Tag Archives: clinical trials

Features & Benefits of Sentry’s Pharmaceutical Labeling & Packaging Services

Sentry BioPharma Services specializes in pharmaceutical and medical device packaging projects of varying scale, complexity and sensitivity to time and temperature. Sentry’s  full service light manufacturing through Food & Drug Administration (FDA) compliant pharmaceutical labeling and custom kitting functions provide clients the ability to store bulk products yet deliver kitted solutions to clinical sites and commercial customers across the global. This one-stop shop structure married with Sentry’s Foreign Trade Zone (FTZ) offers optimal flexibility and cost effective solutions to even the most intricate of drug development projects.

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Sentry Labeling and Packaging

Features of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

GMP operation compliant with FDA regulations

o    FDA labeler code (3007066137)

o    Segregated labeling and packaging area

o    Total label operation accountability (line clearance)

 

Diverse Clinical Trial Labeling & Packaging Support

o    Open and blinded

o    Multi-lingual

o    Peel-off / Perforated

o    Serialized

 

Pharmaceutical & Medical Device Packaging

o    Bulk

o    Double-blind

o    Package inserts

o    Single / Multi-dose cartons

o    Tamper evident seals

On-Demand Services

o    Configurable stock management

o    Expiration management of individual kit components

o    Extend expiration

o    Pharmaceutical kitting

o    Reduce at-risk inventory

 

Adaptable Scheduling

o    Batch or lot specific

o    Batch size

 

Benefits of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

Streamlined Production throughout Drug Development Phases – Avoid cumbersome logistics among vendors with Sentry’s full scope services from GMP pharmaceutical storage, biopharmaceutical labeling and packaging and extensive distribution.

Accurate Inventory Control from Bulk to Finish –  Sentry’s compliant, validated inventory management system and batch record process allow for accurate tracking of inventory levels during clinical trials and commercial launch.

Cost Effective Manufacture – Reduce pharmaceutical drug development costs with Sentry’s flexible storage, labeling and packaging offerings before, during and after FDA approval.

For more information about how a coordinated GMP storage, packaging and distribution model may reduce risk and strengthen the structure of your supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Bring Your Brave: Breast Cancer Awareness Month Begins Today!

braveDid you know that one in eight women in the U.S. will be diagnosed with breast cancer in her lifetime?  At that current rate, that means 13 million breast cancer deaths around the world will occur in the next 25 years.

The most significant risk factors for breast cancer are gender (being female) and age (growing older).  Other factors can be changed by making choices. By choosing the healthiest lifestyle options possible, you can empower yourself and make sure your breast cancer risk is as low as possible.

Reduce Risk Factors:

  • Do not smoke
  • Drink alcohol in moderation
  • Exercise at least three hours per week or about 30 minutes a day
  • Eat a nutritious, low-fat diet (30 grams or less) with plenty of fruits and green and orange vegetables

The National Breast Cancer Foundation launches the annual campaign by raising awareness during the month of October.  The endeavor begins today, October 1, 2016 and lasts through the end of the month.  Getting a high-quality screening mammogram and having a clinical breast exam on a regular basis are the most effective ways to detect breast cancer early.

Early Detection Strategies:

  1. Recognize signs & symptoms
  2. Perform a monthly breast self-exam (BSE)
  3. Have an annual clinical breast exam
  4. Screen for abnormalities with a mammogram

The American College of Radiology (ACR) has established a uniform way for radiologists to describe mammogram findings. The system, called BI-RADS, includes seven standardized categories, or levels. Each BI-RADS category has a follow-up plan associated with it to help radiologists and other physicians appropriately manage a patient’s care.

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Some state and local health programs and employers provide mammograms free or at low cost. For example, the Centers for Disease Control and Prevention (CDC) coordinates the National Breast and Cervical Cancer Early Detection Program. This program provides screening services, including clinical breast exams and mammograms, to low-income, uninsured women throughout the United States and in several U.S. territories. Contact information for local programs is available on the CDC website or by calling 1–800–CDC–INFO (1–800–232–4636).

