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Launching New Pharma Product To Market

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It's beneficial to search for market channels that are dissatisfied, Apathetic/Indifferent when introducing a new product brand. In the Pharma/Biotechnology space it's critical to obtain quick/positive experience and develop "Product Champions" in order to enjoy a successful new product launch.

Published in: Healthcare

Launching New Pharma Product To Market

  1. 1. LAUNCHING NEW PHARMA PRODUCT TO MARKET Innovative Strategies For New Commercial Products in Pharmaceutical/Biotechnology Space Andre’ Harrell (AH2 & Beyond Consulting)
  2. 2. 1st KEY Identify a market that NOT only has the best opportunity for market share points…..but is dissatisfied and/or indifferent.
  3. 3. Market Dissatisfaction/Indifference Disrupt perceived market satisfaction Drive awareness of limitations of current therapies and position your product as an “innovative solution” In most markets you’ll typically have a market leader and depending on that longevity of “Dominance” customers may be ready for an alternative as long as it’s differentiating and offers better value than the leader. In addition, a “dissatisfied/indifferent market may be perceived as a satisfied market because “Apathy” starts to show it’s ugly head. Strategic Imperative Execution Driver
  4. 4. 2nd KEY If your product has a “Unique” profile or an innovative solution….you have to exploit it CONSISTENTLY. This is the “Value Proposition” and “Core Messaging” that will drive distinction.
  5. 5. Market Uniqueness/Innovation This category obviously will rely mostly on your R&D department, however I would also recommend that there is a partnership with R&D, Marketing, Market Research, and possibly Commercial should weigh in on the definition of “Uniqueness”/ “Innovation” in a specified marketplace. We know that gathering “VOC” from the field yields the best intelligence on what will have impact in the marketplace. Bring to market an “Unique”/”Innovative” product that disrupts market Develop a segmentation process where you are gathering feedback from KOL’s and the market research prior to establishing an R&D model. Strategic Imperative Execution Driver
  6. 6. 3rd KEY Gain rapid availability and access to ALL qualified customers across channels that make sense. While this is the 3rd Key it is a crucial step that the distribution process is efficient and targeted through the correct channels
  7. 7. Market Availability/Access Depending on the market there are channels that have varying levels of how products are delivered from a “Buying Process” perspective. These “Varying Levels” are critical to identify, if it’s a product that goes thru an institutional process there’s GPO’s, hospital formulary/buying processes etc that a product has to funnel through. If it’s a retail product there’s a distribution funnel through retail chain channels that need to be identified. Gain rapid availability & access to ALL qualified customer channels Customer targeting and develop “Product Champions” to help fortify product need/distribution. Strategic Imperative Execution Driver
  8. 8. 4th KEY Establish “Leadership Presence” with qualified customers within the market
  9. 9. Market Leadership Presence Developing a “Leadership Presence” takes time and without Keys 1-3 in place… developing any form of leadership will be near impossible. Taking over in a leadership position offers many benefits (e.g. customer loyalty, habit using your product, you will be sought out for expertise). This step is EARNED however can be gain with positive product experience, excellent customer service, and EDUCATION to the HCP and importantly the patient. Establish “Leadership Presence” with qualified customers in market Create “Product” & “Resource” value that establishes a partnership with HCP & patient. Strategic Imperative Execution Driver
  10. 10. 4 Keys To Introducing A Product To Market Disrupt perceived market satisfaction Drive awareness of limitations of current therapies and position your product as an “innovative solution” Bring to market an “Unique”/”Innovative” product that disrupts market Develop a segmentation process where you are gathering feedback from KOL’s and the market research prior to establishing an R&D model. Gain rapid availability & access to ALL qualified customer channels Customer targeting and develop “Product Champions” to help fortify product need/distribution. Establish “Leadership Presence” with qualified customers in market Create “Product” & “Resource” value that establishes a partnership with HCP & patient.
