Category Archives: Clinical Research Organisation & Outsourcing Clinical Research Archives

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The Indian generic drug industry is the largest supplier of medicines worldwide and US is the largest consumer of the same. One of the leading companies, a leading generic manufacturer which is also the leading supplier of generic medicines to the US has come under the FDA scanner since the last 12 months.  The trigger to the Ranbaxy problems came when Dinesh Thakur , ex-Ranbaxy employee, acted as the whistleblower. The same came out as an action from the FDA when Ranbaxy’s key manufacturing plants in India went on a spree of Imports alerts and 483’s. To add to the problems, even Ranbaxy’s’ US based plants came under the FDA lens.

 The problems were many:

  • Response from the Indian regulated DCGI to the Ranbaxy fiasco came only after the FDA warnings to Ranbaxy
  •  Internal conflict within Ranbaxy between the ex-owners, Malvinder Singh and Diachii Sankyo occupied the front pages of the media Continue reading

Clinical trials market in India-Will the same pick up in India?

This is the key question with analysts, investors and all stakeholders who have been observing this market in the recent times. The clinical trial industry since the year 2006 has been expected to grow in double digits because of its vast patient population.

However, things have not been bright for the industry particularly since 2009.

Data available at the Clinical trial registry of India has witnessed a step hike in clinical trial registration since it came into inception. On an international level, data at the Clinical trials Gov. site has also captured this aspect. Continue reading

Self regulation was definitely there with the Industry. Otherwise the business would not have been growing.

In a country like India where majority of the population is not so literate and not so rich, change their “integrity” for their “rights” and ultimately suffer at the hands of people who just want their own mileage. The people who are involved in the law making process do not have the relevant expertise nor the understanding of the business process. Hence the they get incited easily when something like death, or other adverse reactions takes place because of the disease itself and not the trial. Things take an ugly turn when the matter goes to courts and livelihood of people is affected. Moreover, the population which requires cost effective drugs/ new drugs for their diseases suffer too.

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In the business of outsourcing today for CRO’s where competition is stiff , CRO’s  and Sponsors need to find different ways of performing the same service.

“Creation” of innovative ideas to cater to sponsor requirements is the need of the hour. By giving the sponsor , the “routine” midday meal packaged “differently, will invite a better taste for sure.

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Some trends which are happening in the Global CRO market

  1. Market share gains made by larger contract research organisations (CRO) will be underpinned by strategic partnerships.
  2. Strategic outsourcing by Pfizer and its peers will boost the market share of the big six public CROs – Covance, PPD, Parexel, Charles River, Icon and Kendle – and Quintiles. In 2010 these companies had 41 per cent of the market; by 2015 Windley predicts they will have 49 per cent.
  3. In light of this trend many have predicted the CRO sector will split into two groups : large, global service providers working in strategic, high-level relationships; and niche providers focused on one or two therapeutic areas.

The pharmaceutical industry is passing through a very challenging period since the last 2-3 Years particularly in the area of new drug development and its outsourcing of clinical trials (Clinical Research) to external providers.

The rising rate of failures of new compounds in the post Phase I stages has added to the woes of the Global Pharmaceutical companies. Big Pharma is facing challenges ranging from the loss of patent protection on blockbuster drugs to declining R&D productivity. There are unprecedented pressures that drug makers face and what the industry needs to do restore itself to past glory. There are many different things that drug developers can do or need to do because of which they can efficiently spend their R&D dollars and avoid late-stage blow-ups. This would be a key factor in driving the market growth of the CRO’s i.e. in the outsourcing of clinical trials/ research to clinical research organizations particularly in emerging nations like India.

The forecasted/projected growth of the Global CRO market according to Business Insights is shown below:

”The Pharma world space of 3 major global players has united to form the world’s FIRST cancer group to focus towards the emerging markets of Asia to target Stomach and Lung cancer. The news release has got flashed at 6-7 major web sites. An individual news clip was flashed by Elli Lilly in the late evening hours yesterday as well which spoke of its initiatives to start the research work form Singapore. There were mentions of mainly the people from Elli Lilly in Singapore and China in the News release.
The world of the Pharmaceutical Industry has changed. The drug majors are uniting themselves with the changing times, have decided to “”mutually share”” database s for cancer drug development and move in unison towards the emerging markets.
If this is so, then what should be the subsequent strategic initiatives at the CRO’s (the outsourcing providers) in the emerging markets?
Should the CRO’s “”act”” in a similar manner as the Pharma companies or prepare to understand the market on their own with individual capabilities?
This is question which can be answered only when the outsourcing market takes a DECISIVE turn in a direction which today many forecasting experts are trying to understand. ”