HISTORY AND PERSPECTIVE IN MEDICINE

3.06 THE PHYSICIAN IN THE PHARMACEUTICAL INDUSTRY

DR. ROBERT BUENAVENTURA | November 24, 2016
LE 1
I.
OUTLINE

Overview of Pharmaceutical Medicine

century as considered by the Forbes
Magazine
#
One of the critical major drugs in the 20th

A. Pharmaceutical Industry Previously, antidepressants usually work by

B. Pharmaceutical Medicine blocking both serotonin and
C. The Pharmaceutical Physician norepinephrine. The group of scientists
II. The Mexico City Principle wanted to know the effects of blocking only
III. Education and Organizations 1 neurotransmitter. (Intended only to block
A. Masters in Pharmaceutical Medicine serotonin and not norepinephrine = SSRI -
B. Standards of Practice Selective Serotonin Reuptake Inhibitor)
C. Philippine College of Pharmaceutical Molecule was found to be very promising.
Medicine Eli Lilly in the Anapolis bought and
IV. Functional Areas developed the molecule.
A. Medical Affairs Thought about by a Chinese Immigrant and
B. Non-Medical Affairs his American colleagues in the University of
C. Part-Time Roles Illinois
V. Expectations from a Pharmaceutical Physician
In 1972, they did further studies, until 1976,
VI. Pros and Cons in the Industry
VII. Conclusions the IND (Investigational New Drug - a drug
that has not be previously marketed before)
was submitted to the US FDA for further
OBJECTIVES: study
At the end of the lecture, the student should be able to: Underwent clinical trials
1. To introduce the field of Pharmaceutical Medicine o Phase 1
2. To discuss the different roles of the Physician in the -after drug submission
pharmaceutical industry -studies that are done in the labs; tests
on basic clinical science
Legend: o Phase 2
Remember Previous - involves animal studies to determine
Lecturer Book Trans Com
(Exams) Trans general safety of the medication, and
human studies (4 Clinical Phase
G ! & 4 ! Studies - 1,2,3 are Pre-marketing, 4 is
Post-marketing)
I. OVERVIEW OF PHARMACEUTICAL MEDICINE Premarketing: Clinical Phase 1, 2, 3
o Clinical Phase 1
A. Pharmaceutical Industry - Pharmacodynamics (drug-receptor
o One of the biggest industries globally and employs interaction)
several hundred thousands of individuals, - Pharmacokinetics (4 substeps:
including physicians Absorption, Metabolism, Distribution,
Elimination)
- tested on normal human subjects,
US $2.6B (as of 2014): Expenditure for development of or subjects who do not have the
a (single) drug targeted indication or clinical disorder
2015 total global expenditure for drug research and o Clinical Phases 2, 3
development: $150B - involves the target patients; in this
o 10 years ago, the expenditure was only $100 (Up case, Prozac would target patients
>150%) with major depression
o It takes about 10-15 years to develop a drug Postmarketng: Clinical Phase 4/ sales and
successfully disribution
Must be approved by the major regulatory 1976 - Further studies regarding Prozac
agency for marketing
1983- NDA submitted to US FDA
o US Food and Drug Administration
o Europe: EMEA/ European Medicine 1983-1987- US FDA reviewed the results of
Agency the clinical trial of the drug
The drug would be independently reviewed by Initially, Prozacs single indication was for
the agencies before they get approved and depression, but eventually was approved
sold to the market for bulimia nervosa, OCD, premenstrual
For example, Prozac (generic name: dysphoria
fluoxetine) took about 15 years to be approved Prozac was approved 1987, Patent expired
(1972 - 1987) in 2001, but it is still one of the most widely

