Tag Archives: Sentry BioPharma Services

Biologics Contribute to Growth in Pharma Products Cold-Chain Market

In its September issue, Pharmaceutical Commerce details the previous and expected contributions of biologic products to its forecast of cold-chain market growth predicting sales of cold-chain drugs and biologics will outpace overall industry growth through 2022.

It is reported that “as of 2018, global sales of biotech drugs and biologic products exceed $300 billion in value, and the special logistics for maintaining the quality of such temperature-sensitive products as they are shipped from manufacturers to hospitals, clinics, pharmacies and patients around the world account for more than 17% of all biopharma logistics spending”.

The updated forecast for cold-chain logistics spending in 2018 is that “it will be more than $15 billion worldwide, in an $82 billion overall pharma logistics market, of which $10.6 billion will be transportation and $4.4 billion will be specialized tertiary packaging and instrumentation such as insulated boxes, blankets, phase-change materials, shipping containers and various temperature sensors and recorders. By 2022, cold-chain biopharma logistics spending will expand to more than $18 billion.”

To read the full article visit the following link:

https://pharmaceuticalcommerce.com/cold-chain-focus/biopharma-cold-chain-market-forecast/

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.

FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products

In a recent news release the FDA described research it has conducted regarding detection of protein carbonylation, an oxidative reaction that may occur in therapeutic protein drug products during manufacture, storage, use, and transport potentially causing structural alterations and threatening stability, quality, and clinical efficacy of such products. FDA scientists have refined an antibody-binding assay with high sensitivity to detect protein carbonylation allowing many samples to be studied in a short period of time under a variety of conditions. The assay is being used to study the tendencies of various protein products to undergo oxidative carbonylation and whether containers and chemicals that contact proteins may start or speed up these reactions. The goal is to develop methods such as addition of stabilizing agents to counteract protein carbonylation in order to maintain stability, purity, and potency of therapeutic protein products and to avoid any harmful adverse reactions such as unwanted immune responses.

See https://www.fda.gov/Drugs/NewsEvents/ucm571068.htm

 

Full FDA Story:

The potential for biotechnology to transform medicine remains immense, with several therapeutic protein products already having come into widespread clinical use and hundreds of proteins under clinical investigation. For the FDA, the regulatory oversight of therapeutic protein development poses a great challenge, not only because of the increasing number of products, but also because proteins, by their very nature, are highly variable, and compared to small-molecule drugs, more likely to undergo chemical reactions over time. Chemical reactions that occur in these proteins (for example, during storage in vials before administration to patients) can have a significant impact on protein function. For FDA scientists in the CDER Office of Biotechnology Products (OBP), these reactions are of great interest because they can directly impact the quality, safety, and efficacy of protein products.

For decades—before the biotechnological revolution and the rise of therapeutic proteins—FDA drug reviewers focused primarily on small-molecule drugs. Aspirin, for example, contains only nine carbon atoms, whereas the modern protein product bevacizumab contains well over 6,000 carbon atoms. In general, proteins also contain sulfur atoms (bevacizumab has 44!), and biochemists have long known that sulfur-containing molecules are prone to undergo reactions related to the presence of unstable oxygen and other atoms in our environment. (Proteins are not the only molecules that undergo such oxidative reactions. The rusting of iron tools and statues, where iron atoms interact with oxygen atoms in the air and water, is also oxidative.) In some instances, oxidized proteins can be damaged in various ways, which could in turn trigger an unwanted immune response in patients. This feature is a unique concern with therapeutic proteins.

Recently, biochemists have begun to investigate the exact locations of oxidative reactions within large intact protein molecules. Laboratory researchers in OBP, for example, have published important new information (see References) concerning protein carbonylation, which entails the addition of a single atom of oxygen, originating from the environment, to discrete carbon atoms (rather than sulfur atoms) within protein molecules. Although protein carbonylation has been recognized within the context of disease and age-related conditions, its occurrence during the manufacture, storage, use, and transport of therapeutic proteins is a relatively new area of study. For pharmaceutical quality scientists, key issues include: understanding the different tendencies of various protein products to undergo oxidative carbonylation; identifying the role that containers and chemicals that contact proteins may have in these reactions; and discovering reliable methods for specifically and consistently detecting and controlling carbonylation.

To detect protein carbonylation, the OBP team has refined an antibody-binding assay that takes advantage of the reactivity of the “carbonyl group,” which is the name given to the carbon- and oxygen-atom grouping that occurs upon protein carbonylation. Carbonyl groups that form in proteins can make the entire protein molecule less stable and lead to damage after degradation or aggregation. By exposing the carbonyl groups that are formed in proteins to a laboratory reagent known as DNPH, the OBP team found that different proteins undergo carbonylation at different levels and at specific sites. The rate and site of carbonylation can depend on temperature, time, and other variables, such as the presence of small amounts of metals that accelerate protein oxidation reactions. The laboratory also investigated the tendency for certain additives in drug formulations to start or speed up these reactions. The methods developed by the team allow many samples, under a variety of conditions, to be studied in a short period of time. Moreover, the method is sensitive enough to detect as little as a single carbonylation modification within a large protein molecule.

