![Framework for Evaluating Potential Disease Indications
Define the Goals and Guiding Principles (“Boundary Conditions”) for Go / No-Go Decisions
Maximal revenue potential
Fastest time to market (e.g. slim clinical development plan)
Market that can be addressed by a small commercial organization (e.g. orphan disease)
Plan to generate proof-of-concept for potential partnerships
Define the Parameters to Evaluate Disease Indications
Preclinical (availability and validity of animal models)
Clinical (precedence of clinical development pathway)
Regulatory (precedence of regulatory pathway)
Commercial (epidemiology, unmet needs, competitive pipeline) [Remember your “toolbox”!]
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New Product Planning in the Pharmaceutical Industry
- 1. New Product Planning in the Pharmaceutical Industry TONY RUSSELL , PHD, MBA EXECUTIVE DIREC TOR, PRODUC T STRATEGY AND COMMERCIAL PLANNING THERAVANCE BIOPHARMA US, INC. R E V . 6 . 1 4 . 2 0 1
- 2. Disclaimer The views and opinions expressed are solely those of the speaker and do not represent those of my current or previous employers 2
- 3. Tony Russell, PhD MBA Background and Experience Year Company Position 2015 – Present Theravance Biopharma US, Inc. Product Strategy and Commercial Planning 2010 – 2015 Alder BioPharmaceuticals Commercial Strategy 2007 – 2010 ZymoGenetics (acq. BMS) Medical Affairs 2006 – 2007 ICOS (acq. Eli Lilly) Strategic Marketing 2004 – 2006 Corus Pharma (acq. Gilead Sciences) Product Management 2000 – 2004 Amgen Medical Affairs 1999 – 2000 Baxter Global Marketing 1998 University of Washington PhD (Physiology and Biophysics) 1998 Seattle University MBA 3 https://www.linkedin.com/in/arussellbiotech/
- 4. Learning Objectives Describe the value of new product planning in the pharmaceutical industry Describe the various tools utilized by new product planning professionals Describe the key elements of a new product business plan Describe the skills and background relevant to new product planning positions 4
- 5. Background on New Product Planning 5
- 6. New Product Planning 6 The function responsible for working closely with Research and Development teams to help shape and craft new therapeutics with high commercial value that address significant unmet needs for patients. What is New Product Planning? Research and Development Productivity in the Pharmaceutical Industry is Trending Downwards Drug Development Goals Have Evolved New Product Planning is Different from Traditional Marketing Roles New Product Planning Can Be Valuable in Building Commercial Success Why is New Product Planning Important in Drug Development?
- 7. Downward Trend in Productivity Demands Transformative R&D Strategy 7 Deloitte reports decreased R&D productivity as measured by return on late-stage assets Decreased productivity driven by: ◦ Increasing development costs ◦ Decreasing forecast peak sales per asset Smaller specialized pharma companies outperform large-cap pharma companies, but also have decreasing R&D productivity ◦ Higher return due to higher projected forecast sales offsetting higher development costs Success in early research will feed the successes needed in late-stage asset development and launch of new products “Unlocking R&D Productivity: Measuring the Return from Pharmaceutical Innovation”. 2018. Deloitte 10.1% 7.6% 7.3% 4.8% 5.5% 4.2% 4.2% 3.7% 1.9% 17.4% 17.7% 16.1% 11.0% 12.5% 9.3% 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% 2010 2011 2012 2013 2014 2015 2016 2017 2018 AbsoluteIRR(%) Return on Late-Stage (Ph2 Onwards) Asset Portfolio Large-Cap Pharmas Small Spec Pharmas R&D: Research and Development
- 8. Decreasing R&D Productivity is Not a Recent Phenomenon 8 “Productivity: in R&D, healthcare and the whole economy” Richard Jones (7/18/2018) (accessed at: http://www.softmachines.org/wordpress/?p=2243) R&D: Research and Development
- 9. Increasingly Crowded Markets in the US with More Drugs Approved Over Time 9 0 100 200 300 400 500 600 700 800 900 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Count Cumulative BLA Approvals Cumulative NDA Approvals Cumulative Filings Adapted from: http://fortune.com/2016/12/15/fda-new-drug-approvals-plunge/ Note: 1993 is set as a “reference” year for subsequent years to assess the cumulative effect of additional approvals and filings BLA: Biologics License Application; NDA: New Drug Application
