The document summarizes the drug development process and the role of medical affairs departments within pharmaceutical companies. It discusses the various phases of clinical drug trials from phase I to phase IV. It then outlines the structure and responsibilities of medical affairs, including clinical research, pharmacovigilance, medical information services, statistics management, and providing medical support to marketing and sales teams. A key part of medical affairs is the medical science liaison program which aims to educate medical professionals and support clinical trial recruitment through relationship building.

1. Presented By: Dr. Zubair Ali
Medical Affairs Department

2. • Drug Development Process
• Medical Affairs structure
• Medical Affairs Department
• MSL Program
Contents

3. Your Logo

4. Drug Development Process

5. The common objective of all pharmaceutical
companies is to discover, develop and market
safe, efficacious and cost-effective medicines that
will bring benefits to patients, health care
professionals and consumers and result in
profitable returns to the company.
Introduction

6. When developing a potential new pharmaceutical
compound, the primary objectives are to demonstrate
that under the conditions of therapy, the potential
new drug is of constant chemical quality, is effective
in a significant proportion of patients and is safe.
Drug development

7. Drug development process
Stages of Drug development

8. Phase IV Clinical Trails

9. Phases of the clinical programme
Phase I
Humans exposed: 30–50
Phase II
Humans
exposed: 250–500
Phase III
Humans exposed: several hundred to several thousand
Phase IV
It is used to collect adverse event data from a large patient
population.

10. Type of trial : Therapeutic use
Purpose of trial
• Refine understanding of benefit–risk relationship
in general or special populations and/or
environments
• Identify less common adverse reactions
• Refine dosing recommendations
Clinical trials Phase IV

11. • General information
• Signature page
• Summary
• Background information
• Trial design
• Selection and withdrawal of subjects
• Treatment of subjects
• Assessment of efficacy
• Assessment of safety
• Statistics
• Quality control and quality assurance
• Ethics and regulatory aspects
• Data handling and record keeping
• Publication policy
• References
The main contents of the protocol (ICH
GCP section 6)

12. ADRs may be classified by cause and severity.
Causes:
• Type A: Augmented pharmacologic effects - dose dependent and
predictable
– Intolerance
– Side Effects
• Type B: Bizarre effects (or idiosyncratic) - dose independent and
unpredictable
• Type C: Chronic effects
• Type D: Delayed effects
• Type E: End-of-treatment effects
• Type F: Failure of therapy
• Type G: Genetic reactions
Types of adverse drug reaction

13. Medical Affairs

14. • Act as the medical conscience of the company
• Ensure adherence to relevant legal requirements and
guidelines
• Provide a medical perspective to product development
• Provide the medical input to the servicing and support of
marketed products throughout their life cycle
• Provide general as well as specialized medical expertise.
• Act as the company’s expert interface with all sectors of the
medical profession as well as other external stakeholders
(e.g. regulatory authorities, press, health technology
assessment bodies).
Role of the medical department

15. Hierarchic in company’s medical
operations

16. Key players from the medical department are likely to be as
follows
• Pharmaceutical physicians
• Clinical research scientists
• Statisticians and data managers
• Medical information scientists
• Scientific advisers
• Regulatory executives
• Drug safety/pharmacovigilance scientists; and
• Pharmacoeconomics advisers.
Key players from the medical
department

17. Medical Affairs
Department

18. Proposed Structure at Head Office
Manager
Medical Affairs
Clinical Research
Associate
Associate
Medical Services &
Pharmacovigilance
Associate
Training &
Development

19. Structure at Location
MSL
MSL
MSLMSL
MSL
MSL = Medical Science Liaisons

20. • Clinical Research
• Pharmacovigilance
• Medical Services support
• Statistics Management
• Issues Management
• The pharmaco-economics advise
• Support to MSLs
Responsibilities of a Global Manager
Medical Affairs

21. • To provide clinical
research support in all
aspects of clinical trials
from planning, design,
monitoring, report-writing
and publication.
• To design study protocol
that describes, in detail,
the plan for conducting
the clinical study.
Clinical Research

22. • Effective handling of all information’s relating to drug safety.
• Timely processing of spontaneously reported suspected adverse
drug reactions relating to marketed products, as well as adverse
events reported in clinical trials of both pre-licensed drugs and
marketed product in accordance with current International
Conference on Harmonization (ICH) guidelines (ICH E2C)
• To ensure that all staff in the company are trained on adverse event
reporting guidelines and the recognition of potential safety
information and concerns relating to the company’s products.
Pharmacovigilance

