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INTERNATIONAL LAUNCH EXCELLENCE WITH LOCAL CONTROL
BUILDING YOUR LIFE SCIENCES BUSINESS IN EUROPE, NORTH AMERICA AND INTERNATIONALLY
CONFIDENTIAL AND PROPRIETARY. COPYRIGHT (C) BY BRIDGEHEAD. ALL RIGHTS RESERVED
The Problem
Many highly successful, innovative US companies who are considering their expansion into the lucrative (22% of global
pharma sales) European markets, are challenged with the difficult strategic decision; “do we retain and maximise our asset
value, with the risk that direct commercialisation into unfamiliar territories has brought to others (especially with the
uncertainty of Brexit), or out-license and dilute value with an established industry partner?”
As an indication of how difficult this decision has been to make is evidenced by the fact that of the 640 biotech assets with
FDA approval, only 110 are currently EMA approved. Potentially, 530 would benefit from European regulatory planning and
support and 110 from launch and commercialisation support. There is a great unmet need in Europe, particularly for orphan
drugs.
Typical comments from this group:
• “We are a small, clinical-stage company, and we have exciting phase II data, but the truth is we don’t have the market
insights, or the time, to plan an effective strategy outside of the US”
• “We have launched very successfully in the US, but already our investors are asking about international markets”
• “Our investors are nervous about diluting our US effort, and international markets are seen as a possible distraction from
that focus”
• “We do not want to out-license our asset to an international partner and lose control of strategy and value”
• “Europe is just so complex, with all of the various payers, access and pricing challenges”
The Solution
Bridgehead provides a coordinated, professionally managed strategy to retain value, whilst minimising risk. Bridgehead is the only Boston,
London and Zug based group providing an integrated healthcare solution for launch into European and US markets. Bridgehead coordinates
proven, experienced, Professional service providers, who have US and European experience in all of the essential launch and support
components:
• Product launch strategy and operational implementation (Alacrita) www.alacrita.com
• Regulatory, Compliance and Pharmacovigilance (Regulis) www.regulis.com
• Market Access, Pricing and Reimbursement Strategy (PRMA) www.prmaconsulting.com
• Strategic Communications (Consilium) www.consilium-comms.com
• Advisory, commercial, healthcare communications and patient services (Ashfield) www.ashfieldhealthcare.com
• Executive & Leadership Advisory, senior hiring and Interim Solutions (Bailey Montagu) www.baileymontagu.com
• U.S. international corporate law firm (Sidley) www.sidley.com
Alacrita - Product launch strategy & operational Implementation
Alacrita is life science consulting for a networked age. You can expect
the calibre and capabilities of a top-ranked life science consulting
firm, but you’ll find a difference in our expertise.
We’ve built our team carefully, handpicking only those life science
consultants with deep domain knowledge and senior business
experience.
With more than 200 successful client assignments each year, we’re
proving what’s possible for pharma and biotech consulting in a new
era of opportunity.
Founder & Managing Partner, David Sykes
Founder & Managing Partner, Rob Johnson
Managing Partner, Anna Casse
Regulis – Regulatory, Compliance & Pharmacovigilance
Our team of high calibre scientists has a strong reputation for obtaining
fast, high quality product approvals, Pharmacovigilance risk management
and GMP/GDP compliance. Regulis was founded in 2001 and is now a
leading consultancy company with vast experience of working with
pharmaceutical, medical device and borderline substance companies,
helping them grow.
Founder & CEO, Kim Wharton
PRMA Consulting – Market Access, Pricing & Reimbursement Strategy
We have worked on some of the most challenging projects in market
access over the past 10 years, and have developed an extensive portfolio
of services:
• Strategic market access
• Landscape assessments
• Payer and KOL engagement
• Value propositions
• GVDs
• Evidence generation
• Real-world evidence
• Pricing strategy
Founder & CEO, David Sykes
Consilium - Strategic Communications
We are a global leader in strategic healthcare communications and
investor relations. Experts across all sub-sectors of healthcare, our
specialist team enhances profile, reputation and perception with key
audiences for a wide range of international healthcare companies.
