Predictive Modeling, Validating Transport Conditions, and Anticounterfeiting

At PDA Week 2026, which is occurring from March 22-27 in Denver, Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, moderated the session, Predictive Insights and Digital Defense for Product Integrity. Presenters that spoke during the session provided a detailed look into the evolving landscape of pharmaceutical supply chain integrity and digital validation. Parikh sat down with PharmTech to give an overview of the presentations.

A major theme of the discussion, according to Parikh, was the shift toward predictive modeling and digital simulations in transport validation. While these simulations do not yet replace physical studies, they allow companies to identify risk drivers and model “worst-case scenarios,” such as extreme temperature fluctuations and varying transit durations.

Parikh says using hybrid qualification strategies that combine digital results with real-world data is currently the industry standard. However, regulatory bodies have been slow to adapt, leading to a lack of alignment on how to properly utilize simulated data in official validations.

For product authentication, the industry is exploring various digital tools, including AI, 2D barcodes, and mobile applications. Parikh observes that QR codes are being phased out because they are increasingly easy to counterfeit. Instead, organizations are moving toward 2D barcodes containing digital footprints. For these solutions to be truly scalable, they must be accessible to the end user. Parikh identifies smartphone apps as the most promising tool for patient-side authentication, as the widespread ownership of mobile devices makes this the “easiest, most scalable approach” for verifying a product at the point of use.

Counterfeiting continues to escalate as illicit actors become more sophisticated, according to Parikh. These individuals now use the same serial numbers, expiration dates, and labels as original manufacturers, making it difficult to distinguish fake products from real ones. This is especially prevalent in developing countries, where counterfeit drugs are often sold on local e-commerce sites like eBay. Parikh points out that partnering with local authorities to crack down on these operations remains a challenge.

Ultimately, technology alone is not enough; education and awareness are critical. Parikh emphasizes that many patients and healthcare providers do not naturally question the authenticity of their medication. Without proper training on how to use these new digital tools, the technology remains underutilized.

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Hello, my name is Malav Parikh, and I'm with Takeda. I'm the head of Global QRM for the Americas and R&D with Takeda, and I'm also the co-chair for PDA Week 2026 in Denver this year.

PharmTech: How are pharma companies using predictive modeling or simulation to design and validate transport conditions?

Parikh: I think, we heard a lot about it the session today, especially in the PDA, transport survey. My takeaway is that pharma companies are really relying on digital simulations to support transport validation, not to completely replace the physical studies, but the simulated data in general is being used a lot alongside the real-world qualification to understand, you know, first of all, be predictive, but also to understand what are the drivers of risk, what sort of stress conditions there are, and try and simulate those worst-case scenarios.

So, a lot of digital predictive tools are applied, in order to simulate the extremes, whether they are about the temperature or variability in the conditions or the durations, and so on. But one of the things I heard was that hybrid qualification strategies are more prevalent rather than, you know, simulated, results.

PharmTech: As digital authentication technologies (e.g., serialization, smart labels, mobile/QR or NFC-based verification) mature, what criteria are used to evaluate which solutions are truly scalable and GMP-ready?

Parikh: In the presentation, there was a lot of talk about all the different types of digital tools, including use of AI, 2D barcodes, and phone apps to sort of scan and authenticate, for the patient at point in time. So, a lot of those are being worked upon in the industry.

It looks like having something in the hands of the patient, like a phone app that can, you know, you can open your camera and scan a barcode on the product to authenticate it, seems to be the most scalable solution.

Everyone has an Android, everyone has a smartphone or an Apple phone. So, having those apps are definitely going to be probably the easiest, most scalable approach.

But alongside those, there are a lot of other technologies where they're trying to look at, you know, labels, making sure that the labels are verified, digitally, or they're using AI to predict the types of, you know, counterfeit areas that the people who try to counter-counterfeit would be using.

I think what we heard was that QR codes are going away, because it's easier to sort of counterfeit those, but 2D barcodes with digital footprints inserted into those 2D barcodes is something that a lot of organizations are, are moving into.

And in the beginning of your question, I said there are a lot of challenges with these digital tools as well. What I meant with that was, I think one of the biggest challenges even with using digital tools is the education and the awareness aspect.

Because even if you have all of these tools, the mindset of the patient users, doctors, if they're not thinking about could this be, could this product not be authentic I mean, when I take a medication, I'm not thinking whether or not it's authentic. I'm assuming it.

So, if I wasn't educated to actually use these digital tools, I wouldn't even be

trying to authenticate the product.

So, there's some challenges even with the digital tools.

PharmTech: What can you tell us about the presentation you moderated at PDA Week?

Well, there were two topics.

One of them was talking about how do we get ahead of the game and be a little bit more predictive when it comes to tackling with counterfeit products.

We saw how, in a lot of parts of the world, especially some of the developing countries, where drug products are being counterfeited, you can see them being sold on websites like eBay, which are local to those countries.

And, they're getting smarter. The counterfeit, folks are getting very, very smart with the way they counterfeit. They're using the same serial numbers as the original manufacturers, similar, expiration dates, same labels.

So, they're using a lot of the available technology to make sure that the product appears to be sort of authentic, when it's not.

That's a big challenge, especially in some of those countries, and it's not always easy to partner with local authorities to crack that down.

From the other session, we also learned that there were a hundred and four respondents for the PDA transport validation survey, and they unanimously agreed about, you know, the need for coming to an aligned solution as to what to do around transport validation.

But there's some challenges where regulators are slow to adapt.

The specific types of discussions around whether or not to use simulated studies, real-world data, those types of discussions are still where we're, we're seeing less alignment.

So, there's a need for call to action, for the broader industry to sort of take this survey and, and act upon it and, and come up with some sort of a white paper or something like that.

I think it, it was great. Maybe just from a counterfeit perspective, in the room, I saw a lot of energy. It seemed like it was pretty new to a lot of the participants, to learn about, you know, we talk about patient safety a lot in quality in GXP, but we don't necessarily see it from this angle where everything we do is to get the best quality product out there, but there are things outside of our control where people might be feeding, I mean, might be providing not authentic products to patients, and they impact patient safety.

So those are aspects that we don't always talk about, so it was pretty refreshing to see the energy in the room, to understand about it and perhaps do more about it.