  11. 11. ARE YOU SELECTING THE CORRECT CHANNEL TO PLAY IN?? Examples of areas to consider when selecting the channel(s): • Business Need • Where do you want to play • Market Size Segmentation (example) • New Product Landscape (are you in the right channel?) • Segmentation Variable Prioritization (process example)
  12. 12. Hypotheses for Value Maximization What is the…Business Need? Before bringing any product to market an identification of potential hurdles, possible levers for success, and the development of high-level tactics that could support increased performance for the new product. Pricing and Access Clinical Positioning Commercial Strategy Packaging, Manufacturing, and Logistics Potential “Levers” Explored Subsequent Tactics Additional Detailing Increased Focus on Ultiva Value Proposition Refined Pricing Strategy Refined Clinical Data Package Change in OPEX Spend Mix This information can be gained through market research and conducting a “New Brand Diagnostic” designed to uncover potential forecast intelligence/revenue for new product.
  13. 13. Where do we want….to PLAY? The objective is to identify and address what approaches to take for growth across four key areas: Core: 1st Approach  What is the potential penetration of new product within the chosen customer channel? Core: 2nd Approach  To what extent can revenue be increased by increasing the level of “reach” for new product? Ancillary: 3rd Approach  To what extent can additional customers KOL’s (e.g., general surgeons) support the utilization for the new product? Commercial Approach  What additional marketing activities (e.g., medical marketing, KOL outreach), positioning, or pricing could potentially optimize revenue for the new product? 1 2 3 4
  14. 14. Anesthesia Market Segments Market Landscape Market Size and Segmentation (EXAMPLE) Injected Agents $430M Inhaled Agents $424M Local / Regional / Topical $304M - 200 400 600 800 1,000 1,200 2011Sales($millions) The anesthesia market can be divided into three broad segments with almost $1.2B in annual sales.
  15. 15. Treatment to Target Various Levels of Sedation Procedure Setting New product landscape…are we in the right channel? (EXAMPLE) After the need for an anesthetic agent is established, how will relevant stakeholders determine which agent to use based on procedure and patient characteristics? Patient presents with or physician identifies medical condition. Physician determines need for specific surgical procedure or intervention and determines setting. Anesthesiologist determines level of sedation required and specific anesthetic drug regimen based on procedure/intervention characteristics and patient characteristics. Procedure Characteristics (Length, Location, Intra-Operative Pain, Post-Op Pain) Patient Characteristics (Medical History, Age, Renal and Hepatic Function) Doctor’s Office/Out- Patient Setting Operating Room Emergency Room Other Setting (ICU) Minimal Moderate Deep General Anesthesia Anesthetic Agent Choice for Induction and Maintenance Opioids (e.g., Remifentanil) Benzodiazepines (e.g., Midazolam) Α2-AR Agonists (e.g., Dexmedetomidine) GABAA Rec. Agonists (e.g., Propofol) Inhaled Agents (e.g., Desflurane) Origination Evaluation and Diagnosis Treatment Therapy Choice
  16. 16. 54M+ Inpatient Procedures and Diagnoses 5.8M inpatient surgical procedures [within key specialties] 6.8M inpatient non surgical procedures and diagnoses • Orthopedic • OBGYN • General • Urology “Non-Surgical Acute Pain” 18M Opioid Requiring Patients 1.8M other surgical procedures [outside key specialties] • Cardiovascular • Neurological • Vascular(Micro) 38M Unique Inpatients 14M Patients Requiring “Injectable” Opioid Segments included in revenue forecast New product landscape…are we in the right channel? (EXAMPLE)
  17. 17. Segmentation Variable Prioritization Physician Variables l Specialty l Physician Age l Position in Hosp – P&T Membership – PMC Membership – PMT Membership Hospital Variables l HSA Population l HSA Population Density l Ownership Type (Non-profit, for-profit, govt.) Variables Used in Segmentation Frame Physician Variables l Specialty l MSP Behavioral Sgmts l Target Procedure Decile (from HMS) l Target Procedure Self- Reported Volume l Total Target Procedure Volume l Physician Age l Position in Hospital l P&T Membership l PMC Membership l PMT Membership l Tenure l Fentanyl Use l Practice Setting l Basal use with IV PCA l Negative PCA Experience Patient