Tag Archives: pharmaceutical labeling

FDA approves drug to treat Parkinson’s Disease

Sentry BioPharma Services provides drug 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  clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. 

The focus of our post this week is Parkinson’s Disease and treatment.  Therefore, we are sharing this article from the FDA concerning its new drug approval of Xadago.

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremors and difficulty walking.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others.

The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.

In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.

Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology.

The FDA granted approval of Xadago to Newron Pharmaceuticals.

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

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.

Sentry’s New Vaccine Storage Campaign

Sentry BioPharma Services is proud to announce its new vaccine storage and distribution services campaign. Sentry’s decade long commitment to protect product integrity  married with its state-of-the-art facility provides the life sciences industry with a unique level of quality, regulatory and operational advantages that strengthen the vaccine supply chain. Sentry’s vaccine program advantages include:

Proven Track Record of Compliant Vaccine Storage, Rotation And Vaccine Drug Distribution

vaccinecampaignSentry’s long and unblemished regulatory inspection history is a reflection of its superior approach to standard operating procedures and temperature sensitive product management.

Large Scale Repository and Tracking Capabilities Through Advanced Inventory Management Systems

Live 24/7 real-time inventory tracking ensures full visibility of inventory throughout an organization and accurate tracking compliant with GMP storage regulations 21 CFR Parts 210 and 211. High-touch communication with the Sentry Operations and Quality Teams provides proper distribution of vaccines for routine fulfillment or pandemic response.

Advanced Building Management Systems That Monitor And Control Temperature Of Storage Environments

Sentry’s validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to deficient storage methods. The facility’s multi-tiered security structure and flexible storage options help fulfill requirements for specific seasonal or stockpile campaigns.

Trusted By Hospitals, Government Healthcare Agencies, And Manufacturers To Protect Vaccine Products And Stockpile

Over its ten years as a contract service organization, Sentry has been a trusted partner to hospitals, vaccine manufacturers and government healthcare organizations concerned with drug product integrity, vaccine storage security, risk management and timely vaccine distribution.

For more information about how Sentry’s temperature sensitive product management expertise can help you optimize your seasonal vaccine stockpile requirements, contact Sentry via email or by phone at 1-866-757-7400.

Sentry’s Controlled Substance Program Strengthens the Reliable and Secure Pharmaceutical Drug Supply Chain

Regulatory oversight shapes every dimension of controlled substances: licensing, registration, storage, security, use, inventory and controlled drug disposal. Finding a Drug Enforcement Administration (DEA) licensed partner to store, distribute and manage returns and destruction of Schedule III-V controlled substances while maintaining regulatory and quality standards required for a secure pharmaceutical supply chain can be a challenge. Sentry BioPharma Services provides seamless product management required to safeguard controlled substances which are brought into Sentry’s custody and care.

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Features & Benefits of Sentry’s Controlled Substance Program

DEA Regulation Secure Storage – Inspected and approved by the Drug Enforcement Administration  in 2014, Sentry’s state-of-the-art controlled substance capacity provides secure and reliable storage to support your pharmaceutical supply chain needs.

Controlled Substance Importation/Exportation – Sentry’s controlled substance importation and controlled substance exportation capabilities provide pharmaceutical organizations unique flexibility in the drug supply chain. This coupled with Sentry’s high quality standards affords pharmaceutical companies a competitive advantage throughout the drug development process.

Redundant Systems and Extensive Security Measures Product safety, identity, strength, purity and quality (SISPQ) remain intact.  Sentry features which support this agenda include:

  • Auxiliary power feeds and back-up systems
  • Continuous (24/7) security monitoring
  • Foreign Trade Zone (FTZ) status which allows controlled substances to be internationally shipped directly to Sentry where DEA, Customs & Border Patrol (CBP) and FDA clearances can be obtained within the security provided by Sentry’s GMP facility
  • Physical plant security
  • Redundant HVAC systems
  • Secure data and document programs

Pharmaceutical Labeling and Packaging – Sentry’s light pharmaceutical manufacturing capabilities help streamline clinical trial distribution and commercial drug distribution with one stop shop GMP labeling and GMP secondary packaging.

