Dr. Neal Hansen
James Kettlewell

The Loss of Exclusivity Planning Course for Pharma

From Global Strategy to Local Execution

With Dr Neal Hansen & James Kettlewell

Course Details

THE CONTENT

With over $180bn in pharmaceutical company revenues expected to lose exclusivity before 2030, some of the largest brands in the industry will face significant late-lifecycle challenges in the coming years. Yet there is still limited understanding of what Loss of Exclusivity (LOE) really means among pharma professionals — and, more importantly, an underappreciation of the opportunities to continue delivering sustainable value for patients even in the face of generic or biosimilar competition.

This course provides a practical approach to understanding and preparing for LOE, rooted in real-life industry case studies & tangible examples of effective (and ineffective) LOE planning. You will learn how to anticipate the likely impact of LOE, understand the diversity in how post-LOE dynamics evolve across global markets, and be introduced to the processes, frameworks, and tools that enable the effective navigation of LOE events.

If you want to ensure that your brand is adequately prepared for the challenges and opportunities posed by LOE, this course is a must-attend!


THE EXPERTS

Dr Neal Hansen is a dynamic and engaging speaker. You will leave his course inspired and equipped with actionable insights!

  • Founder and CEO of Align Strategy, an international pharma consultancy with over 25 years of experience in advising the pharma industry on LLC management & navigating LOE events.

  • Co-author of Pharmaceutical Lifecycle Management – Making the Most of Each and Every Brand (Wiley & Sons, 2012), and a long-standing CELforPharma faculty member who has always been highly rated by participants for his vast experience and teaching style.

Joining Neal will be James Kettlewell:

  • A Principal Consultant at Align Strategy with over a decade of experience supporting global pharmaceutical and biotech companies in addressing their key strategic challenges.

  • James has extensive experience in supporting clients planning for LOE, through the development and implementation of planning frameworks and tools, and brings knowledge of the post-LOE dynamics of a diverse range of global markets.


THE AUDIENCE & INTERACTIVE LEARNING FORMAT

This course is designed for pharma professionals with responsibility for lifecycle-management planning at the global, regional or local levels, across a wide range of functions including commercial, marketing, medical, access, and clinical. It is particularly valuable for those working with brands expecting to face generic or biosimilar competition within the next 7-8 years — the earlier LOE planning begins, the more opportunities can be realised.

Through a mix of expert-led teaching and interactive exercises, you will learn the key principles that determine when Loss of Exclusivity (LOE) occurs and how it affects a brand. You will also be introduced to practical frameworks and tools that support strong LOE planning. The course format includes real-life case studies, structured group exercises and peer discussions. These activities are designed to help you build the practical skills needed to prepare for LOE and to execute effective plans.

If you are a consultant, please contact Annelies Swaan, who will check with the faculty whether you can attend. 

 

  1. What LOE means and the factors that determine both its timing and its impact.

  2. How and why markets can behave very differently after generics or biosimilars enter, both across countries and within a single market.

  3. The proven processes and frameworks that support effective, cross-functional LOE planning at the global, regional, and local levels, and that ensure buy-in at every stage.

  4. The toolkit of tactical options available for late-lifecycle planning, illustrated with real-world case studies, and how to judge which options are most relevant for your brand.

  5. The critical success factors for building strong LOE plans that support your brand through and beyond the entry of generics and biosimilars.

Course agenda

 

 

