pharmaceutical industry part i & ii phcl 311 hadeel al-kofide m.sc
TRANSCRIPT
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
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
Types of Interactions With Industry Professionals
• Each of the roles described previously in pharmaceutical
industry serve two function:
Types of Interactions With Industry Professionals
Types of Interactions With Industry Professionals
• 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
Types of Interactions With Industry Professionals
Types of Interactions With Industry Professionals
• 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
PSR & Health Care ProfessionalsPSR & Health Care Professionals
• 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
PSR & Health Care ProfessionalsPSR & Health Care Professionals
• 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
PSR & Health Care ProfessionalsPSR & Health Care Professionals
• 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
PSR & Health Care ProfessionalsPSR & Health Care Professionals
• 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 & Health Care ProfessionalsPSR & Health Care Professionals
• 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
PSR & Health Care ProfessionalsPSR & Health Care Professionals
• 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
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
Guidance on Interactions
PhRMAPhRMA
• Key points of PhRMA code:
Guidance on Interactions
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
Guidance on Interactions
Other Career Areas in Pharmaceutical Industry
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