PBI Consultancy Services

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  • PBI Consultancy Services

    1. 1. Pharma & Biotech Innovation Deliver Success through Innovation Michael McNamara MSc MRACI C Chem Pharma & Biotech Innovation ph 03 94997193 mobile 0407713768 [email_address]
    2. 2. Pharma & Biotech Innovation Consultancy Services Strategic & Hands-on Support for Profitable Innovation <ul><li>Clients range from a large multinational pharma and biotech company to a small start-up company developing novel OTCs </li></ul><ul><li>Service offering includes strategic advice and planning, protocol and plan development, project management and performing plant and laboratory studies </li></ul><ul><li>Service offering focuses in the following areas: </li></ul><ul><li>Preparation of Commercialisation and Product Development Strategies for Efficient Innovation </li></ul><ul><li>Design and Review of Organisational Structures, Processes and Resources to effectively Deliver Products to Market </li></ul><ul><li>Design, Implementation and Execution of Outsourcing/Insourcing Strategies including Technology Transfer plans </li></ul><ul><li>Preparation of Business Cases/Business Plans for Funding </li></ul><ul><li>Accessing Funds through Grants to support your Innovation Strategy </li></ul><ul><li>Strategies for Navigating the Clinical and Regulatory Approval Pathway including CTN, CTX, IND, ANDA and NDAs </li></ul>
    3. 3. Michael McNamara Biography <ul><li>Specialist in management of innovation in pharmaceuticals and biotechnology at all phases of product lifecycle </li></ul><ul><ul><li>from research and product concept through to product launch and lifecycle management </li></ul></ul><ul><li>20 years in pharmaceutical and biotechnology industry </li></ul><ul><li>Qualified Biochemist/Chemist with postgraduate qualifications in management and drug regulation </li></ul><ul><li>Senior management roles in R&D, Business Development and Commercial Management at CSL, Faulding Mayne Pharma and Hospira </li></ul><ul><li>Management of key commercial development and contract manufacturing relationships worth $30 million AUD including pricing and forecasts to deliver financial targets </li></ul><ul><li>Development of new business relationships based on existing, internally-patented technology for development and contract manufacture of products with global sales in excess of $1 billion pa. </li></ul><ul><li>Successful preparation of business cases for commercial funding of innovation worth $30 million pa and grant applications worth up to $10 million </li></ul><ul><li>Managed portfolios of up to 30 development projects from early stage/product concept to launch/lifecycle management </li></ul><ul><li>Launched products worth $200 million pa in over 70 countries </li></ul><ul><li>Development of Clinical and Regulatory Strategies involving CTN, CTX, IND ANDA and NDA applications for both small molecule pharmaceuticals and biotechnology products </li></ul>
    4. 4. Commercialisation and Product Development Strategies for Efficient Innovation <ul><li>The Challenge </li></ul><ul><li>How do you translate your research and/or technology into product(s)? </li></ul><ul><li>What is your product’s competitive advantage? </li></ul><ul><li>How will your customers value your product? </li></ul><ul><li>How do you plan the Product Development to add value at each step and deliver products that customers will value? </li></ul><ul><li>These challenges are common causes for innovation failure* </li></ul><ul><li>PBI Supports Efficient Innovation by </li></ul><ul><li>Preparing an integrated strategy to answering these questions and forming a sound commercialisation strategy </li></ul><ul><li>Establishing an early development strategy - leads to a more focused and efficient development effort* </li></ul><ul><li>Preparing a Target Product Profile (TPP) focuses the development team on what is important to the customer.* </li></ul><ul><li>Building a TPP and strategy to evolve during preclinical and clinical development </li></ul>Example of PBI Experience Definition of customer challenges with dosing of an oncology drug lead to strategy to develop a simpler single vial presentation with a cost effective clinical and regulatory development path. * Key indicators of success for innovation see: http://www.stage-gate.net/downloads/working_papers/wp_22.pdf for American Productivity & Quality Centre report
    5. 5. Design and Review of Organisational Structures, Processes and Resources to effectively deliver products to market <ul><li>The Challenge </li></ul><ul><li>How do you set up innovation companies, product development groups and/or projects for fastest path to profitability?* </li></ul><ul><li>How do you balance your portfolio to maximise the profitability of your innovation effort.? </li></ul><ul><li>PBI provides leadership in innovation by </li></ul><ul><li>Establishing new or reviewing existing organisational structures, development and portfolio review processes to support best practice innovation </li></ul><ul><li>Outcomes would include </li></ul><ul><ul><li>Preparing and implementing HR, resource and capital plans to support product development </li></ul></ul><ul><ul><li>Establishing systems to review the portfolio and/or conducting reviews against milestones and KPIs including financial performance and profitability forecasts. </li></ul></ul><ul><li>Examples of PBI Experience </li></ul><ul><li>Implemented effective matrix management structure for 2 development groups </li></ul><ul><li>Lead portfolio review and integration of project and development management process in major merger </li></ul><ul><li>Excellent track record having delivered over 70 products worth over $200m launched in 70 countries </li></ul><ul><li>* A major challenge for innovation companies http://www.stage-gate.net/downloads/working_papers/wp_22.pdf for American Productivity & Quality Centre report </li></ul>
