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Hemophilia is a hereditary bleeding disorder caused by a defect in the X chromosome that contains genetic coding for factor VIII and FIX proteins necessary for normal clotting. It is a lifelong disorder that prevents blood from clotting properly. Hemophilia occurs in all ethnic groups and in all parts of the world.

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  1. 1. US/EU Biologics Commercial Market Plan Competing in the hematology market Presented By: Andre’ D. Harrell AH2 & Beyond Consulting
  2. 2. The Issue Hemophilia is a hereditary bleeding disorder caused by a defect in the X chromosome that contains genetic coding for factor VIII and FIX proteins necessary for normal clotting. It is a lifelong disorder that prevents blood from clotting properly. Hemophilia occurs in all ethnic groups and in all parts of the world.
  3. 3. Mission Statement Our product will address an unmet need in the marketplace for an effective, safe and innovative agent that addresses health issues for the HCP/Patient where current recombinant therapy options have failed.
  4. 4. Strategic Priorities • Identify/Develop “Product Champions” that help will accelerate volume growth. • Continue to strengthen our medical department that will lead in the development of clinical support assets • Improve Efficiency (e.g. budget-financing/ market/customer segmentation/review sales channels) • Personnel Development (e.g. training/succession planning/recruiting & selection)
  5. 5. Global Market Summary • Product A – $178mm in Sales in 2013 with an anticipated10% percent increase in 2018 – Our Mkt. Research indicates 10000 new (competitor product) pts Worldwide this year. Oppty for Product A. • 2018: We Need 25210 (competitor product) conversions to Product A and 60 Elective Surgeries – Opportunities exist in Adult HTC in large metropolitan markets. Pursue “Product Champions” to assist in obtaining conversions from peers. • Product B – 25000 New Patients Starts; 50000 COMPETITOR SWITHCES – 2018 Goal = Anticipated 45% growth vs 2013 – Opportunities for Ped endos in metropolitan markets
  6. 6. Global Market Opportunities Current Status: • Customers have come to be “tolerant” with current product market leader because of minimal effective options. • Current recombinant therapy for bleeding disorders are either ineffective for advanced diagnoses or the side effect profile make it unsuitable for certain patients. • Current patient education resources aren’t helpful in understanding the pathology of certain bleeding disorders.
  7. 7. Global Market Opportunities con’t Opportunities: • Continue bolstering our “Clinical Study Support” resources (“Clinical Study Registry”). Global “Product Champions” that support the clinical evidence and advance knowledge to peers • Our product in the research literature states a positive safety profile, which will be showcased in our marketing and DTC campaigns. • Work with managed markets in US and develop a patient/hospital reimbursement program so that our product is accessible in the hospital and external 3rd party payers. • Stronger partnerships with Medical Department & R&D.
  8. 8. Our Business Concepts Tactical Concepts: • Maximize our “Targeting” (Marketing and Budget Efficiencies) • Call Planning/Reviewing our “Sales Channels” • Alignments (We need to tighten our country territories) • Marketing Excellence Initiatives/Effectiveness • Re-vamping “Salesforce” population (Lacking “CRM” processes) • Performance Measurement (Building “Competency Models” • Incentive Compensation Model (Revise due to sales channel shifts)
  9. 9. Competitive Market The Hemophilia A market stands at 5.2 Billion by our estimates, and we think the market could grow to 7 billion by 2016, representing about a 6% growth over the next 5 years. The major treatments for hemophilia A include recombinant factor VIII drugs such as NovoSeven, Kogenate, Advate, ReFacto, Xyntha, Feiba and others for severe hemophilia cases. Baxter , 38% Novo Nordisk , 14% Pfizer , 14% Bayer , 13% CSL , 11% Grifols , 5% Octapharma , 4% Kedrion , 1% Company 2011 % Baxter Novo Nordisk Pfizer Bayer CSL Grifols Octapharma Kedrion Baxter , 35% Novo Nordisk , 17% Pfizer , 10% Bayer , 14% CSL , 11% Grifols , 5% Octapharma , 4% Kedrion , 1% Biogen Idec, 0% Company 2016E % Baxter Novo Nordisk Pfizer Bayer CSL Grifols Octapharma Kedrion Biogen Idec
  10. 10. Strategic Imperatives • Consistent Communication with EU medical affairs, countries who have MLD/ML infrastructures • Request our “Global Product Champions” to help with our conversion rates. We need at least 60% conversion of patients from market leader • Prepare to maximize growth with our upcoming factor viii long acting agent • Continue to leverage our patient resource programs which have gained National appeal • Aggressively challenge the “Perception” that the market leader is “Effective” & “Convenient”. Our new formulation will address this.
