32 episodes

Biotech—it's complicated.

A successful product launch requires grit, determination, and clear direction.

But let’s be real, the path to launch isn’t a straight one.

There are curves, hard turns, and dead ends.

Here’s the good news, you don’t have to navigate the complexities alone.

Welcome to The Emerging Biotech Leader, where we help biotech leaders maximize the value of their therapeutics from clinical development to product launch.

The Emerging Biotech Leader SSI Strategy

    • Business
    • 5.0 • 7 Ratings

Biotech—it's complicated.

A successful product launch requires grit, determination, and clear direction.

But let’s be real, the path to launch isn’t a straight one.

There are curves, hard turns, and dead ends.

Here’s the good news, you don’t have to navigate the complexities alone.

Welcome to The Emerging Biotech Leader, where we help biotech leaders maximize the value of their therapeutics from clinical development to product launch.

    Growing Early Biotech Startups Through Connection - Dan Bloomfield : 30

    Growing Early Biotech Startups Through Connection - Dan Bloomfield : 30

    In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhad speak with Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. Dan generously shares insights from his diverse career that has spanned academia at Columbia University, over a decade at big pharma giant Merck across multiple leadership roles, and most recently entrepreneurial biotech startups.
    A central theme that emerges in the discussion is the immense value Dan found in intentionally gaining cross-functional exposure early and often throughout his career. This allowed him to develop a well-rounded perspective and understand the critical interdependencies across an organization's many components. 
    Dan openly shares how when stepping into new roles interfacing with specialized teams like discovery and R&D, he'd be upfront with not knowing the intricacies of the things that are just common knowledge to senior scientists. While he understands the overarching goals, the finer operational details fall under the deep know-how of those teams. This humble approach shows an openness to learn from and leverage the subject matter experts around him. As Dan puts it, "I won't be able to tell you how to run an assay or select compounds, but I'll guide our overall direction."
    Dan emphasizes the importance of actively seeking out opportunities to learn about different disciplines and roles. By expressing genuine curiosity about the expertise of others, he has been able to rapidly expand his own knowledge base. 
    The conversation also covers insights Dan gained on the importance of proactively managing board and investor expectations through radical transparency about risks, timelines, required resources, and potential roadblocks at each stage. 
    Dan also shares his perspectives on strategically building the optimal team makeup through a thoughtful combination of full-time hires and leveraging external consultants or contractors based on the inflection points on the horizon. This allows reserving capital while still accessing specialized expertise when needed.
    Overall, this interview is packed with hard-won wisdom on leadership development, making the transition from bureaucratic big pharma to lean, innovative biotech environments, attracting top talent, and cultivating an entrepreneurial mindset. Dan's authentic sharing of experiences offers highly applicable lessons for biotech professionals in executive roles.
    Dan’s key takeaways:
    Continually seek cross-functional opportunities to build a well-rounded skill setMaintain humility and openness to learn from subject matter expertsBalance full-time hires with external consultants/contractors for flexibilityAre you leading a Biotech and would like to share your experience with our podcast audience? We ‘d love to hear from you!  Please reach out to us. 

    • 38 min
    Lessons In Biotechs with Bold Missions : 29

    Lessons In Biotechs with Bold Missions : 29

    In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhad are joined by Bob Honigberg to further discuss the considerable challenge of achieving bold missions in healthcare. Building on their discussion from Episode 28 where they interviewed Cleerly Health founder Dr. Jim Ninh, the episode provides useful perspectives for any mission-driven biotech seeking to prove game-changing healthcare concepts. What does it take to achieve major goals that could reshape patient outcomes worldwide?
    Bob emphasized the most important hurdle companies face when pursuing daring healthcare mission. He noted that "Large, well-designed studies proving impact on outcomes as well as cost are needed for clinical adoption, regulatory approval, and reimbursement. This level of evidence takes significant investment." 
    Bob's point highlights the challenge of gathering robust clinical data at meaningful scales. This perspective resonates throughout the conversation, as generating rigorous evidence through extensive studies is consistently referred to as the foundational requirement for proving solutions and achieving ambitious goals that could transform patient care.
    Some key points were made about generating robust clinical evidence to support these missions:
    Large, well-designed clinical trials involving thousands of patients are needed to prove concepts, change practice, gain approvals and reimbursement. 
    Downstream data is important to show how diagnostic or predictive tools impact treatment decisions and health outcomes. Real-world evidence of clinical utility is critical.
    Long-term studies may be required to demonstrate prevention of disease progression and cost savings over time. This level of evidence takes significant upfront investment.
    Standards of evidence will be high when trying to shift treatment paradigms or gain recommended screening status from influential bodies.
    In summary, Kim, Ramin and Bob made it clear that delivering on bold missions in healthcare requires tackling the difficult challenge of generating robust clinical evidence through extensive studies. While an audacious vision can motivate teams, that alone is not enough - proven impact must be demonstrated to realize the transformation.
    Tune into the full conversation, where our team unpack this issue in greater depth and discuss creative ways that industry pioneers are overcoming these barriers.

