Episodes
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Value-Based Healthcare: Lessons from a HEOR Expert | BioPharma Unscripted! Ep.7
Join Marcus Metcalfe as he speaks with Colette Mankowski, a veteran in Health Economics, Outcomes Research & Market Access with over 25 years of industry experience. In this candid conversation, Colette shares her unconventional journey into health economics, her career trajectory at Astellas, and her transition to independent consulting and mindfulness coaching.
Colette explains how she rose from medical information to become Executive Director of a 25-person regional HEOR team, while providing valuable insights on the evolution of health economics in pharmaceutical decision-making. She discusses why health economics should be integrated from Phase 1 trials, the importance of value-based evidence, and how the US pharmaceutical market is changing through the Inflation Reduction Act.
Beyond her technical expertise, Colette opens up about leadership values, the importance of psychological safety in teams, and how mindfulness techniques have transformed her approach to challenges in her career and personal life.
In this episode you'll learn:
How health economics evolved from an overlooked function to a strategic necessity
Why value-based pricing requires early HEOR integration in drug development
The challenges and rewards of transitioning to independent consulting
How mindfulness can address mental health challenges in high-pressure environments
Colette's plans to demystify HEOR and market access through educational content
The critical attributes of effective leadership in pharmaceutical organisations
How pharmaceutical companies can strategically use interim consultants
Chapters:
00:00 Introduction and reconnection
01:28 Colette's unconventional entry into pharma
03:45 Career trajectory at Astellas
05:30 The evolution of health economics in pharma
07:55 Explaining the importance of early HEOR integration
10:42 Value-based pricing and evidence generation
12:35 Leadership influences and psychological safety
15:20 The challenge of failure in pharmaceutical development
17:30 US healthcare system and regulatory changes
19:15 Transition to interim consulting
21:08 Mental health challenges in career transitions
22:45 Introduction to mindfulness techniques
24:30 Demystifying health economics through content
27:10 Final thoughts on connection and transformationConnect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.
I also work selective Executive Search (perm) projects.
I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.He has placed over 120 HEOR and Market Access candidates during my time across US and Europe.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• CommunicationsSponsor Message
This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences
Podcast produced by www.podforge.co.uk
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Building Successful Market Access Strategies from Day One - BioPharma Unscripted Ep. 6
In this episode of BioPharma Unscripted!, host Marcus speaks with pharmaceutical market access expert Ana Filipa Alexandre, PharmD, MPH about the critical importance of early access planning in drug development.
Ana shares insights from her extensive career spanning regulatory affairs, health economics, and market access, explaining why companies must consider access strategies from the earliest stages of development.
In This Episode You'll Learn
What market access truly encompasses beyond regulatory approvalWhy companies frequently fail to start market access planning early enoughHow to build a compelling "value story" with evidence-based value propositionsThe specific consequences when market access planning is inadequateSpecial considerations for small biotech companies with limited resourcesThe critical relationship between health economics and market access functionsWhy post-launch market access activities remain important throughout a product's lifecycleHow the upcoming Joint Clinical Assessment (JCA) might impact European market accessWhether you're a pharmaceutical professional, biotech entrepreneur or healthcare policy expert, this episode offers valuable insights into how successful drugs make the journey from lab to patient.
Ana Filipa Alexandre, PharmD, MPH: Ana is a pharmacist by training with extensive experience in market access across affiliate and global roles. Connect with Ana on LinkedIn: https://www.linkedin.com/in/ana-filipa-alexandre-pharmd-mph/
Chapters
00:00 Introduction and Ana's background
01:31 Ana's journey into pharmaceutical market access
02:25 Defining market access as a process
04:44 Why companies fail to start market access planning early
07:06 Cross-functional collaboration in market access
08:26 Building the value story for new products
11:04 Challenges for small biotech companies
13:24 Example of effective early access planning
16:38 Advice for early-stage biotechs on market access
19:40 The role of consultants vs in-house expertise
21:42 Consequences of inadequate market access planning
24:16 Career development in market access
27:11 Post-launch considerations in market access
29:19 Concluding remarks
Connect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.
I also work selective Executive Search (perm) projects.