- 10. Crowded Markets Can Impact Ability to Differentiate and Achieve Market Share More challenging to demonstrate higher quality: Efficacy thresholds can increase as technology improves (e.g. better MOA’s, better target engagement, etc.) Safety issues can be minimized with newer generation therapies (e.g. decreased off-target toxicity) More challenging to achieve substantial market share as a late entrant 10 Source: Cha and Yu. “Pharma’s first-to-market advantage.” McKinsey & Co. (https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharmas-first-to-market-advantage) MOA: Mechanism of Action
- 11. Drug Development and Evolving Goals – Obtaining FDA Approval is Not Enough 11 “Biopharmaceutical Research and Development: The Process Behind New Medicines” PhRMA (http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf) Past Goal Current Goal
- 12. Commercialization Roles MARKETING / PRODUCT MANAGEMENT Brand Development Customer Segmentation Salesforce Alignment KOL Engagement Plan Labeling and Packaging Promotional Materials NEW PRODUCT PLANNING / COMMERCIAL STRATEGY Long-Range (3/5/10 Year) Strategic Planning Competitive Landscape Analysis Market Research and Insight Payer Landscape Analysis Market Trends and Analytics Lifecycle Management Plans 12 KOL: Key Opinion Leader
- 13. New Product Planning Role in Drug Development 13 Where We Were Where We Need to Be Image from http://nmtpharma.com/en/drug-development-stages/
- 14. Value of New Product Planning 14 $- $10 $20 $30 $40 $50 $60 $70 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Sales($MM) Sceanrio1 Scenario2 Drivers for Success (Examples) • Clearly defined value proposition • Data above & beyond FDA approval • Strong competitive position Drivers for Failure (Examples) • Value proposition not established • Relatively late entrant • Failed to consider competitive or generic entrants For illustrative purposes only and does not represent any specific set of products PotentialValue
- 15. The New Product Planning “Toolbox” 15
- 16. The New Product Planning “Toolbox” 16 External Assessment Disease Evaluation Patient Journey Treatment Landscape Analytics Market Access Asset Definition Segmentation & Positioning Competitive Intelligence Market Research Target Product Profile Asset Value Pricing Forecasting Portfolio & Risk Management Lifecycle Options
- 17. Disease Evaluation – Defining Unmet Needs 17 Example Disease State Overview Insights Gained from Disease Evaluation: • Patient subtypes • Specific characteristics that define patient subtypes • Overall therapeutic approaches used • Helpful framework for epidemiology evaluation • Good starting point for identifying specific unmet needs Ferranti et al. (2019). Cardiovascular Risk Reduction in High-Risk Pediatric Patients: A Scientific Statement From the American Heart Association. Circulation. 139. Accessed via: https://www.researchgate.net/figure/Figure-High-risk-pediatric-populations-risk-stratification-and-treatment_fig1_331329013
- 18. Diagnosis Map / Patient Journey 18 Insights from Mapping Exercise • Time to diagnosis • Physician specialties involved • Placement of therapies in treatment flow • “Leakage” points where patients stop seeking care • Define specific areas of unmet need Example image from https://medium.com/leoilab/evolving-the-patient-journey-through-artificial-intelligence-8ae0bbc0cd2c
- 19. Treatment Landscape (Current & Future) 19 0 5 10 15 20 25 Preclin Ph 1 Ph 2 Ph 3 Pre-Reg Number of Programs Per Development Stage Disease X Pipeline For illustrative purposes only and does not represent any specific set of products
- 20. Data Analytics Sales and Volume ◦ Sales & volume over time ◦ Days of therapy Prescription Data ◦ Total, refills, new to brand, etc. Epidemiology ◦ Incidence and prevalence rates ◦ Treatment rates 20 0 2 4 6 8 10 2008 2010 2012 2014 2016 2018 2020 PrescriptionVolume(million units) Year Actual Expected In this example, want to understand how the introduction of a disruptive technology impacted the need for a therapeutic class that Company X was interested in introducing new therapies. Widespread Adoption of Disruptive Therapy For illustrative purposes only and does not represent any specific set of products
- 21. Market Access and Reimbursement (US) 21
