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

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.

"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.

Adopting digital therapeutics, such as software-based interventions, has also gained momentum. These interventions can improve patient outcomes, reduce healthcare costs, and increase access to care. However, challenges and barriers still need to be overcome for widespread adoption, including reimbursement and data privacy issues.

Cleerly Health is at the forefront of revolutionizing the field of cardiology. Through their innovative approach, leveraging imaging and artificial intelligence, they are working towards standardizing and personalizing care pathways for coronary heart disease. Their focus on comprehensive evaluation, standardized care, and personalized treatment highlights their commitment to improving patient outcomes and reducing healthcare costs.

As the future of cardiology unfolds, collaboration between companies like Cleerly Health and Verily, along with healthcare providers and regulators, will be crucial. The healthcare industry can strive toward a future where diseases like heart attacks can be eradicated by harnessing the power of advanced imaging and digital therapeutics.

Join us in our next episode as we continue exploring captivating topics in the dynamic world of biotech. 

Until then, keep pushing the boundaries of innovation and maximizing the value of your therapeutics.

We hope you enjoyed yet another informative Episode of the Emerging Biotech Leader. Please leave us a review or rate us on Apple or Spotify.

“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 different functions and data management, the team made necessary adjustments and successfully pivoted their approach. Motivation, collaboration, and good leadership were critical factors in adapting to new goals and adjusting plans.

The Power of Flexibility and Agility

Variables outside a biotech company's control, such as regulators, payers, feedback from the medical community, patients, and investors, can significantly impact outcomes and milestones. A balance between defining critical outcomes and key milestones while allowing flexibility and agility is crucial to navigating these uncertainties.

Adriana emphasizes that outcomes and milestones must be clear enough to rally the team and enable future iterations and adaptation. The ability to pivot and adjust strategy is paramount for success in the biotech industry, especially when considering complex regulatory landscapes, securing funding, and responding to changes in the market.

Looking Ahead for the Biotech Industry

Despite the challenges the biotech industry faces, there is cause for optimism. Improved funding opportunities, increased interest from investors, and alternative sources of capital have enhanced the landscape for emerging biotech companies. Moreover, the development of innovative therapies continues to address unmet medical needs, offering hope for improved patient outcomes.

As we conclude this episode, I thank our guest, Adriana Valenciano, for sharing valuable insights on building an outcomes-driven biotech. Defining intentional goals, embracing a multidisciplinary approach, and staying agile in response to change is essential for success.

Join us in our next episode as we continue exploring captivating topics in the dynamic world of biotech. 

Until then, keep pushing the boundaries of innovation and maximizing the value of your therapeutics.

We hope you enjoyed yet another informative Episode of the Emerging Biotech Leader. Please leave us a review or rate us on Apple or Spotify.

“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: 

1. Navigating people and resource sensitivities as a leader
2. How to move past paralysis analysis when revising the former plan for a new one 
3. Scaffolding regulatory pieces as a framework for planning 
4. Assessing when to bring in council, partners and vendors as a stop gap and expert resource

True 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 looking for a form of major intervention, maybe like a RIF or total change of go to market and others are seeking counsel. I.e ‘How can I make this happen?’”

As you’ve heard on the show before, it isn’t uncommon for early stage biotech founders and teams to have a lot to figure out. Kim sheds more light. “There's the concept that organizations in their earliest stages are trying to figure out, ‘Where do I build my initial programs? What country am I going to for my phase 2 because that seems to give me the greatest path forward from a regulatory perspective? And I need to figure out, ‘How am I going to get to market sooner than later somewhere?”

On the opposite side of that early stage planning and analysis, is the “fix stage” that Doug described when kicking this conversation off. 

Listen more for Kim’s distinction between the two, early stage vs fix stage companies, around 4:40. 

As a key contribution to this topic, Johan shared that regardless of stage, building a biotech and getting a drug to market is a change journey. 

“Even if everything goes according to plan, we have to shift. We have to adjust and we have to make changes because the people in the lab coats are not the people that are going to run our trials and the people who are running our trials are not the people who are going to sell our product, right? So there are these really important transformation points that every company that ultimately becomes successful just has to go through.”

The Role of Regulatory In Planning 

Another key piece of advice and insight from Johan pertained to regulatory. “At the end of the line, it's going to be that regulatory approval that ultimately provides the culmination of all of these years of success. I think from my point of view, and having 

had the great fortune and honor of working in the regulatory space for the last 20 years, I think is very important. And it starts with scaffolding. I would say this is required to start forming the foundation for a meaningful plan and a meaningful organization going forward.”

