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1rem

 podcast episode, UpScriptHealth founder and CEO Peter Ax discusses:

The impact of tariffs on the pharmaceutical industry, highlighting branded and generics medications

How tariffs could lead to strategic supply chain changes, including potential US manufacturing shifts

How digital health platforms can help potentially offset tariff impacts

The importance of telehealth in ensuring medication availability

Strategic partnerships between digital health platforms and pharma companies to improve patient care and access

Podcasts

Peter Ax, founder & CEO of UpScriptHealth, discusses the impact of tariffs on the pharmaceutical industry and how digital health platforms could potentially help offset them.

Tariffs and Drug Prices: Understanding the Impact on Pharmaceuticals

 Podcast, CEO and Founder of Sooth, Ian Baer, is back to discuss:

Why people trust friends and influencers over companies

Ian Baer, Founder and CEO of Sooth, discusses how the growing distrust in social media will impact industry marketing strategies and the relationships between pharmaceutical companies and the patients they aim to serve. He also explains dark social, how to combat misinformation, closing the trust gap, and more.

Navigating Distrust: Pharma in the Age of Social Media

In this episode of the Pharmaceutical Executive podcast, Bill Grambley, CEO of AllazoHealth, explores:

How AI can potentially revolutionize patient engagement and adherence

Utilizing patient-level data and predictive modeling

How AI can identify individual needs and preferences

The importance of ethical considerations and data privacy when leveraging AI in healthcare

Bill Grambley, CEO of AllazoHealth, delves into the potential of AI to revolutionize patient engagement and adherence.

Revolutionizing Patient Adherence: Leveraging AI for Personalized Engagement

The simplified requirements for Camzyos are expected to ease prior contraindications, thereby simplifying treatment and expanding eligibility in patients with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy. 

FDA Updates Prescribing Information for Bristol Myers Squibb’s Camzyos to Reduce Echocardiography Monitoring Requirements

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade. 

Regeneron, Sanofi Get FDA Approval for Dupixent to Treat Chronic Spontaneous Urticaria

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity outcomes compared to Eylea in patients with macular edema following retinal vein occlusion. 

FDA Grants Priority Review to Regeneron’s Eylea for Macular Edema Following Retinal Vein Occlusion

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to expand access to Pfizer’s respiratory syncytial virus vaccine Abrysvo for high-risk adults in their 50s and voted in favor of GSK’s meningococcal vaccine, Penmenvy, for streamlined adolescent protection.

Pfizer, GSK Gain ACIP Recommendations for RSV and Meningococcal Vaccines

Four tips for midsized companies when entering new global markets.


Bringing Biotech Innovation Across Borders 

Marcel Botha, CEO of 10XBeta, explore the role collaboration between private industry, government agencies, and research institutions plays in strengthening pandemic preparedness and ensuring medical device resiliency.

Strengthening Pandemic Preparedness Through Collaboration

 video interview, Marcel Botha, CEO of 10XBeta, discusses shortcomings in the US' emergency plans for rapid innovation and manufacturing during public health crises, highlighting the need for innovation pipelines, supply chain resilience, and regulatory clarity. He also emphasizes the importance of localized manufacturing, public-private partnerships, and advanced manufacturing techniques like AI and additive manufacturing. Botha notes the success of the Spiro Wave project in reducing ventilator size and the need for better coordination and funding structures. He also advocates for a more agile and collaborative approach to ensure rapid response in future emergencies.

Pharmaceutical Executive: What role does collaboration between private industry, government agencies, and research institutions play in strengthening pandemic preparedness and ensuring medical device resiliency?

Collaboration is critical. Consumer level or civilian-led companies do not have the same access and reach as a government agency or research institution. If I take MIT, the city and state of New York, and what we did during the during the pandemic—we all responded as a collective to the pandemic response, specifically the ventilator rapid response here in New York. Making sure that we had a stockpile of our own ventilators should we run out. That project could not have been successful without that consortium of research institution, government agency, and private sector.

That said it was completely under the radar, because at that moment in time it was frowned upon for anybody from MIT to even be on campus. While Moderna and the biotech cluster around MIT was highly active, MIT was hesitant to offer approval at that moment in time to support things that weren't guaranteed.

