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Learn How to Beat Problems Feb23, 2007
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Learn How to Beat Problems Feb23, 2007

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    Learn How to Beat Problems Feb23, 2007 Learn How to Beat Problems Feb23, 2007 Presentation Transcript

    • Tchaikapharma High Quality Medicines Sofia Learn how to beat (regulatory, legal and field problems in new EU member states to ensure a smooth transition and increase your sales) the competition and benefit from the globalization Berlin February 23, 2007
    • Competitiveness:
      • CONTENTS
      • Competitiveness is crucial
      • Innovation is down and plunging with the Big Pharma
      • The new Bulgarian Modern Industry: generic and in-licensed drivers of growth
      • Synergetic partnerships both with R&D and generics: changing the face of the Bulgarian Pharmaceutical Market
      • Corporate feathers securing effectively a comparative advantage: low cost and/or superior technology widespread applicability both domestically and internationally
      • Speed and flexibility of response in a constantly changing environment
      • Decision making that avoids becoming mindlessly global or hopelessly local
      • Why is it so important in our business?
    • Healthcare: crucial economic sector for the world society in the next 50 years(?) Source: UBS
      • The health sector: from cost driver to growth driver
        • Increasing life expectancy, higher incomes and ongoing innovations in medical science add up to a strong demand trend for the health sector
      • Health has some of the attributes of a luxury good: as incomes rise, the proportion of disposable income households are prepared to spend on it increases even faster.
      • The sector is immune to saturation : one can never be too healthy
      • Healthcare: prevalent societal need of the age
      • Services directed not only at the sick but also, increasingly, at the healthy
      • How much extraction of value we get from society from the noble work we do?
      • And when?
    • Synergy: transforming the way our industry work
      • Growing difficulties of the innovative industry to expand gross margins of sales and deliver new molecules: life-cycle management becomes crucial
      • Regulatory and legal hurdles, constant price pressure, portfolio management in a changing environment and multiple entries are a threat to all generic players
      • Synergy: a smart sales strategy; a decision that avoids becoming mindlessly global; enjoy the fast-track positive changes of your business
      • Reduce the costs and time required, manage risk and bring sustainable value
      • Stop outsourcing profits. Strong relationships build bottom lines.
      • You can save millions and make your company millions: success will now come from the reflected glory of cooperation and that is what we call a victory in our business world, otherwise: no innovation, no sales
    • Six Forces That Can Drive Your Company- Or Kill It
      • Players
      • The friends and foes lurking in the healthcare system that can destroy or bolster any chance of success
      • Funding
      • The process of generating revenue, differing from the one in other industries
      • Policy
      • The regulations that pervade the industry, because incompetent advise and action can do tremendous damage
      • Technology
      • The foundation for fast and secure introduction of innovations that can make healthcare delivery more efficient and convenient
      • Customers
      • The increasingly engaged consumers of healthcare, for whom the passive term ‘patient’ seems outdated
      • Accountability
      • The demand from vigilant consumers and cost-pressured payers that innovative health care products be not only safe and effective but also cost-effective relative to competing products
    • How do you manage these forces?
      • Registration and Regulatory Affairs : lots of paperwork
      • Legal department : lawyers and lawsuits (!)
      • Human resources : administration, benefits, training programs
      • InfoTech : software development, tech support, Website design…
      • Analytics : market research, financial analysis, risk calculation…
      • Customer care : CRM, advertising…
      • Manufacturing : facilities, production and warehouse management, service…
      • Marketing : product managers, other different class of managers, field force, marketing dep’t, more field force…
      • Finance and accounting : accounts payable, billing, financial and tax statements…
      • Logistics and procurement : just-in-time shipping, purchasing, after sales follow up…
    • How do you manage these forces when stuck in the middle?
      • Registration and Regulatory Affairs : lots of paperwork MORE
      • Legal department : lawyers(!) MORE
      • Human resources : administration, benefits, training programs MORE
      • InfoTech : software development, tech support, Website design… MORE
      • Analytics : market research, financial analysis, risk calculation… MORE
      • Customer care : CRM, advertising… MORE
      • Manufacturing : facilities, production management, service… MORE
      • Marketing : product managers, other different class of managers, field force, marketing dep’t, more field force… MORE
      • Finance and accounting : accounts payable, billing, financial and tax statements… MORE
      • Logistics and procurement : just-in-time shipping, purchasing, after sales follow up… MORE
      MORE OF THE SAME
    • Remember, Einstein said:
      • Insanity is doing the same thing over and over again, expecting different results.
