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In this episode, I spoke to Cassandra Rix, the owner and chief leadership coach at The Resonance Coach. Our conversation centered around understanding individual motivations and expectations within group efforts, especially in the context of company acquisitions. I think you will find the insights applicable to many situations at work and at home.
Cass's Background and Expertise
Cass has spent over 20 years working with businesses either in the process of being acquired or on the tail end of an acquisition. She specializes in service agencies selling expertise and time, such as consultancies and communication specialists. Her focus now is on helping founders looking for investment or seeking an exit strategy, and the businesses interested in investing in them. She believes that many acquisitions fail despite thorough due diligence because the underlying human motivations and behaviors of the individuals involved aren't fully understood.
Understanding Motivations
While people may outwardly agree on a common goal, such as selling a company, their underlying reasons can be very different. These differences will show up during times of significant change (after the investment or acquisition). Everyone’s motivations are influenced by their own personal experiences and beliefs, which drive their decisions and behaviors.
Cass's own interest in understanding motivations stems from her background in sales and marketing, where she worked with buyers and wanted to comprehend why people made specific purchasing decisions. Our beliefs drive our behavior, and it's crucial to recognize that we often make assumptions about others' motivations based on our own perspectives. We expect them to act the way we would. I’d like to look deeper into this in future episodes.
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The Challenges of Assumptions
It’s risky to assume that everyone's motivations are similar. Cass used the analogy of wearing someone else's shoes – just because you're in their shoes doesn't mean you understand their journey. This is especially relevant in business settings, where assuming that all founders or team members share the same motivations can lead to conflicts and dysfunction.
Cass illustrated this with an example of how misaligned expectations can derail an acquisition. For instance, if one founder decides they have enough financial security post-acquisition and leaves, the remaining team dynamics can be severely disrupted:
So the things that fall apart there is, well, we all think we've agreed to sell this business or invest, have investment in this business so that we can carry on.
What does carry on mean? What if that means that one person has generated enough income in the acquisition process, not to need to stay throughout the earn-out. And suddenly you go from a leadership team or founding team of four to three or three to two. What if the other two people in that business were beautifully balanced by that third individual?
And so the relationship that they're left with is dysfunctional. They don't really like each other. They don't know how to communicate with each other. They've never had to without that third person as a foil. And probably the most flawed thing is the assumption that the rest of the business, whether you're talking about another twenty people, fifty people or thousands of people, the assumption that those people don't know.
This scenario can lead to conflicts and a decline in business performance, which affects everyone's livelihoods.
The Role of Vulnerability and Communication
As individuals climb the corporate ladder, they often create personas that might not align with their true selves. This can lead to exhaustion and dissatisfaction, as they try to maintain an identity that doesn't reflect their genuine motivations.
Cass said that vulnerability is not a weakness but a strength. When leaders and team members are open about their true motivations and feelings, it fosters understanding and empathy. She shared that when people reveal their authentic selves, it often leads to relief and better teamwork. This openness can help teams navigate change more effectively, as everyone understands each other's perspectives and can support one another.
Practical Implications and Real-World Examples
Cass pointed out how small habits and cultural norms, such as which hand you use to hold a fork, can shape our perspectives and lead to emotional attachments about how things should be done. If we feel that strongly about cutlery, imagine the intensity of our feelings about approaches to business where the stakes are much higher.
Translating this to business settings, she explained how deeply ingrained beliefs about success and behavior can affect decision-making and team dynamics. Differing motivations for making money can lead to misunderstandings. Some people might want to make money to retire early and spend time with family, while others aim to leave a legacy or achieve a prestigious position. These differing goals and expectations can create friction if not openly discussed and understood. Whether you are the acquiring/investing company or the company being invested in, understanding these things can make a huge difference in your long-term happiness (money, legacy…).
The Courage to Be Disliked
Our conversation concluded with a serious reflection on the importance of self-awareness and the courage to be true to oneself. Cass recommended the book "The Courage to Be Disliked," which explores the concept that what others think of us often reflects their own beliefs and insecurities. She encouraged leaders and individuals to focus on their own motivations and well-being rather than constantly worrying about others' opinions.
Her final thought: "The most liberating two words in the English language are 'let them...'" Letting go of the need for external validation and embracing one's true self can lead to greater fulfillment and success, both personally and professionally.
Let them.
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In my recent conversation with Larry Kaplow, we talked about brand strategy in the life sciences, why, when and how.
Defining Brand Strategy
We kicked off the discussion with Larry describing the danger of not having a strategy. In a world overloaded with information, a brand has to cut through the noise and make its value clear. Even if a company has groundbreaking technology, it’s easy to be overlooked if the brand strategy isn’t aligned with the audience's needs. People—whether researchers, investors, healthcare professionals, or patients—are primarily concerned with their own interests.
A brand is the sum of all associations that audiences have about a company. This definition, which he credited to Uli Applebaum, highlights that every touchpoint, from sales calls to investor decks, contributes to building these associations. As a result, a deliberate and intentional strategy is crucial for creating consistent and meaningful connections with the audience.
Simplifying the Brand Message
Larry argued that while nuances might change, the core brand message should remain consistent. He likened it to owning a space in the audience's mind—when they think of your company, they should think of one defining characteristic. This consistency makes it easier for the audience to remember and relate to the brand.
Here is a real-world example. Thermo Fisher faced the challenge of convincing diverse audiences to switch from traditional methods to mass spectrometry in toxicology. By identifying two primary audience groups—those looking to grow their business and those pushing the boundaries of research—they could tailor their brand message to resonate broadly. This approach allowed them to lead with a brand-focused message about pushing toxicology forward, which connected with all their target audiences. It took doing some homework to get there. This involves understanding the audience's motivations, barriers, and pain points.
Larry shared another example from a different company in the medication management space in hospitals. The initial tech-focused message wasn't resonating. Hospitals were resistant to new technology because new tech often means a lot of work. By shifting the narrative to focus on patient and hospital safety, they aligned their message with what was truly important to their audience. This not only made the brand message more relevant but also helped position the technology with respect to existing budgets for safety initiatives.
Personality Archetypes for Commoditized Products
Brand personality archetypes can differentiate a company in a commoditized market by mirroring what's important to them or by representing something they aspire to be. For instance, McDonald's uses the "Innocent" archetype, creating a sense of happiness and nostalgia. In contrast, Burger King has struggled with consistency, resulting in a less impactful brand presence. As I look at it, BK is focused on the burger, McDonald’s is focused on the experience.
Crafting a Long-Term Brand Vision for Investors
If we think about smaller biotech firms, even prior to commercialization, crafting a long-term brand vision is crucial, especially when communicating with investors. Larry noted that investors are people too, influenced by compelling narratives. Investors looking for long-term returns want to see a cohesive brand strategy that promises sustainable growth and market relevance. A strong brand story in the investor deck can be as important as the technical details. The other lesson here is knowing what kind of investor you have or are looking for.
Brand Architecture - Balancing Messages Across Different Levels
We wrapped up the conversation by discussing how to balance messages across different levels—company brand, technology, and specific applications. Larry differentiated between brand architecture and communication structure. Brand architecture involves categorizing and integrating different brands, especially post-acquisitions, whereas communication structure focuses on maintaining a consistent brand story across various touchpoints.
He highlighted the importance of having a comprehensive brand position that can be communicated at all levels, from the high-level mission and vision to the detailed technical aspects. This consistency not only strengthens the brand but also adds credibility and value over the long term.
Final Thoughts
Larry’s insights were a masterclass in brand strategy, particularly for the life sciences sector. His emphasis on consistency, relevance, and the importance of doing the homework provides a clear roadmap for any company looking to strengthen its brand. For me, the takeaway was clear: a well-defined and consistently communicated brand strategy is essential for cutting through the noise and making a lasting impact. And for those in the biotech space, understanding and addressing the needs of all your audiences, including investors, is key to building a strong, sustainable brand.
Your deepest insights are your best branding. I’d love to help you share them. Chat with me about custom content for your life science brand. Or visit my website.