They definitely doubled down on everything in the biotech space, but it is essential that all parts of society to come together to make sure that we can offer a seamless response and bring different perspectives. Politicians, government agencies, and bursaries open routes for engagement with the publicly funded health sectors, the military, and others. Research institutions crossover with both military and civilian tech and see a lot of early-stage innovation that we cannot see as the civilian population on a daily basis. Then we bring together a very agile commercial sector approach to commercializing products, so that we can effectively guarantee the cost basis. You can't make everything on a Cost Plus [Drugs] basis and not be held accountable for how you bring innovation to market. 

How we as the private sector show up when it comes to government or public private interactions or contracts to do our best and to be held accountable is very much in the crosshairs in DC right now.

Videos

Marcel Botha, CEO of 10XBeta, discusses lessons from The Spiro Wave project that can be applied in creating more agile and responsive systems for future public health emergencies.

Creating More Agile Systems for Future Public Health Emergencies

Pharmaceutical Executive: The Spiro Wave project demonstrated the potential for rapid development and deployment of critical medical devices. What key lessons from that experience can be applied to creating more agile and responsive systems for future public health emergencies?

It's very important to do a postmortem of how we responded,  what worked, and what failed during the first pandemic and then build pre-approved emergency innovation frameworks of how one might respond to the next disaster. Regardless of whether it is a natural, man-made, or viral disaster—they all have different outcomes and costs of human life. The challenge remains clear, we as a society need to have clear, actionable steps that we can follow when we want to have impact in record time, without the level of waste we saw during the pandemic because of all the wheel spinning and inertia to get going.

In line with bringing manufacturing stateside, building ecosystems, and relying on advanced manufacturing, we need to think about manufacturing similarly to how we think about products. Can we build modern, modular, distributed networks of manufacturing? Can we do it in a way where we build a system of resilience and reliance, where the economic framework for collaboration between everyday competitors is clear and actionable for when we go into emergency mode?

It's fine to be competing on the battlefield, very much like a game of rugby, but afterwards, let's have a drink together. If we have to get on the same page for the collective good, we do that, and then we can trash talk each other next week's game. To make society work, we need to understand when we're competing, when we're collaborating, and when we are celebrating. There needs to be healthy constructs to do all of those things in our society. It can't just be compete, compete, compete; and fail the rest of the time.

We see more of the public private partnerships now, but it’s still not fast enough. There were some rapid response innovation consortia set up between us and the city during the pandemic, but we want to see more of that. We want to go back to the product typologies, more open sourcing, and rapid prototyping ecosystems in place that we can leverage for fast manufacturing. Additive manufacturing, which we have been following since grad school days, has evolved to the point where we can now make metal, plastic, electronics, wire, harness, installations, everything using additive techniques.

There's no reason why we can't leverage these different technologies during a mission-critical or disaster relief response. However, there's always the cost benefit analysis that you have to take of the technology, time it takes to execute, and the response that you have to adhere by.

Matthew Yelovich, Partner at Cleary Gottlieb, discusses the appeal of Elizabeth Holmes and Ramesh "Sunny" Balwani, who were convicted of fraud and the Ninth Circuit's recent affirmation of their convictions.

Analyzing the Theranos Appeals

 video interview, Matthew Yelovich, partner at Cleary Gottlieb, discusses the appeals of both Theranos founder Elizabeth Holmes and the company’s COO, Ramesh “Sunny” Balwani. The Ninth Circuit recently affirmed the duo’s convictions after considering questions about expert and lay testimony. Yelovich emphasizes the importance of careful vetting of statements to investors and the public, especially in tech-driven companies. The conversation also explores the complexities of sentencing in fraud cases, the importance of corporate governance and accountability, and his transition in late-2024 from federal prosecutor to a role at Cleary Gottlieb.

Pharmaceutical Executive: Can you discuss the history of this case and the specific issues involved in the appeal that you handled?


 Theranos founder Elizabeth Holmes and her COO Ramesh “Sunny” Balwani were indicted by the United States’ Attorney’s office in San Francisco for fraud related to statements they made to investors and patients about their technology’s capabilities. They were convicted in separate trials and both appealed, where they raised a number of evidentiary challenges to their convictions, as well as some sentencing claims.

In a published opinion, the Ninth Circuit rejected those claims and affirmed the convictions and sentences.

PE: Having handled the government's response to the appeal, what were some of the most challenging legal arguments you encountered?


 The Ninth Circuit’s opinion reflects that the court found the difference between expert and lay testimony to be a difficult line. Many courts have struggled to navigate that line across the country. This opinion shows a careful parsing of what the court viewed as expert and lay testimony, and when lay testimony may veer into expert testimony.