    • The decision:
      • In the fifth century BC Athens became the first (albeit limited) democracy.
      • In the seventeenth century, Quakers developed a decision-making process that remains a paragon of efficiency, openness, and respect.
      • Starting in 1945, the United Nations sought enduring peace through the actions of free people working together
      • Now it is in crisis of its own though the world peace is not genuinely in danger
    • Contents
      • Competitiveness is crucial
      • The new Bulgarian Modern Industry: generic and in-licensed drivers of growth
      • Synergies: changing the face of the Bulgarian Pharmaceutical Market
    • Situation Analysis : Business environment Bulgaria
      • Political and Economic environment: crystal transparency
      • Economic stability, no inflation and solid economic growth: 5.5 % growth in 2006 (avg. 5.1% since 2000) (source: Bulgarian Center for Economic Development). Foreign deficit rapidly shrinking
      • Euro-Atlantic integration completed: EU Accession January 1 st 2007
      • High credit ratings of the country maintained (S&P, Moody’s, Fitsch)
      • Further pressure from EU and from within for more active structural reforms
      • Healthcare expenditure still is 4.3% -- among the lowest in Europe: significant upside potential as opposed to the world’s healthcare funding crisis. After the 2005 elections all leading political powers united on the healthcare reform highest priority.
    • Situation Analysis : Business environment Bulgaria cont’d
      • Healthcare System & Pharmaceutical market
      • Expanding institutional presence (app. 70% NHIF, MoH, Hospitals): generics’ priority & still complicated access of innovative products ( new pharma law still on 2nd reading in Health Commission – fully harmonized with EU (Directive 2001/83/EC, 2004/27/EC, EU Regulations) sets the frame for merging some steps, which will significantly decrease current time delays (avg.570 days) of access to market and reimbursement for new applications
      • Increased pricing pressures: implementing a cost-containment system based on pharmaco-economic evaluation of drugs with reference pricing system (fixed to the lowest bid) and the co-payment is the difference above price. Institutional & competition influences require market-adapted solutions for improved productivity and new efficiency (INN prescribing and INN substitution are not legally required)
    • Situation Analysis : Business environment Bulgaria cont’d
      • Healthcare System & Pharmaceutical market
      • Strong government support for technology transfer to high quality local producers both generics and original: Sustained Advantages in Positive List / Reimbursement Entries
      • Boom of generic registrations & consolidation in the distribution segment
      • Lagging HC reform & HC system still underfinanced – much better than Spanish hospital 3 year deferred payment practice
      • Long, 8 month payment terms in hospitals, yet to improve in 2007
      • Changes in reimbursement regulations / model (MoH, NHIFund). Positive and Reimbursement Lists will merge in a single formulary. NHIF becomes the only funding body to administrate drugs budget. Application for price and reimbursement - processed by one “single step”. (Healthcare Commission to decide shortly)
    • Bulgarian Pharmaceutical Market: 1990-2000
      • Local production supported by the ‘economy of deficit’
      • Low tech, i.e. low quality (there is still a traditional doubt about quality of local production)
      • Market dominated by expensive, original, branded medicines. More than 80% of the budget dried by foreign production, leading to greater foreign deficit
      • Nontransparent privatization of local production facilities, no investment policy (no GMP) : supporting the status quo
      • No healthcare reform, no health fund
      • Local hi-tech alternative: N/A
    • Bulgaria Today
      • World competitiveness index: comparison chart of EU new members
      • 39 th place for Bulgaria thanks to:
        • health reform (NHIF)
        • medical academia level
        • the new Bulgarian modern pharmaceutical industry
      Source: World Economic Forum Davos
    • The new Bulgarian modern industry Source: Daniel Kahneman Nobel Prize winner in economic sciences 2002 How do you read this?
    • The new Bulgarian modern industry Source: Daniel Kahneman Nobel Prize winner in economic sciences 2002 How do you read this letter?
    • The new Bulgarian modern industry Source: Daniel Kahneman Nobel Prize winner in economic sciences 2002 How do you read it now?
    • The new Bulgarian modern industry Is it a generic company?
    • The new Bulgarian modern industry Is it an original one?
    • OR…?
