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LIFE SCIENCES

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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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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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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Manufacturing Strategies for Sustainable Global Growth: Building a Global Sustainable Supply Operation for the Future Leveraging Digital and Innovation
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Manufacturing Strategies for Sustainable Global Growth: Building a Global Sustainable Supply Operation for the Future Leveraging Digital and Innovation

As Senior Vice President, Global Biologics Operations, Per leads the global biologics operations network, which includes five internal manufacturing sites across four countries, as well as the external biologics supply network. Since April 2020, Per has also served as co-lead for the COVID-19 vaccine program, AZD1222, during which he has led the rapid establishment and start-up of a complex manufacturing network of more than 20 partners across more than 15 countries.

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Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity
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Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity

Ralf Altenburger joined the Technical Operations Leadership Team at Roche/Genentech in July 2015 as Head of Pharma Technical Regulatory. Additionally, in Oct. 2021 he assumed the role of Global Head Cell and Gene Therapy. Ralf has more than 20 years of experience in the pharmaceutical industry and joined Roche in 2009 leading global functions in Technical Development.

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