Drug Product Return and Drug Disposal Services – Sentry completes the controlled substance supply chain with a full-service approach to product guardianship.  Our drug product return and drug destruction program ensures project integrity, reliable inventory tracking and public safety from development to launch.

For more information about how Sentry can provide controlled substance supply chain solutions for your project, contact Sentry via email or by phone at 1-866-757-7400.

Features & Benefits of a Pharmaceutical Foreign Trade Zone

What is a Foreign Trade Zone?

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign-trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industryshutterstock_367703690

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which  resides in a foreign trade zone.  Sentry’s zone allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the CBP and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical  product can be further labeled and secondarily packaged  while greatly mitigating the numerous logistic and economic challenges encountered throughout the  drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Read more about the Greater Indianapolis Foreign Trade Zone: inzone.org

Melanoma: A Preventable Killer

Moles to Melanoma: Recognizing the ABCDE Features by the National Cancer Institute

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. 

The focus of our post this week is preventable cancer.  Therefore, we are sharing this article from the National Cancer Institute (NCI) concerning a multi-year study of skin lesions and moles which resulted in melanoma.

Skin Cancer: Body Mole Map

Skin Cancer: Body Mole Map

Key Points
  • Melanoma incidence rates have doubled from 1982 to 2011.
  • In 2011, in the United States, there were 65,647 cases of melanoma and 9,128 deaths.
  • The annual cost of treating newly diagnosed melanomas is projected to triple by 2030.
  • Melanoma can be prevented by reducing ultraviolet radiation exposure from sunbathing and indoor tanning and increasing the use of sun protection.
  • A comprehensive national skin cancer prevention program could avert 230,000 melanoma cases and $2.7 billion in initial year treatment costs from 2020 to 2030.
  • Additional information available at http://www.cdc.gov/vitalsigns.

Introduction

Skin cancer is the most common form of cancer in the United States, and melanoma is responsible for the most skin cancer deaths with over 9,000 each year. An individual dying from melanoma loses an average of 20.4 years of potential life. Total melanoma treatment costs are about $3.3 billion annually in the United States. Melanoma is the fifth most common cancer for men, and is the seventh most common cancer for women. More than 90% of melanoma cases in the United States are attributed to skin cell damage from ultraviolet (UV) radiation exposure.

The National Cancer Institute has collected photographs of 29 different pigmented skin lesions, presented as case studies, to help patients and other individuals recognize common moles, dysplastic nevi (DN), and melanomas that started from DN. Each case series shows changes in an individual pigmented lesion (mole) over time and across the various mole changes typically seen in individuals from U.S. melanoma-prone families.

What are moles, dysplastic nevi and melanoma?

  • Common MolesA non-cancerous growth on the skin that is formed by a cluster of melanocytes (cells that make a substance called melanin, which gives color to skin and eyes). A mole may be dark or flesh-colored and may be raised from the skin.
  • Dysplastic Nevi (DN) – A type of mole that may develop into a type of skin cancer called malignant melanoma. They look different from common moles. A DN is often larger with borders that are not easy to see. Its color is usually uneven and can range from pink to dark brown. Parts of the mole may be raised above the skin surface.
  • MelanomaA form of cancer that begins in melanocytes (cells that make the pigment melanin). It may begin in a mole (skin melanoma), but can also begin in other pigmented tissues, such as in the eye or in the intestines.

Who is the intended audience?

  • The pictures used in this article were taken over more than a 35-year period. They show moles and melanomas from participants enrolled in the NCI Familial Melanoma Study.
  • The pictures show examples of the variability in pigmented lesions in U.S. melanoma-prone families.
  • Because most of the study participants are Caucasian, the nevi and melanomas shown are not representative of those found in individuals with darker skin.
  • Melanomas and lesions suspicious for melanoma vary widely in appearance; these pictures should not be used to diagnose melanoma.
  • NCI does not provide medical advice to users of its website.
  • Consult with a qualified health care provider if you have concerns about your skin.

About the photos

  • The photographs have variations in color due to differences in photography equipment, lighting, and skin color of the individual (e.g. sunburned or suntanned).
  • Photographs are standardized to ease viewing.
  • Rulers show size of the moles and melanomas in millimeters.

