By SSI Strategy
5
99 ratings
The podcast currently has 44 episodes available.
Have you ever wondered what makes a great biotech CMO? In this episode of the Emerging Biotech Leader, Dr. Steven Zelenkofske shares the practical, hard-earned insights he’s gained from his five CMO positions and multiple board roles, offering straightforward advice on how CMOs can step in early, build strong executive relationships, and drive clinical programs to successful outcomes. This episode is your behind-the-scenes look at the evolving role of biotech’s top medical leaders.
Steven strikingly describes the CMO role as "like an octopus with eight arms," each representing essential functions from external relations to operational oversight. This colorful analogy captures the multifaceted nature of modern medical leadership in biotech, where CMOs must constantly adapt their approach based on company stage and needs.
Beyond One Leader
Timing emerges as a critical theme: companies often delay bringing in clinical expertise until after key development decisions are made. While founders and CSOs excel at scientific innovation, Steven argues that early clinical perspective is essential to bridge the gap between groundbreaking science and effective drug development.
The discussion explores a modern solution to the growing trend of fractional CMO roles. Rather than relying on a single part-time leader, Steven advocates for a "CMO office" model - a team of specialists collectively fulfilling the role's diverse requirements. This approach ensures comprehensive coverage while maintaining cost efficiency in today's resource-conscious environment.
Steven also points out that successful clinical development often relies on preparation and anticipation of challenges. His practical advice includes building strong partnerships between CMOs and other executives, particularly CEOs and CSOs, while fostering a culture where teams feel empowered to provide critical feedback.
If you are building a biotech organization, this episode offers practical answers to your critical questions: When do you need a CMO? What should you look for? And how can you structure the role to maximize impact while maintaining efficiency?
Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you!
The relationship between biotech leadership and their boards is evolving, particularly as private equity takes a larger role in the industry. In this episode of the Emerging Biotech Leader, Nick Amigone from Amulet Capital Partners offers a unique perspective on building effective board relationships from the private equity vantage point.
The conversation explores three distinct board structures that shape company governance:
A key theme that emerges is the importance of maximizing board effectiveness. Nick advocates moving beyond routine quarterly updates to strategic engagement focused on critical decisions.
The role of independent board members is highlighted as vital. Nick outlines three key criteria for selecting these directors:
He emphasizes the importance of finding directors who will make their board service a top priority, noting that "it should be an important part of their professional life."
From avoiding the "quarterly update trap" to balancing short-term milestones with long-term vision, Nick shares how biotech leaders can transform their board interactions from routine reporting exercises into strategic partnerships that drive company success.
Would like to share your experience as a biotech leader on our podcast? Send a message to [email protected]
How can biotech CEOs and their boards foster strong, trusting relationships that drive effective decision-making and long-term success? In this episode of Emerging Biotech Leader, host Kim Kushner explores this critical question together with Don de Bethizy. Don is a seasoned life sciences executive with over 30 years of experience, having served as a founder and CEO as well as board member and advisor.
The episode highlights key strategies for building trust, setting clear objectives, and managing board relationships, making it essential listening for anyone looking to enhance their leadership approach in the biotech industry. Here you’ll find actionable advice that can significantly impact your company’s success and your own professional growth.
Key takeaways include:
The delicate balance of board relations: Don stresses the importance of transparency with the board while maintaining a strategic focus.
Building the right team: "Get the right people on the bus, but in the right seats," Don advises. He discusses the challenges of early hiring decisions and the need to make tough choices quickly when someone isn't the right fit.
Leveraging board expertise: Don highlights the value of specialized committees, like R&D, to dive deeper into critical areas without bogging down full board meetings.
Throughout the discussion, Don's humility and willingness to learn shine through. He candidly shares mistakes and lessons learned, offering a refreshing perspective on leadership growth.
Tune in to gain a deeper understanding of what it takes to successfully manage board relationships, refine your strategic focus, and build a culture of accountability and trust within your organization.
Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you!
In this episode of "The Emerging Biotech Leader" podcast, host Ramin Frahood speaks with Helen Kargaryani, VP Global Head of Quality/Quality Services at SSI Strategy. With over 30 years of experience in the pharmaceutical and biotech industries, Helen shares her expertise on quality and risk management.
Risk management in these industries is a critical process that helps companies identify, prioritize, and mitigate potential issues affecting their operations, compliance, and financial stability. "Quality is the ultimate goal” Helen explains. “A Quality Management System maintains quality, while risk assessment helps us identify and mitigate risks to quality. Together, these three elements build a solid platform for compliance in the company."