Johan's answer sparked a follow up from Doug, “If I could pick up on a piece of what Johan just said, the sliver of work, the regulatory, I mean, that reminds me of a conversation last week. It was with a new CEO in an established company. It's a rebuild of sorts, right? New CEO in a company that has been around a bit. This CEO came from a company that was well funded and much larger. So they had a broader team, had a viable clinical organization, had a strong regulatory partner that reported to them, yet in the new company, it's not there. It's that trusted voice, that hallway. You know, walking down the hallway and getting a point of view, if not a more rigorous structured milestone type activity, it’s not there.”

We’ll let you hear for yourselves the main reason Doug felt compelled to share this story–it lays the groundwork for the next set of challenges a leadership team now needs to evaluate: the people part–specifically the build skillset vs the operate skillset. 

Kim shared a poignant perspective on this as well. “It is often not an FTE or a full-time mindset of what you need to get from A to B, but you do need to bring in ...

“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: 

1. When to think about safety.
2. What role AI might play in safety within the next few years and, 
3. 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 activities and learn about the single case reports and periodic safety update reports. So that was my introduction.”

On The Best Time To Start Safety 

Much like Jason advised in Episode 24, Greg wholeheartedly agrees that the earlier a biotech can think about safety, the better. But the key question here is why? 

“I can see how some of the thinking around safety and pharmacovigilance and more around the operational side of that can sort of get swept up in the onboarding of CROs and thinking about clinical sites, enrollment, and some of the activities that would seem to be, you know, much more on the radar screen of the investors, let's say in the outside world. The reality though, 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.”

One specific example Greg shares on those dividends is using a centralized, single integrated database. 

“Having a single integrated database with a single set of processes allows for the coding and codification of the safety information to be done in a very uniform way across the entire product life cycle so that when we're performing analysis when we 

go back to search for certain things, we don't have to remember how we used to code things, how information was handled, etc., in a legacy clinical trial.”

Greg goes on to share that if you fail to start your safety planning early, that doesn’t mean there aren’t ‘tried and true ways’ to jump in really at any stage in the process–however, the earlier, the better. 

Amit wanted to know more from Greg on how safety systems evolve. Is PV always outsourced? Should it be internal? External? Are there other ways to craft a model? As a follow-up to this, Ramin wanted to also hear more about hiring early. 

“Really what we see, I would say, uniformly across the industry is that there's some capabilities in house and some capabilities that are handled by third party providers. And the third-party providers really span a spectrum of contribution.” Greg dives into much deeper detail on this around 8:46 of the interview. As a quick Cliffsnote: more inside, less outside, or more outside, less inside depends on a lot of factors.

“It's a little bit hard to say, ’there's a cookie cutter model’, but it's quite straightforward when we get in there, and we interview leadership and we understand what their investors are thinking.”

On The Role of AI in PV 

The inspiration for the next point of discussion came from Amit and what he’s been seeing at industry events. 

“I was at a couple of drug safety conferences earlier this year, and a very hot topic right now is AI and Chat-GPT and how we're going to use artificial intelligence in the PV space specifically on looking at and managing the safety profile of an asset. We'd love to hear your thoughts around that to see and really understand where you think this could potentially go.” 

Here’s what Greg shared. AI has been on the radar of safe...

“Safety doesn't live outside of you. It's not a yellow ribbon that you wear in hospitals that says, ‘it's patient safety week.’ It's not a sign in your office that says, ‘this is patient safety month.’ It's a consequence of how we approach our work on a day-to-day and hour to hour basis. And it's by definition, therefore, an emergent property of who we are and how we engage with our work.” Jason Campagna

With great innovation comes great responsibility especially as it pertains to developing new and emerging therapeutics, devices and treatments–which is why we’re covering a new topic here on the show today. We’re focusing on cultivating a culture of safety. 

In previous episodes of the Emerging Biotech Leader, we have talked about various types of responsibility. There’s the responsibility of managing the team. There’s the responsibility of navigating cross-functional stakeholder relationships. We’ve even touched on the responsibility of presenting to the board. 

That said, today’s podcast topic of safety is just as pertinent. By textbook definition, safety is the condition of being protected from or unlikely to cause danger, risk, or injury. 

To help us navigate this topic from the lens of the biotech sector, we have two new voices on the show: Amit Patel, Senior Vice President at SSI Strategy and Jason Campagna, Chief Medical Officer at Q32 Bio, Inc. 