Welcome & Introductions (~15 min)
Loss of Exclusivity 101: The Fundamentals of Biosimilar & Generic Entry (~45 min)
  • Understand what LOE really means and the factors that determine both its timing and its impact
  • Identify the key asset and market characteristics that influence how strongly LOE will affect a brand, and understand how these factors can change over time
  • Recognise the key differences between generic and biosimilar entry when planning for LOE
  • Understand how the roles and influence of different stakeholders in prescribing and dispensing can shift when generics or biosimilars enter the market
Demystifying Local Post-LOE Dynamics (~1 h 15 min)
  • Understand how the factors influencing LOE impact can result in different market archetypes for LOE planning by exploring a range of key markets (US, 4EU + UK, Japan, and beyond)
  • Group Exercise: Predicting the Impact of LOE
    • In groups, attendees will apply their understanding of potential post-LOE dynamics by predicting the impact of LOE on a brand across a series of different asset and market scenarios
The Blueprint for LOE Success (~45 min)
  • Understand what needs to happen, and when, for effective LOE planning at the global or regional level
  • Introduction to proven processes and frameworks that guide LOE planning at each stage of the late-lifecycle timeline
Lunch Break
The Essential LOE Planning Toolkit (~1 h)
  • An introduction to Align Strategy’s PSVA framework and the universe of tactical options that can support effective LOE plans, brought to life with real-world case studies
LOE Planning in Action (~1 h 15 min)
  • How to build effective local LOE plans, including how and when to consider different tactical approaches across different market environments and different types of assets
  • Group Exercise: Building Impactful Local Plans
    • Across a series of breakout groups, attendees will be tasked with building an effective LOE plan for a range of different assets in different markets
    • Groups will be presented with a range of options to consider, including both global and locally led tactics, and must decide which “package” will provide the most robust & impactful LOE plan
LOE Planning Excellence: Validating & Stress-Testing Your Plan (~45 min)
  • How to ensure that LOE plans adapt and evolve with the market over time
  • How to appropriately consider indirect LOE events
  • Key considerations for forecasting the impact of biosimilars and generics
  • How to critically assess the relevance of analogues and benchmarks for generic / biosimilar impact
Wrap-Up and Key Takeaways (~15 min)

 

UPCOMING DATES & FORMATS - FEES

23 June 2026

Live online

Early bird € 1 570

(until 22/05/2026)

(Full fee € 1 770)

17 November 2026

Live online

Early bird € 1 570

(until 16/10/2026)

(Full fee € 1 770)

 


TIMING & LOCATION

Live Online: Zoom sessions between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris time).

All practical details will be shared upon registration. For any questions, please contact Margherita Mutto or call +32 472 03 11 38 .

 

GROUP DISCOUNTS

Team discounts can be offered to 2 or more delegates from the same company.

Email Annelies Swaan for more details. 

 

HOW TO REGISTER

  • Click the green “Register” button on your preferred course session.
    The registration wizard will guide you through the process.

  • Alternatively, download the offline registration form and send the completed form to Annelies Swaan.

 

PAYMENT OPTIONS

  • Credit Card: You’ll receive a secure payment link with your invoice (no immediate payment required).

  • Bank Transfer: Details provided with your invoice.

For help with registration, email Annelies Swaan or contact her by phone at +32 486 98 52 49.

 

INCLUDED IN THE REGISTRATION FEE

  • Access to a highly interactive, small-group online course (max 20 participants)

  • Course materials in both digital and hard copy format

  • Certificate of attendance signed by the experts and CELforPharma

 

VAT INFORMATION

Prices exclude VAT. VAT application depends on course format and your location:

  • Face-to-Face in Belgium: 21% Belgian VAT applies

  • Live online courses: The applicable VAT depends on your invoicing address. Contact your local VAT office for refund procedures where applicable.

 

TRANSFER & CANCELLATION POLICY

Flexible Transfer

If a registrant is unable to attend the scheduled course, they can avoid any cancellation charges by providing a suitable replacement participant.

Alternatively, the registrant may transfer once, on a 'space-available' basis and at no extra cost, to another course of the same value held within one year of the original course date, provided this is done at least three weeks prior to the event.

Registration Cancellation

  • Less than 14 days prior to the course date: The registrant is liable to pay the full invoiced registration fee.

  • Between 15 and 30 days prior to the course date: The registrant is liable to pay 50% of the invoiced registration fee.

  • More than 30 days prior to the course date: The registrant is liable to pay a cancellation fee of € 450 per registrant.

If a registrant postpones their participation to a future course and subsequently cancels again, no refund will be issued for the registration fees.
 

Do you want to upskill your team?

We can organise this training in-company (face-to-face or live online) and customise it to your specific focus and needs.

Fill in the below form and Inge Cornelis will contact you with further information.
 

