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LIFE SCIENCES

The CDMO of the Future
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

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

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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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Accelerating the Pace of Progress for Innovative Biologic Products
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Accelerating the Pace of Progress for Innovative Biologic Products

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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Our Journey in Next Generation Manufacturing: What We Can Achieve Together
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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

As Senior Vice President of Global Technology & Engineering group in Pfizer Global Supply, Roberto leads a group of highly capable Subject Matter Experts and is responsible for capital projects, implementation Integrated Facility Management and Global Reliability programs, technical support for major investigations, Phase III clinical supply sites, technology transfers, implementation of process development and disruptive technology supporting over 35 Pfizer sites and 200 Contract Manufactures globally.

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