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Pharmaceutical Manufacturing

Real-Time Release, a Distant Dream or Reality?
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Real-Time Release, a Distant Dream or Reality?

Olav Lyngberg, PhD leads the MSAT Innovation and Technology Deployment team within, J&J Innovative Medicine Supply Chain. Olav is responsible for orchestrating a talented and innovation-focused group of scientists and engineers to accelerate technology scouting and deployment in the internal and external network of mfg. sites, while leveraging new emerging innovation ideas across platforms, and products.

Prior to his current role Olav was Sr. Scientific Fellow, MSAT where he led teams responsible for developing and deploying technological solutions in manufacturing, to address issues in the areas of process robustness, process efficiency, release timelines and advanced process control.

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Fireside Chat: Navigating Technological Advancements, Global Operations, and Supply Chain Innovation
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Fireside Chat: Navigating Technological Advancements, Global Operations, and Supply Chain Innovation

Craig Beasley joined BlueRock Therapeutics in August 2021. As Chief Technology Officer he is responsible for Technical Operations including cell line derivation, process development, manufacturing, facilities and engineering, lab operations, and analytical sciences.

Prior to BlueRock, Craig served as VP, Cell Therapy Supply Chain and Patient Operations at BMS overseeing cell therapy assets (clinical and commercial stage), demand and supply planning, patient operations, external manufacturing oversight (including oversight for lentiviral vector manufacturing), materials management, cell logistics and Cell Therapy’s Business Process owners.

Craig joined Juno Therapeutics in 2016 as head of manufacturing & supply chain.

Prior to that Craig was VP, Next Generation Manufacturing at Biogen, holding leadership positions throughout the technical operations group. Craig started Biogen leading the Process & Automation engineering group and then transferred to the Director of Manufacturing for Biogen’s RTP large scale manufacturing facility. Further to that, Craig served as head of Supply Chain Quality and in addition, worked as Vice President of Financial Planning and Analysis for 2 years reporting to the CFO.

Craig holds a B.S. in Chemical Engineering from Purdue University.

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Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine
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Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine

How has this changed the CMC ecosystem, and are we overbuilding capacity again?
Avoiding the dangers of fragmentation. How should we better communicate, collaborate, and consolidate our best ideas so we all succeed?
Discussing the reasons to set up a new company today, and imagining how our business ecosystem will continue to grow and evolve
Debating which production platforms will best suit the newer modalities
Exploring the next steps for existing platforms like mAbs, ADC’s, mRNA: How do we efficiently serve giant markets such as Alzheimer’s indications, for example?

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Panel: Optimizing Technical Operations: Best Practices for Manufacturing Next-Gen Medicines
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Panel: Optimizing Technical Operations: Best Practices for Manufacturing Next-Gen Medicines

Anshul Mangal is President of Project FARMA and Precision ADVANCE. Anshul founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. Under Anshul’s leadership, PF has partnered with over 100+ therapeutic innovators, developed state-of-art manufacturing facilities for complex biologics and pioneered the industrialization of advanced therapies including many commercially approved cell and gene therapies. PF was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision’s services uniquely focused on the complexities of research and clinical development, regulatory, manufacturing, and commercial needs to successfully bring an advanced therapy to market.  In addition, Anshul is an investor, board member and advisor at several biotech organizations.  Prior to PF, Anshul was a patent litigator at Jones Day and a consultant at Morgan Stanley & Discover Financial Services.

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Accelerate Your Bench to Production Timeline by Collocating Research with Process Development and Pilot Scale Production
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Accelerate Your Bench to Production Timeline by Collocating Research with Process Development and Pilot Scale Production

Peter is a biopharmaceutical manufacturing expert with more than 20 years of experience in the industry. He comes to SmartLabs from Catalent Biologics where he managed business development efforts in the northeast region. Prior to that, he held various roles in Product Development and Product Management for GE Healthcare’s Biomanufacturing Solutions business incorporating both automated unit operations and single-use connectivity.

