Tag Archives: biological products

Sentry team to participate in the 2019 Susan G. Komen Race for the Cure ®

This Saturday, April 27th, 2019 several Sentry BioPharma Services team members will be proudly participating in the 2019 Komen Central Indiana Race for the Cure ®. 

Over the years this event has raised more than $2 billion dollars to help fund research, education, screening and treatment.  This event is unique in that 100% of the net proceeds are invested in the Komen mission.  25% of all funds go towards research to learn about the biology of breast cancer, advance new screening technologies, develop better treatment protocols and combat metastatic disease.  The remaining 75% is invested in locally through a community grants program.  Last year $697,047 was invested in 9 local breast health programs and provide 40,000 services within a 41-county service area in Indiana.

Our team realizes that fundraising is critical to helping breast cancer patients living right here in central Indiana.  These sobering statistics from the Central Indiana Susan G. Komen website help to bring that need even more into focus.

  • 1 in 8 women in the U.S. will be diagnosed with breast cancer in her lifetime.
  • Every 19 seconds, somewhere in the world, a case of breast cancer is diagnosed.
  • Every 60 seconds, somewhere in the world, someone dies from breast cancer.
  • Every 13 minutes, one woman in the U.S will lose her life to breast cancer.
  • At the current rate, 13 million breast cancer deaths will occur around the world in the next 25 years.

Sentry is determined to take action and this event is our chance to support the Komen organization in its efforts to end breast cancer forever. 

For more info on how you can help please visit the Susan G. Komen® website.

FDA Announces Meeting on Implementing DSCSA’s Product Identification Requirements

Sentry BioPharma Services continues to strengthen its leadership position in providing high quality and secure pharmaceutical supply chain services to pharmaceutical clients and companies utilizing biotechnology to manufacture biological products and vaccines.  Therefore, we would like to draw attention to an upcoming public meeting concerning the Drug Supply Chain Security Act (DSCSA) hosted by the FDA.

fda-dscsaThe Food & Drug Administration (FDA) will be holding a public meeting to provide members of the pharmaceutical distribution supply chain and interested stakeholders an opportunity to discuss with FDA the implementation of the Drug Supply Chain Security Act’s (DSCSA’s) product identification requirements. To be held on October 14, 2016, from 9:00 a.m. to 4:00 p.m. at FDA’s White Oak Campus in Silver Spring, MD, the meeting, “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act,” will include presentations from the public and follow-up questions from an FDA panel. The objective of the meeting is to discuss the pharmaceutical supply chain’s progress toward implementing the DSCSA’s product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and identification.

More Background on the Drug Supply Chain Security Act (DSCSA)

Title II of the Drug Quality and Security Act of 2013

The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will:

  • enable verification of the legitimacy of the drug product identifier down to the package level;
  • enhance detection and notification of illegitimate products in the drug supply chain; and
  • facilitate more efficient recalls of drug products.

Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years.

Among key provisions implemented over the next 10 years are requirements for:

  • Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
  • Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
  • Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
  • Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
  • Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
  • Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

The law requires FDA to develop standards, guidance documents, and pilot programs and to conduct public meetings, in addition to other efforts necessary to support efficient and effective implementation. FDA is developing a schedule for implementing the law’s requirements.

This system will enhance the U.S. Food and Drug Administration’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Failure to comply with the requirements of the law can result in penalties.

The development of the system will be phased in with new requirements over a 10-year period. These requirements will include providing product and transaction information at each sale with lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.

The FDA is soliciting either electronic or written comments related to this public meeting by November 14, 2016. To register or request to make a presentation, visit the public meeting web page.

For more information about how Sentry’s secure drug supply chain management programs can ensure drug product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.

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 https://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, https://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 https://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: https://www.cancer.gov/types/skin & https://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 Strengthens the Pharmaceutical Supply Chain

Biological drugs are generally more delicate and sensitive to temperature than their
pharmaceutical counterparts, thus introducing risks into the global biopharma supply chain.
Longer transit times, extreme climate change between origination and destination, and shipping delays all increase the risk profile during transport.  Product compromise due to temperature fluctuation can cause millions of dollars in revenue loss and delay delivery of drugs and therapeutics to patients.  Sentry Biopharma Services strengthens the pharmaceutical supply chain by helping clients manage these risks.

