Merck

Dusan Ruzic

Dusan Ruzic is an Innovative vaccine/bioprocess development and manufacturing scientist. His primary experience in downstream clarification and purification within both live virus and microbial platforms for programs ranging from preclinical to licensed products.

1. In your opinion, how has Pharma Tech Industry evolved over the years? What are some of the advantages of the current technological evolution?

The COVID-19 pandemic has changed how we live our personal and professional lives, and it has certainly changed how we look at the manufacturing process. Given shortages, supply chain challenges, cold chain capacity and secondary impacts on supply, warehousing and distribution, “end-to-end” considerations have expanded from the process and its direct consumables to including in-depth looks at our supply chains (the suppliers of our suppliers and beyond). An advantage to this evolution is that more consideration will be given to future adverse scenarios, inducing better “future-proofing,” as technology platforms, site selections, distribution networks and digitization are considered. There is also likely to be better running tallies of available global capacities and capabilities by international groups involved in emergency response (e.g., WHO, CEPI, Gates, etc.).

The boundaries between traditional modalities are getting thinner. The intersection of small and large molecules continues to occur, and we can expect to see increasingly complex molecules in the future—combination products where biology, organic and synthetic chemistry meet to produce targeted, high potent therapies that have much better efficacy and tolerability. This introduction of new technologies in pharma has always been slow and laborious. One advantage of the current evolution is better partnership between health authorities and industry working towards alleviating one of the existing barriers to pharmaceutical manufacturing innovation.

2. What according to you are some of the challenges plaguing the Pharma Tech Industry and how can they be effectively mitigated?

The challenges in the Pharma Tech Industry are apparent, chief of which is pricing/access, sustainability and responsiveness of our offerings.

Much more progress is needed to increase access, be it through improvements in the selection of technologies, the establishment of supply chains closer to the patient or flexible manufacturing facilities. These elements can shepherd in a new era of manufacturing—a transformative, patient-centric future where patients can receive lifesaving medicines safely, swiftly, reliably and affordably. Technology is key to addressing these challenges. The rise of new innovations, analytics and big data can be converted into usable knowledge—knowledge that can be harnessed to transform our models and as an industry, build that ambitious patient-centric future.

In terms of manufacturing platform selection, the challenges are many. Technological choices need to address sustainability, religious (kosher, halal) and moral (use of human-hybridized cells) constraints, raw material and consumable supply chain considerations (shortages, diversion to greater need) and distribution supply chain considerations (cold chain capacity). And, of course, cost is becoming an increasingly important factor. In the small molecule arena, sustainability of processes needs to be a main concern, and thus enzymatic synthesis, photochemistry and other renewable platforms need to be further developed.

For biologics and vaccines, productivity (intensification and continuous manufacturing) and careful consideration of process inputs and product components must be a priority. Considerations for product thermostability must be more emphasized during initial product selection.

And given the learnings from the pandemic, manufacturing facilities, equipment and components must be selected keeping in mind supply chain robustness and greater market responsiveness.

In terms of opportunities, the pandemic has given rise to increased harmonization across regulators and there is an increasing number of opportunities for the industry to work together with global organizations (e.g., WHO, CEPI, etc.) for the common good. The ability to address these challenges and seize on the opportunities, coupled with the advances in science, holds the ability to transform our industry.

3. Which are a few technological trends influencing Pharma Tech Industry today? What are some of the best practices businesses should adopt today to steer ahead of competitors?

As our understanding of underlying biology increases every day via the advent of new tools and the use of AI, we will have increasing call for and capability to deliver more personalized/individualized medicines, including bespoke gene/cell therapies and population-directed medicine based on biomarkers and genetics. While the latter can take advantage of the many currently existing platforms (small molecules, monoclonals, traditional vaccine platforms), the nascent and industry-disrupting cell/gene therapy platforms will straddle both bespoke therapies and larger population therapies for unmet medical needs.

In addition, synthetic biology, advances in conjugation technology and improved ability to make much larger molecules synthetically will also deliver new platforms. Organizations need to incorporate new technologies that drive better productivity and lower comparability risks through scale-out and improved measurement systems allow the use of flexible assets, creating an opportunity for speed and capacity on demand. Lastly, the type of capabilities an organization hires for and the way they foster collaboration, digital installation and knowledge sharing will accelerate the innovators’ mindset and the experimentation required to drive that advantage.

4. Do you have any advice for industry veterans or budding entrepreneurs from the Pharma Tech Industry space?

Don’t be complacent. Success has a tendency of driving less organizational learning than failure. As a result, an organization that is on the rise or realizing success may not be thinking about ‘what’s next.’ Individuals must avoid the stagnation that could result from success. As an industry, we need to continuously feed the innovation engine to advance novel medicines, new approaches and better practices. It is only through this relentless pursuit of what’s next that we can truly serve our patients.

Continue to push the status quo and the historical practices that exist within and around our business. All Pharma companies, regardless of organizational maturity, need to demonstrate a willingness and eagerness to challenge, and an openness to partner across industry peers and regulators to challenge the norms.