Tuesday, 23 April, 2024

07 Jul 2023 | Australasian Dental Practice

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An interview with Dr Mark Spilker, Chief Science Officer of Geistlich Pharma AG

By Joseph Allbeury

During my recent visit to the headquarters of Geistlich Pharma AG, I again caught up with Chief Scientific Officer, Dr Mark Spilker. Dr Spilker has a Bachelors degree in Mechanical Engineering from the University of Utah and a Masters and PhD in Mechanical Engineering from MIT. Prior to joining Geistlich as its CSO, he was Executive Vice President, R&D, QA and Regulatory Affairs at MTF Biologics and before that VP, Neurosurgical Marketing and Product Development at Integra LifeSciences.


Great to see you again, Mark and thank you for your time. Can I start by asking why is Geistlich and the products it creates so unique?

Well, I've been working in the area of regeneration and collagen since 1994, with multiple companies including using animal sources for regenerative technologies and human tissue banking. When I came to Geistlich six and a half years ago, I learned that Geistlich does things in a unique way, like how we treat animal tissues, not only bone but also collagen and soft tissue. The approaches that Geistlich uses to purify and refine these materials are very, very different from anything I had seen in my previous career.

Of course, there are some common elements, for example our regenerative goal and also some of our biomaterials, like collagen and calcium-based mineral. However, Geistlich has taken a distinctively different direction. Geistlich has an extensive history and experience in processing animal tissues for purposes like glue, gelatin and fertilizer, spanning over a century. This history has shaped our unique perspective. Our approach goes beyond pure scientific methodology by incorporating learnings from our hands-on craft cultivated by the family over this extensive duration. Geistlich brought together the science and this hands-on craft to create a really unique approach to providing these final refined regenerative materials.

And so, from your perspective, obviously being a noted scientist to the point where you were hired as the Chief Science Officer, was this a very enlightening moment for you?

Well, I have to admit, yes it was. Of course, I knew a lot and believed quite a bit in the background that I already had and I did believe that I could come to Geistlich and add a lot of value in terms of processing and preparing these materials. And it ended up being a little bit the opposite. To be frank, I learned more information about processing materials than I brought. But I was able to add value in terms of translating these concepts into new products and clinical solutions. I helped Geistlich to establish an R&D function that is effective at connecting with customers and building a portfolio that meets customer needs by leveraging the really cool things that I learned about when I arrived.

And what do you think your achievements are in your six and a half years at Geistlich?

From my side, the Geistlich CSO team is really proud of what we've done over the last few years with regard to expanding our product portfolio and with regard to bringing products into the hands of our customers.

In terms of the breadth of our internal portfolio, things are progressing nicely and with regard to recent new product launches, we recently launched an anti-infective product for Europe called Pocket-X® for non-surgical periodontitis treatment and to help boost regeneration.

We're also launching a very unique new product called REGENFAST® that brings together the healing advantages of hyaluronic acid with unique chemical activity from polynucleotides that are intended to enhance regeneration. We've also added a growth factor to our portfolio in the form of recombinant human platelet-derived growth factor (PDGF) through the acquisition of Lynch Biologics.

So we have really expanded the toolbox of unique offerings that Geistlich is bringing to customers. And we are quite proud of what we have done in that regard in the last couple of years.

The last time I was here, which was about the same time in 2019, we didn't have Geistlich Fibro-Gide® in Australia at that stage and now we do. And I hear that it's going very well. And I see there is continuing development of that product with the introduction of a 3mm thickness version. What's next that you can talk about?

What we are seeing with Geistlich Fibro-Gide® is that it is entering a phase where the clinical experience and evidence are becoming very important for determining the best target indications and with which techniques it should be applied. So, the thinner version is a result of the clinical experience. It was clear that a smaller volume was needed for some indications. We are currently supporting quite a few clinical studies in which Geistlich Fibro-Gide® is being evaluated in different anatomies and for different indications.

Is that driving new product development in this area?

It's not necessarily driving new product development. But I would say it's now refining and filling out the clinical evidence that shows where this product can be used successfully and where it cannot. Every product has its limits and I think Geistlich Fibro-Gide®, as a relatively new technology, is being applied and evaluated in a wide range of soft tissue indications, and Geistlich is continuing to evaluate outcomes and expand our recommendations, when supported by the data. Furthermore, it's worth noting that various collagen matrices, including Geistlich Fibro-Gide®, are now being employed in conjunction with other bioactive substances. Therefore, regarding the future of Geistlich Fibro-Gide® technology, we anticipate that clinicians will combine it with elements like growth factors or the aforementioned bioactives such as polynucleotides. In numerous countries, it's already being combined with blood fractions like PRF, and there are even prospects of future combinations in the USA involving growth factors like PDGF, which is an approved product there.

And so, in terms of your new product pipeline, as much as you alluded to before, where do you come up with something that is brand new?

