1. SESSION 1: Opening Remarks, Program Overview
2. SESSION 2: Crafting an Exit Strategy to Satisfy Stakeholders
   1. Importance of a Compelling Story
   2. Uncovering Exit Triggers
      1. Identifying Key Triggers
      2. Importance of Timing
   3. Balancing Objectives & Concerns
      1. Customer: Healthcare Payer/Provider
         1. Objectives
         2. Concerns
      2. Investor: Angels, VCs, etc.
         1. Objectives
         2. Concerns
      3. Acquirer: New Market, defensive, etc.
         1. Objectives
         2. Concerns
   4. Planning and Tools
      1. Planning Importance
      2. Key Milestones
      3. Planning Tools
   5. Benchmarking and Valuation
      1. Finding Benchmarks
      2. Valuation Milestones
      3. Tools for Comparison
   6. Industry Analysis and Readiness
      1. Industry Life Cycle
      2. Purchase Trigger Database
      3. Disease State Fact Book
      4. Macro/Micro Maps
      5. Assessing Readiness
      6. Examples and Case Studies
   7. Market Factors and Acquirer Attraction
      1. Market Value Factors
      2. Diagnosis and Procedure Rates
      3. Product Types and Category Transitions
   8. Final Considerations
      1. Measures of Success
      2. Innovation vs. Improvement
      3. M&A Timing
3. SESSION 3: Assessing if You Have a Project, Product or Fundable Company
   1. How can biopharms assess start-ups of different maturity?
   2. Quick Screen: 3 minute
      1. Can we win
         1. Macro Map
         2. Micro Map
      2. Is there money in it
         1. Customer
         2. Investor
         3. Acquirer
      3. Can Competitive Advantage be created, sustained & evolved
         1. Platform opportunities
            1. Continuous stream of products
            2. Leverageable technology to rest of company
            3. Defensive: capture early to keep from competition
         2. Sales Channel Scale draws M&A
         3. Other
   3. Quick Screen: 30 plus minutes
      1. Opportunty
         1. Objective: Can we express the opportunity is
            1. Playable at both the macro/micro scale
            2. Favorable view of incumbants
            3. Accreditive
            4. Cannabilize
            5. Fits within acquirer model
            6. Product Development
            7. In-house
            8. License, M&A
            9. Segement
            10. Penetration
            11. Salesforce leverage
            12. New Customers or Markets
            13. Product Life Cycle
         2. Analysis Areas
            1. Market Size
            2. Market Growth
            3. Competitive Mix
            4. Unmet Need
            5. Stage of Maturity
            6. Timing
      2. Risk
         1. Objective: Can you make investors comfortable with the various risks
            1. Can we share Plan B alterrnatives
            2. These are category risks and not company risks
         2. Market
            1. Growth
            2. Defensive
         3. Technology
            1. Is the disease MOA well known
            2. Is their a Biomarker
            3. Clinical Evidence
         4. Leadership
         5. Clinical
         6. Regulatory/Legal
         7. Implementation
         8. Leadership
         9. Financial
            1. Dollars in
            2. Non-dilutive vs Dilutive
            3. Downroad
      3. Risk changes over time
      4. Inside Champions
         1. Science or business
      5. Limitations of early partnership
4. Integrated Flow
   1. The Pitch:
      1. Captures interest and provides a high-level overview of the business opportunity, using elements derived from both the Business Plan and TPP.
   2. Business Plan:
      1. Expands on the pitch by offering detailed strategic, operational, and financial plans, including an integrated view of the TPP to provide a complete picture of how the business will succeed.
   3. Target Product Profile (TPP):
      1. Ensures that the product development strategy is well-defined and aligns with the overall business goals and market needs. The TPP feeds into the Business Plan to support its claims and strategies.
   4. The analogy
      1. Pitch as the lure: Captures the attention of investors with a compelling, high-level overview.
      2. Business Plan as the hook: Secures the investor’s interest by providing detailed and comprehensive plans that support the pitch.
      3. TPP as the line and rod: Ensures that the product development is well-prepared and aligned with market needs, supporting the business plan and making the entire investment proposition robust and reliable.
