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Examining a new three-part formula to enable the supply chain function to manage market pressures while delivering on the bottom line.

Supply Chain Analytics: Pharma’s Next Big Bet

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

In an era where personalization of marketing and comms has become the norm in consumer engagement, the pharmaceutical industry is feeling the pressure to deliver for its customers, but it’s proving tough for many.

Digital pharma leaders acknowledge that personalized digital interactions and content are critical for engaging healthcare professionals (HCPs), who are often strapped for time and inundated with information. Those customers want to receive relevant communications, yet many pharma companies are still struggling to deliver.

Our latest research report, ‘Disconnected Pharma’ — based on interviews with 100 senior decision-makers at leading pharma organizations — highlights significant gaps in the sector's journey towards effective digital personalization. Here, we explore the importance of personalization of digital engagement in pharma, the structural and technological barriers to its implementation, and the collaborative efforts needed to drive innovation and disruption in this space.

The importance of personalization in pharma

Healthcare professionals are inundated with vast amounts of information daily. In this context, delivering relevant and personalized content is not just beneficial but essential. Personalization can significantly enhance HCPs' engagement with digital products by ensuring that the content they receive is pertinent to their specific needs and interests. This targeted approach will save HCPs time and demonstrate empathy and understanding for their day-to-day reality — allowing them to focus more on patient care and less on sifting through irrelevant information.

Personalization in pharma goes beyond just tailoring content; it involves understanding the unique preferences and behaviors of each HCP. By leveraging data analytics, pharmaceutical companies can create detailed profiles of their audience, enabling them to deliver more meaningful and impactful interactions. However, achieving this level of personalization requires overcoming several significant hurdles.

Getting houses in order: The challenge of legacy systems

A major impediment to digital transformation in the pharma sector is the reliance on outdated legacy platforms. Approximately 35% of pharma leaders report that these platforms hinder their progress towards adopting new digital technologies and strategies. These legacy systems often lack the flexibility and scalability needed to support advanced data processing and personalization efforts.

To address this issue, many pharmaceutical companies are prioritizing the creation of internal digital tools and systems in 2024. In fact, 40% of industry leaders are focusing on developing robust data processing and quality management systems. These new systems aim to provide a solid foundation for the complex data handling required for personalization, enabling more efficient and effective digital engagement.

Structural issues and regulatory concerns

Beyond technological challenges, structural issues within pharmaceutical organizations also pose significant barriers to personalization. It is widely regarded that pharma companies have operated with siloed mindsets, where different departments work in isolation rather than collaboratively. This fragmentation can prevent the seamless sharing of engagement data and insights on customer needs and preferences.

The industry is also heavily regulated, with stringent guidelines around data security and privacy. While 37% of pharma leaders believe that ensuring robust data security and privacy measures is crucial for driving digital disruption, the risk aversion associated with these regulations often makes it challenging to explore and implement innovative personalization strategies.

To overcome these barriers, pharma companies must work towards breaking down internal silos and fostering a culture of collaboration. This cultural shift can facilitate better data sharing and integration, allowing for a more comprehensive understanding of HCPs' preferences and behaviors. Additionally, embracing regulatory compliance as an enabler rather than a hindrance can help companies navigate the complexities of personalization in a secure and compliant manner.

The value of collaboration and cross-sector learning

Greater collaboration across the pharma and healthcare sector —and potentially with other sectors—could be a game-changer for driving innovation and disruption in digital personalization. Pharma leaders recognize the need for increased knowledge sharing and collaborative efforts to overcome the challenges they face. By learning from other sectors that have successfully implemented personalization strategies, the pharma industry can gain valuable insights and best practices.

An often-cited example of personalization done right is Netflix, who revolutionized the entertainment industry with its highly personalized user experience, which is tailored to individual viewer preferences and behaviors. Key aspects of their personalization strategy included personalized user interfaces, content curation, advanced recommendations algorithms, and interactive content. These are all things that could be replicated across pharma digital experiences with the right data, insight and design approaches.

