Partnerships In Clinical Trials Expands Its Global Reach

The Institute for International Research is pleased to announce that as a chief component of its global branding strategy, the industry-leading Partnerships with CROs event is now known as Partnerships in Clinical Trials. In the nineteen years since the inception of the event, both the biopharmaceutical industry and Partnerships have experienced tremendous growth as outsourcing to suppliers has become more than simply a tactic to control costs, but a leading strategic directive to ensure speed, quality and value of new medicines. “The name Partnerships in Clinical Trials reflects the comprehensive nature of the program, which is the must-attend annual event for clinical outsourcing and development professionals and is increasingly valuable to those with responsibilities in clinical operations, clinical project management, drug safety and quality,” said program director Lesly Atlas. “Our new name also represents our widening global reach with Partnerships in Clinical Trials events already taking place in Europe and the premier of our APAC event in Singapore this December. Collectively the Partnerships in Clinical Trials brand serves over 35 countries.”

Notable speakers include:

• Tom Daschle, Former Senate Majority and Minority Leader, US Senate
• David Holveck, President and CEO, Endo Pharmaceuticals
• Nancy Simonian, MD, Chief Medical Officer and Senior Vice President of Clinical, Medical, and Regulatory Affairs, Millennium: The Takeda Oncology Company
• Ethan Zohn, Winner of Survivor: Africa Chris Anderson, Editor-in-Chief, Wired Magazine and NYT Bestselling Author, The Long Tail: Why the Future of Business is Selling Less of More
• Thomas Senderovitz, MD, Vice President, Global Exploratory Development, UCB Pharma - Belgium
• Jason Hwang, MD, Executive Director, Innosight Institute
• Deirdre BeVard, Vice President, Clinical Operations and Data Management, Endo Pharmaceuticals
• Reinilde Heyrman, Vice President, Clinical Development and Operations, Daiichi Sankyo Pharma Development
• Peter Carberry, Senior Vice President, Global Development Operations, Astellas Pharmaceuticals
• Kenneth Getz, Senior Research Fellow, Tufts Center for the Study of Drug Development
• John Balian, MD, Senior Vice President, Global Pharmacovigilance and Epidemiology, BRISTOL-MYERS SQUIBB
• Amrit Ray, MD, MBA, FCMI, Chief Safety Officer, Head, Global Medical Safety, JOHNSON & JOHNSON PHARMACEUTICALS GROUP
• Philippe Van der Auwera, MD, PhD, Global Head of Safety Risk Management (PDS) & EU-QPPV, Pharma Development, F.HOFFMANN-LA ROCHE LTD - Switzerland
• Mariette Boerstoel-Streefland, MD, MBA, MS(epi), Chief Safety Officer, Vice President, Global Drug Safety, FOREST RESEARCH INSTITUTE
• Juergen Schmider MD, PhD, Corporate Safety Officer and Vice President Global Pharmacovigilance & Epidemiology, CEPHALON, INC
• And many more – complete program information will soon be available at www.clinicaltrialpartnerships.com.

About Partnerships in Clinical Trials – Partnerships is the leading drug development event bringing clinical trials executives timely information and trends in sourcing models and successfully maintaining critical sponsor/provider relationships, as well as valuable best practices and networking for entire clinical teams. As the number one meeting place for clinical trial partners to gather under one roof, Partnerships in Clinical Trials is known for strategic program content that drives business forward and for unparalleled networking. Visit www.clinicaltrialpartnerships.com for more information.

To inquire about speaking, sponsoring or attending Partnerships in Clinical Trials, please contact Allison Rigels via email at ARigels@iirusa.com or phone at 646-895-7327.

Malaria vaccine trail to begin in east Africa

According to The East African, a Phase III trial has begun for a Malaria vaccine. Malaria is one of the most deadly diseases in the world, and scientists believe that it may only be eradicated by a vaccine. This will be tested in seven African countries, and it was the first vaccine developed for primary use in Africa. The research for this vaccine began in the late 1980s. Read the full article here.