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The CDMO of the Future
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The CDMO of the Future

JR Humbert is currently the VP, Quality at INCOG BioPharma Services, and created and implemented the quality system at INCOG, which in three years went from company creation through successful FDA inspection in 3 years.

JR has over 20 years of pharmaceutical and biotechnology industry experience in validation, quality, technology transfer, process engineering, and program management. Some of JR’s previous companies include Piramal Pharma Solutions, Roche/Genentech, Hospira, and Cook Pharmica.

JR has participated in multiple global health authority inspections and developed inspection responses. JR has an MBA from Indiana University, and a BA in Chemistry and Biochemistry from the University of Colorado-Boulder.

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Maximizing Quality and Compliance: A Strategic Approach for Pharmaceutical Manufacturing
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Maximizing Quality and Compliance: A Strategic Approach for Pharmaceutical Manufacturing

Nicolas is an executive leader and change Agent with 34 years of global, well-rounded experience in the Immunodiagnostics, Biopharmaceutical & Medical Device businesses. He holds an outstanding record for driving successful compliance, operational excellence, and personnel development, and has led multiple large-scale projects to grow businesses and organizational capacity.

Before joining Gilead, Nicolás completed 27 years in Abbott Laboratories where he held positions of expanded leadership in Technical Support, Analytical Laboratory Operations, Regulatory Compliance, Quality Assurance Operations and Quality Systems in Puerto Rico, the continental US and in Europe, Northwest Africa and Russia. At Gilead Sciences, Nicolas has been spearheading the Quality digital strategy, including advancing the implementations of Veeva Vault Quality Docs, QMS and RIM. He is complementing these with a global strategy for Advanced Analytics, Data Visualization, Technology Adoption Tools and modernizing the employee learning experience.

Nicolás holds a BS degree in Biochemistry and a Masters in Microbiology Immunology from Stony Brook University and the Temple University Medical School, respectively where he completed research work in hormone biochemistry and in the immunoregulation of autoimmune diseases.

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Connected Supply Chain Planning for the Life Sciences — A Conversation with Bob Honer of Anaplan
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Connected Supply Chain Planning for the Life Sciences — A Conversation with Bob Honer of Anaplan

Robert “Bob” Honer is a seasoned professional with a solid background in finance, supply chain management, and software solutions. He currently holds the position of Senior Director, Supply Chain Practice at Anaplan where he leverages his vast experience to develop effective supply chain strategies and support new software launches. Robert’s education background includes a Masters degree in Finance and Supply Chain Management from Syracuse University. Prior to joining Anaplan, Robert spent over a decade at Blue Yonder, serving in various supply chain-focused leadership roles.

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Peter Shearstone of Thermo Fisher Scientific — Changing the Compliance Paradigm in Large, Global Companies
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Peter Shearstone of Thermo Fisher Scientific — Changing the Compliance Paradigm in Large, Global Companies

As part of the 2024 edition of the Pharma Manufacturing World Summit we interviewed Peter Shearstone, Thermo Fisher Scientific’s VP Global Quality & Regulatory Affairs, about a themed lunch discussion he hosted that revolved around Compliance in the pharmaceutical space, especially as it related to companies with a worldwide footprint. How does Compliance shape the way businesses function? How is that changing over time? How did the pandemic change the way the pharmaceutical industry thinks about itself and problem-solves? What can large organizations learn from the capabilities and outlook of smaller and more nimble companies? What are the things global companies will always do well, but can still do better? What should every leader working in this space be thinking about and learning about and doing more of to improve themselves, their teams, and the industry as a whole? For all this and more, give this episode a listen!

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Alarm Management and What Pharmaceutical Manufacturers Need to Know — A Conversation with Michael Andrews of Applied Materials
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Alarm Management and What Pharmaceutical Manufacturers Need to Know — A Conversation with Michael Andrews of Applied Materials

At the 2024 edition of the Pharma Manufacturing World Summit held earlier this month in Boston, we spoke with Michael Andrews, the Global Product Manager | SmartFactory Rx® of Applied Materials, to talk about an important issue facing pharmaceutical manufacturers and how the experience of the semiconductor industry can help: Alarm Management.