Variables l % Poor Venous Access l % Elderly Patients l % Frail Patients l % Morbidly Obese Pts Initial Set of Variables Hospital Variables l MSA Population l Population Density l Hospital Bed Size l Existence of Rehabilitation Center l # In-patient Surgical Procedures l # Surgical IC Beds l Participation in Healthcare System l Ownership Type l COTH Membership l Geography l Level of Competition l Pain Mgmt Program l Existence of PMC in Hospital l Pain Team in Hospital l Inclusion of Pain in Patient Satisfaction Survey l P&T Committee Size l Residency Program in Target Specialties Evaluation Criteria l Meaningfulness Testing* – Differences between values generated by cuts in variables – Statistical significance of differences – Review of population distribution generated by cuts in variables l Actionability Examination – Available in HMS or AHA databases (higher) vs. further investigation or guess work on the part of the sales rep (lower) l Hypothesizing and assessing correlation between variables New product landscape…are we in the right channel? (EXAMPLE)
  18. 18. INTRODUCING A New PRODUCT TO AN APATHETIC/INDIFFERENT MARKET Brand Building Landscape: The “Ease Phase” Process • Explore Phase • Assemble Phase • Skill Phase • Evaluate Phase
  19. 19. Brand Building Landscape The “EASE PHASE” Process EXPLORE PHASE Situation analysis, review of the market/ brand, its customer(s), and its competition Discover key brand opportunities, current customer segmentation behaviors / brand leverage points, brand positioning Build the “Personality” of the brand/ campaign and implementation strategy Measure effectiveness of the Explore Phase, Assemble Phase, and Sense Phase. A “Checks & Balance” approach Discern the Market Develop Marketing Objectives & Strategy Design & Implement Integrated Campaign Track & Reevaluate ASSEMBLE PHASE SKILL PHASE EVALUATE PHASE
  20. 20. EXPLORE PHASE Market definition Defining Customers • Each customer segment has a different set of interests (preferences, behaviors, and beliefs) • Each customer segment requires a different approach with regard to goal setting and strategies • Identifying “Optimistic Customers” versus just “Rich Customers” Defining Competition • Analyzing your customers through different approaches (e.g. situational analysis, customer segmentation diagramming, etc • “Strategic War Game”, Market Research elements that identify key market areas, market shares, sales force intelligence, marketing capabilities • Intelligence from “Key Opinion Leaders”
  21. 21. ASSEMBLE PHASE Innovative Campaign and Messaging Mapping Positioning Statement • Identify specific customers behaviors • Are there leverage points to consider? • What are the desired behavior changes? What are the “PRIORITY” target segments? What are the drivers & barriers to behavior objectives? Can we carve out a “UNIQUE” product advantage? What is the “Value Proposition”? Strategic Levers Market Map Customer Portrait Benefit ladder Build the “Positioning Statement” Develop Marketing Objectives & Strategy
  22. 22. Design & Implement Integrated Campaign SKILL PHASE Review brand strategic plan I. Gain buy-in on: • Tactical direction • Allocation of funds -Investment by strategy -Distribution of funds by broad bucket -Pre-launch and Post-launch spends -Spend by key tactic • Key Initiatives and Plan of Execution
  23. 23. Track & Reevaluate (Checks & Balances) EVALUATE PHASE EXPLORE PHASE Discern the Market Develop Marketing Objectives & Strategy Design & Implement Integrated Campaign ASSEMBLE PHASE SKILL PHASE
  24. 24. Brand Building Landscape The “EASE PHASE” Process EXPLORE PHASE Situation analysis, review of the market/ brand, its customer(s), and its competition Discover key brand opportunities, current customer segmentation behaviors / brand leverage points, brand positioning Build the “Personality” of the brand/ campaign and implementation strategy Measure effectiveness of the Explore Phase, Assemble Phase, and Sense Phase. A “Checks & Balance” approach Discern the Market Develop Marketing Objectives & Strategy Design & Implement Integrated Campaign Track & Reevaluate ASSEMBLE PHASE SKILL PHASE EVALUATE PHASE