Q32 Bio is a biotechnology company developing therapeutics targeting powerful regulators of the innate and adaptive immune systems, with the goal of re-balancing the immune system in severe autoimmune and inflammatory diseases.

Our main co-host, Ramin Farhood, Sr. Vice President of Medical Affairs Practice at SSI, also lends his thoughts, voice and observations on this topic as well. 

Back to our featured guest. When it comes to safety, Jason Campagna’s expertise is extensive and vast. He's been a licensed physician leader who's practiced in academic, clinical medicine and private practice. He’s held roles in hospital administration and he’s worked and served on boards in industry as well. 

We’re thrilled to have Jason as a guest for many reasons including the opportunity to discuss how he prioritizes and strives to cultivate a culture of safety in any organization he leads. If the quote at the top of the page is any indication of his interview style, Jason holds no punches and offers insights that are clear, direct and compelling. On that note, here are a few key takeaways from this episode.

On The Importance of Safety In Biotech

Amit, Ramin and Jason all agree, building a culture of safety should be a top priority for both established, big pharma companies and smaller biotech startups as well. Afterall, patient safety is a universal concern, and even in the early stages of drug development, safety protocols should be firmly ingrained. 

From a business and planning standpoint, this means prioritizing safety from day one–focusing on the preclinical and phase one stages. Yet for brand new companies navigating this with limited expertise or covering an entirely new patient population, this may not be as cut and dry. In fact, Jason cautions that all companies should exercise prudence when it comes to prioritizing safety very early on. 

After some back and forth on this topic, Amit wanted more context. “It sounds like the output is patient safety but what are the inputs?”, he asked to help our listeners. 

Jason’s answer was very eye opening. 

“So, this is the eternal dilemma that we face. In the 1980s, there was a really interesting Yale psychologist named Scott Perrow. He wrote a book and  it's a widely influential book in the field of safety and risk called Normal Accidents. And he didn't mean “normal” in terms of description of frequency. He meant normal in description of how they unfold. In any major safety event that occurs, it's often the most banal and trivial things that lead to major safety events. It's something very minor. For example, the patient didn't exactly recall that they were supposed to stop their medication at this time. And when they called, the person who got them on the phone was a little rushed and they didn't quite hear the full sentence. And the next thing you know, these banal and trivial events all add up to go, boom, major consequence.”

Listen in for another key learning from Perrow and a story on the Gus Grissom capsule. 

As a pivotal takeaway, one of the inputs is to shift away from the view of “safety is a cost center”, to “it's an ongoing, priceless, life saving priority.” 

In terms of the economic arguments for investing in safety early and on a recurring basis, Jason does dive deeper into the topic around the 14:25 mark while Ramin also provides the invitation to move away from viewing safety as a “necessary evil.”

On  Strategy and Collaboration in Biotech Particularly with PV

All the discussion around unified alignment and ownership of safety in biotech opened up the door for Ramin to glean Jason’s thoughts on collaboration and partnership especially with PV. 

“I've seen in organizations, with my own experience, where PV and drug safety were really a strategic partner cross-functionally and being more proactive,” Ramin said. 

“They were not just sitting in the office and for a drug, you know, addressing events that happened and doing their investigations and the forms and the reporting as requested: they were actually being more proactive. They were trying to look for signals. And making sure that the product continues to sing in the market, because with those signals, there are certain actions you can take. You can focus on education. You can focus on papers, posters, manuscripts that you can have to make sure that the conditions are appropriately knowledgeable and have the education to make the right decisions. So Jason, what is your view about PV and safety as a strategic partner?”

Jason’s answer included a specific mentor, Clive. “I think Clive was the model for me on how safety and PV is, by definition, a strategic asset to a company. That being said, I think it's an anomaly, unfortunately. I think what you just outlined, teams that are consistently able to do that over long periods of time in a cross-functional manner, I think that's rare.”

For more on the importance of working cross-functionally in biotech, tune into Episode 13 of the Emerging Biotech Leader. 

To become a team that does collaborate with PV cross-functionally on a consistent basis, listen to Jason’s thoughts around HRO’s: high reliability organizations as well as how PV alignment can also help with sales. 

One additional perspective Jason shares especially as it pertains to strategy and collaboration is preparing for the worst…even in the absence of it. “In a...

