Drug Development – A Challenging Career

The development of any drug is a very complex and time taking process. Since the advent of medical science, the development of effective and safe drugs has been a challenge. Today, even after so much development of science & Technology, we have not been able to make completely safe medicine. Every Medicine has some side (Adverse) effects with it. The pharmaceutical industry is striving to minimize the adverse effect of medicines and develop the most effective, safe & cost-effective drugs. With the evolving science & technology, the pharmaceutical industry has developed various tools & techniques to support their effort to develop more effective and safe medicines. The modern pharmaceutical industry has adopted some procedures & guidelines for any new drug development. This procedure has not only made medicines more effective and safer but also opened new avenues of jobs in the industry. There are requirements for different types of Experts at various stages of Drug development. Before we delve deeper, let’s understand the process of drug development. Any new drug development goes through the following 5 stages:

Stage 1: Discovery and Development

Stage 2: Preclinical Research

Stage 3: Clinical Research

Stage 4: Drug Regulatory Authority Review

Stage 5: Drug Regulatory Authority Post-Market Safety Monitoring

Stage 1

Discovery and Development

At this stage, the researchers discover new drugs through new insights into a disease process and, tests of molecular compounds to find possible beneficial effects against any of a large number of diseases, existing treatments that have unanticipated effects, new technologies to target specific sites within the body or to manipulate genetic material, new insight into a disease process to stop or reverse the effects of the disease.
At this stage, thousands of compounds are considered to be tested in the funnel, which is further reduced to a small number for further study.
Once researchers identify a promising compound, experiments are conducted to gather information, on various parameters. Such as absorption, distribution, metabolization and excretion. The collected information (Data) is further analyzed for its potential benefit, mechanisms, best dosage, method of intake, adverse effect (Toxicity), its effects on different groups, interaction with other drugs and comparative effectiveness with similar drugs.
This stage is conducted by Medical & Pharmaceutical experts, such as Doctors, Life Sciences, Pharmacy and Chemical researchers.

Stage 2

Preclinical Research

Clinical trial is conducted in 2 phases to evaluate the effectiveness and safety of a new drug or drug combination for a particular indication. Before starting a human trial of the drug, researchers must find out its possibilities to cause serious adverse effects (Toxicity). Drug regulatory agencies require researchers to use good laboratory practices (GLP). To set the minimum basic requirements for study conduct. Usually, preclinical studies are not very large and are conducted over a few hundred people. However, these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their findings and decide whether the drug should be tested in people.
These studies are conducted by experts with the help of Clinical Research & Pharmacology Associates.

Stage 3

Clinical Research

Once preclinical research is complete, researchers move on to clinical drug development, including clinical trials and volunteer studies to fine tune the drug for human use. This is the main phase of drug development as its success is dependent on various factors, ranging from efficacy, toxicity, development cost, prices and market size. This stage requires a very complex process, investment and time. The complexity of Clinical Trial design and its associated costs and implementation issues may affect trials carried out during this phase. Trials must be safe and efficacious and be completed under the drug development budget, using a methodology to ensure the drug works as well as possible for its intended purpose. This stage requires a multidisciplinary approach to reach the desired result. This stage is completed in various stages and involves a few hundred to thousands of patients to be studied.
In this stage, various samples are collected and analyzed. This generates humongous data, which requires to be properly maintaining, formatting & analyzing to reap the desired result. This requires the involvement of experts from different expertise of the pharma industry. The requirement of experts ranges from Clinical Research, Pharmacovigilance, Drug Regulatory Affairs, Intellectual Property Rights & Patents, Clinical Data Management, Clinical SAS and Pharma Business Analytics etc.

Stage 4

Drug Regulatory Authority Review

On the finalization of a new drug formulation for its efficacy and safety. The results generated from Clinical Trial are sent to the Drug Regulatory Authority in approved format for final review and approval from the authority. The approval of the Regulatory Authority depends on various factors. A drug developer must include everything about a drug—from preclinical data to Phase 3 trial data—in an NDA (New Drug Application). Developers must include reports on all studies, data, and analyses. Along with clinical results, developers must include:

  • Proposed labeling
  • Safety updates
  • Drug abuse information
  • Patent information
  • Any data from studies that may have been conducted outside the Country
  • Institutional review board compliance information
  • Directions for use

At this stage expert from Clinical Research, Regulatory Affairs, Intellectual Property Rights, Data Management, SAS and Business Analytics are required to furnish accurate information in lieu to get the new drug approved by the Authority.

Stage 5

Drug Regulatory Authority Post-Market Safety Monitoring

After approval of a New Drug the Authority wants to keep a watch on the drug in order to ensure its safety for humans. The Authority considers that despite the fact that data from clinical trials provide crucial information for understanding a drug's efficacy and safety, it is impossible to know everything about a drug's safety at the time of approval. Even after precise care in the process of drug development, limitations exist. Therefore, the true picture evolves after months and even years of observations. Drug Authority reviews reports of problems with prescription and over-the-counter drugs and can decide to add caution to the dosage or usage information, as well as other measures for more serious issues. Following drug approval and manufacturing, the Authority requires drug companies to monitor the safety of its drug.
This monitoring requires the involvement of industry experts from Clinical Research, Pharmacovigilance, Clinical Data Management and SAS.
For the last 15 years, the pharma industry is under immense pressure to develop more effective, safe &economic viable drugs. A huge fund is being poured in by the Pharma industry and research organizations to boost clinical research and new drug development. The global clinical trials market size was valued at USD 47.0 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.8% from 2022 to 2030 and reach USD 78.3 billion. Whereas the Indian clinical trials market size was valued at USD 1.93 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.2% from 2022 to 2030 and reach USD 3.88 billion. It clearly indicates that there will be a huge demand for Clinical Research Associates in the coming years. It is an appropriate time to enter the industry. But as this is an industry of high precision and high risk, so it requires a high level of training before entering the field. The sad part is that, in India, there are very few institutes offering quality and industry-relevant training. Most institutes are fooling students and just minting money. The students are left in doldrums after doing courses from such institutes. Students must avoid getting themselves trained from low standards and non-affiliated institutes.


In conclusion, drug development presents both challenges and opportunities for safer medications. Despite ongoing efforts, complete safety remains elusive, demanding continuous refinement. Skilled professionals from various fields are vital throughout the process. With the clinical trials market expanding, demand for trained individuals like Clinical Research Associates is rising. However, students must choose reputable training institutions to avoid pitfalls. Prioritizing quality education equips aspiring professionals to contribute to pharmaceutical innovation and healthcare. Take action now by selecting accredited programs to enter this dynamic field, shaping the future of medicine and improving patient outcomes globally.

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