  25. 25. MARKET SITUATION I: “Un-seed the King” II: “Piece of Pie” IV: “King will NOT give up” III: “King in a small kingdom” Competitordominant Competitor hunger The market that we’re playing in is lucrative yet extremely competitive. The competing brands are fighting for their “piece of the pie” as the market continues to grow with the new product entries. Again this is a fiercely competitive market and a customer segment that is apathetic and indifferent to new products…so disrupting that behavior with an innovative unique product with clinical scientific support can possibly make the difference. As always in most markets there’s one leader that dominates the market landscape and typically apathy and indifference occurs when a new product enters the game. New product entries scramble to find their place among the apathetic and indifferent marketplace. A major investment of resources to uncover intelligence such as , customer segmentation (pt & phys) becomes critical. Identifying access gaps to customers takes on considerable importance and building a clinical registry. While the market continues to grow the market leader continues to enjoy current dominance in a fairly medium size market. New product entries and Non-leaders are currently battling for their share of the pie –and we’ll need to determine based off our intelligence….is it worth the battle?. Very thorough segmentation and market research needs to be done in order to ensure we have a product that’s innovative & unique and one that will disrupt the market place. We anticipate the market leader to not relinquish market dominance too easy and will come out on the offensive to our new product entry. We also cannot lose site that the Non-leaders in the market will come after us because of fear that they will lose their current share to a new product entry. The goal/objective will be to strengthen our medical support (e.g. clinical study support), SWOT analysis so that we are in tuned to our handicaps, create objection handler, and create our own offensive strategies. Example Scenario
  26. 26. Primary Commercial Profiles (versus market leader) Our product similarities to Market Leader: parity efficacy & safety; single dosage form; similar value proposition as market leader (+ QD and dose ranging claims,) Albeit a rather improbable scenario, this places our product on par with market leader and allows us to challenge them for leadership. Our product similarities to Market Leader: parity efficacy & safety; multiple dosage forms: similar value proposition to market leader (+ QD and dose ranging claims,) The most likely scenario, our product is virtually identical to market leader except that multiple doses are required. It is our contention that, from a commercial perspective, it does not matter in that we can still make the same claims yet execution of that platform may be different. Unique: Worst efficacy & parity safety; basis of competition will be the broader safety play; (+ QD and dose ranging claims) The 2nd most probable scenario, we have likely shown a safety superiority to market leader. Safety is the driving issue. Efficacy in subpopulations: parity efficacy & worse safety; efficacy in a select subpopulations (+ QD and dose ranging claims,) The 3rd most probable scenario, efficacy is the driving issue & is to be proposed for subpopulations where specific health issue is very prominent. Troubled: worse efficacy & worse safety; little basis for competition ; other non-clinical ways to compete are necessary Also a low probability scenario, it is still prudent to prepare for the worst case scenario –which this likely is How our product stacks up commercially against (market leader) MARKET SITUATION Example Scenario
  27. 27. Our product is entering the market at a perfect time given the apathy and indifference to the market leader and the unique/innovative presence our product has. • Market is growing to be very attractive & will be so until it evolves into a competitor-dominant class • Our product must have a favorable 1st use experience and disrupt a market that’s laced with apathy and indifference to the current products in the space. We have to compete for market share and market leadership. • We will be 5th to market position which may serve us rather well Our internal corporate objectives include: • Unwavering preparation for competition in a market that’s up for grabs • We may have to continue having shaping in order to prepare for a successful launch • In all cases, we must make the needed investments as soon as we can MARKET SITUATION Example: Commercial Conclusions
