Monthly Archives: June 2009

“The forces and the law of nature always have the final say on the well being of the earth. It is only the human force which influences the maximum on nature as it is the most “”intellectual”” in terms of the existing living being on the earth. Human beings dominate the ecological balance of nature in a major way without any serious “”Intelligent”” competition.
Scaling the Health care Industry market forces on an identical platform, which are definitely more dynamic than nature, the same is driven by majority of identified and unidentified forces. The”” identified”” /””captured”” forces drive the market in such a way which work towards the creation of scenario dominated by the Policies, Regulators and the policy makers in a major way. Below is an event Dashboard for the week starting on the 15th June 2009 and the events and news which have taken place in the whole week. Policies are driving the market to an extent of 25% of the market Dashboard followed by the Global & Indian Pharma drug trends to an extent of another 25%. Competition and generic drugs occupy the show with another 24 % in totality.

Policies being the most “”intellectual”” part of the dashboard drivers would be the major driving force of the industry. The economic policies for the drugs, their manufacture, their sale and presence in the market is due to a “”set”” policy framework which on a broader level is sequenced and guided by the governments of the countries where the drugs are manufactured. It is the trends of the recessed times to move towards cost effective drug products and all companies of the drug industry are moving in that direction in their own ways and adopted methods. The most cost effective drugs are the off patent drugs/generics/ copy cat versions of branded drugs. Policy drivers in all major countries of the world whether developed or developing are focused towards manufacturing, promoting, selling and consuming generics in a major way. Adhering to the policies formulated by the regulatory agencies of the respective countries is becoming the major objective of the drug industry today. In case the same does not happen in an effective manner, the regulators or the policy makers move towards enforcement of the same in their own way by declarations (as press releases) or website announcements or notices to the concerned.
The drug companies which sell generic products can do so by conducting Bio-equivalence studies with reference to the branded drug. For the same they outsource the studies to CRO’s of their choice which conducts bio-equivalence studies.
Veeda Clinical Research is an Indian CRO with extensive experience in conducting Bio-equivalence studies. ”

“The changing landscape of the drug industry has also influenced the CRO market in its own way. The Industry patterns have been highly dynamic and greatly influenced by factors relating to the slowing economy, merger and acquisitions, companies aligning portfolios and changing strategies in an effort to maintain profitability. The Big Pharma is eyeing companies for acquisitions in generic space in emerging markets. The companies are “generating” capital for these acquisitions by closing their facilities in the USA & UK or any other location and taking a route to the emerging markets. In the emerging markets the strategies employed are by collaboration or by licensing or by hiking stakes in their Indian subsidiaries.

Similar strategies are being slowly adopted by the generic drug manufacturers as well. The Merger and acquisition route is common to all drug manufacturers in the current scenario.

Looking at broader picture, it would look as if the drug market world is shrinking or giving itself a “squeezed” look. Times are not far when the branded drug and generics “look” alike or appear “cloned”…………

Drug “copying” or “cloning “ would appear a thing of the future which would have its own course and experience in times to come.

The market would be full of “generics” and outsourcing of generic drugs to CRO’s would be rampant.

Veeda Clinical Research is full service Indian CRO which conducts Bio-equivalence studies for all drug companies “

“The Pharmaceutical Industry is faced with major challenges as well as identified and unidentified opportunities today. First and foremost approach from the Pharma Industry is to move with the times and later move ahead of competition. Movements for both directions requires quick thinking and far sighted and advance planning, the goal of the drug industry is to succeed. In the process, the drug industry may have to adopt changes which would mean changing focus towards realignment of strategies and realignment business goals.

Traditionally, Global Pharma has believed in maintaining leadership in selling its patented blockbuster drugs and invested in a major way in clinical development for new drugs. As the process is and has become highly expensive in the current times and the “pipelined” candidates not performing to the desired levels and the ones which are showing “desired clinical results” not able to “raise” or uplift the investor confidence nor the Stock price to the required level, the drug industry faces tremendous pressure. This makes the drug industry diversify into avenues where investor confidence is high and where risk is “mitigated “or is less in comparison to clinical development. The avenues for such diversification are “THE GENERICS”. This means the drug industry needs to adopt the “diversified” or “hybrid” model to sustain its “planned” or “unplanned “growth path. The drug industry looks into emerging markets like India where “presence” would give them a link to the “cost effective and high volume “generic drug market. As the Global Pharma acquires a “Dual” yet “Hybrid “look when analyzed.

Veeda Clinical Research is an Indian CRO which conducts Bio-equivalence studies for generic drugs of the drug industry.”

