Category Archives: New Drug Development

Archives

The ‘Make in India’ campaign by Prime Minister Narendra Modi has 25 sectors in focus including Pharmaceuticals and Chemical sector. This may proven to be a booster dose to the Pharmaceutical Manufacturing Industry.

MII x

The Make India campaign will result in attracting investment from foreign markets. The government has already created a dedicated online cell to answer queries from all over the globe. Primarily, the ‘Make In India’ focuses on zero defect and zero effect. In which zero defect means products which are manufactured in India should not be rejected in the overseas market. Zero effect means that the manufacturing should not have any negative impact on the environment. Continue reading

“Europe’s biopharmaceutical sector is under severe pressure due to the reluctance of investors to gamble on high-risk drug development projects, according to a new report sponsored by the EU. Research-intensive companies have been hardest hit since the financial crisis began, with venture capitalizes shying away from niche bio pharma firms that can spend up to 15 years working for a breakthrough that might spawn new medicines. The report, presented at a meeting of policymakers, industry leaders and financiers in Brussels this week (1 December), calls for a new European Biopharmaceutical Innovation Fund to keep the sector afloat. SMEs across Europe have suffered from the liquidity crisis due to difficulties securing working capital and the ongoing challenge of late payments. However, the impact of decreasing venture capital funding will not be felt for a decade. The study says investors are now looking for lower risk/reward ratios at a time when 40% of SMEs in the bio pharma industry say they will need access to capital within the next 12 months. It recommends offering tax concessions and developing co-investment mechanisms at EU and national level to stimulate investment. Identifying and disseminating best practice in technology transfer and commercialization could also help boost the sector, according to the report. “


The days of the $1 billion blockbuster drug are over, according to a senior industry researcher. Big pharma is now investing in finding multiple uses for medicines developed to treat rare diseases, but is pushing the EU for regulatory changes to make research worthwhile
A ‘blockbuster’ drug is usually defined as a single medicine that treats one disease and generates revenue of more than $1 billion per year (€664 million). Bestselling medicines like the cholesterol-busting drug Lipitor can clock up sales of almost €8 million a year, although it comes off patent in a couple of years’ time.  Nevertheless, there has been much angst in the pharmaceutical sector in recent years as the pipeline of new groundbreaking medicines for common illnesses appears to be drying up. This comes at a time when advances in gene therapy and personalised medicine suggest the days of finding a mass-market drug to sell to large volumes of patients may be coming to an end. ”

“The above cartoon speaks of the Big Pharma’s recessed investment efforts in clinical development.
Cooking a great meal with an ideal flavor requires the ideal ingredients, the right blend of spices, flavors and the right hands to cook as well. The availability of the appropriate utensils of the right size and material are essential to impart the flavor to the end product. All of this requires expenditure. If the meal expectations are in routine and are for a large number, then the expense and the time for the cooking can be in the routine process. However if the expectations are for delicacies and varieties of food, then the right blend and mix of ingredients and utensils is needed to deliver the right food for that time. For the special kind of food, more time and expense is required.
Similar is the case with clinical research. If the clinical trial outsourced to a CRO requires the conduct of a routine Bio equivalence study for a generic/ off patent drug, then the expense and the safety needs in the study may not be necessarily very high. However for New drug development which requires specially trained staff and high levels of investment, a lot of time and expertise is required to deliver an effective and safe drug to the market. ”

The regulatory laws in major Asian countries donot permit the early phase trials on account of the high risk involved. Most of the early phase drug development is considered un ethical in the Asian countries if carried out without regulatory permissions. Hence the market growth in Asian countries tends to take a backseat on account of the same.
Most of the early clinical development takes place in the developed markets of the USA and Europe. The Early Phase trials which are then conducted are then projected and conducted in relevant populations and geographical regions (As per protocol, sponsor and regulatory requirements and the results, i. e. endpoints of the trial. Thus most of the outsourced clinical development market comes to the cost effective Asian regions only in the post early phases i.e. phase II onwards.

Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global and Indian Pharma industry and early phase development in United Kingdom in a major way.

Knowledge of the known is relative phenomenon. Knowledge of the existing unknown is a discovery. The extent of discovery is nothing but development of scientific facts and scientific facts lead to creation of expertise and understanding of the subject under contention. Hence, virtually over a period of time the “unknown “”becomes known. The time period of approaching the unknown is highly variable. The Known is always”” competitive”” and the unknown is sometimes a treat or an opportunity.

Similar is the case with the drug industry. The drug industry has 2 avenues for investment, one is the known i.e. Generics and the unknown which is clinical development. Both the avenues are open to the CRO industry as well. The Generic drugs when tested in human beings have a known response to the drugs whereas the drug response of drugs in clinical development is unknown. Companies have to accordingly devise business strategies to sustain their grow in the short and long term
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry.

