DCS Drug Discovery and Development
India is our fastest growing geography in terms of headcount. About 1,000 employees are in IT services and the rest are supporting business functions in clinical trials. As India returns to the global map due to the recent legislative changes, it will be required to support more global operations in medical, mathematical, bio-statistics skills as well as local clinical trials. We can see thousands of employees more in the next few years easily.
The market clocked an impressive compounded annual growth rate of 17.46% over the period 2005-2016. By 2020, the Indian pharmaceutical market is expected to be among the global top three by incremental growth and is expected to be the sixth largest market in the world in terms of absolute size.India is expected to be among the top 25 nations in the Global Innovation Index within the next 10 years.
Clinical Trial Market sees a Positive Metamorphosis with the Country being viewed as a Drug Discovery Destination, says Frost & Sullivan.The market is growing at a rate of 11-13 per cent as the country builds its track record and gains increasing favour as a base for global clinical trials (phase I-IV). According to ASSOCHAM, Clinical Research industry expected to employ 50,000 professionals in the next five years.
DCS offers a number of programs that fall within the broad definition of drug discovery and development. It encompasses non-clinical and clinical phases of research, monitoring of drug safety on an ongoing basis, managing of clinical trial data, regulatory affairs and even writing of documents related to the whole drug discovery and development process. These unique programs open up a wide range of career opportunities for you in the CRO, SMO, IT, pharmaceutical and biotechnology industry.
DCS Drug discovery and development programs are available for GLP, Clinical Research, Pharmacovigilance, Regulatory Affairs and Health Economics Outcomes Research.
Objective
To contribute in India and the World through excellence in education and research
To establish across globally to be a best academic in research and pharmaceutical industry;
To ensure patient safety, product quality and data integrity inline to latest regulations, ethics and quality;
To provide knowledgeable resources to the industry;
To promote and support drug discovery and development with required skillet;
To be well aligned to the regulatory requirements to protect human kind
The drug and medical device development industry is experiencing a tremendous change globally. This change has geared momentum towards development of unique, newer and safer therapies and towards personalized medicinal drugs. The business models are advancing to the higher levels of niche busters and towards a coexistence of newer and blockbuster therapies used in the past.
Due to the strengthening of economies in the BRIC countries i.e. Brazil, Russia, India & China, drug and device companies are focusing their research and development efforts in these regions particularly the research for clinical development of products i.e. Phase I to Phase IV clinical trials. Further, local pharmaceutical and biotech companies in these regions are also rapidly stepping up their work in Research and Development for developing promising new molecules as well as generics.
With the growth of the industry a number of clinical trial management organizations and business models have come into existence which include full-service Contract Research Organizations (CROs), early phase CROs, Site Management Organizations (SMOs), companies offering fewer but specialized services such as Clinical Data Management, Business Consulting, Knowledge Process Outsourcing (KPOs) etc. This growth has eventually amplified the demand for trained staff in the clinical research industry.
Diploma and Post Graduate Diploma in Clinical Research Course equips you with the knowledge and skills required for making a successful career in drug development and clinical trials. The program has been designed in a way so as to compliment your basic education and to provide you a platform to enter the pharmaceutical and biotech industry as a clinical research professional.
Courses:
- Diploma in Clinical Research
- Post Graduate Diploma in Advanced Clinical Research and Pharmacovigilance
GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries.
GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment. [1] GLP, a data quality system, should not be confused with standards for laboratory safety – appropriate gloves, glasses & clothing to handle lab materials safely. The principles of GLP aim to ensure and promote safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and laboratory testing. But, GLP is not limited only to chemicals. It applies to medical devices, food additives, food packaging, colour additives and other non-pharmaceutical products or ingredients as well.
GLP principles include:-
Organization and Personnel
- Management-Responsibilities
- Sponsor-Responsibilities
- Study Director-Responsibilities
- Principal Investigator-Responsibilities
- Study Personnel-Responsibilities
Quality assurance program
- Quality Assurance Personnel
Facilities
- Test System Facilities
- Facilities for Test and Reference Items
Equipment, reagents and Materials
Test systems
- Physical/Chemical
- Biological
Test & Reference items
Standard operating procedures
Performance of Study
- Study Plan
- Conduct of Study
Reporting of results
Archival – Storage of Records and Reports
The drug development industry is changing in a way where innovation and drug safety are not separate from one another. New business models are maturing leading to the development of new generation therapies and to a coexistence of these newer drugs and well known blockbuster treatments from the past.
Pharmacovigilance is now an essential component of the life cycle of almost all healthcare related products. This is because of a demand for safer and more effective drugs and changes in regulations applicable to their research, development and marketing.
Many global companies such as Pfizer, Quintiles, GlaxoSmithkline etc have developed their own pharmacovigilance centres in all major clinical research regions around the world including India. In addition, local drug companies in these regions are also stepping up their work in research and development for both promising new molecules as well as generics. An industry analysis carried out by Frost & Sullivan titled ‘World Pharmacovigilance Markets in Lifesciences’ has found that the while the global pharmacovigilance industry in 2008 was valued at US $1859.9 million it is estimated to touch US $2252.2 million by 2015. This business report also emphasizes the shifting focus of key drug companies towards outsourcing their pharmacovigilance functions to smaller specialized pharmacovigilance service providers. Developing regions such as India, Latin America etc are slowly becoming a hub for pharmacovigilance business.