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At BIO2024, I spoke Sam Clark, CEO and founder of Terran Biosciences, about their development of new long-duration dosage forms for the treatment of schizophrenia . We discussed the development of prodrugs, the potential of psychedelics, and the journey of founding a biotech company.
The Genesis of Terran Biosciences
Sam's journey into biotech was personal. Growing up around friends and family members with severe mental illnesses like bipolar disorder and Alzheimer's disease, he saw the limitations of existing treatments. Through his studies at MIT and Columbia, he recognized the slow pace of development and the significant side effects of available medications. Existing treatments for mental illnesses have many unpleasant side effects from cause weight gain to Parkinsonian symptoms and hormonal disruptions. All of that led to his decision to found Terran Biosciences hoping to transform the standard of care.
Terran's Pipeline
Terran's lead asset, TerXT, is a novel combination of prodrugs of xanomeline and trospium, compounds that have been around for a long time, but with less than ideal pharmacokinetics. They also have Idazoxan XR, an adjunctive treatment for schizophrenia, and several new forms of psychedelics like psilocybin and MDMA with differentiated pharmacokinetics aimed at making these treatments more accessible and affordable.
Sam explained the significance of prodrugs in their approach. Unlike simple reformulations, prodrugs are entirely new compounds created by attaching a side chain to the original molecule. This attachment improves pharmacokinetics, allowing for more effective absorption and longer-lasting effects. For example, the older compounds xanomeline and trospium, which need to be taken twice daily, have been modified into prodrugs that can be administered once daily or as long-acting injectables with multi-month durations. This innovation not only simplifies the regimen for patients but also leverages the FDA's accelerated 505(b)(2) pathway, potentially bringing these new treatments to market faster.
Overcoming Development Challenges
Creating effective prodrugs is no small task. Sam described the extensive process, involving a team of world experts and over 200 FTE chemists working tirelessly. They designed over 10,000 prodrugs, synthesized 700, and conducted 500 preclinical studies to refine their approach. This massive undertaking, though challenging, has led to promising results.
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The Potential of Psychedelics
I also wanted to explore psychedelics, a field that has generated significant interest in recent years. Terran is developing new forms of MDMA, psilocybin, and 5-MeO-DMT, aiming to improve their pharmacokinetics and make these treatments more accessible. Sam highlighted MDMA's potential, currently under FDA review for treating PTSD, with a decision expected soon. (Right after we spoke, the FDA advisory panel recommended rejecting approval for MDMA. The decision has not been made yet.) By creating new forms and leveraging the 505(b)(2) pathway, Terran aims to overcome patent barriers and ensure these treatments are affordable.
Insights into Brain Function
I am particularly curious about anything we can learn about neurobiology from studies around these therapeutic compounds and psychedelics. Here is the challenge: Psychedelics, for example, act on multiple receptors. Teasing out different pathways in the brain is complicated. Functional MRI studies of people undergoing psychedelic trips show reproducible changes in brain pathways, suggesting potential mechanisms but the circuitry is complicated. There are no simple answers yet.
The Journey of a First-Time Founder
I asked Sam about his experience as a first-time founder. Terran's success is in large part due to its corporate structure, modeled after fast-moving Silicon Valley companies. By avoiding traditional hierarchical structures and instead utilizing a flat organization with world experts leading sub-teams, Terran has managed to solve complex problems efficiently.
Team building has been essential to Terran's achievements. Sam's approach involves creating specialized teams for different facets of a problem, ensuring a comprehensive and collaborative effort.
“Workflows” for the Win
I have seen a pattern in several interviews recently. Changing a process can have as big of an effect on solving a problem (and creating success for a company) as developing a new product. In this case, it’s a bit of both. The problem being solved by TerXT is the patient regimen. Prodrugs with longer-duration pharmacokinetics make adherence easier for the patient. At the same time, I appreciate the enormous amount of development effort that went into creating those prodrugs. A different approach to assembling teams and managing them is also a significant change in the workflow that will have an impact.
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In this episode, recorded at BIO2024 in San Diego, I had the pleasure of speaking with Martin Brenner, the CEO and CSO of iBio. Our focus was the challenges and innovations in developing antibody-based therapeutics, particularly through their AI-driven discovery platform. Martin shared his insights into the current landscape and future directions of antibody therapies, touching on key aspects such as target selection, engineering challenges, and the role of AI in optimizing therapeutic antibodies.
The Challenges of Developing Antibody Therapies
Antibodies have revolutionized therapeutic approaches over the past two decades, with numerous successful drugs already approved. However, as Martin pointed out, we've now picked much of the low-hanging fruit. The target space is becoming increasingly complex, with most approved antibodies focusing on a small set of targets. For instance, about 40% of all approved antibodies target PD-1. While anyone can now develop a PD-1 antibody, the real challenge lies in identifying and effectively targeting novel, more complex antigens.
Another significant challenge Martin highlighted is improving the safety and therapeutic window of antibodies. Highly potent antibodies, particularly in oncology, can cause severe side effects. Enhancing the safety profile while maintaining efficacy is a critical area of ongoing research.
Potency vs. Therapeutic Effectiveness
It turns out that the best-binding antibody isn't always the most effective therapeutic. For example, in bispecific molecules, where one arm binds to a tumor cell and the other to an immune cell, the tightest binding isn't always ideal. Overstimulation can lead to cytokine release and toxicity. Instead, finding the right balance in binding characteristics is crucial to avoid adverse effects.
Traditionally, the goal was to find an antibody that binds quickly and stays bound indefinitely. However, this might not always be the best approach. Understanding on and off rates of antibodies is important for delivering the desired response. Novel technologies now allow us to screen for these characteristics early, optimizing therapeutic effectiveness and safety.
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iBio's AI-Driven Platform
iBio focuses on generating small, high-dimensional data sets to train their models. Their technology starts with an epitope steering engine, which creates engineered epitopes that precisely reflect the surface of target proteins. This innovative approach allows for targeted antibody development, even against challenging targets.
For example, iBio can create PD-1 agonists that activate receptors instead of merely blocking them. This capability opens up a new realm of possibilities in antibody therapies, particularly for complex and hard-to-target proteins.
Discovering New Biology Through Targeting
One of the most exciting parts of our conversation was discussing how iBio's platform not only targets known regions of proteins but also helps uncover new biological functions. By addressing the entire protein surface with engineered epitopes and screening them, iBio can identify antibodies that reveal new aspects of a protein's role. This approach not only enhances therapeutic development but also contributes to our broader understanding of biology.
Smart Antibodies and Masking
Martin explained their concept of smart antibodies, which are designed to be inactive until they reach the disease tissue, like a pro-drug. This masking technique, particularly useful in tumor biology, involves connecting a mask to the antibody with a linker that is cleaved off by enzymes in the tumor environment. This method allows for higher precision in targeting and reduces side effects by ensuring the antibody is only active in the intended tissue.
For example, targeting the epidermal growth factor receptor (EGFR) can be problematic due to its expression in the skin, leading to side effects. Using a masking approach, iBio can target EGFR in tumors while minimizing impact on the skin, potentially allowing for higher dosing and improved efficacy.
Optimization and Rapid Development
iBio's approach to optimization sets them apart. Traditional methods like phage display create large libraries of molecules but require significant time to identify and develop drug-like characteristics. In contrast, iBio uses machine learning to create localized diversity in a smaller, more manageable library. This method mimics the diversity of large libraries while maintaining high developability, drastically reducing optimization time from months to weeks.
Focus Areas and Future Directions
I asked Martin about what areas they are focused on with their pipeline. iBio is currently focusing on cardiometabolic and immuno-oncology areas. Their preclinical pipeline includes promising targets in immuno-oncology, with plans to partner these developments strategically. Additionally, Martin's background in diabetes and obesity research has driven their pivot into cardiometabolic diseases, aiming to develop drugs for those indications that avoid muscle and bone loss, crucial for the aging population.
Other molecules, single chain antibodies from sharks or human heavy chain alone may eventually form the basis of new therapies for more complex targets.
