Pharmaceutical Industry Part I & II PHCL 311 Hadeel Al-Kofide M.Sc

Pharmaceutical IndustryPart I & II

PHCL 311

Pharmaceutical IndustryPart I & II

PHCL 311

Hadeel Al-Kofide M.Sc

Topics to be covered today..Topics to be covered today..

• Introduction

• Jobs opportunities in pharmaceutical industry

• History

• Definitions

• Types of interactions with industry profession

• Guidance to interactions with industry professions

• Other careers in pharmaceutical industry

• Market Leaders in Pharmaceutical Industry

• Deciding if pharmaceutical industry is suitable for you

Why Study Pharmaceutical IndustryWhy Study Pharmaceutical Industry

“We are all members of the pharmaceutical industry – we either

prescribe drugs, or take them ourselves. We need to learn to

work together.”

IntroductionIntroduction

• The pharmaceutical industry develops, produces, & markets

medicinal drugs

• Pharmaceutical companies can deal in generic &/or brand

medications

• They are subject to a variety of laws & regulations regarding

the patenting, testing & marketing of drugs

It includes many job opportunities of pharmacists:

• Drug discovery

• Manufacturing

• Marketing

• Medical information

• Product development

• Quality assurance

• Training & development

• Sales

• Regulatory

• Project management

• Health outcomes research

• Legal

• Information technology

• Scientific communications

Jobs Opportunities in Pharmaceutical Industry




HistoryHistory

• The earliest drugstores date back to the Middle Ages

• The first known drugstore was opened by Arabian pharmacists

in Baghdad in & many more soon began operating throughout

the medieval Islamic world & eventually medieval Europe

• By the 19th century, many of the drug stores in Europe &

North America had eventually developed into larger

pharmaceutical companies

HistoryHistory

• Most of today's major pharmaceutical companies were

founded in the late 19th & early 20th centuries

• Key discoveries of the 1920s & 1930s, such as insulin &

penicillin, became mass-manufactured & distributed

• Switzerland, Germany & Italy had particularly strong

industries, with the UK, US, Belgium & the Netherlands

following suit

DefinitionsDefinitions

• Clinical research professionals

• Drug safety professionals

• Medical or drug information

specialists

• Pharmaceutical sales

representative (PSRs)

• PhRAM

• Pharmaceutical company

• Pharmaceutical products

• Detailing

• Drug discovery

• Drug development

• Pharmacovigilence

Clinical Research ProfessionalsClinical Research Professionals

• Responsible for the oversight of clinical trials

• Include clinical research monitors & administrators

• These two could be separated so the research monitors visit

the site to complete data verification, & administrators will act

as the link external to internal team members

Definitions

Drug Safety ProfessionalsDrug Safety Professionals

• Monitor serious adverse events & respond to Medwatch

• Responsible for global safety surveillance

• Also responsible for post-marketing surveillance

Definitions

Medical or Drug Information SpecialistsMedical or Drug Information Specialists

• Will address specific questions by patients & health care

professionals that require review of data on file or address

topics not directly related to the marketing mission

Definitions

Pharmaceutical Sales Representative (PSRs)Pharmaceutical Sales Representative (PSRs)

• Have the primary responsibility of reaching out to providers &

prescribers within a defined area

• These professionals deliver the marketing message for

pharmaceutical products based on training received by the

pharmaceutical manufacturer

Definitions

PhRMAPhRMA

• Pharmaceutical Research & Manufacturers of America

• Non-profit association that represents leading research based

pharmaceutical & biotechnology companies

Definitions

Pharmaceutical CompanyPharmaceutical Company

• Manufacturer or sponsor

• The company who develops, manufacturers & supplies

medication for patients

Definitions

Pharmaceutical ProductsPharmaceutical Products

• Drug therapies developed by pharmaceutical companies

• Also called pharmaceuticals

Definitions

DetailingDetailing

• Occurs when a PSR meets with a health care practitioner to

deliver their marketing message & provide product details

Definitions

Medical Liaisons (MLs)Medical Liaisons (MLs)

• A healthcare consulting professional who is employed by

pharmaceutical, biotechnology, medical device, & managed

care companies

• The ML is a person who can communicate high scientific

concepts, yet balance clinical objectives with business

opportunities

• Have the responsibility to build relationship with key health

practitioners (i.e. leaders)

Definitions

Drug DiscoveryDrug Discovery

• The process by which potential drugs are discovered

• In the past most drugs have been discovered by isolating the

active ingredient from traditional remedies

• Modern technology focus on understanding metabolic

pathways related to disease state or pathogen, & manipulating

these pathways using molecular biology or biochemistry

• A great deal of early-stage drug discovery has traditionally

been carried out by universities & research institutions

Definitions

Drug DevelopmentDrug Development

• Refers to activities undertaken after a compound is identified

as a potential drug in order to establish its suitability as a

medication

• Objectives of drug development are to determine appropriate

formulation & dosing, as well as to establish safety

• Research in these areas generally includes a combination of in

vitro studies, in vivo studies, & clinical trials

Definitions

PharmacovigilencePharmacovigilence

• Also called safety surveillance

• The monitoring of adverse events for a pharmaceutical product

Definitions

Types of Interactions With Industry Professionals




• Each of the roles described previously in pharmaceutical

industry serve two function:



• Interactions between industry professions & other part of the

medical field usually is related to the business part of the

industry

Focusing on Pharmaceutical care representatives



• PSR & health care practitioners

• PSR & pharmacy/therapeutic committee

PSR & Health Care ProfessionalsPSR & Health Care Professionals

• Goal of PSR: marketing & sale of pharmaceuticals to legal

prescribers

• PSR will need to interact with professionals in regular basis so

they must convey information in appropriate manner so

basic communication skills are essential

• Other essential skills companies look for when employing a

PSR

Interactions


• Other essential skills companies look for when employing a PSR:

