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.