Tag Archives: Sentry BioPharma

Guidelines for US Citizens and Residents Living in Areas with Ongoing Zika Virus Transmission

Secure vaccine storage and distribution services protect your inventory throughout the supply chain. Sentry BioPharma Services ensures proper vaccine storage, rotation, accurate tracking and proper distribution of vaccines for routine fulfillment or pandemic response. Standard operating procedures (SOPs) and validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to inadequate storage methods.  Although today there is no vaccine available for Zika, several Sentry biotech clients are working to develop a vaccine for fast track clinical trials.   Sentry is providing the following information from the U.S. Centers For Disease Control and Prevention (CDC) on the Zika virus in order to update our readers concerning the prevention of the spread of this worldwide epidemic.

What is Zika?

Zika is disease caused by a virus that is primarily spread to people through the bite of an infected mosquito. Many people who get infected never have symptoms. In people who get sick, symptoms (fever, rash, joint pain, and red eyes) are usually mild and resolve completely.

Zika can cause serious birth defects in babies born to women who were infected with Zika shutterstock_363993479virus during pregnancy. Zika has also been linked to Guillain-Barré syndrome (GBS), a rare disorder that can cause muscle weakness and sometimes paralysis. Most people fully recover from GBS, but some have permanent damage and, in some cases, people have died.

Zika can also spread when a man who has Zika has sex with female or male sex partners. A man can pass Zika to his partners even if he does not have symptoms at the time, or if his symptoms have gone away. We do not know how long a man who has had Zika can pass it on to his partners from sex. The mosquitoes that spread Zika usually do not live at elevations above 6,500 feet (2,000 meters). People who live in areas above this elevation are at a very low risk of getting Zika from a mosquito unless they visit or travel through areas of lower elevation. Because there is no vaccine or treatment for Zika, people living in areas with Zika should take steps to prevent infection.

Prevent Mosquito Bites

All residents living in areas where Zika is spreading should take steps to prevent mosquito bites:

  • Cover exposed skin by wearing long-sleeved shirts and long pants.
  • Use insect repellents that are registered with the Environmental Protection Agency (EPA) and contain DEET, picaridin, oil of lemon eucalyptus, para-menthane-diol, or IR3535. Always use as directed.
    • Pregnant and breastfeeding women can use all EPA-registered insect repellents, including DEET, according to the product label.
    • Most repellents, including DEET, can be used on children older than 2 months of age. To apply, adults should spray insect repellent onto hands and then apply to a child’s face.
  • Use permethrin-treated clothing and gear (boots, pants, socks, tents). You can buy pre-treated items or treat them yourself.*
  • Stay and sleep in screened-in or air-conditioned rooms.
  • Sleep under a mosquito bed net if air conditioned or screened rooms are not available or if sleeping outdoors.
  • Mosquito netting can be used to cover babies younger than 2 months old in carriers, strollers, or cribs to protect them from mosquito bites.

*Permethrin should not be used in Puerto Rico.

Pregnant Women and Zika

Zika virus can pass from a pregnant woman to her fetus and can cause a serious birth defect of the brain called microcephaly in babies of women who had Zika virus while pregnant. Babies with microcephaly often have smaller brains that might not have developed properly. Other problems, such as eye defects, hearing loss, and impaired growth, have been detected among fetuses and infants infected with Zika virus before birth.

Pregnant women should not travel to any area with Zika. If you must travel to one of these areas, talk to your doctor or other healthcare provider first and strictly follow steps to prevent mosquito bites and practice safe sex during your trip.

For more information about pregnancy and Zika, visit https://www.cdc.gov/zika/pregnancy/.

Practice Safe Sex

Condoms can reduce the chance of getting Zika from sex. To be effective, condoms must be used correctly from start to finish, every time during vaginal, and oral sex. A man can pass Zika to his partners even if he does not have symptoms at the time, or if his symptoms have gone away. Not having sex can eliminate the risk of getting Zika from sex.

  • Men with pregnant partners should use condoms every time during sex or not have sex during the pregnancy.
  • All pregnant women with male sex partners who live in or have traveled to an area with Zika should use condoms or not have sex during their pregnancy, even if their partners do not have Zika symptoms, or if their symptoms have gone away.
  • All men who live in or have traveled to an area with Zika should consider using condoms to protect their sex partners.

For more information about Zika and sexual transmission, visit https://www.cdc.gov/zika/transmission/sexual-transmission.html.

Zika Testing for Pregnant Women

  • All pregnant women who have visited areas with Zika should receive routine prenatal care, including an ultrasound at 18–20 weeks.
  • Pregnant women who have symptoms of Zika (fever, rash, joint pain, red eyes) and have visited areas with Zika should be tested as soon as symptoms start.
  • Pregnant women who do not have symptoms and have visited an area with Zika can be tested 2–12 weeks after travel.

Pregnant women with possible exposure to Zika virus from sex should be tested if either they or their male partners develop symptoms of Zika.

Discuss Pregnancy Planning with Healthcare Provider

Women and their partners should discuss pregnancy planning with a trusted doctor or healthcare provider. Women who want to get pregnant should talk with their healthcare provider about their goals for having children. They should also talk with their healthcare provider about the potential risk of Zika virus infection during pregnancy as well as their male partner’s potential exposures to Zika virus. As part of counseling with healthcare providers, some women and their partners living in areas with active Zika virus transmission might decide to delay pregnancy.  CDC has guidance to help doctors counsel women who live in an area with Zika who want to get pregnant. The recommended times to wait before trying to get pregnant, based on whether either partner has had symptoms, are described below:

How Long to Wait Before Trying to Have a Baby When Living in an Area with Zika Transmission
Women Men
   Zika symptoms At least 8 weeks after symptoms start At least 6 months after symptoms start
  No Zika symptoms Talk with doctor or healthcare provider Talk with doctor or healthcare provider

Women who do not want to get pregnant should talk with their doctor or healthcare provider about ways to prevent unintended pregnancy, including birth control methods. Women should consider safety, effectiveness, availability, and acceptability when choosing a birth control method.