  11. 11. WHO DO WE TARGET? Competing in the hematology market
  12. 12. The Process Determine the “Value” of your Targets (e.g. # of patients, units prescribed, hospital affiliation etc) Set up “Buying Process” structure (e.g. # of sales per account, ordering dates, inventory on hand) Identify “Exterior Customers” (e.g. HHS, Caremark, BioCare etc) The Planning Process has 3 Variables Country Territories/Customer Planning •Segmenting territories by customer access/product volumes •Identify physician/specialty pharmacy/hospital by location Target List Compilation •Targeting of HCP’s •Determine Human Resource Allocation •Tracking activities in CRM and rep accountability to maintain current database Execution Planning •Determine required # of customer calls •How are we determining our A,B,C customers •Develop “Scorecard” to track R.O.I vs market resources used
  13. 13. Segmentation Requirements Identification of appropriate “Hemophilia Market” * Hemophilia A/B/Inhibitors/von Willebrand Disease Customer Type Segmentation * How to determine which HCPs to call on? Institutional Segmentation based on Factor use * Sales Force Deployment, Target Audience Identification, Forecast Development
  14. 14. Segmentation Deliverables • Quantify growth opportunities and leverage points • Identify richest targets * Identify hcp characteristics that may explain the need to advocate for our product * Identify hospital/specialty pharmacy characteristics that may explain availability/usage of our product • Ability to maximize our marketing investment by customer segment * Invest in “richest targets” * Institutional targeting plan at a hospital/specialty pharmacy level
  15. 15. The “Results” Behind Our Global Segmentation Our Findings • We understand what makes HCPs more likely to become product advocates for our product – Specifically, what are the drivers for Segment I and III? • We have answers why HCPs are likely to become high users of our product – Specifically, what are the drivers for Segments IV, V and VI? • We’ve identified which countries account for differences in product advocacy / usage between various country policies/regulatory etc in Segments IV, V, and VI? HCP Hospital/ Specialty Rx Higher Procedure Volume HEMONC (incl. Intenal Med, Surgeons, Gen Surg) Hematologists Not HEMONC Mgmt Team, Committee, P&T or Chief of Service HEMONC Mgmt Team, Committee, P&T or Chief of Service Not HEMONC Mgmt Team, Committee, or P&T Member HEMONC Mgmt Team, Committee, or P&T Member Age <50 Age 50 and over HSA Population Less than 100,000 HSA Populati on 100,000 or more Not - for- pro fit Pop Dens <1500 ppl/mi 2 Pop Dens 1500+ ppl/mi 2 Other (for profit and govt.) III III IVa V VI IVb (IVA + IVB) IV
  16. 16. Conclusions • ALL initial segmentation assumptions should be validated by market research/quantitative study – HCP Behaviors/buying patterns/accessibility – Role of key stakeholders in territories (countries) – Status in community (e.g. Membership on P&T, organizations, etc. • Quantify differences for product advocacy in eu (e.g. regulatory, product availability, practice setting, product usage patterns • Attitudinal insights will help influence messaging • Building “efficient” territory account planning based on segmentation results
  17. 17. DEVELOPING “BEST IN CLASS” SALES ORGANIZATION Competing in the hematology market
  19. 19. Goals Concentrating on “Grow Skills” • To create “Customer Value” during every customer interaction • To build upon our successes • To tackle the challenge of a changing marketplace • To raise the bar on sales performance • To make an investment in our professional development • To refine the critical skills we need to differentiate ourselves from the competition • Accelerate business growth in all territories & regions
  20. 20. Training Concentrating on “Grow Skills” Key Strategies • Strengthen key training initiatives that can be leverage • Communicate and collaborate with marketing both US & EU to develop consistent message • Identify and understand EU training goals/objectives • Identify key customers on EU side of business (I.e. sales reps, MSL’s, specialty reps etc) • Establish close working relationship with regulatory/compliance unit to ensure training meets compliance policies. Tactics • Build collaboration training team with EU (solidify communication channel) • Assign “EU” /”US” point persons to establish communication channel • Establish a process where training business plans can be communicated between EU & US. • Training initiatives for EU & US have to meet the personality of the client base (I.e. tailor made training tactics). • Communication loop developed with regulatory/compliance to ensure EU & US are working together in our Company ’s best interest.