In this case, those differences didn’t alter the outcome of the trial. As the court said, the evidence was overwhelming, so any errors there were harmless to the conviction. In future cases, courts could take a more specific line on when a percipient or lay witness can talk about highly technical subjects. That’s what the majority of the court’s opinion focuses on.

PE: Holmes and Balwani have each served roughly two years of their sentences. In your opinion, what are the key legal and ethical considerations that arise when evaluating the proportionality of sentences in complex fraud cases like this?


 Speaking broadly (and not these particular sentences), there are two key legal considerations in sentencings like this one. The first is that the court must calculate the advisory United States Sentencing Guidelines, which vary depending on the offense. In complex fraud cases, they’re driven largely by the amount that the fraud cost the victims, which dictates to a large extent what the monthly range will be for the prison sentence that the court must consider.

There’s also a federal law called Section 3553 which says the court must consider a range of different characteristics, including the nature & seriousness of the offense, the history & characteristics of the defendant, and principles of deterrence.

All of that is put together into a sentencing hearing where there is advocacy for both sides, and the court comes up with a proportional sentence that is not greater than necessary to achieve the purposes that are in that law.

Matthew Yelovich, partner at Cleary Gottlieb, discusses the appeals of Elizabeth Holmes and Ramesh "Sunny" Balwani and the Ninth Circuit's recent affirmation of their convictions.

Marcel Botha, CEO of 10XBeta, discusses shortcomings in the US's emergency plans for rapid innovation and manufacturing during public health crises, highlighting the need for innovation pipelines, supply chain resilience, and regulatory clarity.

Critical Shortcomings in the US's Public Health Crisis Plans

Pharmaceutical Executive: It's been five years since the COVID-19 pandemic. Given your experience with the Spiro Wave project, what do you believe are the most critical shortcomings in the US' emergency plans for rapid deployment of innovation and manufacturing during a public health crisis?

 It was an honor to be part of the ventilator crisis response for New York and to work with MIT on open-source technology that was shared globally. However, it was also alarming to realize how unprepared we were—not just at that moment, but in general—for responding to critical challenges quickly. Despite living in a world where disaster scenarios dominate our media and climate-driven and man-made emergencies frequently remind us of our vulnerabilities, we remain in a state of unpreparedness.

Our responses during the pandemic were ad hoc and disorganized, unavoidable due to the lack of established innovation pipelines and a clear framework for emergency responses. We figured things out quickly, with the Emergency Use Authorization process being a prime example. The FDA did a commendable job keeping pace with the speed at which innovators and community members mobilized. Still, the agency was never designed to engage with so many stakeholders simultaneously. This lack of a structured process slowed critical decision-making and introduced uncertainty around whether efforts to help would result in real impact.

Supply chain vulnerabilities were another major issue. During the pandemic, we solved this by vertically integrating everything into one facility. But this level of agility was only possible because we cashed in every favor and pulled together resources creatively. Future responses cannot rely on such improvisation. We need a more resilient and decentralized supply chain that can withstand geopolitical threats and component shortages without collapsing.

Fragmentation between the public and private sectors also hindered an effective, unified response. The pandemic response became politicized, and competition for limited resources created a hierarchy where some groups believed they should be prioritized over others. Private sector involvement filled the gaps, but that shouldn’t be the default response. We need better public-private collaboration to ensure a more cohesive approach in future crises.

High-speed innovation is expensive, and the lack of clear funding and accountability structures made rapid action even riskier. During the pandemic, it became evident that investing in solutions without a clear customer or funding model could be a costly gamble. Future disaster responses need transparent communication around funding, contracting, and vetting to prevent fraud and ensure that resources are used efficiently.

Finally, while vertical integration allowed us to meet the ventilator demand during COVID-19, future responses should not rely solely on centralized systems. We need flexible, scalable manufacturing and supply chain systems that can adapt quickly to evolving needs. Without these improvements, we risk repeating the same mistakes when the next crisis arises. The pandemic made it clear that we can no longer assume the government will step in to save us. Those capable of acting must do so, but we need a more structured framework to ensure those efforts are coordinated, effective, and sustainable.

Critical Shortcomings in the US' Public Health Crisis Plans

Dr. Dina Radenkovic, CEO of Gameto, discusses the key considerations for bringing iPSC-based fertility treatments to market from a regulatory and manufacturing perspective.

