Interview of senior professionals from the Pharmaceutical and CRO business across the region .
In an attempt to understand the affect of regulatory changes on the R&D scenario in Asian and Middle eastern countries several senior leaders from Pharma as well as the CRO domain were interviewed .
The primary focus of the interview was to collate opinions and experiences of these professional to build a baseline that will help develop a strategy for building Clinical trial related regulations across countries that are trial naïve .
The following set of questions were discussed:
1. What are some of the challenges that you perceive that have arisen due to this unstable / changing regulations?
2. With the regulations getting stringent will the
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Abrupt and unplanned changes in regulatory scenario will definitely have an adverse effect on business and R&D in the country. For India most of the top pharmaceutical companies have lost their confidence in conducting clinical trials in India . The challenge for the Indian counterparts is to engage their global teams in Indian businesses and to factor in delays in regulatory approvals into their global research strategies. Time required for completing clinical research activities will be lengthened .
In un-stable regulatory scenarios medical investigators are also skeptical to undertake research activities.
As a direct result of loss in business, the industry also had to deal with the loss of jobs . In such a scenario talent management and employing talent as required will be a huge challenge
In Indonesia, changes of regulations also affected the conduct of clinical trials , as per the Food and Drug Association, USA [FDA] database of Bioresearch Monitoring Information System no new research has been filed with the FDA in 2013 and 2014 as compared to the previous years
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This has lead to an increase in international interest as Turkey as a R&D destination.
• Strategies to manage business and employees in changing /challenging regulatory scenarios.
Any change in regulatory requirements for research activity will have an effect the ongoing research activity as well as future opportunities of research and development for the country . For India the changes in regulations led to a huge decrease in business , it has also made India a high risk destination for clinical research . Few of the strategies are :
Companies are diversifying - Geo diversion – explore new avenues like eastern Europe and Latin America , Portfolio diversion[ Late phase /Bio similar, ], Extended service lines [ Centralized services required for data management in clinical trials
Defining technology required to manage these diversification techniques . Have strategies to manage change and its effects on the organization at the country and global level
To combine OCR's outstanding people, process and technologies in novel ways to create entirely new eClinical services and outcomes that revolutionize how we conduct clinical trials and create value for our customers.
As a QA Manager I would ensure that the following steps are followed in accordance with the ICH, GCP, HIPAA and FDA regulations and guidelines for clinical trial documentation management.
In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. 21st century reforms Critical Path Initiative The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. Patients' rights to access unapproved drugs
The Indian pharmaceutical industry enjoys certain advantages, which include low cost of innovation and capital expenditure, and strong domestic support in production, from raw material requirements to finished goods. The competitive structure of the pharmaceutical industry was being redefined due to the threat of new entrants, intense price competition, entry of large players, and new regulations and rules as well as a shift in focus. In addition, the partnerships between pharmaceutical and biotechnology companies were growing rapidly. The global pharmaceutical market is undergoing rapid transformation. There has been a dramatic shift towards emerging markets as western markets slow down.
trials of investigation medical products. The FDA also has to review and approve in a
“Generally, the UK 's position in the clinical trials space has been improving with NIHR (National Institute for Health Research) support and much greater NHS commitment to clinical trials. There has been a concerted change in attitude toward clinical trials being relevant to activity of the NHS as well as the medical schools, which have always been interested in terms of trials. I think ultimately it would be a disaster if things like Brexit damaged that growth against our European
The globalization of clinical trials is a fairly new phenomenon and the price of developing new drugs on average costs $1 billion and most of that cost stems from human clinical trials. In the “Ethical and Scientific Implications of the Globalization of Clinical Research” essay, the reason for outsourcing clinical trials to developing countries is the increasingly bureaucratic and expensive regulatory environment in many wealthy countries. Regulating clinical research have become very complex, placing a...
...ative aspects of diversification, for example through better corporate planning, human recourse management and reaching further synergies between its various business lines.
If drug costs were to drop 40-45%, the amount of a drug to move from animal testing to human clinics would decrease by 50-60% (Abbott and Vernon). With such high risk and low reward, pharmaceutical companies will likely stop or slow research on new technologies and compounds. In 1969 Canada imposed regulations on drug prices (Weidenbaum). After the regulations were imposed, there was a decline in new drugs being created (Weidenbaum). This change in the pharmaceutical industry would likely have a major effect on the medical industry as a whole.
Government Collaboration - What is it? In the scholarly book, “TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond”, Hoen describes the need and uses of patents in the pharmaceutical industry. The World Trade Organization and Trade-Related Aspects of Intellectual Property Rights Agreement help facilitate the ever growing industry. In order to protect intellectual property, these organizations set out patents to these companies.
Pfizer is one of the largest pharmaceutical companies in the world, its headquarter locates in the US. Pfizer financial report of its fourth-quarter claim a 3% decline in sales diverted to $13.12 billion from Q4 2013 and recording a 4% decline in adjusted profit per share to $0.54 [35]. The challenges that Pfizer face can be generalized to an industrial challenge and the global economic environment challenge [29]. For intellectual rights, Pfizer products, including BeneFIX, ReFacto, Xyntha and Enbrel will have to compete biosimilars (also referred to as follow-on biologics) in the future just when competitors obtain marketing approval for biosimilars or when patent expiated [29]. There are other challenges that put Pfizer
"Pharmaceutical Corporations and Medical Research — Global Issues." Global Issues : Social, Political, Economic and Environmental Issues That Affect Us All — Global Issues. 2 Oct. 2010. Web. 12 Feb. 2012. .
Paul J., Seib R., Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res. 2005; 7(1):e5
This includes being stationed at the site of clinical trials and organizing resources to ensure timely and proper completion of trials and other stages. A job seeker for this positions needs to have a complete and comprehensive background in academic knowledge, clinical practices, ethics, interactions with sponsors and regulators. Travel is almost non-existent. Getting a entry into clinical research is difficult in the current scenario due to a catch-22 situation. Aspirants are not employed by clinical research companies or projects due to a lack of relevant experience and aspirants are unable to obtain experience due to a lack of job opportunities.
...ll as private sectors have gone international with new ventures outside the country. These companies are generating revenue, though modest compared to their overall sales revenue, by deputing their expert personnel outside.