- 22. Strategic Market Segmentation 22 Segment 1 Segment 2 Segment 3 Segment 4 Company Segment 1 Segment 2 Segment 3 Segment 4 Company Concentrated ApproachUnfocused Approach Benefits of Strategic Market Segmentation • Defines a specific and addressable target patient population • Establishes baseline for forecasts and scenario planning • Provides a framework for efficient planning for clinical development and commercial planning 1 American Heart Association (https://professional.heart.org/idc/groups/ahamah-public/@wcm/@sop/@smd/documents/downloadable/ucm_503396.pdf) 2 National Kidney Foundation (https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics) For illustrative purposes only; not intended to reflect an actual set of specific indications Between 2013 and 2016, 121.5 million American adults had some form of cardiovascular disease.1 Kidney disease affects an estimated 37 million people in the U.S.2 Adult patients with primary hyperlipidemia unable to control LDL-C despite use of other lipid-lowering therapies Stage CKD patients (GFR = 15-29 mL/min) with iron deficiency anemia A B Examples Examples A B
- 23. Approaches to Strategic Segmentation 23 Mapping by Subpopulations Mapping by Attributes For illustrative purposes only; does not reflect any actual compound or program
- 24. Market Research 24 Secondary Market Research • Examples include syndicated market research reports and syndicated prescription data • Information and / or data collected by another entity • Useful for initial landscape assessment Primary Qualitative Market Research • Examples: 1:1 interviews, small on-line surveys • Useful in early stage of development to understand themes and rationale behind treatment choices Primary Quantitative Market Research • Example: large-scale on-line survey allowing for statistical analyses • Useful in later stage of development to understand utility of certain product attributes • Informs potential market share useful in forecasting exercises
- 25. Competitive Intelligence 25 Getting Competitive Intell. Right • Anticipate competitor moves and avoid launch pitfalls • Proactively build barriers to competition • Revise business strategy in realtime to respond to rapidly to competitive dynamics Getting Competitive Intell. Wrong • Maintaining harmful blindspots by using competitive intelligence to validate pre-conceived ideas about the marketplace • Underestimating the competition and failing to anticipate marketplace disruption leading to poor sales performance • Being myopic and failing to see competitive threats from other sources leading to business disruption Intelligence Published Data Social Media Investor Relations New Hires Vendors Trade Shows
- 26. Use of Competitive Intelligence (Example) 26 R&D Phase 1 Phase 2 Phase 3 Approved Your Program Competitor A Competitor B Competitor C Example Key Intelligence Questions: • Patient sub-types in competitor studies? • What line of therapy are the competitors focused on? • Formulation details on advanced competitors? • Endpoints used in competitor studies? • Use of active comparators? • Company resources to support a program? • Internal prioritization within the company? For illustrative purposes only; does not reflect any actual therapeutic. CI: competitive intelligence; KIQs: key intelligence questions; KITs: key intelligence topics Best Practices in CI Work: • Ask specific questions built from specific needs • Don’t use CI to as a replacement for market research • Spend time to develop KIQs / KITs with relevant internal stakeholders • Engage with CI firms with the right skill sets • Educate internal teams on the difference between “information” and “intelligence”
- 27. Target Product Profile 27 Target Minimum Indication Indication Target {placement in therapy; subpopulation(s); ages} Indication Target {placement in therapy; subpopulation(s); ages} Efficacy Efficacy Measures: • Relevant Endpoints (Primary / Secondary) • Include relative comparators (Equal to? Better than?) Efficacy Measures: • Relevant Endpoints (Primary / Secondary) • Include relative comparators (Equal to? Better than?) Safety & Tolerability • Relevant safety attributes • Include relative comparators (Equal to? Better than?) • Relevant safety attributes • Include relative comparators (Equal to? Better than?) Presentation & Dosing Formulation / Route / Frequency Formulation / Route / Frequency Value Proposition: Describe the impact of the therapy in terms of addressing unmet needs for the patient (e.g. efficacy / safety improvements, disease management) and impact to the healthcare system in terms of economic benefits (e.g. reduction of direct costs such as decreasing hospital days).
