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LIFE SCIENCES

John H. Adams, Jr. of Spark Therapeutics — Computer Software Assurance for Biopharmaceutical Manufacturers
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

John H. Adams, Jr. of Spark Therapeutics — Computer Software Assurance for Biopharmaceutical Manufacturers

At the 2024 edition of the Biomanufacturing World Summit series we sat down with John H. Adams, Jr., Spark Therapeutics’ Senior Director, Validation, to talk about Computer Software Assurance in the Life Sciences. John has been doing Computer Systems Validation (CSV) for decades as a regulatory requirement, so when talk of a risk-based Computer Software Assurance (CSA) requirement started making the rounds, he was interested to understand the differences so he could best stay ahead of the compliance curve and ensure his best practices were not out of step with expectations. In this episode, John walks us through where the conversation between industry and regulators currently stands, what validation professionals should already be doing, what they should continue to do, what they should confirm they are doing correctly, and what they should prepare themselves for if and when current guidance becomes new regulations. For everyone in the Life Sciences who cares about the compliance of manufacturing systems, give this episode a listen!

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‘First in Human’ Continuous Manufacturing in Biopharmaceuticals — A Conversation with Magnus Schroeder of Just – Evotec Biologics
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

‘First in Human’ Continuous Manufacturing in Biopharmaceuticals — A Conversation with Magnus Schroeder of Just – Evotec Biologics

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Magnus Schroeder, the VP, Process & Product Design for Just – Evotec Biologics, to talk about some of the advantages of continuous manufacturing in biopharmaceutical manufacturing, especially for companies whose products are approaching the First in Human (FIH) stage. It is never too early to think about process optimization, scalability, and controlling costs, but there is an understandable position where companies focused on the medicine and the science believe that can be sorted out later. Just – Evotec Biologics is a passionate advocate for taking lessons from other industries that build their businesses’ success into the R&D stage of their products’ development. So what does that look like in the Life Sciences? What role do CDMOs need to play to help the industry succeed at this, especially at the crucial FIH stage? For all this and more, give this episode a listen!

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How CDMOs are Contributing to the Ongoing Future of Medicine — A Conversation with Nick Maragos of Northway Biotech
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

How CDMOs are Contributing to the Ongoing Future of Medicine — A Conversation with Nick Maragos of Northway Biotech

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Nick Maragos of Northway Biotech to talk about how biopharmaceutical manufacturers are increasingly partnering with CDMOs to advance the future of medicine, how that working relationship is evolving over time, and what CDMOs need to do to continue to grow and meet the needs of the industry. With special reference to Northway Biotech’s own example, Nick talks about how companies can ensure they are compatible, what the working relationship needs to be, and what factors need to be included in any informed decision-making before and during a partnership. Give this episode a listen!

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Martin Müller & Søren Thuesen Pedersen of Novo Nordisk — Collaboration Among Industry Peers to Move the Life Sciences Forward
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

Martin Müller & Søren Thuesen Pedersen of Novo Nordisk — Collaboration Among Industry Peers to Move the Life Sciences Forward

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Martin Müller and Søren Thuesen Pedersen of Novo Nordisk to talk about opportunities biopharmaceutical manufacturers have to work together to lower costs, standardize equipment, build win-win scenarios for procurement and supply chain, and similar initiatives where competitive advantage and IP are not at stake, but costs and compliance and other performance metrics can be improved through joining forces and agreeing on things collectively rather than each company having to reinvent its own wheel on every issue. Building upon their earlier presentation that covered much of the same content, we discuss what would that collaboration look like in real terms? What does getting started look like, and how can interested companies join the ongoing conversations and deliberations? For all that and more, give this episode a listen!

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Where Cell and Gene Therapies are Going — A Conversation with Diluks De Silva of Compliance Architects
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

Where Cell and Gene Therapies are Going — A Conversation with Diluks De Silva of Compliance Architects

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Diluks de Silva to talk about Cell and Gene Therapies. For many years we have been hearing these and other Advanced Therapy Medicinal Products (ATMPs) are moving towards commercialization, and each individual therapy that has been approved is heralded as a pioneer to be celebrated and studied for lessons learned and best practices. This year something like 40 cell and gene therapies came to market, and by every indication this is just the start of a whole new generation of medicine about to help patients around the world. What does that look like on the ground? What is the industry doing to prepare itself for what comes next? How do you control things like cost and scalability while you are still inventing how to manufacture the new therapies in the first place? How are these innovations pairing with medical devices, and what does that mean for the future of medicine? There is so much good work being done, and so much still to do. As always, the experts at Compliance Architects have a comprehensive understanding of where the industry is, where it is going, and what needs to happen to ensure everyone’s success. For everyone looking for the updates that matter most on this exciting frontier of medicine, give this episode a listen!