The findings of the OBP team may help protein drug developers produce therapeutic proteins under optimized manufacturing conditions, potentially with structural alterations or by adding stabilizing additives that could prevent harmful carbonylation reactions. More stable protein drugs could offer a longer shelf life, reduced risk of quality problems, and more predictable clinical performance. Understanding reactions such as protein carbonylation may result in improved versions of current drugs or new drugs with superior stability, purity, and potency. Above all, the goal is to have safe and effective high-quality protein products available for patients. 

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

Sentry representatives attend DCAT week

Sentry BioPharma Services is pleased to announce delegates from Sentry’s Business Development team will be in New York City attending the Drug, Chemical & Associated Technologies Association (DCAT) Week March 19th -22nd. The four-day conference brings together key sourcing, procurement and business development stakeholders within the industry’s top life science organizations.  The Sentry team’s focus will be to connect with current clients and prospective pharmaceutical development and manufacturing companies requiring first-in-class temperature-sensitive product management and global distribution support.

President Tim Mitchell and Business Development Manager Alex Mitchell are looking forward to discussing Sentry’s GMP pharmaceutical storage expertise and expanded service offerings coming throughout 2018 and 2019. They along with representatives from our marketing team will be sharing information regarding Sentry’s services to include:

  • Six validated storage environments
    • +15°C to +30°C
    • +2°C to +8°C
    • -15°C to -25°C
    • -33°C to -43°C
    • -40°C to -60°C
    • -70°C to -90°C
    • Custom Temperature Solutions from 0°C to -90°C
  • Controlled Substance Storage and Security
  • Secondary Labeling and Packaging
  • Foreign Trade Zone Import/Export Support
  • Government, Seasonal/Pandemic, Vaccine and Bio-defense Stockpile and Distribution Support

API Sampling and Dispensing

  • Commercial Fulfillment

Schedule a strategic meeting with the Business Development team to learn how Sentry can optimize GMP solutions for your clinical and commercial project needs.

EMA Announces Brexit Business Continuity Plan

In a press release issued on August 1, 2017, The European Medicines Agency (EMA) announced that it “has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) and the Agency’s relocation”. It was indicated the plan is intended to “preserve Agency’s ability to protect public and animal health”.

The plan outlines 3 categories of EMA activities and prioritizes them “according to their impact on public health and the Agency’s ability to function”.

Category 1, the highest priority activities, includes those related to the assessment and safety monitoring of medicines such as actions taken to protect patient safety and inspections across the EU, or activities vital to maintaining the infrastructure and functionality of the EU regulatory system for medicines such as security of critical IT applications. EMA stated, “It is absolutely crucial to uphold these activities as any disruption would almost immediately have a detrimental effect on the health and well being of citizens in Europe and would also jeopardize production and distribution of medicines in the EU”.

Category 2 activities include the proactive publication of clinical data, various initiatives aimed at promoting availability of medicines, and projects such as EMA’s contribution to the fight against antimicrobial resistance or the Agency’s interactions with Health Technology Assessment (HTA) bodies. EMA indicated, “These activities will be maintained for as long as possible, workload and staffing situation permitting, in order to maintain the development of new medicines”.

However, in order to reallocate personnel for preparations for the UK’s withdrawal from the EU and EMA’s relocation, EMA has already begun to suspend activities in what it terms category 3 including:

  • the development of the European Medicines Web Portal, a new publicly-available online information intended to be a single-source for information on all medicines marketed in the EU; 
  • EMA’s contribution to the e-submission project that will allow applicants to electronically submit documents linked to authorization requests for human and veterinary medicines in a secure and efficient way; 
  • the development of a transparency roadmap for EMA that lays out future transparency measures of the Agency; and 
  • participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.”

EMA said it was also reducing the number of audits, some corporate governance and support activities, EMA meetings and workshops, and participation of EMA staff in external meetings or conferences.

EMA said it will consider “how long these activities can be put on hold before they start to seriously undermine the quality of the Agency’s work and its planning, and the expectations of stakeholders”. However, the press release concludes rather ominously stating, “Further iterations of the business continuity plan will also take into account various scenarios for staff losses and how these may affect the delivery of category 1 and 2 activities. Unexpected higher, faster or more permanent loss of staff as a consequence of the Agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained.”