Gameto: Addressing Regulatory Hurdles in iPSC-Based Fertility

 video interview, Dr. Dina Radenkovic, CEO of Gameto, discusses the company's pioneering use of induced pluripotent stem cell (iPSC) technology in fertility treatments, particularly addressing ovarian aging. Its lead product, Fertilo, is an iPSC-derived ovarian support cell line in phase III clinical trials in the US with FDA clearance, and commercial availability in markets like Australia and Latin America. The company faces challenges including the scarcity of human eggs and regulatory hurdles. Radenkovic also highlights the need for better models to study female-specific conditions and the importance of political advocacy and funding to drive innovation in women's health.

Pharmaceutical Executive: From a regulatory and manufacturing perspective, what are the key considerations for bringing iPSC-based fertility treatments to market? What unique challenges does this present compared to other cell therapies, and how are you navigating them?


 We’re the first people pioneering iPSC therapy for use in women’s health and IVF. We’re also the first iPSC in Phase III in the US. When there is no precedent, you’re chartering new waters. There’s an additional layer of risk that we must deal with and successfully manage. Fortunately, we now have designations and we’re cleared to commercialize or are in the final stages of development for approval.

One of the challenges is just determining how this product is regulated. Given that our product is used in a dish and has no action inside of the body, it legally meets the definition of a device. Products for maturing eggs outside of the body (which is called in-vitro maturation) have been approved in the US and across the world as devices. On the other hand, our product is still made of living cells. We had to work with regulators around the world to get the proper designation and understand how to get it approved.

It took the longest to get the designation in Europe because they initially said it was not a pharmaceutical product. We went to get regulated as a device, but then they said that devices are not made of living cells. We just managed to obtain a designation with EMA, and we worked similarly with regulators across the world since our designation differs across jurisdictions.

In the United States, we’re considered a biologic, so we’re regulated by CBER. Our IND that was cleared for a Phase III trial was for a BLA submission. In other places where we are cleared for commercialization, we are classified as reproductive tissue or a device. The different designations result in different times to market for different jurisdictions.

When it comes to manufacturing, we have a lot of benefits. We are only treating a few cells and not the whole body. Some of the issues that present with cell therapy, like immunogenicity, are not as hard to solve when you’re only treating a couple of eggs outside of the body. We have already set up GMP manufacturing to supply the IVF cycles, and that is because of the lower dose compared to in-vivo cell therapies. There’s also a reduced scientific challenge when you treat the eggs outside of the body because there is no immune system.

We’ve partnered with REPROCELL, we’ve licensed the one of the world’s first female allergenic iPSC lines, we created a proprietary manufacturing differentiation protocol, we have our bank that should give us supplies for the next 40-to-50 years, we’ve developed potency assays and batch release criteria, and we can rapidly produce Fertilo vials in a scalable and efficient way.

It was challenging setting it up for the first time in iPSC. There were lots of problems that we had to solve, like figuring out how to fill vials with such a low cell dose. IVF is a great first application of cell therapy because it’s much easier to do clinically compared to in-vivo cell therapies, particularly when it comes to cost, scale of manufacturing, cell doses, and immune rejection.

DB-OTO Manufacturing Hurdles in Hearing Loss

Last month, Regeneron announced updated results from the Phase I/II CHORD trial in children with otoferlin-related hearing loss. Out of 11 children who received DB-OTO, 10 showed notable hearing improvements at different decibel levels, with some achieving nearly normal or normal hearing thresholds. Pharmaceutical Executive spoke with Jonathon Witton, AuD, PhD, VP, auditory global program head, in more detail about the trial results, the performative potential of DB-OTO, and the company’s work with regulatory authorities.

Pharmaceutical Executive: What are the biggest regulatory hurdles that Regeneron anticipates in bringing DB-OTO to market, and how is the company preparing to address them? 

DB-OTO is an AAV-based gene therapy. For these therapies, there are a couple of major areas to consider, one being the clinical plan. For example, a clinical study will generate data, and we spend most of our time discussing the clinical data because it is exciting—we're talking about results in patients and their impact.

Manufacturing is equally important. Many advanced therapies have complex manufacturing processes, requiring careful planning to ensure that all systems are in place before moving toward approval and commercialization. As a result, manufacturing must remain a significant focus. While we don’t discuss it as often, we have dedicated substantial efforts to ensuring the company is prepared from a manufacturing standpoint.