Fostering collaboration and sector-wide learning requires deliberate effort and the creation of platforms and forums for sharing knowledge and experiences. Industry conferences, cross-sector partnerships, and collaborative research initiatives can provide opportunities for pharma companies to learn from each other and from other industries.

The push for personalization in the pharma industry is both a necessary evolution and a complex challenge. As HCPs continue to face time constraints and information overload, delivering relevant and personalized content becomes increasingly critical. However, the path to achieving this is fraught with technological, structural, and regulatory obstacles.

Action and investment are required. Brands within pharmaceutical companies need to collaborate to meet the needs of their connected customers. A more customer centric mindset is required, which will be difficult for the pharmaceutical industry - which is heavily geared around the product development cycle.

Organizations must prioritize the development of modern digital tools solutions, break down internal silos, and foster a culture of collaboration to overcome these barriers. By doing so, they can harness the power of data analytics and personalization to enhance HCP engagement and drive digital innovation.

Ultimately, the future success of digital pharma lies in its ability to adapt and evolve. With nearly half (49%) of industry leaders acknowledging the need to better utilize data for personalization, there is a clear recognition of the value and potential of these efforts. By addressing the challenges head-on, the industry can unlock new opportunities for growth and improved HCP experiences and patient outcomes through personalized digital engagement.

As HCPs continue to face time constraints and information overload, delivering relevant and personalized content becomes increasingly critical.

Personalizing Pharma: Overcoming Challenges to Drive Digital Customer Engagement

US payers reject 69% of prescriptions during the first year of a new drug’s FDA approval, and these early rejection rates are only nominally improved in the ensuing years.

 Such a high payer rejection rate is stunning on its own, but this doesn’t even reflect the countless instances when healthcare providers, purely out of a learned expectation for payer rejections, choose to prescribe alternative therapies. Biopharma’s hard-earned FDA approvals, physician trust and patient demand often fail to impress payers as drug manufacturers hope. Demand generation at launch reigns supreme, but poor payer coverage is its kryptonite.

Increased control over prescribing in the last decade has given payers more leverage with manufacturers. As a result, market access rebate trends have reached heights once unthinkable for biopharma, serving as evidence that manufacturers have reluctantly accepted their weakening negotiating position. While biopharma has steered its collective pipeline to therapeutic areas better shielded from payer restrictions (think oncology and rare disease), its playbook to launch drugs with payers has changed only incrementally. A biopharma breakthrough that better establishes the value of new medicines to payers is both overdue and within reach.

Payer coverage decision reviews on newly approved drugs always begin with a tri-fold assessment of a therapy’s value: clinical risks and benefits, physician and patient demand, and only then, projected costs. The importance of manufacturers addressing all three of these criteria through payer messaging is hardly new, but their methods to do so are too often outdated. To reverse current launch trends, manufacturers must transform their payer value propositions (PVPs). This can be accomplished in three ways:

Ensure internal stakeholders understand the payer perspective

Create resources payers will incorporate into their coverage decision reviews.

Build and deploy a payer launch insights engine.

1. Ensure internal stakeholders understand the payer perspective

When companies manage payers from silos, strategies are fragmented, execution is compromised, and patient access suffers. The outsized impact of payers on drug launches demands a deep understanding of their needs and interests that is shared by stakeholders beyond manufacturer market access teams. For most, ensuring all departments are aligned and committed to creating value for payers is a strategic imperative only enabled by new routines.

Understanding patient needs is at biopharma’s core, and a similar determination can be applied to understanding 

needs. Such an endeavor does not begin with costly restructurings or McKinsey-led proclamations about transformational change. It begins by simply elevating the voice of the payer across internal stakeholders and doing so consistently.

While recently preparing for a drug launch, a major manufacturer remotely hosted a panel of experts who fielded questions from executives in marketing, medical, finance, and account management. What made this panel especially credible was their decades of experience leading formulary management discussions for PBMs and health plans, and what made this panel especially relevant was the fact they all conducted market access research with a wide range of payer organizations. But what made this event transformational was the diversity of the audience. Concerns were shared firsthand across all stakeholders and the simultaneous dissemination of insights elevated the understanding—and the thinking—of the broader team.

