5 Pharmacy Practice in Industry

Pharmacy Practice in Industry: Potential
Roles for Pharmacists

Objectives
 Outline the life cycle of a drug product clinical testing
 Describe the practice of pharmacy in industry
Mission of Pharmacist : To Provide Pharmaceutical
Care
 Pharmaceutical Care is the direct, responsible provision of

medication‐related care for the purpose of achieving
definite outcomes that improve a patient’s quality of life”
 ASHP Statement on Pharmaceutical Care (1993) – Adaptation of

definition developed by Hepler and Strand (AJHP, March 1990)
The scope of Pharmacy Practice
 The Practice of Community  Pharmacists in Academe
Pharmacy  Nutrition in pharmacy practice
 The Practice of health systems  Nutrients and associated substances
pharmacy
 Veterinary pharmacy
 Pharmacy Practice in Industry:
Potential Roles for Pharmacists  Extemporaneous prescription
compounding
 Pharmacists in Government
 Pesticides
 Pharmacists in public health
 Consultant pharmacy practice
 Nuclear pharmacy practice
 Home infusion pharmacy practice
 Specialty pharmacy
Industry and products
 The healthcare industry encompasses a wide variety of

specific companies of varying size and capabilities.
 The scope of products manufactured and distributed by
these companies is broad and diverse
Product Life Cycle: 4 phases
1. Discovery – new molecule identification

Regulatory Submission  to initiate human testing
2. Development- formulation development and clinical research
(human testing) Regulatory submission – to commercialize
final dosage form  Regulatory approval
3. Commercialization – commercial sale and distribution
additional dosage forms development
4. Termination –product discontinuation
Drug substance and drug product development and clinical
testing
 Work conducted to develop the new drug and new dosage forms for future
commercialization.
 Toxicology studies (animals) are initiated in parallel with human studies
 The major outcome of this work is human testing that determines product
safety and efficacy.
Human clinical testing is generally as:
 Phase I studies: testing on healthy volunteers to determine pharmacologic,
pharmacokinetic, pharmacodynamics, and safety associated data on a
limited population of humans.
 Specific drug-drug interactions are also included.
 Phase II studies: testing in larger groups in patients with the disorder or
disease to assess how well the drug works and continue monitoring Phase I
for safety assessment.
 Assess dosing requirements
 Phase III studies: Randomized, controlled testing on large patient
populations to make definitive assessment of drug efficacy.
 Phase IV studies: also known as Post Marketing Surveillance Studies, are
designed to detect less frequent or long-term adverse events over a larger
population and over a longer period of time than was possible during earlier
testing phases.
Commercialization
 When the government regulatory agency approves the regulatory

submission, commercial manufacturing, distribution, and sale may
be initiated.
 Regulatory activities throughout the product commercial life

maintain the product regulatory status with government agencies.
New dosage form and new therapeutic indication
development
 New or improved dosage forms containing the original patented

molecule may be developed.
 For ex. Oral liquid dosage forms for infants, children and the elderly,
extended release solid dosage form for OD administration, patch, etc.
New dosage form and new therapeutic indication
development
 New indications for the original drug molecule may offer opportunities
in other diseases or disorders.
 Ex. Drugs for epilepsy may be developed for treatment of migraine.
 Additional Phase III clinical studies are then conducted.
 Regulatory submissions are required and must be approved before
product may be sold as new dosage forms or treatment for new
indication.
Generic Prescription (Rx) products and OTC Products
 When patents of the original molecule or dosage form expire, multiple

companies may enter the competitive marketplace by means of generic
products.
 Generic products require that the competitor’s new product be

bioequivalent to the innovator product as demonstrated through
comparative bioavailability testing in humans.
Pharmacy practice in Chemistry, Manufacturing, and
Controls (CMC)
 CMC pharmacy practice is involved primarily with the actual

pharmaceutical product, i.e. the dosage form or delivery system.
 CMC pharmacists are responsible for all functions related to the

pharmaceutical product throughout the entire product lifecycle.
Pharmacy Practice in Clinical Research
 Clinical research is involved primarily with physiological

performance of the drug and drug product, the therapeutic,
pharmacologic and other effects on the patient.
 When a new chemical entity is being planned for development, the

clinical research team is the hub of development activities.
Pharmacy Practice in Business, Marketing, Representation
and Sales
 Pharmacy practice in business, marketing, and sales application is

involved primarily with product commercial strategy, promotion
and advertising, direct interactions with health professionals and
patients, and product sales.
Pharmacy Practice in Regulatory Affairs
 It is involved primarily with government regulations and policies

associated with all aspect of products.
 These complex responsibilities in the global marketplace requires

written and direct oral communication with government agency
officials.
Pharmacy Practice –Patents, Trademarks, and other Legal
Affairs
 This is involved primarily with protection of industry inventions,

proprietary information, intellectual property, commercial product
names, and associated protected information.
 Pharmacy practice in these areas occurs throughout the entire

product life cycle.
Pharmacists in Government
Career Opportunities
 Not merely employment but are truly career opportunities.

 Occupies important positions of this nature because of their greater level
of understanding of health care.
 Entry is through the traditional roles of dispensing and preparation of
pharmaceuticals, then advancing to greater responsibilities in scope and
magnitude.
 Pharmacists in government positions have considerably greater, more far-
reaching impact than do their peers in the private sector.
Uniformed Services
 Provides opportunities to serve as commissioned officer.

 Air Force
 Navy
 Army
 The pharmaceutical industry offers a wide variety of opportunities
for pharmacy practice.
 Their contributions may be in technical, clinical, business,
regulatory, and legal in nature.
 It offers the potential for great impact on the global healthcare
through products manufactured, and direct patient interaction as
well.
Thank you

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Pharmacy Practice in Industry: Potential

Roles for Pharmacists

 Pharmaceutical Care is the direct, responsible provision of

 ASHP Statement on Pharmaceutical Care (1993) – Adaptation of

 The healthcare industry encompasses a wide variety of

1. Discovery – new molecule identification

 When the government regulatory agency approves the regulatory

 Regulatory activities throughout the product commercial life

 New or improved dosage forms containing the original patented

 When patents of the original molecule or dosage form expire, multiple

 Generic products require that the competitor’s new product be

 CMC pharmacy practice is involved primarily with the actual

 CMC pharmacists are responsible for all functions related to the

 Clinical research is involved primarily with physiological

 When a new chemical entity is being planned for development, the

 Pharmacy practice in business, marketing, and sales application is

 It is involved primarily with government regulations and policies

 These complex responsibilities in the global marketplace requires

 This is involved primarily with protection of industry inventions,

 Pharmacy practice in these areas occurs throughout the entire

 Not merely employment but are truly career opportunities.

 Provides opportunities to serve as commissioned officer.

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