Course Details

Dates & Locations

23 June 2026

Live online

Register

17 November 2026

Live online

Register

Upcoming Session

23 June 2026, Live online

Early bird € 1 570

(until 22/05/2026)

 (Full fee € 1 770)

Prices are excl. VAT

THE CONTENT

With over $180bn in pharmaceutical company revenues expected to lose exclusivity before 2030, some of the largest brands in the industry will face significant late-lifecycle challenges in the coming years. Yet there is still limited understanding of what Loss of Exclusivity (LOE) really means among pharma professionals — and, more importantly, an underappreciation of the opportunities to continue delivering sustainable value for patients even in the face of generic or biosimilar competition.

This course provides a practical approach to understanding and preparing for LOE, rooted in real-life industry case studies & tangible examples of effective (and ineffective) LOE planning. You will learn how to anticipate the likely impact of LOE, understand the diversity in how post-LOE dynamics evolve across global markets, and be introduced to the processes, frameworks, and tools that enable the effective navigation of LOE events.

If you want to ensure that your brand is adequately prepared for the challenges and opportunities posed by LOE, this course is a must-attend!


THE EXPERTS

Dr Neal Hansen is a dynamic and engaging speaker. You will leave his course inspired and equipped with actionable insights!

  • Founder and CEO of Align Strategy, an international pharma consultancy with over 25 years of experience in advising the pharma industry on LLC management & navigating LOE events.

  • Co-author of Pharmaceutical Lifecycle Management – Making the Most of Each and Every Brand (Wiley & Sons, 2012), and a long-standing CELforPharma faculty member who has always been highly rated by participants for his vast experience and teaching style.

Joining Neal will be James Kettlewell:

  • A Principal Consultant at Align Strategy with over a decade of experience supporting global pharmaceutical and biotech companies in addressing their key strategic challenges.

  • James has extensive experience in supporting clients planning for LOE, through the development and implementation of planning frameworks and tools, and brings knowledge of the post-LOE dynamics of a diverse range of global markets.


THE AUDIENCE & INTERACTIVE LEARNING FORMAT

This course is designed for pharma professionals with responsibility for lifecycle-management planning at the global, regional or local levels, across a wide range of functions including commercial, marketing, medical, access, and clinical. It is particularly valuable for those working with brands expecting to face generic or biosimilar competition within the next 7-8 years — the earlier LOE planning begins, the more opportunities can be realised.

Through a mix of expert-led teaching and interactive exercises, you will learn the key principles that determine when Loss of Exclusivity (LOE) occurs and how it affects a brand. You will also be introduced to practical frameworks and tools that support strong LOE planning. The course format includes real-life case studies, structured group exercises and peer discussions. These activities are designed to help you build the practical skills needed to prepare for LOE and to execute effective plans.

If you are a consultant, please contact Annelies Swaan, who will check with the faculty whether you can attend. 

 

  1. What LOE means and the factors that determine both its timing and its impact.

  2. How and why markets can behave very differently after generics or biosimilars enter, both across countries and within a single market.

  3. The proven processes and frameworks that support effective, cross-functional LOE planning at the global, regional, and local levels, and that ensure buy-in at every stage.

  4. The toolkit of tactical options available for late-lifecycle planning, illustrated with real-world case studies, and how to judge which options are most relevant for your brand.

  5. The critical success factors for building strong LOE plans that support your brand through and beyond the entry of generics and biosimilars.

Course agenda

 

 

