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Mark Goldberg

Mark Goldberg

Chairman & CEO
Allucent
12 February 2024

What has changed for Allucent and the biotech industry since we last spoke a year ago? 

In the last year, the biotech industry, particularly for small and mid-sized companies, faced challenges emerging from the pandemic. The high interest rates increased the cost of capital, making funding harder to obtain. This situation forced companies to be more efficient and smarter with their resources. However, there is an improvement trend now, with an uptick in IPOs and funding, leading to a positive outlook for 2024.

Is the industry going through a post-pandemic slump?

The biotech sector experienced a slump post-pandemic, following a surge in pandemic-driven research and funding. The distinction between high-quality and subpar science was blurred due to abundant funding, leading to unsuccessful ventures. Now, the market is normalizing, with more rigorous due diligence and decision-making in investments. This shift represents a healthier, more sustainable approach for the industry. 

I view the current market trend positively. The focus should be on directing resources towards the most promising and effective treatments. This approach benefits not only the industry but also the patients who depend on these innovations.

What are your thoughts on the Inflation Reduction Act's impact on biotech?

The Inflation Reduction Act mainly impacts big pharma, not small biotech firms. Most intellectual property in the market comes from these smaller companies, who are the primary innovators. While there may be indirect effects, I do not foresee a significant direct impact on biotech investment. The biotech sector will continue to be a hub of innovation, regardless of these external factors.

Let us talk about Allucent’s work concretely. What challenges do small and mid-sized biotech companies face today, and how does Allucent help address these?

Small biotech companies possess significant intellectual property but lack the resources of large pharma firms. At Allucent, we provide targeted, expert services to these companies. We engage highly skilled professionals who can guide development programs and navigate scientific and regulatory complexities. This approach ensures that these smaller firms can effectively develop drugs and bring them to market. 

Allucent’s approach is unique in its comprehensive and expert-driven services. We do not just offer operational assistance; we also provide strategic guidance to maximize the success likelihood of our clients' projects.

Our team, including ex-regulators, brings valuable insights, ensuring our clients are well-aligned with regulatory requirements and efficient in their development processes. This holistic approach sets us apart in supporting small and mid-sized biotech companies.

Data and AI are becoming more and more important for life sciences. Tell us more about Allucent’s biometric service and its role in facilitating the work of your clients?

Our biometrics group specializes in data management and biostatistics, offering expertise often lacking in small biotech companies. This service is economically efficient for these companies as hiring such high-level statisticians full-time is not feasible. We use model-informed drug development, leveraging mathematical models and diverse data sets to enhance research efficiency and precision. This approach helps in determining optimal initial dosing for human trials, increasing the probability of early success and reducing the number of trials needed.

Another application is in investment decision-making, where our models predict a compound's efficacy and safety. We also enable extrapolation of clinical trial results to different populations, increasing diversity in trials without necessarily recruiting diverse participants. This method has even allowed for drug approvals in new demographics, like pediatric patients, without additional trials.

How close are we to seeing AI-generated drugs on the market?

AI in drug development is more about enhancing efficiency in repetitive processes and signal detection rather than creating drugs outright. AI's capability in pattern detection can be utilized in high-throughput screening to select drug candidates. The real magic lies in the combination of AI with increased computational power, like cloud computing, which enables the handling of larger data sets more effectively. However, AI is not yet at a stage where it can independently undertake drug development; it remains a powerful tool augmenting human expertise.

What are the main trends in clinical trials post-pandemic, and can you tell us about your partnership with THREAD for Patient Direct Trials?

Post-pandemic, one significant trend in clinical trials is the integration of decentralized technology, enhancing diversity in participant recruitment. Decentralized trials reduce the burden on patients, increasing participation rates, especially in less life-threatening diseases. Our Patient Direct Trials aim to bring the trial to the patient as much as possible, maintaining higher retention rates and incorporating diverse populations. However, trials will likely remain hybrid, blending in-person and virtual elements.

Therapeutically, oncology continues to show promise, especially with advancements like CAR T-cell therapy. There is potential for extending its application beyond leukemias to solid tumors and immune-mediated diseases. Additionally, central nervous system diseases, previously a challenging area due to high failure rates, are witnessing renewed interest and investment due to recent successes in Alzheimer's treatments. This shift suggests a broader focus in the industry, balancing oncology with other areas like neurology and psychiatry.