Generic Pharma 2.0 Consulting - Challenge the Status Quo

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

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

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  • 1. Challenge the status quo CONSULTING DIVISION
  • 2. about usThought leaders and experienced professionals combine to help clients challenge the status quo in the pharmaceutical industry. 1|
  • 3. 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. 2|
  • 4. management team Asa 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. 3|
  • 5. GP20 divisions Business Development Agency Management 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 4|
  • 6. Whether you require optimisation your current portfolio or plan your next market entry move, GP20 can definitely assist. our consulting division
  • 7. DEDICATION We help companies capitalize on opportunities across the value chain for generics, branded generics and biosimilars, forging connections among industry stakeholders. EXPERTISE Our work has covered a wide range of topics, including portfolio optimization, market entry, operations, corporate strategy, regulatory affairs and due diligence. PASSION Our 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. 6| what can we do for you?
  • 8. our consulting division We offer broad experience and deep expertise in three key areas: 7| PORTFOLIO OPTIMIZATION & STRATEGY Experience 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 IMPLEMENTATION We 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 MANAGEMENT GP20’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.
  • 9. 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.
  • 10. 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
  • 11. project management The 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. 
  • 12. We are delighted to share some examples of our work and what clients say about us. examples of our work
  • 13. Assessing a hospital portfolio for Central Europe CASE STUDY / PORTFOLIO STRATEGY Challenge A 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. Outcome The 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. Solution GP20 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.
  • 14. Helping a regional player obtaining EU GMP standards CASE STUDY / PROJECT MANAGEMENT Challenge A 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. Outcome The 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. Solution The 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.
  • 15. a selecton of our clients We are proud to have worked with fantastic companies in the last decade Medical Brands Maikel 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 Sprays Brandon 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 Oncology David 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.
  • 16. Let’s Talk We look very much forward to hearing from you soon. Asa Cox asa.cox@genericpharma20.com Miguel Coronado miguel.coronado@genericpharma20.com Offices UK 96 Kensington High Street London W8 4SG CANADA 12 Dunlop Street Barrie, Ontario L4M 1A3 You can also find us at: www.genericpharma20.com