23. Support on advertising and POS
material
• Provide support on scientific
services, advertisement and
other point of sales material.
(Required by Article 13 of
Directive 92/28/EEC (on
advertising) of the Council of the
European Communities)
Medical Services support

24. Support to business development
• In addition to above provide support to business
development on new products development.
Support to Marketing for new launches
• To provide support as a ‘scientific adviser’, as a
specialized information support to a product or therapy
area within the company which could help in launching
products in new therapeutic areas.
Medical Services support

25. • To provide advice on patient numbers and data analysis
as it is essential to endow with a sound statistical
rationale behind a clinical research project if it is to stand
up to scrutiny by regulatory agencies and ethics
committees.
• To provide statistical data to be used in support of
promotional claims
Statistics Management

26. • Ensuring the accuracy and scientific quality of medical
information needed by both internal and external
customers.
• Provide brand-related input into therapeutic area and
disease area in line with company strategy.
Issues Management

27. • With health care costs rising, it is necessary to provide
evidence of effectiveness of the medication and economic
measurements of the benefits that a new drug can provide.
Such comparisons will need to include not only
measurements against competitor drugs, but also against
other medical interventions.
• In line with above should provide timely input on pharmaco-
economics on a new product. (With the guidelines provided by
National Institute for Health and Clinical Excellence (NICE),
the Scottish Medicines Consortium (SMC) and other related
agencies)
Pharmaco-economics advise

28. The MSL Program
• Mission: Medical Science Liaisons partner
with clinicians through medical education
to further the understanding of the
treatment of different diseases.
• MSLs provide educational-based activities
to increase awareness and enhance
accrual into selected clinical trials.
Medical Science Liaisons ( MSL
Program)

29. 1. Medical Expert (ME) Advocacy Development
• Identify and collaborate with Key Opinion Leaders (KOLs), therapeutic thought
leaders and members of the scientific community
• ME relationship management
• Facilitate and maintain scientific dialogue
2. Clinical Trial Support
• Provide on MSL priority projects research site recommendations and
educational activities to support study accrual
• Increase awareness of Herbion clinical research and trial program.
• Identify Investigator Initiated Trials (IIT), Investigator Initiated Research
Programs (IIRP) and Third Party Sponsored (TPS) Studies
Key Roles and Responsibilities

30. 3. Medical Education
• Educate ME on novel and emerging data.
• Provide scientific information to head office on
medically relevant business critical issues.
• Provide medical education to our sales team at location.
4. Scientific Services
• Provide value added scientific services to ME upon their
request.
• Scientific exchange with internal colleagues seeking
external insight to shape companies commercial and
development programs.
Key Roles and Responsibilities (cont)

31. 5. Scientific Projects
• Implement added value scientific projects according to corporate global
strategies
6. Networking
• Alert customers to opportunities (e.g. speaker’s events, clinical studies) that will
allow them to develop professionally.
• Identify, seek and establish connections in the medical community.
• Touch multiple people at customer sites to open more communication channels.
• Participate in scientific groups or societies outside company to establish diverse
networks. Participation should be consistent with company guidelines.
Key Roles and Responsibilities (cont)

32. Training & Development

33. • Training and Development helps in optimizing the
utilization of human resource that further helps the
employee to achieve the organizational goals as well as
their individual goals.
Training and Development

34. • Productivity – Training and Development helps in increasing the productivity of the
employees that helps the organization further to achieve its long-term goal.
• Team spirit – Training and Development helps in inculcating the sense of team
work, team spirit, and inter-team collaborations. It helps in inculcating the zeal to
learn within the employees.
• Organization Culture – Training and Development helps to develop and improve
the organizational health culture and effectiveness. It helps in creating the learning
culture within the organization.
• Organization Climate – Training and Development helps building the positive
perception and feeling about the organization. The employees get these feelings from
leaders, subordinates, and peers.
• Quality – Training and Development helps in improving upon the quality of work and
work-life.
• Healthy work environment – Training and Development helps in creating the
healthy working environment. It helps to build good employee, relationship so that
individual goals aligns with organizational goal.
Importance of Training and Development

35. Responsibilities related to Medical Trainings:
• To conduct need assessment (where applicable) regarding medical education and
try to fulfill gaps before and after the training.
• To conduct basis training courses for sales team.
• To conduct basis training courses for our head office teams especially for
marketing and business development departments.
• To conduct leadership development programs along with sales training team.
• To ensure refresher trainings regularly and on need basis.
Training and Development

36. Questions