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3.04 THE PHYSICIAN IN THE
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used antidepressant due to its good track
record in terms of safety and efficacy
o Only 1 out of 8.5 drugs that reach
Phase I to NDA stage will be approved.
o Most of the drug which goes to clinical
trial do not pass successfully and the
investments put into these simply go
into waste.
B. Pharmaceutical Medicine
o Has gradually evolved into a medical
scientific discipline in the last 50 years.
o A medical scientific discipline for the
discovery, development, evaluation,
registration, monitoring, and medical
marketing of medicines for the benefit of
patients and community health.
o Provides interface and common ground
between the clinical and healthcare
professions (doctors to whom the drugs are
endorsed), pharmaceutical industry (which
produces the drug),
government(regulatory body that approves
the medicine; in PH: it is FDA/BFAD).
o Most clinical trial specialists hired are
pharmacists
The Core of Pharmaceutical Medicine:
o Translation of pharmaceutical drug research
into new medicines (basic research)
o Clinical testing of medicines
o Safety and well-being of research
participants in clinical trials
o Understanding safety profile of medicines
and their benefit-risk balance
! Important responsibility of physician in this field is
understanding the benefits and risks of a single
molecule due to our educational background in
pharmacology, anatomy, physiology, medicine,
neurology etc., we are equipped with all the clinical
information that will best help the patient.
! Hence, physician must also have thorough
understanding of other aspects of drug development
like pharmacoeconomics. Looking at safety, benefits,
and risks these compare the cost-benefits of
treatment. Drug before marketed, the benefits should
outweigh the risks. More helpful, less harmful.
Pharmaceutical medicine is a global discipline,
demanding good communication with other
pharmaceutical specialists, companies and
regulatory bodies across the world.
Pharmaceutical medicine is both international
and global in scope
o International- you work with individuals
form other countries
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o Global- end result/outcomes have global
impact
! You have to broaden your horizons as far as what
your world will look like, be involved in pharmaceutical
medicine and interact with pharmaceutical medicine
specialist in other parts of the world.
Pharmaceutical medicine is a discipline that takes
it place alongside other medical specialties
o It has developed its own professional ethos
o It has established a distinct body of
knowledge based primarily on clinical
science
o Its practitioners represent a cohesive group
of specialists with common goals.
Pharmaceutical medicine has been recognized
as a full medical specialty since 2002 in 4
countries: UK, Ireland, Switzerland and Mexico.
and
There are currently 240 doctors undergoing
training for pharmaceutical medicine in the UK,
making it the 11th largest specialty in that
country.
As a postgraduate medical discipline,
pharmaceutical medicine has:
o A recognized international syllabus
o Training courses with examination and
qualifications o Own research methodologies
o Professional bodies and academic societies
o Journals and texts
It embraces new technologies and regulations in
pursuit of proof of efficacy, safety and
effectiveness of medicines.
The official recognition promotes:
o Establishment and maintenance of standards
of practice and professionalism in the
competency
o Care and conduct applied to their work and
of growing public recognition and
accountability
C. The Pharmaceutical Physician
Roles:
o Work in the pharmaceutical industry and
drug regulatory authorities
o Contact research organizations
o Have a close affinity with their medical
colleagues in primary and secondary health
care and at universities
In addition to expertise in the science of drug
development, pharmaceutical physicians need a
thorough understanding of:
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o Pharmacoeconomics- the medical aspects
of marketing of medicines and business
administration
o Medical aspects of the marketing of
medicines
o Business administration
o Social impact of healthcare on patients and
public health
Pharmaceutical physicians work within legal and
regulatory frameworks, and within ethical and
professional codes of medical practice and
governance.
Developing new medicines and making them
available for patients is an international endeavor
II. THE MEXICO CITY PRINCIPLE
For Voluntary Codes of Business Ethics in the
Biopharmaceutical Sector (finalized in Mexico City)
Ethical interactions help ensure medical decisions are
made in the best interests of patients.
An initiative from the 17 APEC Small and Medium
Enterprises in Ministerial Meeting in Hawaii in 2011.
Biopharmaceutical aspect was finalized in Mexico City
Adopted by the Philippines via the Food and Drug
Administration on September 5, 2013 based on FDA
Circular No. 2013-024.
Guidelines, rules and regulations, and implementation
by the Center for Drug Regulation and Research.
! Affects the relationship between medical practitioners
relationship with the pharmaceutical industry.
! APEC countries are bound by these initiatives they
develop hence every individual country would need to adopt it.
Before there was code of practice applicable only to
pharmaceutical companies, which was voluntary, so there were
those who did not subscribe to this code of practice and used