When executives and marketers can convey payer interests as confidently as market access teams, meaningful alignment is achieved, and real synergies are gained. When preparing to launch a drug to payers, manufacturers can afford nothing less.

2. Create resources payers will incorporate into their coverage decision reviews.

While it is very common for manufacturers to have as few as 1-2 primary contacts at a given payer, the number of people who routinely influence payer drug coverage decisions range as high as 15-20. To positively influence primary contacts at a payer is a good start, but positively influencing the payer’s broader clinical and financial evaluation process is how market access is won.

Relevance drives engagement, and when manufacturers share resources that are tailored to the individual payer’s circumstances, those resources are far more likely to be shared with others involved in coverage decisions. However, only one in four payer decision-makers report that product information provided by manufacturers is specifically tailored to their organization (Formulary Insights research, N=28). In that same study, only 13% of payers feel budget impact models, a staple of manufacturer drug launches, regularly influence their coverage decisions.

The former Chief Pharmacy Officer of Cigna, Rory Davies, shared that “Budget impact models that do not credibly inform a payer’s cost evaluation are readily dismissed, and this is too often the case.”

 A deep understanding of how payers will model a drug category’s direct and indirect costs is essential for a successful payer launch. Just as critical is the need to understand what the payers are likely to overlook, and good market research will provide this. Hidden costs associated with titration, drug wastage, and discontinuation rates are just a few common examples of how a single variable can reframe the financial narrative. By infusing payer insights, budget impact models better establish credibility and ensure the launch drug’s true costs are appropriately measured.

Another opportunity to bolster payer value propositions include references that credibly support drug evaluations. Disease backgrounders, existing treatment overviews, and comprehensive reference lists of the clinical evidence are often welcomed as helpful supplements to what is an arduous process for the many clinical pharmacists at PBMs and health plans. The quarterly 

 is a specific example of such a resource that brings value to payers and is easily incorporated into their drug coverage reviews.

The benefits of tailoring resources to individual payers are numerous. They include increased engagement, more constructive dialogues, better competitive differentiation, a more durable influence on the payer’s internal decision process, and stronger relationships.

3. Build and deploy a payer launch insights engine.

Payer feedback tends to echo loudly throughout manufacturer headquarters, especially during drug launches. These insights are extremely valuable but inherently biased by payer negotiators pursuing added pricing pressure. Manufacturers therefore have a significant need to balance this feedback with alternative information sources. Further exacerbating the risk of misreading the market during the critical launch window, key elements of any primary market research with payers conducted prior to FDA approval become outdated the moment an approved label and pricing are publicly revealed to payers.

When a drug becomes FDA-approved, payers accelerate their drug evaluation machinery. Pharmacy & Therapeutics committees generally determine the limits on their organizations’ coverage decisions in the first 60 days, and these limits then inform the value assessment committees (VACs) which seek to exact maximum discounting from biopharma and manage total costs to the payer. For a manufacturer to limit its payer insights to negotiation feedback and past research during this critical window concedes the value of securing game-changing launch insights in near real-time.

Contrast this timeworn routine with a post-approval plan that executes agile, primary market research studies with payer drug evaluators and net pricing decision-makers, and the opportunity to better inform market access decisions during launch becomes clear. With this approach, payer negotiation feedback and past market research are positioned not as a roadmap but as inputs for further testing. The payer landscape faced by a manufacturer is never more dynamic than the months immediately following its approval; presume significant information gaps and have a plan to reduce them.