MATURITY OF PHARMACEUTICAL COLD CHAIN MANAGEMENT

15 years ago cold chain management was still a buzz phrase that only a few companies could actually deliver.  However, the unique transportation challenges of biopharma products have driven the need to control temperature variability throughout the drug supply chain which has transformed pharmaceutical cold chain management into a burgeoning industry.  Specialized providers like Sentry BioPharma Services now offer dedicated services designed to preserve the integrity of biological products throughout all phases of the pharmaceutical supply chain. Large and small biotech organizations increasingly turn to these specialized providers in a shift from the traditional in-house pharmaceutical logistics model to an outsourced one.

SELECTING A PHARMACEUTICAL SUPPLY CHAIN PARTNER

Although outsourcing to a pharmaceutical supply chain provider can provide many benefits, not every potential partner has the capability to provide services on a global scale. A qualified cold chain logistics expert must be experienced and compliant in all facets of biopharma cold chain management.  This includes domestic and international shipping, drug product handling and tracking, GMP storage and international drug distribution. The provider must have the experience, systems and processes in place to handle the diverse and changing needs of the global biopharmaceutical industry. Criteria that biopharma manufacturers should consider when evaluating potential partners include:

  1. A robust quality systemglobe
  2. Specialized GMP storage facilities and equipment
  3. A reputation for technological innovation
  4. Compliance with global pharmaceutical cold chain regulations
  5. An efficient and reliable biopharma and logistics network
  6. Anti-counterfeiting capabilities
  7. Impeccable customer service record

PHARMACEUTICAL COLD CHAIN REGULATIONS & BEST PRACTICES

As pharmaceutical cold chain management has become a more critical component in the global biopharmaceutical supply chain, regulatory agencies and industry associations have been launched solely to develop standards for compliance in this market.  Achieving regulatory compliance was a much simpler task in traditional supply chain models of the past. Now, due to an increasingly complex set of social, scientific and political pressures, industry mandates and international regulations have become significantly more stringent. Each country has its own body of rules and guidelines governing the shipment and handling of pharmaceutical and biological products. A qualified pharmaceutical cold chain management and 3PL partner must demonstrate compliance with international guidelines.

In addition to mandates prescribed by external regulatory agencies, the industry has begun to develop its own body of industry-accepted standards for biopharmaceutical distribution and handling. Several prominent groups have been formed throughout the world to discuss regional challenges and issues; collaborate on problem-solving; examine emerging trends; and define industry best practices. A pharmaceutical cold chain management partner should be familiar with the standards being developed by leading international pharmaceutical discussion groups.

REPUTATION FOR PRISTINE QUALITY AND IMPECCABLE CUSTOMER SERVICE

A GMP-compliant third-party logistic (3PL) partner must be committed to excellence in quality control and customer service.  As an extension of the drug or vaccine manufacturer’s business, the pharmaceutical 3PL provider must operate as a vested stakeholder to protect product integrity as well as the manufacturer’s business viability and reputation in the marketplace. Measures of excellence in the pharmaceutical cold chain include:

  • A corporate culture of accountability and commitment to the mission
  • Knowledge of best practices for GMP storage, global drug distribution and vaccine management
  • Independent quality assurance personnel, processes and evaluations
  • Careful biological product handling and temperature-sensitive product shipping
  • A uniformed process for continuously improving quality, operations and customer service
  • A singular focus that allows the contract service provider to be an expert

SPECIALIZED GMP STORAGE FACILITIES

At various points in the pharmaceutical supply chain, active pharmaceutical ingredients (APIs), excipients, components, intermediates and finished pharmaceutical products may need to be stored for varying lengths of time, from a few days to a several months.  Short-term or long-term GMP storage facilities might be needed to temporarily house: inventory overflow from a primary GMP warehouse; primary or secondary packaging components that are awaiting assembly; finished drug products that are awaiting international drug distribution; and/or inbound pharmaceutical product shipments that are clearing U.S. Customs. While several pharmaceutical small molecule formulations remain stable at ambient temperature conditions, many biologic products must be maintained within tighter temperature tolerances in refrigerated (+2°C to +8°C), frozen (-10°C to -20°C) and ultra-low storage (-70 to -90°C). Traditional pharmaceutical supply chain facilities are not always designed to accommodate these conditions.