This study only includes individuals in U.S. melanoma-prone families who are at high-risk of developing this form of skin cancer. As shown in Figure 1, Caucasians are at the highest risk of developing melanoma. To date, this study has not identified or enrolled any non-Caucasian families.  Therefore, this tool does not provide images representative of other ethnicities.

Figure 1: Melanoma incidence by race/ethnicity in the U.S. Surveillance, Epidemiology and End Results Program 1975-2012

chart

Reference: Howlader N, Noone AM, Krapcho M, Garshell J, Miller D, Altekruse SF, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2012, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2012/ , based on November 2014 SEER data submission, posted to the SEER web site, April 2015
Data points are not included for clarity of presentation, but may be found at http://seer.cancer.gov/csr/1975_2012/sections.html Figure 16.2.

Where can I find information on Skin Cancer in other Ethnicities?

  • National Cancer Insititure – “Anyone Can Get Skin Cancer”, includes images of skin cancer in people with darker skin
  • Skin Cancer Foundation – “Skin Cancer and Skin of Color”

Where can I find information about Non-Melanoma Skin Cancer?

This collection does not include any pictures of non-melanoma types of skin cancer (e.g. basal cell or squamous cell), since they arise from different cell types in the skin they look very different from melanoma. For information on those types of skin cancer, visit the following websites: http://www.cancer.gov/types/skin & http://www.cancer.org/cancer/cancercauses/sunanduvexposure/skin-cancer-facts.

What information does this resource provide?

This resource provides information about and examples of: common moles, dysplastic nevi (atypical moles) and melanoma. This collection does not include any pictures of non-melanoma types of skin cancer (e.g. basal cell or squamous cell). Since they arise from different cell types in the skin, they look very different from melanoma. Additional information, including resources for other types of non-melanoma skin cancer, can be found in the Intended Audience section.

The “ABCDE” rule describes the features of early melanoma. These features are:

Asymmetry – The shape of one half does not match the other half.

Asymmetry

Border that is irregular – The edges are often ragged, notched, or blurred in outline. The pigment may spread into the surrounding skin.

Border

Color that is uneven – Shades of black, brown, and tan may be present. Areas of white, gray, red, pink, or blue may also be seen.

Color

Diameter – There is a change in size, usually an increase. Melanomas can be tiny, but most are larger than 6 millimeters wide (about 1/4 inch wide).

Diameter

Evolving – The mole has changed over the past few weeks or months.

Evolving

A common mole is a non-cancerous growth on the skin that is formed by a cluster of melanocytes (cells that make a substance called melanin, which gives color to skin and eyes). A mole may be dark or flesh-colored and may be raised from the skin. Most adults have between 10 and 40 common moles. These growths are usually found above the waist on areas exposed to the sun. Common moles are seldom found on the scalp, breast, or buttocks.

  • Common moles are growths on the skin that develop when pigment cells (melanocytes) grow in clusters; also called “common nevi” or “common acquired nevi”.
  • Appearance (using ABCDE rules)
    • Asymmetry: Usually symmetrical, round or oval.
    • Border: Usually have a distinct edge that separates it from the rest of the skin.
    • Shape: Usually round or oval.
    • Color: Usually have an even color; may be pink, tan, brown, black (in deeply pigmented individuals), or a color that is very close to a person’s normal skin tone.
    • Diameter: Usually less than 5 millimeters or about ¼ inch (smaller than a pencil eraser).
    • Evolving: Moles go through a life-cycle. Often they start as small freckle-like spots; gradually round up and form a bump; may lighten, become flesh-colored; become less elevated, flatten and eventually disappear. Life-cycle is a gradual process typically over many years. Some moles do not go through the entire life-cycle. Vast majority are stable and then disappear; rarely develop into melanoma (or cancer).

Mole Case 1: Stable normal mole

Over thirty years, this common mole remained the same size (about 6 millimeters), color, shape, and elevation (height) above the skin.

“ABCDE” features:

  • Asymmetry none
  • Border no irregularity
  • Color even
  • Diameter 6 millimeters
  • Evolving not changing

Clinical Diagnosis Common acquired nevus

M1M2

M3

This picture shows a large mole which is slightly bigger than a pencil eraser. The mole is a smooth light tan and pink bump with normal skin markings (lines) present on the entire surface. Unlike most moles, there are some hairs growing from the center and edges of the mole. All of the features of this mole are normal.

