1. © PBL Solutions Ltd
PBL Solutions Ltd
Pharma, Biotech & Big Data
Guiding Market Entry into Complex and
Diverse Regulatory Environments
PBL Solutions Ltd Capabilities

2. © PBL Solutions Ltd
PBL Solutions Ltd
Expert in:
Negotiating Business Development Agreements
Assessing opportunity and market access barriers
Identifying key stake holders and how best to influence them
Hands-on negotiation (Regulators, MOH, Procurement groups)
Execution within complex and dynamic markets

3. © PBL Solutions Ltd
PBL Solutions Ltd
Specific Recent Engagements
• Highly successful business development track record leading to in-licensing
of more than 18 products in 2014/15, across multiple territories in ASEAN
and ANZ
• Established numerous key opinion leader networks across the region in
different therapeutic areas
• Completed an Entry Point Project (EPP) with the Malaysian government
• Negotiation with regulatory agencies, Ministry of Health, and other
Government agencies concerning multiple filings
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4. © PBL Solutions Ltd
PBL Solutions Ltd
The Value PBL can Offer
• A senior level consultancy to cover multiple territories
• An analytical approach to business leveraging big pharma and biotech
experience at Vice President level
• Demonstrable Marketing and Branding thought leadership
• Identifying the right partners
• Government or semi-government organizations
• Companies operating in multiple territories
• Specialist local companies market-by-market
• Ability to leverage strategic knowledge of highly specialised areas
• Branded generic strategies
• Specialist Rx product entry
• Real World Data (Pharma Big Data)
• Cell Therapies
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5. © PBL Solutions Ltd
PBL Solutions Ltd
Specific skill sets
• Local market knowledge with hands-on negotiation experience
• The ability to use P&L data
• Identifying executable actions
• Backed up by insightful Board level communication (presentation and reports)
• Skilled negotiation of contracts and agreements to deliver high performance
• Regulatory
• Distribution
• Promotional
• Manufacturing
• Significant experience in settling legal entity and manufacturing issues
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6. © PBL Solutions Ltd
PBL Solutions Ltd
Principle Consultant: Giles D. Moss
• First Career Key Achievements
• Rose through the ranks at BMS, Sandoz and SmithKline Beecham to become
VP Operations Europe (Region 1) at UCB Pharma.
• Consistently delivering above budget EBIT in two regional roles covering 17
markets in Asia Pacific and Europe.
• Signed successful BD deals in Indonesia, Australia, and the Philippines.
• Second Career Key Achievements
• Identifying AP regulatory and commercial partners for a biosimilar and a
specialist Rx company.
• Evaluation of business models for Asia Pacific.
• Negotiation of distribution and promotional agreements in Australia, Sri
Lanka, Indonesia and the Philippines for a UK branded company
• Resolution of complex legal entity, manufacturing and promotional issues
for a newly acquired Rx business in Indonesia.
• Key player in an unsuccessful MBO funded by a Middle East Sovereign
Wealth Fund.
• Author of the book “Pharmaceuticals – Where’s the Brand
Logic” Published in America.
• http://www.amazon.com/Pharmaceuticals-wheres-Brand-Logic-Branding-Strategy/dp/0789032589/ref=sr_1_1?ie=UTF8&s=books&qid=1302149846&sr=8-
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7. © PBL Solutions Ltd
PBL Solutions Ltd
Further Project Information
July 2, 2016 7

8. © PBL Solutions Ltd
PBL Solutions Ltd
Examples of Recent or On-going Projects
• Engagements examples:
• Evaluation of business models for regional entry
• Biosimilar partnering assessment
• Partner identification (regulatory and commercial) for a specialist Rx company
• Negotiation of distribution and promotional agreements in Australia, Sri Lanka,
Indonesia and the Philippines for a branded Rx company
• Resolution of complex legal entity, manufacturing and promotional issues for
an acquired business in Indonesia
• Assessment of data technology advances in Europe and future application
• Delivery of branded generic launch plans for three markets (Thailand, Malaysia
and Hong Kong)
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9. © PBL Solutions Ltd
PBL Solutions Ltd
Service Example
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• Finding ideal partners:
• Preparation of confidential data package to start negotiations
• Partner search & initial contacts/visits
• Establishing each potential partners pro’s and con’s
• Preparation and attendance at client meeting with potential partners
• Upon request
• Set-up potential deal structure
• Lead negotiation process
• Complete term sheet
• Follow through to executed legal agreement
• PBL services are available as a complete package or can be individually selected depending on specific needs

10. © PBL Solutions Ltd
PBL Solutions Ltd
Service Example
• Strategic market entry strategy
• Matching a client portfolio to market opportunity
• Molecule and presentation review
• Market potential estimation
• Segmentation by customer grouping
• Initial field interviews to check customer reaction to proposed portfolio
• Regulatory assessment and planning
• Setting the level of ambition and final country selection
• Portfolio sales forecasts and creation of P&Ls
• Agreement of investment levels and timelines
• Creation of launch plans
• Identifying executable actions
• Guiding implementation where appropriate
• PBL services are available as a complete package or can be individually selected depending on specific needs
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11. © PBL Solutions Ltd
PBL Solutions Ltd
Contact details
• General Enquiries
• Giles D. Moss
• giles.moss@pharmabrandlogic.com
• Telephone +60193725670
• Skype: giles.moss1
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