WCCT Global is seeking volunteers with renal impairment to participate in a medical research study with an investigational medication.

Qualified participants must:

- Be ages 18 to 79
- Have been diagnosed with renal impairment
- Be non-smokers or smoke less than 5 cigarettes per day
- Be available for one 8-day stay and one follow-up visit

Qualified participants may receive:

- Compensation for time and travel
- Study related care at no cost

For details, contact:
714-668-1500 ext. 4009
Or visit us online at wcctglobal.com

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WCCT Global is seeking volunteers who have been diagnosed with Rheumatoid Arthritis for at least 6 months to participate in a medical research study with an investigational medication.

You may qualify if you:

- Are ages 18 to 65

- Have been diagnosed with Rheumatoid Arthritis for at least last 6 months

- Have been on Methotrexate for at least last 3 months

Participants may receive:

- Up to $2,350 for time and travel

- Study related care at no cost

- Investigational medication

To see if you qualify call:

714-668-1500 ext. 4009

Or visit us at: wcctglobal.com

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WCCT Global is looking for individuals who are between 1 month and 20 years old who are healthy to participate in a clinical research study. This study will not require taking any investigational medication.

Participants may receive:

- Compensation up to $75 for a one time visit

To see if your child qualifies call:

714-668-1500 ext. 4009

or visit us online at wcctglobal.com

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Dr. Shah of West Coast Clinical Trials is conducting a clinical research trial locally for Celiac Disease.

If you’re 18 – 75, are diagnosed with celiac disease, have been attempting a gluten-free diet for 12 months or longer and are still experiencing symptoms when exposed to gluten, you may qualify.  You must have a diagnosis confirmed by biopsy and lab work.

Celiac Disease is an autoimmune disease that’s triggered by eating gluten, the protein found in wheat, barley, and rye.

Symptoms may include: Diarrhea, abdominal pain, bloating, gas, or anemia.

For a Celiac Disease clinical trial site near you, call West Coast Clinical Trials at

714-668-1500 Ext 1008 or

e-mail  celiacstudy@wcct.com

That’s 714-668-1500 Ext 1008 or e-mail them at celiacstudy@wcct.com.

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4. Message

 

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WCCT Global is looking for children who have asthma or symptoms consistent with the diagnosis of asthma to participate in a clinical research study with an investigational medication. Study participants may be able to continue their current asthma therapy during study participation.

Your child may qualify if he/she:

- Has asthma or symptoms consistent with the diagnosis of asthma for at least 6 months

- Is between ages 5 – 11

Qualified participants may receive:

- Up to $700 for 7 visits

- Study related procedures at no cost

To see if your child qualifies call:

714-668-1500 ext. 4009

or visit us online at wcctglobal.com

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2. Email
3. Phone number
4. Message

 

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Understanding the disease is key:

There are six basic genotypes of HCV infection in the worldwide populations, with 15 recorded subtypes, which vary in prevalence across different regions of the world. Each of these major genotypes may differ significantly in their biological effects – in terms of replication, mutation rates, type and severity of liver damage, and detection and treatment options – however, these differences are all not yet clearly understood.

Results from global epidemiological studies demonstrate wide variance in HCV prevalence patterns with the incidence of HCV being higher among less developed nations. The prevalence of hepatitis C is lowest in Northern European countries, including Great Britain, Germany and France. Higher HCV prevalence rates have been reported in Southeast Asian countries, including India (1.5%), Malaysia (2.3%), and the Philippines (2.3%). The incidence in Japan was 1.2%. Alarming rates were reported for many African nations, reaching as high as 14.5% in Egypt.

Thus, the overall data suggest that over 200 million people around the world are infected with hepatitis C – an overall incidence of around 3.3% of the world’s population. Statistically, as many people are infected with HCV as are with HIV. Many public health experts feel that unless large scale efforts to contain the spread of HCV and treat infected populations, the death rate from hepatitis C will surpass that of AIDS in coming years.

Treatment with a combination of pegylated interferon and ribavirin is the current standard of care for chronic hepatitis C. Unfortunately, nearly 50% of individuals fail to respond to this regimen (sustained virologic response [SVR] defined as undetectable HCV RNA by polymerase chain reaction (PCR)-based assay 24 weeks after the end of treatment). More specifically, up to 60% of patients with HCV genotype 1 infection, the most common genotype in the United States and 20%-30% of patients with HCV genotype 2/3 infection do not respond to initial therapy with the current standard of care. Thus, without a more effective therapy, the risk of developing liver-related complications among those who are chronically infected will increase, not peaking until after the year 2030. This has provided the impetus to develop more novel and effective therapies.

