Market Access Success in Small Biotech | Ray Frost | Ep. 9

Ray Frost shares 20 years of market access expertise, revealing how small biotechs can successfully launch drugs in today's complex US healthcare landscape.
In this episode of BioPharma Unscripted with Marcus Metcalfe, market access veteran Ray Frost discusses building commercial infrastructure from scratch, the critical timing for market access involvement, and why the HEOR partnership is "absolutely critical" for launch success.

KEY TOPICS COVERED
When to hire market access (hint: 18-24 months before launch minimum)
Building vs buying: The unique challenges of small biotech launches
Why one PBM rejection can cost you 60-80 million lives
The evolving role of market access post-IRA
How to educate internal stakeholders on market access value
Real launch failures and lessons learned

CHAPTERS
00:00 Introduction and Ray's Career Journey
05:51 The Appeal of Small Pharma Companies
08:52 Importance of C-Suite Buy-in for Market Access
12:26 Launching Products: "Flying the Plane While Building It"
15:23 Defining "Early Enough" for Market Access
18:02 Internal Education and Stakeholder Management
20:52 The HEOR-Market Access Partnership
27:05 Lessons from Launch Failures
33:10 Impact of Payer Consolidation
36:45 Board-Level Market Access Understanding
39:40 The Future of Market Access Post-IRA

Connect with Marcus: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk

From Forests to Pharma: Rasmus Jensen on Cultural Intelligence and Career Transformation - Ep. 8

Join Marcus Metcalfe as he sits down with Rasmus Jensen for a captivating conversation about one of the most unconventional career journeys in pharma. Starting with ambitions to become a forest ranger, complete with chainsaw training. Rasmus shares how he transformed his forestry economics background into a successful pharmaceutical career spanning global corporations and dynamic startups.

In this episode, Rasmus reveals crucial lessons on cultural intelligence in international business, the art of clear communication in leadership, and the challenges of transitioning from Big Pharma to startup environments. He candidly discusses his experiences at companies like Novo Nordisk and Johnson & Johnson, before taking the leap into biotech with Camurus, where he started with just "a PC, an office package, and a blank piece of paper."

Listeners will gain valuable insights on navigating cultural differences in global organisations, the importance of gaining commercial experience for career growth, and how to leverage diverse functional expertise in leadership roles. Rasmus also shares a powerful story about learning from failure and using AI tools to enhance cross-cultural communication.
Perfect for pharmaceutical professionals considering career transitions, leaders working in multicultural environments, and anyone interested in building a unique career path in life sciences.

Key Topics Covered

Unconventional career paths in pharma
Cultural intelligence and communication
Transitioning from Big Pharma to startups
Leadership lessons and learning from failure
Building breadth across functional areas
The value of commercial experience
Danish vs international corporate cultures
Using AI for cross-cultural communication

Notable Quotes

"If you want to have a career in Pharma, go close to the business... it gives you a breadth of understanding and more gravity in your arguments."
"You start with a PC, an office package, and a blank piece of paper."
"Some of the failures that one has done in careers... are often the biggest opportunities for learning and development."

Chapters

00:23 - Rasmus's unexpected origin story as a forestry student
06:58 - Career advice on getting close to the business
10:50 - The reality of joining a startup
18:09 - Discussion on clarity in leadership
31:08 - Cultural blindness and learning from failure
42:00 - Advice for broad career development

Connect with Marcus: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk

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 transformation

Connect with Marcus: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk

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 approval
• Why companies frequently fail to start market access planning early enough
• How to build a compelling "value story" with evidence-based value propositions
• The specific consequences when market access planning is inadequate
• Special considerations for small biotech companies with limited resources
• The critical relationship between health economics and market access functions
• Why post-launch market access activities remain important throughout a product's lifecycle
• How the upcoming Joint Clinical Assessment (JCA) might impact European market access

Whether 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: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk

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 expertise

Connect with Marcus: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk

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 industry
• What "performance communications" means and why it matters in today's data-driven environment
• The challenges mid-sized organisations face in digital transformation
• How to approach AI with both curiosity and healthy scepticism
• The value of interim management in navigating transformation challenges

Chapters: 

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: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk

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.podforge.co.uk

Connect with Marcus: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk

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 consultants
• How interim specialists offer both specialised expertise and operational flexibility
• Why smaller biotechs and mid-sized pharma companies particularly benefit from the interim model
• The difference between interim consultants, full-time employees, and traditional consulting firms
• How interim consultants can become long-term strategic partners while maintaining independence

Chapters: 

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: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk

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 access
• Impact of the European Joint Clinical Assessment in 2025
• Navigating multiple standards of care across European markets
• Recommendations for approaching European market entry
• Balancing regulatory and market access strategies

Chapters: 

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: 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 on 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
• Communications

Podcast produced by www.podforge.co.uk