“It's not always smooth sailing or a straight line path. So being able to address those different inflection points, being able to resource accordingly, flex in, flex out, and really focus on ‘what are the most important priorities?’ Make sure you're addressing those, the ‘must haves’ versus the ‘nice to haves.’” Jacqui Levine, Vice President, SSI Strategy 

Preparing for a biotech launch now or at some point in the future? Then you’ll want to bookmark Episode 23 of the Emerging Biotech Leader, which serves as a mini masterclass on how to think about launching as well as what's to follow post-launch. 

SSI’s Adriana Valenciano, Senior Vice President, is host again alongside Ramin and a new voice to the podcast, Jacqui Levine, Vice President of SSI Strategy. Based on their collective experience, Adriana, Ramin, and Jacqui provide ways to prepare for all stages of launching and how to understand everything that’s required. 

As a preview of what’s to come in this discussion, our trio cover:

• The difference (and similarities) between launching in biotech vs Big Pharma
• What role communication plays in the launch process
• How to think strategically and also execute
• Presenting to the board and
• What can put your launch at risk

Share this episode with colleagues and peers–and without further ado, let’s get you into the recap. 

On Biotech vs Big Pharma Launches: What’s Different? What’s Similar? 

To kick things off, Adriana, Ramin, and Jacqui discussed the distinctions between launching in biotech vs Big Pharma as well as what was similar.  

On the latter, Ramin did share that while Big Pharma comparatively has bigger budgets, increased headcount, and brand recognition, the skill of prudence and monitoring one’s P&L with attention and discretion is always table stakes regardless of the launch company’s size. “You will have more resources in Big Pharma, but they aren’t unlimited.”

Given their smaller budgets, biotechs do have to plan for different ways of resourcing while also understanding the constraints they’re facing. This is why Jacqui’s quote about the reality of “rough waters” and accepting that things won’t always be smooth sailing is important to remember. 

She adds, “You really need to take a risk-based approach; you can't do everything all at once. So thinking strategically, planning through the life-cycle of what would be needed as well as being able to account for some of the ups and downs, is key.”

Speaking from several launches and a transition from Big Pharma to biotech himself, Ramin also shared more advice.  

“In bringing a new product to market and bringing a new product to patients, there's a lot of excitement internally, cross-functionally, within medical affairs, within clinical, within commercial. So that's really a piece that I enjoy in launching a product. I mean, it is very multi-dimensional. It's not just one focus, and it's definitely not a straight line. I think one thing that I noticed in the smaller biotech companies with regards to the resources, you really have to be hyper-focused on your execution plan, and you have to sequence them.” 

Ramin shares some additional context around the need to be agile and what launching sequentially has to do with the required skill of communication.  Make sure to take notes on this topic because he provides a simple yet clarifying framework with questions for you and your team to answer as part of your launch communication plan. 

For those who may share a similar professional background to Ramin, having worked in Big Pharma and then pivoted to biotech, he emphasized how essential it is to bring those rigorous planning and collaboration skills to your new, albeit smaller, org. Adriana refers to this as “hyper coordination.” 

“You know, we see this often with clients where they're used to operating with individualized functions that are very productive, but when you get them all together, it can be very challenging to keep them coordinated and aligned to the end goal and the end game, which is that launch. And so, it's really about creating many more communication channels and pathways so that you're facilitating a very symbiotic team with clear objectives and plans.”

On Prioritizing Stakeholders and Skills for Launch 

The communication theme created a really natural segue for the next topic, which was prioritizing and involving stakeholders. 

Jacqui shared that who to focus on depends on a few key things. “Is it a rare disease? Is it going more mass market? What are the nuances of it? Because stakeholders are going to be different depending on the scenario. But, you know, regardless, making sure that the patient is at the forefront of why we're all doing this–that is critically important.”

Ramin echoed Jacqui’s answer and added: “I think that the two main groups you want to focus on are these: one is the patient advocacy groups and the patients. And the other one is definitely your KOLs.”

Listen in to hear Ramin’s “words to the wise” about avoiding a shotgun approach and how to be a facilitator between these two groups. You can also pick up more tips on being patient first in Episode 18 of The Emerging Biotech Leader. 

From a skillset perspective, Jacqui shared how important it is to truly and honestly acknowledge what you and your team can do internally versus where you might want to leverage partners. 

And before they moved on to the next topic, which was thinking strategically and also taking action, Adriana said it best when she shared, “Launch planning can be so iterative.”Jacqui then elaborated further. “I think there's a number of different things that are really important. One is to be able to think strategically, but also to be able to translate that into execution.” 