 Regeneron envisions DB-OTO reshaping the standard of care for hearing loss by shifting from symptomatic management with prostheses, such as hearing aids and cochlear implants, to a molecularly targeted therapeutic approach. Historically, clinicians diagnosed hearing loss without understanding its genetic cause, but advances in genetic testing have revealed that over half of childhood hearing loss cases stem from genetic protein deficiencies. DB-OTO aims to correct this by delivering functional DNA to specific inner ear cells, enabling them to produce the missing protein, potentially restoring hearing to near-normal levels.

The transformative potential of DB-OTO is evident in early clinical trials, where 10 out of 11 patients demonstrated hearing improvements, with some achieving normal or near-normal sensitivity. This represents a paradigm shift—clinicians will now need to incorporate molecular diagnostics into routine care, ensuring that patients receive precise, targeted treatments rather than generalized symptom management.

Regeneron has secured multiple regulatory designations, including the FDA’s RMAT designation, which facilitates early and frequent discussions with regulators. These interactions are crucial in navigating the complexities of gene therapy development, accelerating timelines for approval and commercialization.

Challenges remain, particularly in clinical development and manufacturing. Ensuring scalable, high-quality production of gene therapies is as critical as generating robust clinical data. Regeneron has invested heavily in manufacturing capabilities to meet these demands.

Beyond clinical development, Regeneron actively engages with the hearing loss community, including advocacy groups, clinicians, and families. Insights from these discussions have highlighted practical concerns, such as ensuring continuous hearing for safety. This patient-centric approach shapes the development of DB-OTO and future gene therapies, with plans to expand treatments to broader populations, including adults with age-related and noise-induced hearing loss. Regeneron aims to pioneer gene therapy solutions for a currently untreatable public health challenge.

Jonathon Whitton, AuD, PhD, VP, auditory global program head, Regeneron, discusses regulatory challenges for DB-OTO, Regeneron’s AAV-based gene therapy for hearing loss. 

Video Series

Regeneron’s DB-OTO: Overcoming Clinical and Manufacturing Hurdles in Gene Therapy for Hearing Loss

Dr. Dina Radenkovic, CEO of Gameto, discusses the use of iPSCs in fertility treatments, the most significant scientific hurdles they've encountered in developing and scaling these therapies, particularly in relation to ovarian aging, and they're addressing them.

Gameto's iPSC Fertility: Overcoming Scientific Challenges

 video interview, Dr. Dina Radenkovic, CEO of Gameto, discusses the company's pioneering use of induced pluripotent stem cell (iPSC) technology in fertility treatments, particularly addressing ovarian aging. Its lead product, Fertilo, is an iPSC-derived ovarian support cell line in phase III clinical trials in the US. The company faces multiple challenges, such as the scarcity of human eggs and regulatory hurdles, with Gameto navigating different regions and their regulatory bodies. Radenkovic also highlights the need for better models to study female-specific conditions and the importance of political advocacy and funding to drive innovation in women's health.

Pharmaceutical Executive: Gameto is pioneering the use of iPSCs in fertility treatments. What are the most significant scientific hurdles you've encountered in developing and scaling these therapies, particularly in relation to ovarian aging, and how are you addressing them?


 The first problem is that we didn’t have good models to study ovarian aging that causes infertility (including loss of ovarian function, late-term menopause, and unique pathophysiological and medical conditions). A lot of the animal models that we use, like mice or primates, do not experience the same concept of ovarian aging. We decided to tackle that by building iPSC derived ovaries in a dish. We've done that with the sponsor research agreement with Harvard Medical School's Church Lab. We've published research that shows that our ovaries-in-a-dish beat previous mouse chimeric models. We've even collaborated with Johns Hopkins University and the organ transplant unit to receive cadaver organ donor ovaries and linked to primary tissue to truly replicate human biology in our ovaries-in-a-dish. This allows us to develop different treatments and rapidly test them.

That is what enabled us to bring Fertilo, which is an engineered iPSC-derived ovarian support cell line to mature eggs outside of the body, to phase III in the United States. Our trial is available on clinicaltrials.gov and is going to start recruitment at the end of March 2025. We are already clear for commercialization for therapeutic area agnostic and commercial fertility in several large markets like Australia, Latin America, and others. 

That was the ovary-in-a-dish model that helped us understand human biology and overcome the first scientific obstacle, which was: how do you develop novel treatments if you don’t have good models to study and test them in the lab?