Placebos are getting more “effective”. It sounds absurd but many “clinical studies “”in the world of clinical research have proved so. This explains the success and failure of new drugs in the clinical trials during the process of drug development.
The clinical trial endpoints in the process of drug development start from drug action and its toxicity in human beings to efficacy and finally efficacy and safety on a larger base of patients in the final or deciding phase of drug development (i.e. Phase III).
Benchmarking the drug performance in a human body in particular clinical trial phase is conducted by administration of “”blank sugar coated”” tablets to the subjects/ volunteers/patients in a particular phase of drug development. The “”higher “”is the number of the subjects/ volunteers/patients crossing the “”plasma Levels”” of the NCE with respect to the placebo, higher is the success of the clinical trial results. Optimum “”blood plasma”” levels are attainable when a substantial amount of dosage of drug when administered to the drug proves itself effective with respect to its efficacy in the desired number of patients with respect to the placebo. This is the major driving force for all listed companies in Pharma/ Biotech/ CRO’s to generate investor confidence and trigger their interests in investments for their clinical trials for the phase of interest.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global and Indian Pharma industry and early phase development in United Kingdom in a major way. ”

The Drug development process starts with the target identification followed by the Pre clinical studies, First in Man, then trials in patients for efficacy followed by large scale trials in various sets of patient population till the same reaches the approval stage followed by the post marketing surveillance studies. As the drug development stage starts, higher is the uncertainty and lesser is the reliability of the clinical trial results of the stage under study of a drug to succeed. A substantial amount of time and investment is spent by drug companies carrying out experiments of high risk and known and unknown side effects. Till the drug’s safety profile has been established, the stage of clinical trials in patients i.e. Phase II always remains under a “”lacunae””. If the drug safety profile has been established successfully in healthy volunteers, the efficacy of the drug can be established in patients only in the second phase. Once the drug reaches its efficacy mark in a patient population in Phase II, only then it proceeds to Phase III trials only.
The Phase III trials are conducted in large patient populations across the world and are conducted to establish and prove efficacy and safety in all types of population over a substantial period of time. Once this stage is accomplished, it can be safely established that the drug is ready to file for approval for marketing. The drug if approved by the regulatory authority of interest has to be finally tested by the manufacturing company for post marketing surveillance. The drug enjoys a patent exclusivity for some years (varies from drug to drug) before it goes off patent. Once the drug is off patent, other manufacturers can make off patent/ copy cat versions/ generic drugs after the loss of patent exclusivity.
Generics once proven bio equivalent to the original drug after conducting Bio –equivalence studies can be made available for marketing in the country of interest.

Bio equivalence studies are outsourced to CRO’s. Indian CRO’s conduct a large number of Bio equivalence studies.
Veeda Clinical Research is an Indian CRO based in Ahmedabad which provides cost effective Bio-Equivalence studies for the drug industry.

Mathematics is a very complex yet interesting subject for all those who do mathematics in the way numbers should be looked at or counted. For the simplest mathematicians the two plus two is always four. But for many an industry like the drug industry, it is not so. For them two plus two sometimes means “twenty two”as well.
Undoubtedly, it is a surprising and unbelievable conclusion to arrive at. Every lifestyle disease adds to the woes of the patient as the patient age progresses especially cancer and related diseases, heart disease and diabetes to name a few. It goes without saying that most medicines which go into the development phase improve the patient lifeline by acting on the disease progressions areas of action or act directly on the affected organ of the patient. Most of these trials are done in hospitals which have easy access to patient population of interest for the trial. Most of the trials in the Phase II-III phases reach a global testing phase where hundreds of patients are enrolled to conduct the trials. This complex and time consuming process takes around 6-8 years and an investment of billions of dollars before the drug reaches the regulators desk. The drug regulatory authorities before and after commencement of clinical trials, take a complete analytical look at the submitted data for the trials before allowing the drug to go the next stage. New Medicines of listed companies after completion (having favorable or unfavorable) of each stage of the trial announce press releases at various prominent websites and newspapers leading to an increase or decrease or their stock listings. This is a practice which listed companies in clinical development practice to explain their market standings to the masses of interest.
Companies outsource their Clinical Trials to CRO’s of their choice based on their preferences and outsourcing criterion as outlined by their company policies in their allocated time frames.

Veeda Oncology is a dedicated division of Veeda Clinical Research, a renowned Indian CRO which caters to Oncology Clinical trials for the Global Pharma and bio-Pharma industry.