Global Pharma Primer (Syllabus)

Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 1 of 19
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COURSE SYLLABUS
ARETE-ZOE, LLC
Course Title: Global Pharma Primer CPE credits: n/a
Course Number: Length: 10 weeks
Instructor: Arete-Zoe Estimated study time; 6-10 hours a week
Delivery method: Indirect (Internet)
Catalog Description:
The material included in these modules serves many interests by facilitating understanding of construct,
dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately
determine access, availability, and effectiveness of pharmaceutical products. In the following modules
we will introduce and describe the highly specialized and often disconnected components of
pharmaceutical research, drug development/manufacturing, marketing, regulatory policies and
practices, and use case studies to qualify the relative effectiveness of safeguards to prevent
harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected
both aspects of public concern within a global context because transnational interests influence national
circumstances.
Instructor comments:
All essential support materials for this course are provided as assigned readings. Students are
encouraged to submit a brief profile, detailing their background and professional experience and
interests. The information will remain confidential but will be used to refine course scenarios and
themes in order to establish relevant entry points for participants. It is recommended that students
establish, at their expense, an account with on-line library service. Although not essential for the
completion of this course, students are encouraged to explore and review provided further readings to
appreciate complexity and extent of the topic in question. Full texts of academic papers, rather than
mere abstracts which are available from free libraries such as PubMed, provide better understanding
what kind of information can be and cannot be obtained from published biomedical literature.

Broad competencies and terminal objectives:
 Explain how risk to patients and trial subjects is identified, measured, and communicated in
pharmaceutical industry, and define limitations of such approach
 Define operational environment in pharmaceutical industry: datascape, process timeline, and
participants, and describe availability of these datasets to other stakeholders
 Explain the most important differences in enforceability of international standards, and the role of
national regulators and extraterritorial FDA in globalized pharmaceutical industry
 Discuss the legal justification for major criminal and civil settlements in explain how compensation
for Adverse Drug Events (ADEs) relate to civil litigation
 Discuss landmark cases in pharmaceutical industry and their impact
 Describe main trends in pharmaceutical industry and their impact on resiliency against disruptions
 Define how pharmaceutical industry fits into national critical infrastructure in the U.S., EU, India and
China, and what these nations do to gain/maintain self-sufficiency/competitive advantage
 Interpret main issues in intellectual property infringements
 Discuss human factors as a contributing cause in the cumulative sector dysfunction
Course Material List:
Required: None, all necessary materials are linked to each module. References and
informational extracts and factsheets derive from non-commercial publications,
information available from regulatory agencies, news coverage, and publicly
accessible databases. Assigned readings are required for completion of the
course.
Recommended: Further readings expand on the topic and provide context and depth of
understanding of the topic. These materials are not essential for completion of
the course.
Required software: No specialized software required.
This course consists of five modules. Each module correlates to a two-week period and includes assigned
readings and a corresponding comprehension quiz. Additionally, within each module, students will
conduct a practical exercise based upon case study or write an opinion piece in the group discussion on a
topic posted by the instructors. Authors will defend/argue their position in instructor-facilitated group
discussion. Chat sessions will be scheduled for live collaborative exchanges. Selected contributions from
participating students will be presented in Bonus lecture in the end of the course.
Evaluation:
Students will respond to scheduled quizzes designed to help students assess their understanding of
items of particular importance. The final grade will be determined by the quizzes, practical exercises and
opinion pieces/case studies, final exam, and collaborative participation.

Final Grade:
Comprehension quizzes 25% of the final grade
Practical exercises, opinion pieces, case studies 25% of the final grade
Collaborative participation in discussions 25% of the final grade
Final exam 25% of the final grade
Course breakdown
Contents
Broad competencies and terminal objectives:.......................................................................................... 2
Course breakdown................................................................................................................................... 3
MODULE I – HUMAN CRISIS ................................................................................................................. 4
MODULE II – OPERATIONAL ENVIRONMENT......................................................................................... 6
MODULE III – SYSTEMIC VULNERABILITIES & RISK REDUCTION MEASURES........................................... 8
MODULE IV – LEGAL BATTLES............................................................................................................. 11
MODULE V – GLOBALIZATION ............................................................................................................ 13
BONUS LECTURE ................................................................................................................................ 14
Course Road Map……………………………………………………………………………………………………………………………………15