I think the area of synthetic bone substitutes remains a focus area for Geistlich. Number one, we know that there are certain groups of patients, depending on religion or depending on a personal preference, who avoid animal-derived products and will only rely on a synthetic material to meet their needs. So, Geistlich is actively engaged in the development of synthetic bone substitutes. To be clear, these are in the pipeline. They will not be coming to market in the immediate future, but we are definitely looking at meeting certain customer needs in this area. There is also a need for bioactive bone substitutes that can foster quick, rapid bone formation. So this is where the synthetics could meet multiple customer needs in the future.

In terms of looking at the regenerative market in its entirety, do you believe that using bovine bone as opposed to human bone allografts or synthetic products is the optimal pathway? Assuming you have no religious or other predisposition?

Absolutely. The level of favourable evidence for bovine bone by far exceeds the level of evidence for any other technology in terms of a bone substitute for dental and oral applications. There are limitations though. And one of those relates to individuals who have preferences for a synthetic option and it seems like the population of those individuals is actually growing. They will not accept a bovine substitute even though the level of evidence is quite high. So to that end, a company like Geistlich is compelled to look at synthetics because we are completely and ultimately customer focused. Synthetics do offer some additional flexibility because we can create them chemically from the ground up rather than from a bovine-derived raw material. Geistlich has provided best-in-class solutions from bovine chemistry by applying some really clever processing techniques to create a final product. But certain aspects are more straightforward with a synthetic - we can create a material from the ground up to build-in certain characteristics, such as bioactivity.

Are viable synthetic products available at the moment?

There are synthetic materials available and some of them claim to have higher level of bioactivity compared to bovine bone. But when you look at the advantages that are provided by a bovine bone, such as longer-term maintenance of bone volume, none of the synthetics have been supported by clinical data that really compares or is even in the same class as Geistlich Bio-Oss®. But, since a growing number of patients insist on non-bovine-derived treatment, Geistlich wants to meet that need and the potential for custom-tailored bioactivity is very attractive.

What about using human tissue?

Allografts have been commonly used for bone regeneration, particularly in the United States. The US market has the highest utilisation of allografts globally, but this is also true not only in dentistry but also in non-dental bone applications, like orthopaedics. And there is a reasonable level of data for dental allografts in the United States in terms of its clinical effectiveness.

And this is one of the main reasons behind Geistlich's recent choice to offer, in addition to bovine bone in the United States, an allograft product to our customers there. On the spectrum, allograft fits somewhere between bovine bone and a synthetic in terms of its ability to form new bone quickly. This is one of the reasons why the U.S. dental community seems to have chosen allograft as one of their preferred bone substitutes. And so Geistlich has now made a recent decision that in addition to bovine, we will offer an allograft to U.S. customers.

Is that from a third party?

Yes, it's from a well-established tissue bank. It is worth noting that we have chosen MTF Biologics in the classic Geistlich way. We looked for a best-in-class partner in terms of quality and scientific support. MTF Biologics is one of the world's largest providers of human tissue and also happens to be my previous employer. Prior to Geistlich, I worked for 7 years as MTF's Executive Vice President, R&D, QA and Regulatory Affairs. In the past MTF had focused on orthopaedics and had not dedicated significant energy to dental bone substitutes, so that's where Geistlich is a perfect partner. We can help them take their world leading allograft technologies and tailor those to meet the needs of the dental specialists and oral surgeons in the US.

But from a regenerative perspective, bovine bone is superior?

In terms of the published clinical data, bovine bone and in particular Geistlich Bio-Oss® is absolutely in a class of its own. There is no other product that even comes close in terms of the amount of published data for clinical effectiveness - in which indications it should be used, proper application, which techniques, which anatomies - Geistlich Bio-Oss® is unmatched.

But Geistlich does indeed recognise that each region or each country around the world has their own preferences, and we recognise that clinicians have their own techniques that they learned during dental training. And in the United States, quite a few are trained to use allografts. They still use allografts today for certain procedures. Geistlich has decided that now is a good time to provide not only best-in-class bovine bone, but also to provide best-in-class allografts for those American clinicians who currently rely on allografts every day.

So Geistlich exclusively offers MTF Biologics products to dentists?

Correct.

If you look at, say, the history of Apple Computer, is there an iPhone on the horizon at Geistlich? Something that's in a completely new category, completely out of the box, something that will change the world?

In the classic way that you might expect from Geistlich, you know that we keep our secrets "close to the vest". It is well known that the processing secrets of Geistlich Bio-Oss® and Bio-Gide® are absolutely held in a black box. And yes, we do have technologies that are on the way that we believe, in the long term, will change the way that dentists and oral surgeons think about regeneration... in the black box.

Are you able to talk about the product development process at Geistlich?

Geistlich takes a two-pronged approach to generating innovation. One direction of focus is that we direct some researchers to focus on concepts that are ahead of customer expectations, really out of the box. In fact, we have a team of innovators called the "Out of the Box" group. This team identifies and develops concepts that really could leap-frog ahead of whatever the dental community and the oral surgery community are even asking for today. So, on that side, we do intend to try to emulate the iPhone in terms of the jumping ahead of expectations that come from the customers.