As you execute your launch, one thing you may not anticipate–but can think about ahead of time–is how you’ll manage through setbacks and keep your teams engaged. Be prepared for a variety of scenarios.   

Ramin emphasized some final suggestions: you’ve got to be a broad thinker and be receptive to communication reflected towards you. Articulate your points and keep an open mind when people have feedback, especially as you prep to meet and present with the board. 

On What Can Put Your Launch at Risk

Planning a launch keeps you focused on the here and now. But how well are you set up for your post-launch efforts? Adrian, Ramin, and Jacqui strongly advise that you think about your post-marketing world, i.e., do you have the infrastructure, compliance, and other pieces required? You can’t just be what they describe as “product ready”--you must be “organization ready,” aka company ready, too. 

Adriana articulated this best, given what she has seen in the field, with Ramin helping her complete the thought. “If you're not ready from many different lenses: P.V., medical affairs, and obviously commercial payers, etc., take note,” which is when Ramin chimed in with–”I think sometimes we confuse launch date and approval date.” 

He then added, “Approval date is when t...

“You're actually able to make a difference, not just at your local level or your regional level, but much more on a global level. You know, you may be one of the lucky few that is able to get involved in guideline development and those guidelines are then applicable across the world.’” Benit Maru, Senior Vice President, SSI Strategy

“Should I stay or should I go?” You might recognize those words as lyrics from The Clash; however, they also pertain to the decision to stay in academia or join the world of pharma and biotech. What happens when one leaves the sector and role they’ve known to carve out an entirely new career and skills in another? 

This is precisely what Adam Schwartz, Ramin Farhood and Benit Maru discuss in this episode of the Emerging Biotech Leader—a follow up to Episode 21 featuring Victoria Niklas, Chief Medical Officer at Oak Hill Bio. 

All three members of the SSI team further examine the balancing act needed to transition from academia to industry, once again, acknowledging the misconceptions and impacts of 'selling out.' 

In case you are new to our show, Ramin Farhood is Sr. Vice President of Medical Affairs Practice at SSI and a regular staple and host of the Emerging Biotech Leader. Adam Schawrtz is President of SSI Strategy, guest hosting in Kim Kushner’s absence and Benit Maru is the European Lead and Medical SVP for SSI also serving as a Chief Medical Officer for SSI clients. Today, he’s our special guest expanding upon his 25 years in academia plus 7 more of his career recently spent in industry.

Formal introductions aside, let's dig in to a few of the key concepts covered in this episode. 

Those include: 

• The benefits of going from academia to industry 
• How 'guarded optimism' comes into play in developing new therapies
• Why the knowledge and expertise brought over from academia is essential for the success of the industry
• Reflections on CMOs and their delicate balance between science and business considerations

Embracing the Transition: From Academia to Biotech 

Much like Victoria Niklas and other podcast guests who have transitioned from academia or bedside medicine to work in pharma and biotech, Benit, too, received his fair share of caution, stigma and discouragement. 

“I was warned, you know, if you leave, you're never going to be able to come back.”

As a byproduct, Adam and Benit hope this ongoing discussion reminds everyone that diverse experiences are the catalyst for long lasting change. When academics or practicing physicians bring their specific experience to industry, by way of career transition, it actually improves innovation which subsequently improves patient outcomes. Ramin weighed in on this as well. 

“I’ve actually seen that individuals are really successful when they make the transition coming from academia and having been a research scientist. When coming into pharma, they become that voice. They almost bridge the industry and academia together in a very powerful and beneficial way for the patient.”

Keeping on this theme of patient impact, Adam probed to get more understanding from Benit on how to silence any guilt or self-doubt. Listen to the episode for his answer. 

A big part in moving forward, that was available to Benit via hindsight, was how rewarding it was to experience an opportunity to expand beyond adult medicine to treatments in the pediatric sector. 

Benit also went on to share: “It is a challenge to think I'm letting patients down by no longer treating them one to one. But, you know, in hindsight, you're not letting them down because you're going up a notch and you're actually able to make a difference, not just at your local level or your regional level, but much more on a global level. You may be one of the lucky few that is able to get involved in guideline development and those guidelines are then applicable across the world.”  

As a piece of transparency, he does disclose that missing patients is normal as you move into your new sector. Try to stay focused on the bigger cause. 