5. SESSION 4: Crafting Winning Business Plans and Investor Pitches
   1. Business Plan Role:
      1. Detailed document for tackling market, resource application, and achieving scalable success.
      2. Part of due diligence post-pitch to secure investors.
   2. Introduction
      1. Importance of Capitalization Strategy
      2. Overview of Funding Options
   3. Building Blocks for a Business Plan
      1. Market Positioning
      2. Competitive Advantages
      3. Differentiated Technology
      4. Financing Projections
      5. Problem Solution
      6. Team
   4. Pitch Before Plan
      1. Develop and practice the pitch
      2. Write the executive summary and business plan
   5. Elevator Pitch
      1. Capture attention in 10-20 seconds
      2. Highlight:
         1. Importance
         2. Unmet needs
         3. Unique solution
         4. Value creation
         5. Monetization
         6. Team strengths
   6. Pitch Preliminaries
      1. Anticipate questions
      2. Answer "so what?"
      3. Key messages
   7. Essential Topics
      1. Title Slide
   8. Positioning Statement:
      1. Target customer
      2. Need/opportunity
      3. Product name and category
      4. Key benefit
      5. Competitive advantage
      6. Differentiation
   9. Problem
      1. Market need
      2. Current solutions
      3. Customer identification
      4. Market potential
   10. Solution
       1. Product/service offering
       2. Effectiveness evidence
       3. Uniqueness and value
       4. Long-term opportunities
   11. Business Model
       1. Value proposition
       2. Customer channels
       3. Revenue model
   12. Team
       1. Team expertise
       2. Board and advisors
       3. Addressing team gaps
   13. Technology
       1. Unique aspects
       2. IP strategy
       3. Development status
   14. Competition
       1. Landscape
       2. Positioning
       3. Barriers to entry
   15. Finances
       1. Pro forma projections
       2. Key metrics
   16. Market
       1. Size and growth
       2. Target segments
       3. Adoption drivers
       4. Customer acquisition
   17. Status
       1. Milestones met
       2. Future tasks
       3. Financing needs
       4. Exit strategy
   18. Summary
       1. Funding needs
       2. Next steps
6. SESSION 5: Translating Strategy into Execution with a Target Product Profile (TPP)
   1. Introduction
      1. Importance and Components of TPP
   2. Market Assessment
      1. Role of Market Research
      2. Competitive Intelligence
      3. Unmet Needs
         1. Insurers
         2. Physicians
         3. Patients
         4. Healthcare System
      4. Drivers of Use
         1. Insurers
         2. Physicians
         3. Patients
      5. Competitive Assessment
      6. Economic Cost of Disease (health economics)
         1. Direct Costs
         2. Indirect Costs
      7. Patient Populations
   3. R&D Design Specifications
      1. Development Specifications
      2. Target Attributes & Value Drivers
      3. Pricing and Reimbursement
      4. Financial & Strategic Planning
         1. Patient Share
         2. Revenue and Profitability
         3. Pharmacoeconomics
         4. Investments (R&D, COGS, SGA)
         5. Cost of Goods
         6. Licenses and Royalties
   4. MyIP Shield
      1. Problem Identification
      2. Solution Gaps
         1. New IP
         2. M&A
         3. License
      3. Unfair Advantage
         1. Know-How & Assets
         2. Unique Personal Talent
         3. Proprietary Relationships
         4. Intellectual Property (IP, Trade Secrets, Copyrights, Trademarks)
   5. Regulatory Strategy
      1. Regulatory Requirements
      2. Clinical Trials
      3. Reimbursement and Coding
   6. Project, Product, or Platform
      1. Standalone Business
      2. Product Business
         1. Channel Access (Build)
         2. No Channel Access (Partner or License)
      3. Platform (Build)
   7. People Resources
      1. Key Opinion Leaders (KOLs)
      2. Board of Directors
      3. C-Suite
      4. People & Culture
   8. Escalation of Commitment
      1. Momentum
      2. Cost of Change
   9. Strategic Framework
      1. Target Market Profile (TMP)
      2. Strategic Target Profile (STP)
      3. Target Product Profile (TPP)
         1. Indications and Usage
         2. Dosing and Administration
         3. Contraindications
         4. Warnings and Precautions
         5. Adverse Reactions
         6. Description
         7. Clinical Pharmacology
         8. Clinical Studies
         9. Storage and Handling
   10. Collaboration and Communication
       1. R&D and Marketing Collaboration
       2. Cross-Functional Team Assembly