    6. 6. Design and Implementation of Outsourcing Strategies &Technology Transfer <ul><li>The Challenge </li></ul><ul><li>How do you maximise profitability by outsourcing non-core products/functions while maintaining control over critical products/functions? </li></ul><ul><li>How do you maintain the quality of outsourced development studies and outsourced commercial product? </li></ul><ul><li>How do you effectively transfer manufacture of product to an outsourcing partner? </li></ul><ul><li>PBI provides leadership in innovation by </li></ul><ul><li>Establishing new or reviewing existing outsourcing strategies, organisational structures and processes to support outsourcing </li></ul><ul><li>Establishing new or reviewing existing technology transfer and quality agreements that effectively support delivery of the outsourcing strategy </li></ul><ul><li>Establishing new or reviewing existing detailed outsourcing and technical transfer plans </li></ul><ul><li>Establishing systems to review performance against milestones and other KPIs including financial indicators </li></ul><ul><li>Examples of PBI Experience </li></ul><ul><li>Lead major outsourcing initiative for large publicly listed company involving transfer of product development activities worth $7m pa to 3 rd parties with substantial savings </li></ul><ul><li>Successful launch of products worth more than $1million pa to date from outsourcing activities </li></ul>
    7. 7. Preparation of Business Cases/Business Plans for Funding <ul><li>The Challenge </li></ul><ul><li>How do you present a compelling case for funding commercial product development? </li></ul><ul><li>How do you integrate a group of business cases for product development into a business plan for a company? </li></ul><ul><li>PBI supports effectively gaining commercial funding </li></ul><ul><li>Designing business cases that “press the right buttons” with investors </li></ul><ul><li>Integrating groups of business cases into a balanced business plan for a company that fits within available funding and demonstrates the viability of a sustainable business </li></ul><ul><li>Examples of PBI Experience </li></ul><ul><li>Business plans prepared for groups of products for business unit in large publicly listed company with profitability of products in excess of $50 million pa </li></ul><ul><li>Integrated business plans into a business plan for business unit in large publicly listed company to grow the business 5 fold in 5 years (to $100million pa) with minimal internal funds invested (less than $200K) </li></ul><ul><li>Successfully executed plan and gained external funding growing the value of the business from $20 million to $30 million in 2 years and securing external contract development funding of $6million </li></ul>
    8. 8. Accessing Funds through Grants to support your Innovation Strategy <ul><li>The Challenge </li></ul><ul><li>Can you use grants to partly fund your development strategy? </li></ul><ul><li>Which grants will best support your strategy and which ones will not be effective? </li></ul><ul><li>How do you best present your grant application for funding? </li></ul><ul><li>How do you improve your chances of funding? </li></ul><ul><li>How do you set up your application so that management of the grant is simplified </li></ul><ul><li>PBI supports effectively gaining grant funding </li></ul><ul><li>Defining your R&D needs that are applicable for grant funding – which grants to apply for. </li></ul><ul><li>Designing grant applications that address the drivers of granting bodies </li></ul><ul><li>Integrating grant application with best practice project and portfolio management to </li></ul><ul><ul><li>Increase chances of funding </li></ul></ul><ul><ul><li>Simplify management of grants when awarded </li></ul></ul><ul><li>Examples of PBI Experience </li></ul><ul><li>Pharmaceutical Partnerships Program application worth $10 million successfully prepared and managed for large publicly listed company </li></ul><ul><li>Managed R&D Tax concession for large publicly listed company </li></ul><ul><li>Several ARC grant applications successfully prepared and managed. </li></ul><ul><li>Experience with CRC and Start grant applications/management </li></ul>
    9. 9. Strategies for Navigating the Clinical and Regulatory Approval Pathway - including CTN, CTX, IND, ANDA and NDAs <ul><li>The Challenge </li></ul><ul><li>How do you navigate the complex requirements for quality systems and documentation for clinical trials and product approval? </li></ul><ul><li>How do you establish product development, regulatory and clinical strategies that maximise your chances of approval with least time and cost? </li></ul><ul><li>PBI supports effectively gaining regulatory approval by </li></ul><ul><li>Defining the requirements for approval </li></ul><ul><li>Defining alternative pathways to approval </li></ul><ul><li>Designing IND and NDA/ANDA product development and clinical strategies that minimise time and cost </li></ul><ul><li>Integrating these strategies with best practice project and portfolio management to speed path to market </li></ul><ul><li>Examples of PBI Experience </li></ul><ul><li>Several First to Market opportunities achieved using minimal preclinical and clinical studies with NDA and 505b(2) pathway for approval </li></ul><ul><li>Use of NDA and (505b(2)) pathway for biological products </li></ul><ul><li>Experience with managing CTN and CTX/IND product development programs </li></ul>
    10. 10. Pharma & Biotech Innovation Deliver Success through Innovation Michael McNamara MSc MRACI C Chem Pharma & Biotech Innovation ph 03 94997193 mobile 0407713768 [email_address]

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