  28. 28. Defining the Customer Target Audience Customer Characteristics Differences ANALYSIS/Conclusion PCP customers (High-Volume Prescribers) Cardiologists (Medium Volume Prescribers Key Opinion Leaders in community CD are medium prescribers but they have heavy influence Metrics & decision criteria • Differences can be placed in this category • We are targeting treatment initiators (PCPs and CD-minded physicians e.g. PCPs, internists). • These clinical leaders are similar in terms of treatment mindsets. • The role of the PCP may evolve as the market gets more comfortable with the new product entries, but the ultimate decision maker will most likely still be specialists (CD’s) • As the market evolves, what amount of influence will (CD’s) have in the decision making process? • We need to consider the differences in practice settings that may impact (relative emphasis) of messaging. Treatment initiators vs. managers: • Higher risk patients • Higher data requirements • Greater acuity in efficacy/safety trade-offs Treatment flow: CD/Specialist PCP 1. Positioning/campaign should address common needs of all audiences 2. We need to understand how physicians will measure success in managing specified disease state. Example Scenario
  29. 29. Defining Patient Segments • 2 er Consistencies Differences ANALYSIS Within each segment, there are multiple sub-segments • Pre-existing disease • Elderly • Children • Obese • Do we know how physicians determine appropriate treatment for each segment? • We need to understand the dynamics of each patient segment. – EU is conducting market research on patient switching dynamics and emotional drivers. – ATU studies will also give us a sense of the segments; however, they will not provide the reasons behind choices. • At this point, it is still too early to fully understand emotional drivers; however, we will continue to assess Low risk patient as higher priority US: High risk of stroke, low risk of bleeding, but this is TBD as it could be changing • Assumption is “Our Product” will be indicated for a broad range of patients. These risk differences will be addressed at the messaging level. • It is critical that key patient segments are defined at launch and that we are regionally aligned to ensure rapid brand adoption There is always an untreated segment of patients • This segment is significant (up to 40% in the US) ; and 20% globally. The untreated segment should be considered as part of “Our Product’s” patient base across markets. • Do we adequately understand the dynamics of the untreated patient? There are data gaps concerning the patient build • Potentially, different degrees of market evolution 1. We need to understand emotional attributes across segments—including new and untreated patients—that drive choice at the class and brand levels. 2. We need to better define patients where first use will result in a positive “Our Product” experience Example Scenario
  30. 30. Brand Building Landscape The “EASE PHASE” Process EXPLORE PHASE Situation analysis, review of the market/ brand, its customer(s), and its competition Discover key brand opportunities, current customer segmentation behaviors / brand leverage points, brand positioning Build the “Personality” of the brand/ campaign and implementation strategy Measure effectiveness of the Explore Phase, Assemble Phase, and Sense Phase. A “Checks & Balance” approach Discern the Market Develop Marketing Objectives & Strategy Design & Implement Integrated Campaign Track & Reevaluate ASSEMBLE PHASE SKILL PHASE EVALUATE PHASE
  31. 31. Strategic Levers Process Strategic levers process provides a thorough understanding of how customers currently behave in the market at different stages of the patient management process. Objectives of the Process 1. Understanding of current customer behavior 2. Identifying behavior leverage points and desired behavior changes to drive brand choice
  32. 32. Strategic Imperatives and Executional Drivers Optimize communication of value proposition Generate broad product demand Use in appropriate HCP audience and patient population Gain formulary acceptance by compelling P&T to include safety, satisfaction, quality of care measures in their reviews Convince targeted Physicians to prescribe “Our Product” Disrupt perceived market satisfaction Drive awareness of limitations of current therapies and position “Our Product” as an innovative solution Ensure positive initial product experience