    • 26 min
    Lessons In Clinical Trials With The Unlikely Entrepreneur - Jim Min : 28

    Lessons In Clinical Trials With The Unlikely Entrepreneur - Jim Min : 28

    "I believe that we can eradicate heart attacks from this world...If we can leverage these tools to accomplish those three goals, whether it's in coronary heart disease, valvular heart disease, myocardial disease, et cetera, et cetera, I think that's going to not be a slight improvement. I think it's going to be a game changer in terms of improving patient care and outcomes." ~ Jim Min, Founder and CEO at Cleerly
    In healthcare, there is a constant need for innovation and improvement. One company making significant strides in this field is Cleerly Health, founded by Jim Minh. In a recent discussion, Jim and Ramin Farhood, a leading cardiologist, delved into building a research-based business organization and transitioning from prevention in the clinic to prevention at scale. They also explored the challenges of driving behavior change in the medical community to enable prevention. We will closely examine their insightful conversation and the groundbreaking work being done at Cleerly Health.

    Building an Asset in Clinical Practice
    Cleerly Health, founded in 2017, has emerged as a prominent player in the healthcare industry. With a focus on creating a standardized and personalized care pathway for coronary heart disease, the company leverages imaging and end-to-end artificial intelligence (AI) to achieve its goals. Cleerly Health aims to provide a comprehensive evaluation, education, treatment, and tracking system for patients with heart disease
    Jim, a former cardiologist at Cornell Medical College and New York Presbyterian Hospital, has firsthand experience with the effectiveness of personalized medicine in cardiology. However, he realized the need to scale this approach and automate certain processes for more accurate insights. This realization led to the founding of Cleerly Health, with the goal of optimizing personalized medicine in cardiology using imaging technology and AI.

    One of the critical challenges that Cleerly Health faced during its early stages was the feasibility of its approach. Developing algorithms, obtaining FDA clearance, and securing reimbursement from insurance payers were all significant hurdles. Despite these challenges, the founders remained determined to change the standard of care for heart disease prevention radically.

    Cleerly Health focused on building a business that had a strong research foundation. This foundation was crucial for obtaining coverage and reimbursement from insurance providers. The company realized that in the healthcare industry, high-quality science is necessary to drive commercial growth.

    Driving Behavior Change in the Medical Community
    To achieve its ultimate goal of preventing heart disease and heart attacks, Cleerly Health adopted a disease-based approach to cardiovascular evaluation and treatment. This approach places emphasis on treating individuals with disease rather than waiting for symptomatic manifestations. Currently, the majority of heart attack patients do not exhibit symptoms before their events, underscoring the need for a shift in the current symptom-driven model.

    The company is currently focused on treating the symptomatic population but is also pursuing a large-scale randomized control trial called the Transform study. This trial aims to study the efficacy of Cleerly Health's approach in the asymptomatic population. By expanding patient identification and treating individuals proactively, they hope to improve outcomes and reduce costs in the long run.

    The Future of Cardiology and Digital Therapeutics
    While Cleerly Health is making significant strides in the field of cardiology, it is not the only player focused on improving patient outcomes. Verily, a company that combines technology, science, and healthcare, is also working on developing technologies for earlier disease detection, interventions, and more personalized healthcare. Verily has developed advanced algorithms that analyze medical imaging data to predict the risk of cardiovascular disease.