The approach varies between organizations based on their specific business, stakeholders, and patients served.
Key Takeaways:
Proactive risk management is essential for biotech and pharma companies: It helps avoid regulatory issues and financial losses, working in tandem with quality management systems (QMS) to ensure effective compliance.
Risk management should be tailored and integrated: Strategies need to be customized to a company's size, resources, and specific needs. Importantly, risk management should be integrated into company-wide strategy and culture, not isolated to a single department.
Common pitfalls in risk management can have severe consequences: Many companies fail by either not including risk management in strategic planning or not implementing it effectively. This can lead to regulatory non-compliance, financial losses, and potential product shortages affecting patients.
Early implementation is crucial, especially for startups and small biotech firms: Even with limited resources, companies should start implementing risk management early on a small scale, ensuring their approach is scalable as they grow.
This episode provides valuable insights into the critical role of quality and risk management in the biotech and pharmaceutical industries, based on Helen’s extensive professional experience and perspective.
If you'd like to discuss how you might apply these learnings to your own context, contact us at [email protected]
This episode offers critical insights on leveraging risk management as a strategic advantage in medical device development. In a conversation with Ramin Farhood, Bijan Elahi, with over 30 years of experience, provides a roadmap for integrating safety considerations into innovation pipelines, potentially accelerating time-to-market and enhancing competitive positioning.
Key Strategic Takeaways:
Early integration of risk management, starting at the concept stage, can significantly reduce costs and accelerate time-to-market. This approach can level the playing field between firms of different sizes and serve as a market differentiator.
Bijan emphasizes the balance between innovation and safety, noting that firms demonstrating significant benefits, especially in underserved areas, may find more regulatory flexibility.
Risk-based approaches are increasingly expected across all business operations. Implementing this holistically can improve efficiency and reduce vulnerabilities in supply chain and manufacturing processes.
Strategic Implications:
Prioritize early investment in risk management capabilities for long-term cost savings and faster market entry. Consider risk management expertise in key hires and partnership decisions.
Use risk management insights to refine product pipeline strategy, focusing resources on projects with the highest likelihood of regulatory success and market acceptance.
Foster a company-wide culture of safety and risk awareness. This aligns with regulatory expectations and can drive responsible innovation.
Robust risk management practices can serve as a powerful narrative for investors, demonstrating foresight and responsible innovation.
By integrating these insights, companies can potentially accelerate development timelines, enhance their competitive position, and build a reputation for responsible innovation that resonates with regulators, partners, and customers alike.
Are 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.
The latest Emerging Biotech Leader podcast tackles the important topic of patient-focused drug development, offering valuable insights for the biotech industry. Our host Kim Kushner engages in an insightful dialogue with Dr. Laurie Smaldone-Alsup, SVP Regulatory Science at SSI Strategy, who brings years of hands-on regulatory experience to the conversation.
Laurie’s career, spanning from pioneering HIV/AIDS treatments to her current work in rare diseases, underscores a powerful message: patients are not just beneficiaries of drug development, but essential partners in the process. She explains how early collaboration with patient advocacy groups can transform the development process, providing invaluable insights that shape everything from clinical trial design to regulatory strategies.
The discussion explores the delicate balance between scientific rigor and patient needs, particularly in the context of rare diseases. Laurie offers practical advice on educating regulators, developing meaningful endpoints, and building a solid foundation of disease understanding. Her approach challenges the notion that speed always equals progress, advocating instead for a thoughtful, patient-centric strategy that may initially seem slower but ultimately leads to more successful outcomes.
Another often overlooked challenge is getting boards and investors to support a patient-focused approach. Here Laurie shares strategies for convincing stakeholders of the long-term benefits, even when they're focused on short-term results.
This episode is more than just a discussion; it's a call to action for the biotech industry to reimagine drug development with patients at its core. For leaders and innovators in the field, it provides not just food for thought, but actionable strategies to enhance their approach to drug development and, ultimately, improve patients' lives.
If you'd like to discuss how you might apply these learnings to your own context, contact us now.
On this episode of Emerging Biotech Leader, Kim Kushner sits down with Edward M Kaye, M.D., CEO and director of Stoke Therapeutics, to talk about his work in rare disease drug development.
Throughout their conversation, Ed describes the challenges of first-in-class drug development. He explains the importance of understanding diseases thoroughly and the value of natural history studies. He also discusses making the case for long-term research to investors and the lack of established roadmaps.
What stands out is Ed's emphasis on putting patients at the center of the drug development process - not just as a tagline, but in practical, impactful ways. He talks about how Stoke includes patients in their work, from getting input on trial designs to keeping patient groups informed about company updates. This approach, Ed argues, not only benefits the patients but also de-risks development by ensuring the end product truly meets patient needs.
