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WE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW THE WAY IN HEALTHCARE. ™ CSO Partnership Strategies for Successful Advance to Overseas Markets,

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Presentation on theme: "WE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW THE WAY IN HEALTHCARE. ™ CSO Partnership Strategies for Successful Advance to Overseas Markets,"— Presentation transcript:

1 WE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW THE WAY IN HEALTHCARE. ™ CSO Partnership Strategies for Successful Advance to Overseas Markets, Drug Development Strategies in Line with Marketing 2014 MFDS Global Biopharmaceutical Forum

2 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 2 Contents 1.Introduction of inVentiv Health 2.CSO Partnership Strategies 3.Drug Development Strategies in Line with Marketing 4.Summary 5.How Can We Help you?

3 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 3 inVentiv Health Capabilities CLINICALCOMMERCIALCONSULTING 3 We are a Best-in-Class Team of Global Healthcare Experts We manage and support every aspect of the clinical trial process in any therapeutic area. Capabilities include: Phase I - II Phase II - III Phase IV Strategic Resourcing Bio analytical Services inVentiv Health Commercial provides complete 360 degree support and expertise to elevate our clients' brands. We combine a broad range of deep therapeutic expertise with an unparalleled breadth of commercial capabilities: Commercial strategy and design Sales and education programs Branding, advertising, public relations Medical communications Patient access and adherence Through Campbell Alliance, an inVentiv Health company, we provide the experience, time-tested methodologies, innovative thinking and actionable insight you need to make better decisions that accelerate performance. We work with clients on: Commercialization of new and existing products Pricing and market access optimization Medical affairs operational excellence Corporate strategy and business development Product, franchise and portfolio strategy Organizational strategy, design, and development Market research and analytics Custom and catalog education and e- learning solutions 1. Introduction of inVentiv Health

4 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 4 inVentiv Health Global Network AFRICA Cairo, Egypt Capetown, South Africa ASIA Beijing, China Guangzhou, China Gurgaon, India Hong Kong, China Mumbai, India New Delhi, India Pune, India Seoul, Korea Shanghai, China Singapore Taipei, Taiwan Tokyo, Japan Osaka, Japan AUSTRALIA Melbourne, Australia Sydney, Australia EUROPE Athens, Greece Barcelona, Spain Berlin, Germany Budapest, Hungary Cologne, Germany Dublin, Ireland Frankfurt, Germany Freiburg, Germany Istanbul, Turkey Lisbon, Portugal London, UK Madrid, Spain Maidenhead, UK Milan, Italy Moscow, Russia Munich, Germany Paris, France Prague, Czech Republic Ramsgate, UK Rome, Italy Stockholm, Sweden Strasbourg, France The Hague, The Netherlands Uxbridge, UK Vienna, Austria Warsaw, Poland Wiesbaden, Germany Zurich, Switzerland MIDDLE EAST Dubai City, Dubai Islamabad, Pakistan Jeddah, Saudi Arabia Karachi, Pakistan Lahore, Pakistan Riyadh, Saudi Arabia NORTH AMERICA Augusta, GA Austin, TX Basking Ridge, NJ Burlington, Canada Burlington, MA Cary, NC Charlotte, NC Chicago, IL Conshohocken, PA Deerfield, IL Eden Prairie, MN Gurnee, IL Houston, TX Hunt Valley, MD Indianapolis, IN Irvine, CA Irving, TX Lake Mary, FL Lexington, KY Louisville, CO Mexico City, Mexico Montreal, Canada New York, NY Newark, DE Newton, MA Newtown, PA Norristown, PA Parsippany, NJ Princeton, NJ Raleigh, NC San Diego, CA San Francisco, CA Santa Monica, CA Saratoga Springs, NY Somerset, NJ Southport, CT The Woodlands, TX Thousand Oaks, CA Toronto, Canada Totowa, NJ Washington, DC West Chester, OH West Valley City, UT Westerville, OH SOUTH AMERICA Buenos Aires, Argentina Lima, Peru San Juan, Puerto Rico Santiago de Chile, Chile São Paulo, Brazil 12,000 Employees. 40 Countries. 1. Introduction of inVentiv Health

