Tag Archives: GMP pharmaceutical storage

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

vaccine storageSentry’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.

2016-2017 Flu Season; Answers to Common FAQs

Sentry BioPharma Services provides vaccine product management services to a wide group of clients from U.S. Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.  This is Sentry’s second article concerning influenza this season with an emphasis on preventing the flu within the general population of the United States.  Sentry acknowledges the Centers for Disease Control and Prevention (CDC) and its continued efforts in disseminating important information to benefit the health and well-being of all Americans.

New Flu Information for 2016-2017

flu season and vaccineGetting an annual flu vaccine is the first and best way to protect yourself and your family from
the flu. Flu vaccination can reduce flu illnesses, doctors’ visits, and missed work and school due to flu, as well as prevent flu-related hospitalizations. The more people who get vaccinated, the more people will be protected from flu, including older people, very young children, pregnant women and people with certain health conditions who are more vulnerable to serious flu complications. This page summarizes information for the 2016-2017 flu season.

What’s new this flu season?

A few things are new this season:

  • Only injectable flu shots are recommended for use this season.
  • Flu vaccines have been updated to better match circulating viruses.
  • There will be some new vaccines on the market this season.
  • The recommendations for vaccination of people with egg allergies have changed.

What flu vaccines are recommended this season?

This season, only injectable flu vaccines (flu shots) should be used. Some flu shots protect against three flu viruses and some protect against four flu viruses.

Options this season include:

  • Standard dose flu shots. Most are given into the muscle (usually with a needle, but one can be given to some people with a jet injector). One is given into the skin.
  • A high-dose shot for older people.
  • A shot made with adjuvant for older people.
  • A shot made with virus grown in cell culture.
  • A shot made using a vaccine production technology (recombinant vaccine) that does not require the use of flu virus.

Live attenuated influenza vaccine (LAIV) – or the nasal spray vaccine – is not recommended for use during the 2016-2017 season because of concerns about its effectiveness.

Table 1 below illustrates all the influenza vaccines that are FDA-approved for use in the United States during the 2016-2017 season.  Also, Table 2 identifies Contraindications and precautions to the use of influenza vaccines — United States, for the 2016–17 influenza season:

TABLE 1. Influenza vaccines — United States, 2016–17 influenza season

Trade name Manufacturer Presentation Age indication Mercury (from thimerosal)
µg/0.5 mL
Latex Route
Inactivated influenza vaccine, quadrivalent (IIV4), standard dose
Fluarix Quadrivalent GlaxoSmithKline 0.5 mL single-dose prefilled syringe ≥3 yrs NR No IM§
Flulaval Quadrivalent ID Biomedical Corp. of Quebec (distributed by GlaxoSmithKline) 0.5 mL single-dose prefilled syringe ≥3 yrs NR No IM
5.0 mL multi-dose vial ≥3 yrs <25 No IM
Fluzone Quadrivalent Sanofi Pasteur 0.25 mL single-dose prefilled syringe 6–35 mos NR No IM
0.5 mL single-dose prefilled syringe ≥36 mos NR No IM
0.5 mL single-dose vial ≥36 mos NR No IM
5.0 mL multidose vial ≥6 mos 25 No IM
Fluzone Intradermal
Quadrivalent
Sanofi Pasteur 0.1 mL single-dose prefilled microinjection system 18 through 64 yrs NR No ID**
Inactivated influenza vaccine, quadrivalent, cell culture-based (ccIIV4), standard dose
Flucelvax Quadrivalent Seqirus 0.5 mL single-dose prefilled syringe ≥4 yrs NR No IM
Inactivated Influenza Vaccine, trivalent (IIV3), standard dose
Afluria Seqirus 0.5 mL single-dose prefilled syringe ≥9 yrs†† NR No IM
5.0 mL multi-dose vial ≥9 yrs††
(needle and syringe)
18 through 64 years
(jet injector)
24.5 No IM
Fluvirin Seqirus 0.5 mL single-dose prefilled syringe ≥4 yrs ≤1 Yes§§ IM
5.0 mL multi-dose vial ≥4 yrs 25 No IM
Adjuvanted Inactivated Influenza Vaccine, trivalent (aIIV3), standard dose
Fluad Seqirus 0.5 mL single-dose prefilled syringe ≥65 yrs NR Yes§§ IM
Inactivated Influenza Vaccine, trivalent (IIV3), High Dose¶¶
Fluzone High-Dose Sanofi Pasteur 0.5 mL single-dose prefilled syringe ≥65 yrs NR No IM
Recombinant Influenza Vaccine, trivalent (RIV3)***
FluBlok Protein Sciences 0.5 mL single-dose vial ≥18 yrs NR No IM
Live Attenuated Influenza Vaccine, quadrivalent (LAIV4)†††
FluMist Quadrivalent MedImmune 0.2 mL single-dose prefilled
intranasal sprayer
2 through 49 yrs NR No NAS