- 28. Pricing 28 Adapted from “The Strategic Pricing of Pharmaceuticals” (2009) by E.M. Kolassa Value Price Parity Discount Premium “Value” Can be Fuzzy • How is “Value” defined? • Value to whom? Patients? Payers? Physicians? Society? • Value compared to what? No treatment? Current standard of care? Alternative non-drug approaches? Pharmaceuticals are Negative Goods • Tend to lessen the negative effects of a condition (as opposed to adding positive effects) • Not purchased because we want to, but because we must Pricing (in the US) is Under Pressure • Payer and political pressure • Patient advocacy groups
- 29. Forecasting 29 Epidemiology Symptomatic Diagnosed Access Potential Patients Drug-Treated Days of Therapy Price per DOT Revenue $- $10 $20 $30 $40 $50 $60 $70 $80 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Revenue($MM) Base Downside Upside Range Range Range Range Range Range For illustrative purposes only; does not reflect any actual compound or program Range
- 30. Portfolio & Risk Management 30 $- $100 $200 $300 $400 $500 $600 $700 $800 Preclinical Phase 1 Phase 2 Phase 3 Approval RISK-ADJUSTEDNPV($) STAGE OF DEVELOPMENT COMPLETED Example Value Inflection Points Program A Program B Program C For illustrative purposes only; does not reflect any actual therapeutic; the two figures above are not based on the same data; PTRS: probability of technical and regulatory success Tufts Center for Drug Development estimates used in flowchart. Note that certain factors (MOA, delivery mechanism, disease state, etc.) can cause PTRS to vary.
- 31. Lifecycle Management 31 Key Factors Driving Need for Lifecycle Management • Need to Recoup the Costs Involved in Developing a New Therapy • Need for Patent Protection • Need for Risk Management Benefits of Effective LCM Strategy • Extends the “runway” for the revenue stream improving ROI • Provides competitive barriers via new intellectual property against entry of new therapeutics • Provides competitive advantages over other currently available therapeutics Lifecycle Management Options • New Indications • New Patient Populations • New Line of Therapy • New Formulation • New Delivery Options • Integration of Digital Health
- 32. Building the Business Case: Integration of the Inputs 32
- 33. New Product Planning Business Cases 33 Define the Focus of the Program Building the Business Case Evolution of the Business Case Scenario Planning / Strategic Foresight
- 34. Scenarios in New Product Planning 34 Drug X has a unique mechanism of action but entering a crowded market with no clear advantage Drug X is technically feasible but too far behind the competition We have many programs going on, but data read-out on Drug X will be years from now after other programs read out The mechanism of action Drug X means it can be useful in many diseases • As a new product planning professional, common to face multiple scenarios at the same time • Many options and approaches available to deal with the scenarios above • Addressing these issues first will be important as part of building the business case
- 35. Common Scenario in New Product Planning: Drug X with Many Options 35 Drug X Disease #1 Disease #2 Disease #3 Disease #4 Disease #5 Disease #6 • Research and Development teams have developed a drug with a mechanism of action that can address many potential diseases • The Company has limited resources in terms of money and people • Each disease option has significant potential benefit and significant risk • Critical issue: How to sort out the options and prioritize what the company should do? General Description of the Scenario