       3. Market Research in Clinical Trial Planning
       4. Engagement with Payers
   11. Finalizing the TPP
       1. Aligning TPP with Company Goals
       2. Decision Making
       3. Resource Planning and Budgeting
       4. Regulatory Strategy
       5. Market Access and Commercialization
       6. Communication and Collaboration
7. SESSION 6: Navigating Coding Systems and Optimizing Pricing and Reimbursement
   1. Objective: Integrate coverage issues into Clinical Trial Design
      1. TPP
   2. The Middle Way
      1. Coverage with Evidence Development (CED)
      2. paying for enrolled study
   3. Two public agencies with differing authorities
      1. FDA is not the Beginning or End of you pathway
         1. May require more safety data
      2. Medicare efficacy not proven
         1. May require more benefit data
      3. Agencies occasional get confused by their own rules
   4. If you start this at commercialization it may be to late
      1. Coverage
         1. Terms & Conditions for payment
         2. Hearing Aide vs Prosthetic
         3. Coverage is not guaranteed by FDA approval
      2. Coding
         1. How do you identify for billing
         2. Having a code does not mean coverage or payment
         3. ICD-10, CPT, HCPCS, DRG, APC, RUG
         4. Key coding Issues
            1. Site of Service
            2. Professional vs Technical Codes
         5. Who owns the code set?
            1. AMA
            2. CMS
            3. HIAA
      3. Payment
         1. Methodology for payment
   5. Happiness of the various down stream contributors
      1. Allies
      2. Adversaries
      3. Does it make economic sense for all players
   6. Coverage Considerations
      1. Who will benefit
      2. What are the outcomes
         1. Outside of a well controlled clinical trial
      3. Are their specific prerequisites
      4. Key coverage areas
      5. Understand realistic timeframes is critical
      6. Where will the benefit be derived
      7. Benefits to traditional approaches
         1. Breakthrough
         2. Replacement
         3. Compliment (additive)
      8. Immediate vs long-term benefits
   7. Why is coverage declined
      1. Experimental/investigational
      2. Not approved by FDA
      3. Lack of evidence
      4. Innovation not in a defined benefit category
      5. No reliable evidence for the targeted population
         1. Lack of design power
      6. Does not fit withint existing practice guidelines
      7. Unproven services
   8. CPT Code Process
      1. Slide 34
   9. Sunshine Act
      1. Payment to physician and hospitals
      2. Products in research phase are an exception for 3 yrs or 1 yr after FDA approval
         1. Reported
8. SESSION 7: Demystifying Regulatory Pathways for Market Entry
   1. Introduction
      1. Importance of Regulatory Pathways
      2. Overview of Regulatory Agencies
   2. Regulatory Bodies and Organizations
      1. FDA Organization
         1. Office of the Commissioner
         2. Center for Biologics Evaluation and Research (CBER)
         3. Center for Drug Evaluation and Research (CDER)
         4. Center for Devices and Radiological Health (CDRH)
      2. Other Regulatory Agencies
         1. European Medicines Agency (EMA)
         2. Health Canada
         3. Medicines and Healthcare products Regulatory Agency (MHRA)
   3. Acts and Regulations
      1. PHS Act (42 USC 262-63) Section 351
      2. FD&C Act (21 USC 301-392)
      3. Prescription Drug User Fee Act (PDUFA)
      4. FDA Amendments Act
      5. Biologics Price Competition and Innovation Act
      6. FDA Safety and Innovation Act
      7. Other Relevant Acts and Regulations
   4. Regulatory Pathways for Different Products
      1. U.S. Biologic Products
         1. IND (Investigational New Drug Application)
         2. BLA (Biologics License Application)
      2. U.S. Drugs
         1. IND (Investigational New Drug Application)
         2. NDA (New Drug Application)
      3. U.S. Medical Devices
         1. 510(k)
         2. IDE (Investigational Device Exemption)
         3. PMA (Pre-Market Application)
      4. International Regulatory Pathways
         1. EMA (European Medicines Agency)
            1. Centralized Procedure
            2. Decentralized Procedure
            3. Mutual Recognition Procedure
         2. Health Canada
            1. New Drug Submission (NDS)
            2. Abbreviated New Drug Submission (ANDS)
         3. MHRA (UK Medicines and Healthcare products Regulatory Agency)
            1. Marketing Authorization Application (MAA)
   5. Regulatory Phases and Milestones
      1. Preclinical Phase
         1. Safety Studies
         2. Toxicology
         3. Pharmacology