Abbreviations: ACIP = Advisory Committee on Immunization Practices; ID = intradermal; IM = intramuscular; NAS = intranasal; NR = not relevant (does not contain thimerosal).
*Immunization providers should check Food and Drug Administration–approved prescribing information for 2016–17 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm . Availability of specific products and presentations might change and differ from what is described in this table.
Standard dose intramuscular IIVs contain 15 µg of each vaccine HA antigen (45 µg total for trivalents and 60 µg total for quadrivalents) per 0.5mL dose.
§For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration may be found in the ACIP General Recommendations on Immunization, available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm.
Quadrivalent inactivated influenza vaccine, intradermal: a 0.1-mL dose contains 9 µg of each vaccine HA antigen (36μg total).
**The preferred injection site is over the deltoid muscle. Fluzone Intradermal Quadrivalent is administered using the delivery system included with the vaccine.
††Age indication per package insert is ≥5 years; however, ACIP recommends that Afluria not be used in children aged 6 months through 8 years because of increased risk for febrile reactions noted in this age group with Seqirus’ 2010 Southern Hemisphere IIV3. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5 through 8 years who has a medical condition that increases the child’s risk for influenza complications, Afluria can be used; however, providers should discuss with the parents or caregivers the benefits and risks of influenza vaccination with Afluria before administering this vaccine. Afluria may be used in persons aged ≥9 years. Afluria is licensed for administration by jet injector for persons aged 18 through 64 years only.
§§Syringe tip cap might contain natural rubber latex.
¶¶High-dose IIV3 contains 60 μg of each vaccine antigen (180 μg total) per 0.5mL dose.
***RIV3 contains 45 μg of each vaccine HA antigen (135 μg total) per 0.5mL dose.
†††ACIP recommends that Flumist (LAIV4) not be used during the 2016–17 season.

TABLE 2. Contraindications and precautions to the use of influenza vaccines — United States, 2016–17 influenza season*

Vaccine Contraindications Precautions
IIV History of severe allergic reaction to any component of the vaccine or after previous dose of any influenza vaccine Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
RIV History of severe allergic reaction to any component of the vaccine Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
LAIV For the 2016–17 season, ACIP recommends that LAIV not be used. Content below is provided for information.
History of severe allergic reaction to any component of the vaccine† or after a previous dose of any influenza vaccine
Concomitant aspirin or salicylate-containing therapy in children and adolescents
Children aged 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a health care provider has told them during the preceding 12 months that their child had wheezing or asthma or whose medical record indicates a wheezing episode has occurred during the preceding 12 months
Children and adults who have immunosuppression (including immunosuppression caused by medications or by HIV)
Close contacts and caregivers of severely immunosuppressed persons who require a protected environment
Pregnancy
Receipt of influenza antiviral medication within the previous 48 hours
Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
Asthma in persons aged ≥5 years
Other underlying medical conditions that might predispose to complications after wild-type influenza infection (e.g., chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)

Abbreviations: ACIP = Advisory Committee on Immunization Practices; IIV = Inactivated Influenza Vaccine; LAIV = Live-Attenuated Influenza Vaccine; RIV = Recombinant Influenza Vaccine.
* Immunization providers should check Food and Drug Administration–approved prescribing information for 2016–17 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, and precautions. Package inserts for US-licensed vaccines are available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm .
History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of IIV and LAIV. However, ACIP recommends that any licensed, recommended, and appropriate IIV or RIV may be administered to persons with egg allergy of any severity (see Influenza Vaccination of Persons with a History of Egg Allergy).

What viruses do 2016-2017 flu vaccines protect against?

There are many flu viruses and they are constantly changing. The composition of U.S. flu vaccines is reviewed annually and updated to match circulating flu viruses. Flu vaccines protect against the three or four viruses that research suggests will be most common. For 2016-2017, three-component vaccines are recommended to contain:

  • A/California/7/2009 (H1N1) pdm09-like virus,
  • A/Hong Kong/4801/2014 (H3N2)-like virus and a
  • B/Brisbane/60/2008-like virus (B/Victoria lineage).

