At PMWS23 we recorded a panel on how the way people, processes, and technologies interact will change in the next ten years.
From discussing some of the forces and factors that are changing the way we operate, to debating how these influences will continue to evolve, and how they will shape our organizations, give this a listen!
Continue reading
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 network. In addition, Morrey is responsible for assuring reliable supply of Vertex’s transformative medicines.
Morrey is a trained laboratory scientist who brings more than 25 years of experience leading the development and commercial manufacturing of multiple products at organizations like Eli Lilly and Bristol Myers Squibb. An accomplished leader and builder of strong scientific, engineering, and operations teams, Morrey also has prior experience in process development for cell and gene therapies, including the development and manufacturing of one of the first gene therapy candidates for cystic fibrosis.
Continue reading
Jennifer Baxter has over 20 years of experience in pharmaceutical development and manufacturing activities. During her tenure at Merck, Jennifer has worked in research & development, technical support, and strategic planning of small molecules in roles across the human health, animal health, research and manufacturing divisions. Jennifer is currently the Vice President of Small Molecule Science and Technology, leading a group of approx. 800 scientists and engineers located worldwide. The group is responsible for the late-stage development of Merck’s small molecule pipeline across drug substance, drug product and packaging for both worldwide and regional products as well as all technical support for in-line small molecule products and lifecycle management activities. The group also manages manufacture and supply of late-stage clinical materials, technology development of new and innovative manufacturing technologies and provides site based technical support to all of Merck’s small molecule sites. Jennifer holds BS, MS and PhD degrees in Chemical Engineering from Rutgers University.
Continue reading
Dr. Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at MIT, where he conducts research into advanced biopharmaceutical manufacturing systems. In this role, he leads process data analytics, mechanistic modeling, and control systems for several projects on campus, including those focused on monoclonal antibody, viral vaccine, and gene therapy manufacturing. Dr. Braatz received an M.S. and Ph.D. from the California Institute of Technology and was the Millennium Chair and Professor at the University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard University before moving to MIT.
Dr. Braatz has collaborated with more than 20 companies including Novartis, Pfizer, Merck, Bristol-Myers Squibb, Biogen, Amgen, Takeda, and Abbott Labs. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Excellence in Process Development Research Award, the Technical Innovation Award from the International Society of Automation, and the IEEE Control Systems Society Transition to Practice Award. He has published over 200 papers and three books, including Fault Detection and Diagnosis in Industrial Systems. Dr. Braatz is a Fellow of IEEE, IFAC, AIChE, and AAAS and a member of the U.S. National Academy of Engineering.
Continue reading
As the senior vice president of go-to-market strategy, Marty Smyth is responsible market intelligence, product strategy, and bringing MasterControl quality and manufacturing products to market globally. He brings 20 years of technology strategy, marketing, sales, and support experience across high-growth private SaaS companies as well as Fortune 500 companies.
In previous roles, Marty has driven strategic planning, customer experience, and go-to-market for technology leaders like Cisco, Panasonic, Verizon, and AT&T. He is a University of Notre Dame alumnus.
Continue reading
Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Before he was appointed Chief Innovation Officer at Azzur Group, he was President and Chief Operating Officer of Azzur Cleanrooms on Demand™. In 2019, Ravi was the General Manager of Azzur Boston and has been with the company since 2012. Prior to Azzur, Ravi has been part of the technical operations and quality/validation departments at Baxter, Amgen, and Shire. Ravi is an expert in phase-appropriate cGMP implementation, process validation, supplier management, and technology transfer.
Chris Mansur serves as Azzur Group’s Executive Vice President of Corporate Development and specializes in providing innovative quality and compliant solutions to the life sciences industry. Throughout his career, Chris has specialized in the startup of new and renovated facilities, project management, commissioning and qualification, computer validation, quality management systems, and application of QRM principles. He is passionate about the use of phase appropriate GMPs to help companies solve problems that accelerate their product’s lifecycle or project timeline. Chris holds a Bachelor of Science degree in Mechanical Engineering from Worcester Polytechnic Institute.
Continue reading
Kim is a partner with Deloitte’s Life Sciences Supply Chain and Network Operations practice. Based in New York, she has over 20 years of consulting operations experience across the pharmaceutical, biologics and medical device sectors. Having held leadership positions at Amazon and SAP, she brings smart / digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence and market entry operations strategy expertise. Her current focus at Deloitte is enabling advanced analytics across the end-to-end global supply chain.