Information about free or low-cost mammography screening programs is also available from the National Cancer Institute’s (NCI’s) Cancer Information Service at 1–800–4–CANCER (1–800–422–6237) and from local hospitals, health departments, women’s centers, or other community groups.

For more information:

September is Charcot-Marie-Tooth (CMT) Awareness Month, Spread the Word!

CMT affects 1 in every 2,500 people worldwide, (a total of 2.8 million). That’s 1 too many.

What if each of those 2.8 million people ALL told five people about CMT?  Fourteen million new people would learn about CMT!  This is why the Charcot-Marie-Tooth Association (CMTA) declared September as CMT Awareness Month six years ago!

What is CMT? 

Charcot-Marie-Tooth Disease, or CMT, is a group of inherited disorders that affect the peripheral nerves, which are the nerves outside the brain and spinal cord. There are 90 kinds of CMT. Each kind is caused by a different kind of mutation, and more causes are being discovered every year.

CMT is just one kind of neuropathy (also called peripheral neuropathy), meaning simply that the peripheral nerves are damaged. There are many other causes of neuropathy, including the most common cause—diabetes.

CMT affects about 2.8 million people worldwide, of all races and ethnic groups.

Where Did the Name CMT Come From?

Charcot-Marie-Tooth is named after the three physicians who were the first to describe it in 1886: Jean-Martin Charcot, Pierre Marie and Howard Henry Tooth.

Charcot        Marie        Tooth

Inherited Disorders

CMT is inherited. It is not contagious, nor is it caused by anything in the environment. The most common forms of CMT are passed down from one generation to the next, meaning that it is dominantly inherited.

Some forms of CMT are recessively inherited—a person may be affected even though his or her parents do not have CMT. In this case, each of the parents harbors a mutation in one of their two copies of a CMT gene. If a child inherits one mutated CMT gene from each of their parents (the chance of this happening is one out of four), the child will develop CMT.

Sometimes the mutation that causes CMT happens spontaneously during the process that produces the eggs or sperm. In these rare cases, a child will have CMT even though neither parent has CMT. If a child has such a spontaneous mutation, he/she may pass that mutation down to his/her offspring.

Symptoms

Some types of CMT cause damage to the covering (myelin sheaths) that surrounds nerve fibers. Other kinds of CMT directly damage the nerves fibers themselves. In both cases, the damaged nerve fibers result in neuropathy. The nerves in the legs and arms, which are the longest, are affected first. Nerve fibers that create movement (called motor fibers) and nerve fibers that transmit sensations (called sensory fibers) are both affected. CMT causes weakness and numbness, usually starting in the feet.

In the most common kinds of CMT, symptoms usually begin before the age of 20 years. They may include:

  • Foot deformity (very high arched feet)
  • Foot drop (inability to hold foot horizontal)
  • “Slapping” gait (feet slap on the floor when walking because of foot drop)
  • Loss of muscle in the lower legs, leading to skinny calves
  • Numbness in the feet
  • Difficulty with balance
  • Later, similar symptoms also may appear in the arms and hands
  • CMT almost never affects brain function

foot

The foot of a person with CMT. The lack of muscle, a high arch, and claw toes are signs of this genetic disease. 

Diagnosis

A diagnosis of CMT is established through a thorough neurological evaluation by an expert in neuropathy, including a complete family history, physical exam, and nerve conduction tests, and appropriate genetic testing.

A physical exam may show:

  • Difficulty lifting up the foot while walking
  • Difficulty with dorsiflexion of the toes and ankles (upward movement, away from the ground) and other foot movements
  • Reduced or absent deep tendon reflexes (like the knee-jerk reflex)
  • Loss of muscle control and atrophy (shrinking of the muscles) in the feet and lower legs (and later the hands)

Genetic testing can provide the exact cause for most people who have CMT.