Four component vaccines are recommended to include the same three viruses above, plus an additional B virus called B/Phuket/3073/2013-like virus (B/Yamagata lineage).

When and how often should I get vaccinated?

Everyone 6 months and older should get a flu vaccine every year by the end of October, if possible. However, getting vaccinated later is OK. Vaccination should continue throughout the flu season, even in January or later. Some children who have received flu vaccine previously and children who have only received one dose in their lifetime, may need two doses of flu vaccine. A health care provider can advise on how many doses a child should get.

Can I get a flu vaccine if I am allergic to eggs?

The recommendations for people with egg allergies have been updated for this season.

  • People who have experienced only hives after exposure to egg can get any licensed flu vaccine that is otherwise appropriate for their age and health.
  • People who have symptoms other than hives after exposure to eggs, such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who have needed epinephrine or another emergency medical intervention, also can get any licensed flu vaccine that is otherwise appropriate for their age and health, but the vaccine should be given in a medical setting and be supervised by a health care provider who is able to recognize and manage severe allergic conditions. (Settings include hospitals, clinics, health departments, and physician offices). People with egg allergies no longer have to wait 30 minutes after receiving their vaccine.

Flu Activity

What sort of flu season is expected this year?

It’s not possible to predict what this flu season will be like. While flu spreads every year, the timing, severity, and length of the season varies from one year to another.

Will new flu viruses circulate this season?

Flu viruses are constantly changing so it’s not unusual for new flu viruses to appear each year. For more information about how flu viruses change, visit How the Flu Virus Can Change.

Will the United States have a flu epidemic?

The United States experiences epidemics of seasonal flu each year. This time of year is called “flu season.” In the United States, flu viruses are most common during the fall and winter months. Influenza activity often begins to increase in October and November. Most of the time flu activity peaks between December and March and can last as late as May. CDC monitors certain key flu indicators (for example, outpatient visits of influenza-like illness (ILI), the results of laboratory testing and flu hospitalization and deaths). When these indicators rise and remain elevated for a number of consecutive weeks, flu season is said to have begun. Usually ILI increases first, followed by an increase in flu-associated hospitalizations, which is then followed by increases in flu-associated deaths.

For the most current influenza surveillance information, please see FluView at Weekly U.S. Influenza Surveillance Report.

When will flu activity begin and when will it peak?

The timing of flu is very unpredictable and can vary in different parts of the country and from season to season. Seasonal flu viruses can be detected year-round, however, seasonal flu activity can begin as early as October and continue to occur as late as May. Flu activity most commonly peaks in the United States between December and March.

How many people die from flu each year?

CDC does not count how many people die from flu each year. Unlike flu deaths in children, flu deaths in adults are not nationally reportable. However, CDC uses mortality data collected by the National Center for Health Statistics to monitor relative levels of flu-associated deaths. This system tracks the proportion of death certificates processed that list pneumonia or influenza as the underlying or contributing cause of death of the total deaths reported. This system provides an overall indication of whether flu-associated deaths are elevated, but does not provide an exact number of how many people died from flu. For more information, see Overview of Influenza Surveillance in the United States, “Mortality Surveillance.”

CDC also uses modeling studies to estimate numbers of flu-related deaths, but these studies apply only to past seasons and are not done each year. For more information, see Estimating Seasonal Influenza-Associated Deaths in the United States.

Why is it difficult to know how many people die from flu?

There are several factors that make it difficult to determine accurate numbers of deaths caused by flu regardless of reporting. Some of the challenges in counting influenza-associated deaths include the following: the sheer volume of deaths to be counted; the lack of testing (not everyone that dies with an influenza-like illness is tested for influenza); and the different coding of deaths (influenza-associated deaths are often a result of complications secondary to underlying medical problems, and this may be difficult to sort out). For more information, see Estimating Seasonal Influenza-Associated Deaths in the United States: CDC Study Confirms Variability of Flu.

Protective Actions

What should I do to protect myself from flu this season?

CDC recommends a yearly flu vaccine for everyone 6 months of age and older as the first and most important step in protecting against this serious disease.

In addition to getting a seasonal flu vaccine, you can take everyday preventive actions like staying away from sick people and washing your hands to reduce the spread of germs. If you are sick with flu, stay home from work or school to prevent spreading flu to others. In addition, there are prescription medications called antiviral drugs that can be used to treat influenza illness. Visit What you Should Know About Flu Antiviral Drugs for more information.