Founder & CEO, Mary-Jane Elliott
Ashfield – Advisory, Commercial, & Patient Services
We’re the No.1 contract sales organisation in 12 European countries,
working flexibly so our clients can deploy powerful sales teams, fast.
With over 4,000 pharmaceutical sales representatives, hospital
specialists, key account managers and medical science liaisons
worldwide, we’ve got a reputation for genuine partnerships and
talented people. But that's not all. We continually innovate, invest and
use intelligent analytics to maximise our customers’ returns, every
time.
Julian Tompkins, President Commercial & Clinical
Greg Flynn, Regional President Commercial & Clinical US
Sidley – U.S. International Corporate Law Firm
Sidley has a powerful, fully integrated Global Life Sciences
practice. European Union regulatory and policy decisions affect
the way Sidley’s Life Sciences clients conduct business throughout
the world. The scope of the EU’s influence - based on a single set
of rules and procedures for 28 European countries - continues to
grow, both within Europe and globally. Partner, Mark Thompson
Bailey Montagu – Senior Executive Hiring & Interim Solutions
Bailey Montagu understands how the convergence of the markets is
shaping the opportunities and challenges facing today’s Life sciences
businesses. We will provide you with the leadership and talent to
navigate the ever more complex market. Our consultants have expertise
to assist in the follow arenas:
• Pharmaceutical
• Biotech
• Digital
• Healthcare
• Biologics
• Medical Devices
• Professional Services
Founder & Managing Partner, Rachel McKenzie
Partner, Head of Life Sciences, Laurence Callow
Launch at BIO 2018
The UK Pavilion at BIO International Convention 2018 in Boston
From the 4th – 7th June 2018, The Department for International Trade will be facilitating
key business support for UK companies at BIO, the largest biotechnology event in the
world. BIO is attended by top decision-makers and buyers from more than 76 countries,
attracting 16,000 biotechnology and pharma leaders.
Bridgehead will be meeting with delegates at the offices on the Pavilion, and at several
receptions and events during the week of the Convention, including a large reception on
Tuesday 5th June on the UK Pavilion. Further support is provided by MedCity and London &
Partners.
International Locations
UK USA EUROPE
Bridgehead London
Second Floor
Berkeley Square House
London, W1J 6BD
UK
+44 203 301 6890
Bridgehead USA
245 First Street
Suite 1800
Cambridge, MA 02142
USA
+1 617 444 8411
Bridgehead Europe
Artherstrasse 7,
6300 Zug,
Switzerland
+41 79 220 4006
The Executive and Advisory Team
Laurence Callow, CEO
International manager, expert in partnering and leadership architecture, extensive senior network
across international markets. Has held senior leadership positions internationally with Bridgehead,
Bailey Montagu, Mead Johnson, Pfizer, Warner Lambert. International business developer.
https://www.linkedin.com/in/laurencecallow/
Anna Casse
Global Biotech executive and entrepreneur with broad experience of defining and building successful
businesses. Advisor and investor in biotech start-ups, pioneer and general manager of European
launch projects and experienced business development leader and negotiator. Has held senior roles in
global marketing and business development with Aegerion, Ariad, Sandoz, Novartis.
https://www.linkedin.com/in/anna-casse-sumeray-0239461/
Kurt Hawtin
Board level executive with 20 years biopharmaceuticals and professional services career holding
senior leadership and general management roles in both the USA and European markets. Most recent
experience focused on guiding small biotech and biopharma companies on launch strategy and
readiness in Europe. Head of Europe for Syneos.
https://www.linkedin.com/in/kurthawtin/
The Executive and Advisory Team
Richard McIntyre (Cello, PA Consulting, BMS, PwC, GSK)
Richard has over 25 years experience in the Life Sciences sector, and has held senior roles consulting to
and working for many Global Pharmaceutical companies. Richard has extensive experience in
transforming commercial operations in Pharmaceutical companies. Previously, Richard held senior
positions in major pharmaceuticals companies including GSK and Bristol-Myers Squibb.
