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Biotechnology in Practice > L18 Business Plans > Flashcards

L18 Business Plans Flashcards

1
Q

Licensing steps

A
  1. non-confidential disclosure
  2. face to face meeting under CDA
  3. due diligence
  4. negotiate Term Sheet
  5. sign contract
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2
Q

Spinout company to hold IP - steps

A
  1. raise funds with VCs or other investors
  2. add value with more development/trials
  3. exit - sell company or float IPO on stock exchange
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3
Q

License IP to industry pros and cons

A

see onenote table

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4
Q

Spinout company to hold and develop IP - pros and cons

A

see onenote table

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5
Q

Foundations of a biotech business

A
  1. passion and purpose
  2. product idea
  3. technology
  4. disease focus
  5. customer focus
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6
Q

Choosing a direction to build a business plan around

A

see onenote slides

  1. company mission
  2. resources
  3. capabilities
  4. unsolved clinical problems
  5. goals, measure of success
  6. strategy for growth
  7. how to make it happen
  8. leadership, communication and HR plans
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7
Q

Why do you need a business plan?

A
  1. internal document to show board of directors you know what you’re doing
  2. external document to show investors you know what you’re doing
  3. planning document to figure out what you’re doing
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8
Q

Typical business plan headings

A

see onenote

  1. The Business
  2. The Market
  3. The Future
  4. The Finances
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9
Q

Execution or Exploration

A

see onenote

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10
Q

Alternatives to traditional business plans

A

writing a full business plan with detailed projections can trap you into believing them and not looking for what’s really going to impact your business

more flexible, early planning tools have emerged:

  1. business canvas
  2. lean launch pad/startup methods
  3. pitch pack - VC
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11
Q

The business canvas

A

see onenote slides

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12
Q

Is there an unmet need?

A

see onenote slides

First, talk to doctors and patients to find out what are the big unsolved clinical problems?

a. check with clinicians whether what researchers think is an unmet need, really is an unmet need
b. does your solution meet the needs of clinicians and patients
c. would your solution offer a big improvement on how clinicians are dealing with the problem now

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13
Q

Market Research

A

To discover if they’ll buy your product

Primary research sources for unmet needs, user preferences, work practices

  • interviews
  • questionnaires
  • focus groups
  • observation

To discover the size and shape of your potential market

secondary research sources for demographics, pop growth, age, prevalence, incidence etc.

  • gov’t agencies
  • census
  • industry associations
  • company websites
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14
Q

Example - Opthamology market segment analysis

A

see onenote table

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15
Q

Your value proposition

A

see onenote

  • based on understanding your key customer’s problems and desires
  • what compelling benefit will your product/service product that they really care about?
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16
Q

Entrepreneur issues - a solution in search of a problem

A

see onenote

17
Q

Startup methods for Life Sciences - dual pathway

A

Dual part

  1. Making technology, science better, efficacy in humans
  2. What are the commercial things we need to know
    a. Is it commercially valuable
    b. Regulatory issues
    c. IP
    d. Reimbursement - who pays for the drugs, therapeutics, diagnostics
    e. Understanding clinical trials

Get the key scientist/principal investigator outside the lab, to understand the commercialisation
- To understand the second part, not just the science

18
Q

Biotech customers

A

Who your customers are changes as you go

  1. clinicians
  2. patients
  3. patent offices
  4. investors
  5. industry
  6. regulators
  7. reimbursement agencies

with every customer, you need to test your hypotheses about your assumed “truths”

19
Q

Target product profile

A

see onenote

To guide product development

  1. indication
  2. usage
  3. efficacy
  4. marker
  5. safety
  6. dose/delivery
  7. manufacture
  8. patent
20
Q

Guiding lights for the business

A

see onenote slides

  1. vision
  2. mission
  3. core capabilities
  4. target customers
  5. objectives/goals
  6. strategy
  7. values
  8. culture
  9. leadership
  10. risk management
21
Q

Vision

A

see onenote

  • ambition of you you want to be in the end
22
Q

Mission statements

A

see onenote slides

  • can define the business you’re in
23
Q

Goals

A 
SMART goals:
Specific
Measurable
Attainable
Realistic
Timely
24
Q

Strategy and Tactics

A

strategy - game plan you develop to reach your goals

tactics - changes you make in the heat of the game

25
Q

Business models

A
  1. FIPCO - fully integrated pharma company
  2. speciality pharma
  3. services, databases, tools
  4. biotech global value chain sausage, factory in-license, add value, then out license
  5. one shot biotech (favoured by VCs)
  6. virtual company - outsourcing everything but management
26
Q

Values

A

see onenote

provides a reference for decisions and desired behaviours

27
Q

Culture

A

how the group actually behaves

28
Q

Risk management

A

see onenote slides

raise more money than you need every chance you get

don’t skimp on extensive preclinical trials to work out dose, efficacy and safety as much as possible before human trials

build relationships with more than one company

have insurance and build a team

29
Q

Leadership needs can change

A

see onenote

  1. early - visionary, founder
  2. mid - investor facing
  3. mid to late - portfolio manager
  4. late - mergers and acquisitions expert
30
Q

Pitch Pack in today’s Business Plan

A
  1. cover slide with tag line
  2. problem
  3. solution
  4. market opportunity
  5. team
  6. competitive analysis
  7. business model
  8. financial data and projections
  9. the ask
  10. closing slide
31
Q

reasons companies fail

A
  1. no market need
  2. ran out of cash
  3. not the right team
  4. competition was better
  5. needed a better business model
  6. product mistimed

Biotechnology in Practice (25 decks)

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