“The multinational pharmaceutical companies look at generics i.e. off patent or copy cat versions as the serious threats to their monopoly in branded drugs in a major way. These companies aim at their level best to “”influence”” the regulatory authorities in a lawful and legal manner to block generic drugs in their way.
In another way, they sell the same drug with a different brand name in another country or liaison with a generic company to sell their “”branded”” generic version of their drug. These are some of the techniques Global Drug MNC’s do in order to sustain their growth and profitability. Larger the company in terms of sales growth and geographic presence more are the “”threats”” to it.
All generic manufacturers which manufacture off patent/ copy cat versions/ generic drugs face patent litigations or file for their generic drug in the country of interest in order to promote/sell their generic drugs against the respective branded equivalent of the drug.
Generic drugs need to be proven bio-equivalent. For this, there is need to conduct bio-equivalence studies with CRO’s.
Veeda Clinical Research is a leading Indian CRO which specializes in conduct bio-equivalence studies. “

“Some questions needing immediate attention-

Which is the direction on which the Global CRO world is moving towards? Is it towards the growth paths of acquired strategies, new services or going with a conventional route with the conventional approach with the conventional people? With the economy taking a turn towards a very slow path and the current conventional ideas being insufficient to hold on the business growth of the concerned companies, the time has come for the CRO world to take a reoriented look. The realignment should not only be broad based but also micronized to the Business goals and employee level as well.

This realignment/ reorientation is called as the changing focus of the CRO world towards the massive requirements of Cost effective and Bio-equivalents by the end consumer i.e. the patient or the customer. When will this happen/ how long will it take for this to happen?

Some Viable answers-

The rising disease incidence and their increasing spread followed by the increasing drug consumption of “expensive “branded drugs puts pressure on the payers (reimbursement authorities) of the various nations of the western world has placed the drug industry to reorient to a “Generic “ Drug focus in major emerging markets primarily India. Therefore, the CRO does also need to reorient in a parallel way to cater to the need of the drug industry and further the end consumer in a major way. As this is a demand of the times, the CRO’s which” Reorient” themselves “faster” and adapt to the changing times will not only survive but also grow with a positive statistical turn in the times to come.

The Best service provider -

Veeda clinical research is a renowned Indian CRO which caters to BA BE Studies (For off patent/Copy cat generic drugs) drugs in a major way. ”

“The Drug Industry “”speaks”” for itself. It has to sway and succumb to the varying natures of lobbying trends prevailing with the times. The Drug industry looks at “”mega”” blockbuster drugs only in a “”micro”” manner. It has to face the economic pressures, changing government policies and “”recessed”” healthcare budgets followed by an increasing investor pressure on returns. Looking further the companies generally “”wish”” to remain “”niche for a long as they can or try to establish the “”Julius Caesar”” supremacy in there are of operation or sales for as long they can sustain. But when times become “”turbulent and fraudulent””, the need arises for them to move in a “”cost effective”” way which is the “”generic”” route and divert them from their “”niche wish”” route.
Generic biologics are likely to occupy a market exclusivity of not more than 5-7 years as the increasing pressures on the Obama government from the FTC and industry leaders surmount in their own way paving the way for generic bio similar drugs to “”show”” their existence on the drug market in a major way in times to come.
Many Generic drug manufacturers are “”planning”” or have already established their presence in the generic biological market either by acquiring manufacturing facilities or a licensing or strategic alliance strategy for their long term business goals.
Veeda Clinical Research is an Indian CRO which conducts BA BE studies (Bio-Equivalence studies of Generic drugs) for the Drug industry. “

“The Drug Industry is dominated by existing players, new players, niche players and a variety of contemporaries. Some companies which are large and have attained sizeable growth continue to follow their traditional growth patterns. There are some which follow the leaders in the industry and some which create a niche in their field and some promote themselves in the market as completely new players.
The drug industry is dominated by a host of generic players which sell cost effective drugs (off patent/ generic drugs) to the consumer as per the laws of their country of origin. The regulations for simple and uncomplicated molecules remain less complicated as compared to generic biologic drug products. The generic biologic drug products have a complicated chemical structure. Branded biotech drug products are the sold by Big companies which enjoy patent exclusivity for a substantial period of time. The Biotech companies are in the process of convincing the US government to increase the exclusivity period to at least 15 years. On the other hand, the some reports from the FTC are of the opinion that generic biologics/ bio –similar drugs do not require patent exclusivity for more than 7 years. The “”pressures”” on the Obama government are very high from all ends and a need to implement a “”concrete regulatory pathway for generic biologics is the need of the hour.
As Japan has already taken lead in allowing the “”first generic biologic drug”” based on EMEA guidelines in its territory, the “”Me too”” factor for the regulatory authorities of the USA holds well too in its way.
Veeda Clinical research is renowned Indian CRO which conducts Bio-equivalence studies for generic drugs in a major way. “

