In this interview, NewsMed spoke with Joseph P. Ivan regarding the Comprehensive Assessment and Management Approach to Optimizing Pharmaceutical Supply Chains.
How do you optimize supply chain strategies while navigating the complexities of international regulation guidelines?
Navigating international regulations demands the employment of diverse strategies. While consolidating supplies into a single global source is an ideal scenario, it often proves impractical due to various factors, such as differing timelines, that require strategic adaptations.
A specific approach may entail prioritizing certain locations, such as Georgia, for early implementation, with subsequent plans for their inclusion in resupply operations.
Regulatory filings, such as IMPD, demand meticulous attention to detail, which can vary from one European country to another and extend to regions like Latin America and Asia Pacific.
Each country’s acceptance of stability data, such as Georgia’s 12-month period and Bosnia’s 18-month periods, necessitates thorough consideration. Effectively managing this complexity across a range of countries requires precise organization, typically utilizing tools like Excel to monitor country-specific regulations, product details, expiry dates, IMPD versions, and other pertinent supply chain details. This process is labor-intensive.
Could you describe a strategy you have employed to harmonize supply chain processes internationally in addition to the Excel files?
Executing processes in countries like Georgia and Bosnia may begin with tailored approaches, possibly using individualized panels, while simultaneously considering plans for expansion to encompass a broader range of European nations and those within their vicinity, with a focus on the Quality Person (QP) aspect.
The strategy entails beginning with simpler countries using these panels, then progressing to develop a comprehensive guidebook that encompasses all targeted nations, ensuring alignment with various health regulatory filings. This approach necessitates careful attention to regulatory considerations.
As a subsequent step, consolidating supplies into a unified global inventory leads to the creation of a single, potentially extensive guidebook, possibly spanning 100 pages, outlining the specific requirements of each country. However, this method may encounter challenges in universal acceptance due to unique formulations or expiry date regulations in certain nations. In such cases, a customized approach becomes imperative.
For instance, India mandates specific manufacturer and manufacturing date details on labels, a requirement not uniformly observed across Europe. As such, maintaining India on an individual panel basis is prudent to prevent unnecessary information from being presented to countries with differing regulations, thus aiming for a harmonized supply strategy.
In pharmaceutical supply chains, what proactive steps have you found to be most successful in reducing risk?
The proactive approach involves having a supply chain expert who can pose pertinent questions while devising your strategy. Brazil imposes distinct requirements at its pharmaceutical port of entry.
For example, following the completion of global supply preparations and the compilation of a booklet containing expiration dates, it is sent to a depot in Brazil during an ongoing trial. As the trial progresses smoothly, updating the expiration date becomes necessary. This entails sending new labels to Brazil, which World Courier can deliver, to be applied over the old expiration date, providing a convenient solution for updates.
However, importing these labels into Brazil raises regulatory considerations. The labels contain an adhesive component, are deemed a chemical, and must be listed on the import license, health authority filing, and pro forma invoice, thereby incurring taxes.
This requirement is a reflection of Brazil’s customs and health authorities’ efforts to ensure the legality of adhesives within the country, underscoring the unique regulatory environments across nations. The introduction of regulations such as mandates for biodegradable plastic bags highlights the intricate nature of aligning supply chains with global environmental and health standards.
These details underscore the importance of initiating early and consistent discussions, necessitating the expertise of a professional or subject matter expert skilled in navigating such intricacies. Without such expertise, even a Clinical Operations (ClinOps) professional with a directorial position might encounter challenges, as they lack the insight to pose relevant questions for efficient supply chain management.
Could you give an example of how a risk-based management strategy improves the overall supply chain compliance?
There are various stages of manufacturing, including API, drug substance, and the final drug product, each involving several lengthy processes that carry associated risks. These risks may include potential specification failures, increased impurities, or incorrect capsule assembly.
From a risk-based perspective, there are numerous tools available. These can be as simple as an Excel document to help identify risk. It is essential to ask appropriate questions and determine whether a risk exists or not. If so, it can then be identified and categorized accordingly.