Source: https://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/07/news_detail_002789.jsp&mid=WC0b01ac058004d5c1

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.

EU Countries Contend to Be New Host Country of the European Medicines Agency

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients.

 

The European Medicines Agency, (EMA), oversees medicine regulation within the EU and evaluates applications for medicines to receive marketing authorization across the bloc. It has been based in London since it was founded in 1995.

However, as Brexit is completed the regulatory body will move from its current headquarters in London and as many as 20 EU countries may bid to host the headquarters of the EMA and its staff of almost 1000.

Portugal is the latest to join the competition and other contenders include the Netherlands, Ireland, Sweden, Austria, Denmark and Spain. Potential interest has also been expressed by Belgium, France, Germany, Luxembourg, Finland, Cyprus, Malta, Greece, Portugal, Slovenia, Slovakia, Poland and Hungary. Only the Czech Republic and Estonia have said they would not be vying for the EMA headquarters.

No precise timetable for the transfer has been set, and the EMA itself will have no direct say in the decision. Rather, representatives of the EU Member States will vote to determine the outcome.

Hosting the headquarters should be financially attractive. In addition to the large permanent staff, regulators from member countries are constantly in attendance at the headquarters for meetings and work. It could also be expected that established international big pharma companies as well as emerging European pharmaceutical businesses might locate offices or headquarters in the EMA host city.

However, a number of potential problems loom as the relocation is considered. Pharmaceutical companies fear there could be drug approval delays when the headquarters makes its move. Reportedly a large number of senior staff have left EMA since the Brexit vote and EMA is also likely to suffer a further loss because of the significant amount of review and approval work done by the UK Medicines & Healthcare Products Regulatory Agency (MHRA). And, the MHRA will face a challenge of how closely to continue to harmonize its regulations with those of the EMA which some UK critics say would allow EMA to continue to dictate the content of the regulations.

As with much of the economic and political adjustments being made during the transition period after Brexit, the one constant at this time seems to be uncertainty.

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.

Emergency Preparedness and You

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients.

Many people are concerned about the possibility of a public health emergency such as a natural disaster, act of terrorism, or disease outbreak. You can take steps now to help you prepare for an emergency and cope if an emergency happens. To help you prepare, we’ve provided step-by-step actions you can take beforehand to protect yourself and your loved ones.

Gather Emergency Supplies

Are you Prepared

If a disaster strikes in your community, you might not have access to food, water, or electricity for several days. You may think that you will have enough time to run to the grocery store, but stores quickly sell out of important supplies following emergency warnings. Unfortunately, about half of adults in the United States do not have the resources and plans in place for a possible emergency. Preparing emergency kits for your family is an important step in keeping them safe and healthy during a disaster.

Pack an emergency supply kit. Here’s what you’ll need:

At Least a 3-day Supply of Food and Water

  • Water – one gallon per person, per day
  • Food – foods that are easy to make and won’t spoil, like canned soup, dry pasta, and powdered milk
  • Manual can opener
  • Basic utensils to prepare and serve meals

Health Supplies

  • 3-day supply of all medicines, at a minimum
  • Medical supplies like syringes, a walking cane, or hearing aids with extra batteries

Personal Care Items

  • Soap
  • Toothbrush and toothpaste
  • Baby wipes
  • Contact lenses or glasses

Safety Supplies

  • First aid kit
  • Emergency blanket
  • Multipurpose tool (that can act as a knife, file, pliers, and screwdriver)
  • Whistle

Electronics:

The National Oceanic and Atmospheric Administration (NOAA) provides weather updates during emergencies. Look for a radio labeled “NOAA Weather Radio.”

  • Flashlight
  • Radio (battery-powered, solar, or hand-crank) for updates on the situation
  • Cell phone with chargers
  • Extra batteries

Documents

Keep copies of your important documents, cash, spare keys, and maps in your emergency supply kit.

  • Copies of important documents such as insurance cards and immunization records
  • Paperwork about any serious or ongoing medical condition
  • Your completed family emergency plan, complete with family and emergency contact information.

You should also keep

  • Extra cash
  • Maps of the area
  • Extra set of car keys and house keys

Taking Care of Others

You may need additional supplies to make sure the whole family is ready

For Children

  • Baby supplies like bottles, formula, baby food, and diapers
  • Games and activities for children

For Pets

Plan ahead so you’re ready to take care of your pet during an emergency.