5 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 5 inVentiv Health Korea  Commercial ›Sales teams and sales support ›Education and Training ›Call center ›MedComms  Clinical ›Phase II – IV Clinical Trials ›Strategic Resourcing Services  Kihwan Park, President  Tel : +82-2-6206-1625  Mobile: +82.10.6606.7590  Email : kihwan.park@inventivhealth.com  Office Locations : ›Commercial 4F Sean Bldg, 17 Teheran-ro 88gil Gangnam-gu, Seoul 135-846, Korea ›Clinical 13F Gangnam Finance Center 152 Teheran-ro Gangnam-gu Seoul 135-984, Korea Line of serviceContact Info 1. Introduction of inVentiv Health

6 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 6 Product Life Cycle inVentiv Health Consulting – Services (Selection) We offer our consulting services along the product life cycle. Market Assessment and Opportunity Identification Before Launch After Launch Clinical Development 11 MaturityMaturity Growth Growth LaunchLaunch NHI Price Listing Product Application/ Approval Phase III Phase II Phase I Pricing and Market Access 22 Market Entry/ Go-to-Market Strategy 33 Product Launch 44 Commercial Excellence (Field Force Excellence) 55  Performance monitoring  Sales revenues optimization  Performance optimization (of individual MRs)  Market size  Sales forecast  Field force organization  Number of MRs  Geographical allocation of MRs In-/Out Licensing 66 Consulting Services 1. Introduction of inVentiv Health

7 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 7 1. Flexibility - use us when you need us. 2. Your reputation as a 'hirer and firer' goes away. 3. Cost - we are often 12%~15% less expensive. 4. 'Try before you buy'...can you tolerate low performers? 5. Cherry pick the best: give back the rest! 6. We take over the (painstaking) HR Recruitment function. Dedicated Team. 7. CSO can take over most of the Training, too! 8. You can cancel anytime. You don't have the 'burden' of permanent staff. 9. With Gain Share deals, CSO also share risk. 10. You outsource nearly everything else...why not your Field Force? TEN Reasons Why Using a CSO Partner, Such As inVentiv is Correct 2. CSO Partnership Strategies

8 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 8 Co-Promotion Business Model 〔 Client Needs 〕 It is often difficult to invest money and resources in orphan drugs which serve a huge social purposes but only have a limited number of patients and sales It is difficult to focus the sales resource on just the main therapeutic areas and new drug sales Not satisfied with the co-promoting with other pharmaceutical companies 〔 Our Solutions 〕 inVentiv will take on an consignment project: For products that have no synergistic effect with the leading products With allocation of highly specialized and passionate MRs For co-promoting a certain therapeutic areas or products Project Manager Field Managers Experienced MRs or Inexperienced MRs … … Point1 : When you explore new opportunities in the new therapeutic areas, inVentiv can create a sales force suited to your needs with the right number of managers and MRs Point2 : inVentiv will evaluate the performance of MRs by setting up KPIs Point3 : inVentiv can prioritize the promotion of your products better than the pharmaceutical companies would do Point1 : When you explore new opportunities in the new therapeutic areas, inVentiv can create a sales force suited to your needs with the right number of managers and MRs Point2 : inVentiv will evaluate the performance of MRs by setting up KPIs Point3 : inVentiv can prioritize the promotion of your products better than the pharmaceutical companies would do 2. CSO Partnership Strategies

9 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 9 Point: By sharing the MRs with Company X, the cost for Client will decrease significantly Point: By sharing the MRs with Company X, the cost for Client will decrease significantly Co-Promotion Business Model with Shared MRs 〔 Client Needs 〕 Cutting down on cost by sharing MRs to sell non-competitive products of multiple pharmaceutical companies 〔 Our Solutions 〕 inVentiv will take on a consignment project by: Allocating the MRs with specialized knowledge and therapeutic areas Selling multiple products that has no conflicts Co-promoting a certain areas and items Pharma X Hospital A Hospital B Hospital C Consignment Contract Hospital A Hospital B Hospital C Very efficient if the destination (doctors and institutions) are the same Very efficient if the destination (doctors and institutions) are the same Cutting down on the cost by sharing the MRs Cutting down on the cost by sharing the MRs Pharma Client 2. CSO Partnership Strategies