The Competition in the CRO market is intense and very global in nature. As the nature of the CRO market takes a shift towards early stages and generics in a major way, realignment of goals and strategies in tune with the trends of the times is necessary for a CRO to compete on a global platform. For doing so, the services have to be aligned in such a way that they are oriented with scientific capabitiles globally, associated with a mapped risk management profile and capable of producing the desired profitability for the CRO growth forecast in line with the market dynamics prevailing at the time frame of interest.
The early clinical development phase i.e. Phase I is most crucial to identifying the “”safest “”(Zero Toxicity) levels for drug product for further testing on patients in the next phase. The Risk map for a drug in this phase is defined for ADR (Adverse Event Reaction) and monitoring with the necessary equipments and experienced staff capabilities to handle the same. Once identified, the process becomes more complex and more expensive in the Phase II Clinical Trials and further testing.
For the generics and the off patent drugs, the risk assessment criterion is well mapped and designed for conducting the relevant Bio-equivalence study with the relevant Test Drug / Reference drug of interest. The CRO’s which have expertise in the Bio-equivalence studies (BA BE Studies) face less risk profiles from all angles and relevant areas of interest for the study. With the changing dynamics of the market, the slowness of the market and the increasing emphasis of the payers (Governments of the western world lie US and Europe) on cost effective generics, outsourcing of generic drug studies to cost effective locations of emerging markets like India is the need of the hour.

Veeda Clinical research is an Indian CRO which has expertise and experience in Bio-Equivalence studies and is located in Ahmedabad.

“Many wise men on this earth have said that fear disappears when the facts are faced with courage and patience.
Similar is true for the drug industry in today’s’ recessed times. Many key Global MNC CEOs’ and management professionals have admitted that it has been not only a painful task but also a fearful task of revamping their growth strategies and business in the recessed times. They have succeeded in their own way but fear has not crept towards them as they have faced the appropriate facts in the most accurate way to realign company goals with employee needs towards a better future. Looking at the way today the drug industry is moving there are only two things that Global drug industry is looking at: One is a cost effective generic presence in a cost effective generic market.
The “”Fearless and Untiring”” efforts towards generics in full swing in the drug industry today are available from their freely available press releases and statements from company correspondents from freely available internet sources. The trends towards generics indicate that the drug market is striving towards a stable environment of safe and cost effective generic drugs which the end consumer can take without any “”fear’ because the same would be equivalent to the parent /reference drug.
Drug companies which manufacture generic drug products sell their products only after conducting relevant Bio-equivalence studies. The same are outsourced to the preferential CRO which the drug manufacturer chooses based on a certain well defined regulatory criterion of its own.
Veeda Clinical Research is a well known Indian CRO which conducts bio-equivalence studies for the drug industry. ”

“The word Policy is very significant for the drug industry in driving their growths and strategies in the long and the short term. The policies can be related to all aspects of the drug industry wherever there is a need or a presence for regulation in the market scenario. All countries have their own policy makers & regulators/ regulatory bodies which work as an interface between the government and the drug industry. The members of the regulatory bodies have a representation from the government and the industry as per procedures outlined by the authorities of the respective countries. The drug industry is known for its “”influence”” in its own direct and indirect way on the government. Millions of dollars are spent which signifies these lobbying trends.
If the governments of a country are in favor of generic drugs then the companies which are in the big pharma arena of drug development, will influence certain lawmakers/ influence the government policies which will block generics. Currently the objectives of most governments (regulated markets i.e. USA and Europe and the semi-regulated markets are all in favor of the cost effective generic drugs). This move comes as per the existing need to save healthcare cost which the governments of the respective countries reimburse as payers to the ailing population. Waves of pressures are on the Obama government (Release of an FTC commission report which aims at “”proving “”that generic versions of bio similar drugs”” are bio-equivalent to the original version) to “”outline”” the laws which favor bio-generics/bio-similars. In which direction will the “”policies”” drive the market remains to be seen. The market seems to be dominated by a host of policy news which are and will be influencing the decision makers to formulate their pricing policies and look at their outsourcing budgets for their CRO’s of choice.
Policies keep undergoing a change when governments change or market dynamics change.
If the government policies favor the generic market the outsourcing budgets take their “”shapes and figures”” accordingly.
The CRO’s which conduct BA BE studies are in turn influenced by the flow of the policy makers decisions in a major way.
Veeda Clinical Research is an Indian CRO which specializes in conducting BA BE studies (Bio-equivalence) studies in a major way. “