      2. Clinical Trials
         1. Phase 0, 1, 2, 3
      3. Product Approval
         1. BLA/NDA Submission (for Biologics and Drugs)
         2. 510(k)/PMA Submission (for Medical Devices)
      4. Post-Marketing Studies (Phase 4)
   6. Regulatory Planning and Compliance
      1. Product Development Plan (PDP)
         1. Manufacturing Development Plan
         2. Preclinical Development Plan
         3. Clinical Development Plan
         4. Regulatory Development
      2. Good Manufacturing Practices (GMP)
      3. Good Laboratory Practices (GLP)
      4. Good Clinical Practices (GCP)
      5. Quality System Regulations (QSR) for Medical Devices
   7. Expedited Review Pathways
      1. Accelerated Approval
      2. Fast Track
      3. Breakthrough Therapy
      4. Priority Review
   8. Effective Communication with Regulatory Authorities
      1. Pre-IND Meetings
      2. End of Phase 2 Meetings
      3. Pre-BLA/Pre-NDA Meetings
   9. Final Considerations
      1. Understanding Regulatory Expectations
      2. Comprehensive Product Development Planning
      3. Importance of Upper Management Support
      4. Achieving Regulatory Compliance
9. SESSION 8: Intellectual Property Mastery: From Fundamentals to Strategic Defense
   1. Types of IP Rights
      1. Patents
      2. Trademarks
      3. Copyrights
      4. Trade Secrets
   2. Patenting Essentials
      1. Key Requirements
         1. Composition of Matter: Chemical Structure
         2. Methods Claims: How It Is Made
         3. Utility Patents: New and Useful Processes, Machines, Manufactures, or Compositions of Matter
         4. Design Patents: Ornamental Design of Functional Items
         5. Plant Patents: Asexually Reproduced Plant Varieties
      2. Filing Strategies & Timing
      3. Confidentiality Agreements
   3. Strategic IP Management
      1. MyIP Shield
      2. SWOT Analysis & Innovative Approaches (break & repair)
      3. Linking IP to Business Functions
   4. Challenges & Requirement
      1. Patent Challenges & Solutions
      2. Patent Requirements: Utility, Novelty, Non-obviousness, Enablement
      3. Freedom to Operate (FTO)
   5. Ownership & Inventorship
      1. Determining Inventorship
      2. Ownership & Agreements
   6. Integrating IP into Business Strategy
      1. Positioning & Competitive Edge
      2. Preparing Investor Pitches
      3. Communicating IOP Value
10. SESSION 9: Expert Q&A - Applying Frameworks to Your Venture
11. SESSION 10: Building an Effective Board and Managing the Relationship
    1. What do boards do?
       1. Provide overall guidance for the company
       2. Governance
          1. Finance & audit
          2. Policies such as signing authority
          3. Compensation
             1. Approve capitalization table
             2. Approves ESOP Plan
          4. Budgeting & Key Hires
       3. Hire/Fire Sr. Management
       4. Provide connections & network
       5. Determine the financing events
          1. Equity
          2. Loans
          3. Other
          4. Approve capitalization table
       6. Determine liquidity event
          1. Acquisition
          2. Merger
          3. IPO
          4. Management buyout strucutures
       7. Strategic Transactions
          1. Major partnerships
          2. Joint Ventures
    2. Board composition
       1. Depends on the stage of the company
       2. Not necessary but most choose odd number to reduce risk of tie votes
       3. Founders usually keep 2 seats for common stock holders
       4. After seed, a board seat starts getting allocated to the person who leads the round
       5. Keep in mind when you accept an investor, you are accepting a board member
       6. Some investors will attach a board seat to the term sheet
       7. After 2nd or 3rd round, you should try to get an independent
       8. How to plan from R&D to Commercialization Boards
       9. The representative of the board member represents the entire series
       10. If the board gets to big, transfer to observers
           1. They can participate
           2. They don't vote
    3. Where do their loyalties lie?
       1. Fiduciaries
          1. A person entrusted to benefit others
       2. Obligation to act responsibly
          1. Duty of Care
          2. Duty of Responsibility
       3. A common misperception is that they are their to protect their own investment
       4. Maximize value of all stockholders
       5. The board can get sued by stockholders
          1. D&O Insurance
          2. If not executing their duties
    4. Duty of Care
       1. The duty of care says that directors must be informed about what is going on and make decisions armed with the relevant facts.
