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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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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How AI is Changing Supply Chain Risk Management — A Conversation with Serena Peirson of ParkourSC
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How AI is Changing Supply Chain Risk Management — A Conversation with Serena Peirson of ParkourSC

ParkourSC delivers agility and transparency in supply chain operations for pharmaceutical, life sciences, and biologics companies, to drive strategic innovation and resilience, enable timely decisions, narrow demand and supply variances, and increase revenue.

Our digital supply chain operations platform improves patient outcomes by ensuring compliance, quality, and timely delivery of sensitive therapies. The platform provides a “command center” to predict at-risk situations in the supply chain by monitoring the performance of every entity, flagging quality and compliance risks, automating workflows across organizations, fostering collaboration to resolve issues and prevent waste, and to bridge the gap in planning and execution cycles by automatically delivering real-time updates to planners.

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The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services
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The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services

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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Daniela Ottini of Sanofi — How AI is Helping the Pharmaceutical Industry Reinvent Itself and Build Smart Factories
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Daniela Ottini of Sanofi — How AI is Helping the Pharmaceutical Industry Reinvent Itself and Build Smart Factories

At the 2024 edition of the Pharma Manufacturing World Summit we spoke with Daniela Ottini, Sanofi’s SVP, Manufacturing and Supply Head of Specialty Care, as a follow-up to a keynote presentation she gave the day before showcasing Sanofi’s ongoing transformation that is turning science into reality for patients. We explore how one of the giants of pharmaceutical manufacturing is embracing Artificial Intelligence with real-world examples, what kind of mindset is required from senior leadership to guide an organization through such a transformation, and what the new general of smart factories coming online promise for patients and the future of medicine. It is an exciting and inspiring conversation about the aspirational becoming reality. Give it a listen!

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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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Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects
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Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects

At the 2024 edition of the Pharma Manufacturing World Summit we sat down with Teresa Gorecki of Compliance Architects to speak with enthusiasm and optimism about the future of medicine, the most recent developments and what they mean for patients, but especially the most recent ideas and information pharmaceutical manufacturers and other senior leaders in the Life Sciences need to know as the industry moves forward together into a very exciting time. What are some of the top-of-mind challenges and opportunities pharma manufacturers are dealing with right now, and how are the early adaptors already addressing those issues? How are regulators working with industry to improve end results for patients? How is commercialization of ATMPs progressing, and what can we all learn from the first examples coming online now? For all this and more, give this episode a listen!

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