In an era where the complexities of payer dynamics are rapidly intensifying, the need for biopharma companies to evolve their payer launch playbooks is more critical than ever. Biopharma leaders who proactively reimagine their approach—by deeply understanding payer perspectives, tailoring resources to payer drug coverage reviews, and harnessing real-time insights—will not only better navigate these challenges but set new standards for success in the industry. By committing to transformation, biopharma can ensure their innovations reach the patients who need them most, while also securing the financial return required to fuel future breakthroughs. Now is the time to act; the stakes are far too high, and the trends are far too troubling to rely on yesterday’s routines.

Greenwalt, L. (2024, May). Findings presented at the Asembia conference. IQVIA.

Samsung Bioepis. (2024). Biosimilar Market Report: Q3 2024.

The profitability of biopharma drug launches in the US will remain in decline until manufacturers reimagine their approach with payers

Biopharma Must Transform its Payer Launch Playbook

In an interview with Pharmaceutical Executive, Melissa Krebs, the CEO and founder of GelSana, discusses her journey in developing novel biomaterials that aim to revolutionize the $78 billion wound care market. 

Melissa Krebs Shares GelSana’s Vision for Innovative Wound Care Solutions 

, Melissa Krebs, Ph.D., the CEO and founder of GelSana, discusses her journey in developing novel biomaterials that aim to revolutionize the $78 billion wound care market. Krebs, a chemical engineer and biomedical researcher, has dedicated her career to advancing the field of biomaterials and their application in wound care. As the CEO and founder of GelSana, a startup based at Fitzsimons Innovation Community in Aurora, Colorado, Krebs is leading the charge in developing innovative polymer-based solutions that address the underlying biological challenges of chronic wounds. With a strong background in academia and industry experience, Krebs has leveraged her expertise to create materials that can reduce inflammation, repel bacteria, and facilitate controlled drug delivery—all with the goal of accelerating the healing process and improving patient outcomes:

00:22 - Krebs' journey and background that led her to start GelSana

01:41 - Overview of GelSana and the company's wound care technology

03:14 - Explanation of GelSana's polymer technology and how it addresses wound healing

04:33 - Potential impact of GelSana's technology on the $78 billion annual wound care market

05:50 - GelSana's grants and awards, and how they support the company's development

07:04 - GelSana's focus on military applications of their technology

07:23 - GelSana's aspirations for improving patient care, experience, and cost

08:32 - Updates on GelSana's growth, fundraising, and upcoming product launch

In this interview, Melissa Krebs,Ph.D., CEO and founder of GelSana, shares her journey in developing cutting-edge biomaterials that could transform the $78 billion wound care market.

Twenty years ago, pharmaceutical product launches were dominated by primary care drugs. These launches were focused on achieving the largest share of voice and were led primarily by sales representatives. Since then, the market has advanced to the specialty era, which includes a more complex patient journey and numerous physician specialties—sometimes as many as seven. Engagement has become more multichannel, and payers are demanding more integrated evidence with increased requirements. These increasingly complex product launches can benefit from the many advantages of generative artificial intelligence (AI), and yet the debate about its usefulness and ethics continues.

To further compound these issues, we see the trajectories of post-pandemic launches underperform and decline. For example, median cumulative sales of post-pandemic drug launches were 28% lower than they were pre-pandemic. This was seen in an analysis of innovative launches during the first six months and across the top eight markets. As we know, the first six months is a pivotal time when determining a drug’s long-term success, as only 20% or fewer struggling launches are able to significantly change their trajectory.

WHY GENERATIVE AI SHOULD BE YOUR LAUNCH ASSISTANT

Getting the right information and insights quickly is imperative for a drug launch. For those launches that are more complex, which involve updating and generating hundreds of documents and have multiple teams searching for information, this is especially true. Using large language models to perform a multitude of language processing tasks allows generative AI to assist marketing teams by optimizing the search and retrieval of information. For example, a generative AI assistant that is trained using online data and documents can understand the semantic context of each query and provide results that are specific to what the user is seeking. This enables users to have an easier time finding what they need quickly and accurately without having to sort through irrelevant content.

