Download Key Points Handouts - Hansen Resource Development Inc

A Pharmaceutical Company Values,
Mission
and
Corporate Objectives
Important Information
 A Pharmaceutical Company’s three core values are:
 Respect for People
 Integrity
 Thirst for Excellence
 A Pharmaceutical Company’s mission statement is:
 A Pharmaceutical Company and Company is a global researchbased pharmaceutical corporation dedicated to creating and
delivering innovative pharmaceutical-based health care solutions that
enable people to live longer, healthier and more active lives.
 A Pharmaceutical Company’s four Corporate Objectives are:
 Development of People
 Scientific Innovation
 Demand Realization
 Shareholder Value
 A Pharmaceutical Company’s core values are the foundation of its
mission and objectives. Without these core values, we cannot achieve
our mission or objectives. We must particularly ensure that we develop
our people, because our people develop our products and ensure our
success in the marketplace.
 We believe that each employee’s dedication to our core values and
corporate mission are important links in A Pharmaceutical Company’s
efforts to meet our Corporate Objectives.
Global Pharmaceutical Market
Important Information
Sales
Information
and Statistics
 Global pharmaceutical sales for 1999 totaled $134
billion (U.S. dollars).
 A Pharmaceutical Company sales for 1999 totaled
$10 billion (U.S. dollars).
 Internal factors are things A Pharmaceutical
Company can control or take into account when
planning, even those that are outside A
Pharmaceutical Company’s direct control such as
competition and regulation. Internal factors are:
 Competition
 Cost
 Regulation
 Product risk
 External factors are those A Pharmaceutical
Company cannot directly control. External factors
are:
 Disease focus
 Demographics
 Government/individual spending
 Decision maker/influencer
Global Presence
Important Information
 A Pharmaceutical Company has approximately 31,000 employees
globally
 A Pharmaceutical Company products are marketed in 179 countries
 A Pharmaceutical Company Research and Development facilities are
located in 9 countries:
 Australia
 England
 Singapore
 Belgium
 Germany
 Spain
 Canada
 Japan
 United States
 A Pharmaceutical Company has 24 Manufacturing facilities located in 20
countries:
 Australia
 Hungary
 Pakistan
 Brazil
 Ireland
 Poland
 China
 Italy
 Puerto Rico
 Egypt
 Japan
 Spain
 England
 Korea
 Taiwan
 France
 Mexico
 United Kingdom
 Germany
 United States
Organizational Structure
Important Information
Policy
Committee
Charter
 At the corporate level, approve and own:
 Performance targets
 Strategies
 Policies
 Ensure compliance throughout the organization
Policy
Committee
Activities
 Manage corporate strategy
 Monitor and asses corporate strategy
 Manage major tasks and projects with companywide strategic impact
 Manage changes to planning process
 Manage product and project team guidelines
 Manage targets for three-year and one-year plans
 Allocate resources by setting targets for Demand
Realization, Scientific Innovation and the Policy
Committee
Continued on next page
Organizational Structure
Important Information
(continued)
Policy
Committee
Activities
(continued)




Manage performance of the corporate asset portfolio
Review investment recommendations
Provide oversight for compliance activities
Act as Board of Directors for the A Pharmaceutical
Company Foundation
 Review organizational policies
 Succession plan management
 Executive development of key people
 Major changes in organizational architecture
 Global compensation and benefits
 Review litigation, public policies and financial policies
that have company-wide and/or external impact
Product Life Cycle
and
Drug Development
Important Information
Product Life Cycle
Drug Discovery
and Development
Launch
Off Patent
No Longer
Manufactured
Product Life Cycle begins with the discovery of a molecule or compound
that is developed into a A Pharmaceutical Company product and ends
when the product is no longer manufactured.
Drug discovery and development occur at the beginning of the product
lifecycle. A Pharmaceutical Company has developed a three-stage
rocketship (shown on the next page) to illustrate the Drug Discovery
Process.
 The three stages of the Drug Discovery Process are:
 Hypothesis Generation (Discovery)
 Candidate Development (Development)
 Commercialization (Registration and Marketing)
 There are three phases that correspond to these three stages
 Project Phase
 Program Phase
 Product Phase
Product Life Cycle
and
Drug Development
Important Information
(continued)
Stages
Hypothesis
Generation
(Discovery)
Candidate Development
(Development)
Commercialization
(Registration & Marketing)
1
4
5
6
7
8
9
10
11
2
Project
Phase
Program Phase
Product Phase
3
Phases
The Drug Discovery Process rocketship
[Note: Numbers in the rocketship correspond to the numbered activities in
the descriptions of the stages on the following page.]