illegal tactics. Physicians were not covered also by this code.
Hence, implementation of the Mexico Principle became
mandatory which are not directed only to pharmaceuticals but
also to physicians (PMA and PCP). All doctors practicing in
Philippines with PRC license are bound by Mexico City
Principles.
6 Basic Principles
1. Healthcare and Patient Focus
Everything we do is intended to benefit the
patient.
Top responsibility is to ensure patient safety.
2. Integrity
Dealing ethically, honestly, and respectfully in
everything we do.
3. Independence
To respect the need of autonomous decision
making of all parties free from improper
influence.
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4. Legitimate Intent
Everything we do is for the right reasons, is
lawful, and in alliance with spirit and values of
this principle.
5. Transparency
General willingness to be open about our
actions or respecting legitimate commercial
sensitivities and intellectual property rights.
6. Accountability
Willingness to be responsible of our actions
and interactions.
! By next year the US FDA will fully implement this principle.
Physician actions are covered by this principle and will be held
liable for misdeeds usually in the form of fines. Example,
physician samples are to be given to patients for free but some
doctors sell them to pharmacies which is unethical. At this
moment, it is unethical but is not illegal. Since the Mexico
Principle will be fully implemented next year then doctors who
do this kind of trade will be fined, imprisoned, and eventually
license will be removed upon subsequent offenses
respectively.
Top of responsibility of physicians is to ensure patient safety.
Moreso, if involved in the pharmaceutical field. The two major
core of Pharmaceutical physicians is research but more
importantly is to ensure the wellbeing of the patients.
III. EDUCATION AND ORGANIZATIONS
A. Masters in Pharmaceutical Medicine
Full medical specialty
Recognized specialty field in UK, Switzerland,
Mexico
Faulty of Pharmaceutical Medicine in England (11th
recognized field)
Basic courses are familiar to physicians; Elective
courses are new as far as the physicians are
concerned
Only physicians working in the industry are allowed
to enroll
Tuition is generally offset by salary deduction with
the company that the physician is working for
Existing Curriculum/Syllabus:
o As a postgraduate medical discipline,
Pharmaceutical Medicine has a recognized
international syllabus, training courses with
examinations and qualifications, its own
research methodologies, professional bodies
and academic societies, journals and texts, and
embraces new technologies and regulations in
pursuit of proof of efficacy, safety and
effectiveness of medicines.
B. Standards of Practice
This official recognition promotes the establishment
and maintenance of standards of practice and
professionalism in the competency, care, and
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conduct applied to their work and of growing public
recognition and accountability.
Australian Standards must pass a get a certificate
to be able to practice pharmaceutical medicine
C. Philippine College of Pharmaceutical Medicine
Association of Filipino physicians working in the
pharmaceutical industry in the country
Affiliated with the Philippine Medical Association
(PMA)
PMA general organization of all physicians
Other business affiliations:
o PHAP (Pharmaceutical Healthcare Association
of the Philippines) association of all the major
pharmaceutical companies in the country
IV. FUNCTIONAL AREAS
A. Medical Affairs
1. Basic Drug Research
Early phase studies including those conducted
in labs and on animals
2. Clinical Trials
Hospital-based
Involves studies in humans, from phase 1 to 4
Prospective biomedical or behavioral research
studies on human subjects that are designed
to answer specific questions about biomedical
or behavioral interventions
3. Pharmacovigilance
Drug safety or adverse event reporting
Collation and analysis of observations on
adverse drug reactions (ADRs)
Observes what happens to patients when
given a trial drug, noting for any toxic effects
and reporting if there are any
Focuses on adverse drug reactions which are
defined as any response to a drug which is
noxious and unintended
Primary responsibility of the Food and Drug
Administration of the Philippines
4. Regulatory Affairs
Involves the documentation, submission,
processing, review and approval of
consolidated information about the new drug to
ensure it meets legal requirements
When a new drug is to be marketed, it must
first be approved by the regulatory agency #
certificate of product registration issued
approximately 10 months after approval
allowing the drug to be released into the
market
Medication errors such as overdose, and
misuse and abuse of a drug as well as drug
exposure during pregnancy and breastfeeding,
are also of interest because they may result in
an ADR
5. Continuing Medical Education
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Provision of learning usually to
customers/prescribers
Sharing and updating of medical knowledge to
improve evidence-based practice
Physicians organize lectures for other
physicians to discuss disease, products or both
Lecture-type or conference type
6. Medical Communications and Information
Provision of information usually to
customers/prescribers but also to patients
May be part of continuing medical education
when geared towards physicians
7. Ethics and Compliance
Application of the framework of working in the
industry
