Indian drug market to grow to $20 bil in 2015

According to the Economic Times, the Indian Pharmaceutical market will grow to $20 billion by the year 2015. This is up radically from $7.1 billion in 2007. Many factors account for the increase of the standards and rules put in place to protect the patients, including patent examiners, decentralization of the filing process and digitization of records. In addition, due to the growing middle class, many more citizens are expected to be able to afford high value medication.

Read the full article here.

Concern for Outsourced Drug Clinical Trials

This article in the guardian highlights how many companies like Pfizer and other big pharmaceutical companies have paid a lot of money to settle claims after controversial trials in countries like India and China. In these countries, it is by far easier to recruit volunteers, cheaper to conduct and manage trials, and easier to get past ethical issues and rules most times. Outsourcing though brings forth an ethical issue where there are many desperate individuals that will participate in experimental drug clinical trials. In many cases drug clinical trials carry out little relevance to the local population in which it is conducting the trial. Will any regulations be set in the future that will set more rigorous scrutiny of ethical conduct?

Partnerships APAC looks at clinical trials in the Asia region

Due to the rapid growth and increasing interest in the Asia Pacific clinical trial market, we are happy to announce that in a few short months, we will debut Partnerships in Clinical Trials Asia Pacific – our first program specifically tailored for conducting clinical trials in this region.

Partnerships APAC represents a time and cost-effective way to evaluate CROs without visiting each region one by one. From local, regional specialists to well-known global partners – this is your chance to figure out which partners match up with your trials’ needs. Our diverse speaking faculty represent experts from most of the region’s key areas for clinical development, saving your time and travel budget with just ONE meeting for the complete picture of conducting clinical trials in the APAC region.

In addition to key industry speakers from India, China, Japan, Singapore, Vietnam and more, the event also features US counterparts talking about proven strategies that they’ve implemented in conducting trials overseas. Combine this with the local regulatory insight you will gain and you’re not just buying a pass to a conference – you’re investing in future clinical trials by preventing delays and determining how to best navigate in this region.

New Bill Might Boost Recruitment Rates for Rare Disease Clinical Trials

This article in outsourcing-pharma.com discusses how a bill introduced by US Congress Representative Edward Markey would allow patients with rare diseases to disregard up to $2,000 of compensation received for participating in clinical trials. Current legislation categorizes compensation from clinical trials as income and puts patients' earnings above the Social Security Income eligibility threshold. This in turn would most likely boost recruitment rates for clinical trials for rare diseases, which has often been problematic in the past. Do you agree with the bill?

Are you interested in clinical trials taking place in the Asia-Pacific region?

Asia-Pacific is becoming a hotbed of activity for clinical trials, growing at more than 50% in recent years. Not to mention, China’s own drug market is growing at an impressive 28 percent compounded annual growth rate (Pharma Focus Asia).

Are you interested in connecting with others who have examined critical issues and decisions around different sourcing models, which ones to implement, who to outsource our clinical research to, and best practices in successfully managing these relationships?

Join our Clinical Partnerships Asia 2009 group to network and communicate with others who have a stake in the clinical research outsourcing in the Asia-Pacific region here:
http://bit.ly/ZQH4I

Clinical trials for medical devices

A recent article at the Annals of Internal Medicine looks at whether or not new technologies in drug development need to be tested in clinical trials. According to Joel E. Tepper, MD and William Blackstock, MD, there is little knowledge about how to best evaluate these items for clinical use. They use proton radiation therapy to examine this problem. Read the article here.

Where are Clinical Trials Being Conducted in the US?

This post in outsourcing-pharma.com has a couple of interactive maps that explores the question of where are clinical trials being conducted in the US. There are trials ongoing in all states of the US but the majority take place in California, New York, and Texas. The state with the least clinical trials is Wyoming with only 218 currently in progress. Do these numbers shock you? Take a couple of moments to view the maps.

