Planning is the nervous system of the pharmaceutical supply chain. In few other industries must planners simultaneously contend with scientific uncertainty, evolving clinical programs, stringent regulatory requirements, long manufacturing lead times, constrained capacity, limited product shelf life, complex global supply networks, and patient demand that can change dramatically.
A planning decision made today can determine whether millions of dollars of inventory ultimately become obsolete—or whether a medicine reaches a patient when it is needed. For this reason, pharmaceutical planning must extend far beyond traditional Materials Requirements Planning (MRP), spreadsheets, and statistical forecasting. It must continuously balance capital, inventory, capacity, quality, scientific constraints, risk, and patient demand across the clinical-to-commercial continuum.
As part of the Bio Supply Management Alliance’s strategic mission to bring the expertise and innovative capabilities of industry solution providers to the broader Life Sciences community, Devendra Mishra, Executive Director and Co-Founder of BSMA, interviewed Peter Bigelow, CEO and Co-Founder of SCmple, to explore the changing role of pharmaceutical planning.
The conversation focused on three strategic outcomes: Reduce Working Capital. Reduce Waste. Reduce Risk to the Patient. Together, these objectives elevate planning from an operational process to a strategic business capability.
HIGHLIGHTS OF THE INTERVIEW
1. Why Traditional Planning No Longer Works
DEVENDRA: BioPharma is unlike almost any other industry. Clinical programs evolve continuously, regulatory pathways change, manufacturing lead times are long, and patient demand can shift rapidly. Planning therefore cannot be reduced to MRP calculations or statistical forecasting. How has SCmple reimagined pharmaceutical planning to address these realities—and particularly the need to balance inventory investment, obsolescence risk, supply continuity, and patient demand?
PETER: Planning in the pharmaceutical world is unique in many ways. Understanding obsolescence risk, receiving clear signals about when material needs to be ordered throughout the supply network, and optimizing inventory levels are absolutely critical. SCmple has drawn upon years of pharmaceutical supply chain experience to build a planning environment that provides accurate information and supports better decision-making. The objective is not simply to create another forecast. It is to give supply chain professionals the information they need to make the right decisions about materials and inventory throughout the network.
2. The Journey Beyond Spreadsheets
DEVENDRA: Many emerging biotechnology companies begin their planning journey with spreadsheets because they are inexpensive, familiar, and flexible. But as pipelines grow, the same flexibility can become a liability. Ordering signals can be missed, different versions of the truth emerge, and planners can inadvertently build too much—or too little—inventory.
When does an organization know that it has outgrown spreadsheet-based planning, and how can it make the transition without creating an expensive and overwhelming technology project?
PETER: Spreadsheets become problematic for a number of reasons. The fundamental issue is that it becomes easy to miss important ordering signals and consequently build either too much or too little inventory. Enterprise-wide decision-making is also hampered when planning resides in customized spreadsheets or systems that are not easily shared throughout the organization. SCmple provides a cloud-based, intuitive solution designed to retain much of the flexibility people value in spreadsheets while providing proven reports, metrics, and an integrated planning environment. The transition is therefore not about abandoning flexibility. It is about gaining control, visibility, consistency, and scalability.
3. How Should We Measure Planning Success?
DEVENDRA: Planning success has traditionally been measured by forecast accuracy. But from a CEO, CFO, or supply chain executive’s perspective, a perfect forecast is not the ultimate objective. The real questions are: Did we avoid a shortage? Did we prevent unnecessary inventory? Did we reduce working capital? Did we avoid an expedited shipment or a study delay? And ultimately, did we protect uninterrupted patient supply? How does SCmple define planning success beyond forecast accuracy?
PETER: You cannot reduce operational risk if you do not know where the risk resides or understand its magnitude. We define planning success as giving supply chain professionals access to clear and comprehensive analytics and a scenario-planning environment that can immediately map out alternatives when a supply concern is identified. Planning also has to integrate effectively with a company’s data and decision-making processes. And it must be scalable. As companies grow, add products to clinical trials and commercial production, and expand the people managing the supply chain, the planning processes must continue to meet the needs of the organization. Planning success, therefore, is not simply about producing a more accurate number. It is about enabling better decisions.
4. Breaking Down Organizational Silos
DEVENDRA: Inventory obsolescence is rarely caused by one planner making one bad decision. More often, it is the consequence of disconnects among Clinical Operations, Supply Chain, Manufacturing, Regulatory Affairs, Quality and Finance—magnified by long lead times, minimum batch quantities and limited shelf life. How does SCmple enable these functions—and potentially external partners—to plan from a common understanding of reality?
PETER: SCmple provides a “single source of truth” across the links of the supply chain. It can also be integrated with key Regulatory, Quality, Financial, and Inventory Management processes so that the relevant information remains connected and cross-linked. Where appropriate, suppliers, 3PLs, depots, and clinical IRT systems can also be integrated and aligned. This allows planning decisions to be based on current analytics and established planning parameters rather than disconnected information residing in different parts of the organization. The more effectively these functions and partners can operate from common information, the better the enterprise can anticipate risk rather than simply react to it.
