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At CPhI North America, we are hosting a breakfast meeting to provide a sneak peek of next year’s all-new event: BioLive. We caught up with one of our expert speakers, Mary Lynn Bercik of Johnson & Johnson ahead of the event to find out a little more about the focus of her presentation.
Could you briefly introduce yourself and tell us more about the NIBRT?
My Name is Mary Lynne Bercik and I have been a Sourcing and Procurement professional for 27 years, 17 of which has been spent supporting the Biopharmaceutical Industry.
Over the years, I have watched the BioPharma industry grow, from it’s infancy into a robust and specialized offering supported by well-defined processes. Supply Chain Procurement has played a critical role in this growth. They have prioritized purchases that support the manufacturing of Biologics throughout it's lifecycle; capital equipment, operating supplies, chemicals and complex raw materials. SC Procurement has spent countless hours ensuring Suppliers, and their materials, are fully qualified and meet the requirements of this highly regulated environment.
The National Institute for Bioprocessing Research and Training (NIBRT) is located in Dublin, Ireland, and is an internationally recognized, world class training institute which provides a "hands on” simulated environment for their students.
NIBRT is able to replicate "real life" manufacturing scenarios without the risk to a licensed manufacturer using commercialized materials. This approach is appealing to manufacturers, as it reduces the risks in their manufacturing processes while providing opportunities to gain efficiencies.
NIBRT is also unique in it’s ability to customize training programs for each company and each of their unique products. This level of training creates standards of excellence for the industry. Suppliers and Manufacturers are fortunate to have NIBRT in the EU and now JIB in North America!
You will be speaking on ‘Accepting the Challenge' at CPhI North America, why is this an important topic to address now?
Over the past 3-5 years the industry has seen a significant increase in the production of Biologic products, it’s no longer the big 3 or 4 name brands that are extending our quality of life. Flagship products have been so successful they have created pipelines within their products.
However, this success, coupled with recent Biosimilar approvals, has stretched the Industry’s ability to meet the demand. Internal and external manufacturing, as well as Suppliers, have been challenged to meet this accelerated growth. Capacity constraints became apparent beginning in 2014 and began impacting how Supply Chain Procurement managed critical suppliers as early as 2015.
One obvious imbalance was the lack of skilled workers to support this growth. This was exacerbated when Companies began targeting talent at their competitors. Trying to ensure they had the best expertise, but with such a limited pool of talent, it became a costly and limited solution.
At the same time, Large Molecule New Product teams were being asked to switch gears and apply their large molecule knowledge to the new frontiers of Cell and Gene Therapy. Pipelines were no longer 100% homegrown, heading towards > 50% M&As. Fast track approvals meant teams worked in a 24/7 environment, from discovery to commercialization, which was clearly not sustainable.
Current employees were too overwhelmed to train new talent, making it hard for new employees to be properly on-boarded. Successful launches made it seem feasible to push through normal limits. R&D had done what they were asked, creating a successful pipeline. Now it was up to Commercial to take it across the finish line, from both a materials and COGS perspective. It became obvious that the lack of skilled workers was beginning to hurt the process.
To create a more secure future for manufacturing we needed to turn to the experts at NIBRT and work with them to replicate what they had done in Ireland. With their support and guidance, and the right industry and academic commitments, we could meet this challenge and be prepared for the future of BioPharmaceuticals.
What are the challenges faced by the bioprocessing sector at present?
The number one challenge is a properly skilled workforce. Second, is understanding and adapting to the changing technology which is needed to support the diversity in the emerging pipelines. Without the skilled workforce it will make the ability to adapt to the new technology more costly and less efficient.
What are the solutions to these challenges?
The primary solution is to have a mature and up skilled workforce, constantly learning about the next phase in the evolution of manufacturing. As we evolve toward personalized medicine, we need to be increasingly sophisticated and efficient in our manufacturing processes. If employees receive "best in class” Bioprocess training, it makes it easier to apply continuous improvement methodology, even if the type of product changes.
This training is applicable to all the enabling functions of a manufacturing Supply Chain, not just those who work in the manufacturing suites.
What role will the NIBRT play in addressing these challenges?
The National Institute for Bioprocessing Research and Training located in Dublin, Ireland has spent most of the last decade creating internationally recognized world class training.
As a result, when BioPharma is looking to invest in manufacturing facilities in Ireland, Ireland is able to offer a sophisticated skilled work force along with their impressive tax incentives. It's the perfect combination for investors and one I wish to replicate here in the United States. NIBRT has agreed to work with Jefferson to provide this world class training in the United States.
I am proud to say this partnership has created the Jefferson Institute for BioProcessing which will open in Spring of 2019 just outside of Philadelphia.
How do you see the industry evolving in the next 5 years?
The next 5 years will see the continued use of Stainless Steel Bioreactors in Biologics Manufacturing, as well as, the increased use of Single Use Technology (SUT). The unique and “newer” technologies used in Cell and Gene Therapies will no longer be considered groundbreaking. You will start to see Suppliers evolve in the new technology spaces. Some will choose not to participate, as they have assessed the risk/reward opportunity in the past and feel it’s still not part of their business model and they will remain supporting Biologics only. Others will be formed as a result of the void in the marketplace, and some will try and straddle both worlds, similar to what big Pharma has done over the last 5 years in the diversifying their pipelines. Most interesting will be the use of technologies found in other industries which have supported Cryo needs for decades, examples include organ transplants and fertility centers.