Want To Know What 7 Biopharma Manufacturing Execs Expect for 2020 – And Beyond?
By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
During the 2019 annual J.P. Morgan Healthcare Conference (JPM), I attended a number of breakout Q&A sessions. Several of these involved gene therapy companies where executives placed significant emphasis on the criticality of manufacturing to their ultimate success. But let’s be honest — gene therapy companies don’t have a monopoly on the popular manufacturing phrase, “The product is the process.” Because the reality is, when it comes to meeting a patient’s unmet medical need, whether small or large molecule, precision medicine or gene therapy, OTC or vaccine, if the patient can’t access the product because of some sort of manufacturing issue, then nothing else matters. From my perspective, quality manufacturing is the most important ingredient for a biopharma company to achieve sustainable success. Breakthrough Therapy designations and FDA approvals don’t mean much if the product can’t be manufactured at the level necessary to meet market demand. In that spirit, we’ve lined up a cross section of biopharma manufacturing executives to gain their perspectives for what to expect in the world of biopharma manufacturing for 2020 — and beyond.
Q: What’s Going To Be Big In Biopharma Manufacturing In 2020?
NATALIE HOLLES
President and COO, Audentes Therapeutics
Manufacturing, particularly large-scale cGMP manufacturing, is a key area of focus for companies in the cell and gene therapy space. As more of these product candidates approach commercialization in the coming year, it will be interesting to watch the technical and regulatory precedents being set by the leaders in the field. The move toward the establishment of a cell and gene therapy manufacturing road map for the future will be similar to what large-scale biologics manufacturers (e.g., Biogen, Genentech, and Amgen) did for the antibody field a generation previous.
AZITA SALEKI GERHARDT, PH.D.
EVP Operations, AbbVie
Analytics, data, and digital tools will continue to enable manufacturing to optimize end-to-end processes. Advancements in process verification, serialization, automated equipment readings, and data-driven product indexes will drive secure, increased automation and more visibility across product lines. Machine learning (ML) in yield and maintenance will offer exciting new opportunities to optimize the supply chain and improve the precision of distribution timelines. As the world faces the threat of climate change, an industry focused on promoting global health must also focus on environmental stewardship. Sustainability is a key trend impacting biopharmas striving to balance business activities and health missions. Biopharma manufacturing will continue to adopt a more sustainable growth mindset, proactively integrating environmental sustainability into planning and development processes. It is my hope that the manufacturing workforce continues to trend toward reflecting the true diversity and differences of global society at every level, including leadership. A diverse and inclusive workplace can unlock the full potential for innovation to positively impact patients.
Q: What Disruptive Technologies Will Transform Biopharma Manufacturing In The Next Three To Five Years?
JACKS LEE
SVP, Global Vaccines Operations, Merck Manufacturing Division (MMD)
Digital: Accelerated adoption of digital technology with innovative applications like AI and ML into the evolving good manufacturing practice (eGMP) ecosystem will enable and enhance machine decision-making. A strategically implemented digital initiative across the end-to-end (E2E) supply chain will optimize demand-supply planning, capital expenditure, and operational expenditure investments, increasing employee engagement and job gratification.
Anti-counterfeiting: Beyond ongoing serialization and aggregation measures, a blockchain-like system coupled with unit-level orthogonal identifications will enable patients and/or healthcare providers to determine product integrity in real time.
Smart Materials: Contamination in biomanufacturing not only suspends production but demands significant investigational resources and time to ameliorate. Smart contact materials can prevent contamination propagation and then be expressed for easy detection to expedite mitigation.
Q: What Biomanufacturing Trends Have Been Lagging/Leading In Adoption And Implementation?
WILLIAM (BILL) FALLON
SVP, ENHANZE Success Team Leader & CMC Operations, Halozyme Therapeutics
One current industry trend lagging in adoption has been the implementation of gene therapy manufacturing. There have been several obstacles to overcome. One was the development and validation of the methods of therapy delivery. Although gene therapies have been under development for over two decades, the optimal mechanisms for delivery (e.g., viral vectors, autologous cell transfection) had to be developed and their safety demonstrated in clinical trials. Though gene therapy products are now being approved for commercial sale, there is a shortage of available manufacturing capacity, which needs to be addressed to better support adoption of this innovative approach to treatment.