Our new and evolving understanding of the HCV lifecycle has allowed development of agents designed to interrupt viral infection and replication. It is hoped that this new knowledge will translate into effective treatment options for nearly all patients with HCV.

The HCV Lifecycle

HCV is a small, enveloped, linear, single-stranded RNA virus. The genome encodes a single polyprotein that is then processed by both host and viral proteases into smaller proteins that assist in viral replication. Research has identified several steps during this replication process that are fundamental to the HCV lifecycle and thus represent excellent Direct Anti-HCV therapeutic targets.

• Binding, cell entry, nucleocapsid uncoating, and release
o Viral envelope proteins (E1 and E2) bind to host CD81 allowing internalization

• HCV translation
o Amino acid sequencing at RER to form the HCV polyprotein

• Polyprotein processing
o Protease cleavage into 6 NS (nonstructural) proteins that support viral RNA replication

• Assembly of the RNA replication complex
o NS Proteins are required for assembling the RNA replication complex (replicase)

• RNA synthesis (NS5B RNA polymerase)
o Nearly 1 trillion particles are produced each day
o An exceptionally high mutation rate

• Virus assembly and release
o Phosphorylation of NS5A may trigger the virus to switch from “replication mode” to “assembly mode”

The genomic RNA is packaged into the icosahedral protein shell and then enveloped in a host lipid cell membrane. The assembled virulent virus is then released from the hepatocyte through a cellular secretory pathway. Significant strides in drug development have accompanied this increased understanding of the HCV lifecycle. The enthusiasm about the potential of these agents continues to grow as more data confirming anticipated efficacy surface.

Although each aspect of the HCV lifecycle has been targeted for potential therapeutic intervention, many therapeutic strategies are under investigation, including novel interferon products, ribavirin analogues, and drugs targeting viral enzymes required for viral replication (direct-acting antiviral agents [DAAs] or small-molecule therapies). Among these novel anti-HCV therapies on the horizon, the DAAs temporally represent the class of agents most likely to affect disease management. Two protease inhibitors have already reached the commercial market. The polymerase inhibitors will be soon to follow.

The staff at WCCT Global has extensive experience working with Pharma in the development of HCV treatments. While at Schering-Plough, Mel Affrime, WCCT Global’s SVP of Research & Development designed and executed the studies that lead to an industry understanding of interferon’s antiviral mechanism. Mel carried out the initial Schering proof of concept study demonstrating the synergistic activity of ribavirin when combined with interferon and is on the patent which describes the mechanism for the additional HCV activity gained with pegylation of interferon. Mel Heads up WCCT Global’s Hepatitis Center of Excellence.

WCCT Global has carried out numerous healthy volunteer safety and tolerance trials as both an investigational site and a CRO managing an early development PoC study at several sites. They have studied both immediate release interferons and Pegylated interferon with and without ribavirin and WCCT Global has also been a Phase II/III investigational site for several of the new Direct Acting Anti-HCV compounds in development. We leverage this knowledge to strategically help the clients we serve.

As the industry looks to get more data from phase 1 trials, there is an increasing interest in including patient populations in the phase 1 program. WCCT Global, during the protocol development phase, would help sponsors design an integrated SAD/MAD in healthy volunteers intercolated with SAD/MAD proof of concept in Hepatitis C, treatment naïve, patients. (click here for study design concept) Such an integrative design enables the sponsor to collect safety, tolerance and exposure-response information efficiently and enables go/no-go development decisions to be reached much sooner than before WCCT Global is strategically based in a densely populated area of 8 million people found throughout the Southern California region and thus has access to a diverse set of patient populations. Therefore, WCCT Global is able to recruit Hepatitis C treatment naïve subjects within timelines that sponsors need by utilizing their proprietary advertising strategy.

WCCT Global’s Hepatitis Center of Excellence works with sponsors early in development process to offer strategies that more rapidly demonstrate the anti-HCV actions of the novel viral targets being tested. Because WCCT Global has access to healthy volunteers of diverse ethnic lineage and patients with HCV, they work with sponsors to rapidly get the information necessary to launch a Global Development Program months ahead of the classic development paradigms.

