Tag

Pharmaceuticals

Real-Time Release, a Distant Dream or Reality?
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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.

Continue reading
Fireside Chat: Navigating Technological Advancements, Global Operations, and Supply Chain Innovation
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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.

Continue reading
Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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?

Continue reading
Panel: Optimizing Technical Operations: Best Practices for Manufacturing Next-Gen Medicines
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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.

Continue reading
Accelerate Your Bench to Production Timeline by Collocating Research with Process Development and Pilot Scale Production
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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.

Continue reading
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.

Continue reading
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.

Continue reading
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.

Continue reading
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.

Continue reading
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!

Continue reading
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

Jim Cafone has been with Pifzer since 2010.  In his current role as Senior Vice President, Global Supply Chain, Jim oversees global demand forecasting, demand and supply planning, worldwide logistics, and inventory management for Pfizer.

In his previous role, as Vice President, Network Design & Performance, Jim was responsible for business development, supply chain network design, Pfizer’s lean production system, all performance reporting and analytics, innovation, and recognition programs.

Continue reading
Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?

At PMWS23 we recorded a panel on ‘Next’ Generation Manufacturing that looks at where the industry has come from, and where it’s going in the future.

From discussing how today’s pipeline and technologies are reshaping biomanufacturing, to looking at the technologies that enable next generation manufacturing processes, give this one a listen!

Continue reading
Fireside Chat: The New Normal and Beyond: How to Design the Fit for Purpose Technical Operations Organization of the Future
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Fireside Chat: The New Normal and Beyond: How to Design the Fit for Purpose Technical Operations Organization of the Future

An international operations executive with global technical, operational, and P&L experience, Carlo has deep expertise in designing and operating global supply chains in complex regulatory environments, leading accretive M&A activity and devising and executing value-creating strategies in global markets.

Since May 2020, Carlo has been the lead advisor for Manufacturing and Supply Chain to Operation Warp Speed/Federal Covid Response, the US government initiative to support the acceleration of development and supply of Covid-19 vaccines and therapeutics. He has collaborated with the sponsors, suppliers and CDMOs to ensure the fast scale-up of manufacturing and distribution for the entire US.

Continue reading
Managing Innovation and Variability in a Growth Environment
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Managing Innovation and Variability in a Growth Environment

Andrew (Andy) Wirths is a senior pharmaceutical operations leader with over 30 years’ experience in the industry spanning small and large molecule manufacturing.

Andy joined AstraZeneca in 2015 and is currently Senior Vice President, Americas Supply, where he is responsible for overseeing the manufacturing operations of 8 sites in North and South America.

Previously Andy held various senior positions at Merck where he was fundamental to the development of their manufacturing strategy and its execution at multiple sites.

Continue reading
Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics
LIFE SCIENCES

Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics

Spencer has more than 30 years of experience in Manufacturing and CMC product development. While at Rubius, Spencer built the technical functions to design and deliver the RED™M manufacturing platform, including clearance of 4 IND’s over 4 years.

He also led the acquisition and re-fit of their Red Cell Therapeutics manufacturing site in Smithfield Rhode Island, where the team transferred and delivered clinical supplies for their 3 oncology programs. Prior to joining Rubius, Spencer served as VP & Global Head of Cell & Gene Technical Development and Manufacturing at Novartis where he led the CMC development and manufacturing organization to deliver the CAR-T portfolio. Under his leadership, the team successfully registered and launched the first CAR-T cellular therapy product, Kymriah, which has demonstrated transformative efficacy in patients with acute lymphoblastic leukemia. While at Novartis, Spencer also led technical development teams across the Novartis Biologics portfolio in support of the commercialization of Cosentyx® and the registration and approval of Erelzi™M? and Rixathon®.

Continue reading
Transforming a Global Development & Product Supply Network for Delivering a Multi-Modal Portfolio – It’s More than Flexible Facilities
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Transforming a Global Development & Product Supply Network for Delivering a Multi-Modal Portfolio – It’s More than Flexible Facilities

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of professional and leadership experience in the area of biologics operations, development and technology management. From 2012 until 2020, he held positions of increasing responsibility at Boehringer Ingelheim (BI), including as President and CEO of BI Fremont Inc and member of BI’s Biopharma Executive Committee. Prior to his years at BI, Dr. Vogel was a member of the Biologics Development Leadership team at Bayer in Berkeley. Jens holds a PhD in Biotechnology from University of Braunschweig, Institute of Technology, Germany.

Continue reading