Archived Web Seminar: REMS, EU-RMP and FDAAA: Navigating Clinical Trial Safety

If you missed the web seminar presented by Dr. Stephen A. Goldman here's your chance to view it at your own leisure. Here's a brief description of the webinar and you can find the archive link below as well. Enjoy!

Current pharmaceutical safety is a sophisticated system in which benefit/risk assessment begins with animal testing and continues throughout human clinical trials, licensing approval and marketing of the product. It is critical to monitor evolving safety profiles of marketed products throughout their life cycles, and optimally employ risk management tools in service of public health.

This seminar will examine current national, regional and international perspectives and approaches to clinical trial safety, pharmacovigilance planning and risk management. Current EMEA and FDA regulatory requirements and standards, in combination with the vital ICH E2E guideline, will be discussed and also examined via case examples of risk assessment, communication and minimization methods.

Watch the archive
https://www1.gotomeeting.com/register/729981465

Stem cell treatment fails clinical trial

According to the New York Times, the a treatment in clinical trials from Osiris, which used adult stem cells was no more effective, over all, than a placebo in treating a life-threatening complication of bone marrow transplantation, though certain patients seemed to be helped.

This is a major set back for the company producing the stem-cell treatment, as they hoped that it would be the first stem cell product approved by the FDA. Read the full article here.

H1N1 vaccine trials effective

Emax Health discloses that clinical trials in the UK proved that one dose of the H1N1 vaccine proved beneficial for warding off the H1N1 flu. However, two doses proved to be the most effective. The distribution of the vaccine world wide will depend on the individual governments. Read the full article here.

Reminder: Free Web Seminar Next Week

REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup

Wednesday, September 9
2-3PM EST
Register: https://www1.gotomeeting.com/register/729981465
Priority Code: G1P1500W1TwitterBlog

This seminar will examine current national, regional and international perspectives and approaches to clinical trial safety, pharmacovigilance planning and risk management. Current EMEA and FDA regulatory requirements and standards, in combination with the vital ICH E2E guideline, will be discussed and also examined via case examples of risk assessment, communication and minimization methods.

What you will learn:
• ICH “Pharmacovigilance Planning” E2E guideline’s critical importance in today’s pharmaceutical safety environment

• Similarities and differences among FDA’s “Development and Use of Risk Minimization Action Plans” (RiskMAP) guidance, EMEA’s “Guideline on Risk Management Systems for Medicinal Products for Human Use” (EU-RMPs) and FDAAA-mandated Risk Evaluation and Mitigation Strategies (REMS)

• Relationship between pharmacovigilance planning and postmarketing risk management

• FDA’s new paradigm for pharmaceutical risk communication

About the presenter:

Stephen A. Goldman, MD, FAPM, DFAPA
Dr. Goldman is an independent consultant with extensive experience in academic/clinical medicine, public health, federal medical product safety regulation, and pharmaceutical industry. As Managing Member of Stephen A. Goldman Consulting Services, L.L.C., he internationally provides services that include risk communication/risk management program preparation, clinical trial safety and pharmacovigilance auditing, in-house training courses (clinical trial safety and pharmacovigilance; clinical trial safety for medical monitors/other development personnel; crafting quality medical case narratives) and medical signal review.

Privacy Notice: IIR is dedicated to bringing you valuable information services such as this free Webinar. By registering for this event, you acknowledge that IIR may contact you electronically or by any other mean

Albany hospital sees increase in cancer clinical trials

At the Phillip L. Roberts Cancer Pavilion at Phoebe Putney Memorial Hospital in Albany, New York, they've increased the number of their participants in Phase III and Phase IV clinical trials. There are currently more than 30 trials going on at the hospital, and have also seen the number of sponsors increase. While the hospital is currently working in treatment clinical trials, they're looking to shift their patients towards prevention and quality of life trials soon. Their goal is to try to continually provide clinical trials to their patients. Read the full article here.