Recognizing the ABCDE Features

Common Moles

Dysplastic Nevi (DN)

Melanomas

A dysplastic nevus (DN) is a mole that may develop into malignant melanoma, a skin cancer starting in pigment cells. DN look different from common moles. DN are often larger than common moles (more than 5 millimeters) and have borders that are not easy to see. Their color is usually uneven and can range from pink to dark brown. Similar to common moles, parts of the DN may be raised above the skin surface. Some doctors use the term “atypical mole” to refer to DN.

  • The word “dysplastic” in its name refers to the look and pattern of cells in the nevi as they appear under a microscope.
  • Appearance (according to ABCDE rules)
    • Asymmetry: irregular shape
    • Border: indistinct (blurry) borders
    • Color: mixture of colors (tan, brown, and red or pink shades)
    • Diameter: greater than 5 millimeters or ¼ inch and have a flat part
    • Evolving: Majority are stable and then disappear; typically start to show these features when small and show all features by the time they reach the size of most moles; become larger than most moles and eventually disappear.
  • The “ABCDE” rules were made for identifying early melanoma, but can also be used to describe DN.
  • Clinicians use the number of DN to identify some individuals who are at increased risk of developing melanoma.
  • DN most likely found on sun-exposed areas, especially intermittently exposed, such as the back, but are also frequent on chest, arms and legs.
  • Approximately 10% of adult populations of northern European descent have at least one DN.
  • DN are frequently found in melanoma-prone families in North America, Europe, and Australia.
  • Melanomas may develop from DN.
  • Risk of melanoma is high for people who have a large number of DN; especially high for people with a family history of both DN and melanoma.

All Cases

Stable and Fading

Evolving Toward Melanoma

Examples

Case 1

case1

Over five years, this dysplastic nevus more than doubled in size, increasing from 3 millimeters to 10 millimeters wide. The color lightened from dark brown to very light in the center and reddened around the edges. The shape became more irregular and the borders became more indistinct. The mole was mostly flat but slightly raised in the center, and then became flatter. The mole was removed because it continued to change in color and the patient reported that it had been itching.

Case 2

case2

Over seventeen years, this DN increased in size to 8 millimeters and then decreased to 4 millimeters. The nevus went from reddish brown, partially flat with an irregular outline and indistinct borders to light tan and barely visible. The large papule (bump) in the center flattened.

Case 3

case3

Over twenty-six years, this DN grew from 14 millimeters wide to about 17 millimeters, and then decreased to 14 millimeters. The mole contained shades of tan to dark brown, red and pink, but as the mole became smaller it faded considerably to light pink. The lighter area in the right lower portion became a flesh-colored almost flat bump that was barely visible. The irregular scalloped-shaped outline filled in as the nevus grew into a more irregular shape. Later the mole started fading and became less irregular.

Case 4

case4

Over twenty-two years, these two mostly flat DN with irregular and indistinct outlines were stable and then regressed (faded). Both nevi were approximately 5 millimeters wide, and after several years, decreased to about 4 millimeters. Both nevi had slight mixtures of tan, brown, and red shades which became more uniform. Both nevi faded; the “B” nevus became flat and barely visible.

Case 5

case5

Over eight years, this DN increased in diameter from 4 millimeters to 7 millimeters. The mixture of tan to dark brown colors lightened and then darkened. The partially flat mole with indistinct borders had a slightly irregular outline which became more irregular. The mole was removed because it was getting darker (after having lightened) and was growing slightly larger.

Case 6

case6

Over four and a half years, this DN increased in diameter from 8 millimeters to 9 millimeters. The mole is partially flat and has an irregular shape and indistinct border. It contains a mixture of tan to dark brown colors which lightened and then darkened. The upper central and right side lightened considerably with an arc of very light color across the central portion. The shape became more irregular as the pigment receded (color faded). Then, much of the nevus darkened considerably and a new area of very dark brown color developed that extends inwardly at the 4 o’clock to 5 o’clock position. The mole was removed because it had changed in color over the past year.

Melanomas

Melanoma is a form of cancer that begins in melanocytes (cells that make the pigment melanin). It may begin in a mole (skin melanoma), but infrequently can also begin in other pigmented tissues, such as in the eye or the intestines. Melanoma is potentially dangerous because it can spread to nearby tissues and other parts of the body, such as the lung, liver, bone, or brain. The earlier that melanoma is detected and removed, the more likely that treatment will be successful.

