Last year, at the American Biomanufacturing Summit, we sat down with some thought leaders from MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical and asked them: “What do the Next Five Years Look Like in the Biomanufacturing Industry?” Most agreed that it will be an exciting time with new product modalities improving patient care, but that these new product modalities will give rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. We asked them to go further and tell us what key challenges organizations need to overcome to be successful in this period of unprecedented change.
Read More →What Do the Next Five Years Look Like for the Biomanufacturing Industry?
Last year, at the American Biomanufacturing Summit, we sat down with some of our thought leaders to ask them where they see the industry going in the next five years. It was clear that major changes are on the horizon. It will be an exciting time, with new product modalities improving patient care, but giving rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. Read on for insights from thought leaders at MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical.
Read More →iBASEt: Following the Digital Thread Into the Future
What is the digital thread? The digital thread links systems used to execute and track design, engineering, manufacturing and MRO (maintenance, repair, and overhaul), establishing a seamless flow of information from product conception to delivery and beyond. The concept of the digital thread was spearheaded by the military aircraft industry, from its desire to improve the performance of future programs by applying lessons learned. Why is it important? With the emergence of the Industrial Internet of Things, smart manufacturing, and automation, it is integral to create a communication framework that connects data flow from initial design to development. “The digital thread brings customers, vendors, and suppliers close, tying them into holistic feedback and evaluation loops. To learn more about the Digital Thread, read Tom Hennessey’s (Vice President of Marketing at iBASEt) article on Following the Digital Thread Into the Future.
Read More →Supply Chain Strategy: Managing an Aggregated Demand Network
XPO’s Supply Chain Aggregation Strategy consolidates the global demand and distribution of the managed commodity. The strategy provides a self-regulating consumption-based process that ensures optimal inventory levels at all points of the supply chain. XPO’s solution is flexible, scalable and can be applied to a wide range of commodities in various industries.
Read More →Case Study: How to lead progressive changes through project leadership
“Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes into its larger business strategy, the benefits go far beyond compliance.” To learn more about the benefits from project leadership, check out the case study by Integrated Project Management, click here.
Read More →The Serialization Challenge
Successful serialization strategies require a global approach and considerations regarding installation and aggregation capabilities, traceability optimization and adherence to varying regional regulations. In order to better understand the serialization challenges and opportunities that pharmaceutical companies face, we sat down with the specialists from Clarkston Consulting to gather their insights. The eBook explores and explains: The Current Regulatory Landscape The Serialization Challenge Best Practices in Serialization Operationalizing a Serialization Program Check out the eBook below! eBook, The Serialization Challenge To hear insights on Manufacturing Excellence, CMO Strategies, Capacity Management, Quality and Compliance, join Clarkston Consulting at the American Biomanufacturing Summit taking place in San Diego next week!
Read More →Younok Dumortier Shin: A speaker review of the American Biomanufacturing Summit 2015
We were fortunate enough to have Younok Dumortier, Director of Large Molecule Technology Platform at Janssen join us as a speaker at the American Biomanufacturing Summit last year. We caught up with Younok and asked her to share some of her opinions about the event and participating as a speaker. The American Biomanufacturing Summit is returning to San Diego in May 2016. Find out more about the American Biomanufacturing Summit 2016!
Read More →Addressing the Challenges in Biomanufacturing
The life sciences industry is evolving on a global scale. Shifting market demands, healthcare reforms and more stringent regulations are presenting new challenges to the industry at large. “It is particularly challenging to manage operations globally when dealing with vastly different regulatory review periods for new drug applications as well as making any significant changes to existing dossiers.” explains Ryan Cox, Director, Bulk Manufacturing at CSL Behring. Increased pressure to reduce the cost of healthcare in the US is pushing manufacturers to streamline processes while finding new ways to produce “bio-better” drugs that have a vastly improved pharmacological profile. To remain competitive “biomanufacturers must continue to focus on innovation in terms of making improvements to existing products” explains Ryan. As a result “the industry will need to become much more flexible and “lean” over the next 5-10 years.” Taking a holistic approach to the challenges and opportunities that biomanufacturers face, Generis’ American Biomanufacturing Summit 2016 will present attendees with first-hand case studies, strategies and best practices to advance manufacturing excellence, drive innovation and develop the necessary leadership strategies to ensure long-term success. Produced with the thoughtful input of some of the world’s leading organizations, this senior level program is designed to provide biomanufacturing executives with current trends and strategic insights on internal manufacturing, external manufacturing, operational excellence, quality management and compliance. Annually attracting 150 senior level delegates from across North America, this years program will provide delegates with strategies and insights to …
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