Florida Senator wants to see clinical trial expenses covered by insurance

The Insurance Journal reports that Florida Senator Don Gaetz wants to to see insurance companies begin to cover the cost of clinical trials for cancer patients. If insurance companies do not begin to comply with his demands, he'll introduce a bill into the Florida legislature to begin to force them to do so. He feels that the patients who enter clinical trials should not have to do so at their own financial risk. Read the full article here.

PPD Makes Significant Inroad into China Biotech with Single Deal

SeekingAlpha.com reports yesterday that PPD, Inc. has reached an agreement to acquire Excel PharmaStudies, Inc., a China-based CRO specializing in Phase II-IV clinical trials. Founded in 2000, Excel has offices in 15 China cities and over 300 employees. It has worked with more than 120 pharmas and biotech companies. PPD said the purchase will add capacity and expertise in China, while also increasing its employee count and client base in the Asia Pacific region. Financial terms of the acquisition were not disclosed.

For more information on the acquisition, please click here.

Studies may be failing to show adverse effects of clinical trials

According to a new study conducted by French researchers shows that adverse effects in clinical trials may not be properly reported when the results are written up in case studies. In the study published in the Archives of Internal Medicine, of the 133 studies read, there was a total of 11% that made no mention of any adverse effects observed in the clinical trials. The researchers also noted that 36 of the studies did publish adverse effects, but didn't draw attention to the difference between minor and severe side effects. The article concluded that the reporting of harm caused in clinical studies remains inadequate. What do you think? Should doctors and patients demand to know more about the harmful effects that some are affected with while taking the medication during a clinical trial? Read the full article here.

Genzyme begins Phase 3 clinical trial

The Boston Globe reported last week that Genzyme Corp., the Cambridge drug maker, said it has begun enrollment in the first of two global Phase 3 clinical trials of a potential new oral therapy for Gaucher disease, a rare genetic disorder.

Genzyme currently markets Cerezyme, an injectable treatment for Gaucher disease, an enzyme deficiency in which fatty substances accumulate in the spleen, liver, lungs, bone marrow, and sometimes the brain.

For more information, please click here.

Amarin Appoints Medpace as CRO for Two Phase 3 Cardiovascular Trials

Reuters reports that Marin Corporation announced that it has executed an
agreement with Medpace, Inc. to engage their services in the execution
of its Phase 3 clinical trials with AMR101 in patients with very high
triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia.

Amarin has secured agreements from the U.S. Food and
Drug Administration (FDA) through the Special Protocol Assessment (SPA) process
for both of the Phase 3 trials. The trials are expected to commence shortly,
report top line data in 2011 with the New Drug Application (NDA) expected to be
filed with the FDA not later than 2012.

The Phase 3 AMR101 MARINE Study will be a multi-center, placebo-controlled,
randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2
grams and 4 grams of AMR101 in patients with fasting triglyceride levels of ≥500
mg/dL.


For more information, please click here.

Top 5 Clinical Trial Partnering in Asia Pacific Questions Answered

Partnerships in Clinical Trials Asia Pacific provides the answers to your most pressing partnering and outsourcing questions so your trial can benefit from the tremendous opportunities presented by outsourcing to Asia.

This December get your top 5 questions Answered at Partnerships in Clinical Trials Asia Pacific and walk away with the tools you need to overcome the unique operational, regulatory and ethical challenges in each region.

1. How can I leverage the advantages and disadvantages of local CROs versus global CROs?

Asia is highly regarded as a preferred location for global clinical trials, providing cost savings and a broad spectrum of available patient pools. Now, as outsourcing strategies mature, the focus is turning to finding the right partner mix and the most competitive sponsors are focusing on leveraging the right partner for the right trial in the right region. Experienced outsourcing experts from Astrazeneca Singapore, Bristol-Meyers Squibb Japan, and Boehringer Ingelheim USA will share proven strategies on how to select global and regional partners in the Asia-Pacific region.

