Low risk, high reward
Low risk, low reward
High risk, high reward
High risk, low reward
Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Device & Radiology/Vet Medicine/Food Safety Centers, Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development
Drug Enforcement Agency (DEA), Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development, Center for Biologics Evaluation and Research (CBER)
Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development, Office of the Inspector General, Federal Trade Commission (FTC)
Drug Enforcement Agency (DEA), Office of the Inspector General (OIG), Federal Trade Commission (FTC)
Indemnity-type coverage plans
Restricted access to products/services
Reduced level of service to patients depending on level of patient health insurance
Increase the cost of most commonly use products
Public, not-for-profit companies
For-profit, private companies
M Squared Life Sciences Practice
A giant, unethical body of greedy people
Scientists without borders
Drugs and lots of them
A complex amalgam of science and business
They are smaller so they carry less inherent risk making them a safer investment.
They are more innovative and focused and can supplement the internal pipelines of their larger partners
To help out when Big Pharma gets into trouble.
Smaller pharmaceutical companies have less stringent regulatory standards to which they must adhere, thus bringing products to market more quickly.
Large or small
Research based or focused on meeting regulatory guidelines.
Focused on meeting regulatory guidelines or maintaining high ethical standards
Research based or focused on manufacturing
In-licensing, out-licensing and co-promotion
Supply chain management, commercial manufacturing, customer service
Legal, information technology, HR, finance and accounting
Sales, marketing, and customer service
Research and development, marketing and sales, regulatory
Marketing and sales, manufacturing and operations, corporate and administrative
Marketing and sales, research and devlopment, manufacturing and operations
Business development, regulatory, corporate and administrative
Same as OSHA - to create obnoxious rules to which no one can adhere and to make nice people jump through a lot of hoops
To prevent the production of harmful drugs, and to protect consumers against anti-competitive behavior and misleading claims
To ensure drug safety and efficacy and to prevent misleading product claims and illicit inducements
To regulate the distribution and use of narcotics and other controlled substances
Other companies are free to market drugs with the same active ingredient and equivilent efficacy.
Other companies are free to market drugs with the same active ingredient but they must alter the efficacy so they are not creating an identical drug.
Other companies may make drugs with an equivilent efficacy but they must contain a different active ingredient.
A company loses its ability to market the product
All hell breaks loose.
Because we have sexy employees. I mean, have you checked out Steve Jaben lately?
Companies have been forced to downsize recently due to the economic downturn and so consultants supply a source of cheap, effective labor.
Because they are too large to handle finding quality talent on their own.
Because the requirements and market environment in the industry are so compex, pharma companies need the support of vendors who are dedicated to the industry and are well versed in its intricacies.
A drug with sales over $1 billion annually
A drug with more than several hundred million dollars in sales annually
A drug that is first to market in a novel therapeutic area
A drug with over $100 million in investment
A drug sold through video retail chains
Country specific regulatory requirements
Industry-wide guidelines with input from relevant regulatory bodies
A combination of active company and industry self-regulation with governmentally enforced standards
Ethical guidelines for physicians adopted by pharmaceutical companies
To obtain funding
To obtain expertise
To exploit the product's full market potential
To avoid regulatory burdens
To expand their product portfolio
1. Research and Development, 2. Manufacturing and Operations, 3. Marketing and Sales.
1. Research and Development, 2. Business Development, 3. Marketing and Sales
1. Regulatory, 2. Manufacturing and Operations, 3. Business Development
Marketing and Sales, 2. Corporate and Administrative, 3. Research and Development
HMO, PPO, HSA, CRAP
CMO, CRO, CBO, CDO
FDA, DEA, CBA, ADA
CSO, CRO, CPO, CMO