In these situations, a cold chain logistics partner can provide immediate access to a state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It must offer: validated, temperature controlled storage and temperature-monitoring equipment; redundant power, cooling and environmental monitoring systems; redundant data storage capabilities; and sophisticated data security systems.

For more information about how Sentry’s cold chain management programs can ensure biological product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.

WHO’s World Blood Donor Day 2016: Blood Connects Us All

The World Health Organization (WHO) has declared Tuesday, June 14, 2016 as World Blood Donor Day.  The theme is “Blood Connects Us All”.

shutterstock_419643730  wallpaper-girl

In May 2005, at the Fifty-Eighth Session of the World Health Assembly, 192 Member States of the WHO adopted resolution WHA58.13 to establish World Blood Donor Day as an annual event, to be celebrated each year on 14 June.

According to the WHO, “The safest blood donors are voluntary, non-remunerated blood donors from low-risk populations. In the key global fact and figures of 2011 (Fact sheet number 279), in 62 countries, national blood supplies are based on 100% or almost 100% (more than 99.9%) voluntary unpaid blood donations. Forty countries collect less than 25% of their blood supplies from voluntary unpaid blood donors. The primary goal of the WHO is for all countries to obtain all blood supplies from voluntary unpaid donors by 2020 in accordance with World Health Assembly resolution 28.72, which was adopted in 1975.”

Ms. Jennifer Marcum, Sentry BioPharma Services’ CEO, acknowledges the significance of the international event by scheduling an appointment to donate whole blood at the American Red Cross on June 17, 2016.  Ms. Marcum offers, “The National Institutes of Health (NIH) says approximately five million Americans require blood transfusions every year.  The need is continuous.  To this day blood cannot be manufactured on an industrial scale.  There is some research being done at The University of Edinburgh to create blood type O red blood cells using pluripotent stem cells, but a true biological blood substitute has not been commercially approved by the FDA.   So, in the absence of a safe and effective blood surrogate, we donate.  A blood donation not only forges a bond between human beings, but it also creates links to our local and global community.  It is the one common denominator among us all.”

Ms. Marcum continues, “Protecting the integrity of the entire blood cold chain should be an integral part of the global blood distribution system.”  The WHO says, “Deviations from specified temperature ranges and conditions during storage and transportation of blood and blood products can seriously affect the viability of the constituents of blood, thus leading to reduced clinical benefits. It can also increase the risk of bacterial proliferation in blood components during storage and may cause potentially life-threatening transfusion reactions, such as septic shock and even death.”

The WHO notes, “A break in the blood cold chain leads to wastage and discard of unsuitable blood units, which may adversely affect the supply of blood and blood products for transfusion. An effective blood cold chain is essential for the countries to implement strategies to expand safe blood transfusion services to cover wider geographic areas and achieve universal access to safe blood transfusion for all patients who need transfusion.”

Sentry BioPharma Services offers biological product storage to pharmaceutical companies, hospitals and organizations with need for validated refrigerated (+2°C to +8°C) storage and temperature-sensitive product shipping services.  For more information about how Sentry’s GMP warehouse can help protect the integrity of the blood cold chain and biological products in general, 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 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.

Proper Blood Storage and Distribution Helps the Shortage

Did you know that blood cannot be manufactured?  In this age of advanced pharmaceutical and biological product development, that comes as quite a surprise to many; but it is true.  The American Red Cross faces blood shortages.

According to the American Red Cross website:

  • One pint of blood can save three lives.
  • Every two seconds someone in the U.S. needs blood.
  • A single car accident victim can require as many as 100 pints of blood.
  • Approximately 36,000 units of red blood cells are needed every day in the U.S.
  • Nearly 7,000 units of platelets and 10,000 units of plasma are needed daily in the U.S.
  • Nearly 21 million blood components are transfused each year in the U.S.
  • The average red blood cell (RBC) transfusion is approximately three pints.
  • More than 1.68 million people are expected to be diagnosed with cancer in 2016. Many of them will need blood, sometimes daily, during their chemotherapy treatment.