    • The new Bulgarian modern industry
    • The new Bulgarian modern industry Is a part of CL BioPharma Group
    • Vertically Integrated Powerhouse on the Balkans Commercial League warehouse Tchaikapharma production site Tchaikapharma production site PROJECTED Cardiac hospital Cardiac hospital PROJECTED Haemodialysis center PROJECTED
    • The CL/ Tchaikapharma Advantage: Winning Concept for beating regulatory, legal and market problems
      • Big pharma, biomedical and generic manufacturers are able to utilize the CL BioPharma Group platform from late-stage clinical trials to take-the-drug market
      Trials Regulatory Manufacturing Marketing Distribution Tchaikapharma Inc Commercial League NPC Macedonia Pharmacia Distinguished Pharmacies Inc
      • Late Stages Clinical Trials & Safety Testing
      • Product Marketing & Promotion
      • Co-Marketing & Co-Promotion
      • Reimbursement Upgrading
      • Lobbying Services
      • Wholesale & Distribution
      • Retail Pharmacies &
      • Medical Centers Management Support
      • Registration (Marketing Authorization)
      • Post- & Pre-Registration Monitoring
      • Reimbursement
      • Central Tendering
      • CL Sourcing Licensing +
      • R&D Contracting
      • CL Sourcing Pre-Market
      • Research
      • CL Sourcing Contracting
      • Manufacturing
      • Packaging
      Medical Activities
      • Cath-Labs
      • Cardio Surgery
      • Haemodialysis Centers
      • Primary Care Centers Management
      Bulgarian Cardiac Institute, JSC Reaching Across The Entire Value Chain
    • The CL/ Tchaikapharma Advantage: cont’d Winning Concept for beating regulatory, legal and market problems
      • CL/Tchaikapharma thrives with the philosophy of being a broadly-based vertically integrated healthcare company and delivering healthcare solutions to the patient, rather than just producing & selling drugs: “ Patient always comes first ”
      • Academia Partnerships Built On Solid Foundation
        • Advance market research: disease prevalence, market potential, feasibility studies
        • Introduction of world class standard guidelines in treatment practices
        • Disease management & portfolio planning
      • Extended diagnostic programs: nation-wide prevention & diagnostic campaigns in Cardiovascular Diseases, Diabetes, respiratory, oncology etc.
      • Disease management: therapeutic baskets, combined therapies, end curing or/and continuous therapeutic solutions
      • Precisely targeted investment policy, aiming at improving state and quality of healthcare- Haemodialysis centers project and CathLabs Project
    • The CL/ Tchaikapharma Advantage: cont’d Winning Concept for beating regulatory, legal and market problems
      • Specialty hospital chains per therapeutic areas (or state hospital privatization) of:
        • Five to ten specialized hospitals in Invasive cardiology, Metabolic, CNS and Respiratory diseases in collaboration with leading Bulgarian & European (Czech Republic, Italy & Austria) key opinion leaders. The pilot clinic in Pleven opens March 2007
        • Six to twelve Haemodialysis Centers in cooperation with Majors
        • Four Drug Addiction Treatment Centers in cooperation with a Big Pharma.
      • Health Insurance Fund establishment in Bulgaria
      Strategic Investment Projects
    • Contents
      • Competitiveness is crucial
      • The new Bulgarian Modern Industry: generic and in-licensed drivers of growth
      • Synergies: changing the face of the Bulgarian Pharmaceutical Market
    • Spearheaded Entry/Re-Entry of Major Generic Players
      • Only few of the foreign generic companies come closer to the local players’ performance
      Source: IMS Data
    • Novartis / CL BioPharma Group Generics Cooperation
      • Sandoz (Lek) & Tchaikapharma : very successful, though limited scale model of bulk supply
    • Case Study Enalapril (Bulk Supply from Sandoz) Market Share (# of patients) Nov ‘06 Distancing leadership position in a very crowded generic market Source: NHIF, number of patients
    • Case Study: ACE Inhibitors Tchaikapharma In-licensed from La Roche (results for just 3 months) and elevated Pfizer to market leader in 1.5 year time only Source: NHIF, number of patients
    • Case Study on own Nordipin (Amlodipine): Leader In Three Months Only Source: NHIF/ in patients
    • Case Study: In-licensed Dilatrend (carvedilol) Roche Market Share Nov ’06 Against Multiple Generic Entries Source: NHIF, number of patients
    • Case Study: In-Licensed Symbicort (AstraZeneca) Time Under CL Marketing Only Source: NHIF, number of Patients
    • Case Study on own Klacar (clarithromycin) : Leading Anti-infectives Brand Just Three Months After Launch Source: NHIF, Value BGN
    • Marketers judgment doesn’t always look like action to their colleagues in Sales ( Stop Einstein’s insanity) Thank You Very Much