Prognosis (Expectations)

CMT usually gets worse, slowly, with age; rapid progression is rare, and should motivate a prompt re-evaluation. The problems with weakness, numbness, difficulty with balance, and orthopedic problems can progress to the point of causing disability. Pain can be an issue, either as a direct result of the neuropathy (neuropathic pain) or as consequence of orthopedic problems. Other potential complications include the following:

  • Progressive inability to walk from weakness, balance problems, and/or orthopedic problems
  • Progressive inability to use hands effectively
  • Injury to areas of the body that have decreased sensation

Treatments

There are no known treatments that will stop or slow down the progression of CMT, but the CMTA is funding research to find these treatments.

Physical therapy, occupational therapy, and physical activity may help maintain muscle strength and improve independent functioning.

Orthopedic equipment (such as braces, inserts, AFOs or orthopedic shoes) may make it easier to walk.

Orthopedic surgery on the feet can often maintain or even restore function to enable walking.

Clinical Trials

Although there is no cure for CMT, there are many clinical trials both completed and ongoing currently.  As many as 199 according to the website clinicaltrials.gov.

Participating in a clinical trial is an invaluable way to get involved in helping the research community cure CMT and related inherited neuropathies (INs). There are various types of clinical trials. Clinical trials are sometimes referred to as clinical studies or clinical research involving human volunteers that have been Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved, the regulatory agencies for the U.S. and Europe. These agencies require that a potential therapy be extensively tested in large groups of human volunteers before it can receive approval for commercialization.

Clinical trials are a vital part of the scientific research process and essential for developing therapies to prevent, treat, reverse and cure CMT. 

Strict adherence to clinical trial material management protocols, in combination with proven GMP storage, clinical trial labeling, secondary packaging and global drug distribution allows Sentry to provide clinical trial outsourcing clients with a variety of flexible services.

For more information about how Sentry BioPharma Services can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.

For more information please visit the following websites:

https://www.cmtausa.org/

https://clinicaltrials.gov/

Sentry BioPharma Services Offers Clinical Trial Support for Muscular Dystrophy

Sentry BioPharma Services serves pharmaceutical and biotechnology firms developing drugs for multiphase clinical trials for various indications.  One such indication is muscular dystrophy (MD).   According to the Muscular Dystrophy Association’s (MDA’s) website, “Muscular dystrophy, amyotrophic lateral sclerosis (ALS) and related muscle-debilitating diseases take away a person’s physical strength, independence and life.”

md

Source: https://www.cdc.gov/ncbddd/musculardystrophy/freematerials.html

The National Institute of Neurological Disorders and Stroke (NINDS) indicates there is no specific prescription drug, biological product or vaccine to prevent, stop or reverse any form of MD. Treatment may include physical therapy, respiratory therapy, speech therapy, orthopedic appliances used for support, and corrective orthopedic surgery. Drug therapy includes corticosteroids to slow muscle degeneration, anticonvulsants to control seizures and some muscle activity, immunosuppressants to delay some damage to dying muscle cells, and antibiotics to fight respiratory infections.  Some individuals may benefit from occupational therapy and assistive technology.   Some patients may need assisted ventilation to treat respiratory muscle weakness and a pacemaker for cardiac abnormalities.

Some of the life-threatening diseases are as follows:

According to ClinicalTrial.gov, an on-line service provided to the public by the U.S. National Institutes of Health (NIH), there are approximately 125 open clinical studies in process currently.

Strict adherence to clinical trial material management protocols, in combination with proven GMP storage, clinical trial labeling, secondary packaging and global drug distribution allows Sentry to provide clinical trial outsourcing clients with a variety of flexible services.

For more information about how Sentry BioPharma Services can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.

FDA Removes Clinical Hold on Phase II of Juno’s “ROCKET” Trial

On Tuesday, July 12, 2016, Juno Therapeutics, a biopharmaceutical company developing cell-based cancer immunotherapies headquartered in Seattle, Washington, announced on the company’s website that the U.S. Food and Drug Administration (FDA) removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).  Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.