For me, the attraction of this approach is the broader look at the target molecules to survey all the possibilities beyond developing a small molecule that fits in a binding site and the benefit of everything we learn about biology that may lead to new discoveries in the future.
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In this episode of CC Life Science, I had the pleasure of hosting Neil Spooner, the founder and chair of the Patient-Centric Sampling Interest Group (PCSIG). Neil shared his insights into patient-centric sampling and its potential to revolutionize healthcare and clinical trials.
Introduction to Patient-Centric Sampling
Neil began by explaining the concept of patient-centric sampling, which prioritizes the patient's needs over traditional methods that often inconvenience them. Traditional methods like venous phlebotomy or standard urine collection are designed with the analytical labs, clinicians, and logistical chains in mind rather than the patients. For patients, that means they have to have to take time out of their day, possibly missing work or school, to visit a clinic for sampling.
This is an added burden for patients, particularly those with chronic conditions requiring frequent testing. I shared the example of a family member, who had leukemia and needed to visit the hospital twice a week for tests. This was a significant strain not only on her but also on family members. Neil explained that patient-centric sampling offers a more convenient alternative, allowing samples to be collected at a time and place that suits the patient, whether at home or any other location.
Benefits for Clinical Trials and Healthcare
I was curious about what this approach would mean for clinical trials and healthcare. Neil pointed out that easier and more flexible sampling methods could improve patient recruitment and retention in clinical trials. It could also help gather data that is currently difficult to obtain, such as samples taken during a clinical event like a migraine. This approach not only enhances data collection but also broadens the patient pool to include those who might otherwise find it difficult to participate due to geographical or physical constraints.
Current Research and Stakeholder Engagement
Bring this concept to life isn’t just about workflows and analytical science. Marketing plays a big role as well. And I don’t just mean promotion. I mean understanding the needs of everyone involved. Neil explained that the PCSIG is actively engaging with various stakeholders to understand their concerns and benefits regarding patient-centric sampling. They are doing market research to identify key stakeholders in different use cases, such as clinical trials, therapeutic drug monitoring, diagnostics, and drug testing in sports. By having conversations with these groups, PCSIG aims to educate and address their concerns while identifying potential benefits and gaps in the current system.
Addressing the Resistance to Change
One of the significant challenges discussed was the resistance to change within the healthcare and clinical trial sectors. Neil ponted out the importance of finding passionate individuals within organizations who can champion the adoption of new sampling methods. These individuals need the support of their superiors and a network of like-minded professionals to overcome the inevitable hurdles that come with implementing new technologies.
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Technological and Logistical Innovations
We spent a little bit of time discussing sample formats and logistics. Currently labs doing routine analyses operate large analyzers that are set up for huge volumes of a standard set of tubes. Neil provided insights into the technological and logistical innovations required for patient-centric sampling. He mentioned various devices that can collect blood samples through finger pricks or from other body parts like the arm or thigh, often producing dried samples that can be mailed to labs. The COVID-19 pandemic demonstrated the feasibility of such home-based testing, showing that logistical systems can adapt to handle new sampling methods.
Impact on Drug Testing in Sports
I was surprised to hear about the application of patient-centric sampling in drug testing for sports. Chain of custody is crucial here to ensure the integrity of the samples. Neil explained that while athletes would still need to be witnessed during sample collection, blood sampling could be a more comfortable and less invasive (in terms of witnessing) option compared to urine sampling. Ultimately it’s likely to be complementary to urine testing. It does bring benefits for the athlete. It can make ongoing monitoring more practical for providing valuable data for athletes' training and health.
Sponsorship and Future Plans
Finally, we touched on the PCSIG's funding and sponsorship. Neil explained that the organization aims to keep sponsorship levels low to encourage broad participation, including startups and companies from less affluent regions ensuring that no one sponsor has outsized influence on the direction of the group. Sponsors benefit from visibility on PCSIG's platforms and involvement in the sponsors' advisory group, which helps shape the group's activities. Sponsors recently voted on nine proposed activities, and the top two priorities would soon be announced.
Reducing the burden on patients needing frequent testing alone makes this effort worthwhile in my opinion. The benefits for recruitment and retention in clinical trials and drug/health monitoring in sports are icing on the cake.
Your deepest insights are your best branding. I’d love to help you share them. Chat with me about custom content for your life science brand. Or visit my website.
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David Ormesher, the CEO of CGLife, and I had a conversation about communicating science broadly to the public and within the scientific community. David went immediately to the power of storytelling in making science approachable. He highlighted the hero’s journey, the narrative arc used in literature and film, as a powerful tool to engage various audiences, whether they are scientists, physicians, patients, or the general public.
That narrative of the hero’s journey applies to patients and caregivers as well as scientist looking for breakthroughs. Not only can it help demystify science but it can also create emotional connections that make complex scientific concepts more relatable and engaging for the general public.
I think it’s important for society to understand and appreciate the work of scientists as well as understand how science is done especially when the details might not seem immediately relevant to them. By highlighting the human element and the persistence required in scientific exploration, we can help the public understand that scientists are ordinary people with an extraordinary commitment to solving complex problems. This can shift the public perception from seeing science as something inaccessible to recognizing it as a collective effort aimed at improving lives as well as simply appreciating the universe we live in.
What does this mean for life science marketers? David gave us a complete primer on the journey of a new medical product from inception to market launch. I was roughly aware of the roles various teams play in bringing a new drug to market. He covered the spectrum and filled in the details for me. Market insight, brand development, and market shaping involves understanding the needs of both physicians and patients, conducting extensive research, and building awareness through unbranded communications. As has come up several times over the years on this podcast, the importance of early engagement with healthcare professionals and patients before a product is approved can not be overstated. It helps ensure that by the time a drug is approved, there is demand and a well-informed audience.
It's that ability to personalize content that is also key. And this is where not only the agencies of the future that we need to help shepherd these products from clinical development through approval, launch and growth, they need to understand the science. They also need to understand that digital component of targeting, segmentation, (and) personalization.
Data and analytics play a critical role in this process. By capturing and analyzing data from the early stages, companies can refine their marketing strategies, personalize content, and measure the effectiveness of their campaigns. This data-driven approach ensures that the communication is relevant and impactful, reaching the right audience with the right message at the right time.
One aspect I found particularly interesting was the preparation for day zero – the day the FDA approves a new drug. David described having all the marketing materials ready, including a “day one” website and direct email marketing. At the same time, a launch team needs to be prepared to very quickly make any changes required for labeling, etc. when the approval comes along.
Finally, we touched on the challenges of educating physicians about the latest medical advancements. For a doctor who completed medical school 20 years ago, and has been seeing patients all day every day, keeping up to date is near impossible. Highly targeted communications including bite-sized, relevant, and easily accessible content, such as short video interviews and 3D animations can help physicians keep up with the latest developments.
As marketers, there is plenty of work to be done to keep both the public and people in the healthcare sector educated on the value of the science being done, ultimately helping patients find the treatments they need.
Your deepest insights are your best branding. I’d love to help you share them. Chat with me about custom content for your life science brand. Or visit my website.
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I kept hearing about the use of organoids in clinical trials and elsewhere and was curious to know more. Luckily, I connected with Samantha Nicholson, the Global Technical Marketing Manager for Cell Culture at Millipore Sigma. She has a very cool job. Samantha is a hub, as she calls it, bringing together scientists to make progress in this exciting new area of research. She described her role, the applications of organoids, and their implications for future scientific research and healthcare.
Organoids, as Samantha explained, are critical in basic research like organogenesis and developmental biology, offering insights into organ functions and disease modeling. Beyond that, their utility spans from drug discovery, where they aid in understanding drug effects and disease development, to pharmacogenetics and even regenerative medicine, potentially leading to breakthroughs like synthetic organs or alternative meat production.
Organoids are not just a mix of cells from a particular organ, they mimic the structure and function of the organ itself. She gave the example of a colon and an organoid having a mucosal layer, an absorptive layer, and a muscle layer , derived from a specific subset of adult stem cells. This allows them to model diseases and organ functions more accurately than traditional 2D cell cultures.