  21. 21. Field Sales Operations Concentrating on “Grow Skills” Revise our current field sales strategy to ensure training components meet the needs of the field & customers Key Strategies Tactics • Consistent communication with field leadership on training gaps • Mandatory field “coach plans” with skill gaps included • Revamp new hire process • Have in place field goals, objectives and direction • Understand field demographics (I.e. tenure, new hire ratio, turnover percentage) • Identify and understand training class metrics (I.e. training performance) • Conference Calls, face to face meetings, etc (I.e updates on training, new hire performance) • Develop a consistent feedback form that closely aligns to Company X’s field coach plan to ensure the importance of training pull-through • Build a seamless home-bound new hire training process so that home-office training is efficient. • Company X’s “ field environment” will dictate how we plan, develop and rollout training classes (I.e. turnover ratio, sales tenure, management involvement.
  22. 22. Contingency Plan/Supporting Tactics Contingency Plan/Supporting Tactics Contingency Plan/Supporting Tactics Contingency Plan/Supporting Tactics Sales Call Objective (What do you want the customer to do?) Customers Receptivity To YOUR Message Customer Call Planning Concentrating on “Grow Skills”
  23. 23. People Development Concentrating on “Grow Skills” Key Strategies & Tactics 2018 Key Strategies • Build career development plans • Thorough understanding of sales personnel (I.e. experience & development plans) • Developmental Program Construction (Succession Planning) • Set up action plans for “Ready Now” personnel • Build “Competency Model” Tactics • Ensure development plans are updated and reviewed quarterly • Ensure sales personnel development plans are updated to avoid morale issues, and continue career progression • Help build management development programs that focuses on “Job & Career Development” • Proactively PR “Ready Now” candidates, and ensure career development plans are updated.
  24. 24. Personnel Assessment Concentrating on “Grow Skills” CULTURE PERFORMANCE KEY CONTRIBUTORSYELLOW LINERS RED LINERS YELLOW LINERS Personnel Assessment Based On Competencies
  25. 25. Strategy/Tactics Concentrating on “Grow Skills” Strategy Tactic Progress / Results Actual Create an effective learning environment  Consistently promote the value of training by identifying skill gaps of each direct report  Encourage team members to share best practices/lessons learned with each other at team meetings.  Model my commitment to development by sharing my development and asking for feedback on progress. Coach Plans will be done after each work- session  Field Conference Report (FCR) will be delivered within 24hrs after the work-session has completed  Weekly Status reports from team will also help aid the the development process.  Identify readings, training programs etc to help supplement the person’s development and ways to help them apply training to current job. Ensure learning opportunities exist on every one-on-one  Discuss with each team member and gain agreement on ways to work with them that will promote partnership and a learning opportunity.  Review work-session feedback report with team member to ensure alignment and agreement on how success can be gained moving forward.
  26. 26. Tactics Q1 Q2 Q3 Q4 Account Business Plans 2/18 Revise Revise Revise Career Development Plans 2/18 5/18 8/18 10/18 Allocation (Financial) 60% Re-evaluate 30% Re-evaluate Unit Promotions 2 Recruiting & Selecting 2/18 5/18 9/18 Winter Break Team Mentor-ship Program 2/18 Stretch Assignments/Action Plans 2/18 4/18 7/18 11/18 Salesforce/CRM Team Experts (Training Initiatives) 2/18 6/18 ----- ------ Quicken New Hire Progress/Development 2/18 4/18 6/18 ------- Track Personal Development Plan 2/18 4/18 7/18 10/18 Insert Retention Tactics to “A” & “B” players (Development) 2/18 4/18 7/18 10/04 Development Tactical Planning Calendar (Example) Concentrating on “Grow Skills”
  27. 27. Thank You! This presentation illustrates a brief example at ways to capitalize your business in a very tough marketplace “Biologics” (Hematology). While there are of course many ways to grow your business there’s one constant that remains true….raising the level of competence with your Sales & marketing personnel should be the highest priority!
  28. 28. Checkout my “Global Sales-Marketing Business Plan” for the Pharma/Med Device Industry featuring Pain Management. plan You can also checkout my background/work by clicking on the following links: Consulting/267898536570725 Contact Us
  29. 29. Andre’ Harrell AH2 & Beyond Consulting 267-221-8529 Contact Us