Ms. Jennifer Marcum, Sentry BioPharma Services’ CEO, acknowledges the need by stating, ” Blood can only come from generous donors.  There are approximately 7 million blood donors in the U.S.  A healthy donor may donate red blood cells every 56 days.  Most people don’t think they will need blood, but there is a tremendous continual need.”

Ms. Marcum continues, “Proper blood storage and temperature-sensitive product shipping is of great importance to the blood supply chain.  After donated whole blood passes processing and testing, red blood cells are stored in refrigerators at 6°C for up to 42 days.  Blood used in an emergency must be readily available on the shelves before the event occurs.  Effective cold chain management protects the biological product’s integrity.”

Sentry BioPharma Services offer biological product storage to pharmaceutical companies, hospitals and organizations with need for validated refrigerated (+2°C to +8°C) storage and temperature-sensitive product shipping services.  For more information about how Sentry’s GMP warehouse can help protect the integrity of the blood supply chain and biological products in general, contact Sentry via email or by phone at 1-866-757-7400.

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Sentry Helps the DEA to Raise Public Awareness about the 11th National Prescription Drug Take-Back Day Initiative

As part of the U.S. Drug Enforcement Administration’s (DEA’s) National Prescription Drug Take-Back Day Initiative (NTBI), people will be able to dispose of expired, unwanted or unused prescription drugs on Saturday, April 30, 2016 from 10:00 a.m. to 2:00 p.m. at numerous collection sites around the U.S.

“The DEA’s program is designed to focus national attention on the proper disposal of prescription drugs and controlled substances,” said Ms. Jennifer Marcum, Sentry BioPharma Services’ chief executive officer.  Marcum continued, “During the event, people can bring their unwanted prescription pharmaceuticals and over-the-counter (OTC) medications to a participating drop-off site for proper drug disposal by law enforcement authorities with no questions asked.  The service is not only free and anonymous, but also an ideal way to preserve the environment from unwanted pharmaceutical contamination.  This is a terrific opportunity for those who missed the previous events, or who have subsequently accumulated unwanted, unused prescription drugs, to safely dispose of those medications.”

Americans that participated in the DEA’s tenth annual National Prescription Drug Take-Back Day on September 26, 2015, turned in more than 350 tons of unwanted or expired medications for safe and proper drug disposal at more than 5,000 take-back collections sites available in all 50 states and U.S. territories.  When the results of the ten prior Take-Back Days are combined, the DEA, and its state, local, and tribal law-enforcement and community partners have removed 5,525,021 pounds of drugs from circulation.

“The numbers are shocking—approximately 46,000 Americans die each year from drug-related deaths.  More than half of those are from heroin and prescription opioids,” said Acting DEA Administrator Chuck Rosenberg.  “With four out of five new heroin users starting with prescription medications, I know our take-back program makes a real difference.”  The NTBI addresses a crucial public safety and public health issue.  According to the 2014 National Survey on Drug Use and Health, 6.5 million Americans abused controlled prescription drugs.  That same study showed that a majority of abused prescription drugs are obtained from family and friends, including from the home medicine cabinet.  The DEA’s NTBI events are also a significant piece of the White House Office of National Drug Control Policy’s prescription drug abuse prevention strategy.

Sentry BioPharma Services will also continue its support of the DEA’s efforts by helping to raise public awareness of this important initiative.  For more information about the drug disposal program, general public inquiries can be made by calling the DEA toll free at: 1-800-882-9539.

Sentry BioPharma Services’ Employees Make a Declaration to Fight Breast Cancer

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

While certain factors affect prognosis (chance of recovery) and treatment options, research on the biology of cancer is necessary to answer the most basic questions about what is and what is not normal.  The outcomes of basic research in cancer biology are often uncertain, which makes oncology funding from profit-driven sources a risky undertaking.

