Ask our experts

Do you need life sciences supply chain expert advice? Check our FAQ or submit your own question. We're happy to help you.

Jade Herbots

Senior Project Manager at OMP Belgium

Biography

As well as being a Senior Project Manager, Jade is the solution owner of our life sciences solution. She uses her expertise to optimize the supply chains of our customers and promote best practices for the life science industry.

Let's connect

Philip Verhulst

Senior Consultant at OMP Belgium

Biography

Philip, a Senior Consultant in the semi process team, collaborates closely with our customers in the life science industry to find the best possible solution for their complex planning problems.

Let's connect

  1. How are shelf-life constraints included in planning?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    Shelf-life rules are fully embedded in the planning engine. On the demand side, the minimum remaining shelf life requested can be handled per region, plant, DC, or customer. This requested shelf life is matched to total shelf life on the supply side. This also involves multilevel inheritance. For example, the drug product date of manufacture is used to calculate the shelf life of distributed finished goods. This minimizes disposal due to products exceeding their expiry date. Service levels are assured by planning for an expected shelf life.

  2. How do you include regulatory constraints in planning?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    The characteristics-based planning and registration frameworks in OMP allow full control of regulatory constraints. You can define product flavors, along with the sequence of plants, production lines, and working cell banks involved. Combined with batch-specific characteristics, the flavors can be linked to time-phased regulatory approvals at regional or national levels. This ensures that the right product is available in the right way at the right time, even in uncertain regulatory contexts.

  3. How do you manage the complexity of drug substance fermentation processes?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    OMP can model complex routings and recipes, with multiple operation steps in converging, diverging, and parallel sequences, as well as BOMs with continuous linear or non-linear product release and consumption. Our industry experts are familiar with typical production methods, for example perfusion or fed batch. They provide best practices guidance in modeling, allowing reality-based planning, resulting in optimal use of capacity.

  4. How do you manage external manufacturing and supplier collaboration?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    In OMP, CMOs and other suppliers are modeled as an integrated supply chain node providing full inventory visibility. Through the OMP cloud portal, suppliers can jointly work on the plan in an integrated way, managing committed supplies, planned capacity, and batch allocation, etc. In addition, it is possible to model contractually agreed minimum and maximum volumes and values over different time periods and product groups. Leading CMOs also use OMP as their SCP SOR.

  5. How do you manage the impact of clinical trials on the commercial supply chain?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    There is great value in integrating clinical and commercial supply chain planning processes, because there are multiple areas where they interact, such as competing for capacity on production lines. OMP allows you to plan both streams concurrently, allowing for separate ownership but shared visibility.

  6. How do you manage artwork changes on finished goods?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    Artwork versions can be modeled using time-phased bill of materials changes which can be linked to regulatory approvals at region or country level. This makes it possible to optimize the transition between artwork versions, minimizing wastage.

  7. How do you track and handle potency differences between drug substance batches?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    Potency factors are managed at batch level. In addition, an average expected potency factor can be defined for planned production. This factor is used to calculate grams of active ingredient from volume-based inventory projections. In more advanced optimizers, the factor allows the optimal blend of drug substance intermediates to be determined.

  8. How do you manage tank availability as a drug product scheduling constraint?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    Bottleneck tanks and other storage equipment can be modeled. Their degree of occupation is linked to filling and emptying production steps within or across multiple orders. Availability can be used as either a soft or a hard constraint, with smart solvers available to optimize the tank flow schedule.

  9. How do you apply quantity tolerances in automated planning?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    You can define rules on how and when to apply quantity tolerances, avoiding unwanted or unneeded new orders being created, ensuring plan stability and minimizing noise.

  10. How do you use downstream signals, such as POS data or other external data, in demand planning?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    Downstream POS or serialization data can be used to identify trends and anticipate sudden increases or decreases in upstream demand. In life sciences, IQVIA is a typical data source used for this purpose. Other examples include forecasting per therapeutic area based on parameters such as patient prevalence rates, bypassing the need for historical data. The net result is a more agile supply chain, able to respond more rapidly to such forces as market dynamics, competitor stockouts, and parallel trade.

  11. How do you manage QA/QC scheduling?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    Quality lead times can be modeled along with changeover, production, and transport times. This also allows for intense collaboration with quality department planners, who can sequence and prioritize batches for release, resulting in shorter lead times in the event of urgent patient need.

  12. How are product launches managed?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    Product life cycle management is fully embedded in both demand and supply planning, allowing the modeling of new product introductions, phase-in and phase-out (for example of artwork changes), and other types of events. In tracking inventory, it is possible to separate qualification batches from commercially approved batches. This all results in a quicker time to market for newly developed drugs.

  13. How do you deal with tenders?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    In OMP, tenders can be tracked separately from base demand and forecasting. You can assign certainty levels (probabilities) to be used in simulation planning. This ensures that your supply chain is prepared for any possible outcome.

  14. How do you track actual and future movements across the network using pegging?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    You can peg any demand and supply element in compliance with the various rules that you integrate into the model, including regulatory, quantity tolerance, and shelf-life related rules. In addition, pegging can be applied retroactively by tracing and storing the full genealogy of batches produced. This creates true end-to-end visibility over the internal and external networks, from the drug substance and its components all the way to final demand.

  15. How do you simulate changes in planning parameters such as safety stock?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    The what-if simulation framework in OMP allows you to make changes to master data parameters as well as demand and supply changes. This could include changes to safety stocks, shift plans, etc., allowing you to respond quickly to any possible future scenario.

  16. How do you apply campaigning and rhythm wheel production rules?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    Campaigning rules can be defined to group production runs with similar characteristics, on all levels from drug substances to finished goods, to reduce changeover times and allow lean manufacturing. Smart solvers are available to automatically derive the optimal campaign length and sequence, and apply fixed or dynamic rhythm wheels.

  17. How do you track inventory at batch level?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    Inventory can be tracked per batch and can be tracked separately per inventory type, such as ‘available’, ‘in quality inspection’, and ‘blocked’. In addition, batch characteristics such as shelf life are used in pegging and planning. OMP delivers a fully compliant plan which takes into account all the possible batch level constraints.

  18. How do you optimize inventory levels across the entire supply chain?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    OMP includes multi-echelon inventory optimization (MEIO). This involves a holistic calculation of optimal safety stocks across the entire network from the production of drug substances, drug products and finished goods to the distribution network. Global cost and value are optimized, with target service levels at end nodes. This reduces inventory levels while at the same time guaranteeing or even improving service levels.

  19. How do you deal with controlled substance quotas?

    Philip Verhulst

    Senior Consultant at OMP Belgium

    Production or inventory volume constraints over different time periods and groups of products can be modeled similarly to contractual agreements with CMOs.

  20. How do you manage multi-sourcing options in the network?

    Jade Herbots

    Senior Project Manager at OMP Belgium

    OMP offers full support for modeling multi-sourcing strategies. Using smart solvers, you can either predefine percentage splits (depending on plant targets) or automatically derive cost-optimal splits, while considering capacity and other constraints. This allows you to prepare your supply chain for future growth.


page

Not found what you were looking for?

Ask our experts!

 

By clicking Submit, you give OM Partners nv permission to store your personal contact details for further communication. Your contact details will be treated with care and in accordance with our privacy statement.

I give consent*