Page 52 - New Employee Glossary

Glossary 52

Power of Attorney (POA)

Ability to act in a legal capacity on behalf of Biogen

Pre-Approval Inspection (PAI)

Food & Drug Administration (FDA) inspection of a facility to ensure it is up to standards
before they approve the production of a drug.

Preclinical Development Board (PDB)

Governance committee that oversees preclinical development at Biogen.

Prescription Drug User Fee Act (PDUFA)

PDUFA authorizes Food & Drug Administration (FDA) to collect fees from companies that
produce certain human drug and biological products. Since the passage of PDUFA, user fees
have played an important role in expediting the drug approval process.

Price/Earnings (P/E) Ratio

The most common measure of how expensive a stock is. The P/E ratio is equal to a stock's
market capitalization divided by its after-tax earnings over a 12-month period. The higher the
P/E ratio, the more the market is willing to pay for each dollar of annual earnings.

Price/Earnings to Growth Ratio (PEG)

A stock's price/earnings ratio divided by its year-over-year earnings growth rate. In general,
the lower the PEG, the better the value, because the investor would be paying less for each
unit of earnings growth.

Primary Progressive MS (PPMS)

Type of Multiple Sclerosis (MS) where patients progress in disability without discernible
relapses. This type is relatively rare and affects about 10% of patient population.

Principal Investigator (PI)

Site personnel responsible for the conduct of a clinical study

Product Complaints (PC)

Any communication suggesting a deficiency related to labeling, identity, strength, purity,
stability, durability, reliability, effectiveness, performance, or quality of a Biogen product, or a
possible failure of the product to meet any of its specifications.