1.
Table of Contents
2.
THE ENTREPRENEUR'S GUIDE TO A BIOTECH STARTUP
3.
ACKNOWLEDGEMENTS
4.
AUTHOR'S NOTE
4.1.
ORIGIN OF THE GUIDE
4.2.
THE PURPOSE OF THE GUIDE
4.3.
RECOMMMENDED READING
5.
THE BIG PICTURE
5.1.
BIOTECH PAST
5.2.
DEFINING BUSINESS SUCCESS
5.3.
BIOTECH FUTURE
6.
EVALUATING THE IDEA
6.1.
FIVE BASICS
6.2.
THE STARTING LINE
6.3.
INTELLECTUAL PROPERTY
6.4.
BUSINESS MODEL
6.5.
MARKET
6.6.
MANAGEMENT
7.
THE BUSINESS PLAN
7.1.
Section 1: SUMMARY/MISSION STATEMENTS
7.2.
Section 2: THE OPPORTUNITY
7.3.
Section 3: THE TECHNOLOGY
7.4.
Section 4: THE BUSINESS MODEL
7.5.
Section 5: THE COMPETITION
7.6.
Section 6: INTELLECTUAL PROPERTY
7.7.
Section 7: EXIT STRATEGY & COMPARABLES
7.8.
Section 8: PEOPLE
7.9.
Section 9: FINANCIALS
7.10.
Saved For Last: THE EXECUTIVE SUMMARY
8.
PEOPLE
8.1.
FOUNDERS
8.2.
MANAGEMENT TEAM
8.3.
SCIENTIFIC ADVISORY BOARD
8.4.
BOARD OF DIRECTORS
9.
PATENTS
9.1.
PATENTS IN ACTION
9.2.
CRITERIA FOR PATENT ISSUANCE
9.3.
CLAIMS
9.4.
PRIOR ART
9.5.
COSTS AND TIMING
9.6.
INTERNATIONAL PATENTS
9.7.
FREEDOM-TO-OPERATE
9.8.
TRADE SECRETS, TRADEMARKS, & COPYRIGHTS
9.9.
LICENSING FROM UNIVERSITIES
10.
ATTORNEYS
10.1.
CORPORATE ATTORNEY
10.2.
PATENT ATTORNEY
11.
LEGAL ISSUES
11.1.
INCORPORATION
11.2.
INTELLECTUAL PROPERTY
11.3.
TRANSACTIONAL DOCUMENTS
11.4.
STOCK OPTION PLAN
11.5.
COMPLIANCE WITH FEDERAL AND STATE SECURITIES LAWS
12.
ACCOUNTING & FINANCE
12.1.
FORMS OF ENTITIES
12.2.
FINANCIAL SOFTWARE
12.3.
INSURANCE
12.4.
DEBT FUNDING
13.
REAL ESTATE
13.1.
REAL ESTATE CYCLES
13.2.
ROLE OF LANDLORDS
13.3.
LOCATION
13.4.
NEXT GENERATION SPACE
13.5.
FINISHED VS. SHELL SPACE
13.6.
ESTIMATING COSTS
13.7.
BUILD-OUT
13.8.
OTHER STARTUP OPTIONS
14.
RISK MANAGEMENT & INSURANCE
15.
MEDIA & PUBLIC RELATIONS
16.
PHARMACEUTICAL BUSINESS DEVELOPMENT
16.1.
DEFINING A PROGRAM
16.2.
TELLING THE STORY
16.3.
DEAL STRUCTURES
16.4.
NEGOTIATING AN AGREEMENT
17.
DEVICE, DIAGNOSTIC, & INSTRUMENT MODELS
17.1.
MEDICAL DEVICES
17.2.
DIAGNOSTICS
17.3.
INSTRUMENTS
18.
DRUG PRICING PRINCIPLES
18.1.
GENERAL PRINCIPLES
18.2.
US PRICING AND DISTRIBUTION
18.3.
MARKET SEGMENTS
19.
CLINICAL DRUG DEVELOPMENT
19.1.
GETTING FROM THE LAB TO IND
19.2.
A STRATEGIC APPROACH TO CLINICAL DRUG DEVELOPMENT
19.3.
CLINICAL DEVELOPMENT TEAM
19.4.
THE MAJOR TASKS OF EACH PHASE OF CLINICAL DEVELOPMENT
19.5.
PRACTICAL CONSIDERATIONS
19.6.
FDA TAKES ACTION
20.
MEDICAL DEVICE APPROVAL
20.1.
REGISTRATION, LISTING AND LABELING
20.2.
THE PREMARKET APPROVAL APPLICATION (PMA) -- FDC ACT ยง515
20.3.
SUBSTANTIAL EQUIVALENCE - PREMARKET NOTIFICATION, 510(K)
20.4.
COSTS
21.
EQUITY
21.1.
SHARES AND OPTIONS
21.2.
EQUITY DISTRIBUTION
22.
RAISING MONEY
22.1.
ANGELS
22.2.
VENTURE CAPITAL
22.3.
KEY ISSUES
22.4.
BOOT-STRAPPING
22.5.
INCUBATORS
22.6.
LOANS AND VENTURE LEASING
23.
GOVERNMENT GRANTS
23.1.
SUMMARY OF GOVERNMENT PROGRAMS
23.2.
TIPS ON GRANT WRITING
23.3.
GETTING OUTSIDE HELP
24.
IPO: GOING PUBLIC
24.1.
HISTORY OF BIOTECH IPOS
25.
NETWORKING
Light
Rust
Coal
Navy
Ayu
Guide To Biotech Startups
ATTORNEYS