Dose #22: Reducing Downtime and Unlocking Hidden Capacity in Pharma Manufacturing with Andrea Wagner (PharmaPhixx)

Dose #25: The Evolving Role of Supply Chains and Future Skills with Abe Eshkenazi (ASCM)

In this episode of SCW for Pharma, Evren Ozkaya welcomes Abe Eshkenazi, Chief Executive Officer of the Association for Supply Chain Management (ASCM). The conversation begins with Abe’s professional journey, starting from his early career in pharmaceutical operations, including manufacturing and supply chain management. He shares how his current role focuses on helping organizations build more agile, resilient, and risk-aware supply chains, while also fostering a global community that advances the profession across areas such as strategy, geopolitics, compliance, and sustainability. Evren and Abe then explore how the perception of the supply chain has evolved since COVID-19. Abe emphasizes that supply chain is no longer a back-office function but a critical topic at the C-level. The pandemic exposed major gaps in transparency and visibility, pushing organizations to rethink their priorities beyond cost and efficiency to include resilience, ethics, and sustainability. The discussion then shifts to the gap between academic education and real-world supply chain challenges. Abe reflects on how supply chain management was not historically a dedicated academic discipline and how many professionals entered the field from engineering or finance backgrounds. He highlights the role of certification and continuous education programs in bridging this gap, as well as ASCM’s contributions in this regard. Evren and Abe also discuss the importance of continuous learning and cross-functional development. Abe underscores that supply chain professionals must go beyond operational efficiency, developing capabilities in finance, analytics, sustainability, and strategy. At the same time, he highlights the growing importance of soft skills, including relationship management and the ability to navigate complex, dynamic environments while balancing short-term disruptions with long-term strategic goals. The conversation then touches on ASCM’s documentary “The Chain: How The World Works,” which illustrates the hidden complexity of global supply chains and is streaming on Amazon Prime. Abe explains how supply chains impact everyday life in ways most people do not realize until disruptions occur, emphasizing that supply chains are ultimately human systems that directly affect societies and livelihoods. Focusing on the pharmaceutical and life sciences sector, Abe highlights the critical importance of quality, accessibility, and reliability. He explains that pharma supply chains go beyond operational complexity, as they are directly linked to patient health and wellbeing. He also points to global dependencies, such as the concentration of active pharmaceutical ingredient (API) production, and exposed vulnerabilities in ensuring access to essential medicines. Looking ahead, Abe identifies the skills that will be most in demand over the next five years. He emphasizes the growing importance of leadership, communication, and collaboration skills, as supply chain professionals must translate complex insights into actionable strategies across organizations. With increasing geopolitical uncertainty, technological advancement, and demand volatility, the ability to influence and align stakeholders will be critical. Finally, Abe shares his perspective on talent in the healthcare sector. He highlights the need to recruit individuals who are motivated by impact and committed to improving people’s lives. While digital transformation is essential for improving visibility and efficiency, he stresses that technology should be seen as a tool, not a replacement for human judgment. Evren and Abe conclude the conversation with a powerful reflection: supply chain is not a support function, but a critical, cross-functional discipline that plays a vital role in delivering what people need, when they need it—ultimately making a meaningful difference in the world.

Dose #24: Capacity Utilization and the Future of CDMOs with Tim Tyson (TriRx Pharmaceutical Services)