    Adopt

    • 38 min
    Building A Biotech : 27

    Building A Biotech : 27

    “I think outcomes for a lot of people means meeting milestones. So hitting that next clinical milestone, CMC milestone, et cetera, and that's, I think, one way of looking at it. Still, it's also about the culmination of outcomes and achieving something greater than bringing together one discipline and one win." ~ Adriana Valenciano, SVP, SSI Strategy
    In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Adriana Valenciano discuss building an outcome-driven biotech company. The conversation focuses on three key themes: planning for globalization from the earliest stages of development, taking a multidisciplinary approach to defining milestones, and ensuring your team has the right skills at each growth stage.Key Takeaways
    The importance of planning for global markets, not just focusing on the US (5:14)Strategic considerations when deciding which markets to prioritize (6:14)The advantages of taking a parallel global strategy approach (7:31)Why biotechs should build in flexibility for pivoting regulatory strategies (10:17)Tips for setting up global success early on (10:45)The downsides of siloed, function-specific milestones (11:43)Ways leaders can facilitate cross-disciplinary collaboration (13:17)An example of a company pivoting its strategy after regulatory feedback (14:45)The agility required when strategies change unexpectedly (16:52)Ensuring your team has the skills to handle changing milestones (18:31)Sourcing talent with multidisciplinary biotech experience (20:56)Building an Outcomes-Driven Biotech
    Achieving specific goals and milestones in biotech is crucial for organizations to thrive. This intentional results-oriented approach forms the foundational principle of being outcomes-driven. As Adriana explains, these outcomes go beyond clinical and CMC milestones; they encompass achieving regulatory buy-in, creating a straightforward patient-focused story, and ultimately moving the organization forward.
    Planning for Global Success: A Multidimensional Approach
    Regarding global success in the biotech industry, traditional paths may not always be the most efficient. While the default for many US-based companies is to run clinical trials in the US and seek FDA approval first, exploring other regions and countries as part of a global strategy can yield significant advantages.
    Adriana highlights Canada's excellent centers and patient populations as a strategic platform for specific disease areas. Moreover, Europe may favor companies targeting pediatrics due to different regulatory requirements. Understanding the global regulatory landscape and what regulators prioritize in different regions is essential for successful international expansion.

    A parallel development approach can also be advantageous, such as having a leader and a follower or running programs in parallel. In addition, economic benefits and reimbursement incentives in other parts of the world can support biotech organizations with limited funding. By considering these factors and taking a global approach, companies can accelerate their drug development process and increase efficiency.

    Break Silos With A Multidisciplinary Approach
    The biotech industry is composed of multifaceted challenges that demand a multidisciplinary approach. It is not enough for individual functions to address their own problems and milestones independently; cross-disciplinary collaboration is essential.

    In smaller organizations, there is often a high level of connectivity and collaboration across disciplines. However, it is essential to remember that cross-discipline collaboration doesn't automatically account for organizational-wide planning. Influential leaders ensure that disciplines work together and collaborate seamlessly, allowing the team to build alternative strategies and adapt to new goals.

    Adriana shares an example of a biotech company that had to reevaluate their strategy and bring the team together due to regulatory feedback. By involving differen

    • 23 min
    Recalibrating Early Stages of Corporate Build - Johan Strömquist : 26

    Recalibrating Early Stages of Corporate Build - Johan Strömquist : 26

    “Getting a drug to market is a change journey. The whole process is a change journey. And we pass through so many different stages and gates on the way there: we need to adapt almost regardless of circumstances, even if everything goes according to plan, we have to shift.” Johan Stromquist, President, NDA Group

    As the quote above alludes, launching a biotech is never a linear journey. While there are tried and true processes and a documented multidisciplinary approach in bringing assets to market, adaptation to change is also required. 

    And there’s no better trio equipped to discuss this vital topic–navigating change when planning and bringing innovations forward–than Kim Kushner, Doug Locke and Johan Stromquist. 

    During this Episode, a first for Johan in the guest seat, you’ll hear a candid discussion on the various transformational stages organizations go through at major inflection points of growth, both funding and clinical. We hope you agree, this topic could not be more timely or relevant. Today’s market and landscape are forcing all sorts of change regardless of biotech companies being in the early stages of corporate build or, much further along in maturity. 

    On that note, here are a few of the overarching themes to listen out for during this episode: 
    Navigating people and resource sensitivities as a leaderHow to move past paralysis analysis when revising the former plan for a new one Scaffolding regulatory pieces as a framework for planning Assessing when to bring in council, partners and vendors as a stop gap and expert resourceTrue to form in each episode of The Emerging Biotech Leader, there is so much more covered including the types of people you need on your team (build vs operate talent), their key strengths and how to ensure you have both at the right time. With that foundation set, let's delve into some of the quotes and soundbites from Episode 26. 

    On Building, Fixing and Meeting Change Head On 
    Kim kicked off this topic and conversation by first inviting Doug to weigh in on how leaders are thinking about their design–where to start and where to build–across inflection points. 

    Here’s what he’s been seeing in terms of the market and shifts. “I've been in about 15 meetings in the last three months where our corporate sponsors, usually the CEO, sometimes the CMO, or R+D regulatory head, they're up against some major change in the company. I mean, we all know what's going on in the marketplace right now with the cost of capital: interest rate, debtor and lender agreements are tough. Some movement there is precipitating a fresh look. At the timeline of the company relative to market facing goals and capital, you know the questions are, ‘Can we afford this program? Do we need to look at what we were going to deliver and are we going to change the timeline? Do we need to change the timeline because we don't have the bandwidth we thought we had?’ All of those issues are on the table. So a lot of different use cases of, ‘I have plenty of capital, but what we have is unworkable. I have limited capital and I have a goal that's too grand. And what do we do about that?’ This is the basis of the inflection point you're talking about.” 