A generative AI assistant can also compile a response that connects information from a variety of sources. As a result, responses can be tailored to different personas and be based on preferences that determine the information that is necessary. These assistants can also be used to generate cognitive responses, much like the way individuals process, interpret, and respond to information. Additionally, the assistant can provide the logic behind its produced answers, which can help instill the user’s confidence in the results.

Medical, legal, and regulatory (MLR) reviews of marketing content are another area in which generative AI can help and even accelerate the process. Sample promotional messages that received MLR approval can be used to train a generative AI model. In this way, the model can emulate language flow and produce messages that have a high probability of getting through the review process. Market access teams can also use this model to adapt to global values.

Need insights on the drivers of launch success? Generative AI models can help here, too, and account for variations and the impact of numerous factors unique to specific countries and markets. These models can evaluate timelines and ascertain physician perceptions six months post-launch versus one year. They can also be used to inform tactics by comparing the channel mixes of successful launches versus those that were not effective and determine the optimal channel mix.

Success from using generative AI assistants has been evident. For example, one customer completed a targeted literature search in just two weeks. This was significantly faster than the previous six-week norm. Others using generative AI saw a 50% gain in productivity in creating value dossiers. Value dossiers are the information that manufacturers submit to payers to determine whether the effectiveness of a product justifies its proposed price. Additionally, using a conversational AI model on top of anonymous real-world data enabled customers to conduct the analysis 70% faster. The team didn’t need to know programming, the right international classification of diseases, or other codes to quantify the segment size. This helped expand the use of real-world data.

ENHANCE CUSTOMER ENGAGEMENT WITH GENERATIVE AI

Generative AI can enhance the understanding of various healthcare professional (HCP) segments and allow for more tailored engagements. As AI assistants are used among payers, HCPs, and physicians to help inform prescribing and treatment decisions, pharma may need to start viewing these assistants as another type of stakeholder segment.

As we see other industries using AI-powered chatbots for salesforce training, it may also be advantageous for pharma to create a field force assistant for a launch. A generative AI field force assistant can be invaluable when launching in a new therapeutic area or a new indication, especially when the understanding of key stakeholders isn’t clear. The use of “digital twins” personas can mimic how HCPs communicate and increase the overall familiarity with different personas before sales reps go into the field. This can enhance conversations on specific topics and facilitate responding to difficult questions with new data and insights, as well as promote which answers best resonate with a particular persona.

INNOVATIONS ARE NEEDED TO ENSURE LAUNCH SUCCESS

Launch planning and execution can benefit greatly from generative AI and the game-changing opportunities it provides. The ability to analyze and learn from terabytes of structured and unstructured data is a key advantage of using generative AI. Its ability to generate new content via text, images, or code, and learn to become more intuitive and conversational, are other advantages that can help overcome the hurdle of adoption. Generative AI can also increase productivity in launch planning and execution by providing real-time, personalized, and smarter insights to generate content. Predicting uptake curves and the outcomes of health technology assessments are other benefits, and they can be used to create capability models to predict the future events in the product lifecycle.

DRIVING LAUNCH PRODUCTIVITY AND VALUE FORWARD

By assisting, augmenting, and automating insights, generative AI models can provide enhanced clarity and focus for evidence-based decision-making. Better access to insights encourages and empowers cross-functional collaboration. These insights can facilitate operational agility and allow teams to respond more quickly and with certainty to changing internal and external environments.

The future of pharma is now, which is why incorporating generative AI into product launches should be a serious launch team consideration. Generative AI offers numerous advantages in addition to enhancing launch speed and efficiency. These assistants can also improve the effectiveness of different work streams by enabling quicker processing of reams of data and insights for faster decision-making. Their ability to personalize customer engagement messages and get these messages through the MLR-approval process more quickly provides further support.

Generative AI can mitigate launch challenges and drive productivity, enhance decision-making, and elevate customer engagement to achieve launch excellence. Those who incorporate generative AI into their launch plans are sure to see its incredible value realized. Will your launch team be among them?

