AstraZeneca Sure To Slash More R&D Jobs As It Signs 3 Year Outsourcing Deal With CRO Charles River Labs

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In yet another outsourcing deal from pharmaceutical giant AstraZeneca, it has inked a 3 year deal with CRO and publicly traded company Charles River Labs for the purposes of handling “regulated safety assessments and development”. Here is a link to the official report on Charles River Labs official press release page.
This is the latest of a series of outsourcing deals in which AstraZeneca is seeking to boost its struggling drug pipeline and create more innovations at a lower cost. In a story I reported earlier in the week, AstraZeneca signed a contract with Chinese CRO Pharmaron, which actually followed a larger deal with Chinese CRO WuXi. These Chinese outsourcing clearly pave the way not only for cheaper R&D, but also introduce them to China’s growing population of potential drug consumers. This deal with Charles River is just the latest in what will probably be followed by more R&D cuts from AstraZeneca and other struggling Pharma companies.

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Greater Transparency For Clinical Trials After GSK Announcement

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In a story I reported on last week, drugmaker giant, GlaxoSmith Kline announced That they will be sharing clinical trial results and data for anyone who puts in a request and can demonstrate that they will be using the data for “appropriate scientific research”. This is noteworthy becuase it goes above and beyond the FDA mandate for releasing study data summaries on web portal clinicaltrials.gov. What GSK will actually do, as we learned from Darshan, is to provide patient level details that may be of particular interest to a researcher, even a competitor, as opposed to just clinical trial summary results. I will certainly follow up to see how this develops, especially how it could potentially impact pharma patent laws as Darshan points out, due to patent bars. In this interview with Darshan Kulkarni of Kulkarni Law Firm, we get into the specifics of why GSK’s announcement as well as other Pharma giants such as Eli Lilly and their efforts to make clinical trial data more accessible is important for the clinical reserach industry and what we may be able to expect in the near future.

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Phase 3 Clinical Trials Just May Be Your Best Option!

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I got asked a great question by a viewer who is considering to participate in a clinical trial. He asked me what phase of trial would be best for him. For those that want to learn more about the various phases of clinical trials, I recently wrote about it here.
My answer is addressed in the video, but basically if a clinical trial gets to Phase 3, it is often called a pivotal trial. These studies usually recruit a large number of study participants, usually between 500 and 2500 total participants. The dose and the majority of side effects are believed to have been determined by this point, so the main objective is to determine whether the drug works in comparison to a placebo (sugar pill). Safety and side effects are still closely observed as well. These studies usually occur in outpatient settings and involve many study visits (between 10-30 at times). If the drug proves to have efficacy (does it actually work?) over placebo, or a comparable drug that is already approved and on the market, the drug company will file an NDA (New Drug Application) for FDA review. The FDA may take as long as 1 year to make a decision on whether the drug will be approved, or whether even more trials are needed to determine safety or efficacy. At this point, labeling issues (what information appears on the bottle, and what the drug company can claim regarding the drug) are addressed.

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Ethical Concerns Regarding Clinical Trials in India

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The below is an excerpt from my latest ebook available on Kindle, Clinical Trials in India (99 cents!!). It basically introduces some of the ethical issues regarding clinical trials and India and discusses some measures by which the Indian government has restructured its regulatory agencies. I will report much more on this in the near future, but for now check out this interview I did with a Researcher/Marketer from India from a few years ago, it is truly a MUST watch!

Could you afford to pay $100 for medication if your monthly income was only $100 or perhaps even less? Could you comprehend an Informed Consent Form if you could not even read a single word of it? What would you do if you were offered a sizeable amount of money for joining a clinical trial if you were only eating one meal a day? What would you do if you came across a new medication or treatment option if you were seriously ill and fed up with the medications already available in the market? Do these questions scare you? Most of us can’t imagine ourselves in these situations, but many people in India are facing these and participating in clinical trials every single day. Poverty is rampant in India, with the poverty line being the equivalent of 50 cents per day and roughly 29.8% of the population falls below that line.

India has been and continues to be a favorable destination for clinical trials over the years. A tremendous increase in the clinical trials market from $70 million in 2002 to $485 million in 2011, attributes to India’s strong value proposition in skilled medical professionals, low-cost services, diverse genetic pool and world-class hospitals to undertake clinical trials. In addition, India’s huge patient base in a plethora of diseases ranging from tropical to nutrition and lifestyle related, has been enticing for many Pharmaceutical companies, Contract Research Organizations (CROs) to evaluate efficacy and safety of new molecules, also safety and suitability of existing drugs before marketing them in India. As per the recent Frost & Sullivan report, the domestic contract research organization (CRO) market is set to reach $ 1 billion by 2016.