What should I do to protect my loved ones from flu this season?

Encourage your loved ones to get vaccinated. Vaccination is especially important for people at high risk for developing flu-related complications, and their close contacts. Also, if you have a loved one who is at high risk of flu complications and they develop flu symptoms, encourage them to get a medical evaluation for possible treatment with influenza antiviral drugs. CDC recommends that people who are at high risk for serious flu complications who get flu symptoms during flu season be treated with influenza antiviral drugs as quickly as possible. People who are not at high risk for serious flu complications may also be treated with influenza antiviral drugs, especially if treatment can begin within 48 hours.

Some children 6 months through 8 years of age will require two doses of flu vaccine for adequate protection from flu. Children in this age group who are getting vaccinated for the first time will need two doses of flu vaccine, spaced at least 28 days apart. Some children who have received flu vaccine previously and children who have only received one dose in their lifetime also may need two doses. Your child’s doctor or other health care professional can tell you if your child needs two doses. Visit Children, the Flu, and the Flu Vaccine for more information.

Children younger than 6 months are at higher risk of serious flu complications, but are too young to get a flu vaccine. Because of this, safeguarding them from flu is especially important. If you live with or care for an infant younger than 6 months of age, you should get a flu vaccine to help protect them from flu. See Advice for Caregivers of Young Children for more information. Also, studies have shown that getting the flu vaccine during pregnancy can protect the baby after birth for several months.

In addition to getting vaccinated, you and your loved ones can take everyday preventive actions like staying away from sick people and washing your hands to reduce the spread of germs. If you are sick with flu, stay home from work or school to prevent spreading flu to others.

Vaccine and Vaccination

How much flu vaccine will be available this season?

Flu vaccine is produced by private manufacturers, so supply depends on manufacturers. For the 2016-2017 season, manufacturers projected they would provide between 157 million and 168 million doses of injectable vaccine for the U.S. market. (Projections may change as the season progresses.)

Will live attenuated intranasal influenza vaccine (LAIV) be available this season even though it is not recommended for use?

FluMist Quadrivalent is still an FDA-licensed product. As such, there may be some supply of FluMist Quadrivalent on the U.S. market during the 2016-2017 season. It is important for clinicians and the public to be aware that because of concerns about this vaccine’s effectiveness, CDC recommends that this vaccine not be used during the 2016-2017 influenza season.

Where can I find information about vaccine supply?

Information about flu vaccine supply is available at Seasonal Influenza Vaccine & Total Doses Distributed.

When will flu vaccine become available?

Flu vaccine is produced by private manufacturers, so the timing of vaccine availability depends on when production is completed. As of late September, more than 90 million doses of 2016-2017 flu vaccine had already been distributed in the United States. Vaccine supply updates are available at the link above.

When should I get vaccinated?

Getting vaccinated before flu activity begins helps protect you once the flu season starts in your community. It takes about two weeks after vaccination for the body’s immune response to fully respond and for you to be protected so make plans to get vaccinated. CDC recommends that people get a flu vaccine by the end of October, if possible. However, getting vaccinated later can still be beneficial. CDC recommends ongoing flu vaccination as long as influenza viruses are circulating, even into January or later. Children aged 6 months through 8 years who need two doses of vaccine should get the first dose as soon as possible to allow time to get the second dose before the start of flu season. The two doses should be given at least 28 days apart.

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the pharmaceutical global supply chaincontact Sentry via email or by phone at 1-866-757-7400.

For additional information please visit:

https://www.cdc.gov/flu/

https://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

New CDC Study: Influenza Vaccination Reduces Risk of Hospitalization by More Than Half Among Seniors

Influenza season is upon us, so now is an appropriate time to remind ourselves to line up for our flu shots.  Sentry BioPharma Services provides vaccine product management services to a wide group of clients from the US Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.

Recently, the US Center for Disease Control (CDC) published a study on the beneficial effects of influenza vaccines on older populations within the USA.  We have provided an overview of the study below for your review and consideration.Influenza Vaccination Reduces Risk of Hospitalization

August 2, 2016—A new CDC study published today in the journal Clinical Infectious Diseases (CID) provides more evidence on the benefits of flu vaccination among older adults. The study looked at flu-associated hospitalizations among people 50 and older during the 2010-2011 flu season and found that people who had received a flu vaccine reduced their risk of flu-associated hospitalization by half.