I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.He has placed over 120 HEOR and Market Access candidates during my time across US and Europe.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• CommunicationsSponsor Message
This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences
Podcast produced by www.podforge.co.uk
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Missing episodes?
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Regulatory Expertise for Early-Stage Biotechs | BioPharma Unscripted! Ep.5
Join Marcus Metcalfe in conversation with Ming Ewe as they explore the critical role of regulatory expertise in early-stage biotech companies and advanced therapy development.
In this insightful discussion, Ming shares her extensive experience as a regulatory mentor for biotech startups, explaining why engaging regulatory professionals early can prevent costly mistakes and streamline development pathways. She highlights common pitfalls that young companies face, including failing to "start with the end in mind" and underestimating the complexity of regulatory requirements.
Ming provides practical examples from her work helping clients navigate challenging regulatory scenarios, from rescuing clinical trial applications to securing valuable designations that enhance development timelines. She explains the important distinctions between different types of regulatory expertise and why startups need to understand these differences when building their team.
Whether you're involved with an early-stage biotech or considering how regulatory strategy fits into your development plans, this episode offers valuable insights that could save you significant time and resources.
In this episode you'll learn:
Why early regulatory involvement is crucial for biotech success
Common regulatory pitfalls that startups encounter
The value of regulatory designations like PRIME and RMAT
How external regulatory mentorship differs from internal expertise
The importance of having the right regulatory specialist for your specific needs
Chapters:
00:00 Introduction and background
01:40 Ming's role as a regulatory mentor
03:30 Common pitfalls for early-stage biotechs
05:10 The importance of regulatory designations
07:45 Distinguishing between regulatory specialties
09:50 Case study: Rescuing a clinical trial application
12:20 Navigating complex regulatory scenarios
15:40 The value of external regulatory expertiseConnect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.
I also work selective Executive Search (perm) projects.
I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.He has placed over 120 HEOR and Market Access candidates during my time across US and Europe.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• CommunicationsSponsor Message
This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences
Podcast produced by www.podforge.co.uk
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Performance Communications in a Digital World | BioPharma Unscripted! Ep.4
Join Marcus Metcalfe in conversation with Jens Christmann as they explore the evolving world of corporate communications and digital transformation in the life sciences sector.
In this engaging discussion, Jens shares insights from his journey transitioning from the FMCG world at Mars to leading digital transformation at Mundipharma , and now to establishing his own interim management and consulting practice. He explains his unique approach to "performance communications" - bringing digital marketing and data-driven methodologies to corporate communications.
Jens offers practical perspectives on the challenges organisations face in today's rapidly changing digital landscape, including budget constraints, transformation demands, and the AI revolution. He provides valuable insights on how companies can navigate these challenges while maintaining authentic human connections.
Whether you're a communications professional looking to enhance your strategic impact or an organisation navigating digital transformation, this episode offers thought-provoking insights on balancing technology with authentic human connection.
In this episode, you'll learn:
How consumer goods experience can bring customer-centric thinking to the pharmaceutical industryWhat "performance communications" means and why it matters in today's data-driven environmentThe challenges mid-sized organisations face in digital transformationHow to approach AI with both curiosity and healthy scepticismThe value of interim management in navigating transformation challengesChapters:
00:00 Introduction and background
01:48 Transitioning from FMCG to pharmaceuticals
04:53 Building digital transformation at Mundipharma
08:14 The T-shaped leadership approach
13:30 Transitioning to independent consulting
17:37 Current challenges in corporate communications
20:46 Navigating AI and digital transformation
27:31 Performance communications explained
30:20 Ideal client scenarios for interim support
34:27 Finding the right balance in business development
38:53 Closing thoughts on entrepreneurship
Connect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.
I also work selective Executive Search (perm) projects.
I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.He has placed over 120 HEOR and Market Access candidates during my time across US and Europe.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• CommunicationsSponsor Message
This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences
Podcast produced by www.podforge.co.uk
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Navigating the Freelance Path in Life Sciences | BioPharma Unscripted! Ep.3
Join Marcus Metcalfe in conversation with Hannah Kurth as they explore the rewarding yet challenging world of freelance consulting in the life sciences sector.