Effective Communication for CMOs: Navigating Stakeholders and Challenges

Effective communication is another topic that finds its way into each Emerging Biotech leader episode. Timing, knowing your audience and delivery of communications in biotech are essential. 

In her interview, Victoria Nikklas spoke to this need for ‘guarded optimism.’ In agreement, Benit also shares that those who have worked bedside before understand this really well. 

“You kind of have to be really careful about what you say to a patient, that to me is a parallel where you think, ‘Okay, this is good. But I just need to be careful’ and that is kind of that ‘guarded optimism’ piece that Victoria mentioned.”  

Adam expanded upon guarded optimism from his perspective, too. 

“I feel like in medicine in general, and especially when you're talking about developing new therapies, you have to be optimistic. Otherwise, you wouldn't be thinking of these ideas. You wouldn't be taking the steps to even try to get there if you weren't optimistic about the idea. But at the same time, we have to be realistic, and we have to be understanding of what the limitations are. Make sure that you're grounded in some reality, right? And waiting and taking the appropriate steps to test the science and prove things out before you're sort of just running.”

This sparked the topic of CMOs needing to speak across multiple stakeholders, especially balancing science and business conversations. 

Benit provided a few insights into how this was a struggle initially at the beginning of his career. “You know, how granular do you need to be? Too scientific? Not scientific enough? I think that's one of the challenges of communication–knowing the audience and how to communicate.”

As a CMO, communication is one area where you can’t shy away from asking for help, which spurred another myth Benit wants to debunk–that asking for help “looks bad.” To further make the case for transferable skills and relevant experiences from academia to industry, Benit shared, “Somebody that's actually got quite a good tenure in medicine and academia, they're comfortable in asking for help when needed.” 

To provide further encouragement, Adam reminds our listeners: “You need to be able to rely on a team around you because no CMO is going to be great at everything that is part of their responsibilities.”

What causes this false belief? The misconception and pressures of “needing to know all the answers.” Adam, Ramin and Benit dive deeper into managing this form of imposter syndrome further. Keep your ears opened for that topic. 

On Fostering Growth and Adaptability in the Biotech Industry

The topic of communication inspired yet another theme: confidence. Only in this case, having the confidence to reach out to others–peers, your network, your team, whomever can help close knowledge and skills gaps. 

It's one thing to acknowledge you need and w...

“I will always have deep empathy for patients and want to do the best that I can, but I feel very satisfied that I'm driving development of OHB 607, which has the potential to change the trajectory. So, I don't have to sit and remind myself why I'm doing that–there are patients on the other end.” Victoria Niklas

How can you break into biotech from academia without guilt, fear, or self-doubt? After listening to our guest, Victoria Niklas, in Episode 23 of the Emerging Biotech Leader, you may just have the answer to that question. Victoria is the Chief Medical Officer at Oak Hill Bio. As you’ll soon learn, she has been in pharma and biotech just shy of 10 years–7 to be exact. Prior to this time, Victoria was an academic neonatologist and translational scientist beginning at UCLA, rising through the ranks at the University of Virginia in Charlottesville, Children's Hospital of Los Angeles, and finally returning to UCLA before taking her first industry role with Prolacta Bioscience as their first Chief Medical and Scientific Officer. 

In addition to our new guest and a new topic–we have a new guest host: SSI President Adam Schwartz, who is joined by Ramin. 

True to form, both get Victoria to open up and share more on the uncertainty and upside in pursuing a new path, especially in making the transition from academia to pharma to biotech. 

As a preview of what’s to come, Victoria shares more on:

• The skills she leveraged to make this career jump 
• How to keep an open mind and disregard stigmas about one sector vs. the other 
• Her experience in establishing a licensing agreement, along with the regulatory components of that 
• The role of the CMO 
• Embracing lifelong learning 

No matter your career crossroads–big Pharma to biotech, academia to biotech, bedside medicine to biotech, we know you’ll find this interview invaluable.  

From One Sector To The Other - In Pursuit of Impact

While it’s still evolving some seven years in, Victoria’s pharma career includes a background in research spanning various roles, including time at Takeda. “My experience in research helped me develop a strong foundation and understanding of the scientific and medical aspects of drug development, which has been invaluable in my current role at Oak Hill Bio.”

Her first stepping stone into this world from academia came by way of a professional connection–just as she felt a nudge to pursue a new path. “I began to feel as if I wanted a bigger stage with which to have an impact, you know, particularly in the care of extremely premature newborns where drug development in that area doesn't rival that of other areas. In thinking about how to do that, I was very fortunate. I was approached by the CEO at Prolacta Bioscience, who said, ‘You know, we'd love to have you come and join us as our first chief medical and scientific officer.’ So I took that opportunity and never looked back.”