       2. If the director has a conflict of interest, the conflict must be disclosed to the other board members and the conflicted board member should recuse him/herself from the discussion and approval process
    5. How often should a board meet
       1. Depends on stage of company
       2. Pre-seed/Seed - could be once a month
          1. Usually 60-90 minutes
       3. Early-stage - quarterly
          1. Lasts about 3 hours
       4. Executive Session
          1. Have one every meeting
          2. Any board member can generally request a Board Meeting to discuss a specific issue
    6. Do I pay board members
       1. Varies by stage
       2. Varies by board member type
          1. Investors
          2. Founder
          3. Independent
       3. Board members who represent their own funds generally not compensated
       4. It is typical for independent to get compensated for time and services
          1. For early-stage range is 0.5% to 2.0% equity
          2. Percentage drops over time as company gets more de-risked
          3. In some cases, cash compensation is included $500-$2000 a meeting
       5. All directors are reimbursed for travel and out-of-pocket expenses
          1. A policy is adviseable
       6. Board members are also supported by indemnification and D&O insurance
          1. Secure against loss or action
          2. Generally a $1M per member
    7. Problems and Issues
       1. My board wants to get rid of me
          1. More complexity requires more experience
          2. Founder may find themselves removed from the board
          3. CEO/Founder can control ESOP for more voting power
          4. Try to plan for a future founder role upfront
       2. My board members disagree
          1. Board members should cooperate yet have vigorous discussions
          2. Consensus must be met by a vote
          3. If you have a board where votes are frequently divided and contentious, then you have a serious problem at the company itself
          4. The issue may sit with one particular board member, you should address that member’s issues separately
       3. Some of my investors want to be observers
          1. Some investors have made large investments but not enough to warrant a seat
          2. You might want to compromise if they cause problems among investor base
          3. Directors are bound by confidentiality requirements and have fiduciary duties and are covered by attorney/client privilege, while observers are not
          4. Involve lawyers to make correct observer agreements
    8. What makes a good board meeting
       1. Keep your company story aligned
       2. Have clear meeting objectives
       3. Tie actions and decisions between each board meeting
       4. Do what you say, and they will trust what you do
       5. You will not always get what you want, prepare for a Plan B
       6. A board presentation is as important as an investor pitch
       7. The board works for you (CEO)
          1. Yes - Governance and oversight
          2. Strategic choices, not strategic direction
          3. Not tactical decision makers
12. SESSION 11: De-Risking through Strategic Alliances
    1. Forms and Definitions of Strategic Alliances
       1. Joint Venture
       2. Equity Partnerships
       3. Non-Equity Partnerships
    2. Increasing Biopharmaceutical Partnerships
       1. Historical Data and Trends
       2. Examples of Successful Partnerships
    3. Reasons for Partnering
       1. Utilize Additional Resources
       2. Share/Reduce Risks
       3. Expand Market Access
       4. Build Credibility/Brand Awareness
       5. Leverage Expertise
       6. Drive Innovation
       7. Acquire Capabilities
    4. Benefits of Strategic Alliances
       1. Access to Resources and Capabilities
          1. Supplementary Knowledge
          2. R&D Facilities and Services
          3. Additional Expertise and Functions
          4. Network of Key Opinion Leaders
       2. Cost Sharing and Accelerated Timelines
    5. Using a Partner’s Brand
       1. Enhancing Technology Development
       2. Reducing Risks
       3. Building Trust and Credibility
       4. Due Diligence Waiver
       5. Positive Reputation Impact
    6. Borrowing Brand through Proprietary Relationships
       1. Due Diligence
       2. Government and Regulators
       3. Channel Partners and Customers
       4. Acquirers and Capital Providers
       5. Management Team and Advisors
       6. Legal Structures and Grants
    7. Driving Innovation and Market Access
       1. New Geography
       2. New Applications
       3. New Regulatory Pathways
       4. New Launches
       5. New Partnerships
    8. Challenges of Strategic Alliances
       1. Finding the Right Partner
          1. Similar Vision and Values
          2. Long-Term Commitment
          3. Adequate Resources
          4. Brand and Reputation
       2. Lack of Control
          1. Shared Responsibilities and Resources
          2. Limited Influence and Alternative Processes
          3. Complex Decision-Making
       3. Additional Liability
          1. Financial Constraints and Mismanagement
       4. Communication Issues
          1. Lack of Transparency
          2. Miscommunication and Teams Disconnect