  • A type of skin cancer that begins in melanocytes (cells that make the pigment melanin).
  • Early, thin melanomas are curable by minimal surgery alone.
  • Advanced melanomas may spread to others parts of the body; treatments such as additional surgery, chemotherapy, radiation therapy, immunotherapy and/or new types of treatment being tested in clinical trials may be used.
  • Appearance of early melanoma (according to ABCDE rules)
    • Asymmetry: Often irregular and asymmetrical (the shape of one half does not match the other half).
    • Border: Usually irregular. Edges often ragged, notched, or blurred in outline. The pigment may spread into the surrounding skin.
    • Color: Usually uneven in color. Shades of black, brown, and tan may be present. May also have areas of white, gray, red, pink, or blue.
    • Diameter: Change in size, usually an increase. Melanomas can be tiny, but most are larger than 6 millimeters wide (about ¼ inch wide). The surface may appear scaly.
    • Evolving: The mole has changed in size, shape, and/or color over the past few weeks or months. Development of a new mole that has any of the ABCDE features in an area of previously normal skin.
  • Melanomas can vary greatly in how they look. Many show all of the “ABCDE” features; however, some may show only one or two of those features.

Warning Signs

Guidelines for Individuals at Increased Risk of Melanoma

Examples

Case 1

case1a

A new and unusual mole developed on the arch of the foot in an area of skin that was previously normal. The mole steadily increased in size and irregularity. It was 10 millimeters in diameter, and larger and more irregular than any of the moles nearby. The mole was mostly flat with an irregular darker border, and a mixture of light brown to very dark brown with some lighter color in the center. It was removed because it displayed several of the warning signs for melanoma (changes in size, color, and shape).

Case 2

case2a

Over two years, this DN changed in size, color, shape and surface. It was predominantly flat with some tiny bumps in the center, and uniformly tan with a triangular shape and indistinct borders. The nevus then enlarged slightly to 6 millimeters by 5 millimeters and developed a new black slightly raised area and a fine scale on the surface. The mole was removed because it was changing in ways highly suspicious for melanoma.

Case 3

case3a

Two relatively small nevi were on the left abdomen at about 4 o’clock from the navel. Two years later, the mole closer to the navel had become very prominent and was circled as #60. (The smaller, more distant mole did not change.) The nevus was 8 millimeters in diameter. It had very indistinct borders, an irregular outline, and an asymmetric shape. The color varied from reddish dark brown to a very dark brown in the center portion. The lesion was removed because it was changing in ways very suspicious for melanoma (rapid growth, dark coloration, and asymmetric shape).

Case 4

case4a

The patient reported that the mole was new and had grown much larger during the previous six months. The mole is large (7 millimeters in diameter), and contains a mixture of reds and browns. The area of very dark brown color in the right central part is especially concerning in a patient with very fair skin. The borders are indistinct and quite irregular. The mole is larger, darker, and more irregular than any of the moles nearby. The mole was removed because it was new, and had changed in size, color, and shape during a very short period of time.

Case 5

case5a

The DN of interest (marked with an arrow and then circled as #30) was stable and appeared mainly unchanged for many years. The DN was partially flat and had an irregular outline and indistinct borders. It contained multiple shades of tan and brown. After a long period of relative stability, over two years, it increased in size to about 8 millimeters in diameter and darkened when most other moles had faded. The mole was removed five months after the picture shown in image 5 because it continued to darken over a short period of time.

Case 6

case6a

Over two and a half years, the small tan mole of interest developed into a DN which changed in size, color, shape and surface. It grew to about 8 millimeters in diameter. A very dark brown portion developed at top of the mole. Then most of the rest of the mole darkened considerably while the central area lightened greatly. It was darker than all of the other moles and quite irregular in shape. The mole was removed because it was changing in ways suspicious for melanoma.

Conclusion

While cancer of the skin is the most common form of cancer, it is also the most preventable.  One can reduce one’s risk of skin damage and skin cancer by seeking shade under an umbrella, tree, or other shelter before you need relief from the sun. Your best practice to protect your skin is to use sunscreen or wear protective clothing when you’re outside—even when you’re in the shade.  Prevention practices, regular self-exams and having one’s doctor exam any mole changes are the keys to living a skin cancer free life.