From Prolacta, she was then recruited to go work at Takeda to lead a drug pipeline focused on extremely premature newborns. Then, the work at Takeda led to Oak Hill Bio–a byproduct of them choosing to out-license that program. This next role, however, did require a different approach–she didn’t just apply and interview. Listen for specifics on how this all came together during the podcast. 

On The Transferable Skills Required To Make A Move 

As we’ve discussed in previous episodes of The Emerging Biotech Leader, transferable skills go a long way when making a career pivot. 

Chris Morabito covers this topic in Episode 15 of The Emerging Biotech Leader. 

The key skills that helped Victoria transition from academia to biotech included multitasking, leadership, and guarded optimism. Most likely a new term for you, here’s how she defined that for Adam and Ramin: “So I think it’s being optimistic, but, you know, not necessarily guarded–but just realistically optimistic, always.” 

A final transferable skill she mentioned is thriving and surviving on very little sleep. We hope you appreciate her honesty there. 

On Disregarding Stigmas and Preconceived Notions

Adam was curious to uncover how Victoria overcame questions and skepticism about her new pursuits. 

“Victoria, you mentioned some of your colleagues in academia sort of “warning you” as you were thinking about taking that step into pharma. And it's obviously something that many medical professionals and scientists go through when they're in academia, and then they're thinking about whether or not it's a good step for them. What are some of the things that colleagues of yours were warning you about? And were they true?”

Victoria did shed light on the misconceptions about "selling out" or abandoning patients, emphasizing how many in her same shoes venture into the industry driven by a genuine desire to make a difference and keep the patient at the heart of drug development. She covers more specifics of the “sell out” and skepticism on her motives and commitment–be sure to listen for those details. 

As a solution to break this stigma down, Victoria highlights the importance of increasing education and understanding within the medical community–to bridge the gap between academia and pharma.

For those currently in medical school, contemplating which path to take, or even making the leap from another sector to biotech, Victoria shares more about why this should change, even starting at the academic level. 

“There's no class in medical school where you go to learn the pharmaceutical drug development process. So, it is a gap. But appreciation for what the pharmaceutical industry and biotech are doing to expand drug development, I think that sentiment people completely understand and get. So much of it, I think, is just not being aware of the nuances of it. Number one. Number two the expense of it. And number three, how long it takes, especially to have a robust process to prove efficacy with an appropriate safety profile.”

On Managing Out Licensing–What Was Required To Make This Happen? 

If you’re a loyal listener of this show, you know that Ramin has a remarkable way of asking questions that provide teachable moments for the biotech community. This was the basis for his inquiry around the licensing agreement between Takeda and Oak Hill–and how Victoria played a part in moving that forward. 

“What was your negotiating strategy? What regulatory aspects did you have to consider in that whole process? Basically, how did you make that happen?” 

We won’t make you wait to get Victoria’s answer. Here’s what she said.

“One was shoring up the team because I think given the nature of the population and the incredible connections that people on our team at Takeda had developed, you know, we had to take the view that it's not over. Ok? This doesn't mean these patients will never receive this drug in the longer term. So, shoring everybody up and keeping people laser-focused on that. 

“And the second thing was helping develop the message. From Takeda's perspective, I was sitting there as the representative, as the on...

“There are clear distinctions, as we've talked about, between device and pharma from a medical affairs perspective. I think they each require this special touch and strategic medical affairs plan, but I think what we're also converging on is that they’re almost more similar than we think.’” Leah Damesek, Vice President of Medical Affairs, SSI Strategy. 

Disruption. It’s a word that many associate with dramatic or abrupt change. But in order to disrupt something in biotech, particularly shifting a standard of care from one type of treatment to a new protocol using a medical device, there has to be collective, cohesive, methodical buy-in. In Episode 19 of the Emerging Biotech Leader, our interview with Shon Chakrabarti of Inari Medical echoed how disrupting a care pathway has many moving parts. 

Now, in Episode 20, Kim Kushner, Ramin Farhood, and a new voice from the SSI team, Leah Damesek, Vice President of Medical Affairs Strategy, continue exploring what it takes to bring disruptive devices to market. Listen in to observe a few overarching themes that emerge and guide the conversation.