Welcome & Introductions (~15 min)
Loss of Exclusivity 101: The Fundamentals of Biosimilar & Generic Entry (~45 min)
  • Understand what LOE really means and the factors that determine both its timing and its impact
  • Identify the key asset and market characteristics that influence how strongly LOE will affect a brand, and understand how these factors can change over time
  • Recognise the key differences between generic and biosimilar entry when planning for LOE
  • Understand how the roles and influence of different stakeholders in prescribing and dispensing can shift when generics or biosimilars enter the market
Demystifying Local Post-LOE Dynamics (~1 h 15 min)
  • Understand how the factors influencing LOE impact can result in different market archetypes for LOE planning by exploring a range of key markets (US, 4EU + UK, Japan, and beyond)
  • Group Exercise: Predicting the Impact of LOE
    • In groups, attendees will apply their understanding of potential post-LOE dynamics by predicting the impact of LOE on a brand across a series of different asset and market scenarios
The Blueprint for LOE Success (~45 min)
  • Understand what needs to happen, and when, for effective LOE planning at the global or regional level
  • Introduction to proven processes and frameworks that guide LOE planning at each stage of the late-lifecycle timeline
Lunch Break
The Essential LOE Planning Toolkit (~1 h)
  • An introduction to Align Strategy’s PSVA framework and the universe of tactical options that can support effective LOE plans, brought to life with real-world case studies
LOE Planning in Action (~1 h 15 min)
  • How to build effective local LOE plans, including how and when to consider different tactical approaches across different market environments and different types of assets
  • Group Exercise: Building Impactful Local Plans
    • Across a series of breakout groups, attendees will be tasked with building an effective LOE plan for a range of different assets in different markets
    • Groups will be presented with a range of options to consider, including both global and locally led tactics, and must decide which “package” will provide the most robust & impactful LOE plan
LOE Planning Excellence: Validating & Stress-Testing Your Plan (~45 min)
  • How to ensure that LOE plans adapt and evolve with the market over time
  • How to appropriately consider indirect LOE events
  • Key considerations for forecasting the impact of biosimilars and generics
  • How to critically assess the relevance of analogues and benchmarks for generic / biosimilar impact
Wrap-Up and Key Takeaways (~15 min)

 

UPCOMING DATES & FORMATS - FEES

23 June 2026

Live online

Early bird € 1 570

(until 22/05/2026)

(Full fee € 1 770)

17 November 2026

Live online

Early bird € 1 570

(until 16/10/2026)

(Full fee € 1 770)

 


TIMING & LOCATION

Live Online: Zoom sessions between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris time).

All practical details will be shared upon registration. For any questions, please contact Margherita Mutto or call +32 472 03 11 38 .

 

GROUP DISCOUNTS

Team discounts can be offered to 2 or more delegates from the same company.

Email Annelies Swaan for more details. 

 

HOW TO REGISTER

  • Click the green “Register” button on your preferred course session.
    The registration wizard will guide you through the process.

  • Alternatively, download the offline registration form and send the completed form to Annelies Swaan.

 

PAYMENT OPTIONS

  • Credit Card: You’ll receive a secure payment link with your invoice (no immediate payment required).

  • Bank Transfer: Details provided with your invoice.

For help with registration, email Annelies Swaan or contact her by phone at +32 486 98 52 49.

 

INCLUDED IN THE REGISTRATION FEE

  • Access to a highly interactive, small-group online course (max 20 participants)

  • Course materials in both digital and hard copy format

  • Certificate of attendance signed by the experts and CELforPharma

 

VAT INFORMATION

Prices exclude VAT. VAT application depends on course format and your location:

  • Face-to-Face in Belgium: 21% Belgian VAT applies

  • Live online courses: The applicable VAT depends on your invoicing address. Contact your local VAT office for refund procedures where applicable.

 

TRANSFER & CANCELLATION POLICY

Flexible Transfer

If a registrant is unable to attend the scheduled course, they can avoid any cancellation charges by providing a suitable replacement participant.

Alternatively, the registrant may transfer once, on a 'space-available' basis and at no extra cost, to another course of the same value held within one year of the original course date, provided this is done at least three weeks prior to the event.

Registration Cancellation

  • Less than 14 days prior to the course date: The registrant is liable to pay the full invoiced registration fee.

  • Between 15 and 30 days prior to the course date: The registrant is liable to pay 50% of the invoiced registration fee.

  • More than 30 days prior to the course date: The registrant is liable to pay a cancellation fee of € 450 per registrant.

If a registrant postpones their participation to a future course and subsequently cancels again, no refund will be issued for the registration fees.
 

Do you want to upskill your team?

We can organise this training in-company (face-to-face or live online) and customise it to your specific focus and needs.

Fill in the below form and Inge Cornelis will contact you with further information.
 

Dates & Locations

23 June 2026

Live online

Register

17 November 2026

Live online

Register