In November 2004, the Indian ‘Central Drugs Standard Control Organization’ (CDSCO) launched the National Pharmacovigilance Program under the aegis of Directorate General of Health Services and the Union Ministry of Health and Family Welfare which has now been replaced by the Pharmacovigilance Program of India (PvPI) introduced in 2010.
This Diploma and Advanced Pharmacovigilance Training Course is an integrated program that will give you a methodical understanding of the key areas of drug development, clinical research processes, clinical trial management, and pharmacovigilance systems thus boosting your skills and knowledge to the level expected of a Clinical Research and Pharmacovigilance Professional. In addition to clinical trial management, this Advanced Pharmacovigilance Training Program trains students to put together, evaluate and organize data related to drug side effects so as to make regulatory decisions pertaining to marketed drugs. Both clinical research and pharmacovigilance are now generating a significant number of new exciting career opportunities.
Courses:
- Diploma in Pharmacovigilance
- Post Graduate Diploma in Advanced Clinical Research and Pharmacovigilance
Clinical research is a rapidly progressing, essential field of medical science that deals with the evaluation of new medicines and therapies with an ethical approach. Developing these new medicines is very challenging considering the inter-individual, inter-racial and cultural diversities that we possess as human beings.
Advancement towards the idea of developing personalized treatments is giving a new dimension to the research and development efforts of the global drug development industry.
Fundamental to clinical research is the domain of regulatory affairs which forms a network of standardized laws, regulations and guidelines creating an equilibrium between facilitation of innovation and safety of subjects enrolled in clinical trials.
In the present global clinical research landscape, regulatory affairs professionals lead multinational assignments and make sure that clinical trials are performed in compliance to the applicable regulatory requirements of the sponsor’s nation as well as the international locations where the clinical trial is being conducted.
At JLI we strive to develop clinical research and regulatory affairs professionals who are equipped with the most relevant and up-to-date knowledge and skills. This Advanced Clinical Research and Regulatory Affairs training program is practically driven and centered on the tasks expected of a regulatory affairs professional in the clinical research industry. In this Regulatory Affairs training you are provided with the understanding of the global regulatory structure and acquire skills needed for regulatory strategic planning throughout the product lifecycle.
In this training course you will understand the techniques of critical evaluation for risk/benefit analysis by assessing the economic, societal, regulatory and corporate requirements. You will also attain the expertise essential for performing in an advisory role as a regulatory affairs specialist for pre and post marketing projects.
Additionally, you will learn how to interface with the regulatory agencies and other key stakeholders for accomplishing regulatory compliance.
The curriculum for the program – Post Graduate Diploma in Clinical Research & Regulatory Affairs (APGDCR-RA) is comprehensive, has been developed and evaluated by experienced pharmaceutical regulatory affairs professionals and is fully endorsed by the clinical research industry. Not only is this online training course suitable for new graduates but also for working professionals who either wish to grow further in their clinical research and/or regulatory affairs career, or those who wish to make a move to the clinical research or pharmaceutical regulatory affairs domain from any other related industry.
Courses:
- Post Graduate Diploma in Clinical Research and Regulatory Affairs
HEOR / HTA is basically a multidisciplinary policy approach which uses clinical effectiveness, cost-effectiveness, policy and ethical perspectives to provide insights and evidence upon which rational policy decisions on the usage of health technology can be made. HEOR / HTA can be applied for either a single technology (such as a drug or device) or complex interventions (such as rehabilitation). It can be used for individual patient care or public health.
HEOR / Health Technology Assessment HTA is used as a tool to enable the assessment and comparison of health technologies using same metric of cost-effectiveness. Its outcome results in benefit of the patient as well as technology producers because only those technologies which are cost effective are promoted for widespread use.
What would be the job profile of someone graduating from this course?
Academic/research centers or universities – undertake HTA research projects funded by HTA agencies, national research bodies or health technology companies to support reimbursement or develop HTA methods. Private industries including pharmaceutical companies, bio-technology companies and health insurance companies design and undertake evaluations (effectiveness and/or cost-effectiveness) for presentation to reimbursement agencies in support of health technology products. Local or national government agencies, regulators, health service providers and international health organizations (example: WHO) commission and review assessments submitted to support reimbursement of health technologies; undertake systematic reviews, evidence synthesis and evaluations to focus and direct health care policy; evaluate policy and programmes previously funded. National or international consultancy companies undertake HTA projects for governments, HTA agencies or industry clients.
Courses:
Diploma in Health Economics Outcomes Research
Conducting clinical trials in emerging markets with reduced expenses and a bigger pool of patient benefits sponsor pharmaceutical companies, and it is also beneficial for the local healthcare system and the economy of the developing country.
As per reports of clinicaltrials.gov, 1.4% of global clinical trials are done in India, while the country has 16% of the world’s population and carries 20% disease burden in the world. However, the number of clinical trials in India is expected to grow by 2018-19 as a result of regulations for clinical trials in India becoming more stable and predictable, according to Dr. Chirag Trivedi, President, Indian Society for Clinical Research (ISCR).