Perhaps most interesting is how organoids can significantly improve the inclusivity and diversity of clinical trials. Historically, clinical trials have suffered from a lack of diversity, often excluding women and other demographic groups. Organoids can be developed from tissue samples from diverse populations worldwide, allowing for a broader understanding of how diseases and treatments affect different demographic groups without the ethical and logistical complexities of human trials.
We'll also be able to do patient stratification. So we're able to look at specific metabolic profiles or racial profiles or genetic mutational landscapes and thentest those drugs in those patients as a stratified process.
So we can compare female and male, Caucasian versus African versus Middle Eastern, for example. And we can also start to develop patient-specific models. So we can take, for example, someone who has hereditary cholesterol and compare it to somebody who has developed cholesterol. And what does that mutational profile, differences in that mutational profile, what does that mean for those people?
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As someone whose last job in a lab was studying host pathogen interactions, I got pretty excited when she told me about the applications in this area. Organoids may fill the goldilocks region between expensive experiments in small animals like mice and the limitations of 2D cell cultures with representing a single cell type. I could have used this 25 years ago!
We briefly dove into process of creating organoids, starting from the isolation of stem cells from a tissue biopsy or through induced pluripotent stem cells. This involves cultivating these cells in specialized media to promote growth and differentiation, mimicking the natural growth environment of cells within the human body.
Despite the promising applications, there are challenges in organoid technology concerning the variability and reproducibility of organoids. The size and shape of organoids can vary, which complicates their use in high-throughput screenings and other standardized tests. Achieving full functionality and maturation of organoids remains a hurdle, as they often lack certain cell types found in natural organs, such as immune or endothelial cells.
When I asked her what is next in the world of organoids, Samantha was optimistic about their potential to democratize drug development and reduce reliance on animal models. She believes that advancing organoid technology could lead to more personalized and effective treatments, enhancing the inclusivity and ethical standards of biomedical research.
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By now, I imagine most of you have interacted with ChatGPT in some way. You can use it to summarize a document, brainstorm a campaign or plan a vacation away from technology. The capabilities are mind-boggling and the BS (if you detect it) is amusing. All that aside, how can you use an internal vertical GPT to serve your customers?
I spoke to Ian Birkby, CEO of AZONetwork about Azthena, the internal vertical GPT they built as an AI assistant deployed on their various websites to help users find relevant news and product information. If you are not familiar with AZONetwork, Chat GPT describes them like this:
The AZoNetwork is a company that specializes in digital marketing and content solutions within the science, healthcare, and technology sectors. They provide a range of services aimed at connecting scientific, medical, and technology communities globally. These services include content creation, marketing strategies, and communication solutions designed to disseminate knowledge and promote products through various online platforms. AZoNetwork operates several websites that publish articles, news, and resources relevant to professionals in these fields, helping them to stay informed about the latest developments and technologies.
As a media and marketing company, AZONetwork has a lot of content, over a million assets, by Ian’s estimate. This is the content was used to train Azthena to to answer users queries.
The value of this type of GPT is that the data it has been trained on has been reviewed and vetted by humans in the course of publication over many years. The same can’t be said for everything one finds on the internet, some of which ends up in the answers to your ChatGPT queries, not to mention outright hallucinations.
General LLMs, if I'm going to exaggerate, are a mile wide and a few inches deep. We're trying to be, you know, maybe 12 inches wide, but three foot deep… - Ian Birkby
Azthena took nine months to build. That was impressive to me given that includes putting some structure around all of their content.
The quality of the output should enhance the customer experience by providing specific answers to queries along with relevant references.
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Ian and I discussed what this will mean for companies, buyers and human creativity broadly.
External GPTs trained on the same broad collections of data may all end up homogenized. How will you differentiate your company to be a source of unique and valuable (essential) information? Building your own specialized GPT is one possible answer.
We agreed that the buyer’s journey will change. Once people adapt to the new approach (this will take some time but too much), they’ll expect to find answers and recommended next steps regarding what to look for or look at along the way to a purchase. No more clicking through multiple links hoping to find the best information. As I write that last sentence, I’m stunned at how quickly we are spoiled by new technologies. I’m old enough to remember mailing away to get a catalog or brochure from one vendor! If you are a marketer, you should be thinking about what comes next.
In reaction to this change, big information providers e.g. The Guardian, etc. are blocking crawlers from sucking up their information. Models built on search might also change. Will we have to pay for things that were free for the last 20 years?
Finally, I asked Ian about the future of human creativity.
…emotional intelligence… that's definitely an area where, you know, the human has still got a role I think, in that, very pure form of creativity… seeing what nobody else has seen before and thinking something different. You know, that I still think there's mileage in, in humans having a role to play there. However, there's probably 80 percent of the drudgery-related tasks that we all face that are going to end up sitting on the desk of AI.
But for those routine tasks, the efficiencies will be too attractive to pass up. The next question is where is the line that makes a task routine?
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Could bacteriophage be an alternative to antibiotics for Group B Strep (GBS) in pregnant women?
GBS is a commensal bacteria, found harmlessly in the gut of some people. But it is an opportunistic pathogen that can cause significant disease - sepsis, meningitis, lung injury and bacteremia - in newborns exposed to it in the vaginal tract during birth, for example.
Lucy Furfaro is an Emerging Leadership Fellow at the University of Western Australia in Perth. I spoke to her about her research in this area, how she became interested in the microbiology of newborns and their mothers, and the advantages of living in the most remote city on Earth.
Lucy works at the King Edward Memorial Hospital, the referral center for all of Western Australia which covers an area approximately equal to the US west of the Rocky Mountains.
What makes the hospital unique is that it hosts The Raine Study, the world's oldest prospective birth cohort, which has been collecting ongoing health data on mothers and their babies for 35 years.
Preventing infection of newborns is done differently depending on where you are. The standard in Australia and the US is universal screening, typically a swab test. Expectant mothers testing positive for GBS in the vaginal tract (about 1 in 4) are given antibiotics pre-emptively.
The UK and New Zealand take a risk-based approach (e.g., a history of infection) to determine who gets the antibiotic. While antibiotic resistance is not an issue of concern in GBS yet, we know that eventually it can be. Also of interest is what antibiotics do to the microbiome of moms and their babies.
These concerns lead to the consideration of phage as a possible targeted therapy for GBS. At least a few challenges, both scientific and regulatory, remain to be solved.
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Bacteriophage or simply phage are viruses that infect and kill bacteria. They are typically specific to a single type or closely related bacteria. Some are obligately lytic phages that infect a bacterium, replicate inside, lyse the cell and move on to the next bacterium. Others can hedge their bet, taking either the lytic pathway or occasionally integrating their DNA into the DNA of the host bacteria. These temperate phage might later be induced to lyse their host cells and move on.
Ideally, phages chosen for antimicrobial therapies are of the lytic variety. But every phage found to infect Group B Strep so far is a temperate phage. That is either a sampling problem or an interesting biological question of why that is so.
Beyond the biology are the regulatory questions. Are phage biologicals? They aren’t alive. However, neither is an engineered antibody, which is subject to a lot of analysis to confirm its identity.
One possible solution is to avoid using intact phage particles. It involves the engineering of phage lysins, the enzymes that disrupt bacterial cell walls and membranes. These might be delivered in a topical cream to prevent infection at birth avoiding broad spectrum antibiotic resistance and causing minimal disruption to the maternal microbiome.
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When I’m eating blueberries from Chile here in California, I assume that they arrived by air after being picked a couple of days ago. That isn’t necessarily true. Delivery by sea could take weeks from the time they are picked by the grower until they arrive on the shelf at my local grocery store.
In this episode, I talked to Tristan Kaye, Director of Global Marketing and Business Development at It's Fresh about the challenges of shipping fresh produce across the planet while avoiding waste and spoilage.