https://www.linkedin.com/in/richard-mcintyre-119a83/
Ben Cons (Vitruvian, IQVIA, GSK)
A passionate entrepreneur who designs, builds and operates business solutions across the international
pharmaceutical community to accelerate product development, maximise product lifecycle value and
create optimum healthcare solutions. Ben has over 25 years experience in drug development and
commercialisation for Bayer, Schering, GSK and Quintiles. He has managed more than one billion dollars
of deals.
https://www.linkedin.com/in/ben-cons-83381b17/
Jez Moulding (UDG/Ashfield, Sanofi, Lorex, Astra)
Jez is a Senior Global Executive recognized for his ability to create a compelling long term vision, swiftly
securing trust and rapport, building cultural sensitive teams. He has a high capability to navigate
complexity and define the core issue to achieve business objectives. Jez is seen as a key Industry player
and has been invited to sit on influential boards in Asia Pac.
https://www.linkedin.com/in/jezmoulding/
The Executive and Advisory Team
Nazira Amra (Independent Consultant)
Nazira is a physician with an MBA from INSEAD and experienced pharmaceutical commercial leader who has
spent the last 18 years working at the intersection of both strategy and operations in both big and small pharma,
delivering results in product launch as well as later stages of the product life cycle across developed and
emerging markets. Most recently, Nazira served as Vice President of Global Commercial Strategy at Intercept
Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of novel
therapeutics to treat chronic liver disease and she has held numerous senior leadership positions spanning over
14 years at Sanofi.
https://www.linkedin.com/in/nazira-amra-2a80235/
Luis Iglesias (President and Head of Europe, Middle East and Africa at Santen)
Luis has extensive industry experience across EMEA with Allergan, BD, Covidien, Abbott. He is a specialist in
international commercial Pharmaceutical, Medical Devices and Diagnostics.
https://www.linkedin.com/in/luis-iglesias-320b9415/
Chris Wardhaugh (Chief Operating Officer at Clyde Biosciences)
Chris has 27 years of international industry experience gained from many years with Quintiles (Global
Commercial Partnering) and ProStrakan (Global Strategic Planning and Business Development). Based in the UK,
he has also lived and worked several years in the United States. He is a specialist in launching biotech, small
pharma, medical device and service companies in Europe and the United States; making deals, designing their
organisational structure and advising on their launch strategy.
https://www.linkedin.com/in/chriswardhaugh/

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Bridgehead credentials slide deck

  • 1. INTERNATIONAL LAUNCH EXCELLENCE WITH LOCAL CONTROL BUILDING YOUR LIFE SCIENCES BUSINESS IN EUROPE, NORTH AMERICA AND INTERNATIONALLY CONFIDENTIAL AND PROPRIETARY. COPYRIGHT (C) BY BRIDGEHEAD. ALL RIGHTS RESERVED
  • 2. The Problem Many highly successful, innovative US companies who are considering their expansion into the lucrative (22% of global pharma sales) European markets, are challenged with the difficult strategic decision; “do we retain and maximise our asset value, with the risk that direct commercialisation into unfamiliar territories has brought to others (especially with the uncertainty of Brexit), or out-license and dilute value with an established industry partner?” As an indication of how difficult this decision has been to make is evidenced by the fact that of the 640 biotech assets with FDA approval, only 110 are currently EMA approved. Potentially, 530 would benefit from European regulatory planning and support and 110 from launch and commercialisation support. There is a great unmet need in Europe, particularly for orphan drugs. Typical comments from this group: • “We are a small, clinical-stage company, and we have exciting phase II data, but the truth is we don’t have the market insights, or the time, to plan an effective strategy outside of the US” • “We have launched very successfully in the US, but already our investors are asking about international markets” • “Our investors are nervous about diluting our US effort, and international markets are seen as a possible distraction from that focus” • “We do not want to out-license our asset to an international partner and lose control of strategy and value” • “Europe is just so complex, with all of the various payers, access and pricing challenges”