- 36. Framework for Evaluating Potential Disease Indications Define the Goals and Guiding Principles (“Boundary Conditions”) for Go / No-Go Decisions Maximal revenue potential Fastest time to market (e.g. slim clinical development plan) Market that can be addressed by a small commercial organization (e.g. orphan disease) Plan to generate proof-of-concept for potential partnerships Define the Parameters to Evaluate Disease Indications Preclinical (availability and validity of animal models) Clinical (precedence of clinical development pathway) Regulatory (precedence of regulatory pathway) Commercial (epidemiology, unmet needs, competitive pipeline) [Remember your “toolbox”!] 36
- 37. Systematic Evaluation of New Indications 37 Establish Core Group Define Goals and Guiding Parameters Cross- Functional Examination Refinement Initial Review Final Guidance for Exec. Review
- 38. Evaluation Framework (simple example) 38 Functional Domains Option #1 Option #2 Option #3 Clinical Development • Execution feasibility Regulatory Affairs • Available pathways & precedents Non-Clinical Development • Available & reliable preclinical models Legal Affairs • Strength of patent real estate Commercial • Time to market Manufacturing • Feasibility of formulation options For illustrative purposes only; not intended to reflect an actual set of analyses
- 39. Evaluation Framework (advanced example) 39 25 25 25 12.5 25 12.5 12.5 25 12.5 12.5 12.5 12.5 25 12.5 20 20 10 20 10 10 10 15 15 15 15 7.5 7.5 7.5 10 5 10 10 10 5 5 5 5 5 5 5 5 2.5 100 82.5 77.5 75 70 65 50 Max Disease #1 Disease #2 Disease #3 Disease #4 Disease #5 Disease #6 Commercial Assessment Clinical Development Regulatory Non-Clinical Development Alignment to Corp. Strategy Legal Assessment ScoreWeighting For illustrative purposes only; not intended to reflect an actual set of analyses
- 40. Business Case for New Products 40 Acts as a General Repository of Relevant Information Commercial Positioning Competitive and Environmental Threats Forecasts and Assumptions Provides an Important Summary of Information for Various Groups Clinical Development Teams Business Development Teams Senior Leadership Provides Consistent Framework of Evaluation Portfolio Management Gap Assessment Program-to-Program Comparison
- 41. Key Sections of the Business Case 41 Proposed Positioning in the Treatment Landscape • Including value proposition Unmet Needs in Therapeutic Area • Including health economic burden Overview of Competitive Landscape • Marketed and programs in development Target Product Profile • Target and minimum cases defined Pricing Assumptions • Including relevant analogues High-Level Program Timeline • Time to market Revenue Forecasts • Including detailed description of assumptions Lifecycle Management Options • Timing and prioritization Regional Considerations • US only vs. US + ex-US (5EU, Japan, China, ROW) Risk Factors • Including competitive, program, and environmental risks
- 42. Evolution of the Business Case 42 Update Business Case New Clinical Data New Competitor Info New Market Research New Landscape Info
- 43. Scenario Planning / Strategic Foresight 43 Utility of Scenario Planning / Strategic Foresight • Helps teams to think through probable future scenarios and how to respond • Can help uncover potential weak spots in a program as well as discover new opportunities Assumption Relationship Mapping Scenario Planning and Logic Flow
- 44. Pulling It All Together 44 Program with Strong Support Target Product Profile Competitive Landscape Value Proposition Expert Advice Corporate Culture Evaluation Framework & Guiding Principles “Quick Win / Fail Fast” Mentality Analytics Forecasts, PTRS, & rNPV Analyses Sales and Rx Data Strategic Foresight Future Trends Scenario Planning PTRS: Probability of Technical and Regulatory Success; rNPV: Risk-adjusted Net Present Value; Rx: Prescription
- 45. Group Exercises 45 The Research and Development Team have developed a compound to address a rare disease#1 The Research and Development Team have developed a compound to address a common disease#2 Will You Recommend that the Company Invest in Developing this Therapeutic?