The second challenge was really around our lead product, Fertilo, which is used for egg maturation. You need to get access to human eggs, which are a very scarce resource. This is why the IVF industry exists.

When we did our first wave of human studies, we looked at egg maturation as the end point. We wanted to see if Fertilo matures human eggs and are those eggs genetically, epigenetically, and morphologically healthy like the eggs that have been matured inside of the body with standard of care IVF. We've managed to partner with RMA of New York (one of the leading fertility clinics in Mount Sinai) and worked with one of their fertility specialist doctors. We worked with fertility clinics around the world to build the largest library of sequenced human eggs to truly show and be confident that our eggs are genetically and epigenetically normal.

Dr. Dina Radenkovic, CEO of Gameto, discusses the use of iPSCs in fertility treatments, the most significant scientific hurdles they've encountered in developing and scaling these therapies (particularly in relation to ovarian aging), and how they're addressing them.

Recent Regulatory Impacts on the Pain-Management Space

Pharmaceutical Executive: Can you describe South Rampart’s work in pain medication?


 For several years now, we've been working on the development of a novel manipulated small molecule to reduce pain without having the addictive potential of opioids. We’ve submitted an IND with FDA to get into the clinic and are now working on phase two. Our molecules is ready in three different pipelines, and we are eyeing the very first one as acute pain. I'm the PI of two funded NIH grants. We just submitted two others in January and February of this year.

The NIH has had an incredibly supportive Small Business Office that has been very entrepreneurial with a lot of critical resources that have allowed small biopharmas like ours to move forward and go all the way from concept to pre-clinical characterization into the clinic.

PE: Since the situation with NIH is a bit unpredictable at the moment, how are you strategizing around that?


 The NIH has been an immense supporter of our work and of others in this field, particularly through the HEAL (helping end addiction long-term) Initiative, which was actually started by Congress almost six years ago. Our project is a prime example of taking academic knowledge and supporting it based on strong foundational science, coupled with significant commercialization plans that must be submitted. We also had to demonstrate to the study section about how the assets are going to be commercialized.

In these study sections, both researchers were neuroscientists and had good fundamental understandings of how to relieve pain in the brain or in the periphery. The set of sections were also grouped with individuals who had done this before, who had commercialized assets, so they understand the different obstacles that could occur. They knew what could happen. They evaluated us based on both their scientific rigor as well as the commercialization potential. And because it goes through such a thorough process, the funding rate has sometimes been in the single digits.

You learn a lot from the process, and you really streamline, so that as you execute, you're doing so the best way possible. There are a lot of market resources that they share through the EIR (entrepreneurs-in-residence) Program that can give you feedback on different things. It's a good networking opportunity. Obviously, you learn a lot from other people that are going through it.

In regard to what’s happening now with NIH, the main thing to do is diversify. You raise both non-dilutive funding through NIH which is the very best, obviously, and then as well as dilutive and to try to move the program forward.

PE:How risky is the traditional pain medication market still to this day?


The pain market has really had a blemish on it going as far back as 15-to-20 years. I think there were not well-validated targets that were being developed based on not the most stringent science. When these molecules were being developed into clinical trials, the endpoints that were being utilized were questionable. One of the challenges with pain is that the endpoints are have to be really well designed, because pain is something that is subjective.

In clinical medicine, pain is something that a patient says that they feel. Your assessment of pain, your threshold, may be much higher than mine, or vice versa. It's so important when designing a trial to objectify something that's objective as much as possible. Clearly there's a science to that. There are individuals and a few groups that have had a lot of experience and success doing that, and that has obviously come with experience in the last 10-15 years.

I think we're now, fortunately, in a really good state.

Dr. Hernan Bazan, CEO of South Rampart Pharma, discusses his company’s current pipeline.

Fred Aslan, MD, CEO, Artiva Biotherapeutics, explains what the FDA Fast Track designation for AlloNK in autoimmune diseases means for the acceleration of its development and potential approval of the therapy.

FDA Fast Track: Accelerating AlloNK's Development

 video interview, Fred Aslan, MD, CEO, Artiva Biotherapeutics, discusses the company’s current trials for autoimmune indications in the US. The first is a company-sponsored trial focusing on lupus, while the second is an investigator-initiated trial exploring four conditions: lupus, rheumatoid arthritis, pemphigus vulgaris, and vasculitis. This second trial is uniquely being conducted in a community setting to assess the practicality of outpatient treatment.

Regulatory

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