  • 3. The Solution Bridgehead provides a coordinated, professionally managed strategy to retain value, whilst minimising risk. Bridgehead is the only Boston, London and Zug based group providing an integrated healthcare solution for launch into European and US markets. Bridgehead coordinates proven, experienced, Professional service providers, who have US and European experience in all of the essential launch and support components: • Product launch strategy and operational implementation (Alacrita) www.alacrita.com • Regulatory, Compliance and Pharmacovigilance (Regulis) www.regulis.com • Market Access, Pricing and Reimbursement Strategy (PRMA) www.prmaconsulting.com • Strategic Communications (Consilium) www.consilium-comms.com • Advisory, commercial, healthcare communications and patient services (Ashfield) www.ashfieldhealthcare.com • Executive & Leadership Advisory, senior hiring and Interim Solutions (Bailey Montagu) www.baileymontagu.com • U.S. international corporate law firm (Sidley) www.sidley.com
  • 4. Alacrita - Product launch strategy & operational Implementation Alacrita is life science consulting for a networked age. You can expect the calibre and capabilities of a top-ranked life science consulting firm, but you’ll find a difference in our expertise. We’ve built our team carefully, handpicking only those life science consultants with deep domain knowledge and senior business experience. With more than 200 successful client assignments each year, we’re proving what’s possible for pharma and biotech consulting in a new era of opportunity. Founder & Managing Partner, David Sykes Founder & Managing Partner, Rob Johnson Managing Partner, Anna Casse
  • 5. Regulis – Regulatory, Compliance & Pharmacovigilance Our team of high calibre scientists has a strong reputation for obtaining fast, high quality product approvals, Pharmacovigilance risk management and GMP/GDP compliance. Regulis was founded in 2001 and is now a leading consultancy company with vast experience of working with pharmaceutical, medical device and borderline substance companies, helping them grow. Founder & CEO, Kim Wharton
  • 6. PRMA Consulting – Market Access, Pricing & Reimbursement Strategy We have worked on some of the most challenging projects in market access over the past 10 years, and have developed an extensive portfolio of services: • Strategic market access • Landscape assessments • Payer and KOL engagement • Value propositions • GVDs • Evidence generation • Real-world evidence • Pricing strategy Founder & CEO, David Sykes
  • 7. Consilium - Strategic Communications We are a global leader in strategic healthcare communications and investor relations. Experts across all sub-sectors of healthcare, our specialist team enhances profile, reputation and perception with key audiences for a wide range of international healthcare companies. Founder & CEO, Mary-Jane Elliott
  • 8. Ashfield – Advisory, Commercial, & Patient Services We’re the No.1 contract sales organisation in 12 European countries, working flexibly so our clients can deploy powerful sales teams, fast. With over 4,000 pharmaceutical sales representatives, hospital specialists, key account managers and medical science liaisons worldwide, we’ve got a reputation for genuine partnerships and talented people. But that's not all. We continually innovate, invest and use intelligent analytics to maximise our customers’ returns, every time. Julian Tompkins, President Commercial & Clinical Greg Flynn, Regional President Commercial & Clinical US
  • 9. Sidley – U.S. International Corporate Law Firm Sidley has a powerful, fully integrated Global Life Sciences practice. European Union regulatory and policy decisions affect the way Sidley’s Life Sciences clients conduct business throughout the world. The scope of the EU’s influence - based on a single set of rules and procedures for 28 European countries - continues to grow, both within Europe and globally. Partner, Mark Thompson
  • 10. Bailey Montagu – Senior Executive Hiring & Interim Solutions Bailey Montagu understands how the convergence of the markets is shaping the opportunities and challenges facing today’s Life sciences businesses. We will provide you with the leadership and talent to navigate the ever more complex market. Our consultants have expertise to assist in the follow arenas: • Pharmaceutical • Biotech • Digital • Healthcare • Biologics • Medical Devices • Professional Services Founder & Managing Partner, Rachel McKenzie Partner, Head of Life Sciences, Laurence Callow
  • 11. Launch at BIO 2018 The UK Pavilion at BIO International Convention 2018 in Boston From the 4th – 7th June 2018, The Department for International Trade will be facilitating key business support for UK companies at BIO, the largest biotechnology event in the world. BIO is attended by top decision-makers and buyers from more than 76 countries, attracting 16,000 biotechnology and pharma leaders. Bridgehead will be meeting with delegates at the offices on the Pavilion, and at several receptions and events during the week of the Convention, including a large reception on Tuesday 5th June on the UK Pavilion. Further support is provided by MedCity and London & Partners.