5. When Pharmaceutical Science Becomes a Planning Variable
DEVENDRA: This is where pharmaceutical planning becomes fundamentally different from planning in most industries. A BioPharma planner cannot simply look at demand, capacity, and inventory. The planner must understand stability, temperature sensitivity, humidity and light exposure, release timelines, shelf life, CMC changes, and regulatory approvals. In other words, scientific information becomes supply chain information. How does SCmple incorporate these scientific and CMC parameters into planning decisions?
PETER: These critical parameters can be incorporated into the SCmple configuration by SKU and Material ID. Our scenario-planning capability also allows the supply chain professional to anticipate the impact that changes in CMC parameters could have. For example, many companies launch products with a reduced shelf life while anticipating approval of a longer shelf life once sufficient real-time stability data becomes available. SCmple can allow the planner to see the potential effect on inventory and obsolescence risk if that longer shelf life is subsequently approved. SCmple can also manage the complexity associated with multiple regulatory approvals across global markets. Our “pegging” capability links API and starting materials to the appropriate steps through the supply chain and ultimately to finished product, while FEFO—first expiration, first out—logic helps optimize inventory according to expiry.
6. Balancing Working Capital, Inventory and Patient Risk
DEVENDRA: Every pharmaceutical planner faces a fundamental dilemma. Too little inventory creates the possibility of shortages, delayed clinical trials, missed launches, and interrupted patient supply. Too much inventory consumes working capital and creates exposure to expiration and obsolescence. At the same time, the planner must contend with GMP requirements, manufacturing capacity, long lead times, shelf life, service levels, and cost. How do you help the planner find the right balance?
PETER: It starts with having the best possible data to facilitate decision-making. SCmple provides deep analytics and metrics, easy-to-understand S&OP-style graphics, and comprehensive scenario-planning capabilities. We also incorporate Cost of Goods information into the planning process. This allows supply chain professionals to understand not only where operational risks exist but also their financial implications. The result is an environment in which people across the organization can collaborate and make more timely and informed decisions.
7. Extending Planning Beyond the Enterprise
DEVENDRA: The pharmaceutical supply chain no longer resides within the four walls of the company. CDMOs, CMOs, API and raw-material suppliers, packaging partners, logistics providers, 3PLs, clinical depots, and technology providers may all participate in delivering a single therapy. How does planning become a collaborative capability across this extended ecosystem?
PETER: SCmple provides tools and methodologies to collaborate with and manage relationships across supply chain partners. For example, internal forecasts can be converted into clear multiyear forecasts for suppliers. Supplier processes can be integrated to provide visibility into shipping dates, work-in-process status, quality issues, and other important information. Clinical systems such as IRTs and depots can be connected so that the organization can react more quickly to changes in supply requirements. SCmple can also integrate with ERP systems and 3PLs to share inventory and sales information at the frequency required by the organization. The objective is to create visibility across the network so decisions can be made before an emerging issue becomes a disruption.
8. Artificial Intelligence: From Building Scenarios to Asking Questions
DEVENDRA: Traditional planning asks the planner to construct a forecast and then manage deviations from it. The future may be very different. AI could allow planners to continuously evaluate multiple possible futures. How is SCmple incorporating Artificial Intelligence into scenario planning, forecasting, and decision support?
PETER: First, our software-development team is already using AI in its own work and has experienced a substantial increase in productivity. Second, we are implementing AI capabilities within the planning platform. One area is Conversational Scenario Planning, where the supply chain professional will be able to ask a “what-if” question in plain language and receive an answer without manually building the scenario. We are also developing an AI-enabled tool for Clinical and Commercial forecasting. Finally, we are implementing Intelligent Plan Monitoring & Proactive Alerting, where SCmple continuously monitors the plan and surfaces the exceptions that require the planner’s attention. The opportunity is to allow technology to handle more of the monitoring and analysis while enabling the planner to concentrate on the decisions that require judgment.
9. Planning Across the Clinical-to-Commercial Continuum
DEVENDRA: Clinical and commercial supply planning share a common foundation, but they operate in very different worlds. Clinical planning faces uncertain enrollment, evolving protocols, limited historical demand, blinding requirements and changing shelf life. Commercial planning operates with more established demand patterns and larger-scale supply requirements. How can one planning architecture support the product from early clinical development through commercialization?
PETER: Clinical trial material and commercial product planning are in some ways similar and in other ways very different. As SCmple Co-Founder Dilip Tavargeri likes to say, “Planning is planning.” The fundamental principles remain the same: start with a forecast, determine which materials are required to meet that forecast, and develop a plan to make those materials available at every stage of the supply network. But managing that plan in the clinical environment is vastly different. In a blinded study, distributors—and even the patients themselves—may not know which product they are receiving. I cannot think of another supply chain application with that kind of complexity. SCmple is designed to support both environments and, importantly, the transition between Clinical and Commercial, when materials such as API may simultaneously be required for ongoing clinical trials and commercial production.
10. From Reports to Executive Decision Intelligence
DEVENDRA: Senior executives do not need more reports. They need to know where risk is emerging, what it could cost, what alternatives exist, and what decision needs to be made. How does SCmple convert planning data into executive decision intelligence?
