Forecasting is complex, there is no debating that. Being able to accurately forecast is important to running an effective clinical trial. It is therefore any clinical supply specialist’s dream to have the ability to forecast all the problems that will arise through the trial while ensuring delays are minimal. Doing this effectively allows you to budget, avoid over production and ensure accurate levels of supply.

Charlie Abrines sits down with David Larwood, CEO/President, Valley Fever Solutions, to discuss how forecasting and using Excel can trump the use of more sophisticated systems. What’s more, Larwood explains the challenges contract manufacturing poses to small biotechs’ ability to ensure trials run smoothly and without delay.

Clinical Trials Arena: What is the value of using Excel as a forecasting tool in comparison to purpose built forecasting systems?

David Larwood: At a certain scale, trials benefit greatly from specialized forecasting and SCM tools. But even at a very large scale, a simpler tool can provide great value, and even in parallel with the special tool.

You can get a lot of mileage with Excel. It’s a pretty useful tool if you know how to use it. When managing clinical supplies, especially if you are handling large chunks of information, you can use Excel because it has the available settings to enable you to process information quickly and effectively. Another asset of Excel is that you can easily share the information with others as everybody has access to the program. However, if you are using proprietary systems, others may not be able to open the information you might want to share with them. If, however, you are doing more specific things which require a more precise level of detail it may be more advisable to harness the power of specialised systems that can serve to forecast information in a more detailed manner.

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CTA: Is it cost-effective to invest in specifically designed software to carry out your forecasts?

DL: Programs, such as Microsoft Project or Enterprise and Resource Planning (ERP) tools are great because they allow you to forecast individual aspects of your supply chain while automating the system. However, while there is a value in investing in expensive tools, at the end of the day this doesn’t guarantee your forecasting will be more accurate than if you were using Excel. It’s important to note these systems can’t account for any unexpected changes that occur in your supply chain – unless you anticipated the given unknown, or can get that programmed in quickly.

CTA: How accurate are your forecasts?

DL: No matter how accurate your forecasts, we don’t work in a vacuum. As a small biotech we don’t manufacture our drug supply, so knowing what lead times manufacturers need to ensure our drug can be produced on time is paramount to ensuring the trial runs smoothly. Ultimately, no matter what projections you’ve made, if the manufacturer can’t slot your drug in then you may miss out and delay your trial further. This is even more important mid-trial where there may be a risk of losing a subject partway through the trial for lack of drug product supply.

CTA: What are the key challenges in contract manufacturing?

DL: One of the biggest issues here is slots timing. You may engage with a manufacturer who is working at 80 percent capacity, and you may find they’re unable to fit your order into their schedule, resulting in delayed drug production. One alternative to this is to have a second source – a company you can fall back on and rely to produce your drug. Having a second source is something that you can turn too if your first manufacturer bumps you and doesn’t allow you to produce on time. The other standard response to supply uncertainty is to maintain larger buffer stock inventory. Note that this needs to be managed, at a cost, and for many products the inventory may be at risk of expiring.

For small biotechs, it’s paramount to have a backup plan because it’s quite typical for manufactures to prioritize the orders of a larger company over that of your own. Another reason for doing this is that having a second source gives the sponsor protection against intermittent outrages and pricing fluctuations.

CTA: Why are small biotechs struggling to work alongside manufactures?

DL: In most cases the smaller companies get pushed to the back of the line because they don’t have the purchasing power that large pharmaceuticals possess. Large CMOs often cannot cater to the needs of small pharma whose orders are smaller than those of large pharma.

CTA: How are you going around solving this?

DL: We at Valley Fever Solutions are considering investing in our own manufacturing plant at a scale that becomes rational so that we can control the flow of our own production and not be affected by other companies being able to displace our order because of their size. By making this initial investment, we’ll be able to minimize delays and potentially manufacture for other pharma companies, which will help make a return on our investment quicker.


*David Larwood is the CEO/President of Valley Fever Solutions