A trend where biopharma has become a leading adopter is the outsourcing of production and analytical testing to CDMOs. These options are now available for products in early-stage development to commercialization and used by a wide variety of companies. The FDA guidance on cooperative manufacturing arrangements defined the relative responsibilities of the parties involved and enabled the development of the contract manufacturing industry to meet industry needs. Wide adoption of this model has enabled competition, thereby reducing costs. Further, the approval of products produced by CDMOs has helped to overcome the bias that existed when ceding some element of control of product manufacturing to a third party.
RAN ZHENG
CTO, Orchard Therapeutics
Despite being used in the chemical industry for years, continuous manufacturing for downstream bioprocessing is lagging in adoption. One of the biggest obstacles has been the lack of robust and scalable technology solutions. Compared to the traditional purification process with discrete unit operations, the current continuous process technologies are more complicated and not yet proven. As the upstream process continues to push the envelope with higher productivity, the drive to intensify the downstream process and reduce the manufacturing footprint has become even stronger. Close collaboration between industry, solutions providers, and regulators will continue to advance and mature technologies for biopharma to fully realize the benefit of continuous manufacturing. One of the manufacturing trends that has been successfully adopted by biopharma is single-use technologies. In the early days, there were numerous technological challenges and plenty of nonbelievers. However, the flexibility, ease of use, and lower cost for implementation reduced barriers to entry and grew the customer base. The growing number of companies that experimented with and adopted single-use technologies not only helped resolve the key challenges but helped improve the technologies themselves.
Q: What Is Your Vision For Global Biopharma Manufacturing In 2030?
CHARLENE BANARD
Former Head of Quality and Technical Operations, Shire
Purposefully leveraging technology advancements and working in a more collaborative manner with internal and external stakeholders can transform our operating model. High-treatment pricing is not sustainable and undermines the biopharma industry’s reputation. While the price tag is not entirely based on discovery, development, and manufacturing expense, if we could reduce spending in these areas by an order of magnitude, we would have a transformative impact. Digitalization and (bio)technological innovations can help us share and use resultant and/or surrogate information to speed decision-making. However, without a disciplined, empowered organization and strong external partnerships, we will fail to use the speed of technological advancements as a competitive advantage. We also can engage external parties from our complex development and manufacturing chains to collaborate and drive effective decision-making and execution through an integrated design and production approach. By doing so, we can help minimize translation errors, increase data control, streamline communication, and in general, reduce the chance of errors and the need for rework, all of which results in shorter development cycles. Cybersecurity is a critical enabler, and we must partner both internally and externally to help all (including regulators) gain confidence in the technology to enable regulatory decision-making speed com-mensurate with the advancements biotechnological evolutions afford.
Q: What Trend Do You Find Most Exciting For 2020?
KATHY WENGEL
EVP and Chief Global Supply Chain Officer Johnson & Johnson
The trends I find exciting are product personalization, digital innovation, and partnerships. Science and technology are intersecting, fundamentally changing how we work, enabling us to innovate new products, services, and experiences for those we serve. For example, we are working toward personalized therapies, which have novel supply chain processes and unique care pathways. We have similar work underway in medical devices, developing tailored kits for surgeries and 3-D printed implants. Achieving this requires close collaboration with our R&D and commercial teams, as well as customers and suppliers, to get treatments to patients when, where, and how they need them.
Q: What Impact Would A U.S. Economic Slowdown Have On Biopharma Manufacturing?
AZITA SALEKI GERHARDT, PH.D.
EVP Operations, AbbVie
Each sector of the industry would be impacted differently. My advice on preparation would be to first make no assumption that our industry is in any way recession-proof. Pharma leaders should constantly review their existing processes against potential financial pressures across all aspects of manufacturing and distribution and drive increased efficiency wherever and whenever possible, without sacrificing effectiveness. Specifically, in light of a recession, executives also can work cross-functionally within their organizations to monitor local programs and governmental policies proposed in response to pressures to save money or promote consumer spending and anticipate the potential effect these programs and policies may have on manufacturing before they are ever implemented.