In this candid discussion, Hannah shares her journey into freelance consulting after over two decades of experience across pharmaceutical, biotech, and medical device companies. Having recently launched her own consultancy, she offers fresh insights into the decision-making process, the pros and cons of freelancing, and the scenarios where interim consultants add particular value.
Hannah explains her specialty in helping companies "navigate the road to revenues" through market access, pricing, reimbursement, and commercial strategy expertise. She highlights how her experience across the entire product lifecycle—from startup development through launch and lifecycle management—allows her to provide strategic guidance to companies at various stages of growth.
Chapters:
00:00 Introduction to freelance consulting
00:52 Hannah's journey to launching her consultancy
02:14 Pros and cons of the freelance career path
04:22 Working with biotechs and mid-sized pharma
06:15 Scenarios where freelancers add particular value
08:54 Serving as an alternative to traditional agencies
10:21 Hannah's core expertise and service offerings
Connect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs. I also work selective Executive Search (perm) projects. I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• Communications
This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences
Produced by www.pConnect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.
I also work selective Executive Search (perm) projects.
I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.He has placed over 120 HEOR and Market Access candidates during my time across US and Europe.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• CommunicationsSponsor Message
This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences
Podcast produced by www.podforge.co.uk
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The Power of Interim Talent: Strategic Healthcare Expertise | BioPharma Unscripted! Ep.2
Join Marcus Metcalfe as he speaks with Andrew Xia about using interim consultants in the life sciences sector.
In this insightful conversation, Andrew shares his perspective as an experienced interim consultant specialising in health economics, market access, and real-world evidence. He explains why clients and consultants find the interim model beneficial, addressing common misconceptions and highlighting the unique value proposition that interim specialists bring.
Andrew discusses how his broad skillset across pricing, market access strategy, health economic modelling, and real-world evidence allows him to support companies at various stages of development. He provides practical insights on when to use interim consultants versus full-time employees or large consulting firms.
In this episode, you'll learn:
The financial and strategic benefits of using interim consultantsHow interim specialists offer both specialised expertise and operational flexibilityWhy smaller biotechs and mid-sized pharma companies particularly benefit from the interim modelThe difference between interim consultants, full-time employees, and traditional consulting firmsHow interim consultants can become long-term strategic partners while maintaining independenceChapters:
00:00 Introduction to interim consulting
00:50 Andrew's path to interim consulting
01:41 Expertise in HEOR and market access 03:54 Types of clients and project scenarios
04:51 Benefits of interim consultants vs. permanent staff
07:31 Misconceptions about the interim model
09:30 The sweet spot for interim consulting
11:15 Closing thoughts on the interim career path
Connect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.
Marcus works on selective Executive Search (perm) projects, helping clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor, or for those simply needing an extra pair of hands. With an extensive HEOR and Market Access network, this is his sweet spot.
Connect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.
I also work selective Executive Search (perm) projects.
I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.He has placed over 120 HEOR and Market Access candidates during my time across US and Europe.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• CommunicationsSponsor Message
This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences
Podcast produced by www.podforge.co.uk
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European Market Access Strategy: Navigating the Joint Clinical Assessment | Elucid8 Podcast Ep.1
Join Marcus Metcalfe speaking with Martin Gisby about European market access and the upcoming Joint Clinical Assessment (JCA) launching January 2025.
Martin explains successful market access strategies in Europe, emphasising demonstrating comparative effectiveness versus standard of care. He offers practical guidance on the changing regulatory landscape for pharmaceutical companies planning European market entry.
In this episode:
Demonstrating comparative effectiveness for European market accessImpact of the European Joint Clinical Assessment in 2025Navigating multiple standards of care across European marketsRecommendations for approaching European market entryBalancing regulatory and market access strategiesChapters:
00:00 Introduction
01:20 Market access considerations
04:07 Introduction to JCA
05:10 Purpose and implementation
08:05 Focus on oncology medicines
09:40 Considerations for pharma companies
12:00 Strategic approaches
14:25 Multiple standards of care
16:40 Recommendations for early-stage companies
Connect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.
I also work selective Executive Search (perm) projects.
I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.He has placed over 120 HEOR and Market Access candidates during my time across US and Europe.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• CommunicationsSponsor Message
This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences
Podcast produced by www.podforge.co.uk