MODULE I – HUMAN CRISIS
Overview: Human crisis, patient casualties
Significant and persistent harm is inflicted, because of process failures and vulnerabilities. Harm includes
injury and death to trial subjects and to patients after drug approval. Harm is also inflicted by failure to
treat conditions for which safe and effective treatment is available, inappropriate medication, and failure
to develop and approve safe and effective medications for major public health problems. Significant and
persistent harm is inflicted on patients because patient casualties are the only driver of change toward a
safer system. Unlike in engineering in which risk can be identified without actual death/injury through
the assessment of systemic controls, in pharmaceutical industry actual death or injury is the only way to
prove there is a risk to patients. Pharmacovigilance system is based on active reporting of ADRs by
healthcare professionals and patients to drug license holders and/or regulators. Although drug license
holders have the obligation to disclose reports they received to regulators in a timely manner, this does
not always occur. Because of inability to independently verify true performance of the drug on the
market, hazard identification and risk communication largely depend on industry’s voluntary disclosure.
Adverse Drug Events (ADEs) are an important public health issue, namely because of additional costs of
disability/incapacity to the system and to the individuals. Module I explains causes of harm to trial
subjects and to patients after drug approval and basic concepts used in the industry to identify hazards
and communicate risks. Public health implications of unidentified/unmitigated hazards are analyzed,
including estimated human toll and monetary costs of adverse effects of medicines and medication
errors as well as under-treatment. Challenges in individual assessment of risk are also discussed.
Module Objectives:
By the end of this module, the student will be able to:
 Explain basic concepts of identification of drug-related hazards and risk communication in
pharmaceutical industry
 Discuss public health implications and system/individual costs of adverse drug events and reactions
 Differentiate predictable and preventable ADEs from those unforeseen and non-preventable
 Estimate probability of occurrence of adverse effects based on information they can find in product
labels.
Module Activities:
Directed readings orient on hazard identification concepts in pharmaceutical industry, both in clinical
research and in post-approval use explained on historical examples which triggered systemic change.
Students will extrapolate from assigned readings and presentations to locate relevant information in
publicly available sources and evaluate its content.
Reading Assignment:
 View presentation: Human crisis
 View presentation: Assignment Guide
o FDA: A History - Pre 1906 (2008)
o Fast The Latest News: The Tragic Death of President James Garfield

o Shuster, Evelyne. Fifty Years Later: The Significance of the Nuremberg Code
o World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research
Involving Human Subjects
o Winerip, Michael. The Shadow of the Thalidomide Tragedy
o IMNG: FDA Panels Revisit Rosiglitazone’s Cardiovascular Safety
o FDA. Sulfanilamide Disaster: Taste of Raspberries, Taste of Death The 1937 Elixir
Sulfanilamide Incident
o Allison Dnamap. Pharmacogenetics (PGx)/Pharmacogenomics Thorough Introduction.
Practical exercise:
Drug label is the main document which communicates risk-benefit profile of a drug to healthcare
professionals and patients. Familiarity with the document and its format and language is essential. It also
shows that the same drug comes with different information in different jurisdictions (U.S. v. EU). Lipitor
is a well-known drug; it will be discussed again in part on litigation; and the information provided in both
versions (U.S. and U.K.) is consistent. The drug is prescription only, but there was a long debate that the
drug would be available to patients OTC (over-the-counter). Patients are expected to be able to extract
basic information from the label.
 Read document online: 1 Patient Information Leaflet - UK
 Read document online: 2 Summary of Product Characteristics – UK
 Read document online: 3 Physician Prescribing Information – USA
 Read document online: 4 Patient Product Information – USA
Further Readings:
See bibliography
Evaluation:
 Comprehension Quiz
 Practical exercise: Locate requested information in the provided drug labels.