Kim is a partner with Deloitte’s Life Sciences Supply Chain and Network Operations practice. Based in New York, she has over 20 years of consulting operations experience across the pharmaceutical, biologics and medical device sectors. Having held leadership positions at Amazon and SAP, she brings smart / digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence and market entry operations strategy expertise. Her current focus at Deloitte is enabling advanced analytics across the end-to-end global supply chain.
Continue reading
At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Teresa Gorecki of Compliance Architects LLC about what pharmaceutical manufacturers should expect from regulators as the pandemic winds down, where we are and where we’re going as the pipeline of Cell & Gene Therapies marches towards commercialization, and a wide range of other industry issues, challenges, and opportunities. This is a great conversation that speaks to a lot of key points of interest for pharmaceutical manufacturers of all shapes and sizes. Give it a listen!
Continue reading
At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Michael Kamarck, a senior industry executive, and Pascal Bécotte, the Managing Director of Russell Reynolds Associates, about the most serious challenge threatening to bottleneck the otherwise very bright future of medicine. For a number of reasons explored in both this interview and in this recent blog post, there are not enough qualified people to fill all the top jobs that need to be done, and this is not something that is going to be fixed in a day or even a few years without the industry working together in a decisive and unprecedented way to collectively develop its rising Top Talent in the technical operations space into the senior leaders that Small Molecule, Large Molecule, and especially the emerging Advanced Therapy Medicinal Products sectors cannot do without.
Continue reading
At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Judith Koliwer, PhD, the Principal Consultant Cell & Gene Therapy Software, Körber Business Area Pharma at Körber Pharma Software. Judith is one of the industry’s leading experts on Cell and Gene Therapies, as she led an academic research group on CGT processes years before these new therapies were approaching commercial manufacturing. At PMWS23 she gave a presentation entitled, “The Iterative Approach to a Digital Cell and Gene Therapy Process – an Overview & Best Practice.” In this interview we discuss what she shared with the audience, as well as her thoughts on current issues and trends pharmaceutical manufacturers need to be aware of as they forge a path into the new frontier of medicine. Give this one a listen!
Continue reading
At the most recent edition of the Pharma Manufacturing World Summit we sat down with Hunter Malick of Sharp Packaging Services to talk about how pharmaceutical manufacturers are working internally and externally to improve their capabilities and capacity when it comes to packaging, especially as it relates to changes and updates that could potentially bottleneck the industry’s supply chain. In a business landscape where the rate of innovation keeps accelerating, the product pipeline coming to market is full, and regulatory requirements are frequently adjusted in relation to packaging and labeling, it has never been more important to understand the options available to scale up packaging production and make quick adjustments as needed to make sure the flow of products to patients is not interrupted. Give this one a listen!
Continue reading
At the most recent edition of the Pharma Manufacturing World Summit we sat down with Andy Alasso, Aizon’s Chief Product and Customer Successor Officer, to talk about what Artificial Intelligence is going to do for Pharmaceutical Manufacturers now, in the near-future, and in the years to come. It may surprise many business leaders to learn they are closer to being ready to incorporate AI tools into their existing toolbox than they think. The very nature of pharmaceutical manufacturing, which is data-centric by nature, lends itself well to AI. What should industry leaders be thinking about and learning about when it comes to these powerful new tools? Give this episode a listen to find out!
Continue reading
Torsten Pilz is Senior Vice President and Chief Supply Chain Officer. Torsten has broad responsibilities for the integrated supply chain, including procurement and driving improvements in plant efficiency and working capital while continuing to enhance quality and delivery.
Continue reading
John Sampson is Senior Vice President, Operations, Manufacturing & Engineering for Dow. In this role, Sampson presides over the Operations Leadership Team (OLT) and is accountable for the global Operations organization consisting of more than 22,000 employees worldwide. He is a member of Dow’s Leadership Team (LT), responsible for executing the Company’s strategy in addition to the Operations Team (OT), accountable for the Company’s productivity and performance.
Continue reading
Elito Siqueira is the Global Senior Vice President of Supply Chain and Logistics. Over his career, he has 25 years of experience with roles across manufacturing, logistics, procurement, and sales. In that time, Elito has led important business transformations including M&A integrations, Digital Transformations, and Operating Model / Process Excellence definition. In all roles, he has been able to deliver strong service level, rigorous cost management, while building engaged teams and organizations.
Continue reading
David Johnson is the SVP, Manufacturing and Supply Chain Management. Prior to this role he was Vice President, Production Engineering and New Model Quality, Nissan North America, Inc. where he was ensuring the highest level of quality possible at the maximum output in all of Nissan’s U.S. and Mexican manufacturing operations.
Continue reading
