Biotech Entrepreneurship

apply for

grants

networking

build a team of advisors and consultants

talking to a lot of people

to learn about customers, market, partners, and business strategy

negotiates rights to

ip

apply for grants

university commercialization ipportunities, state and federal

work on business pitch

one page executive summary, non-confidential slide deck, business plan

entrepreneurship

training opportunities

move into

physical space and lab

complete

key preclinical studies

ingredients to start a company

new idea, team, capital, intellectual property

many of skills needed to succeed not usually

taught in engineering courses

multidisciplinary teams

science and engineering, business, law, and medicine

shareholders

own the company, vote to elect a board of directors

board of directors

supervise the company and vote on company decisions

ceo

runs the company

ceo

highest ranking employee, makes managerial decisons

coo

responsible for daily company operations (MBA)

cso

heads scientific research of the company (phd)

cto

heads development and implementation of technology (phd)

cmo

heads the clinical development and clinical trial strategy (MD)

patents

composition of matter, utility, design

other intellectual property

trade secrets, copyrights, trademarks

patent rights

the us government gives you exclusivity 20 years from filing date to be the only one to commercially use that invention

patents give you the opportunity

to prevent others from practicing your invention

patents don’t

give you the right to practice it yourself, if you may be infringing on other company patents or using their components

freedom to operate

learn what may be blocking

patent necessities

novel, useful, non-obvious

composition of matter patent

strongest, lasts 20 yrs from filing date

utility patent

patent how a product, process, or machine can be used + includes a new administration procedure or indication for a drug

design patent

protects a design from 14 years of signage

trade secrets

protects information if employees can keep a secret

copyrights

protect original creative work such as books, art; last 70 yrs after death of author

trademarks

symbol/words legally registered; lasts as long as it is used and defended

full cost to develop drug

1 billion (covers costs of fails)

clinical trials phase 1: safety

2-10 million

clinical trials, phase II: efficacy

10-50 million

clinical trials, phase 3: efficacy with many

~$50 million

seed funding

friends and family; angel investors, $1 million

series A

venture capital/wealthy families; ~$5-30 M

series B

venture capital/instutional investors/~$30 M

public markets

IPO ~$100 M

acquisition

bigger company buys you/$100+ M

customer

patient, physician, reimburser, big pharma, FDA, investor

market

number of people with the diseases, new cases a year, costs charged directly for treatment, other costs charged for broader care, competition, how people pay

partners

manufacturer, contract research organizations, patient advocacy groups, nonprofits, universisties, key opinion leaders

consultants

cmc, fda, regulations

critical

sign contracts that you understand fully and get legal help for patnents, NDAs, and term sheets

law firms

specifals for startups

short and long term goals

decide on goals you want to reach, plan out path and timeline, assess strengths and skills, communicate and discuss plan and needs with supervisors and mentors, implement plan

explore

netwoking, on-campus recruitment and career fair

network

talk to everyone you know, talk about your goals, practice networking and interviewing

letters

1 month or more

communication

focus on clarity and simplicity

most important writeup

abstract/specific aims