DRUG DEVELOPMENT TEAMS Industrial Pharmacy B.Pharmacy 7th Semester 2022 (2021-2022) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

Swami Dayanand Post Graduate Institute of Pharmaceutical Sciences (SDPGIPS)
Pt. BD Sharma University of Health Sciences, Rohtak
DRUG DEVELOPMENT TEAMS
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 therapeutic product.
The drug development team includes a diverse group of individuals with different philosophies and approaches to the development process. All team members must work closely together to ensure that a drug is both safe and efficacious.
#Composition of Drug Development Teams:
The drug development team includes the following:
1. Project team leader (assigned by management)
2. Coordinator
3. Regulatory Affairs (RA) professionals
4. Quality Assurance (QA) professionals
5. Analytical chemists
6. Manufacturing analysts
7. Marketing analysts
#Drug Development Teams Classification:
The drug development teams are classified into the following on the basis of their function:


1. DISCOVERY TEAM:
The primary responsibility of this group is to identify lead compounds or classes of compounds worthy of continued research. Basically this group is comprised of the basic scientists and chemists who created the new molecule. This group synthesizes drug substances for “drug screening”, pharmacology and toxicology studies and also prepares clinical supplies.
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.
2. PRECLINICAL DRUG DEVELOPMENT TEAM:
The responsibility of this group is to establish the preclinical development of a lead candidate in coordination with other new teams. This group studies the drug product in animal models for efficacy and safety in order to identify potential efficacy and safety in humans. It is critical for the clinical and development groups to work closely with the lexicologists in the design of animal studies to ensure their relevance to the clinical development.
As the development the drug candidate moves into the clinic, the preclinical team becomes a clinical team.
3. CLINICAL RESEARCH 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 and ,marketing team.
Clinical research has the ultimate responsibility for testing drug products in humans: the monitoring of drug safety rests squarely on the shoulders of clinical research. It interacts with the FDA and responsible for the generation of study reports with input from biostatisticians and regulatory affairs. Moreover, it can also generate the publications necessary for marketing of any drug product.
4. REGULATORY AFFAIRS TEAM (RA 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.
5. MARKETING TEAM:
The marketing group has the ultimate responsibility for marketing and selling the drug. This team determine whether a drug candidate has potential in comparison to others company’s product or drugs already in the market for indicating the diseases.
Marketing has to provide creative concepts for the prescribing physician, the patient and the company’s senior management. They also have to make assure that budget goals are met.
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 in its power to avoid lawsuits from potential competitors. The legal group also ensures that neither the FDA nor the other organization or company will challenge advertising and promotional materials.
7. MANAGEMENT TEAM:
They co-ordinate with all the respective teams and responsible for successful completion of project in a time bound manner.

#RESPONSIBILITIES OF DRUG DEVELOPMENT TEAMS:
The responsibilities of drug development teams includes the following but are not limited to:
1. Reviewing research results from experiments conducted by any of the various scientific disciplines.
2. Integrating new research results with previously generated data.
3. Planning research studies to further characterize a drug candidate.
4. Preparing a detailed drug development plan, including designation of key points or development milestones, generating a timeline for completion, and defining the critical path.
5. Monitoring the status of researched 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.
6. Comparing research results and development status and timelines with the drug candidates under development by competitors.
7. Conducting appropriate market surveys to ensure that the development of a drug candidate is economically justified and continues to meet a medical need.
8. Reporting the status of the drug development program to management and making recommendation on the continued development of the drug product.

#PHARMACEUTICAL DRUG DEVELOPMENT:
Pharmaceutical Drug Development is a process of bringing a newly synthesized drug molecule to the market once a lead compound has been identified through the process of drug discovery. These newly synthesized drug molecules which also known as New chemical entities (NCEs) or as New molecular entities (NMEs) are identified as Lead compound if they show promising pharmacological activity against a particular biological target that play a major role for a particular disease.
Drug Development process consist of a number of events that took place between the discovery of Lead compound to its eventual marketing. Broadly, the process of drug development can be divided into pre-clinical/non clinical and clinical phases.
• Pre-clinical or Non- clinical Phase of Drug Development:
Pre-clinical Drug Development involves pharmacological and toxicological assessment of the potential new drug in animal models in order to establish its safety and efficacy before the administration to human volunteers in clinical trial phase. Pharmacological and toxicological assessment of the potential drug candidate is carried out by both in-vitro and in-vivo methods and in accordance with the guidelines of good laboratory practice (GLP). The GLP regulations are found in - 21 CFR Part 58.1: Good Laboratory Practice for Nonclinical Laboratory Studies. It includes the following studies:
1. PHARMACOLOGICAL STUDIES:

 PHARMACOKINETIC PROFILE STUDY:
It deals with study of ADME. Generally, ADME studies are conducted in two species, usually rats and dogs, repeated with different dose levels in males & females. The main task of pharmacokinetic studies is to find an optimal dose level and to provide information about the dose-effect relationship.
 PHARMACODYNAMIC PROFILE STUDY:
It deals more specifically with:
• Primary pharmacodynamic (PD) study - Study Physiological effects of drug
• Secondary pharmacodynamic study - Study Mechanism of drug action and effects of the relevant compound which are not related to its desired therapeutic target.
• Safety pharmacology studies - Safety pharmacology studies are conducted to identify possible undesirable pharmacodynamic effects of a compound on selected physiological functions which may have an impact on human safety.
2. TOXICOLOGICAL STUDIES:
Toxicology defines the preclinical part of the safety assessment during drug development. By conducting toxicity studies, possible hazards and risks are identified.