies resulting in high demands Building flexible global capacities at various scales and multiple global locations to ensure reliable supplies and serve patients’ needs worldwide Business continuity planning, crisis management, pandemic preparedness & implementation of additional specific protection measures Close collaboration, intensive and solution-oriented exchange with customers and partners to ensure global patient supplies Managing diverse and complex challenges through digital transformation Critical success factor: Operational excellence, capacity & capabilities expansion and our peoples dedication — Uwe Buecheler Corporate SVP Biopharmaceuticals Boehringer Ingelheim Uwe Buecheler, Ph. D. joint Boehringer Ingelheim (formerly Dr. Karl…

Continue reading
Rethinking our Supply Chain to be Patient-Centric
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Rethinking our Supply Chain to be Patient-Centric

May 19, 2021

Challenges biotech companies are facing as patients expectations are increasing Ensuring the end-to-end supply chain can respond in the face of fierce competition for innovation Leveraging data and analytics to increase value and service to patients Keeping patients central as external factors accelerate need for resiliency — Kimberly Lounds Foster SVP Global Supply Chain Bristol-Myers Squibb Kimberly Lounds Foster is Senior Vice President, Global Supply Chain at Bristol-Myers Squibb, where she oversees the clinical and commercial supply chain. Bristol develops and manufactures products on multiple technology platforms, including small molecules, biologics and cell therapies. Kimberly joined Bristol through the Celgene…

Continue reading
Reducing Drug Shortages… and High Prices
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Reducing Drug Shortages… and High Prices

May 19, 2021

How hospital systems and philanthropies came together to establish their own supply chain for essential quality generic medicines Living the mission to make quality generic medicines accessible and affordable to everyone Improving the resiliency of the supply of essential medicines used in hospitals, often for critical care, day-to-day and during a pandemic Ensuring a safe and stable supply of essential medicines for U.S. patients — Donna Gulbinski Chief Quality & Regulatory Affairs Officer Civica Rx Donna’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history…

Continue reading
Keynote: Delivering Excellence While Navigating Transition
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Keynote: Delivering Excellence While Navigating Transition

May 19, 2021

Highlighting how operations and manufacturing can think differently to pivot for crises and global events Preparing for M&A opportunities and adapting for a changing business model Discussing the importance of equity, leadership and people as catalysts of culture and change within the industry as we work to serve patients better — Azita Saleki-Gerhardt EVP, Operations Abbvie Dr. Azita Saleki-Gerhardt is Executive Vice President, Operations, at AbbVie, leading a team of scientific, engineering, business, quality, supply chain, security, purchasing and manufacturing professionals responsible for supply and distribution of all AbbVie products, as well as a number of corporate services. Dr. Saleki-Gerhardt…

Continue reading
Disrupting Quality Standards (or Beliefs) Through Digitalization
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Disrupting Quality Standards (or Beliefs) Through Digitalization

January 11, 2021

 The current state of digital transformation in life science How to disrupt the quality standards: Digital transformation roadmap and the situation ongoing at SBL Digital transformation’s Value proposition: Improve quality, productivity, and for unparalleled client experience Samsung Biologics’ P4 plan and vision: We’re building the future Sam MacHour SVP & Chief Quality Officer Samsung Biologics Prior to joining Samsung Biologics in 2019, Sam spent more than 32 years supporting large MedTech, Bioscience and Biopharmaceutical companies achieve business operational excellence and gain leadership in the areas of Research & Development, Quality, Compliance, Regulatory, Operations and product commercialization. Sam’s experience covers…

Continue reading
Panel: The Past, Present and Future of the Global Bio-Pharma Supply Chain
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Panel: The Past, Present and Future of the Global Bio-Pharma Supply Chain

December 1, 2020

How our “new normal” is affecting our critical materials procurement and how do we adapt for the future? Examining how the proposed nationalization of our supply chains will affect risk management and operations planning What does post-COVID19 Supply Chain robustness look like? How do novel modalities (mRNA, Cell & Gene Therapy) with already existing supply chain challenges cope with these new global constraints? How will high volume ultra cold chain products affect existing specialized ultra cold chain logistics? Seismic shifts and emerging fault lines create lasting affects, what are they and how do they shape our industry in the years…

Continue reading
Accelerating Delivery of New Medicines
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Accelerating Delivery of New Medicines

December 1, 2020

Examine approaches to accelerate the pace of biopharmaceutical development across multiple platforms and modalities Clinical development velocity can affect CMC approaches, and what we’ve learned through this experience How does acceleration impact our quality, regulatory, and development functions? Understanding acceleration effects on process monitoring and analytics throughout the product lifecycle Discuss what steps we, as an industry, will need to take together to make this the new normal — John Pinion EVP Translational Sciences, Chief Quality Operations Officer Ultragenyx Pharmaceutical John Pinion has over 26 years of global experience leading biologic, small molecule pharmaceutical, gene therapy and device operations across…

Continue reading

  • NASCES

  • NAFS

  • NAFMS

  • EUSCES

  • BMWS

  • NALES

  • MDMES

  • NAFES

  • NASRS

  • NAHRES

  • NAMES

  • PMWS

  • NAISS