CAR-T

Earlier this month Juno received notice from the (FDA) that a clinical trial hold has been placed on the pivotal clinical trial of JCAR015.  This Phase II clinical trial, also known as the “ROCKET” trial, was being conducted in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).  As of last Friday, a total of three deaths have occurred in adult patients during clinical trials.

According to an article published by FierceBiotech on July 8, 2016, “All three deaths were in young patients, all under the age of 25, and all were due to cerebral edema.  All three of these patients were also on a preconditioning regimen of fludarabine.”

While this “living drug” may offer cancer patients a possible option where none previously existed, it is uncertain as to whether or not the class of chimeric antigen receptor T cells (CAR-T) treatments poses safety issues.  This new technology focuses on re-engaging a patient’s own immune system (T cells) via genetically engineering to recognize the antigen and kill cancerous cells.  One big question is:  Can this be done in conjunction with standard leukemia chemotherapy drugs like fludarabine and cyclophosphamide?

The removal of the clinical hold suggests that the FDA appears to satisfied with Juno’s response in addressing worrisome side effect and safety concerns resulting from the reaction between JCAR015 and the chemotherapy drug fludarabine.

Phase I of the JCAR015 study had a “complete response rate” (i.e., detectable cancer did not appear present after treatment), this cancer treatment offers much promise and hope to individuals and families battling this devastating and too often fatal disease.

For more information about how Sentry can implement a custom solution to provide GMP storage for clinical trial materials and/or meet your unique biopharmaceutical supply chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

Sentry Goes Purple in June for Alzheimer’s & Brain Awareness Month

Sentry is going purple! On Friday, June 24, 2016 Sentry BioPharma Services invites employees to wear the color purple in recognition of Alzheimer’s and brain awareness month.

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Alzheimer’s disease is the sixth leading cause of death in the United States; it kills more citizens annually than prostate and breast cancer combined. Worst of all, there presently is no cure for Alzheimer’s disease. Researchers possess great hope that there will be treatments that can stop or slow Alzheimer’s in the near future.

The National Institute on Aging (NIA), one of the 27 Institutes and Centers of the National Institutes of Health (NIH), leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. NIA is the primary Federal agency supporting and conducting Alzheimer’s disease research. For more information about Alzheimer’s disease, please watch the video below.

Several medications are approved by the U.S. Food and Drug Administration to treat symptoms of Alzheimer’s. Donepezil (Aricept®), rivastigmine (Exelon®), and galantamine (Razadyne®) are used to treat mild to moderate Alzheimer’s (donepezil can be used for severe Alzheimer’s as well). Memantine (Namenda®), is used to treat moderate to severe Alzheimer’s.

These drugs work by regulating neurotransmitters, the brain chemicals that transmit messages between neurons. They may help maintain thinking, memory, and communication skills and help with certain behavioral problems. However, these drugs don’t change the underlying disease process. They are effective for some but not all people and may help only for a limited amount of time.

For more information about how Sentry can implement a custom solution to meet your unique GMP storage and pharmaceutical cold chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

NIH: Increased Physical Activity Associated with Lower Risk of 13 Types of Cancer

Sentry BioPharma Services provides oncology product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both cancer clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients.  With this in mind, the most successful cancer drugs are no match for avoidance of cancer altogether.  Therefore, we are sharing this article from the National Institute for Health (NIH) concerning a new study which links physical exercise with lower cancer rates. 

A new study of the relationship between physical activity and cancer has shown that greater levels of leisure-time physical activity were associated with a lower risk of developing 13 different types of cancer. The risk of developing seven cancer types was 20 percent (or more) lower among the most active participants (90th percentile of activity) as compared with the least active participants (10th percentile of activity). These findings, from researchers at the National Cancer Institute (NCI), part of the NIH, and the American Cancer Society (ACS), confirm and extend the evidence for a benefit of physical activity on cancer risk and support its role as a key component of population-wide cancer prevention and control efforts. The study, by Steven C. Moore, Ph.D., NCI, and colleagues, appeared May 16, 2016, in JAMA Internal Medicine.