Q: What Should Biopharma Do In The Next Three To Five Years To Reduce The Risk To Global Supply Chains Posed By Natural Disasters?
WILLIAM (BILL) FALLON
SVP, ENHANZE Success Team Leader & CMC Operations, Halozyme Therapeutics
To minimize significant disruptions to supply chains caused by natural disasters, you should have a comhas prehensive business continuity plan focused on disaster recovery. This plan should be based on a detailed risk assessment covering all aspects of the supply chain and should lay out the logistics of response management and execution. Redundant facilities for production, testing, and storage should be evaluated and adopted for critical intermediates and processes. Adequate inventories should be maintained taking into account the time required to establish, validate, and obtain required health authority approvals of new facilities. Information access and retrieval is equally important. Data storage on external servers accessed via the cloud is useful in mitigating this risk. Contracts with key external suppliers should contain adequate indemnity and insurance provisions to ensure financial coverage in the event of lost assets.
JACKS LEE
SVP, Global Vaccines Operations, Merck Manufacturing Division (MMD)
Companies must continually weigh competing priorities as they approach disaster planning. Winning solutions focus on patients and customers. Potential key areas to consider:
Reducing Distribution & Logistics (D&L) Impacts: Partnership with specialty carriers who focus on disaster deliveries, strategic collaboration with comparable businesses and even competitors, proactive securing of integrated D&L capabilities with adjacent communities, engagement with local or international agencies (including military), and alternate transport technology (e.g., drones, hovercraft).
Recovery of Impacted Supply Nodes: Strategic dual or multisourcing from different locations, specific hardening of critical supply assets (e.g., prequalified backup equipment, pretrained ready-to-drop-in contingency workforce, and strategic product stockpiling at predefined locations) and leveraging of AI to move products to alternate locations for natural disaster-prone regions (e.g., earthquake, hurricane).
Q: What Should Biopharma Do To Implement Newer Strategies Toward Improving Product Quality And Compliance In 2020 And Beyond?
RAN ZHENG
CTO, Orchard Therapeutics
Biopharma companies should tap into the power of technologies, such as robotics, process automation, smart sensors, deep learning, cloud-based computing, and blockchain The convergence of biology and technologies can potentially transform biomanufacturing and improve the industry’s competitiveness. Robotic technologies have already made inroads into the areas of bioprocessing, filling, and inspection. Digital plants with process monitoring, multivariate analysis, and automated data flow enable parametric release, ensure product quality, and reduce manufacturing cycle time and labor cost. Integrated analytics will enhance our understanding of product quality attributes. Deep learning and predictive technologies can help translate data into insight and identify opportunities for product and process improvements.
Q: What Biopharma Hub Will Have The Biggest Impact On Biopharma Manufacturing In The Next Three To Five Years?
CHARLENE BANARD
Former Head of Quality and Technical Operations, Shire
As the world’s second largest economy with more than 1.3 billion people, China is a significant market. China’s authoritarianism and economic growth policies, its status as a mass market manufacturing powerhouse, and its regional influence, especially in North Africa through its belt and road initiative (BRI), make it a strong competitor, especially in less-innovation-dependent products (e.g., generics and bioprocessing supplies). China’s impact on Western biopharma manufacturers necessitates building relationships and manufacturing capacity in China and navigating provincial and national Chinese regulatory expectations to enable access to the Chinese market while bracing for competition from Chinese manufacturers.
Q: What Are The Top Emerging Innovations That Will Impact Biopharma Manufacturing Within The Next Five Years?
KATHY WENGEL
EVP and Chief Global Supply Chain Officer Johnson & Johnson
Digital is transforming how supply chains improve productivity, quality, reliability, agility, and responsiveness. For example, our adaptive process control (APC) capability collects real-time data from our manufacturing processes, allowing us to see how they are performing and adjust in real time. Digital also opens up possibilities to improve access, create greater on-demand traceability, and increase personalization. We also see increasing innovation in biopharma modalities, including areas such as gene therapy, cell therapy, and radiopharmaceuticals – coupled with better patient targeting by using diagnostics. To deliver on these, we need innovative supply chain approaches and technologies, and we need to begin preparing for these new modalities now.