10 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 10 Gain Share Model 〔 Client Needs 〕 Needs a result oriented contract by committing to the sales Not fully satisfied by the co-promotions with other pharma companies 〔 Our Solutions 〕 inVentiv will analyze the market trends of the relevant products and create a strategy including sales forecasts and manpower Agree on the sales plan and costs with the client Share the gained profit (highlighted in ■ ) with the previously agreed ratio 〔 Upward Trend 〕 For new drugs and supplemental indication, etc. 〔 Downward Trend 〕 For long-term listed drugs and non-core products, etc. ■: Past Performance ■: Sales Forecast ■: Actual Sales Project Proposal Project Proposal Data Analysis (using ims, etc.) & Market Analysis Data Analysis (using ims, etc.) & Market Analysis Pilot plan Proposal Pilot plan Proposal Conclusion of Letter of Intent (LOI) Conclusion of Letter of Intent (LOI) Set-up Meetings & Conclusion of Contract (MSA) Set-up Meetings & Conclusion of Contract (MSA) Industry Trainings, Prior Trainings, Product Trainings Industry Trainings, Prior Trainings, Product Trainings Launching Pilot Program Confirmation of Results/ Agreement Launching the Country Wide Project Launching the Country Wide Project 〔 Process before the Project Start-up 〕 Increased Profit 2. CSO Partnership Strategies

11 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 11 Business Model Based on MR Performance 〔 Client Needs 〕 A price system with clear cost-effectiveness of CMRs. Clarity on what value was added by having the CMRs in comparison with the Client MRs 〔 Our Solutions 〕 inVentiv can clarify the cost effectiveness by: Setting up and agreeing on KPIs (number of visits, market shares, comparison with the previous quarters, sales) Comparing the performance of the Client MRs and inVentiv MRs Setting up and agreeing to paying incentives and penalties based on the previously agreed price system KPI Evaluations Daily Rate ( JPY ) 100%90%110% X X-a X+a Chart: Performance-based cost ±5% Assumption KPI Example  # of calls  # of new clients  Market share  YoY  QoQ  Actual Sales 1. Quantify inVentiv MRs using KPIs 2.Calculate the average amount of inVentiv MRs and client 3. Setting the average of client MRs as 100, calculate the average of inVentiv MRs, e.g. when client average is 105 and inVentiv average is 108, KPI Evaluation : 108÷105 = 102.8% ※ Present data on monthly basis ※ Evaluate the KPIs based on all the institutions of each area Point: Incentives and penalties will be decided based on the previously agreed KPIs so client will be paying for the actual performance of inVentiv MRs Point: Incentives and penalties will be decided based on the previously agreed KPIs so client will be paying for the actual performance of inVentiv MRs 2. CSO Partnership Strategies

12 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 12 Remote e-Detailing Model 〔 Client Needs 〕 To discover potential patients by providing information to General Practitioners For patients to get appropriate treatments by being recommended to the specialist through a general practitioner 〔 Our Solutions 〕 To inform general practitioners so they can refer patients with a rare disease to appropriate specialists Our call center consists of 2 functions: DI Center handling incoming calls from specialists and pharmacists, and Remote e-detailing Center giving information about rare diseases to general practitioners via internet and phone calls Therefore, we can assist your company in: Developing potential patients Giving proper treatments to patients Medical specialists Pharmacists ・ Asking advice on drugs ・ Ordering medical instruction booklet ・ Asking advice on drugs ・ Ordering medical instruction booklet ・ Instructing on drug usage, dosage, side effects, etc. ・ Answering inquiries ・ Instructing on drug usage, dosage, side effects, etc. ・ Answering inquiries DI Center ( Receiving calls ) Remote e-detailing ( Calling up ) Obtaining Permission To Visit Providing Information Obtaining Permission To Visit Providing Information General Practitioners Detailing and visiting e-Detailing Center 2. CSO Partnership Strategies

13 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 13 Proprietary Training. Good promotional practices, fraud & abuse. Sample Compliance Software Solutions. Annual system validation conducted by third party. Compliance Solutions Regulatory ComplianceCommercial Compliance Creation of and sign off of the final business rules document. Development of training for LMS and live training. Individual State training if requested for States with acting legislative requirements (US). Continual monitoring and updating as guidelines, laws, change during the course of the year. Recertification process every 12 months for all Reps and Managers in all sales teams. Stand up live training for new hires, launches, national sales meetings. Management of all Hotline calls and collaboration with client. Investigations and enforcement when required through human resources, client contact, or internal monitoring. Interaction with all project management when called upon or when the need to proactively address a situation or a change is necessary. Continual interaction with clients in reference to compliance issues, or initiatives. Training, Debarment, Annual Certification to the client. All inVentiv Personnel Receive Thorough Compliance Training and Testing 13 2. CSO Partnership Strategies

