Natalie Balanovsky, Manager of Strategic Innovation
Natalie Balanovsky, Manager of Strategic Innovation, started at Almac in 2015. In her time here at Almac she has worked in various groups including Project Services Operations, and now Business Systems. Natalie has held various roles including Global Project Leader and Project Manager of Distribution, her role in Project Services has awarded Natalie the opportunity to partner with sponsors to implement a lean management method to effectively reduce waste and optimize efficiency.
Natalie went on to apply the lean principles to her role as Just In Time Manufacturing Solutions Manager, part of Almac’s strategic initiative to develop solutions that support our customers need for adaptive, efficient supply chain strategies. As the Manager of Strategic Innovation, Natalie will continue to build upon her contributions and deliver on Almac’s strategic imperative “to drive intelligent, value-based solutions focusing on simplification & acceleration to enhance the customer & patient experience.”
Natalie has over 20 years of professional experience within Project Management, Business Development, GMP Operations, and Quality Compliance. She holds a Bachelor of Science degree in Business from Delaware Valley University and a Master of Business Administration degree from LaSalle University. She is a certified Project Management Professional and a Member of the Delaware Valley Chapter of Project Management Institute.Contact us
Ask the expert
Ten minutes with Almac’s Natalie Balanovsky, Manager of Strategic Innovation
The challenges associated with the production, storage and distribution of high value, low stability biologics are complex. Without sufficient internal resource (the proven people, processes, infrastructure and technology) needed to take compounds through each stage of development, risk can escalate and outweigh potential reward for small and medium sized biotechs.
One of the ways biotechs can reduce risk and promote optimized supply chains is by embracing a demand led, Just in Time Manufacturing (JTM) approach.
But what exactly is JTM and how do you know if it’s a sound investment for your next biologics study? We’ve compiled some of the most frequently asked questions surrounding JTM and put them to our in-house expert, Natalie Balanovsky.
Here’s what she had to say…
How can JTM help studies eliminate delays and meet timelines?
One of the biggest benefits of JTM, especially for biotechs working with limited availability of expensive, time sensitive products, is its ability to eliminate delays and keep timelines on track.
Generally speaking, the best way to think about JTM in relation to avoiding delay is to see it as a strategy that aligns speed with need throughout the clinical supply chain. This reduces set-up times and allows sponsors to produce smaller lots based on shorter projection windows. The shorter timelines enable clinical teams to meet key milestones sooner and implement rapid responses to mid-study protocol changes that effect supplies.
How does JTM deliver waste reduction and cost savings?
This is one of the questions sponsors ask most frequently and for good reason. With fewer goods being produced and shipped to sites, storage, distribution and destruction costs will typically be lower utilizing JTM. Equally, when JTM is used for pooled studies, the need to source and purchase less IMP and comparators translates into tangible cost savings.
However, the big sell for JTM relates to waste reduction, which is particularly beneficial for biotechs dealing with high value, low stability products. Significantly less waste is generated because supply overages are not required.
We know that around half of sites fail to recruit in line with estimates. This means that seeding stock – produced through batch manufacturing – will remain unused and require replacement, due to expiration. We also know that a bulk approach requires sponsors to forecast large quantities of bulk drug for packaging, which typically see errors of 50%-200%. Yet if these studies are changed or stopped mid-stream, all is lost.
Contrastingly, with JTM, clinical supplies remain unpackaged and unlabelled in inventory and can be utilized in another configuration for the same or a different study as and when site or patient need arises.
Does JTM provide operational flexibility?
The fundamental premise of JTM is to enhance flexibility, while achieving operational efficiencies and preserving drug product, and there are multiple ways this can be realized across the clinical trial process. For example, as supplies are prepared only as needed, study changes may be implemented almost immediately.
Another example relates to labelling. Labels are printed on demand rather than being pre-printed en masse, which increases flexibility of the packaging and labelling process. JTM also facilitates the use of labels containing variable text, like site and patient-specific information: a capability that will become increasingly important as the number of patient-centric medications under development increases.
What if the study requires personalized, patient-centric kits/dosing levels?
JTM is perfect for personalized studies that incorporate patient-centric dosing. Unlike batch manufacturing, which adopts a one-size-kit-fits-all approach, JTM creates a personalized kit for each patient.
So, instead of patients using what is prescribed for them and wasting the remainder of the kit’s contents – leading to misunderstanding of and in some cases non-compliance with prescription instructions, as well as frustration that can lead to patients dropping out of the trial, patients receive kits that meet their individual dosing needs. This reduces waste of precious IMP, while JTM’s single panel, country-specific labels provide enhanced patient experience and, with text in patients’ native languages, lowers the risk of misunderstanding or misuse of medication.