How does technological integration affect the regulatory compliance and product quality of pharmaceutical supply chains?
Consider the scenario in the United States, mirroring similar processes in other countries, where various government agencies closely examine incoming shipments. These include Customs and Border Protection, which is responsible for tax collection; the Food and Drug Administration (FDA), which serves as the health authority; and the United States Department of Agriculture (USDA), which ensures adherence to regulations concerning animal-derived products.
Depending on the nature of the product, involvement from agencies such as the Environmental Protection Agency or the Nuclear Regulatory Commission might also be required. These agencies utilize a technological platform accessible by customs brokers at entry points, facilitating the efficient coding and processing of shipments.
Known as the Automated Commercial Environment (ACE), this platform enables seamless interaction among these agencies by facilitating the submission and review of tariff codes, FedEx details, FDA product codes, and USDA guideline exemptions for items containing animal parts but classified as pharmaceutical grade. This classification exempts them from certain permits.
The efficiency of the system relies on the accurate entry of these codes. Correct submissions allow shipments to bypass manual inspection, proceeding directly to logistics providers like FedEx or DHL for delivery. However, inaccuracies can disrupt the system, prompting inspection by a compliance officer and potentially causing delays. While random inspections are possible, accurate code submissions typically ensure expedited clearance, with officials essentially confirming the shipment’s compliance without further scrutiny.
In what ways does DSI’s methodology improve clinical and commercial supply chain management and overrides?
Having a skilled professional or an individual with the necessary level of experience supporting either your commercial supply chain or clinical supply chain ensures they can adeptly pose relevant questions to the appropriate people.
DSI has the capacity to bring in a professional like myself. In the realm of consultancy, smaller companies may find it impractical to hire a full-time employee, nor is it necessary. Consulting offers access to a wealth of expertise on an as-needed basis, allowing clients to pay only for the services they use.
From a business and cutting purchase orders standpoint, it is really easy for clients to add and subtract services as they need. Supply chain is one of those services.
Similarly, in commercial operations, it is not uncommon for organizations to consider reassigning a Clinical Supplies Director to oversee a commercial product launch. However, while the underlying principles may seem similar, the practical aspects of clinical and commercial operations differ significantly. A clinical expert lacking commercial experience may find themselves unprepared and unaware of the specific inquiries essential for a successful commercial debut.
This is where DSI steps in, providing the expertise of professionals like myself who have experience navigating commercial launches. We formulate the necessary questions and facilitate connections with essential partners for tasks such as acquiring state licenses or implementing supply chain security measures, which often include assigning unique serial numbers to products.
Selecting the appropriate partner for these tasks is critical, and we guide clients on how to effectively engage with these companies, stressing the importance of asking the right questions during the contracting process.
What benefits have you seen from optimizing and assessing the end-to-end supply chain?
The primary advantage lies in the cost. When executed correctly from the outset, millions of dollars can be saved on your supply chain.
Efficiently optimizing your supply chain demands an initial investment in effort, time, and overhead expenses. Nonetheless, this initial investment proves to be economically viable over time, as the resultant savings from the optimization far exceed the initial expenditures.
How can ERP software help to modernize pharmaceutical supply chain operations?
In the clinical sector, third-party services known as Clinical Enterprise Resource Planning (ERP) are available for purchase. Within clinical contexts, the corresponding term is IRT, or Interactive Response Technology, which refers to software designed to aid in randomization processes.
In blinded clinical trials, effective management of inventory and coordination of shipments are crucial tasks. Specialized software is employed from the outset to handle these responsibilities, including the distribution of supplies to various depots or sites.
This system allows site personnel to easily select medications for patients with a simple click. Such management tools are particularly invaluable in large, blinded trials, where their absence could lead to increased costs and complexity without significant benefits. Conversely, for smaller trials, the added expense and complexity of such tools may not justify their use.
However, in larger, double-blinded trials spanning multiple countries and involving thousands of patients, the utilization of Interactive Response Technology (IRT) becomes indispensable. Without IRT, the coordination of inventory across potentially hundreds of sites in various countries would necessitate manual oversight, a task far more efficiently handled by software.