          3. Missing Information
    9. Survey Insights on Joint Venture Success and Failure
       1. Key Factors for Success
          1. Clear Objectives and Goals
          2. Strong Governance and Management
          3. Effective Communication and Transparency
          4. Aligned Vision and Values
          5. Adequate Resources and Capabilities
          6. Regular Monitoring and Review
       2. Common Reasons for Failure
          1. Misaligned Objectives and Goals
          2. Poor Governance and Management
          3. Lack of Effective Communication
          4. Cultural and Operational Differences
          5. Insufficient Resources and Capabilities
          6. Inadequate Monitoring and Review
13. SESSION12: Developing Your Investment Pitch (Homework)
    1. Introduction
       1. Importance of Aligning Strategy with Investor Expectations
       2. Crafting a Compelling 30-Second Pitch
    2. The Preview
       1. Overview and Summary of the Opportunity
       2. Key Aspects of the Venture Concept
       3. Quick Pitch Components
    3. The Venture Concept
       1. Market Need and Problems
       2. Solution and Customer Pain Points
       3. Existing Market Gaps
       4. Customer Profiles
    4. The Market Need
       1. Identifying Clear Market Needs
       2. Current Methods Addressing the Problem
       3. Primary and Secondary Customer Profiles
    5. The Product Offering
       1. Near-Term Product/Service Description
       2. Functionality and Technology Overview
       3. Intellectual Property and Protection Strategies
       4. Development Status and Proof-of-Concept
       5. Long-Term Market Potential and Scalability
    6. The Market Opportunity
       1. Market Opportunity Analysis
       2. Patient Demographics and Treatment Methods
       3. Market Size, Growth Rates, and Trends
       4. External Factors Influencing Market Growth
       5. Competitive Advantage Sustainability
       6. New and Untapped Market Demands
    7. The Competition
       1. Major Companies and Product Lines
       2. Competing Technologies in Development
       3. Competitive Positioning
       4. Competitive Landscape Overview
    8. The Business Model
       1. Comprehensive Market Strategy
       2. Manufacturing, Marketing, Sales, and Distribution Plans
       3. Cost of Goods Sold (COGS) Analysis
       4. Projected Market Share and Revenue Forecasts
       5. Scaling and Pricing Strategy
    9. The Commercialization Plan
       1. Detailed Commercialization Plan
       2. Intellectual Property Strategy
       3. Market Selection Rationale
       4. Product Adoption Drivers
       5. Performance Metrics and Data
       6. Reimbursement Strategies
       7. Regulatory Pathway and Compliance
       8. Sales Channel and Pricing Strategy
    10. Future Milestones
        1. Key Product Development Milestones
        2. Regulatory Milestones
        3. Product Launch Timelines
        4. Hiring Plan for New Positions
        5. Additional Significant Milestones
    11. The Management Team
        1. Team Composition
        2. Scientific Advisory Board
        3. Board of Directors
        4. Domain Experience and Special Skills
        5. Special Relationships
    12. Funding Needs
        1. Current Funding Requirements and Use of Funds
        2. Future Funding Needs and Timelines
        3. Investor Profit Realization and Exit Strategy
        4. Summary of Funds Raised to Date
    13. Opportunity Summary
        1. Fundability Assessment
        2. Potential Sources of Follow-Up Funding
        3. Strategy for Securing Additional Funding
        4. Key Fundable Milestones and Progress Tracking
14. SESSION 13: Presenting Your Pitch for Expert Feedback
15. SESSION 14: Building an Entrepreneurial Management Team
    1. Building the Entreprenuerial Team
       1. Focus: Selection, Balance, and Evolution of Team Members
       2. Key Activities
          1. Identifying skill gaps and potential roles
          2. Assessing fir for the company's culture and stage
          3. Making decisions on hiring, firing, and role adjustments
       3. Evolution
          1. Preparing team members for changes as the company grows
          2. Replacing or reassigning roles to align with company needs
       4. Leadership Involvement
          1. CEO and BOD members discuss real decisions and changes
    2. Team Building
       1. Focus: Enhancing Cohesion and Performance of Current Team
       2. Key Activities
          1. Developing interpersonal relationships
          2. Improving communications and collaboration
          3. Organizing team-buildning events and activities
       3. Goal:
          1. Stengthening the team's ability to work together effectively
          2. Addressing and resolving conflicts
       4. Implementation
          1. Activities are led by team leaders or external facilitators
16. SESSION 15: Building Your Capitalization Strategy
    1. Introduction
       1. Importance of Capitalization Strategy
       2. Overview of Funding Options
    2. Funding Sources
       1. Bootstrapping
       2. Friends and Family
       3. Incubators and Accelerators
          1. Startup programs providing funding, mentorship, and resources in exchange for equity or a small investment