    Doug goes on to detail the amount of people, processes and systems impacted by these changes. Leaders have to think through funding, the talent on the team, the marketplace, their board, and their investors as well.

    If you should find yourself at a similar crossroads, Doug, Kim and Johan discuss how to start navigating this and here’s a hint. As cliche as it may sound, you don’t have to navigate it alone. 

    Johan shares, “I think that one of the greatest signs of leadership is the courage to ask for help. I think that is so important when you find yourself in these quite precarious leadership positions in biotech companies.”
    In terms of the types of changes leaders are evaluating, Doug does go on to clarify. “Some are looki

    • 27 min
    When's the Best Time to Think About Safety? It's Now - Gregory Fiore : 25

    When's the Best Time to Think About Safety? It's Now - Gregory Fiore : 25

    “The reality is that the earlier one thinks about and invests in a safety process and a safety system, the more dividends that early thinking pays downstream.” Dr. Greg Fiore

    Harvard-Trained Physician. McKinsey Consultant. Startup Advisor. These are just a few of the titles that describe our next guest, Dr. Greg Fiore.   

    As one might imagine, with these titles comes a unique lens and broad array of experience within the world of pharmacovigilance (PV). 

    Expanding upon the topic of PV and safety from Episode 24, “Cultivating A Culture of Safety” with Dr. Jason Campagna, Greg, the CEO of Exacis Biotherapeutics, joins Amit and Ramin to carry the conversation forward–providing best practices and wisdom from his 25+ year career. 

    During this interview, all three cover topics that emerging biotech founders should have top of mind when it comes to pharmacovigilance including: 
    When to think about safety.What role AI might play in safety within the next few years and, The skill sets and strengths that a safety/PV career cultivates and relies on. 
    As a fun fact, did you know? The etymological roots for the word “pharmacovigilance” are: Pharmakon (Greek) = medicinal substance, and Vigilia (Latin) = to keep watch. (Source: Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over Pharmacovigilance. Int J Clin Pharm. 2018 Aug;40(4):744-747. doi: 10.1007/s11096-018-0657-1. Epub 2018 Jun 15. PMID: 29948743; PMCID: PMC6132952.) 

    Back when Greg and Ramin first started their careers, pharmacovigilance had very little to no budget, and Greg even joked that he had to look the word up in the 
    dictionary. Times have changed. As of today, LinkedIn shows 3,000+ pharmacovigilance roles available in the United States alone. 

    What you’ll hear during this conversation as well is that a key piece to a PV career entails building and maintaining subject matter expertise as it pertains to regulations around safety especially mandated by health authorities such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe. 

    Before you settle in to listen to the full episode, take a quick glimpse at these overarching highlights. 

    On His Start In PV/Safety 
    If Greg’s various titles piqued your interest, here’s how a few of them came to be plus a backstory on how he made his way to safety. 

    “I was training in internal medicine and went into a pulmonary fellowship up in Boston at Brigham and Women's Hospital. And at the time, many of my colleagues had transitioned into non-traditional medical careers. This is going back 25 years and that was much less commonplace than it is today. So I started to explore what else was out there, you know, where else I could learn new skills. And I stumbled across McKinsey and Company and subsequently joined the company a couple of years into my fellowship in pulmonary. I never even completed the pulmonary fellowship. While I was at McKinsey, I learned quite a bit. As I started to look into my next step, the pharmaceutical industry made a lot of sense to me. And I ended up having a conversation–as many of us do–with a recruiter who really caught my attention around a very unique role at a large pharmaceutical company who had just acquired another pharmaceutical company.

    And they had budgets in many of the different functions to complete the integration activities, but the pharmacovigilance department did not have such a budget at that time. I had to look up the word pharmacovigilance because I really didn't know what it was actually back then. The job really was a hybrid of a medical role, pharmacovigilance physician, but also really taking the lead on the integration activities so it sounded great. It was in a wonderful city. And I made the move into that company. Very shortly after I joined, the integration project got put on hold for a bit. And immediately, I had to dive very deeply into the pharmacovigilance

    • 27 min

Customer Reviews

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Livvvggg ,

Great series of guests!

SSI brings in such an interesting array of guests to their show- I am always to see who will be next!

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