According to the UN Food and Agricultural Organization, up to 45 percent of all fresh produce grown is never consumed. For two reasons. One is food loss. So this is through poor infrastructure, lack of appropriate cold chain, mishandling these sorts of things, or food waste.
Another significant challenge in the supply chain is controlling the levels of ethylene, which is a signaling molecule produced in plants for many things, including maturation and ripening. And it doesn’t take much to have an impact on fruit during shipping.
…kiwi fruit can be sensitive down to four or five parts per billion. So to give that a sort of sense of context, a billion seconds is about 33 years. So it's lik if you're looking for ethylene in kiwifruit, that is the equivalent of trying to find five seconds of a 33-yearr period… But it fundamentally affects all of the elements in terms of the fruit and many vegetables that are developed.
It’s Fresh offers an interesting solution to this challenge. We didn’t go deep into the chemistry of their ethylene control technology. It allows growers to pick fruit a little early and allow it to ripen slowly so that, ideally, it shows up on our local shelves ready to be consumed. Our conversation focused on all the other aspects of the supply chain that illustrate the challenge of getting fruit to market in a condition that consumers expect regardless of where they were grown:
Growers get paid based on what arrives at the destination. They must decide when to harvest their fruit at some interval before ripening, yet they have no control over much of what happens or how long it takes before fruit arrives.
Market pricing and seasonal demand influence the decision of whether to ship by air or sea.
There can be tremendous uncertainties around the time spent in a warehouse at either end. Even shipping routes are facing uncertainty as there is a restriction on what can go through the Panama Canal due to a drought that has Lake Gatun at record low levels. Ships may have to wait in an anchorage at the canal, deliver some containers elsewhere or go around the tip of South America. Conflict near the Suez Canal, or the inability to access the Port of Baltimore might also be a factor right now.
Damaged fruit produces ethylene as a stress response. To top it all off, there is ethylene in the exhaust of internal combustion engines. Warehouses that store fruit may use electric machinery like forklifts, but imagine the challenge of keeping motor exhaust out of your entire supply chain.
The next time you grab a handful of blueberries grown out of season in the other hemisphere, give a thought to all the considerations and decisions that help preserve them from the moment of harvest to the moment you enjoy them.
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If you have a PhD in life science, are working toward one, or just considering it with an eye toward getting an academic job, the math is not in your favor. There are way more PhDs than the number of academic slots available. How that gets resolved with respect to your career was the core of my discussion with Ali Divan, Founder of Trulitica, where he is helping life science PhDs get into biotech.
Don’t miss the SPECIAL OFFER at the bottom of this post.
For many, there is a mismatch between expectations of what a career in life science might look like and where you end up working. But it’s not all bad. There are good jobs to be had. Just maybe not the ones you expected.
Ali’s job is helping folks reframe their skills (and conversations) to open up new opportunities.
A math problem
Our discussion covered the challenge from several angles. PIs need to generate publications. Historically, that has been done in the process of training scientists who then go on to train more scientists in their own quest for publications.
This has led to an oversupply of scientists looking for academic jobs. Entering graduate school now betting on an uncertain outcome eight years down the road (generously) is risky. But should you give up your dreams of doing science? No. The system is definitely ripe for change. At the same time, it’s important to be open to new possibilities. That’s good advice for anyone looking eight years ahead.
We don't really walk in and go, “Yeah, I'm, I'm going to do some career planning. I'm going to figure out what I'm going to do.” Most of us, we go, “Hey, I'm pretty good at school. I should keep doing it.”
Universities need to change
Check out Ali’s article at the end of this post for details. Ali says some of them are aware:
What I've seen when I started speaking to the deans of graduate schools at universities, they're very well aware of this. And a lot of them, what they say is, “You know, I think we just need to be a little bit more responsible at the time that graduate students are applying and beginning.
We need to tell them what they're signing up for and what the landscape is” so that they don't show up thinking, as I thought, that if you just show up and be excellent and try hard enough, that's enough because (for) everything up to that point in your life, that was enough.
The other challenge for PhD graduates is that university career centers are set up for undergrads. For a new PhD, your PI and whatever network you have created through conferences, your committee etc. is your career center. The problem is that the only job they can likely help you get is one that looks exactly like theirs. Because of the bottleneck or for other reasons, some people will decide to leave academia. But their training (they’re 30+ years old now) has not prepared them.
The rest is up to you
How do you build a good life as a scientist? Isn’t that the real goal? Do good science, make discoveries, solve problems and enjoy all the other things life has to offer?
What should you do if you had planned on a career as academic scientist and now need to look elsewhere? And how do you make that transition? How do you frame the skills you have in a way that’s relevant for employers?
Here’s the good news: Ali says most of what you need is around strategy and communication, not hard skills. You’re only a few months away from being ready.
The way that I help them is we first start out by sort of dismantling some of the practices that are that are so common and valued in academia. And so, as an example, in academia, it's highly valued to debate.
It's highly valued to ask anytime you feel like you have a question or an argument. You just, you put it out. What I generally say is, well, in the industrial setting, when you don't have time, you have to have a very good reason for meetings. It's much more valuable to listen…
That’s just one example of the difference you might find in industry.
Focus on skills as opposed to topics
You must realize that the people who will be hiring you probably don’t have a problem that your dissertation will solve. They have problems that require similar skills. Talk about those.
The first step is networking. Ali also gives some great recommendations here. I could go on forever about this because there is good networking and bad networking. I’m sure I have been an instigator and a recipient of both types. No one enjoys it until they really understand it. But it doesn’t have to be uncomfortable. Be human. Build a relationship and don’t be in a rush to hand someone your resume.
This is a valuable skill worth developing for the long haul. You had a long view when you started grad school didn’t you? I’d add that getting good at making conversation with anyone, is not only a good skill to have, it actually will bring you joy.
I like what Ali said here:
…so if somebody says something nice to you, and they're sincere, and they say, “Oh, hey, it looks like we also both study at this university, or I see you're a fellow immunologist… You know, my default answer, when I don't know anything, is cytokines. That'd make them laugh and they'll go, okay, who is this, who is this guy?
My own perspective
I find this whole topic fascinating. I went to graduate school because I didn’t look around enough to see the opportunities a bachelor’s degree would give me. I thought, “Who’s going to hire me?” My undergrad advisor founded a biotech with some of my other professors. I didn’t even ask them for fear of being laughed at. They wouldn’t have.
It took me too long to realize that I wasn’t cut out for the bench. I feel fortunate to have eventually found positions using what I had learned that were scientifically stimulating, fun and rewarding. Personally, I enjoy a broader view of cutting-edge science as opposed to chasing a single thread to the end in the hope of a significant discovery.
I also hope that the life science ecosystem (universities, funding agencies etc.) can evolve to help people find their path more quickly while maintaining the pipeline of PhD scientists we need to do basic research. Because beyond the bench, we need more science and appreciation of science in our communities.
There are so many ways to use your scientific knowledge and skills. I promise that there is a job out there that you will enjoy. I only wish I had met Ali thirty-five years ago.
SAVE 10% on the Trulitica Biotech Careers Course (Affiliate link valid until 5pm PST, April 30, 2024.) Use Code: LIFESCIENCE
And if you’re in a hurry, you can hire Ali to work with you at Trulitica.
How universities can prepare Ph.D.s for a changing job market.
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Reduce. Refine. Replace. These are the three Rs of animal research. The intent is to reduce the number of animals used, refine methods to be efficient and humane and replace animals with other models where possible.
This cc: Life Science episode is sponsored content, courtesy of MediLumine.
I talked to Stephen Marchant, Founder and CEO of MediLumine about the importance of animal research, how imaging in small animals is different from humans and innovations that support the 3Rs of laboratory animal sciences.
While the FDA no longer requires the testing of all new drugs in animal models prior to clinical trials, for some drugs, the requirement may stand. Animal research has been essential for many advances in human health and will surely remain relevant in the quest to discover new treatments in the future.