If You or Your Partner Becomes Pregnant, Talk with Your Doctor

  • You are at risk of getting Zika throughout your pregnancy. For this reason, CDC recommends testing at the first prenatal visit and a second test in the second trimester.
  • If you have symptoms of Zika (fever, rash, joint pain, or red eyes) at any time during your pregnancy, you should be tested for Zika. A healthcare provider may also test for similar diseases, like dengue or chikungunya.
  • CDC has guidance to help doctors decide what tests are needed for pregnant women who may have been exposed to Zika.

For More Information, go to www.cdc.gov and search Zika Virus.

All Countries & Territories with Active Zika Virus Transmission

As of July 26, 2016zikamap

Americas
  • Anguilla
  • Argentina
  • Aruba
  • Barbados
  • Belize
  • Bolivia
  • Bonaire
  • Brazil
  • Colombia
  • Commonwealth of
    Puerto Rico, US territory
  • Costa Rica
  • Cuba
  • Curacao
  • Dominica
  • Dominican Republic
  • Ecuador
  • El Salvador
  • French Guiana
  • Grenada
  • Guadeloupe
  • Guatemala
  • Guyana
  • Haiti
  • Honduras
  • Jamaica
  • Martinique
  • Mexico
  • Nicaragua
  • Panama
  • Paraguay
  • Peru
  • Saba
  • Saint Barthélemy
  • Saint Lucia
  • Saint Martin
  • Saint Vincent and the Grenadines
  • Sint Eustatius
  • Sint Maarten
  • Suriname
  • Trinidad and Tobago
  • U.S. Virgin Islands
  • Venezuela

 

Oceania/Pacific Islands
  • American Samoa
  • Fiji
  • Kosrae, Federated States of Micronesia
  • Marshall Islands
  • New Caledonia
  • Papua New Guinea
  • Samoa
  • Tonga

 

Africa
  • Cape Verde

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Content source:

Centers for Disease Control and Prevention
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Division of Vector-Borne Diseases (DVBD)

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/

Sentry BioPharma Services Implements Technology Upgrade with State-of-the Art Systems

Sentry BioPharma Services admits one of the most exciting and frustrating aspects of information technology is the speed with which change occurs. New hardware and software products emerge with attractive features that make it easier for users to perform their jobs.

This becomes even more challenging when upgrade activities must comply with GAMP5 and 21 CFR Part 11 for GMP systems. The pharmaceutical and biotechnology industries mandate change control and software validation to prove control, avoid a breach and maintain data integrity. This is a very intentional process.

Information technology comprises:

  • Client software
  • Computer systems
  • Network devices (routers, switches, network printers)
  • Network infrastructure (cabling, internet connection)
  • Peripherals (monitors, scanners, local printers)
  • Security devices (firewalls, biometric and smart card readers, IDS appliances)
  • Server hardware
  • Server software
  • Software packages

In 2012, Sentry BioPharma Services planned a multi-year technology upgrade program which commenced with an upgrade of user’s work stations, business servers and moved into upgrading the company’s non-GMP enterprise resource planning (ERP) system to optimize efficiencies. In the past two years, Sentry successfully upgraded and validated the building management system (BMS).

“Sentry’s information technology program is important to all of our pharmaceutical and biotech clients,” says Jennifer Marcum, CEO. She continues, “The U.S. Department of Homeland Security (DHS) warns of sophisticated cyber attackers and nation-states planning to exploit vulnerabilities to steal information and corrupt systems. The ‘bad guys’ are developing capabilities to disrupt, destroy, or threaten the delivery of essential services globally. We must be vigilant in maintaining awareness and managing the risks to thwart their plans whenever possible.”

Sentry’s technology upgrade program even includes upgrading the company’s website with mobile-friendly enhancements designed to improve prospective and existing client’s Web experience. The new website “Go Live” date is presently scheduled for the end of March, 2016.

https://www.dhs.gov/topic/cybersecurity

Sentry – Vetter Joint Clinical Trial Delivery System

Safeguarding the health of clinical trial participants and the progression of trial results demands strict adherence to protocols. A disciplined approach to project management adds value within the constraints of client needs, including time and budget.

Sentry BioPharma Services (Sentry) provides clinical trial services to clients utilizing contract manufacturing organizations (CMO). Throughout Sentry’s history we have developed strong ties to contract manufacturers and their pharmaceutical and biotechnology clients by providing the following services:

  •  Cold chain management activities
  •  Drug product shipping services for worldwide international and domestic distribution
  •  Drug product returns and destruction programs
  •  GMP compliant drug product storage (ambient to -90°C)
  •  Import/export optimization including foreign trade zone (FTZ) status
  •  Labeling, kitting and secondary packaging

As a continuation of Sentry’s CMO extended services, Sentry BioPharma Services and Vetter Development Service USA (Vetter) have announced their combined services offering to support new drug development from compound through clinic trials. From planning to filling to tracking, Vetter and Sentry will guide your compound through the clinical trial manufacturing process.

Sentry Vetter Brochure P1 Sentry Vetter Brochure P2