MODULE II – OPERATIONAL ENVIRONMENT
Overview: Operational environment: Research concepts, process timeline, datascape, and participants
Solution shall be developed in sequence. The first and essential part of solution development is
accurately defined operational environment. Operational environment in pharmaceutical industry is
defined by generally accepted scientific research concepts; timeline the industry follows to produce the
data necessary to achieve its objectives; and participants and their respective commercial interests. This
module defines operational environment in pharmaceutical industry. Specifically it elucidates basic
concepts used in pharmaceutical research, explains basic types of design of clinical trials, describes the
process timeline, indicates key steps in the process of drug development and commercialization, places
these steps on a timeline, identifies datasets produced in each stage of development, lists and classifies
individual participants and stakeholders in the pharmaceutical industry, and recognizes their business
purpose in order to acknowledge their self-interest biases and predict their behavior within the system.
The module presents basic principles of Good Clinical Practice (GCP), Good Manufacturing Practice
(GMP), and Good Pharmacovigilance Practice (GPvP) and their implementation and enforceability
around the world.
Module Objectives:
By the end of this lecture, the student will be able to:
 Define main components of operational environment in the pharmaceutical industry
 Describe basic research concepts in pharmaceutical research and types of design of clinical trials
 Explain how the industry measures performance of the drug research and development system
 Indicate key steps in the process of drug development and place them on a timeline
 Identify datasets produced in each stage of drug development and commercialization
 List individual participants in pharmaceutical industry, and recognize their business purpose
 Define availability of datasets produced by individual participants to other stakeholders
 Define self-interest biases of individual participants.
 Utilize publicly available registries to locate and download information on clinical trials for analysis
 Match published studies to registered clinical trials to detect publication bias and multiple
publication bias
Module Activities:
Directed readings orient on operational environment in the pharmaceutical industry, basic research
concepts in pharmaceutical research including design of clinical trials, and essential guidelines in clinical
research. Students will extrapolate from assigned readings and presentations to select a trial design in
which the trial subjects are most/least likely to receive investigational product, standard treatment, or
placebo. Students will be asked to match published studies to registered clinical trials to detect
publication bias and multiple publication bias.
Reading Assignment:
 View presentation: Operational environment
 Familiarize yourself with key resources: Assignment Guide

o View video: Hamilton, G: Body parts on a chip, TED Talks
Further reading:
See bibliography
Evaluation:
 Comprehension quiz
 Practical exercise I: This exercise is designed to allow students to apply their knowledge of
terminology and designs of clinical trials. This is essential to practically master content of this module
and retain knowledge for future use. Informed consent is only relevant if the user understands basic
research concepts and applies the knowledge in a real situation. Research fraud will be discussed in
Module III (Systemic vulnerabilities).
 Practical exercise II: This exercise is designed to guide students through the process of search,
collation, and assessment of information available on drugs under development and approved drugs
in public domain. Students will be able to utilize publicly accessible resources to obtain relevant data
from two major clinical trial registries – ClinicalTrials.gov and ICTRP, and from medical literature
database PubMed, and to compare the datasets. Approved US and EU label will be provided as a
reference material. A series of guiding questions will lead students through analysis of the datasets,
specifically to compare approved indications vs. indications under investigation, geographical origin
of data, publication bias and multiple publication bias, availability of study results, and timing of
publication of results in medical journals with respect to drug approval.

MODULE III – SYSTEMIC VULNERABILITIES & RISK REDUCTION MEASURES
Overview: Systemic vulnerabilities and risk reduction measures
Module III summarizes participants’ objectives, describes system goals in its ideally balanced state, and
design requirements of a safe system and its safety constraints. Systemic hazards are identified in the
drug development process, approval and commercialization. Examples of failure to detect safety issues
using current methods of detection of drug toxicity in clinical research and post-approval use are
presented to demonstrate vulnerability of the system. The process of regulatory review and approval is
presented on a decision-tree model to show instances of correct and incorrect rejection and approval.
Differing interests and motivators of individual stakeholders and inherent systemic risks are explained on
a series of drug withdrawals adjudicated to the part of process where the system had failed. Specific
examples of drug withdrawn or severely restricted for safety reasons are broken down to demonstrate
where, how, and why the system failed to identify/address the safety concern before inflicting serious
harm to trial subjects and patients.
Module Objectives:
By end of this module, the student will be able to:
 Summarize objectives of participants in drug development
 Describe system goals and design requirements, and safety constraints
 Define systemic hazards in the drug development process, approval and commercialization
 Explain principles and methods of hazard identification and mitigation in pharmaceutical industry
 Correlate cause of failure to process timeline on a series of specific examples
Module Activities:
Directed readings orient on identification of systemic hazards in the pharmaceutical industry and specific
examples of safety withdrawals as they occurred. Case studies will be adjudicated to process timeline
with explanation why and how the specific failure occurred. Students will explore publicly available
information on drug safety withdrawals and discuss why the system failed to identify/address the safety
concern before inflicting serious harm to trial subjects and patients. The students will analyze
consistency of safety measures employed around the world on a series of specific examples.
Assigned reading:
Materials included in assigned reading explain fundamental principles of assessment of toxicity of
pharmaceuticals and limitations in prediction of their adverse effects. The materials guide students
through the process in historical context which is necessary to understand why some disasters could not
be discovered in the past. Limitations of knowledge and technology at time of safety review have to be
distinguished from evidence of toxicity which was at the time of review ignored. Summary article on
differences in withdrawal between the U.S. and other countries shows inconsistent approach of
regulators globally toward the assessment of limiting toxicity. A series of examples of drugs withdrawn
for safety reasons shows where the process failed in each particular case to detect the safety problem
before the drug reached the market.