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

Sentry Attends CBP’s International Trade Meeting for Q2-2016

Several members of Sentry BioPharma Services’ compliance team voluntarily attended the Q2-2016 international trade meeting hosted by the U.S. Customs and Border Protection (CBP) on Wednesday, June 8, 2016 at the Indianapolis International Airport (IND).   James Moore presently serves as Port Director for Indianapolis, Indiana and opened the meeting by welcoming guests and reviewing the agenda.

The three main topics were discussed during the event:international

H.R. Bill 644 was passed by the 114th Congress on February 24, 2016.  Section 101 of the bill states, “This bill directs the U.S. Customs and Border Protection (CBP) to ensure that CBP partnership programs, such as the Customs-Trade Partnership Against Terrorism, provide trade benefits to importers, exporters, and certain other private sector entities that meet program requirements.”

Port Director Moore reinforced the CBP’s position by saying, the CBP port in Indianapolis, Indianapolis will make every effort to protect your brand and run as smoothly as possible.

Director Moore commented, “The U.S. Customs and Border Protection (CBP) enforces Intellectual Property Rights (IPR), most visibly by seizing products that infringe IPR such as trade­marks, copyrights, and patents. The theft of intel­lectual property and trade in fake goods threaten America’s economic vitality and national security, and the American people’s health and safety. Trade in these illicit goods funds criminal activities and orga­nized crime.

To protect both private industry and consumers, CBP has made IPR enforcement a priority trade issue. CBP has developed a multi-layered, strategic approach to IPR enforcement. In addition to seizing goods at U.S. borders, the strategy includes expanding the border through post-import audits of companies that have been caught bringing fake goods into the United States, collaboration with our trading part­ners, and partnering with industry and other federal agencies to enhance these efforts. CBP also issues civil fines and, where appropriate, refers cases to other law enforcement agencies for criminal investigation.

CBP uses technology to increase interdiction of fake goods, facilitate partnerships with industry, and enhance enforcement efforts through the sharing of information and intelligence. CBP is refining its risk modeling technology to more accurately identify sus­pected shipments of counterfeit and pirated goods for inspection.

Rights holders can use our web-based tool, e-Recordation, to record their trademarks and copyrights with CBP. Recordation makes information on protected rights available to CBP offices through­out the United States.

Our online trade violation reporting system, e-Allegations, makes it easier for the private sector to notify CBP of possible IPR violations and other trade violations.

In IPR audits, an innovative enforcement practice, CBP audits the business records of companies at high risk for importing counterfeits, issues penalties for infringing goods uncovered in the audits, and works with companies to improve their internal controls.

CBP is a partner at the interagency National Intellectual Property Rights Coordination Center (IPR Center). The IPR Center is designed to leverage the resources and authorities of partner agencies for criminal enforcement of IPR.”

Learn more about Customs and Border Protection and the Indianapolis port at https://www.cbp.gov/contact/ports/indianapolis.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import process, contact Sentry via email or by phone at 1-866-757-7400.

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 http://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.

Sentry Successfully Launches New Website

Sentry BioPharma Services is very excited to announce the launch of our newly designed website. The site’s homepage fully embraces Sentry’s brand while showcasing an elegant design while providing intuitive navigation. The newly streamlined menus highlight Sentry’s main services from vaccine distribution and GMP pharmaceutical storage to custom solutions such as biopharmaceutical labeling and packaging, controlled substance distribution and our foreign trade zone (FTZ) offering.

One of the most noticeable changes is the full integration our company logo, the Sentry molecule.  Each atom organizes Sentry’s services into five main categories:  temperature, packaging, distribution, clinical trials and custom solutions all of which are held together by Sentry’s stringent quality standards and GMP storage and drug distribution expertise. The ”Learn More” buttons under each service category allow customers easy access to relevant details regarding Sentry’s biorepository and drug distribution capabilities to include controlled substance importation and exportation, API storage, clinical trial labeling and packaging.