• Leah and Ramin share their thoughts and experience on changing a care paradigm to meet an unmet need
• All three discuss the actions required when disrupting a care pathway change the physician base
• And lastly, Kim, Ramin, and Leah circle back on the use of real-world evidence in changing physician behavior

The trio keep no secrets–the medical device industry is more advanced, compared to pharma, when it comes to strategically utilizing real-world evidence. And as you’ll hear, this is brought up not to poke holes but to provoke thought and understanding for anyone looking to shift from one sector or the other. 

Throughout this episode, Kim, Ramin, and Leah also discern additional differences and similarities between device and pharma. What’s vital to both–no matter which side of the industry you find yourself on–is that the main goal never deviates from this credo: do right by the patients. 

On that note, enjoy these highlights, and as always, we encourage you to listen to the full episode, too. 

On Bringing The Medical Community Along 

Right at the top of the interview, Kim asked Leah about the challenges with conversations–from a medical affairs lens–when meeting with the physician community. 

Many of these physicians have been treating their patients in a specific way for decades. To that point, Leah shared, “Bringing the medical community along to make a change in their practice that has been so instilled in them for so many years and through so many different variations of guidelines is a really big change. Something that I think about a lot as we're working with our clients is helping all sides of the care continuum and the caregiver team move with the industry change. So, it's not just about bringing new physicians and new specialties on board, but also what's in it for the existing specialists that are treating these patients?”

What else does driving disruption and adoption entail? 

• Learning that some patients are more receptive to new technologies while others are slower to adopt or change 
• How to get physician buy-in so that none feel displaced by these new care paradigms 
• The concepts of patient segmentation, deploying centers of excellence, and understanding the role of all inputs involved to drive change: patients, physicians, nurses, and real-world data

Leah highlights the importance of helping physicians feel like valued participants on the cutting edge of care for new devices or drugs, as opposed to pushing them to the sidelines. Ramin agreed and added this reminder from Episode 19: “It's really, really important early on that you have the customers (doctors)  involved and that they get the right training to feel comfortable using the device and they feel comfortable that they can also make the patient feel comfortable with what they're doing.” 

As they navigate a new normal, Doctors must understand device use, who it’s best for, what updates and advancements are coming, post-approval, and more considerations for full adoption. Building on that, Kim points out that a new ecosystem gets created when a treatment pathway is disrupted by a new device or drug. 

“It's more than just training the physician who's going to be the user, but it's also training the physician who now has to be a referer, and historically was the person to treat that patient. If we can't actually get the patient to the appropriate, in this circumstance, Interventionalists, where, you know, they've been typically treated in their home cardiology office, that's a really different care pathway for a patient.”

Working In Harmony: More Than A Pipe Dream

With disruption overhauling the “old way of doing things,” how do you mitigate friction to ensure the current physician, new physician, and patient are all aligned?

Ramin describes this unit as a “triangle.” While the talk track and training for both physicians is mostly procedural and straightforward, driving patient confidence and adoption is where there is more variability. 

“Maybe you've been on a particular drug for many years, and now maybe it's not working right? Or maybe the side effect profile is not good anymore. So, you have to have that conversation with the patient so that they feel comfortable to be referred and have some type of procedure. Even if it’s not a full-blown operation, it still becomes really scary for them.”

As a best practice, Ramin shares a few things to remember. Nurses need to be included in this training/adoption loop as they spend a significant amount of time with patients as well. 

Also, enabling and training both physician groups–former and newer–with aligned messaging is vital. And this all has to be done in harmony, which really falls on the founding team to ensure and plan for from day 1. 

On Setting Up A Center of Excellence 

While Kim was hearing these points come up, she requested a few tangible examples of what success looks like when Centers of Excellence are executed flawlessly. “In particular, I'd love to hear what you've seen be successful in setting up those models and what some of the barriers to success have been for industry.”

Leah jumped right in to answer with a success example first: the early adopter approach. 

“The successful factor was the early adopter model. What I've seen in setting up that Center of Excellence is that no one wants to feel like they're not on the cutting edge of research. I'm actually thinking about this in a gene therapy context, going from potentially a surgical intervention to moving towards a one-time treatment that 

would no longer need potentially any intervention from a surgeon. And so thinking about what, ‘What's in it for the surgeons?’ How can you be an early adopter? How do you want to think about how you're giving a certain device to a patient now, and you're moving towards a different type of surgery, right? That's one way to think about it.”

As for barriers, Leah points out that those can arise from low data volume or if a treatment, even though minimally invasive, is no...