 View presentation: Systemic vulnerabilities, risk reduction measures and specific examples
 View presentation: Assignment guide
Case studies:
Materials included in assigned reading explain fundamental principles of assessment of toxicology of
pharmaceuticals and limitations in prediction of their adverse effects. The materials guide students
through the process in historical context which is necessary to understand why some disasters could not
be discovered in the past. Limitations of knowledge and technology at time of safety review have to be
distinguished from evidence of toxicity which was at the time of review ignored. Summary article on
differences in withdrawal between the U.S. and other countries shows inconsistent approach of
regulators globally toward the assessment of limiting toxicity. A series of examples of drugs withdrawn
for safety reasons shows where the process failed in each particular case to detect the safety problem
before the drug reached the market.
 TGN1412
 Troglitazone
 Thalidomide
 Diethylstilbestrol
 Triparanol
 Mefloquine
 Rosiglitazone
 Trovafloxacin
 Fen-Phen (exercise)
Assigned reading:
 Speid: Lessons Learned From the TeGenero First-in-Man Phase 1 Clinical Trial
 Taniguchi: Drug toxicity
 FDA Clinical White Paper 2000: Hepatotoxicity
 Huang: Predicting adverse side effects of drugs
 Ninan: Withdrawing drugs in the U.S. v other countries
 Jacobs – Hatfield: History of chronic toxicity and animal carcinogenicity studies for
pharmaceuticals
Videos:
 Herbst, Arthur. 40th Anniversary of DES Paper.
 Nevin, Remington. Neuropsychiatric Adverse Events Associated with Mefloquine.
 O’Reilly, Rita. “RTE’s Investigations Unit Asks If the Anti-Malarial Drug Lariam Be Linked to
Suicides among Irish Defence Forces Soldiers.”
 Democracy Now: WikiLeaks Cables: Pfizer Targeted Nigerian Attorney General to Undermine Suit
Further reading:
See bibliography

Evaluation:
 Practical exercise: Utilizing provided resources, students will define cause of failure to detect a
safety concern on the example of Fen-Phen.

MODULE IV – LEGAL BATTLES
Overview: Legal battles in pharmaceutical industry and why they matter
Module IV compares securities class action settlements in pharma to other industries, as well as trends
in federal and state settlements which resolved criminal and civil liabilities resulting from violations of
Food, Drug and Cosmetics Act and the False Claims Act; qui tam provision of the False Claims Act, and
the Foreign Corrupt Practices Act. Since the largest fines related to off-label promotion of approved
drugs, special attention is paid to specifics of marketing and advertising of pharmaceuticals. Landmark
cases which had major impact on pharmaceutical industry are briefly explained: Robertson v. Mc Gee
and its significance for the accountability of IRB/ECs; securities fraud cases Dura Pharmaceutical Inc. v
Broudo and Halliburton v Erica P John Fund; free speech cases Sorrell v IMS Health Inc. and U.S. v
Caronia; Wyeth v Levine as an example of successful state tort product liability claim; limitations on
liability of generic manufacturers as expressed in Pliva v Mensing and Mutual v Bartlett; and U.S. ex-rel.
Ge v Takeda as an example of unsuccessful qui-tam suit with impact on interpretation of reporting
obligations. Overall trends in personal injury lawsuits are presented and notable settlements are
discussed. This module compares and contrasts the correlations between criminal and civil settlements
and product liability lawsuits in the context of actual patient casualties, and discusses ambiguous liability
that results in rare compensation to the victims for safety failures.
Module Objectives:
By the end of this module, the students will be able to:
 Compare securities class action settlements in pharma to other industries
 Explain the basis for criminal and civil liability in the largest pharma settlements
 Discuss the implications of off-label promotion of approved drugs
 Comment on overall trends in personal injury lawsuits and discuss notable cases
 Discuss landmark cases which had large impact on pharma
 Discuss if and how settlements and lawsuits motivate stakeholders in pharmaceutical
industry to make pharmaceuticals safer for patients and trial subjects
 Relate settlements to patient casualties
Module Activities:
Directed readings orient on grounds for prosecution and largest settlements relating to off-label
promotion of approved drugs, as the most important regulatory enforcement activity, and the impact of
landmark cases in pharmaceutical industry. Students will extrapolate from assigned readings and
presentations to comment on a series of questions posted by instructors.
Reading Assignment:
 View presentation: Legal battles in pharmaceutical industry
 View presentation: Resource Guide
Landmark Cases
o Robertson v McGee
o Dura Pharmaceuticals v Brouda
o Sorrell v IMS Health