- 46. Description of Disease: • A rare debilitating disease affecting lower limb muscular control resulting in total loss of lower limb function. Patient Information: • The disease tends to develop later in life with most patients in the age range of 45 – 55 years. Given the relatively slow onset of disease, confirmation of diagnosis can take 5 years on average. Specialty physicians (Neurologists) typically make the confirmatory diagnosis and there are about 20 centers around the United States that specialize in treating the disease. The condition leads to a significant impact to mobility and daily functioning. The prevalence of the disease in the United States is estimated to be less than 200,000 and is considered an orphan disease by the FDA. Current Treatment(s): • No pharmaceutical approaches have been approved specifically for the condition. Current treatment options include surgical procedures and use of therapies approved for other indications to help alleviate symptoms. Success rate with current approaches is about 20% and the condition returns in about 3 – 4 years. Market Research: • Research with treating physicians indicate a certain level of satisfaction with surgical procedures but would welcome new options with better success rate in treating and managing the disease. • Research with payers indicate a high level of unawareness of the disease. Given the prevalence data, payers indicate that new treatments for the condition would likely not receive strong barriers to access. Pipeline Assessment: • There are no compounds in Phase 3 clinical development. There are at least 10 compounds in Phase 2 clinical development and 5 compounds in Phase 1 clinical development. A couple of compounds in Phase 2 development are based on novel mechanisms of action. Group Exercise: Case Study #1 46 The Research and Development Team have come to you with an exciting new potential therapeutic and have asked for your commercial perspective. Your input will be important as the organization decides to invest in the program. You have done some preliminary work and compiled the following information: The case study is based on a fictional disease and does not reflect any actual disease state or compounds in development. The case study is for educational purposes only.
- 47. Group Exercise: Case Study #1 47 Description of the Proposed Therapeutic: • The proposed therapeutic in currently in preclinical testing. The compound is designed to target what is believed to be the root cause of the disease via a novel mechanism of action. The scientific rationale is based on early animal model data and there are no relevant human clinical data for similar approaches to the disease. Key Issue to Address: Will You Recommend that the Company Invest in Developing this Therapeutic? If yes, why? If no, why not? Critical Factors: • What are the risks with the proposed therapeutic? • What is the value proposition for the therapeutic? • What are the potential pricing implications? • What are the market access considerations? • What is the competitive strengths / weaknesses of the proposed therapeutic? • What additional information would help in the decision-making process? The case study is based on a fictional disease and does not reflect any actual disease state or compounds in development. The case study is for educational purposes only.
- 48. Group Exercise: Case Study #2 48 The Research and Development Team have come to you with an exciting new potential therapeutic and have asked for your commercial perspective. Your input will be important as the organization decides to invest in the program. You have done some preliminary work and compiled the following information: Description of Disease: • A relatively common inflammatory condition that causes the fingernails to turn a purplish-black color. Patient Information: • The disease typically occurs later in life after the age of 65. The disease is not typically associated with any other inflammatory-related disorders. Given the common occurrence of the condition and the age of the patients, confirmatory diagnosis is typically made by Primary Care Physicians. In some cases, patients will seek care from Dermatologists. The condition is primarily cosmetic but can lead to decrease in quality of life for patients and can limit social behavior. Prevalence of the condition in the United States is estimated to be about 3.0 million in the United States Current Treatment(s): • A wide range of therapies are typically used in the treatment of the condition. These include over-the-counter use of low-potency topical steroids that the patients will usually start with. If low-potency topical steroids are not effective, then a physician will likely prescribe higher-potency topical steroids and oral steroids in more refractory cases. Success rates with topical steroids are about 50% and about 70% with oral steroids. A number of topical steroids are available as generic options. Market Research: • Research with physicians indicate a high level of satisfaction with current treatment options, but would welcome new non-steroid options for patients. • Research with patients indicate a level of dissatisfaction with current treatment options given the need to try different options and frequent physician visits and the need for frequent application of the current topical therapies (6 – 8 times per day). • Research with payers indicate a high level of awareness of the condition. Given the availability of generic options and competing branded options, payers have implemented various access controls (e.g. step-edits, prior authorization) to manage costs. Pipeline Assessment: • There are no relevant therapies in clinical development for the condition. A few of the branded therapies are expected to be available generically in the next 5 – 7 years. The case study is based on a fictional disease and does not reflect any actual disease state or compounds in development. The case study is for educational purposes only.