In this episode of SCW for Pharma, Evren Ozkaya welcomes Tim Tyson, Chairman and CEO of TriRx Pharmaceutical Services. The conversation begins with Tim’s professional journey in the pharmaceutical industry. Starting his career in operations and manufacturing, he worked closely with major pharmaceutical companies before rising to executive leadership roles at GSK, where he served as the president of the Global Manufacturing and Supply Division. Tim reflects on what continues to resonate with him about the pharmaceutical industry: the opportunity to contribute to life-altering and life-saving medicines that have a meaningful impact on patients around the world. Evren and Tim then compare the pharma services (CDMO) industry with consumer goods manufacturing. While the industries differ in many ways, Tim highlights a surprising similarity: both operate with relatively tight margins, making operational efficiency and continuous improvement essential for long-term competitiveness. The discussion then shifts to Tim’s perspective on the Contract Development and Manufacturing Organization (CDMO) business model. Tim explains that outsourcing specialized manufacturing capabilities allows pharmaceutical companies to increase efficiency and reduce costs, particularly when CDMOs can achieve higher capacity utilization across their facilities. He emphasizes that making the right investments in facilities and technologies is essential for serving both human and animal health markets effectively. A major challenge across the industry, however, is low capacity utilization. Tim notes that average utilization rates can be as low as 24%, while a sustainable business typically requires at least 40–45%. Although many CDMOs target utilization rates closer to 70%, regulatory constraints and market dynamics often make this difficult to achieve. According to Tim, improving utilization and operational efficiency will be critical for the long-term sustainability of pharmaceutical manufacturing. Evren and Tim also discuss the recent wave of investments in new pharmaceutical factories, particularly in the United States. Tim argues that from both an engineering and financial perspective, building new facilities may not always be the most rational solution when significant unused capacity already exists. Instead, he advocates for modernizing existing facilities, adopting new technologies, and improving operational performance to unlock value from current infrastructure. At the same time, the industry is experiencing growing regionalization, with reshoring trends emerging not only in the U.S. but also across Europe, China, and India. The conversation then turns to the role of visibility and digitalization in pharmaceutical manufacturing. Tim emphasizes that successful CDMOs must build strong customer relationships based on trust and consistently deliver products that meet regulatory standards and arrive on time and in full. Achieving this requires moving beyond fragmented spreadsheets toward digital factories that provide real-time operational visibility. With better data and transparency, organizations can identify hidden inefficiencies, drive continuous improvement, and maximize operational performance. Finally, the discussion addresses the growing interest in AI across the pharmaceutical sector. Tim believes predictive tools can provide meaningful value in manufacturing environments, particularly for identifying improvement opportunities and supporting data-driven decision-making. However, he stresses that organizations must first establish strong data foundations before.

Dose #23: Scaling Biologics CDMOs, Capacity, and Digitalization with Kevin Sharp (Samsung Biologics)

In this episode of SCW for Pharma, Evren Ozkaya welcomes Kevin Sharp, Executive Vice President and Head of Sales and Operations at Samsung Biologics. Kevin shares his more than 20 years of experience in the pharmaceutical industry, spanning procurement, manufacturing, supply chain, and business development roles across companies such as GSK, Contract Pharmacal Corp, and Samsung Biologics. With the last decade focused on biologics, he offers a broad and practical perspective on how the industry has evolved. The conversation begins with an overview of Samsung Biologics and its position in the CDMO market. Founded in 2011, Samsung Biologics has rapidly become a leader in biologics manufacturing capacity, leveraging Samsung’s deep engineering expertise and manufacturing DNA. Kevin explains how the company’s end-to-end CDMO model addresses one of the biggest pain points for biopharma companies: the cost, risk, and time associated with tech transfers across multiple suppliers. Evren and Kevin then dive into the unique complexity of biologics supply chains. Kevin highlights how longer planning horizons, strict quality requirements, and capacity slot management make timing and end-to-end coordination critical. As molecules become more complex and new drug modalities emerge, even small disruptions in sequencing or release timing can have significant consequences for quality and supply reliability. The discussion expands to broader biopharma trends, including the growing share of combination therapies and novel modalities. Kevin notes that a significant portion of products expected to be approved in the coming years will fall outside traditional standards, putting pressure on CDMOs to invest in modern facilities, scalable platforms, and standardized yet flexible production processes. He emphasizes that while there is room in the market for CDMOs of all sizes, larger players differentiate themselves through integrated, one-stop-shop capabilities and scalable capacity. Digitalization is another key theme of the episode. Kevin explains how Samsung Biologics applies its technology-driven heritage to biologics manufacturing, drawing parallels between semiconductor production and biopharma in terms of precision and environmental control. He discusses the use of MES, supply chain visibility tools, AI, and digital twins, and how real-time data transparency creates value for clients while improving consistency and operational performance. Finally, Evren and Kevin explore why digital transformation remains slow across much of the pharma CDMO landscape. Kevin points to investment requirements, long implementation timelines, sunk costs, and concerns about technology obsolescence as major barriers. He also shares advice for younger professionals in the industry, encouraging early exposure to different functions and the importance of building strong, long-term relationships. They conclude by reflecting on how capacity, technology, and adaptability will continue to shape the future of biologics manufacturing, and why companies that commit early to scalable platforms and digital foundations are likely to widen the gap in the years ahead.