  • 12. International Locations UK USA EUROPE Bridgehead London Second Floor Berkeley Square House London, W1J 6BD UK +44 203 301 6890 Bridgehead USA 245 First Street Suite 1800 Cambridge, MA 02142 USA +1 617 444 8411 Bridgehead Europe Artherstrasse 7, 6300 Zug, Switzerland +41 79 220 4006
  • 13. The Executive and Advisory Team Laurence Callow, CEO International manager, expert in partnering and leadership architecture, extensive senior network across international markets. Has held senior leadership positions internationally with Bridgehead, Bailey Montagu, Mead Johnson, Pfizer, Warner Lambert. International business developer. https://www.linkedin.com/in/laurencecallow/ Anna Casse Global Biotech executive and entrepreneur with broad experience of defining and building successful businesses. Advisor and investor in biotech start-ups, pioneer and general manager of European launch projects and experienced business development leader and negotiator. Has held senior roles in global marketing and business development with Aegerion, Ariad, Sandoz, Novartis. https://www.linkedin.com/in/anna-casse-sumeray-0239461/ Kurt Hawtin Board level executive with 20 years biopharmaceuticals and professional services career holding senior leadership and general management roles in both the USA and European markets. Most recent experience focused on guiding small biotech and biopharma companies on launch strategy and readiness in Europe. Head of Europe for Syneos. https://www.linkedin.com/in/kurthawtin/
  • 14. The Executive and Advisory Team Richard McIntyre (Cello, PA Consulting, BMS, PwC, GSK) Richard has over 25 years experience in the Life Sciences sector, and has held senior roles consulting to and working for many Global Pharmaceutical companies. Richard has extensive experience in transforming commercial operations in Pharmaceutical companies. Previously, Richard held senior positions in major pharmaceuticals companies including GSK and Bristol-Myers Squibb. https://www.linkedin.com/in/richard-mcintyre-119a83/ Ben Cons (Vitruvian, IQVIA, GSK) A passionate entrepreneur who designs, builds and operates business solutions across the international pharmaceutical community to accelerate product development, maximise product lifecycle value and create optimum healthcare solutions. Ben has over 25 years experience in drug development and commercialisation for Bayer, Schering, GSK and Quintiles. He has managed more than one billion dollars of deals. https://www.linkedin.com/in/ben-cons-83381b17/ Jez Moulding (UDG/Ashfield, Sanofi, Lorex, Astra) Jez is a Senior Global Executive recognized for his ability to create a compelling long term vision, swiftly securing trust and rapport, building cultural sensitive teams. He has a high capability to navigate complexity and define the core issue to achieve business objectives. Jez is seen as a key Industry player and has been invited to sit on influential boards in Asia Pac. https://www.linkedin.com/in/jezmoulding/
  • 15. The Executive and Advisory Team Nazira Amra (Independent Consultant) Nazira is a physician with an MBA from INSEAD and experienced pharmaceutical commercial leader who has spent the last 18 years working at the intersection of both strategy and operations in both big and small pharma, delivering results in product launch as well as later stages of the product life cycle across developed and emerging markets. Most recently, Nazira served as Vice President of Global Commercial Strategy at Intercept Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver disease and she has held numerous senior leadership positions spanning over 14 years at Sanofi. https://www.linkedin.com/in/nazira-amra-2a80235/ Luis Iglesias (President and Head of Europe, Middle East and Africa at Santen) Luis has extensive industry experience across EMEA with Allergan, BD, Covidien, Abbott. He is a specialist in international commercial Pharmaceutical, Medical Devices and Diagnostics. https://www.linkedin.com/in/luis-iglesias-320b9415/ Chris Wardhaugh (Chief Operating Officer at Clyde Biosciences) Chris has 27 years of international industry experience gained from many years with Quintiles (Global Commercial Partnering) and ProStrakan (Global Strategic Planning and Business Development). Based in the UK, he has also lived and worked several years in the United States. He is a specialist in launching biotech, small pharma, medical device and service companies in Europe and the United States; making deals, designing their organisational structure and advising on their launch strategy. https://www.linkedin.com/in/chriswardhaugh/