A good analogy that can help illustrate India’s clinical trial industry dilemma can be the following: you have prepared a scrumptious recipe that you cannot wait to eat. If you don’t store it under regulated conditions, what would happen? It would remain good for some time but afterwards it will begin to spoil unless you find a way to curb the growth of bacteria. Likewise, the regulatory system in India, with respect to clinical research before 2009, had no stringent rules, no compulsory registration of clinical trials and had combined with an illiterate and largely impoverished population of study participants to essentially create a cesspool of bad and unethical data. In 2006, when Netherlands-based WEMOS Foundation, also a partner of the World Health Organisation, cited 22 examples of unethical clinical trials, eight of these were found to be operating in India. These comprised Sun Pharmaceuticals and Novartis’s Letrozole for inducing ovulation, Novo Nordisk’s for diabetes treatment, Solvay Pharmaceuticals’ for treating diarrhoea, Johnson and Johnson’s for treating acute malaria, Pfizer’s for cardiac events, Otsuka’s for arterial disease and the John Hopkins’ University’s trials for treating oral cancer. These trials violated the Indian Council of Medical Research’s Ethical guidelines for biomedical research on human subjects and the World Medical Association’s Declaration of Helsinki. These trials exploited the fact that most Indians do not have access to affordable and quality care, therefore may accept offers that might provide the premise of “free treatment”. The patients were also vulnerable because they were seriously ill. In the case of psychiatric patients, they might not have been able to provide informed consent. The examples were almost endless. These trial designs do not seem to have violated regulations for the conduct of clinical research in India, but the regulatory apparatus that existed during that time permitted unethical trials that provided no benefit to Indians. The infrastructure for regulation, ethics review and monitoring was insufficient. Ethical concerns raised by these trials ignited the fire which led to drafting of compulsory registration of clinical trials in CTRI (clinical trials registry of India) mandatory by DCGI (drug controller general of India) on June 15th, 2009.

In 2010, one year after enactment of compulsory registration of clinical trials in CTRI, there was a shocking incident in Khammam district (Andhra Pradesh) and Vadodra (Gujarat) where a HPV vaccine clinical trial was conducted on nearly 23,500 girls in the 10-14 year age group. Most of their informed consents were signed by a headmaster, as the ‘guardian’. Moreover, the justification given by them was ridiculous: the parents were not easily accessible! Reporting of a death was delayed for five months, while two deaths in Khammam district were not reported. Ironically, while measuring and reporting the adverse events after vaccinations which were the “primary end points of the study,” the Principal and Co-Principal investigators failed to report all such events to the sponsor within a day, as required under the Drugs and Cosmetics Rules 1940.
The way in which human trials were being carried out within the country had become a matter of public debate for some time. Human rights activists and NGO forums kicked up more dust when arguing that the country was becoming a testing ground for a large number of therapies banned in other parts of the world. Their clamour surged soon after a couple of stories made headlines in national and international media, and forced the government to set up a committee to investigate alleged irregularities in the conduct of the clinical trial. Controversially, the final report released on the HPV vaccine issue strangely declared no relation of deaths to the vaccine. It has, however, exposed abnormalities at various levels of the conduct of clinical trials; from the informed consent to the reporting of the adverse reactions.

This incident had been a matter of debate in parliament for couple of years, soon after, registration of ethics committee associated with CROs has been made mandatory by DCGI (Drug controller general of India) in August 2012. Furthermore, ethics committees are requested to remain vigilant on clinical trials under their jurisdictions and may make surprise visits to ensure whether the trials are being conducted as per Schedule Y, GCP guidelines and to ensure the rights and safety of trial subjects are protected. To further streamline the clinical trials, union health ministry is preparing grounds to amend Schedule Y of drugs and cosmetics act, to make a provision for audio and video recording of informed consent in clinical trials.

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Overworked Monitors Causing Payment Hold Ups In Your Clinical Trial?

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Not a day goes by that I do not learn something new in this industry. This past week I learned that overworked monitors (CRA’s learn what that is here) can impact a research clinic’s cashflow for subject activities they have completed in their clinical studies, even when they meet the sponsor’s demands for data entry in EDC systems within 48 hours of study visits.

I recently encountered a situation where a monitor reviewed data at one of my sites, but did not actually enter these visits in the sponsor’s internal database because the monitor was overburdened with monitoring activities at numerous sites. When I contacted the study sponsor after 3 months of non-payment to request payment for roughly 100 study visits we had completed, the sponsor said they did not “see” any of our activity entered in their database. As it turns out, our monitor never entered the data that we worked so hard to complete and which the monitor worked so hard to review. What bothers me is how overworked monitors (and these days most of them are), can actually impact the financial viability of a research clinic. The lesson for you research clinics out there is to keep track of your study visits and make sure that any roadblocks towards you receiving study payments are dealt with in a timely manner.

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Are Chinese CRO’s The Wave of The Future?

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In a deal announced by drug giant AstraZeneca today, it has hired Chinese CRO Pharmaron to handle many of its Research and Development functions such as pharmacokinectics, chemistry, etc. This deal follows AstraZeneca’s recent deal with Chinese CRO giant WuXi who took over some inflammatory disease products in AstraZeneca’s R&D pipeline. So what do these recent deals mean for the future of clinical trials? In my humble opinion, US and European Pharma companies are looking to China to not only provide R&D services at a lower cost than the US CRO’s, but also to prepare themselves for marketing these drugs to the over 1 billion people in China who will soon have a better ability to pay for some of these drugs. We have seen a lot of outsourcing to India in the past and have even reported on it here, but China provides and even larger market with an arguably somewhat better financed population of future pharma product users. While financial details of this deal have not been announced, it is clear that these are multi-year deals that could provide some guidance towards what more US and European pharma companies will be doing in order to increase their drug pipelines while decreasing costs. This will certainly also mean loss of R&D jobs in the United States and Europe that are redundant. I will certainly report on more of this as I get more details.

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