The document outlines the various teams involved in the drug development process, detailing their responsibilities and interactions throughout different stages, from drug discovery to post-marketing evaluation. Key teams include the drug discovery project team, preclinical development team, clinical development team, marketing team, regulatory affairs team, legal team, and management team. Each team plays a vital role in ensuring that drug candidates are thoroughly researched, developed, and brought to market while complying with regulations and addressing market needs.

1. DRUG DEVELOPMENT TEAM
ALLADURGAM. SAI KEERTANA
18Z51R0002
B.PHARMACY IVth year SEC-A

2. Introduction
• The drug discovery and development process requires the close
interaction of a large number of scientific disciplines for many years.
Most pharmaceutical and biotechnology firms employ teams to guide
the processes involved in taking a discovery through the various drug
development stages and making the drug candidate into a
therapeutic product

3. THE DRUG DEVELOPMENT TEAM IS CLASSIFIED BASED ON
THEIR FUNCTION AS FOLLOWS
1.DRUG DISCOVERY PROJECT TEAM
The primary responsibility of this group is to identify lead
compounds or classes of compounds worthy of continued
research. They include other scientific disciplines such as
synthetic chemists, therapeutic disease groups
(cardiovascular, CNS, cancer. infectious diseases, or metabolic
pharmacologists or biologists. Once a lead or class of leads
has been identified, the discovery team further includes
bioanalytical chemists, pharmacokinetics, and toxicology
experts for the development of the drug candidate

4. 2.Preclinical drug development project team
• The responsibility of this group is to establish the preclinical
development of a lead candidate in coordination with other new
teams. These include a management-assigned project team leader
and coordinator, RA and QA professionals, clinical trial team,
analytical chemists, manufacturing and marketing analysts. One of
the final responsibilities of the preclinical drug development project
team is to prepare an IND and to submit the appropriate documents
to the FDA or other regulatory agencies. As the development of the
drug candidate moves into the clinic, the preclinical project team
becomes a clinical project team.

5. 3.CLINICAL DRUG DEVELEOPMENT PROJECT TEAM
• After the IND is submitted the project team is again expanded to
include physicians, clinical research associates, drug product
production, QA, statisticians, clinical pharmacokinetics, regulatory
team medical monitors, marketing team.
• Manufacturing team: Manufacturing team, concurrently work with
various other teams, during nonclinical and clinical drug development
stage which includes pilot plant and scale-up process, validation,
regulatory documentation, packaging, and labeling requirement
according to GLP or GMP guidelines.

6. 4.Marketing team(post marketing and pre
marketing)
This team determines whether a drug candidate has potential in
comparison to others company’s product or drugs already in the market
for indicating the disease. Further, Phase IV studies are undertaken after
marketing has begun and evaluated new indications, new doses or
formulations, long-term safety, or cost-effectiveness. These include the
identification and monitoring of new additional adverse drug (ADR)
events from doctors or other health professionals.

7. 5.Regulatory affairs team :
• The regulatory affairs department is the interface with the FDA.
• It is their responsibility to ensure compliance with the rules and
regulations established by the Federal Food Drug and Cosmetic Act
and its amendments

8. 6.Legal Team
• In order for a drug to be financially successful, patent protection is a
key element
• The legal group must submit patents at the appropriate time and do
all its power to avoid law suits from potential competitors
• The legal group also ensure that neither the FDA nor the other
organization or company will challenge advertising and promotional
materials

9. 7.Manganement team
• They co- ordinate with all respective teams and responsible for
successful completion of projection in a time manner

10. Team consists of :
• Chemist
• Pharmacologist/Biologist
• Small group of team – responsible for
identifying lead compounds or classes of
compounds worthy of continued research
• Toxicologist
• Experts in Engineering, computer science and
Bioinformatics- help integrate new advances in
the technology
• Statistician
• Physicians
• Pharmacists

11. Responsibilities of these project teams include, but
are not limited to :
• Reviewing research results from experiments conducted by any of
the various scientific disciplines
• Integrating new research results with previously generated data
• Planning research studies to future characterize a drug candidate
• Preparing a detailed drug development plan , includes designation
of key points or development milestones, generating a timeline
for completion, and defining the critical path

12. • Monitoring the status of research studies to ensure that they are being
conducted according to the timeline and critical path in the development
plan and if appropriate modifying the plan as new information becomes
available
• Comparing research results and development status and timelines with the
drug candidates under developments by competitor
• Conducting appropriate market surveys to ensure that the development of a
drug candidate is economically justified and continues to meet a medical need
• Reporting the status of the drug development program to management and
making recommendations on the continued development of the drug
candidate