14 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 14 Performance Tracking Performance Management Key Performance Indicators & Quality Metrics Performance Management Certification during initial sales training Yearly performance goals established Mid-year and annual performance evaluations Field Coaching ›Ride alongs ›Field contact reports Monthly performance reports Goal Attainment Qualitative Provider Market Research Commitment to Plan Actual or Relative Growth Relative Contribution Call Metrics 2. CSO Partnership Strategies

15 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 15 Questionnaire survey 3 months after placement with line managers of the client organization. Does the MR meet expectations; where can he/she improve? Based on the survey results, inVentiv will work with the MRs to meet and exceed client expectations! Follow-up surveys to be held twice yearly for the duration of the project, at our cost! Activity Tracking: Example 2. CSO Partnership Strategies

16 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 16 Case Study: Solving Headcount Constraints for a Global Pharma’s Multiple Affiliates Global Pharma company. Launching several new products, but in-lines still had growth potential. Had pressure NOT to hire additional MRs (worldwide), yet all affiliates were requiring them. They came to us for a solution, which was... We concluded a worldwide MSA, covering multiple markets. The MSA allowed a staged reduction based on numbers (a rebate scheme). We were made a preferred provider. No affiliate was 'forced' to use us, but were 'strongly encouraged' to do so. 'Pick of the crop' in the therapeutic areas was to go to them. They could then hire the best MRs after the contract with no penalty. We have since 'taken over' some of their older products with our MRs, against agreed KPIs (as a separate Field Force). We have also taken over older MRs, giving them a 'new lease on life'. The numbers, worldwide are in the hundreds, and are still growing. The relationship is now 3 years old and is set to grow. OutcomeSituationinVentiv Solution 2. CSO Partnership Strategies

17 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 17 Points to consider for a successful product development… 1.Start thinking about commercial aspects of your product in the early stages of the development, typically Phase II. 2.Keep an eye on the market development - it’s likely scenario at the time the product is launched (size, market segments, pricing, competition, regulatory environment), check feasibility of the product development. 3.Understand the market: needs and perceptions of the stakeholders such as KOLs, prescribing physicians, patients organizations, pharmacists, payers. 4.Optimize the value of the product by focusing on the most important endpoints and the necessary performance levels, create competitive advantages (e.g. efficacy vs. side effects). 5.Examine global implications of the product development, in particular international pricing and launching sequence.  Ensure maximum return on investment of the product being developed! 3. Drug Development Strategies in Line with Marketing Successful Product Development is Always Aligned with Marketing

18 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 18 As a result, CSO partnerships and drug development strategies in line with marketing will increase your profits. CSO partnerships will give you the necessary flexibility to run effective operations. CSO partnerships will help you to achieve success in the marketplace. Summary 4. Summary Investing in market analysis and examination of impacts starting in early stage of product development will render high returns.

19 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™ 19 How Can We Help You? - Please Contact Us Sanghwa Kim Business Development Director inVentiv Health Korea 4F Sean Bldg, 17 Teheran-ro 88gil Gangnam-gu, Seoul 135-846, Korea T +82 2 6200 5341 F +82 2 6200 5399 M +82 10 9409 4989 sanghwa.kim@inventivhealth.com http://www.inVentivHealth.com Pawel Komender Regional General Manager Japan Campbell Alliance inVentiv Health Consulting 6F, Glass City Koraku 1-1-7 Koraku, Bunkyo-ku, Tokyo 112-0004 Japan pawel.komender@inventivhealth.com T: +81-(0)3-5804-3939 (Main) F: +81-(0)3-5804-3959 www.campbellalliance.com/japan www.campbellalliance.com www.inventivjapan.co.jp www.inventivhealth.com CLINICALCOMMERCIALCONSULTING Eunyoung Kim, M.B.A. Business Development Manager inVentiv Health Korea 13F Gangnam Finance Center 152 Teheran-ro Gangnam-gu Seoul 135-984, Korea T 82 2 6206 1602 F 82 2 6206 1699 M 82 10 6279 5048 eunyoung.kim@inventivhealth.com http://www.inVentivHealthclinical.com eunyoung.kim@inventivhealth.com http://www.inVentivHealthclinical.com THANK YOU! 5. How Can We Help you?


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