In most manufacturing facilities, an alert, an alarm, a warning, or a notice is going off somewhere every few seconds. Different machines inform different operators of different data. Very few manufacturers have a clear overview of what is being flagged everywhere at any one time, and the human operators who work with their systems day in and day out quickly learn to ignore some alarms while perhaps putting too much time and attention into monitoring others. Would it not be to everyone’s advantage to have an overarching system that brings all alarms up to the same level of visibility and then helps human operators recognize which ones to focus on at any one time? As luck would have it, the ever-evolving semiconductor manufacturing space has already created a system that operates in an even more fast-paced and exacting manufacturing environment than the one most pharmaceutical companies operate in, and Applied Materials is helping taking the hard-won lessons of Alarm Management from that industry and bringing it to the tightly regulated, patient-focused, quality-centric pharmaceutical manufacturing space. For every pharmaceutical executive who worries things are getting missed in their manufacturing facilities, give this episode a listen!

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Operational Excellence, Innovation & Teamwork as Enablers for Reimagining Medicine
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Operational Excellence, Innovation & Teamwork as Enablers for Reimagining Medicine

As President, Operations, Steffen Lang leads a team of 35,000 associates dedicated to manufacturing and supplying high-quality medicines to patients, and providing operational support to the entire Novartis enterprise. Novartis Operations incorporates the company’s manufacturing, quality, and supply organization, as well as information technology, data and digital, procurement, environmental sustainability, facility services, and other global services.

Prior to taking on this role, Steffen was Global Head of Novartis Technical Operations (NTO). Under his leadership, NTO underwent a transformation to become one of the leading manufacturing and supply organizations in the industry, providing agile, efficient support to the business, and reliably delivering life-changing medicines to patients around the world. During this time, the unit adapted its manufacturing capacity and capabilities to the changing needs of the Novartis strategy and product portfolio, maximizing the potential of its assets and expertise. As well as delivering technological innovation to enable the production of advanced therapeutic platforms, the unit collaborated with industry partners to support global demand for COVID-19 vaccines and therapies.

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Our Journey in Next Generation Manufacturing: What We Can Achieve Together
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Our Journey in Next Generation Manufacturing: What We Can Achieve Together

Jim Cafone has been with Pifzer since 2010.  In his current role as Senior Vice President, Global Supply Chain, Jim oversees global demand forecasting, demand and supply planning, worldwide logistics, and inventory management for Pfizer.

In his previous role, as Vice President, Network Design & Performance, Jim was responsible for business development, supply chain network design, Pfizer’s lean production system, all performance reporting and analytics, innovation, and recognition programs.

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Quality and Compliance from the Regulators’ Perspective
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Quality and Compliance from the Regulators’ Perspective

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 in January 2016.

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Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?
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Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?

At PMWS23 we recorded a panel on ‘Next’ Generation Manufacturing that looks at where the industry has come from, and where it’s going in the future.

From discussing how today’s pipeline and technologies are reshaping biomanufacturing, to looking at the technologies that enable next generation manufacturing processes, give this one a listen!

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Leading Through Transformations and Integrations – The Evolution of Global Product Development and Supply
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Leading Through Transformations and Integrations – The Evolution of Global Product Development and Supply

Karin Shanahan oversees worldwide product development, manufacturing and supply for Bristol Myers Squibb as executive vice president, Global Product Development & Supply (GPS). GPS develops and produces active ingredients and drug products and delivers the company’s medicines throughout the world. The GPS team achieves this mission through a relentless focus on innovation, quality, safety and agility.

“I’m excited to return to Bristol Myers Squibb, where I began my career in the pharmaceutical industry. Though I’ve worn many hats in the industry since then, I was drawn back to Bristol Myers Squibb because of its unwavering dedication to quality and delivering innovative medicines to patients in need,” says Karin. “I am honored to help lead the integral GPS team as we navigate an everchanging landscape.”

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