WCCT Global  is seeking adults between 18 to 65 years old who have been diagnosed with Hepatitis C  Genotype 1 to participate in a clinical research study.

You may qualify if you:

- Have been diagnosed with Hepatitis C Genotype 1
- Are between ages 18-65*
- Are treatment naive

* Females must be postmenopausal for 2 years or surgically sterile.

Participants may receive:

- Up to $1,150 for time and travel
- Study related health care at no cost
- Investigational Medication

To see if you qualify call:

714-668-1500 ext.4009

or visit us online at wcctglobal.com

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WCCT Global is seeking adults between 18 to 50 years old who have been diagnosed with intermittent or mild or moderate persistent asthma to participate in a clinical research study.

You may qualify if you:

- Have been diagnosed with intermittent or mild or moderate persistent asthma

- Are between ages 18-50

- Are a non-smoker for at least the last 90 days

Participants may receive:

- Compensation for time and travel

- Study related health care at no cost

- Investigational Medication

To see if you qualify call:

714-668-1500 ext.4009

or visit us online at wcctglobal.com

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WCCT Global specializes in complex Phase I-IIa special population studies, which assess a drug’s efficacy and dosage requirements within a particular subset of a larger population. The company has extensive expertise in protocol design, volunteer enrollment, and management of ethno-bridging, thorough QTc (important cardiac safety parameter), respiratory, infectious disease, pediatric, post-menopausal and renal trials.

Dr. Kenneth Kim, CEO, said, “We are very pleased and excited to have Lee heading up our CRO expansion initiative and joining the management team.  His in-depth knowledge of the CRO space and his extensive experience running complex clinical trials in various therapeutic areas, gives us confidence that his addition to our team is the right one to guide WCCT Global through its next stage of growth and development.”

Dr. Kim continued, “We also are pleased to announce our opening of an East Coast Office in Bucks County, Pennsylvania to better serve and support our East Coast clients and biotechnology and pharmaceutical companies worldwide.”

About Lee Barsky, MBA, PMP, Vice President, Program Management

Mr. Barsky is a results-driven professional with over 17 years of diversified Project Management, Business Development and Clinical Trial/Operations experience.

Mr. Barsky has a balanced perspective from both CRO/service providers and Sponsors that enable him to analyze existing operations, manage staff and implement strategic processes to improve productivity and efficiency. Additionally, his expertise in Global Project Management, Cross-functional Pharmaceutical Project Management/Program Management, Clinical Operations/Clinical Development, Clinical Affairs/Regulatory Affairs, Clinical Compliance, Quality Assurance and Data Management, make him the right person to help expand our CRO offering. Prior to joining WCCT Global, he held a similar leadership position at Accelovance which under his direction was named the Best Vaccine CRO in 2009, 2010, and 2011. His areas of therapeutic expertise include vaccines, infectious disease, immunology, oncology, cardiovascular, CNS, metabolic disease, women’s health, respiratory, gastrointestinal, and neurology.

About WCCT Global
WCCT Global is a global provider of outsourced early drug development services to the pharmaceutical, biotechnology and medical device industries. As a drug development partner, WCCT Global partners with domestic and foreign innovator companies who need regulatory, program management, and strategic consulting support from First-in-Man thru the proof of concept stage with an emphasis on overseeing and executing on trials in special disease populations, ethnobridging volunteers, and cardiac safety studies. Visit WCCT Global on the web at http://www.wcctglobal.com.

Contact for WCCT Global
Talia Nikolao
Executive Director, Business Development
talia.nikolao@wcct.com

714-668-1500

What is meningococcal disease type B (MnB)?

Meningococcal disease type B (MnB) is caused by a certain type of bacteria that can make your adolescent very sick.

No vaccine to prevent MnB is currently available.

Your child (ages 10-12) may be eligible to take part in a clinical trial* to test an investigational† vaccine for MnB.

* A clinical trials is a carefully managed study done by doctors to learn more about potential new medicines and treatments.
† An investigational vaccine is an unapproved vaccine that is being tested in a clinical trial.

Please contact our office
WCCT Global (formerly known as West Coast Clinical Trials)

1-877-777-9228

www.wcctglobal.com

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