One of the major roles of physicians is the
implementation of the Code of Practice; it is
their responsibility to ensure that the company
they work for complies with ethical principles
B. Non-Medical Functional Areas
1. Training
Mostly involves internal training of product
managers or sales representatives (medical
representatives) on drugs to be marketed, as
well as the underlying diseases treated by
these drugs
2. Sales and Marketing
The non-medical role of the physician
Ensures that a pharmaceutical product
reaches every potential market
Communication of the value of medicines in
a restricted fiscal environment to a broad
range of stakeholders
3. Business and Development
Health services need a financial backbone
for it to achieve sustainability
Especially so for services that are offered to
those that cannot afford it
4. Operation and Management
Physicians can be general managers (CEOs)
of pharmaceutical companies
Physician need to lend their medical
background to running a hospital or
pharmaceutical company
5. Health Outcome and Pharmaeconomics
Must have a good economic background
Subdiscipline of Health Economics
Refers to the scientific discipline that
compares the value of one pharmaceutical
drug against the others
Evaluates the value, cost, and effects of a
pharmaceutical drug:
1. COST is different from VALUE
2. Cost is a monetary term expressed
in peso, dollars, etc.
3. Something may be costly, but not
valuable.
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4. All of the pharmacoeconomic
studies role is to guide optimal
health care resource allocation
5. Example: Resource Allocation- Free
antiretroviral drugs for HIV Patients,
DOTS Program for TB Patients-
making sure they are taking their
medications.
C. Part-Time Roles
1. Speaker / Lecturer
Sharing knowledge about pharmaceutical
medicine towards continuing discovery and
improvement of evidence-based practice.
Engaging in conferences involving updates in
pharmacologic interventions.
Giving a short lecture about pharmaceutical
medicine; introduction and importance, to
medical students.
2. Consultant / Medical Advisor
Aiding in the collection, detection,
assessment, monitoring, and prevention of
adverse effects with pharmaceutical
products.
3. Clinical Trial Investigator
Physician can work as a clinical trial
investigator when a pharmaceutical company
is trying to market new medication. By this,
he can be involved in a team that will test the
effectiveness of a drug including its side
effects or reactions.
V. EXPECTATIONS FROM A PHARMACEUTICAL
PHYSICIAN
Medical degree / theoretical knowledge
Clinical expertise / background
Flexibility / versatility / adaptability
Motivation to work and willingness to learn
Leadership traits / proactive attitude
Teamwork and people management
Open to criticism
Fortnight / honest / direct
No ego
VI. PROS AND CONS IN THE INDUSTRY
A. PROS
1. Exciting
a. Cutting edge research
Being one of the first to know about medicine
that is under development
You get access to information which is
generally not available
Last year, Biogen Idec from Boston was said to
have the much awaited drug for Alzheimers
Dementia, neurodegenerative disease in which
the hallwark manifestation is memory
impairment. The drugs that we have right now
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only works to delay the impairment or stop the
progression of the disease. And when the
patient stops taking it, the effects would
abruptly trigger the effects.
The company has the drug for this which is a
monoclonal antibody drug in Phase 2 or 3 of
the clinical trial. This drug promises not only to
stop but reverse the effects of dementia.
7 years ago, Eli Lilly developed a drug specific
for brain substance which targets
deteriorations in the brain. This dye is used to
show the plaques and tangles in brain of a
person with Alzheimers. Previously, cognitive
tests are the only ones used to monitor
developments in a person with Alzheimer.
There is a new antidepressant which is
administered thru inhalation so that absorption
by the brain would be faster. Usually,
antidepressants are given orally but these
medications undergo first pass effect(drug
pass thru the liver and about 80% are
metabolized and excreted by the body)
This medication would bypass the livers first
pass effect so there would only be little drug
needed.
b. Travel
2. Challenging
Experience is highly regared
3. Very generous
Very well paid
13th month pay
Benefits
4. Flexible
A physician can ask for a flexible work
schedule providing that in can benefit both
sides.
If the company sees the ability, they are willing
to adjust.
5. Generally stable
Dependent on the number of patients
Everyday work is paid unlike in clinics that
there will be a day with no patient, therefore
less income.
Specialists are paid a premium by the
company
6. Long-term option
B. CONS
1. Demanding
Physical presence is highly required
2. Exacting
3. Difficult
4. Stressful
Monitor all his patients time to time.
5. Ordinary employee
vs. clinical practice you are the boss
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PHARMACEUTICAL INDUSTRY


VII. CONCLUSIONS
The Physician is suitably qualified to work in the
Pharmaceutical Industry.
There are a variety of roles that a Physician can go into
and excel in.
This is an exciting career option in pharmaceutical
medicine that one can consider and be satisfied with in
the long term - advantages in the field of pharmaceutical
medicine.

REFERENCES:
1. 2019C Trans
2. Lecture Notes
3. Dr. Buenaventuras PPT

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