Product Life Cycle
and
Drug Development
Important Information
(continued)
Hypothesis Generation
 The goal of this stage is a testable, valuable hypothesis.
 Activities that occur during this stage are:
1 Target Identification and Validation
2 Assay Development
3 Lead Generation
Candidate Development
 The goal of this stage is a proven or disproven hypothesis for a drug
candidate.
 Activities that occur during this stage are:
4 Lead Optimization
5 First Human Dose Preparation
6 Phase IA Clinical Trials
7 Phase IB/II Clinical Trials
Commercialization
 The goal of this stage is a successful commercial product.
 Activities that occur during this stage are:
8 Phase III Clinical Trials
9 Submission to Regulatory Agencies
10 Global Launch
11 Global Optimization
Product Life Cycle
and
Drug Development
Important Information
(continued)
 QSV is a strategy to improve the quality, speed and value of decisionmaking and processes at A Pharmaceutical Company. For product life
cycle and drug discovery, these are defined as:
 Quality: Working on the best drug discovery and development
opportunities
 Speed: Finding ways to discover, develop and deliver drugs to
patients in half the time
 Value: Doubling the number of products for every research and
development dollar spent
Terms and acronyms
Adverse reactions
Referred to as an adverse drug event. Defined as,
“any untoward medical occurrence in a patient or
clinical investigation subject administered a
pharmaceutical product and which does not
necessarily have to have a casual relationship with
this treatment.”
Acute effects
Short-term effects of a drug demonstrated when
administered in a single dose, or in multiple doses
during a period not exceeding 24 hours.
BLA
Biologics License Agreement
Blinded study
Clinical study design in which the investigator, the
patient, or both, do not know if the patient is receiving
the study treatment or control treatment.
Carcinogenicity
Ability of a substance to induce cancerous cell growth in
the species studied.
CDS
Core Data Sheet
Chronic effects
Long-term effects of a drug demonstrated when
administered on a continuous basis (180 days or
longer in duration).
Controlled study
Clinical study design in which the treatment being
investigated is compared in two like patient
populations that only differ in that one group receives
the investigational compound.
D.R.U.G.
Drug Research and Development User Guide
Draft label
This document is created early in the drug
development process and “drives” the development of
the compound. When the development phase is
complete, draft labeling is used to create the Core
Data Sheet.
EMEA
European Medicines Evaluation Agency
EU
European Union
FDA
Food and Drug Administration
Terms and acronyms (continued)
FHD
First human dose
Genotoxicity
Ability of a substance to produce chromosomal
damage or mutation.
Lead compound
A compound or molecule showing “promise” as a viable
candidate for development into a pharmaceutical product.
LRL
A Pharmaceutical Company Research Laboratories
NDA
New Drug Application
Pharmaceutical form
The dosage form (i.e. tablet, capsule, ointment,
intravenous solution).
Pharmacodynamics
Describes what a drug does to the body. It is a study
of biochemical and physiological effects of drugs and
their mechanisms of action.
Pharmacokinetics
Describes what the body does to the drug. It deals
with the absorption, distribution, metabolism, and
excretion (ADME) of drugs. These factors, coupled
with dosage, determine the concentration of a drug at
its site of action and, hence, the intensity of its effects
as a function of time.
Pharmacology
The properties and reactions of drugs especially with
relation to their therapeutic area.
Pharmacological
screening
Process by which molecules are evaluated for
properties necessary to treat, prevent, or diagnose a
particular condition.
PMC I
Portfolio Management Committee
QSV
Quality Speed Value
SPC
Summary of Product Characteristics
Sub-acute affects or
Sub-chronic effects
Effects demonstrated when administered over a period
ranging from 14 to 90 days.
TA
Therapeutic area
Terms and acronyms (continued)
Therapeutic
indications
Uses for which the product has been shown to be
safe and effective at treating, diagnosing or
preventing.
Toxicokinetic
Studies that evaluate the relationship between
systemic exposure and toxicological findings.
Toxicology
The science of the adverse effects of chemicals on
living organisms. Drugs are often studied in animals
to determine if the risk of adverse effect is low
enough to justify administering it to humans.
USPI
US Package Insert
VLC
Virtual Learning Center