2. How can I avoid common pitfalls and set up clinical trials efficiently and effectively in a new region?

From choosing the right partner for your trials to accelerating patient recruitment and retention to assuring project excellence through quality staffing and improved communication strategies, global executives from GSK Biologics, Amgen, Wyeth, Glenmark Pharmaceuticals and Wockhart will address these challenges to help you successfully run your clinical trials in the Asia Pacific region.

3. What can I do to minimize delays and truly expedite clinical trials when outsourcing to the Asia Pacific?

Every session at Partnerships in Clinical Trials Asia Pacific delivers industry insights from Pharma's most experienced outsourcing professionals including Merck Sereno, Genzyme, Genentech and Biogen IDEC. In addition you will gain access to the leading regional and global CROs all in one place so you can see who is truly getting the work done and delivering results.

4. How do I work with our partners to ensure quality and minimize safety concerns?

In order to define and manage quality in clinical trials in Asia Pacific it is important to ensure quality is taking place at all levels, plan for post-marketing requirements on the future of drug developments partnerships and work with sites and partners to ensure patient safety. Hear from sponsor companies from China along with the Safety and Pharmacovigilance team from the NIAD, NIH, DHH. Also make sure to sign up for the full day pharmacovigilance and product safety seminar.

5. What are the regional IP laws and regulatory nuances that I must be aware of to ensure that our company’s intellectual property is protected and our trials are regionally compliant?

With the rapid increase in clinical trials globally, the regulatory differences of each country can have a tremendous impact on timing and quality of your trials. Key regulatory agencies from USA, EU, Japan and China will discuss the requirements and what each region is focusing on with respect to priorities.

So join the conference December 1st and hear from 30+ Speakers on these and
all the other critical issues clinical trial executives are facing when expanding
their trials into the Asia Pacific region.

Kansas Cancer Center to Join Clinical Trials

KOAMTV.com reports that The Tammy Walker Cancer Clinic in Salina, Kansas has joined a group of other institutions that conduct clinical trials to fight cancer.

The Salina center on Monday joined the Midwest Cancer Center, which is based at the University of Kansas and includes a dozen hospitals and cancer research centers in Kansas and western Missouri.

For more information about this story, please click here.

New guidance draft document for REMS

The FDA issued a draft guidance on Wednesday, September 30, for industry on Risk Evaluation and Mitigation Strategies or REMS. The guidance, which is called "“Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications” can be found here.

Adaptive Clinical Trials Benefit Smaller Laboratories

This latest article in outsourcing-pharma.com highlights that according to research done by Pacific Biometrics (PBI), the use of adaptive clinical trials and biomarkers will benefit smaller laboratory services companies, even though has been generally detrimental to CROs. The use of biomarkers and adaptive clinical trials used together are completed quicker and use less money from a company's backlog.

PBI has been able to achieve a growth of five percent from revenues in 2008 to this year, and is expecting the same trend to continue in 2010. PBI executives believe that the changes in adaptive clinical trials have directly impacted the volume of work flowing through their laboratories.

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.

Pfizer and Private Team Access Launch New Patient Recruitment Website

According to this article in outsourcing-pharma.com Pfizer has teamed up with Private Access Team to boost trial recruitment over the web.

Pfizer will launch a new site which will allow patients to control access to personal health information they upload using a "privacy enhanced" search technology. Pfizer states that patients can now be directed more efficiently to appropriate clinical trials based on what interests them. Pfizer seems very excited about this new launch, Greg Simon, Pfizer’s SVP for worldwide policy even mentioned that the “new website has the potential to accelerate medical progress.”

The lack of participation in clincial trials

In a recent article at the News & Observer, the newspaper serving Raleigh, North Carolina, Dr. Susanne B. Haga writes about the current lack of participation in clinical trails that is currently slowing down the discovery and development in the drug industry. She focuses specifically on cancer trials, which currently only have 3% of adult cancer patients participation. As for other clinical trials, only 1/2 of them are meeting specific patient trial goals. May trials go undone, leaving many medical questions up in the air.

How do you feel about the current state of patient recruitment in clinical trials?