Dose #22: Reducing Downtime and Unlocking Hidden Capacity in Pharma Manufacturing with Andrea Wagner (PharmaPhixx)

In this episode of SCW for Pharma, Evren Ozkaya welcomes Andrea Wagner, CEO of PharmaPhixx. The conversation begins with Andrea’s professional background, spanning academia and industry. She holds a doctorate in toxicology and a master’s degree in analytical chemistry and spent the early part of her career in universities before transitioning into the pharmaceutical industry. Andrea later co-founded a CDMO, built a manufacturing operation from the ground up, and successfully exited the business (Berkshire Sterile Manufacturing). In 2023, she founded PharmaPhixx, a company focused on helping CMOs and CDMOs reduce the negative impact of production downtime by partnering with pharma manufacturers, OEMs, and engineering organizations. Andrea also highlights her commitment to mentoring women in engineering and pharma, noting that the “xx” in PharmaPhixx represents women. Building a CDMO & Market Dynamics Evren and Andrea discuss the high barriers to entry in the CDMO sector, noting it took 18 months post-construction to secure a first client—a testament to the industry's long operational timelines. Regarding domestic capacity shifts in the U.S., Andrea argues that "overcapacity" is relative; while some segments are saturated, others remain constrained. She emphasizes that true capacity isn’t just about floor space—it requires years of regulatory approval and trust-building. The conversation highlights a major industry pain point: average equipment utilization (OEE) is only around 35%. Andrea explains how PharmaPhixx uses automation, robotics, and AI to minimize downtime and handle repetitive tasks, freeing engineers for higher-value work. Despite the industry’s slow digital adoption, she predicts a total transformation of pharma factories within the next decade, driven by the need for better data to improve P&L performance. Andrea identifies "operational firefighting" and financial constraints as the primary hurdles to modernization. She suggests that instead of relying on external advisors, senior management should empower internal operations teams—who understand the bottlenecks best—with the time and resources to innovate. The shift from paper-based systems to digital batch records is cited as the essential first step for AI applications like automated quality inspection. Andrea expects the FDA and EMA to accelerate the push for paperless systems as a younger, tech-savvy workforce takes over. The episode concludes with advice for young professionals and women in pharma. Andrea encourages them to build strong support networks and seek mentorship, reaffirming her commitment to developing the next generation of industry leaders.

Dose #21: Supply Chain Planning for Advanced Therapies and Overcoming Complexity with Tom Walls (Spark Therapeutics)

In this episode of SCW for Pharma, host Evren Ozkaya welcomes Tom Walls, former Head of Supply Chain Planning at Spark Therapeutics, a Roche company. The conversation kicks off with Tom sharing his career evolution from small molecules to his current focus on advanced therapy medicinal products, expressing his optimism for the potential of cell and gene therapies to treat many previously untreatable rare diseases. Evren and Tom then explore the different types of advanced therapies, clarifying that some are highly personalized (batch for a single patient) while others follow a bulk production model, all targeting rare diseases but never reaching the scale of high-volume small molecule drugs. The discussion then delves into the unique complexities of the cell and gene therapy supply chain. Tom outlines several challenges, including highly variable yields, the need for skilled teams for stability studies, small batch sizes leading to production difficulties, and the hurdles of country-specific regulations. He underscores that the short 36- to 72-hour shelf life necessitates precise scheduling, and the high cost of manufacturing capacity makes idle time a financial challenge. Tom confirms that this inherent complexity is a primary factor contributing to the therapies' high price points, often reaching the million-dollar plus range. Evren and Tom shift their focus to what defines a strong planning organization in this specialized field. Tom explains that top performers are clear communicators who make confident, data-aware decisions and can quickly align teams during unexpected issues. He highlights that planning covers several areas, including analytical, regulatory, and clinical planning, with risk management being central. Tom notes that while AI-driven production scheduling can help manage complexity and yield variability that traditional ERPs miss, the technology landscape remains fragmented, lacking a single holistic platform that covers regulatory, supply chain, demand planning, production scheduling and production monitoring domains. The conversation continues by examining the need to link planning and execution systems on top of others to understand the impact of decisions, especially with yield variability. Bringing planning and execution closer together supports optimization and strengthens communication, since plan adjustments need to translate into clear actions for teams on the ground. Evren then asks about tariffs, trade tensions, and reshoring in the United States. Tom explains that many inputs, from plasma materials to tubing components, come from China. While the US is large, not everything can be reshored due to the specialized nature of these materials. Decisions must be made carefully. They close by examining the role of AI in cell and gene therapy. Tom highlights the importance of linking regulatory, supply chain, demand planning, and execution. He sees opportunities in digital twins and anomaly detection to help teams manage risk more effectively. In the final segment, Tom shares the advice he would give his younger self. He wishes he had worked at more production sites to better understand how different operations run and how planning decisions affect people in manufacturing. He also would have spent more time with finance and regulatory teams, since planning sits at the intersection of all these functions. He encourages future professionals to build skills across these domains to succeed in this field.