generic pharma 2.0 consulting - challenge the status quo

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Challenge the status quo CONSULTING DIVISION

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International Market Entry, Portfolio Selection & Strategy, Technical Project Management

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Page 1: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

Challenge the status quo

CONSULTING DIVISION

Page 2: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

about usThought leaders and experienced professionals combine to help clients challenge the status quo in the pharmaceutical industry.

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Page 3: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

a little bit of backgroundWe started out in 2008 as a spin out of the renowned regulatory and technical services provider in the UK, ICE Pharma Group, founded in the mid 90s. Since 2008 we have launched several on-line platforms, which have opened a rich dialogue with an international community of C-level executives and decision makers around the globe.

Our first platform, Genericlicensing.com was the industry’s first searchable database of dossiers – with 8,000+ products, reaching hundreds of product developers and licensing teams. GP20 also launched NewPharmaThinkers, a digital magazine that today inspires key thought leaders in our industry.

These innovative communication and data platforms have helped create an unparalleled industry network; supporting an unique channel for new opportunities and ideas. Together with a solid industry background of over 15 years, GP20 is ideally positioned to bring you specialised consulting services.

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Page 4: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

management teamAsa Cox

Asa has been involved in the generic pharmaceutical industry for

15 years; his work experience covers both technical and commercial aspects of the

industry. Sourcing, finished dose contract manufacturing, regulatory

approvals and formulation development. He also has extensive experience in negotiating global licensing deals with all the major players.

Asa has worked on projects for Merck & Co, Sanofi, Teva, Apotex, Reckitt Benckiser, Sandoz & many more.

Miguel Coronado Miguel has over 8 years international

experience both in technical and commercial roles within the pharma industry. He has provided strategic consulting to pharmaceutical

companies in Europe, LATAM and MENA regions with specialized

expertise in Strategy, Market Entry and Portfolio Management in generics. 

Miguel holds a Master degree in Pharmacy and is a fellow member of RPSGB.

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Page 5: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

GP20 divisions

Business Development

AgencyManagement

Consulting Marketing Digital Platforms

• GENERICS & BIOSIMILARS

• OVER THE COUNTER

• MEDICAL DEVICES

• PORTFOLIO STRATEGY

• MARKET ENTRY

• PROJECT MANAGEMENT

• ON-LINE MARKETING

• WEB & PRINT DESIGN

• LEAD GENERATION

• GENERIC LICENSING

• NEW PHARMA THINKERS

• GENERIC PHARMA INDUSTRY

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Page 6: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

Whether you require optimisation your current portfolio or plan your next market entry move, GP20 can definitely assist.

our consulting division

Page 7: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

DEDICATIONWe help companies capitalize on opportunities across the value chain for generics, branded generics and biosimilars, forging connections among industry stakeholders.

EXPERTISEOur work has covered a wide range of topics, including portfolio optimization, market entry, operations, corporate strategy, regulatory affairs and due diligence.

PASSIONOur people bring new ideas, inspiration, and dedication to help you succeed in the pharmaceutical field. We are passionate about the possibilities ahead for those that challenge the status quo today and are pleased to work with all participants in the generics industry, API manufacturers, specialty pharmaceutical, and private-equity players.

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what can we do for you?

Page 8: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

our consulting divisionWe offer broad experience and deep expertise in three key areas:

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PORTFOLIO OPTIMIZATION & STRATEGYExperience in industry best practice to help you integrate and implement portfolio strategy across the organisation. Implementing best practice in portfolio strategy requires more than market data and profit & loss analysis. We believe that without an integrated vision across the organisation successful portfolio strategy is extremely challenging.

MARKET ENTRY PLANNING AND IMPLEMENTATIONWe apply our understanding of the pharmaceutical industry on international and regional markets to develop long-term perspectives that help clients achieve sustained competitive advantage in target regions.

PROJECT MANAGEMENTGP20’s project management expertise is applied to maximize of shareholder value, as well as to opportunities in M&A due diligence and licensing. We work with clients to transform their companies, improve effectiveness, increase productivity, and build new capabilities. Our experience in technical and commercial project management means you can focus on your core activities.

Page 9: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

portfolio optimization and strategy

We believe that planning and decision making must be aligned and integrated with all divisions involved in portfolio development. At GP20 we can help you create a living framework that enables stakeholders communicate efficiently at all stages of portfolio processing.

OUR PROPRIETARY FRAMEWORK HELPS YOUR ORGANIZATION ON:• Portfolio planning process globally

• Data capture

• Communication approach between stakeholders

• Portfolio optimisation tools

• Risk management

• Guidance and training material

ARE INNOVATION AND CONTINUOUS IMPROVEMENT INGRAINED AT THE CORE OF YOUR COMPANY?Whether you are planning the development of high quality generics, biosimilars or new molecular entities into new markets, achieving operational excellence is a key factor to succeed in the long run. Here are a few hints that will help you avoiding portfolio disaster across a single or multi-country market approach.

• The company strategy must drive the portfolio

• Horizontal integration in relation to the portfolio presents interesting upsides

• Consider the implementation of a dedicated cross-functional portfolio team

• Establish an integrated platform that monitors all divisions in your organisation closely.