PETER: SCmple has analytical capabilities that can be configured into meaningful reports and graphics. These can take the form of standard reporting or be customized to meet the sponsor’s requirements. As long as the necessary data resides within SCmple, it can be represented in the manner most appropriate for decision-making. Our customers find that SCmple makes S&OP reporting considerably easier and improves informed decision-making at multiple levels of the organization.
11. Implementation and Time to Value
DEVENDRA: Technology has no value until people use it successfully. BioPharma companies—particularly emerging companies—cannot afford multiyear planning transformations.
What does implementation require, and how quickly can an organization begin receiving value?
PETER: One of SCmple’s strengths is that it can be implemented relatively quickly, allowing customers to begin obtaining value from the platform in a short period. We typically see implementations taking approximately 8 to 15 weeks. The implementation includes data loading, training, system integration, and testing. Because the product is designed to be intuitive, users can come up to speed quickly. We also provide an extended hypercare period after go-live so that we remain engaged with the customer and can address concerns quickly.
12. Five Years From Now: Will AI Replace the Planner?
DEVENDRA: Looking ahead five years, AI, autonomous decision support, digital twins, connected ecosystems, and increasingly intelligent planning systems could transform the profession. What will the pharmaceutical planner of the future actually do—and how is SCmple preparing for that future?
PETER: I have two bold predictions about pharmaceutical supply chain planning five years from now. First, the impact of AI will be profound. Data will become increasingly accurate, automatically generated, and shared more effortlessly from process to process. Considerably less time will be required for data input, and data integrity should improve dramatically. My second prediction is equally important: the need for human interpretation, priority-setting, and decision-making will not go away. Understanding risk, building consensus, establishing priorities, and making decisions that involve complex compromises will remain the responsibility of supply chain professionals and pharmaceutical executives. SCmple is committed to making planning as efficient and optimized as possible, and we look forward to continuing to contribute to supply chain innovation.
BSMA PERSPECTIVE: THE STRATEGIC IMPERATIVE OF PLANNING
DEVENDRA MISHRA: My conversation with Peter reinforces why BSMA considers planning to be far more consequential than forecasting. Planning is where science meets operations, where uncertainty meets capital, and where corporate decisions ultimately meet the patient. Every unnecessary batch consumes capital. Every unit that expires represents both financial and societal waste. Every shortage creates risk. And every failure to anticipate a disruption can ultimately affect a patient waiting for therapy. The strategic progression is therefore compelling:
Better Visibility → Better Planning → Better Decisions → Less Working Capital → Less Waste → Lower Risk → Better Patient Care
Artificial Intelligence will undoubtedly make planning faster, more predictive, and increasingly autonomous. But Peter makes an equally important point: technology does not eliminate the responsibility of the planner. It elevates it. The planner of tomorrow will spend less time assembling numbers and more time interpreting risk, evaluating alternatives, reconciling competing priorities, and orchestrating decisions across an increasingly complex ecosystem. That is the paradigm shift BSMA seeks to advance. Because the ultimate measure of pharmaceutical supply chain performance is not simply forecast accuracy, inventory turns, or cost.
It is whether the right therapy reaches the right patient at the right time. Flawless execution in the supply chain saves human lives. This structure, in my view, is stronger than converting the interview into a conventional press article. It gives you two voices: Devendra as the industry thought leader who frames the problem, and Peter as the experienced pharmaceutical executive who explains the solution and practical implications. It also preserves Peter’s particularly important observation that clinical planning differs profoundly because in a blinded trial even distributors and patients may not know which product is being supplied.
About Peter Bigelow
Peter Bigelow is Co-Founder and CEO of SCmple. His career spans senior leadership roles across pharmaceutical manufacturing, operations, and supply chain management. Prior to co-founding SCmple, he served the industry as an advisor and consultant. Earlier leadership positions included Division President of Qualitest, Endo Pharmaceuticals’ generic drug division, and President of North America Commercial Operations and CEO at Patheon Pharmaceuticals.
Bigelow also spent 14 years with Wyeth Pharmaceuticals, where his responsibilities included major portions of Manufacturing and Supply Chain across consumer products, branded pharmaceuticals, and vaccines, as well as global engineering and expansion programs supporting pharmaceutical manufacturing and R&D. Earlier, he spent 14 years with SmithKline Beecham, now part of GSK, including international assignments and experience in injectable-product manufacturing.
He holds a BS in Mechanical Engineering from Villanova University and an MBA from Philadelphia University.
About the BSMA Executive Interview Series
The Bio Supply Management Alliance engages CEOs, innovators, and leaders from service-provider companies within the BSMA community to bring their experience, technologies, capabilities, and perspectives to the broader Life Sciences industry.
The purpose extends beyond showcasing solutions. BSMA seeks to create an industry platform where practitioners can learn about innovations capable of solving consequential supply chain problems, improve operational and financial performance, accelerate the adoption of best practices, and ultimately improve the delivery of therapies to patients.
Media and Industry Contact
Devendra Mishra
Executive Director & Co-Founder
Bio Supply Management Alliance (BSMA)
818-224-1552
devendra@biosupplyalliance.com