Patience

Diligence

Ability to understand basic medical & pharmaceutical terminology

Organization skills

Acceptable appearance

Ability to accept criticism & deal with it appropriately

Interactions


• During interaction with professionals the PSR offer the latest

marketing information about their products

• Product information is usually distributed in the form of:

Brochures

Medical literature reprints

Multimedia presentations

Interactions


• The health professional expect certain information from the

PSR about a certain pharmaceutical product which include:

Indication

Therapeutic benefits

Safety data

Comparative data with new or old drugs

Price

Interactions


• A study was conducted to determine if the physician received

these information, the results showed that most of sale

representatives focused on indication & giving less

information in regard to drug safety, comparable efficacy &

cost

• Pharmacists working in the hospital can help physicians in

providing additional information in case PSR did not cover all

the aspects

Interactions


• PSR may also distribute drug samples

• Drug sample: a package containing a limited quantity of

pharmaceutical product sufficient to evaluate clinical

response, distributed to authorized health care practitioners

free of charge & for patients for treatment

Interactions


• Positives & negatives of drug samples:

Interactions

Positives Negatives

Treatment option for some patient

Poor drug control including incorrect labeling & packaging

Opportunity to experience a new product for a physician

Access to prescription drugs by inappropriate personnel

ConvenienceEncouragement of poor prescription practices

PSR & Pharmacy/Therapeutic CommitteePSR & Pharmacy/Therapeutic Committee

• Sale representatives may be asked to provide information upon

request to address specific concerns of the P&T committee

• Formulary adoption of a particular drug is extremely valuable

to the PSR

Interactions

Medical Liaisons & Thought LeadersMedical Liaisons & Thought Leaders

• MLs deliver medical education message as opposed to

marketing message

• MLs share scientific information about drug products with

PSR & instruct them on key points

• They may give presentation to practitioners

• MLs have extensive medical background allowing them to

have more information about a product

Interactions

Pharmaceutical Marketing & PatientsPharmaceutical Marketing & Patients

• Companies tend to use DTC (Direct To Consumer)

advertisements

• This makes patient demand the new medication, leading to

increase profit

• Pharmacists specially community pharmacists can help

educate the patient if he has any question regarding a drug he

saw in an advertisement

Interactions

Guidance Interactions With Industry Professionals




• Institutional policies & procedures

• PhRMA code

• Food & drug administration (FDA)

• Others

Institutional Policies & ProceduresInstitutional Policies & Procedures

• Health institutes generally have policies & procedures related

to the activities of PSR within their facility

• ASHP published a guideline for pharmacists for the activity of

PSR

• Each hospital can have its own policy & procedure

Guidance on Interactions

PhRMAPhRMA

• In 2002 the PhRMA adopted a code for pharmaceutical

manufacturers as related to marketing interactions with health

care professionals, & specifically the gifts & gratuities given

to health care professionals

• The Code attempts to ensure that all interactions focused on

informing healthcare professionals about products, providing

scientific & educational information, & supporting medical

research & education


PhRMAPhRMA

• Key points of PhRMA code:


Category Guidance

General interactions

The interactions should focus on providing medical educational information

Entertainment Should not be included in interactions, except if there is a venue related to proving scientific information

Continuing education

Sponsors can provide support for conferences but not individual participants. Sponsors should not be involved specifically with the content

Gifts Gifts with personal benefit only are not allowed. Items for health care of patients are allowed if less than 100 $. Example of allowed gifts include office pens, notepads & anatomical models

FDAFDA

• In addition to its expected role in drug development the FDA

regulate direct to consumer advertising

• They mandate that these advertisements portray a fair balance

for medications this include the major risk of the product


Other Career Areas in Pharmaceutical Industry




• Clinical research administrators

• Clinical or product development professional

• Drug discovery professionals

• Health outcome professionals

• Project management

• Quality assurance professional

• Regulatory professional

• Scientific communications professionals

Drug Discovery ProfessionalsDrug Discovery Professionals

• Professionals who are involved in early stages of molecular &

chemical identification

• They usually require more specific skills in areas including but not

limited to:

Organic & medicinal chemistry

Pharmacology

Pharmaceutics

Pharmacogenomics…

Health Outcome ProfessionalsHealth Outcome Professionals

• They are professionals who utilize pharmacoeconomic

backgrounds to create models & studies to investigate the

benefits of a given pharmaceutical product

• May be involved in:

Phase IV post-marketing studies

Discuss economic considerations at their institute

Or utilize this information when making formulary decisions

Quality Assurance ProfessionalQuality Assurance Professional

• They are different than quality control professionals

(quality control professionals test chemical products &

evaluate manufacturing processes)

• Quality assurance professionals work with:

Clinical development

Training & development

Regulatory components of the company

To assure that business

operations function at an

acceptable level of quality

Regulatory ProfessionalsRegulatory Professionals

• Interact with regulatory agencies throughout the world

• Unlike legal department, regulatory professionals are more

likely to have science & medical backgrounds

• They must have an understating of the medical environment &

how a product might position it self in the market

• They must be able to communicate scientific & medical

information to regulators to support positive product approval

SummarySummary

• Pharmaceutical industry carries different career pathways for

pharmacists & open new work ideas

• The relationship between the industry & healthcare

professionals is mostly done through marketing or advertising

agents

• This relationship has its own guidance & protocol to prevent

bias

Thank youThank you

Documents

Pharmaceutical Industry Part I & II PHCL 311 Hadeel Al-Kofide M.Sc