Natalie Harb is Vice President, Offering Development, Global Commercial Solutions, IQVIA

1. Launch Excellence VIII. IQVIA. July 12, 2023. 

https://www.iqvia.com/library/white-papers/launch-excellence-viii

How drugmakers can reap value from using generative AI in their market-entry strategies and decision-making, including mitigating launch challenges and enhancing the customer conversation.

The Future of Launch Excellence is Generative AI

Spinal cord injuries (SCI) can be devastating. Victims can often be left with permanent disabilities and debilitating pain. Mike Kelly, president and CEO of 

, spoke with Pharmaceutical Executive about the company’s unique approach to actually repairing these injuries. The company’s primary drug, NVG-291, has shown the ability to activate the body’s ability to heal itself.

Pharmaceutical Executive: How did you become involved with NervGen?


 I’ve been in pharma for about 30 years, starting off on the commercial side of the business. For my last several jobs, I was at the executive level at different companies. At my last job, I was involved in launching the Narcan nasal spray. I joined NervGen after a friend of mine introduced me to the company and said I should look at the technology. I got in touch with the company’s founder Dr. Jerry Silver and had a fantastic conversation. We booked a half-hour and an hour-and-a-half later, Jerry realized he had to leave because he had another call to get to.

Jerry is a great inventor, but he’s also a fantastic teacher. Since I’m not a scientist, he’s been able to take complex science and break it down so he can educate a non-scientist like me about his technology and the series of discoveries he made that led to NVG-291.

Then I met the company’s founder, Dr. Harold Punnett. He started the company after his daughter-in-law fell and became paralyzed. Harold had been a dentist and had a science background, so he began searching the world for spinal cord injury treatments. This is when he discovered Jerry’s research. Ultimately, he convinced Jerry to out license the technology, got a group of investors together, launched an IPO, and started the company.

It's not your typical path for a biotech.

After I met with Jerry, I met the board and core management team. With each conversation, I became more excited that I could actually help the company. The skillset that I brought to the table would get the company to next level.

PE: How significantly can SCI impact a patient’s quality of life?


 There are 18,000 new cases a year, and there’s over 300,000 people living with these injuries, which can range from a minor motor-incomplete injury to a severe, full-paralysis injury. When people think of SCI, they think of someone like Christopher Reeve who was in a wheelchair and needed a ventilator. However, there are folks that had a small accident or sports injury. One of our board members was an avid bike rider. One day, he got run off the road by a truck and got a lot of different injuries. However, one small tweak of his spine left him in a wheelchair for the rest of his life.

The average age for people with SCI is 43. These are people whose lives changed in an instant. It’s pretty devasting to go from being fully functional to having a permanent condition. Some folks have minor injuries that leave them unable to grasp things. Other people are left with more severe injuries and are unable to walk or lose the use of an arm. They must very quickly figure out how to get through life impaired.

It’s not like a disease that has a slow onset. Something happens and these people very suddenly found themselves in a hospital being told that this is how things will be for the rest of their lives.

PE: How does NVG-291 differ from traditional SCI treatment?


 Traditional treatment is just rehab. There’s a lot of cutting-edge things that are starting to happen, but there is no pharmaceutical treatment. Our product works in a simple way. When you cut your hand or break a bone, your body repairs itself. If you damage your spinal cord, however, your body protects itself, and that inhibits repair.

One of the molecules involved in this protection process is CSPG, and this is where Jerry’s research came into play. He had discovered that these molecules could inhibit the repair process, so he started to look into how to turn these molecules off. Through a collaboration with Harvard, a receptor was discovered where these molecules were attaching to cells. He then began developing drugs that could disrupt that process, which is where NVG-291 was discovered.

We’re still trying to determine the specific molecular mechanism of action, but the action we’ve seen is that when the drug is introduced into a rodent model, it turns off those molecules and the body is able to regenerate. We’re not propagating anything; we’re just shutting off the inhibitor and allowing the body to the work on its own.

Kelly discusses how the company takes a different approach to spinal cord injuries.

Srihari Rangarajan

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