o Halliburton v EPJ Fund
o Wyeth v Levine
o Pliva v Mensing
o Mutual v Bartlett
o U.S. v Caronia
o U.S. v ex-relator Ge v Takeda
o (GVK Biosciences scandal)
Marketing & Advertising
o FDA untitled & warning letters 2014
Federal Settlements
o Largest FDCA and FCA settlements
FCPA:
o GSK Chinese bribery scandal, 2013
Meningitis Outbreak, 2012
Personal Injury lawsuits – Notable Settlements
o Breast implants class action 1994
o Risperidal
o Vaginal meshes
o M-o-m hip implants
o Blood thinners
o Asbestos
o Lipitor, Crestor, Zocor
o Nigerian Trovan trials (ATS clause)
o EU PIP crisis
Evaluation:
 Participation in discussion: Students have to post at least 2 qualifying contributions (min. 200
words per contribution) in discussion topics posted by instructors.

MODULE V – GLOBALIZATION
Overview: Globalization in pharmaceutical industry
Module V explains the impact of globalization on resiliency of the system, starting with geolocation of
key activities around the world (big pharma and biotech headquarters, manufacturing, clinical research),
important shipping routes, namely vulnerability to disruptions and creation of strategic dependency in
commodity which is part of critical infrastructure. The module breaks down the process of drug
development, approval, and commercialization by location where these activities mostly take place, and
illustrates important trends within the industry such as consolidation, outsourcing and globalization.
Special attention is paid to globalization of enforcement activities of the FDA, its partnerships with
national regulators in India, China and Europe, and global initiatives that address counterfeiting and
intellectual property rights infringements. Human factors in cumulative sector dysfunction are discussed
as the consequence of globalization and consolidation of the industry, specifically limited cross-training
and overspecialization, creation of data, personnel and communication silos, vested interests, and
exploitation of human frailties especially during the time of global economic recession.
Module Objectives:
By the end of this lecture, the student will be able to:
 Indicate geographical location where key activities in pharmaceutical industry mostly take place and
show main shipping routes
 Evaluate impact of consolidation, globalization and outsourcing in pharmaceutical industry
 Describe the role of national regulators and extraterritorial FDA with regards to oversight of
manufacturing of pharmaceuticals produced in India and China
 Define how pharmaceutical industry fits into national critical infrastructure in the U.S., EU, India and
China, and what these nations do to gain/maintain self-sufficiency/competitive advantage
 Describe main trends in pharmaceutical manufacturing and their impact on resiliency of the sector
against disruptions
 Describe impact of counterfeiting on resiliency of supply chain and distribution chain
 Interpret main issues in intellectual property infringements
 Discuss human factors as a contributing cause in the cumulative sector dysfunction
Module Activities:
Directed readings will orient on impact of consolidation, globalization and outsourcing in pharmaceutical
industry and the role of counterfeiting and intellectual property infringements, strategic dependencies,
and vulnerability of supply chain to disruption as a consequence of these trends. Students will
extrapolate from assigned readings to discuss the roles of national regulators in this increasingly
globalized sector, and how these interdependencies and influences affect behavior of individual
stakeholders and participants to consider patient and research subject safety and well-being.
Reading Assignment:
 Read provided material: Critical infrastructure in the U.S. and the EU
 View presentation: Global Pharma Geography
o Review resources: Main shipping routes and maritime security incidents