Page 10: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

market entry planning and implementation

At GP20 we share our experience for mitigating the risks inherent in entering any new market, helping achieve desired outcomes in the most cost effective way possible.

OUR PROPRIETARY FRAMEWORK HELPS YOUR ORGANIZATION ON:• Analysis: identifying the entry option and validating

target market

• Planning: assembling a coherent market entry strategy and implementation plan

• Implementation: pilot project

• Operations: business set up, marketing launch, recruitment

• Communication approach between stakeholders

• Risk management

HAVE YOU PERFORMED A PROPER MARKET VALIDATION TO VERIFY YOUR PLAN WILL WORK?We would like to share with you a few points when considering market validation.

• Assess the resources and capabilities required for different scenarios

• Validate your market entry portfolio from a cross-functional point of view

• Validate your pricing strategy

• Evaluate the ability to completely address the need, making sure your portfolio and associated procedures will satisfy customers and stakeholders

Page 11: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

project managementThe right mix of planning, monitoring, and controlling can make the difference in completing a project on time, on budget, and with high quality results.

OUR PROPRIETARY FRAMEWORK HELPS YOUR ORGANIZATION ON:• Identify strategic options: GP20 brings clarity to the

project goals, aligned to a detailed understanding of your business needs

• Project definition and planning: we design a rigorous programme, including team roles and responsibilities, identifying risk and saving opportunities

• Project execution: we act quickly, operating from within the organisation and working harmoniously with your company culture

• Project closure: we aim to deliver to the satisfaction of all stakeholders, demonstrating real value in both quantitative and qualitative terms

Our project management experts offer a flexible and highly bespoke service based on a strong focus on delivery. Working alongside our clients, GP20 adopts a value-driven approach to defining project objectives.

Regardless the scale or complexity of a project, we refine our systems and processes to provide control, governance and transparency from inception to completion. At the point of every decision, we challenge the status quo and work diligently to find the smartest, most efficient and most cost effective solution.

GP20 provides a full spectrum of project management services along all functions of the value chain in pharmaceuticals, including manufacturing, supply chain, regulatory affairs, quality & compliance, and commercial operations. 

Page 12: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

We are delighted to share some examples of our work and what clients say about us.

examples of our work

Page 13: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

Assessing a hospital portfolio for Central EuropeCASE STUDY / PORTFOLIO STRATEGY

ChallengeA leading generics manufacturer wanted to leverage one of their injectable facilities to build a hospital portfolio targeting simultaneously several countries in Central Europe. The company was facing certain complexities to align their internal resources and capabilities with a commercially attractive portfolio on a multi-country level.

OutcomeThe final portfolio proposed by the GP20 team was agreed and accepted by the executive management and core

divisions. The client now has an optimal portfolio and associated guideline for introduction, which allows full visibility across market entry implementation processes.

SolutionGP20 assessed the portfolio opportunities in the hospital sector and the entry requirements for the targeted regions. GP20 conducted extensive research that answered essential questions regarding the portfolio options and what approach would truly succeed as a value proposition. Our consultants and Subject Matter Experts worked with the client to define several approaches and associated risks/benefits for the portfolio across the targeted regions and facilitated a set of recommendations.

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Helping a regional player obtaining EU GMP standardsCASE STUDY / PROJECT MANAGEMENT

ChallengeA pharmaceutical distribution company with operations in MENA engaged GP20 to handle all its technical and regulatory processes in Europe, including the production of a Quality Management System suitable for obtaining EU GMP certificate. At the time the client had no consistent QMS framework in place and ownership of SOPs and other process documents was unclear.

OutcomeThe client is now able to demonstrate a coherent quality and compliance infrastructure to its clients and other

stakeholders in MENA region. The integrated project management service supported the production of a coherent QMS framework and helped the organization focus on their core activities.

SolutionThe GP20 team provided a fully integrated project management and planning support handling all aspects of quality assurance and regulatory affairs. We helped designing a set of SOPs that supported the new Quality Management System of the organization and provided liaison with regulatory agencies in Europe for obtaining GMPc.

Page 15: Generic Pharma 2.0 Consulting -  Challenge the Status Quo

a selecton of our clientsWe are proud to have worked with fantastic companies in the last decade

Medical BrandsMaikel Hendriks, CEO

We have been working with the GP20 team for many successful years. The company has grown fourfold in this time, with Asa and his colleagues contributing significantly in all aspects of the business. We have secured major clients purely because of the good relationships GP20 has developed with them.

“ “ “Marz SpraysBrandon Marz, CEO

We have been very happy with Generic Pharma 2.0’s work. They’re professional, efficient and get done what they say they will get done. They’ve helped us set up our CRM and Business Development processes/templates. They’ve helped guide us through the process of International Sales making it a lot easier! They’ve also provided us access to decision makers while orchestrating a follow-up system for our leads.

Resolute OncologyDavid Guy, CEO

Generic Pharma 2.0 have been an extremely valuable partner with the building of our business, the team’s experience in the generic business and his wealth of connections have helped us at every step.

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Let’s TalkWe look very much forward to hearing from you soon.

Asa [email protected]

Miguel [email protected]

OfficesUK 96 Kensington High Street

London W8 4SG

CANADA 12 Dunlop Street Barrie, Ontario L4M 1A3

You can also find us at:www.genericpharma20.com