When it comes to success in biotech, Ed takes a broad view. He explains that while drug approval matters, the real aim is ensuring patients can access and use the treatments. This involves working with various healthcare systems and considering patient costs.
For biotech leaders tuning in, Ed offers some straight talk on building company culture and the sometimes lonely reality of the CEO role. It's a conversation that gets into the weeds of biotech leadership while never losing sight of the ultimate goal: creating meaningful therapies for patients who need them.
This conversation with Ed Kaye offers a practical look at the realities of biotech leadership and rare disease drug development. Whether you're new to the field or an experienced executive, Ed's insights provide valuable perspective on balancing scientific innovation, business challenges, and patient needs in the pursuit of new therapies.
Are 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.
Summary:
In this episode, host Kim Kushner is joined by Dr. Chantal van Gils, a leading expert in evidence and value strategy at SSI Strategy. Building on the previous podcast discussion with Christian Howell of Cognito, this episode delves into three key themes:1) differing evidentiary requirements for medical devices versus pharmaceuticals, 2) the critical importance of patient-focused drug development, and 3) strategies for getting buy-in to invest in real-world evidence generation.
Chantal explains the historical divide between the evidentiary burdens for drugs versus devices is narrowing as innovative companies push the boundaries. The role of real-world evidence is becoming increasingly vital - not just for post-market surveillance, but to help define the problem that needs solving and guide the entire clinical development journey.
Chantal emphasizes that RWE data is critical not just for regulatory approvals, but for convincing payers and patients of a product's value in the real world. She shares insights on how leading companies are building the business case and narrative around building real-world evidence as this strategic imperative.
Overall, this conversation offers a nuanced, forward-looking perspective on the evolving evidence standards shaping the biotech and medtech industries. Chantal's expert insights and the relatable style make this a must-listen episode for anyone seeking to understand the changing landscape and stay ahead of the curve.
If you'd like to discuss how you might apply these learnings to your own context, contact us now.
This episode features an interview with Christian Howell, Chief Commercial Officer at Cognito Therapeutics, a biotech company pioneering a neurotechnology approach to treat Alzheimer's disease. Christian draws on his diverse background spanning the military, medical device giant Medtronic, and now the biotech industry.
The conversation covers Cognito's evidence generation strategy to demonstrate the value of their non-invasive neural stimulation therapy. As Christian states, "It's critical to bring all the key players to the table early and be fully transparent about your data - that's how you build trust and alignment around value."
Key takeaways include:
With experience implementing value-based healthcare models at Medtronic, Christian also shares unique perspectives on driving innovation while developing novel therapies.
Learn from Christian’s approach spanning evidence generation, collaborative value demonstration, and creating an environment primed for breakthrough thinking. Listen in and get inspired!
Are 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.
Episode Overview:
In this podcast interview, Ramin Farhood hosts Dr. Thomas Lönngren, an expert in drug regulation, approval, and market access. Thomas has an impressive career spanning over three decades, including a transformative tenure as the executive director of the European Medicines Agency (EMA). He currently serves as a strategic advisor, leveraging his experience to guide pharmaceutical companies and biotech through the complex landscape of regulatory approval and market access in the US and Europe.
A central piece of advice is the critical importance of early engagement with regulators, as he states, "Lesson number one, talk with the regulators first, and then you could start to build your regulatory strategy." This is especially important for novel modalities or complex products, allowing companies to shape their approach from the outset, understand the development path, and anticipate associated costs.
However, Thomas emphasizes that regulatory approval alone is insufficient for commercial success in today's landscape. Companies must also consider health technology assessment (HTA) and payer requirements, which can be more stringent than regulatory approval. Designing clinical trials with comparative data and incorporating real-world evidence from the start is essential to demonstrate meaningful value for patients and secure reimbursement.
Many biotech boards, particularly those dominated by US members, often overlook the global nature of the industry. Thomas advocates for boards to maintain a worldwide perspective, considering regulatory and access hurdles beyond just the US market. Failure to do so can result in costly delays and potential failure to commercialize a product successfully.
Looking ahead, he highlights emerging trends such as increased use of real-world data, remote monitoring of clinical trials, and joint HTA evaluations in Europe for oncology and advanced therapy products. Companies must stay informed of these developments and adapt their strategies accordingly.
Key takeaways:
If you’re facing similar challenges to those discussed in our podcasts, contact us now.
The podcast currently has 44 episodes available.
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