“With the changing ways in which information is viewed on the Internet, we wanted to provide a consistent experience across many types of devices.  Our new website is designed using “Responsive Web Design“.  This provides an optimal viewing experience across a wide range of devices, from computer monitors, to tablets and phones.” – Mike Wilson, Information Technology Manager

“As a biopharmaceutical leader, it’s important for us to make information regarding solutions, services and trends easily accessible for our current and prospective clients. We endeavor to provide our clients with the most accurate, up-to-date information and share our knowledge and expertise in the field of temperature- sensitive product management.” – Tim Mitchell, President

“Sentry is a biopharmaceutical contract service provider which maintains an exceptional quality record and provides superior customer service. Our new site is an extension of that service and we are excited to have a platform the effectively reflects our dedication to providing outstanding quality to our clients in every facet of our business and throughout the pharmaceutical supply chain.” – Jennifer Marcum, Chief Executive Officer

For more information about how Sentry can help optimize your solutions for biopharmaceutical product storage, drug distribution, clinical trial packaging and commercial fulfillment, contact Sentry via email or by phone at 1-866-757-7400.

Clinical Trial of Chikungunya Vaccine

Safeguarding the health of clinical trial participants and the progression of trial results demands strict adherence to protocols.  Sentry BioPharma Services specializes in vaccine drug product storage, labeling, kitting and effective distribution for clinical trials worldwide.   Please see the following article concerning the National Institute of Health’s (NIH) phase 2 clinical trial of Chikungunya Vaccine which is now open and seeking patients.

NIH-Sponsored Clinical Trial of Chikungunya Vaccine Opens

This digitally-colorized transmission electron micrograph (TEM) depicts numerous chikungunya virus particles, which are composed of a central dense core that is surrounded by a viral envelope.
Credit: CDC
TEM

An experimental vaccine to protect against the mosquito-borne illness chikungunya is being tested in a Phase 2 trial sponsored by the National Institutes of Health. Results from an initial trial of the vaccine, which was developed by scientists at the NIH National Institute of Allergy and Infectious Diseases (NIAID), were reported in 2014. In that study, all 25 vaccine recipients developed robust immune responses and no safety concerns were noted. The new trial is designed to enroll 400 healthy adult volunteers aged 18 to 60 years old at six sites in the Caribbean. It will continue to gather data on the candidate vaccine’s safety and ability to elicit immune responses, including antibodies.
The hallmark symptoms of chikungunya are severe joint pain accompanied by fever and headache. The pain typically eases after about a week but can persist for months or years in some cases. There are no specific treatments for chikungunya infection and no vaccine to prevent it.
Since its appearance in the Western Hemisphere in late 2013, cases of chikungunya have skyrocketed. So far in 2015, more than 621,000 suspected and confirmed cases have been reported throughout the Americas.
“The recent re-emergence of chikungunya virus in this hemisphere has rapidly become a significant health burden,” said NIAID Director Anthony S. Fauci, M.D.  “Our chikungunya vaccine development efforts are part of a broader research effort to prevent, diagnose, treat and ultimately control this painful illness, which can strike anyone unlucky enough to be bitten by an infected mosquito.”
The experimental vaccine, developed by investigators at NIAID’s Vaccine Research Center, uses virus-like particles (VLPs) instead of either inactivated or weakened whole virus. VLP vaccines can stimulate immune responses comparable to those resulting from naturally acquired immunity following infection and, because virus is not needed to produce VLP vaccines, they do not need to be prepared in high-level biocontainment facilities.
Eligible volunteers will be randomly assigned to enroll into one of two groups of 200 people each. Study participants will receive either two doses of the candidate vaccine spaced 28 days apart or two doses of an inactive placebo. Blood samples will be drawn at multiple time points following the injections to assess whether the candidate vaccine prompted the production of antibodies to chikungunya virus.

Additional details about the trial can be found at ClinicalTrials.gov  using the identifier NCT02562482.

References:

L-J Chang et al. Chikungunya virus-like particle vaccine elicits neutralizing antibodies in healthy adults in a phase I dose escalation clinical trial. The Lancet DOI: 10.1016/S0140-6736(14)61185-5 (2014).

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

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.

Strict adherence to clinical material management protocols, in combination with proven GMP storage, secondary packaging, distribution, and shipping expertise allow Sentry to provide a variety of flexible services to our clinical trial outsourcing clients.

For more information about how Sentry 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.