  33. 33. Strategic Levers Key Business Questions • How do patients enter into market ? Is this a growing patient segment market?  What physician specialties are part of the diagnosis process and are they different from treaters?  How long does it take before a formal diagnosis is made?  What are the barriers to diagnosis? Origination Diagnosis / Evaluation Treatment Choice Brand Choice Fulfillment Persistence Class Choice  What is the treatment algorithm?  What are the common treatment options/choices? First line? Second line?  What are the drivers and barriers to treatment use?  What are the common classes of treatment options?  Are classes differentiated in the minds of customers?  Can class differentiation drive brand choice in this market?  How are brands differentiated in the minds of customers?  What are the drivers and barriers of brand choice? Is there a dominant brand?  What is the role of the patient?  What are the barriers to fulfillment?  What is the duration of treatment?  What are the primary reasons for discontinuation?  Who monitors and follows up on progress and compliance? Example
  34. 34. Brand Building Landscape The “EASE PHASE” Process EXPLORE PHASE Situation analysis, review of the market/ brand, its customer(s), and its competition Discover key brand opportunities, current customer segmentation behaviors / brand leverage points, brand positioning Build the “Personality” of the brand/ campaign and implementation strategy Measure effectiveness of the Explore Phase, Assemble Phase, and Sense Phase. A “Checks & Balance” approach Discern the Market Develop Marketing Objectives & Strategy Design & Implement Integrated Campaign Track & Reevaluate ASSEMBLE PHASE SKILL PHASE EVALUATE PHASE
  35. 35. Patient & Efficacy/Safety Patient & Physician Satisfaction “Our Product” KOL Development/Clinical Studies Resources Our Product “Value Proposition” Example
  36. 36. Who: (target audience) For all healthcare professionals For: (patient types) …..whose patients have pre-existing diseases and require therapy (competitive framework) outstanding efficacy and side effect profile with pharmacoeconomic clinical support which (customer benefit – emotional/end use/functional benefits) is a convenient QD dosing and easy to swallow capsule that can be taken w/o food, which makes my life easier because it is comfortable, safe and easy to use, providing optimal therapy (reasons to believe –product attributes) Global Positioning Example
  37. 37. Emotional benefits End-use benefits Functional benefits Product benefits Benefit Ladder Product Benefit Ladder  Therapeutic equivalence to market leader  Better safety profile than market leader  Convenient, New Option, Effective, Safe  Innovative, Unique, Convenient, Safe  Quality of Life:  Convenient  New Option  Effective  Safe It makes my life easier End-use benefits: Internist/Primary Care Physician Convenient, Efficacy, and safe New tool in my armamentarium Happier patients Example
  38. 38. Advertising 2,000$ HCP Education 1,160$ Website Program 500$ Speaker Training and Programs 4,375$ Marketing Research 1,200$ Promotional Materials 5,250$ Samples 5,300$ Publication Plan 370$ Conventions and Exhibits 2,200$ Internet 600$ Public Relations 870$ Selling Aids 6,335$ Incentive Plan 1,500$ Strategic Customer Marketing 440$ Journal Advertising 2,500$ TOTAL 34,600$ Implementation Strategy Example (areas to consider)
  39. 39. Brand Building Landscape The “EASE PHASE” Process EXPLORE PHASE Situation analysis, review of the market/ brand, its customer(s), and its competition Discover key brand opportunities, current customer segmentation behaviors / brand leverage points, brand positioning Build the “Personality” of the brand/ campaign and implementation strategy Measure effectiveness of the Explore Phase, Assemble Phase, and Sense Phase. A “Checks & Balance” approach Discern the Market Develop Marketing Objectives & Strategy Design & Implement Integrated Campaign Track & Reevaluate ASSEMBLE PHASE SKILL PHASE EVALUATE PHASE
  40. 40. Track & Evaluate Process Develop teams to track & evaluate the below initiatives with timelines, milestones and goals. This is a checks and balances process. • Market Analysis • Competitive Analysis • Buying Process • Customer Analysis • Segmentation • Value Proposition • Positioning • SWOT • Critical Success Factors • Strategic Priorities
  41. 41. Let us help you prepare for your new product launch, contact us at: Andre’ Harrell AH2 & Beyond Consulting www.ah2andbeyond.com 267-221-8529

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