       4. Government Grants and Programs
          1. Accessing non-dilutive funds through government initiatives
          2. Benefits: Independent validation of technology, significant funding opportunities
          3. NIH
             1. Benefit: Dilutive Funding
             2. Benefit: Independent validation of technology
             3. $45 Billion available, 10% for research
       5. SBIR/STTR
          1. Turbo Tax Version: User-Friendly Application Process
          2. Find & Fund Platform: Centralized Resource for Funding Opportunities
    3. Forming Alliances
       1. Necessity of partnerships to bring a drug to market (de-risks follow-on investment)
       2. Clear value proposition that benefits all parties involved (2-way benefit)
       3. Assembling a reputable and experienced team to reduce perceived risk (borrow brand)
       4. Understanding the in-licensing process and timing associated with each company (triggers)
    4. Angel Investors
       1. High-net-worth individuals providing capital, expertise, and mentorship in exchange for equity
       2. Attributes and Considerations
          1. Investment Horizon
          2. Diligence Approach
          3. Deal Terms
    5. Venture Capital
       1. Funding from venture capital firms for high-growth startups with potential for significant returns
       2. Substantial funding in exchange for equity and active support
       3. Understand needs
          1. Money per deal needed
          2. Exit timing for their fund
    6. Corporate Investors
       1. Partnerships with established corporations or strategic investors
       2. Alignment with business interests or potential synergies
       3. What is their play?
          1. New Market
          2. Defensive Move
          3. Salesforce Leverage
    7. Impact Investors
       1. Attracting investors focused on financial returns and positive social/environmental impact
       2. Example, Parkinson, Alzheimers
    8. Crowdfunding
       1. Raising funds from a large number of people through online platforms (one investment class)
       2. Contributors receive rewards, equity, or pre-orders of the product
    9. Private Equity
       1. Funding from private equity firms for established startups or mature companies
       2. Goals: Growth, operational improvements, and eventual exit strategies
    10. Initial Public Offering (IPO)
        1. Raising capital by offering shares of the company to the general public through a stock exchange
    11. Debt Financing
        1. Loans or lines of credit from banks, financial institutions, or alternative lenders
        2. Repayment with interest
    12. Key Considerations
        1. Non-Dilutive Funding
           1. Government grants and programs
        2. Investor Criteria
           1. Needs and timing for investments
        3. Corporate Partnerships
           1. Strategic alliances for market entry
    13. Strategic Elements of Out-Licensing and Partnering
        1. Importance of forming alliances
        2. Development expertise (preclinical, clinical, CMC, regulatory)
        3. Commercial capacity and capabilities
        4. Long-term Considerations
           1. Cost-effectiveness
           2. FDA approval and payer reimbursement
           3. Comparative efficacy
        5. Partnering Realities
           1. Innovation, risk, and strategic fit
           2. Intellectual property (IP) and freedom to operate
           3. Deal structure and financial commitments
    14. Doing Business with NIH
        1. Benefits of collaborating with NIH
        2. Top Non-Dilutive NIH Opportunities
           1. In-licensing of NIH technology
           2. Research collaborations
           3. Pre-clinical and clinical research services
           4. Selling products/services to NIH
           5. Grants and contracts from NIH
           6. Utilizing NIH information sources
    15. De-Risking and Gaining Momentum
        1. Incremental Risk Removal
           1. Identifying and mitigating key risks
        2. Borrowing Brand Equity
           1. Leveraging reputable partners and funders to enhance credibility and reduce perceived risk
        3. Gaining Momentum
           1. Building investor confidence and accelerating progress through strategic alliances
    16. Additional Insights
        1. Number of deals and capital raised by deal type in healthcare
17. SESSION 16: Pre-Seed/Seed
18. SESSION 17: Early-Stage
19. SESSION 18: Managing Media Relations
    1. Why Media Relations Are Important
    2. Raising Money
       1. Essential for attracting investors
       2. Visibility to potential funders
    3. Driving Perception
       1. Influences public and market perception
       2. Media coverage shapes how your company is viewed
    4. Generating Google-able Data
       1. Ensures presence in online searches
       2. Boosts discoverability and credibility
    5. Public Relations vs. Advertising
       1. PR: Third-party endorsement
       2. Advertising: Self-promotion
    6. Types of Media
       1. Traditional Target Media
          1. Financial Markets Media
          2. Bioindustry Press
       2. Mainstream Media
          1. Larger audience reach
          2. Includes TV, radio, print, and digital platforms