As compassionate beings, we want to help our fellow humans whenever possible. When a child has cancer or a mother with a diagnosis of early onset Alzheimer’s tells her children that at some point she may not recognize them (or they her), no options will be left unexplored to look for and find solutions and those options likely include some research using animal models to better understand disease.
The animal technicians and scientists working in laboratory animal sciences have a passion for developing therapies and treatments for human disease but also for taking care of animals. For those interested to know more, Stephen recommends the GetReal Podcast by Dr Cindy Buckmaster to truly appreciate the reality of this and what it is like to work with laboratory animals in the life sciences.
In vivo imaging is used to better understand disease progression or response to treatment, and it is one aspect of research that isn’t likely to be replaced soon. The development of novel contrast agents allows scientists to visualize structures such as tumors or vasculature much deeper in the organism thus precluding the use of visual inspections and use of a caliper to measure tumor size. This breakthrough is built in to MediLumine’s tag line ‘Vision without Sacrifice’.
Imaging structures in a mouse, whether by MRI or PET scan is very different from imaging in humans. The structures are (obviously) much smaller. What I hadn’t realized previously is how the small size requires longer measurements to get the desired resolution. Typical contrast agents like CT contrast agents used in the clinic are rapidly cleared making it more difficult for small animal micro-CT systems to generate high resolution images with these contrast agents. Stephen explained how the development of contrast agents like Fenestra HDVC, allows improved imaging of mouse organs with in vivo micro-computed tomography (CT).
Depending on the goal of an experiment, modalities like MRI or CT can provide good resolution which allows researchers to calculate, for example, the volume of an object such as a tumor. Other modalities, such as optical imaging, are preferred when sensitivity is important. Bioluminescent reporters can sensitively be detected in vivo with the trade-off being resolution.
…with optical imaging, it's a very sensitive modality. So you might be able to see something at lower concentrations, for example, with bioluminescent imaging. If you look at some of the tumor studies, in some of the publications, we see even a few days after the injection of tumor cells, we're able to see signals, but we're not necessarily able to localize them very well. So, for example, if you have, let's say, a signal in the right lobe of the liver, you would see something coming with optical imaging, but you wouldn't necessarily be able to localize it and say precisely exactly where it is.
Without these in vivo imaging methods, understanding the biology of tumor progression would require a larger cohort of animals, with a requirement to euthanize some fraction at various time points to locate tumors and measure their size. That’s the reduction element of the 3 Rs.
Refinement is also possible. Stephen shared an example of how new contrast agents in microCT allow the study of fatty liver disease that couldn’t be done previously with terminal studies and histology.
As for replacement, the development of organoids, small collections of differentiated cells, offer an alternative to some animal assays while more closely reflecting an in vivo condition than monolayer cell cultures. I’ll be covering that in a future episode.
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AgBio, sustainability and DoE all come together in this episode. Tim Cuthbertson is the Chief Science Officer at VelociGro where they are using Design of Experiments to optimize plant growth media for vertical farming.
I was curious to learn about the concept of vertical farming and how it can make an impact relative to the massive acreage involved in traditional agriculture. There are scenarios where it makes a lot of sense. First of all, greenhouse-grown produce is nothing new. Tomatoes are the most commonly grown crop in what is known as protected agriculture. And overall, in 2019, 55% of vegetable growers had some component of indoor operation, extension of the growing season being the primary reason. A greenhouse can produce 2.5 pounds of food per square foot per year. That’s horizontal growth.
Growing plants vertically should increase that productivity further. So where is the impact? Consider what it takes to send blueberries from Chile to Alaska. Now what if blueberries could be grown indoors locally year-round? With LED lighting (which apparently doesn’t have to work on a 100% duty cycle) there could be significant savings in carbon emissions. Not to mention loss from spoilage etc in transit.
In case you haven’t heard, the Panama Canal is backed up and the largest container ships can’t go through with a full load currently because there is not enough water in Lake Gatun due to decreased rainfall. That means produce either being offloaded elsewhere and sent by train or truck or a longer trip around Cape Horn and associated delays. Don’t miss my upcoming episode on “the ethylene problem”. We’ll talk about what it takes to keep fruit “fresh” on those long journeys.
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Either way, I appreciate you spending time here.
Local access to fresh produce in urban areas is another opportunity to deploy vertical farming. It occurs to me that a lot of empty office space is ripe (yeah, I said it) for conversion to urban indoor agriculture. I’m beginning to imagine a back-to-the-office campaign where a company leases some of its space for growing produce to be sold while allowing people who come back to the office to have access to a share of the crop to take home each week.
Where does Design of Experiments come in? We covered DoE in a previous episode. Briefly, it’s a method of testing multiple variables simultaneously to quickly iterate and find the optimal solution to a problem or process. A typical one-factor-at-a-time (OFAT) approach makes all the results dependent on the optimal value of the first variable you test. That doesn’t in any way guarantee the best final outcome.
How is VelociGro using DoE? We didn’t go into details about their products. Whether plants are grown on a substrate or in a soil-free environment, they need nutrients to grow. DoE allows their company of six people to iterate and optimize formulas for new products in as little as six weeks. Even if agriculture is not your field, you can see how DoE can save huge amounts of time in product or method development.
It strikes me that once again, regardless of what area of the life sciences you work in, thinking about how things are done is as important for delivering a successful product as the science that goes into the product itself.
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Thomas Farb-Horch is the CEO of Thrive Bioscience. He has founded 18 companies. Seven of those turned out to be unicorns (sold at a valuation of >1 billion dollars).
I was curious to know how he had identified so many opportunities correctly. BTW, Tom is not a scientist and has no advanced degrees in case you were thinking that was a requirement.
He credits his success to being observant and inquisitive. That means keeping your eyes open for problems and asking why things are the way they are. The most attractive problem is one where people have been working the same way for a very long time. And if a process can be digitized, even better. As ever more computing power and storage capacity becomes available, more processes are in reach.
Yet good ideas and smart solutions aren’t enough. Tom told me that every one of those unicorns came close to failure multiple times.
How did he manage to dodge the bullet so often? One area where data and computing power won’t solve anything is our interactions with other people. To be successful as an entrepreneur, in addition to solving whatever technical challenges you have identified, you are still left to deal with customers, investors and board members. This is where Tom’s experience struck me.
If you think reproducibility is a challenge in science, no amount of data or computing power can make humans more predictable.
Getting people to change something that has been done the same way for decades is difficult. First for them to recognize the value and then to adopt new behaviors. Even early and late adopters won’t respond the same way. Your solution needs to appeal to both.
At another level, while all your investors have a common goal of getting a return on their money, how and when they expect that to happen may be different. As you are likely to pivot at some point, it’s worth considering how you will keep them aligned on the new approach.
The makeup of your board is critical and Tom has some essential advice on how you should negotiate their selection with investors. Listen to the episode for details. When it comes to what you are looking for, I’ll share one example here. Board members are sometimes (often?) selected for their name recognition as opposed to their domain expertise. Alexander Haig (former NATO Commander and Secretary of State) might have fit that description. Nevertheless, he brought value to the table in other ways. Tom told me that his skill at observing people and making sure everyone was heard to get to a result was off the charts. Given the roles I just mentioned, maybe that’s not so surprising. These skills are applicable everywhere.
Board of directors is one of my favorite topics. It's so incredibly important. Many entrepreneurs don't spend enough time focusing on compatibility across the board. And kind of the profile of what they want.
Every founder is likely to encounter a dark night of the soul moment. Tom said, “Fear is a terrible advisor.” It’s at those times when having chosen the right investors and board members will pay off. Who will stand by you and brainstorm solutions to see you through?
Science is complicated and often difficult. Human behavior is even more so. It strikes me that in science, even if we don’t yet know the answer, we know it’s there and that certainty is comforting. I wonder if we shouldn’t spend more time thinking about how the people around us are going to affect our success and who we choose to do that.
As an example of how humans can make an impact in our interactions, more than once over several conversations, Tom asked me, “How can I make this podcast successful for you?” I replied, “That mindset alone is all I need.”