And in a second direction of focus, we dedicate a team to developing products that are intended to address the immediate needs of the customers in the market today. For example, customers often ask for a trusted regenerative biomaterial but with specific handling properties or perhaps specific packaging or product configuration to make surgery, storage and logistics easier. Those types of deliverables are developed with direct communication and direct input from both everyday customers and key opinion leaders. These tend to be incremental product improvements that are very helpful, but not necessarily game-changing.

Therefore, we take two approaches. One approach targets concepts that are truly out of the box, trying to leapfrog the expectations that everyday customers might not yet even recognise. And the other is more directly customer-driven, trying to meet incremental, near-term needs.

And as a scientist, do you play in any of those spaces?

For Geistlich's game-changing approach, I am a co-leader of the "Out of the Box" group. And, as I mentioned earlier in the interview, I bring quite a bit of experience in customer-driven product development. In this context "product development" can be defined as distinctly different from "research". One of the most common examples of product development is the step-wise evolution of product characteristics to meet the changing needs of the customer. So, the original Geistlich Bio-Oss® was a true game-changing technology and it was followed by development of Geistlich Bio-Oss® Collagen and Geistlich Bio-Oss® Pen. Geistlich Bio-Gide®, another game-changer, was followed by Geistlich Bio-Gide® Compressed and Geistlich Bio-Gide® Shape. These incremental adaptations to products are a direct response to customer needs.

I certainly play an active role in both approaches, not only to help a product development group meet near term customer needs, but also as co-leader of the "Out of the Box" group.

So what is the process for launching new products?

For Geistlich, each of our new technologies is tested and evaluated quite thoroughly before launch. Frankly, it means that we are not always the fastest to market. But it does mean that when a new technology does come to market, it has been tested very carefully from the lab bench through pre-clinical and clinical evaluation.

When we come to market, Geistlich doesn't jump from the laboratory straight into a market launch. Following proper evaluation in preclinical models, our standard practice is to conduct what we call a Pioneer Phase. This phase consists of putting a new technology into the hands of a broad spectrum of clinicians. The purpose is to gather early feedback and data on whether that product is meeting the expectations that we established when we did the preclinical work.

We determine if the product needs any refinement before broader application. And it's only after a successful Pioneer Phase that we move into a more formal launch phase for the broad community of customers.

How long is the Pioneer Phase?

The Pioneer Phase can be quite variable. For a new concept like Geistlich Fibro-Gide®, where there was really no prior equivalent in existence, the Pioneer Phase in Europe and the US required more than five years. Even after a European Pioneer Phase and eventual launch, we still decided to conduct a separate US Pioneer Phase before our market launch. This was done to address certain differences in soft tissue treatment between the US and Europe. In comparison, for an incremental product change, the Pioneer Phase might only be six to nine months.

Do you test competitors' products to see if they work?

Absolutely. We test them internally quite often. Our researchers routinely perform chemical characterisation and comparison to our own products. This is commonplace at Geistlich and at many medical and pharmaceutical companies.

Do the competitors' products work?

In terms of chemical characteristics, our researchers have still not seen any products that are truly equivalent to Geistlich products. We know that competitors have been trying to copy our products for decades. We still have not seen anything that matches. But do these products work clinically? I think the complex answer is yes and no. Many of them can work clinically. But what are the rates of clinical complications? What is the level of evidence? What is the true level of performance in these products? Again, no competitor is even close to the level of published clinical evidence for the Geistlich products.

You briefly mentioned before about the unique process Geistlich uses to manufacture its products, how novel is it? Is it like the recipe for Coca Cola or the 11 herbs and spices?

Well, I can tell you a quick story about how secretive Geistlich can be. I joined Geistlich in 2016, and I was taking the position of Chief Scientific Officer. But even during my entire first year at Geistlich, I was not allowed to have access to the secret recipe and the formula by which Geistlich Bio-Oss® and Geistlich Bio-Gide® are made. I had to spend the time, gain the trust and show that I was committed to Geistlich before I would be trusted with the secrets that we hold in the black box!

As a matter of fact, almost everyone who works at Geistlich doesn't know how Bio-Oss® and Bio-Gide® are made. The formulas and the know-how are only held within a very small number of people inside the company. Even when we have external government regulators come in, we provide information and details only up to the point where they can assess whether or not we meet their requirements, and we do not share anything beyond that.

And you alluded to the fact that it was a surprise to you?

It was. It's one of those odd situations for me, a trained expert in regeneration and in processing animal and human tissues over decades. My mind was blown when I learned the content of Geistlich's black box, about how Geistlich Bio-Oss® and Geistlich Bio-Gide® are made. My first question was, "Why on earth did Geistlich do it this way?" Because it didn't make sense. It was only later, when I eventually understood the biological function of these products that I truly appreciated the significance of Geistlich's unique approach. Geistlich's truly unique manufacturing processes yield unique biological properties, and those properties are responsible for the best-in-class clinical performance.

Each person at Geistlich does an important job. Each person does their part. But only a very few people know how the overall secret process from start to finish and how the secret recipe is followed. The black box is the key to our success.

Thank you for your time Mark.

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