On December 19, 2015 the National Institutes of Health (NIH) received a nearly $2 billion increase in funding for FY16 by way of approval of the Omnibus Appropriations Bill.  The bill provided for continued funding for the Department of Defense’s Breast Cancer Research Program.   Despite the increase, the National Cancer Institute’s (NCI’s) budget falls $238 million short of the $5.5 billion the institute requested for the fiscal year 2017 budget.  Federal funding helps but is simply not enough to develop the arsenal of tools and strategies needed for sharing and communicating about oncology research results.  More help is needed to fight this battle!

Amber M. Reed, Sentry BioPharma Services’ Warehouse Supervisor, declares her commitment to be a “Pink Warrior” by participating in the 25th Anniversary Komen Central Indiana Race for the Cure® on Saturday, April 16, 2016 commencing at the historic Military Park in downtown Indianapolis, Indiana.  Ms. Reed says, “I have lost my grandmother and great-grandmother to breast cancer. My grandmother was like a mother to me. Since her passing in 2006 I have pledged to do whatever I can to help in the research to find a cure for this awful disease. I have participated in either Relay for Life® or Race for the Cure® every year since. I love the fact that I work for a company that also shares my dedication in helping to find a cure for cancer. Together I believe we can make cancer a thing of the past.”

According to the race sponsor’s website, “the Susan G. Komen Race for the Cure® Series is the world’s largest and most successful education and fundraising event for breast cancer ever created.  The event raises significant funds and awareness for the breast cancer movement, celebrates breast cancer survivorship and honors those who have lost their battle with the disease.

This race is unique in the fact that 100% of the net proceeds are allocated to our mission. Seventy-five percent of the net income stays in our community to help fund local programs offering breast health education and breast cancer screening and treatment. The remaining 25% of the net income supports the Susan G. Komen® Grants Program.

Sentry BioPharma Services supports Ms. Reed’s efforts and commits to helping raise public awareness of this important cause.  The company pledges on-going help to vaccine manufacturers by offering reliable GMP warehousing and drug distribution services to eliminate variables in oncology clinical trials in hope of one day eradicating this deadly disease.

 

Warehouse Coordinator Chris Harris and Chief Operations Officer Dwayne Marcum

Warehouse Coordinator Chris Harris and Chief Operations Officer Dwayne Marcum

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Left to right: Warehouse Supervisor Amber Reed, Inside Sales Representative Jasmine Enlow, Chief Executive Officer Jennifer Marcum, Warehouse Coordinator Chris Harris

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Sentry BioPharma Services Confirms Attendance at BIO 2016 in San Francisco, California

Sentry BioPharma Services returns to the birthplace of biotech, San Francisco, California in June 2016. This marks Sentry’s 11th consecutive year attending the Biotechnology Innovation Organization’s (BIO’s) International Convention. Sentry leadership selects this conference annually primarily because it attracts over 15,000 biotechnology and pharma representatives from all over the world who unite for one week in the U.S. The topics discussed during this event and in the exhibit hall cover a wide spectrum of relevant life science topics as well as areas like drug discovery, GMP compliance, bio-manufacturing, genomics and cell therapy.

“BIO One-on-One Partnering™ serves as a cost effective way to interact globally without the extensive international traveling requirements” states Sentry’s President, Tim J. Mitchell. “There are 3,100+ companies participating in these meetings. We find the online scheduling tool to be exceptionally user-friendly and effective which allows us to interact with a vast number of prospective pharmaceutical partners and companies developing biological products. We efficiently present information concerning our customized pharmaceutical labeling, packaging and kitting processes. We also entertain numerous questions concerning Sentry’s international drug distribution services in the pavilions and/or at booths in the exhibit hall, all within the allotted 25-minute time frame. It’s amazing what can be accomplished in 3 1/2 days at BIO!”

The BIO One-in-One Partnering™ feature allows Sentry’s leaders to network and discover new opportunities and potential partnerships. Please meet us at the 2016 BIO International Convention in San Francisco, USA.

Contact Sentry via email or by phone at 1-866-757-7400.

https://convention.bio.org/2016/