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Susanna Harris is the Director of Community at Breakout Ventures. She is also the Founder of PhD Balance, a collaborative community empowering graduate students to build their personal and professional resilience and the 2023 recipient of the SAMPS Young Person of the Year Award.
This episode is a little different. For the last couple of years, I have interviewed the winner of that SAMPS award on this podcast. Susanna has been a guest before and although we’ve chatted a few times since and both live in the Bay Area, we had never met face to face. Susanna mentioned hiking in one of our calls so I thought this would be an opportunity try something new. I suggested we meet up for a hike and record some stuff along the way. Thank you Susanna for being game for one more experiment.
We had a free-flowing conversation covering our inspirations in science, science communication, marketing, career paths, longevity, mental health, and more. AI, psychedelics and The Andromeda Strain all came up as well. Give it a listen to find out the context.
I typically focus these episodes around a theme and try to point toward a specific takeaway. While there is a thread to the topics we discussed, the takeaway for me this time was simply about the value of conversation. I trust that the listeners to this podcast will learn something about each of us and may be prompted to think about something they heard from a new perspective.
As a listener, you don’t have to be part of a conversation to benefit from it. That’s the magic of this medium. You can listen in as if you were there. Taking that beyond podcasts, consider the value of people listening to your team members, executives and subject matter experts in their natural, unscripted style. Podcast listeners report (and I can verify this both as a host and a listener) that they feel like they know the people they hear from regularly. There is a level of know, like, and trust that is hard to replicate except face-to-face.
Finally, one never knows where having a conversation will lead in the long run. I don’t even remember how Susanna and I connected initially. Yet here we were, 3 years later, hiking the hills, sharing our experiences in science and creating unique content along the way. If we get a chance to help one another out in the future, that would be icing on the cake. It all started with a conversation.
Mentioned in this episode:
Books: Where Good Ideas Come From by Steven Johnson
The End of the World is Just The Beginning by Peter Zeihan
Movie: The Andromeda Strain (also a book by Michael Crichton)
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Kurt Mussina is the CEO of Paradigm Clinical Research. Their model involves dedicated sites chosen for access to their desired patient and physician populations to participate in clinical trials. Access to historically underrepresented populations for both patients and healthy volunteers is a key requirement.
One can imagine it takes a lot of effort to figure that out from demographic data etc.
Kurt shared with me their approach using ChatGPT with some plugins not only for determining the best places to lease space, but also for qualifying and scheduling potential participants and determining which contracts to pursue based on their historical successes and current strategy.
3 Applications of ChatGPT or AI:
Where to lease and build out clinical trial sites
Kurt and his head of clinical operations are based in Boise Idaho. The first requirement was to be able to visit sites without spending too much time traveling. He searched the website of the Boise airport for nonstop destinations that were reachable in a half day or less. That narrows things down to the western half of the US. They queried ChatGPT to identify which of those have, within a two-hour drive, populations with a significant proportion of people historically underrepresented in clinical research.
For example, Chico California is one of those cities. Paradigm already has sites in Sacramento and Redding, which allows them to use the staff they already have on the ground and existing relationships to get a good start.
Using AI chatbots to qualify patients and volunteers for studies
Paradigm runs ads on Facebook to recruit potential participants. When a person visits the website looking for trials to participate in, rather than delivering a long list to browse, a chatbot will ask them questions about their age, background etc, to preview relevant trials and pre-qualify the person. It can then help schedule a phone appointment for further information and qualification.
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Contract assessment and budgeting
There are thousands of trials going on at any one time. Which ones does Paradigm want to bid on based on their patient populations, investigators, and desired indications?
Paradigm uses Salesforce to manage their sales pipeline. A sponsor or CRO may send out a feasibility questionnaire. This clip from the interview explains how an AI, based on their previous successes, helps decide which studies they’d like to bid on as well as providing a range of cost estimates and contract terms.
I asked Kurt, how they decided to take this approach to all of these important steps. It turns out the husband of a board member is pretty AI-savvy. Would you be as comfortable trying something similar if you didn’t know anyone with that kind of AI expertise?
In a couple of years, no one will think twice about this kind of approach. As I see it right now, the real barrier is our own imagination in terms of what problems do we need to solve and how to ask the right questions. Many of the current examples we see are using AI to generate content - images or drafts of written content, or some data analysis. It might be helpful to think of ChatGPT and its “colleagues” as individuals you hire to do a specific job.
In this example, it would be like, “Hey Joe, can you compile a report on cities we can get to easily that have historically underrepresented populations? When you are done with that, set up a web page to qualify and inform people interested in participating in a clinical trial. Oh, and then, take a look through our historical data and let me know which of our leads in Salesforce are the most promising.”
Those are the jobs to be done. I should say that Kurt was very clear that they worked with people outside the company to get these tasks done. In the end, one can see how it improves efficiency at every step.
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Up to this point, I have resisted doing any episodes around cannabis because 1. I’m a little old-school 2. I probably don’t know enough and 3. I want to avoid, in the words of my guest, “being painted with green paint” and tainting the brand.
Separating emotions from logic, however, if there are cannabis components that could be effective therapies, it would be foolish to ignore them.
There is already one cannabis-derived compound approved by the FDA. Epidiolex is pharmaceutical-grade cannabidiol (CBD) prescribed for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. Pebble Life Science is taking a rigorous approach to investigate whether other compounds derived from hemp might be effective as therapies, either for other neurological disorders or even cancer, initially focused on ovarian.
I spoke with Patrick Moran, the founder and CEO of Pebble Life Science about their approach, the challenges they have faced, and the success they have had in forming collaborations with the MD Anderson Cancer Center as well as participating in the NCI Applicant Assistance Program.
Everything we discussed is in the pre-clinical phase, preparing for and gearing up toward clinical trials. A key event in this journey was the 2018 farm bill that allows the cultivation of hemp as long as the THC content is below 0.3%. That opened the door to growing and extracting components from hemp, all non-psychotropic, for investigation.
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Either way, I appreciate you spending time here.
One obstacle was bridging the gap between (clinically unproven) claims of cannabis killing cancer and putting in place procedures to rigorously investigate those possibilities. Another challenge, as mentioned above, was breaking through the cloud of suspicion that exists around cannabis. After being invited to apply for a drug development grant by the Cancer Prevention and Research Institute of Texas, one reviewer labeled them as drug dealers.
While the research staff took that hard, their legal team suggested taking their data and the positive feedback they had received from the other three CPRIT reviewers and contacting the NCI. That led to an NCI sponsorship for the NIH Applicant Assistant Program which Patrick said was invaluable in helping his executive team prepare to submit an SBIR grant to help fund clinical trials.
Based on pre-clinical studies in mice, Pebble is currently focused on the potential of a hemp-derived compound as both an adjuvant therapy and a frontline monotherapy for ovarian cancer.
At the end of our interview, I asked Patrick what he had learned that would be helpful to any biotech startup whether or not they are in the cannabis space.
Interestingly, I’ve recently had another conversation with someone I hope will be on this podcast soon. We concluded that science is difficult. People can be more so. It’s yet one more challenge to get people to change their thinking or to deal with the obstacles they place in front of you, intentionally or not. I hope this episode help you figure that out on your own journey.
There were a few terms I had to look up in our conversation. You may find these useful:
RPPA analysis
Entourage effect
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This week, I talked to Dr. Michael Harman, an executive advisor, and consulting partner at Harmon Consulting about commercializing medical diagnostics, exploring various aspects from technology development to market trends and the integration of different scientific disciplines.
I asked Michael about the process of transitioning laboratory technology into clinically viable products. He described a series of well-defined steps, starting from concept generation to prototyping and feasibility testing, eventually leading to a minimally viable product ready for market launch. It starts with identifying a gap in the market and scouting relevant technologies.
Scouting is the process of identifying existing technologies that can be utilized to construct different subsystems of the proposed diagnostic tool. He used the analogy of assembling Lego pieces. While innovation can add value and is, of course, a little more exciting, it also increases risk.