Hundreds of previous studies have examined associations between physical activity and cancer risk and shown reduced risks for colon, breast, and endometrial cancers; however, results have been inconclusive for most cancer types due to small numbers of participants in the studies. This new study pooled data on 1.44 million people, ages 19 to 98, from the United States and Europe, and was able to examine a broad range of cancers, including rare malignancies. Participants were followed for a median of 11 years during which 187,000 new cases of cancer occurred.

The investigators confirmed that leisure-time physical activity, as assessed by self-reported shutterstock_426808351surveys, was associated with a lower risk of colon, breast, and endometrial cancers. They also determined that leisure-time physical activity was associated with a lower risk of 10 additional cancers, with the greatest risk reductions for esophageal adenocarcinoma, liver cancer, cancer of the gastric cardia, kidney cancer, and myeloid leukemia. Myeloma and cancers of the head and neck, rectum, and bladder also showed reduced risks that were significant, but not as strong. Risk was reduced for lung cancer, but only for current and former smokers; the reasons for this are still being studied.

“Leisure-time physical activity is known to reduce risks of heart disease and risk of death from all causes, and our study demonstrates that it is also associated with lower risks of many types of cancer,” said Moore. “Furthermore, our results support that these associations are broadly generalizable to different populations, including people who are overweight or obese, or those with a history of smoking. Health care professionals counseling inactive adults should promote physical activity as a component of a healthy lifestyle and cancer prevention.”

Leisure-time physical activity is defined as exercise done at one’s own discretion, often to improve or maintain fitness or health. Examples include walking, running, swimming, and other moderate to vigorous intensity activities. The median level of activity in the study was about 150 minutes of moderate-intensity activity per week, which is comparable to the current recommended minimum level of physical activity for the U.S. population.

There are a number of mechanisms through which physical activity could affect cancer risk. It has been hypothesized that cancer growth could be initiated or abetted by three metabolic pathways that are also affected by exercise: sex steroids (estrogens and androgens); insulin and insulin-like growth factors; and proteins involved with both insulin metabolism and inflammation. Additionally, several non-hormonal mechanisms have been hypothesized to link physical activity to cancer risk, including inflammation, immune function, oxidative stress, and, for colon cancer, a reduction in time that it takes for waste to pass through the gastrointestinal tract.

Most associations between physical activity and lower cancer risk changed little when adjusted for body mass index, suggesting that physical activity acts through mechanisms other than lowering body weight to reduce cancer risk. Associations between physical activity and cancer were also similar in subgroups of normal weight and overweight participants, and in current smokers or people who never smoked.

The study was a large-scale effort of the Physical Activity Collaboration of NCI’s Cohort Consortium, which was formed to estimate physical activity and disease associations using pooled prospective data and a standardized analytical approach.

“For years, we’ve had substantial evidence supporting a role for physical activity in three leading cancers: colon, breast, and endometrial cancers, which together account for nearly one in four cancers in the United States,” said Alpa V. Patel, Ph.D., a co-author from the American Cancer Society. “This study linking physical activity to 10 additional cancers shows its impact may be even more relevant, and that physical activity has far reaching value for cancer prevention.”

The National Cancer Institute leads the National Cancer Program and the NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at https://www.cancer.gov or call NCI’s Cancer Information Service at 1-800-4-CANCER.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Reference

Moore SC, et al. Leisure-time physical activity and risk of 26 types of cancer in 1.44 million adults. JAMA Internal Medicine. May 16, 2016. DOI:10.1001/jamainternmed.2016.1548.

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP storage can help protect the integrity of your biological products in general, contact Sentry via email or by phone at 1-866-757-7400.