People 65 and older are at high risk of serious flu complications and account for the majority of flu hospitalizations and deaths each year. The CID study “Case-control study of vaccine effectiveness in preventing laboratory-confirmed influenza hospitalizations in older adults, United States, 2010-11,” cites data from three recent influenza seasons, during which an estimated 115,000 to 630,000 hospitalizations and 5,000 to 27,000 deaths occurred. It’s estimated that people 65 and older accounted for between 54 percent and 71 percent of hospitalizations and between 71 percent and 85 percent of deaths.

The study, which compared 368 flu-hospitalized patients and compared them against case controls selected from the community, found that vaccinated people 50 years and older were 57 percent less likely to be hospitalized from flu than unvaccinated people. The benefits were similar by age group, including adults 75 years and older. This is a notable finding since flu effectiveness studies that have looked at how well vaccine protects against flu-related doctor’s visits have generally found that effectiveness is declines with age. This study indicates that protection against hospitalization was level among older people.

Annual influenza vaccination has been recommended for adults 65 and older in the U.S. since the 1960s and for adults 50 years and older since 2000. Since 2005, CDC has conducted annual influenza vaccine effectiveness studies to assess how well the vaccine works in preventing medically attended illness. Until recently, there have been few studies that look at how well the vaccine works in preventing more serious outcomes, like hospitalization. The CID study adds to a growing body of evidence that supports the importance of vaccination in order to prevent these more serious outcomes.

Study findings also support current U.S. recommendations for annual influenza vaccination among adults, especially among adults 65 years of age and older who are at high risk of influenza-associated complications. During 2015-2016, an estimated 66% of people 65 and older got a flu vaccine. While this is the highest vaccination rate among the public for any age group, that still leaves nearly one-third of people 65 and older unvaccinated.

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the pharmaceutical global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Visits Biotech Clients in the Pacific Northwest to Discuss API Importation and FTZ Benefits

Sentry recently completed a week-long trip to the Pacific Northwest region to satisfy multiple requests to learn more about the company’s foreign trade zone (FTZ) service offering.  Client interest focused on importing high value active pharmaceutical ingredients (API) into Sentry’s FTZ for an indefinite storage term.

As supply chains become more intricate in our ever shrinking world, any weak link that chain can produce devastating results for temperature-sensitive biotech drug products.  “Most of us in pharma and biotech have our stories of disasters or near calamities concerning product movements globally” stated Tim Mitchell, President of Sentry.  “In light of the tremendous investment in treasury and time required to bring a new medication to market, it is critical to not allow product safety, identity, strength, purity and quality (SISPQ) to be impacted by delays which are inherent with the standard drug importation process.”

Sentry can help prevent time-out-of-temperature excursions through the utilization of its Foreign Trade Zone (FTZ), subzone 11 of zone 72 located at its facility in Indianapolis, Indiana.

What is a Foreign Trade Zone?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 Industry

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 FTZ 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 U.S. Customs and Border Protection agency (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.

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 IndustryForeign Trade Zone

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

Operation Silver Snake Sets CBP Field Operations Seizure Record in San Juan, Puerto Rico

Last month, the U.S. Customs and Border Protection (CBP) San Juan Field Operations announced that approximately 268 seizures were made of counterfeit products, valued at $2.4 million, which were illegally imported into Puerto Rico via international mail.  This is a record number of counterfeits seized by CBP in Puerto Rico during a single week.

A wide range of counterfeited products was seized during the week-long enforcement effort, called Operation Silver Snake, to include: consumer products, apparel, footwear, textiles, pharmaceuticals, and more.

CBP Operation inspection

International Mail packages are inspected by CBP to verify compliance with US laws

This is the second iteration of a week-long operation carried out in San Juan this year by the Mobile Intellectual Property Enforcement Team (MIPET), with the support of CBP’s Centers of Excellence and Expertise (CEEs), IPR-National Targeting & Analysis Group (NTAG), Homeland Security Investigations (HSI), and United States Postal Inspection Service (USPIS).

“Our dedicated CBP officers, Import Specialist, International Trade Specialists and Seized Property Specialists were key ingredients to this successful enforcement effort to protect the U.S. economy and consumers from counterfeit products,” said Edward Ryan, Assistant Director of Trade for Puerto Rico and the US Virgin Islands. “We are looking forward to conducting follow-up operations with our partners to further protect legitimate businesses and consumers from intellectual property thieves, said Ryan.

Various international mail packages inspected by CBP officers at the San Juan International Mail Branch revealed products that infringed intellectual property rights.  The products were shipped from vendors in China.