The engineering process of diagnostics involves bringing together various fields like industrial design, electrical and mechanical engineering, and crucial business aspects like sales and marketing.
I didn’t know much about the world of diagnostics that lies between lateral flow tests like the ones we all use for COVID-19, and large analyzers running thousands of samples per day delivering results of multiple assays to your doctor.
Michael noted a significant shift from centralized laboratory instruments to more compact, point-of-care devices, largely influenced by the COVID-19 pandemic. He highlighted the growing trend towards personalized medicine and home testing kits, demonstrating the evolution of diagnostic technology in response to global health challenges.
This got me curious about the role of electrical engineering in diagnostics. So we took a little sidebar into the intricacies of technologies like thermocyclers for PCR. While heating a metal block seems straightforward, doing so evenly across 96 samples may not be. And I never put much thought into what it takes to cool that block quickly and where the heat needs to go. Needless to say, I have a new appreciation for electrical engineering beyond circuits and robotics.
A key takeaway from our conversation was the integration of various scientific disciplines, such as computer science, biology, and physics, in developing new diagnostic methods. He mentions several innovative diagnostic projects he's involved in, such as non-invasive tests for endometriosis and personalized contraception compatibility tests. These projects exemplify the potential of predictive diagnostics to revolutionize patient care and treatment.
There have been significant strides made in this field, largely due to the collaboration across different scientific domains. He emphasizes the importance of bioinformatics and the role of computer science in medicine, marking a paradigm shift in how medical research and diagnostics are approached. It also presents challenges:
People don't always necessarily know what to do with diagnostic information either. That is a big challenge in terms of, okay, great. You've identified a marker now exists, but what is that now? How do you then inform the patient of or change their treatment based on that information?
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As we often do, we discussed the challenges faced by academic founders in transitioning their ideas from academia to industry and the mindset changes required for successful commercialization. He notes that while academics are used to being highly independent and handling various aspects of a project, success in the industry often requires a more collaborative approach. Founders must learn to trust and leverage their teams, allowing each member to contribute their expertise to the project.
Michael mentions the debate about the necessity of having clinicians or scientists in leadership roles in medical companies. While their deep understanding of the technology is beneficial, it can also be challenging for them to step back and allow others to handle aspects of the business they are less familiar with. This transition, from being an independent academic to a team-oriented industry leader, is crucial for the successful commercialization of medical technologies.
Our conversation shed light on the complexities of commercializing medical diagnostics and highlighted the importance of interdisciplinary collaboration in driving innovation in this field.
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When it comes to chemical reactions, if you can imagine it, somewhere out there a microbe is already doing it. This was something we used to say in graduate school. The challenge is finding that microbe among the billions that exist in environments all around us.
Surehka Karudapuram is the VP, Commercial Operations at Isolation Bio where they are helping researchers solve that needle in a haystack problem. In this episode we talked about the what, the how and the why.
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Isolation Bio specializes in high-throughput and automated isolation and cultivation of microbes. Surehka explains that Isolation Bio's platform consists of an instrument, consumables, and accessories that enable the efficient study of new microbes, their unique products, and their impact on the world.
One could isolate many different microbes by diluting and plating extracts from your environment of interest on petri plates and then waiting to see what grows. Isolation Bio's technology allows researchers to perform massively parallel cultivation of hundreds of bacteria from various samples, such as soil or feces. This takes place in an array with over 6,000 nanoscale wells. I found it amazing enough to sort microbes into the wells. What blew my mind was the ability to then pick the desired samples out of those wells and transfer them to 96- or 384-well plates for further analysis.
Incubating the array under specific conditions is the first step in screening for the type of bacteria you are looking for. In one example, the desired bacterium grew slowly and would typically be overtaken by other species. Creating individual isolates gave researchers the chance to find and cultivate exactly the species they were looking for.
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Microbiome research has evolved from observation and cataloging into studying actual biology. We’ve gone from metagenomics (identifying what's there by next-gen sequencing) to identifying the capabilities of bacteria and purifying compounds. We discussed various application areas, including human health, animal health, agriculture, and environmental sciences, where microbiome research and bacteria play a crucial role.
Human health is a big area for our customers and the microbiome space and it's just so many kinds of diseases that are now being linked to the microbiome and then also getting to that point of that causation. I'll just use the example of drug response or immunotherapy response in cancer patients. There's a clear population difference between the responders and the non-responders.
And now we're starting to see work where the bacteria from the responders are being isolated and then being used in mouse models and then again, down to the next step, which is purifying, you know, maybe from the supernatant, the molecules, and then seeing that that can enhance immunotherapy drug response.
Getting back to “If you can imagine it…”, we discussed potential commercial applications of isolated bacteria, including the development of probiotics, therapeutics, and products for various industries. Surehka highlighted the possibility of bacteria as "chemical factories" that produce beneficial compounds and explained how synthetic biology can be applied to engineer bacteria for specific functions, such as producing biodegradable plastics.
It’s an exciting time to learn about the connection between our gut microbiome and other aspects of human health. On the other end of the spectrum is the possibility of discovering useful new compounds or ways of synthesizing them in living chemical factories. Where do you see the biggest potential?
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Rochelle Prosser is the founder and president of Orchid Healthcare Solutions, the company she created to consolidate cancer treatment information and improve access to that information. We discussed the difficulties in navigating healthcare systems and the importance of having comprehensive, scientifically-driven resources for cancer patients and caregivers.
Rochelle is a neurotrauma critical care nurse with 30 years of experience. She has had her own journey in healthcare and felt the impact of cancer on both her husband ( a two-time survivor) and young daughter. She described the challenges of a family trying to stay together and making decisions for a daughter who was only beginning to experience life when she was diagnosed with a rare cancer at the age of four.
She had this arbitrary, completely rare brain cancer and it took nine years to figure it out for her to find survival. And that's a long time. Most people can't deal with that. Marriages are lost, finances are ruined, but we remained intact.
Although her daughter was put into hospice five times, Rochelle never gave up advocating for her. I was curious about how you persuade a doctor to try something new when your child is already in end-of-life care. Her advice was to try to always be collaborative. Doctors and nurses want to help. There is value in being persistent, but it’s also important to listen. Not every treatment is the right one. If the doctor says no, there is likely a reason. But that doesn’t mean you stop trying:
And so I had to find a way. to politely and effectively navigate and communicate so that I could get to that next cure, to that next option. For me, 50 percent chance of working for two years until the next treatment was a better option than 10 percent chance on a conventional treatment.
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Based on genomic analysis, her daughter’s tumor was a mosaic of glioblastoma and DIPG (diffuse intrinsic pontine glioma). Imagine how complicated that sounds even to a healthcare professional, let alone anyone else. In addition to advocating for her daughter, Rochelle decided she would try to help others in similar situations.
I felt the need to intercede in that space intentionally with what I knew and how to navigate. So this is why I started Orchid Healthcare Solutions. I created a cancer treatment library that houses all cancer treatments from soup to nuts. Everything that's out there that is scientifically driven in one place. One of the biggest pain points, being on the provider side, but also on the recipient and caregiver side that I found was there wasn't a place that had a unified place to go.
It was really difficult to navigate to get information just to find out that knowledge. And I said, if there was one way that I could share my knowledge was to consolidate that, remove the silos so that you have effective and appropriate information sharing, and that will help vulnerable populations. That will increase knowledge and awareness and increase participation in clinical trials.
Because genomics was so important in her daughter’s case, Rochelle feels strongly about the need for diversity in clinical trials to understand how treatments affect different populations. Representation in those trials is critical to advance medical science that benefits everyone. At the same time, she is very clear about the importance of informed consent and the conditions around consent for participation. Bottom line - we need more people to participate AND understand their rights regarding their tissues and data. That’s how we get to the end goal of more diversity and better understanding of which treatments will work for different populations.
That is the only way to move us forward. We all must come together because where it works or is expressed in one, it doesn't work (in another), but we need to find out why. And when you find out why, it is that nuance of why that then can put protection and then advancement and an improvement in care overall for all of us.
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