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Fireside Chat: A Vision for the Future: Moderna’s Plans for mRNA Technology, Manufacturing and Scale
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Fireside Chat: A Vision for the Future: Moderna’s Plans for mRNA Technology, Manufacturing and Scale

As Chief Technical Operations and Quality Officer, Dr. Collins is responsible for the technical development, quality, and supply of preclinical, clinical and commercial programs within Moderna’s portfolio.

Dr. Collins joined Moderna from Novartis, where he held roles of increasing responsibility over the last nearly 30 years, focused on pharmaceutical production and manufacturing, including roles serving as Head of Global Chemical Operations and Anti-Infectives and as Head of Global Chemical Operations.

Dr. Collins received his Bachelor of Science in Chemistry and his Ph.D. in Organic Chemistry from University College Cork, Ireland. He also conducted post-doctoral cancer research at Arizona State University.

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Driving Transformation in Quality to Meet the Needs of Our Customers
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Driving Transformation in Quality to Meet the Needs of Our Customers

A relentless visionary, Robin Kumoluyi consistently moves people and organizations forward. Throughout her career, she has expertly crafted complex quality management strategies for multi-billion-dollar matrixed organizations. Committed to the belief that patients and customers must have access to effective medicine, Robin intentionally chose the quality function within the pharmaceutical indutry.

Robin Kumoluyi is the Vice President and Chief Quality Officer, Pharmaceuticals at Johnson & Johnson Corporation. Robin has responsibility for Quality & Compliance for the Global Pharmaceuticals Segment in Pre-Market R&D, Supply Chain and Post Market Commercial. Prior to her current role, Robin was VP, Global Quality Services at Johnson & Johnson, where she drove the organization’s Enterprise Quality transformation by defining, leading, and executing the strategic direction and oversight of the Quality Policies, Standards, Digital Healthcare, Innovation and Analytics, Value Chain Quality, and the overall Q&C Strategy and associated processes.

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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients
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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

As the Senior Vice President for Specialty Care Manufacturing & Supply at Sanofi in Paris, Daniela Ottini oversees the global Manufacturing Network for Specialty Care products. With extensive experience spanning over a decade at AbbVie, she has held leadership positions such as Vice President of External and Contract Manufacturing in Rome, Italy, and Vice President of Biologics Manufacturing in Dublin, Ireland. Her career highlights include managing diverse portfolios and leading strategic initiatives like the integration of AbbVie-Allergan for Operations. Previously, at Abbott, Daniela held various roles over 16 years, including Manufacturing Director in Italy and Regional Purchasing Manager in the UK. She holds a degree in Chemical Engineering from Sapienza Università di Roma and a Master’s in Business Engineering from the University of Rome Tor Vergata.

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Becoming a “Best in Class” Supply Chain Network to Deliver More Medicines to More Patients, Faster
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Becoming a “Best in Class” Supply Chain Network to Deliver More Medicines to More Patients, Faster

Catalina Vargas is the Senior Vice President of Global Supply Chain and as such plays a strategic role in driving enterprise initiatives.

Catalina has more than 20 years of experience in the biopharma industry and has held positions of increasing responsibility in a range of local, regional and global roles in global strategic sourcing and procurement as well as manufacturing; she has also served as the Chief of Staff to the CEO prior to current role and also as a product portfolio leader.

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Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy
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Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy

Anil Sawant is Senior Vice President, Global Quality Compliance at Merck. He is a healthcare Executive with over 35 years of operations experience in Quality Operations, Ethics & Compliance, Research Integrity and Auditing functions. A strategic thinker experienced in development and deployment of management controls, governance processes, and quality and compliance systems in diverse business environments and cultures. Anil leads groups managing branded and generic products, small molecules, vaccines, bio-pharmaceutical, medical devices and consumer products. He was part of the teams that commercialized the first antibody-drug conjugate product and first photoactive drug. Expertise in interpretation of GMPs, GLPs, and GCPs. Good understanding of SOX, Anti-Kickback, Anti-Trust, Privacy and FCPA. Skilled crisis manager and pragmatic thinker with excellent understanding of regulatory requirements, global pharmaceutical supply chain and R&D operations. Extensive experience in resolving compliance matters with US FDA and international regulatory agencies. Subject matter expert in pharmaceutical microbiology and aseptic processing.

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Manufacturing as a Strategic Enabler for Serial Innovation
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Manufacturing as a Strategic Enabler for Serial Innovation

Ciaran joined Vertex in 2021 and is the Vice President of MSAT, which provides technical leadership within the commercial manufacturing organization. This includes partnering with the R&D teams to develop and implement robust and scalable processes that are capable of reliably supplying patients with high quality medicines. The team also directly support the manufacturing sites to resolve complex technical issues and implement new technologies and technical agendas to drive continuous improvement.

Ciaran previously worked at Human Genome Sciences, Eli Lilly and Co. and Bristol-Myers Squibb in roles of increasing responsibility and has over 20 years of industry experience in manufacturing and process development, primarily for biologic medicines. During his career, he has directly contributed to the successful approvals, launches and supply of medicines such as Benlysta, Trulicity, Taltz, Opdivo and Orencia.

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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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