Similarly, in the commercial sector, Enterprise Resource Planning (ERP) systems serve a comparable function by managing resources and information across the enterprise. Nevertheless, for startups or small companies with a limited product range, investing in an ERP system may prove to be uneconomical, potentially resulting in unnecessary expenditure and complications.
Initial reliance on simpler solutions, like spreadsheets or basic financial software, can suffice until the business expands. However, as the product range, geographic scope, and operational complexity increase, the investment in an ERP system becomes justifiable despite its high cost and maintenance requirements. This is because an ERP system streamlines operations across multiple sites and distribution centers. Nonetheless, it is crucial to recognize that the effectiveness of an ERP system is directly linked to the accuracy of the data inputted into it, making it less advisable for companies with only a few products.
What are some of the difficulties in integrated cloud-based ERP solutions in the biomedical and pharmaceutical industries?
Consider a scenario where a biotech company decides to forego an Enterprise Resource Planning (ERP) system during the launch of its inaugural commercial product, deeming it an unnecessary expense. Later, the company acquires an additional asset from another entity or develops a second product in-house. Over a few years, this pattern continues, and the company finds itself with three commercial products. The challenge then becomes integrating the extensive data accumulated from these products over six or seven years into an ERP system, necessitating a significant data management project.
Once integrated, the company shifts its focus towards the ongoing maintenance of the ERP system. With the ERP system being cloud-based, the company benefits from reduced risk; even in the event of physical disasters like fires or tornadoes, the data remains secure on remote servers with backup systems in place, ensuring data preservation.
However, the efficacy of the ERP system relies heavily on the quality and accuracy of the inputted data. Integrating with other systems, such as Interactive Response Technology (IRT) or external commercial vendors like McKesson or its subcontractors, introduces additional complexities. Seamless communication between different ERP systems poses a logistical challenge, underscoring the importance of efficient data flow management both into and out of the system.
How can specialized ERP solutions for the pharmaceutical industries help with supply chain optimization and cost reduction?
Some of the IRTs come equipped with built-in optimizers, and some perform exceptionally well in this regard. However, it’s essential to have a comprehensive understanding of the software’s functionality to maximize its benefits.
Some of the other IRTs are simpler, allowing users to establish buffer stock levels. Users can optimize their inventory management by defining their stocks and avoiding triggers for orders of minimal quantities. Additionally, users can wait until a certain threshold, such as 50 units, is reached before initiating orders, thereby reducing shipping costs.
Each time a shipment arrives, someone needs to receive it, unpack it, inspect it, and update the online solution accordingly. Whether they perform these tasks daily for a single unit or once every 50 days, the process is quicker and easier when done less frequently. Users will also save money from a bandwidth perspective. Again, it boils down to a question of value proposition. You must balance the investment in your IRT or ERP system with the bandwidth and potential shipping costs you may incur.
From an optimization standpoint, Excel comes into play once more. Excel is a fantastic program that offers optimization tools if you don’t want to make a significant financial investment. However, to fully utilize its potential, it’s essential to involve a subject matter expert in programming or development. Such experts can leverage their past experiences and tools to tailor solutions specifically to the current scenario.
About Joseph P. Ivan
Mr. Ivan has over 20 years of experience in the pharmaceutical industry, eight years in manufacturing, and 12 years in supply chain. He has designed, implemented, and managed both clinical and commercial supply organizations for various-sized companies.
Ivan’s experience includes protocol development and review, forecasting, label management, inventory management, IRT management, ancillary supply management and global logistics management for all clinical phases, protocol types (blinded, open) and world regions.
His specialties include North America, Asia Pacific, the European Union, Eastern Europe, and Latin America. In particular, he is a subject matter expert for importing clinical drugs into China. He has authored and managed site and subject-facing materials such as Pharmacy Manuals and Dose Card instructions. Additionally, he holds certification as an International Trade Compliance Certified (ITCC) professional for Import/Export operations in the US.
As a leader in bioanalytical laboratory testing, his experience includes assay development, validation, and execution for clinical laboratory operations supporting clinical operations.