CBP protects businesses and consumers every day through an aggressive intellectual property rights (IPR) enforcement program.  CBP targets and seizes imports of counterfeit and pirated goods, and enforces exclusion orders on patent-infringing and other IPR goods.

CBP label counterfeit products

CBP Officers label counterfeit products seized during the operation.

To effectively enforce intellectual property rights, CBP relies heavily on the cooperation of the owners of these rights. If your intellectual property is registered with the Patent and Trademark Office, the Copyright Office or the subject of a United States International Trade Commission exclusion order, you will want to inform CBP.

Information about counterfeit merchandise being illegally imported into the United States can be submitted to the CBP using an on-line tool called E-Allegation.  The e-Allegation provides a means for the public to anonymously report to CBP any suspected violations of trade laws or regulations related to the importation of goods into the U.S.

For more information about how Sentry’s import/export team can add value to your international supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Source: https://www.cbp.gov/newsroom/local-media-release/2016-07-20-000000/cbp-stops-millions-unsafe-counterfeits

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.

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.

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.

Five Benefits of a Self-Directed FTZ Audit

On Thursday, April 21, 2016, Sentry BioPharma Services completed a self-directed (voluntary) inspection of the company’s foreign trade zone (FTZ) and compliance with 15 CFR Part 400.  Randall L. Higgins, Sentry’s Senior Manager of Compliance and Validation, defines five main benefits of an independent compliance evaluation as follows:

Establishes a Professional Relationship

Sentry BioPharma Services establishes a professional relationship with an experienced and specialized service provider for several reasons.  Familiarization with Sentry’s organization, employees, facility layout, policies, procedures, daily activity and compliance history facilitates the uptake of tacit knowledge.   Clear communication channels streamline response time when trouble-shooting a problem or developing a new business opportunity.  Having an established relationship also creates a new avenue for gaining important information and insight, which is especially important as new regulations evolve.

Builds Regulatory Alignment

Tapping the knowledge and experience of a foreign trade zone expert helps a company build stringent alignment with requirements of various regulatory agencies (DEA, FDA & CBP).  Normally, the specialized consultant starts with an unbiased gap analysis to test the company’s system for robustness.  This analysis offers a realistic picture of the present state of affairs.  It also simulates the way a regulatory agency may conduct an impromptu CBP inspection.  The non-threatening environment fosters collaboration to proactively reveal unknown deficiencies and opportunities for improvement.

Drives a Competitive Advantage

Teaming up with a foreign trade zone specialist serves as a competitive advantage.  The FTZ consultant identifies operational inefficiencies and offers suggestions to improve routine and in some cases repetitive tasks.  The import/export professional advice can lead to the elimination of non-value added tasks, simplification of paperwork and the reduction of redundancies.  In some cases, the objective analysis minimizes or eliminates duties, processing fees, violations, fines and penalties.

Cooperates with Administrator of the Grant of Authority

Sentry BioPharma Services’ FTZ is part of Zone 72 and is identified as subzone 011.   Sentry’s zone is located at the Indianapolis International Airport (IND) and is not considered within the customs territory of the United States.  Sentry intends to continue participation in the Federal Foreign Trade Zone program for years to come.  By voluntarily completing an internal FTZ system audit, it demonstrates Sentry’s intent to maintain a good compliance record year-after-year with its grantee.

Cultivates New Business Opportunities

The advice of a foreign trade zone consultant typically brings solutions to pain points in the pharmaceutical supply chain.  In many cases, unique problems serve as opportunities to grow the business and expand the service offering. Clients with temperature-sensitive pharmaceutical products are often looking for ways to better control the pharmaceutical supply chain.  Protecting pharmaceutical product integrity tops the list.  Also high on the list of client needs are expediting shipping and/or customs clearance requests.   Customers benefit from the added level of drug product protection which results in time-saving and overarching risk mitigation.

Mr. Randy Higgins expands, “Sentry BioPharma Services has delivered a pristine regulatory compliance record to existing and prospective clients’ year-after-year.  By embracing self-directed and independent evaluations, Sentry protects the safety, identity, strength, purity and quality (SISPQ) of the pharmaceutical products and controlled substances moving through our GMP warehouse on a daily basis.”

Sentry’s active FTZ status and customs bond support import optimization and control of temperature-sensitive biological and pharmaceutical ingredients, materials, semi-finished and finished drug products.  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.

https://enforcement.trade.gov/ftzpage/grantee/regs.html

International Trade