    7. Key Strategies for Media Engagement
       1. Know Your Audience
          1. Tailor your message to the specific media outlet and its audience
          2. Understand what is important to them
       2. Building Relationships with Journalists
          1. Develop trust and rapport with key journalists
          2. Provide valuable and relevant stories
       3. Utilizing Press Releases
          1. Crafting effective press releases
          2. Distributing through multiple channels
    8. Effective Communication Techniques
       1. Speaking the Right Language
          1. Financial Markets Media: Language of money
          2. Bioindustry Press: Language of bioentrepreneurship
          3. Mainstream Media: Simplified, everyday language
       2. Writing Clear and Compelling Messages
          1. Avoid jargon and technical terms
          2. Use relatable and understandable language
    9. Leveraging Social Media
       1. Integration with Traditional Media
          1. Enhance reach through social media platforms
          2. Engage with audiences directly
       2. Viral Potential
          1. Amplifying news through social sharing
    10. Managing Media Relations
        1. Proactive Engagement
           1. Regular updates and consistent communication
        2. Crisis Management
           1. Addressing negative coverage promptly
           2. Strategies for mitigating damage
    11. Measuring Media Impact
        1. Tracking Media Mentions
           1. Monitoring coverage in different media outlets
        2. Analyzing Media Exposure
           1. Evaluating the reach and effectiveness of media engagements
    12. Rules for Working with Journalists
        1. Know your journalist’s interests
        2. Be truthful and transparent
        3. Provide accessible and credible spokespersons
        4. Always respond to media inquiries promptly
        5. Never attempt to control the story; focus on providing valuable information
20. SESSION 19: The Mechanics of Capitalizing Your Venture
    1. Formation
       1. Why Formation Matters
          1. Choosing the right entity structure for tax, operational, and investment purposes
       2. Types of Entities
          1. C Corporation: Default choice, well-understood structure, M&A/IPO advantages
          2. Limited Liability Company (LLC): Tax advantages, simplified structure
       3. Entity Structure and Location
          1. Where to Incorporate/Organize
       4. Words with Similar Meanings
          1. Corporation vs. LLC Terminology (e.g., Board of Directors vs. Board of Managers)
    2. Value Proposition
       1. Key Components
          1. Entity structure, equity distribution, employee compensation plan
          2. Identifying and mitigating risks in technology development and product acceptance
          3. Credible estimates of market size, timeline to market entry, pace of acceptance, and reimbursement scale
       2. Novel vs. Not Novel
    3. Governance
       1. Governance 101
          1. Roles and responsibilities of the Board of Directors/Managers and Stockholders/Members
       2. Decision-Making Roles
          1. Key decisions: budget, management compensation, material agreements, exit planning, future financings, exit
       3. Board-CEO Relationship
          1. Effective communication and adherence to board policies
    4. Financing and Capitalization
       1. Capital Stock
          1. Types of stock: authorized, issued, reserved, fully diluted shares
       2. Building the Cap Table
          1. Process of allocating shares through different financing rounds
       3. Financing Process and Documentation
          1. Key steps: term sheet, due diligence, definitive agreement negotiation, closing
       4. Key Investment Terms
          1. Valuation, capitalization structure, securities laws
    5. Taxation Models
       1. Corporation vs. LLC Taxation
          1. Comparison of tax implications
       2. Capital Gains Tax Forgiveness for C Corp Stock Sale
       3. Revenue Distribution
          1. Differences in revenue distribution between entity types
    6. Preferred Stock Terms
       1. Liquidation Preference
          1. Protects investors by ensuring they receive their initial investment (plus dividends) before common stockholders
       2. Anti-Dilution
          1. Protects investors from dilution in future financing rounds
       3. Voting Rights
          1. Significant influence over company decisions
    7. Valuation Methods
       1. Founder-Friendly Method
       2. Investor-Friendly Method
       3. Dollars Invested Compromise Method
    8. Exit Strategies
       1. Payout “Waterfall”
          1. Sequence of distributions to different classes of stockholders during an exit
       2. Return on Investment
          1. Calculation of returns for different exit scenarios
       3. Liquidation Waterfall Examples
          1. $20M Exit, $120M Exit
    9. Key Considerations for Capitalization
       1. Early Life of the Company
          1. Different financing structures: convertible notes, equity rounds
       2. Documentation
          1. Essential agreements: stockholders agreement, investor rights agreement, right of first refusal & co-sale agreement, voting agreement