Life Science Leader is thankful for having so many executives and thought leaders willing to take part and contribute to our annual outlook issue (published in December). That being said, there are times when we can’t fit all of the great insight within the print pages of just one publication. When this happens, we turn to our exclusive and increasingly popular online section — Beyond The Printed Page. Here you will find 100 articles from biopharmaceutical industry thought leaders sharing opinions on very diverse topics — from the importance of being hyper focused, to the lonely role of CEO, and just about everything in between.
For this installment, we have seven biopharmaceutical industry manufacturing executives sharing their perspectives toward helping their peers prepare for 2020 and beyond. Participants in this article include:
Charlene Banard, former head of quality and technical operations, Shire
William (Bill) Fallon, SVP, ENHANZE Success Team Leader & CMC Operations, Halozyme Therapeutics
Natalie Holles, president and COO, Audentes Therapeutics
Jacks Lee, SVP, global vaccines operations at Merck Manufacturing Division (MMD)
Kathy Wengel, EVP and chief global supply chain officer, Johnson & Johnson
Ran Zheng, chief technical officer, Orchard Therapeutics
What Manufacturing Trend Do You Anticipate Having The Biggest Impact On Biopharma In 2020 And Beyond?
Natalie Holles, president and COO, Audentes Therapeutics:
The coming of age in cGMP manufacturing for cell and gene therapies will have an enormous impact on the development and regulatory paths for the future generations of these transformative medicines. As the field evolves toward unified best practices for production and purification systems, analytical methods, and other elements of large-scale cGMP manufacturing, the development path for future cell and gene therapies will become smoother, faster, and hopefully more successful, to the benefit of patients and families living with devastating diseases.
I expect molecules (both large and small) and product types will continue to become more diverse and be able to treat a wider range of personalized patient needs. Therefore, we will see new technologies, such as cell and gene therapy, and innovative product improvement ideas developed to not only manufacture more complex molecules, but also to more quickly transfer them from one development stage to another and distribute them to patients, while still meeting the high standards set by regulatory agencies. As more companies develop and accelerate these solutions within manufacturing, the tremendous impact could be game changing for patients.
What Are The Top Emerging Innovations That Will Impact Biopharma Manufacturing Within The Next Five Years?
Charlene Banard, former head of quality and technical operations, Shire:
Improved sensors, interfaced instruments, process streams, and personal equipment increase relevant data collection. Advanced analytical capability provides an opportunity for better process understanding and real-time decisions. Broad application of virtual reality technology will dramatically change our antiquated training approaches. Additive manufacturing, specifically 3D printing, significantly enhances and streamlines prototyping of product administration devices and bioprocess manufacturing equipment. Advances in material science and 4D printing (adds dimension of transformation over time) will further enable flexibility for localized manufacturing.
What Disruptive Technologies Will Transform Biopharma Manufacturing In The Next Three To Five Years?
William (Bill) Fallon, SVP, ENHANZE Success Team Leader & CMC Operations, Halozyme Therapeutics:
Innovative product design technologies such as bi-specific antibodies and antibody-drug conjugates are emerging to improve drug targeting and increase the therapeutic window for treatment with otherwise potentially toxic agents. On the drug delivery side, the development of technologies such as hyper-concentration, use of dispersal agents (e.g. hyaluronidases) and on-body devices have allowed large volumes (up to several hundred mL) to be delivered subcutaneously which has the potential to significantly reduce the patient treatment burden while also reducing the cost of drug administration.
Ran Zheng, chief technical officer, Orchard Therapeutics:
In viral vector manufacturing, process intensification can significantly improve productivity. In cell therapy manufacturing, automated processes coupled with functionally closed systems can reduce labor, facility construction, and maintenance costs. Rapid analytical technologies can reduce the cycle time for release testing. Advanced sensor technologies, integrated data analytics, machine learning and adaptive process control can help address inherent starting material variabilities and improve product consistencies. These disruptive technologies will make the manufacturing of cell and gene therapy products faster, more reliable and more efficient.
What Biomanufacturing Trends Have Been Lagging/Leading In Adoption And Implementation?
Jacks Lee, SVP, global vaccines operations at Merck Manufacturing Division (MMD):
Some obstacles to biomanufacturing include frequent requests for more data; clinical or complex production control strategies lacking deep scientific understanding of technology capabilities and limitations; and the inability of innovators and manufacturers to effectively communicate the relevant sciences, data, and compliant risk-benefit propositions to regulators. Manufacturing leaders need to have the foresight to bring together end-to-end stakeholders (e.g., innovators, manufacturers, and regulators) to invest in joint learnings to demystify new technologies; transparently share data, ; and collaborate toward gaining alignment on proposed data requirements, regulatory filings, and approval paths.