- 49. Group Exercise: Case Study #2 49 Description of the Proposed Therapeutic: • The proposed therapeutic in currently in preclinical testing. The compound is designed to target what is believed to be the root cause of the disease via a novel mechanism of action. The compound is based on a similar compound that was in development by another company but stopped for unknown reasons. The proposed compound is expected to have a longer half-life, which should provide for less frequent administration. Key Issue to Address: Will You Recommend that the Company Invest in Developing this Therapeutic? If yes, why? If no, why not? Critical Factors: • What are the risks with the proposed therapeutic? • What is the value proposition for the therapeutic? • What are the potential pricing implications? • What are the market access considerations? • What is the competitive strengths / weaknesses of the proposed therapeutic? • What additional information would help in the decision-making process? The case study is based on a fictional disease and does not reflect any actual disease state or compounds in development. The case study is for educational purposes only.
- 50. Classroom Scenario Exercise: Instructions This an TEAM Project assignment(teams will be randomly assigned) Each student will need to create their own Report & Recommendations on the “template” provided – using the attached TEMPLATE Each student has to end-of-the-day Sunday June 14, 2020 to complete their work ON THE TEMPLATE PROVIDED All work must be turned into HCDA designated “BB designated link” by the end of day Sunday, June 14, 2020 ! Be sure to indicate you name and email address on your deck (along with all other team members). Each Individual’s deck WILL BE GRADED Decks will be graded equally based upon: Completeness of Response, Problem Solving & Insights, Application of Marketing Principles, Quality & Explanation of Recommendations 50
- 51. 51 List your answers in most important to least important order 1-3 as noted below: A.. List what are the risks with the proposed therapeutic? (corporate and clinical) 1. 2. 3. B. What is the value proposition for the therapeutic? (value to the Payer) 1. 2. 3. C. What are your main advantages of this product: 1. 2. 3. D. What are your main disadvantages of this product: 1. 2. 3.
- 52. 52 List your answers in most important to least important order 1-3 as noted below: E. What are the potential pricing implications or limitations? 1. 2. 3. F. What are the market access and product coverage by Payers considerations? 1. 2. 3. G. A. List necessary resources and consultation that could support your decision? 1. 2. 3. H. What additional information would be helpful in making your determination? 1. 2. 3.
- 53. 53 List “in-priority” highest to lowest - the 3 critical factors and how they will impact this scenario: Factor #1: Factor #2 Factor # 3 (You may add additional factors if they are relevant & critical)
- 54. 54 • Explain you “final recommendations” and limitations in answering this scenario: “Will You Recommend that the Company Invest in Developing this Therapeutic? If yes, why? If no, why not”? • Include any changes you wish to “suggest” to the Company (if any), & support those recommendations and how they will impact your business decision (positive or negatively) Add pages to your final recommendations if needed, but do not exceed a total of 10 pages total
- 55. Careers in New Product Planning OPTIONAL SESSION: 4:30-5:00PM ANTHONY RUSSEL, PHD 55
- 56. Career Pathways to New Product Planning 56 New Product Planning Marketing Business Analytics Research Clinical Development
- 57. Foundational Skills in New Product Planning Product marketing (launch experience is ideal) Market research (conducting primary research and familiarity with secondary resources) Business analytics and forecasting Competitive intelligence (familiarity with principles and practice) Working with Research and Development functions as part of cross-functional teams Scientific background (MS, MD, PhD, PharmD, etc.) Effective communication and presentation skills Leadership abilities 57
- 59. Re-Cap 59
- 60. Learning Objectives Describe the value of new product planning in the pharmaceutical industry Describe the various tools utilized by new product planning professionals Describe the key elements of a new product business plan Describe the skills and background relevant to new product planning positions 60