o Read document: 2014 Special 301 Report (Counterfeiting)
o Read case study: Exubera (Human factors)
o Read document: Beijing Review. China Pledges to Speed Entry of U.S. Pharmaceuticals.
o View video: Food and Drug Administration. FDA’s Global Transformation.
o View video: PhRMA. Foreign Sourced Active Pharmaceutical Ingredients vs. Imported
Drugs.
o Read article: Poustourli, A, and Naouma, K. “Standards for Critical Infrastructure
Protection (CIP) - The Contribution of ERNCIP.”
o Read document: WTO. “Implementation of the WTO General Council Decision on
Paragraph 6 of the DOHA Declaration on the Trips Agreement and Public Health - Health
Economics and Drugs Series No. 016,” 2004.
Further reading:
See bibliography.
Evaluation:
Comprehension quiz
Participation in discussion: Students have to post at least 2 qualifying contributions (min. 200 words per
contribution) in discussion topics posted by instructors.
BONUS LECTURE
Best contributions from student discussions will be presented in the form of bonus lecture, which will be
made available in the form of free preview.

MODULE I – HUMAN CRISIS
 Causes of harm to patients and trial subjects
 Injury and death to trial subjects
 Injury and death to patients after approval
 Safety v Security
 Hazard identification in engineering and computer science
 Hazard identification in pharmaceutical industry
 Pharmacovigilance system
 Public health implications of unidentified/unmitigated risks
 Individual assessment of risk
FURTHER READING ASSIGNED READING
New life science doctrine: Miasmic vs.
Germs theory
New life science doctrine: The death of
President Garfield
Early FDA history: patent medicines,
the Wiley Act, 1938 FDCA, tetanus
serum, sulfanilamide disaster
FDA history pre-1906
The Nuremberg Code: Nuremberg
Trials, informed consent before
Nuremberg
The significance of the Nuremberg Code
Thalidomide: The Kefauver-Harris
Amendment, legal aftermaths
Declaration of Helsinki
DES: timeline, use after 1971, Sindell
vs. Abbot Labs (market share approach)
The Shadow of Thalidomide
Safety vs. Security: Hacking
pacemaker, Therac 25, Panama syrup,
cybersecurity
FDA Panels Revisit Rosiglitazone’s
Cardiovascular Safety
Pharmacovigilance system: FAERS;
comparison of UK, US and German
hospitals
Sulfanilamide Disaster
Medication errors, national plan for
ADR prevention, warfarin
Pharmacogenetics and
Pharmacogenomics Thorough
Introduction.
Robertson vs. McGee: Patients injured
in a clinical trial
US Critical infrastructure
MODULE
I
MODULE
I

MODULE II – OPERATIONAL ENVIRONMENT
 Research concepts in pharmaceutical industry
o Basic concepts in pharmaceutical research
o Types of design in clinical trials
 Process timeline
o Key steps in the process of drug development
o Key steps in the process of drug commercialization
o Datasets produced in each stage of drug development
 Participants and their objectives and commercial interests
o List and classification of participants and stakeholders
o Business purpose of individual participants/stakeholders
o Self-interest biases and behavior
 Basic principles of GCP, GMP and GPvP
o Enforceability of these principles around the world
FURTHER READING ESSENTIAL RESOURCES
Clinical trial designs: study
designs, methods and
terminology, adaptive design
Websites of major regulators:
FDA, EMA
Clinical trial process: EudraCT
Public Report, UK CT toolkit
Drug safety reporting systems:
EudraVigilance; FAERS; Yellow Card
scheme
Research Ethics: Declaration of
Helsinki, Belmont Report, CIOMS
Human Subjects
EU Public Assessment Reports
Research metrics: success rate,
cost, speed and access to new
drugs
Databases of clinical trials:
Clinical Trials.gov (NIH) and ICTRP
(WHO)
Good Manufacturing Practice:
Inspection databases, GMP
resources
EXERCISE I: Do you know which drug
you are likely to get in a clinical trial?
Labeling: Physician Labeling Rule
EXERCISE II: How can you verify industry
claims using databases and academic
libraries?
Case study: Exubera
ASSIGNED READING:
Human on a chip
MODULE
II
MODULE
II