What Impact Would A U.S. Economic Slowdown Have On Biopharma Manufacturing?
Holles, Audentes Therapeutics:
Periods of economic retraction can create financing pressure for the biopharmaceutical industry, which can make capital-intensive investments in new or expanded manufacturing facilities more difficult to green-light. This may result in more reliance on contract manufacturing versus investing in internal capacity. Although this may make short-term financial sense, it comes with its own drawbacks in terms of loss of control over manufacturing know-how and timelines.
What Is Your Vision For Global Biopharma Manufacturing In 2030?
Wengel, Johnson & Johnson:
By then, I expect our industry will be investing heavily in manufacturing capabilities for new modalities and harnessing digital to design our plants and supply chains in new ways. We will more highly segment our supply chains and manufacturing footprints to drive differentiated outcomes. We will continue to drive down the cost of chronic disease management by leveraging scale and standardization, opening space for breakthrough innovation, which by its nature, is much more specialized and personalized. Our supply chains are moving beyond products to services and experiences — and technology underpins everything. This is especially important given we will be manufacturing personalized solutions in a complex regulated environment where channels to access care are increasingly evolving.
What Trend Do You Find Most Exciting And Why?
Banard, formerly of Shire:
Organizations are connecting the dots on how to enable greater innovation and sustainability. There is increasing recognition that diverse workforces bring innovative value to organizations. To attract and engage the diverse, millennial workforce, a genuine approach to corporate social responsibility is crucial. According to Gallup, millennials, more than any other age group, search for meaning from their work and purpose in their patronage. At a recent panel discussion in Boston in which board service trends were discussed, corporate social responsibility (CSR) and environmental social governance were second only to cybersecurity as a critical focus. We are awakening to what is important to the largest segment of our workforce, as well as to many discriminating investors.
What Should Biopharma Do To Implement Newer Strategies Toward Improving Product Quality And Compliance In 2020 And Beyond?
Fallon, Halozyme Therapeutics:
A good place to start is to implement the principles of Quality by Design (QbD) promulgated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (specifically ICH Q8-Q11) and the FDA’s most recent guidance on Process Validation (2011). These guidelines integrate the use of process knowledge, product requirements and risk management to define a robust control strategy and ensure that quality is designed into a process and not simply tested in the final product. The QbD framework, although not a regulatory requirement per se, has generally been implemented by the biopharma industry for products more recently developed, and can be implemented retrospectively for legacy products. This has become the expectation of health authorities to better align manufacturing with a life cycle, knowledge-based approach to continuous improvement. Another framework introduced by the FDA, Process Analytical Technology (PAT), has lagged in adoption. The goal is to move away from the reliance on univariate discrete off-line testing to assess product quality to more real-time, continuous monitoring and assessment against a defined product profile. This innovative approach represents a sea change in the way companies are organized and quality systems designed, and where successfully implemented, holds the potential to significantly reduce the cost and time to achieve product approval and implementation of continuous process improvements.
Lee, Merck Manufacturing Division (MMD):
Companies are more inclined to accelerate newer strategy implementation to improve product quality (e.g., compliance 2020 and beyond) when there is better clarity of the risk-benefits to patient safety, product efficacy, clinical implications, supply reliability, and economics. To proceed, companies should consider engaging patient groups, regulators, key health providers and insurers to understand true patient risks/benefits, holistic understanding of newer strategic investments versus ROI in broader relevance (e.g., quality KPIs, supply reliability, product differentiation), and also, consider a phased implementation approach to maximize continuing successes.
What Do You Envision Biopharma Doing In The Next Three To Five Years To Reduce Risk To Global Supply Chains Posed By Natural Disasters?
Zheng, Orchard Therapeutics:
To reduce the supply risk, a comprehensive strategy must be in place to ensure sufficient mitigations through each stage of the end-to-end process — from planning and sourcing to making and delivering. This is especially important for autologous cell and gene therapy products. While autologous products are made to order, companies can plan for an appropriate level of inventories for raw materials, consumables and viral vectors while minimizing single-sourced materials. Companies should also take into consideration the geolocations for manufacturing sites and build appropriate redundancies to improve risk resilience. Construction technologies can also reduce impact and speed up recovery following a natural disaster. Finally, a robust business continuity plan and regular crisis-management exercises are key for preparedness.