CDSCO has issued another circular which indicates that CDSCO is making Rules and Regulations more Industry Friendly

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CDSCO has issued circular dated 03 Aug 2016 regarding “Requirement of NOC from DCGI for addition of new clinical trial site or investigator”wherein they have stated that just notification of addition of site/investigator to DCGI is required. However the respective Ethics Committee approval is essential.

This is yet another remarkable decision which will surely be welcomed by Industry and will give shot to improve number of clinical studies in India

NOC from DCGI for addition of Clinical Trial site or Investigators

Non-compliances Observed During Review of Applications for Registration and Import Licences of Medical Devices

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CDSCO has come up with a presentation to support device industry for a common Non-Compliances observed during review of Applications for Registration and Import Licenses of Medical Devices.

This is yet another step which indicates the support of CDSCO to Industry.  Devices companies and CRO who are conducting clinical studies in Devices should have a look in the attached presentation prepared by CDSCO. 

This will enable companies to plan and manage their submission as expected by CDSCO.

Non-compliances-Applications-Registration-&-Import(1)

CDSCO is determined to Boost Clinical Studies in India

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In yet another boost to clinical research in India CDSCO has published two circulars wherein they have withdrawn two pre-conditions for approving clinical studies which was imposed in year 2013.

  1. Requirement of 50 bedded site to conduct clinical studies
  2. Restriction of conducting three clinical trials per Investigator

These were two rate limiting factors which has impacted the number of clinical studies in India

Requirement of 50 bedded Restricion of conducting three Trials

Restricion of conducting three Trials

 

Dynamic and different L&D prospect for Pharma marketers and teams

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Mark Lawson, sales and marketing director at Lundbeck and member of the Executive Steering Committee, said: “Taking part in the competition is superb development for marketers. It tests their analytical capability, understanding of strategy and tactics and most importantly it benchmarks them against their industry peers. The Marketer of the Year continues to evolve with challenging case studies and entrants from a diverse set organisations.”

Demonstrate your pioneering thought processes, unexpected ways of using technology and data, and new attitudes towards marketing.

Entries close 31st August: Free to enter, the PharmaTimes Marketer of the Year competition calls on entrants to demonstrate a dynamic combination of knowledge, creativity and strategic thinking in real-time challenges within a protected environment. It’s a unique opportunity for individuals and teams, from new and aspiring marketers through to senior and international, to sharpen their skills and showcase their talents against marketers industry-wide. Click here for category descriptions.

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For more information about sponsorship opportunities or entries, please contact Gill Chalk on +44 (0)20 7240 6999 or gill.chalk@pharmatimes.com

KEY DATES

Singles Finals: 6th Oct 2016

Team Finals: 19th Oct 2016

Awards: 10th Nov 2016

Sponsors 62% more likely to engage CROs than 5 years ago

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A recent survey by Worldwide Clinical Trials reveals that 62% of respondents are more likely to engage a CRO partner for clinical research than they were five years ago, demonstrating the increasingly vital role that CROs are playing in modern drug development, and the importance of partnering with a CRO that offers medical and scientific expertise.

Conducted at DIA 2016, held June 26-30, 2016, in Philadelphia, Pa., the survey gauged the opinions of nearly 300 drug development leaders and executives from pharmaceutical and biotechnology companies who visited the Worldwide booth during the DIA meeting.

“As one of the industry’s leading events, we saw DIA as an opportunity to gather input from leaders in the industry—to discover what is important to sponsors, including potential barriers to drug development, areas where they are looking for CRO innovation, and key factors they consider when selecting a CRO partner,” said Peter Benton, president and COO at Worldwide Clinical Trials.

In response to a question about the impact of innovative approaches from a CRO, almost a third (29%) of respondents said that innovation in overall trial management would have the greatest impact on clinical development, with just over a quarter (26%) saying that innovation in patient recruitment and retention would have the second biggest impact.

When considering barriers to a new drug development, those surveyed by Worldwide selected the cost of discovery research and clinical development, regulatory guidance and the risk associated with the clinical development process as the most critical issues. In terms of choosing the perfect CRO partner, respondents listed the capability for the CRO to deliver high quality data as the most important factor (83%), closely followed by the ability for the CRO to deliver on time (76%) and within budget (68%). Interestingly, the findings demonstrate little variation in when respondents are likely engage with a CRO partner, with later phase investigations (phase II to phase III) narrowly ranking the highest, over earlier phase investigations.

“The survey results confirm our focus at Worldwide, where we deliver a strategic balance of science, medicine and operations, including effective planning and risk management, open and ongoing communication, and frequent measurement and reporting. This ensures that we can achieve successful trial execution for our research partners,” said Benton.

Top three therapy areas dominate pipelines

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The world’s top three therapy areas accounted for 68 percent of the overall pharmaceutical industry pipeline as of Q1 2016, according to business intelligence provider GBI Research.

The company’s Innovation Tracking Factbook 2016 states that oncology is by far the largest therapy area, with almost 7,000 products in active development, almost matching the combined size of the next two therapy areas, infectious diseases and central nervous system disorders, which each have over 3,000 products in active development.

However, there is a great deal of pipeline activity in the next few therapy areas, with immunology, metabolic disorders and cardiovascular diseases each having pipelines consisting of over 1,000 products.

Dominic Trewartha, Managing Analyst for GBI Research, says: “The pipelines in these therapy areas are the largest because they have substantial patient populations and strong unmet needs within the indications that account for the majority of patients in each area.

“Oncology is a rapidly growing therapy area, in terms of both me-too and first-in-class oncology products. This growth was generally substantial in Q1 2016, with the largest three indications in terms of the number of products – namely breast, lung and colorectal cancer – each exhibiting pipeline growth in excess of 15 percent.”

GBI Research’s report also notes that the overall pharmaceutical industry pipeline increased by 5 percent in Q1 2016. This trend generally holds true across all therapy areas, with only CNS disorders and immunology having marginally decreased in size. The most rapid growth was witnessed in the smallest therapy areas, led by women’s health, which grew by 55 percent in Q1 2016.

Trewartha adds: “Virtually all therapy area pipelines increased in size in Q1 2016, and within certain therapy areas, particularly in oncology, the majority of major indications have seen their pipelines increase in size since 2015.

“Although the majority of these pipeline products are at an early stage of development, meaning their safety and efficacy profiles are generally unproven, the large overall pipeline size demonstrates that there is likely to be a steady stream of incremental and breakthrough innovation that reaches the various disease markets in the foreseeable future.”

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