MODULE III – SYSTEMIC VULNERABILITIES & RISK REDUCTION MEASURES
 Participants’ objectives
 System goals
 Design requirements
 Safety constraints
 Systemic hazards
 Adjudicated safety withdrawals
o UN consolidated list of withdrawals
o Major safety withdrawals 1960s-1990s
o Case studies: TGN1412, mefloquine, trovafloxacin, troglitazone,
thalidomide, diethylstilbestrol, triparanol, rosiglitazone, fen-phen
UN Consolidated list of products
withdrwan or severely restricted
by governments
Drug toxicity: Animal toxicity tests,
predicting side effects, CDER 2001
hepatotoxicity white paper, mechanisms
Protein targets
Diethylstilbestrol: Arthur Herbst’s landmark
DES paper
Leveson: The use of STAMP in
modeling healthcare system
Mefloquine: Dr. Nevin’s presentation on
mefloquine neurotoxicity
Thalidomide The Trovan scandal: WikiLeaks Cables
Diethylstilbestrol (DES)
TeGenero lessons learned
Triparanol
Drug withdrawals worldwide – a
comparison
Mefloquine
EXERCISE:
Fen-Phen: adjudication on process timeline
Trovafloxacine
Troglitazone
Rosiglitazone
TGN1412
MODULE
III
MODULE
III

MODULE IV – LEGAL BATTLES IN PHARMACEUTICAL INDUSTRY
 Overall Trends
 Federal v. State Settlements
 Largest Federal Settlements
 False Claims Act & Qui Tam provision
 Food, Drug and Cosmetics Act
 Foreign Corrupt Practices Act: Globalization & Fraud
 Marketing & Advertising
 FDA Marketing & Advertising
 Personal Injury
 Generics
Security Class Action
Settlements
DOJ and OIG Healthcare Fraud
and Abuse Control Program
Annual Report
Federal Settlements: Highest
pharmaceutical settlements (Depakote,
Aranesp, Seroquel, Aggrenox, Azor-Benicar-
Tribenzor-Welchol, Endo Pharmaceuticals,
Risperidal, Zyprexa, Vioxx, Bextra, Hyalgan);
statistics; discussion Epstein vs. Abbott
Gibson Dunn healthcare
enforcement update
DEA Controlled Substances List
National Action Plan for Adverse
Drug Event Prevention
Landmark cases in pharmaceutical
industry:
o Dura Pharmaceuticals vs. Broudo
o Halliburton vs. EPJ Fund
o Sorrell vs. IMS Health
o Robertson vs. McGee
o Pliva vs. Mensing
o Mutual Pharm. vs. Bartlett
o Wyeth vs. Levine
o U.S. vs. Caronia
o Free Speech in pharma advertising
o U.S. rel. Ge vs. Takeda
FDA letters regarding marketing and
advertising in 2014
GSK Chinese bribery scandal
Multistate outbreak of fungal meningitis
Personal Injury Suits: Asbestos, Biomet
Bone Growth stimulants, Blood thinners,
Breast implants, Risperidal, vaginal meshes,
statins and diabetes, McKesson vaccines,
MoM hip implants, Nigerian Trovan trials,
OtisMed knee replacement, Adderall
MODULE
IV
MODULE
IV

MODULE V – GLOBAL PHARMA GEOGRAPHY
 Geography
o Big pharma headquarters
o Innovation
o Clinical research
o Regulators
o Manufacturers
o Major markets
 Trends
o Globalization
o Consolidation
o Outsourcing
 Pharmaceutical industry as part of critical infrastructure
 Vulnerabilities
Indian patent lawsuits
 Bayer vs. Natco
 Gilead vs. Natco
 Merck vs. Glenmark
 Roche vs. Cipla
 Novartis vs. Union of India
Innovation:
 Special 301 Report 2014 and 2015
 Case study: Exubera
Innovation:
 TRIPS Amendment
Regulators:
 Extraterritorial FDA
 Consistency of EU safety communications
 Chinese FDA
Innovation:
 WTO Paragraph 6
Consolidation:
 Pfizer bid on Astra Zeneca
Critical infrastructure:
 Healthcare spending
Critical infrastructure: US vs. Europe
Strategic dependencies:
 Foreign sourced vs. imported drugs
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Global Pharma Primer (Syllabus)

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