  • Food and Water:
    • A 3-day supply of food and water for each pet. A cat or a dog will generally need 1 gallon for three days.
    • Bowls or bottles
    • Manual can opener
  • Cleaning Supplies:
    • Depending on the pet, you may need a litter box, paper towels, plastic trash bags, grooming items, and household bleach.
  • Health and Safety:
    • Medicines and medical records stored in a waterproof container
    • First aid kit with a pet first aid book
  • Transport supplies:
    • A sturdy leash, harness, and carrier to transport pets safely. A carrier should be large enough for the animal to stand comfortably, turn around, and lie down. Your pet may have to stay in the carrier for several hours.
  • Comfort Items:
    • Pet toys and the pet’s bed, if you can easily bring it, to reduce stress.
  • Paperwork:
    • Current photos and descriptions of your pets to help others identify them, and to prove that they are your pets, in case you become separated from them.
    • Information on feeding schedules, medical conditions, behavior problems, and the name and telephone number of your veterinarian in case you have to board your pets or place them in foster care.

Keep these tips in mind!

Check and replace your supplies throughout the year.

Personalize

Every family is unique. You may have emergency needs not included in this list. Also, remember to update your kit according to changing needs of your family.

Be sure it’s ready to use

In a disaster situation, you may need to get your emergency supply kit quickly, whether you are sheltering at home or evacuating.

  • Once you have gathered your supplies, pack the items in easy-to-carry containers.
  • Clearly label the containers and store them where you can reach them easily.
  • Remember that certain items, like medications and paper documents, need to be kept in waterproof containers.

Keep it Fresh

Check the expiration dates on food, water, medicine, and batteries at least two times per year. It’s extremely important that all items in your kit are functional at the time of an emergency.

Involve Children

Families can make emergencies less stressful by preparing in advance and working together as a team. Ask your kids to think of items that they would like to include in an emergency supply kit, such as books, games, and pre-packaged foods.

  • Your kids can mark the dates on a calendar for checking emergency supplies. Tell them to remind you when it’s time to check the supplies.
  • Include kids in planning and creating disaster kits for family pets.

Know Your House

Find out where your gas, electric, and water shut-off locations are, and how to turn them off.

Prepare For Everywhere

Emergencies can happen anywhere. Remember to prepare supplies for home, work, and vehicles.

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

FDA approves drug to treat Parkinson’s Disease

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both  clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. 

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

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

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

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

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

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

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

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

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

The FDA granted approval of Xadago to Newron Pharmaceuticals.

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

CDC’s 2016 National Influenza Vaccination Week (NIVW)

The Centers for Disease Control and Prevention’s (CDC’s) National Influenza Vaccination Week (NIVW) is scheduled for December 4-10, 2016.  The CDC established National Influenza Vaccination Week (NIVW) in 2005 to raise public awareness about the importance of flu vaccination.  The 2016 national awareness week focuses on highlighting the importance of influenza vaccination and continuing flu vaccination through the holiday season and beyond.  To learn more about what is new for the 2016-2017 flu season, view the CDC’s Factsheet by clicking HERE.

It's National Influenza Vaccination Week (NIVW)! Did you know that flu season can begin as early as October, it usually peaks between December and February, and it can last as late as May? As long as flu virsues are spreading, it's not too late to get a flu vaccine to protect yourself and your loved ones through fall, winter and into spring. #GetAFluVax

NIVW Timing

Flu vaccination coverage estimates from past years have shown that influenza vaccination activity drops quickly after the end of November.

CDC and its partners choose to December for NIVW to remind people that even though the holiday season has arrived, it is not too late to get your flu vaccine.  As long as flu viruses are spreading and causing illness, vaccination can provide protection against the influenza virus and should continue.

Even if you haven’t yet received a vaccine and have already gotten sick with one flu virus, you can still benefit from vaccination since the flu vaccine protects against three or four different flu viruses (depending on which flu vaccine you get).

Flu Vaccination for People at High Risk

Another goal of NIVW is to communicate the importance of flu vaccination for people who are at high risk for developing flu-related complications.  People at high risk of serious flu complications include young children, pregnant women, people with certain chronic health conditions like asthma, diabetes, heart disease or lung disease, and people aged 65 years and older.  For people at high risk, getting the flu can mean developing serious flu-related complications, like pneumonia, or a worsening of existing health conditions, which can lead to hospitalization or death.

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.

To contact CDC by phone call (800) 232-4636 (800-CDC-INFO) or visit the website at

www.cdc.gov/flu/nivw .

FDA’s Know Your Source: Protecting Patients from Unsafe Drugs

Beware of Rogue Wholesale Drug Distributors

Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day.

While the U.S. health care supply chain is one of the most secure and sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market.

kys

Reduce the Chance of a Potentially Unsafe Drug Reaching Your Patients

In order to protect your patients from unsafe or ineffective drugs, the FDA urges health care professionals to verify that their supplier is licensed by the state. Drugs from rogue wholesale drug distributors may harm your patients and expose them to unknown risks or side effects.  The FDA advises health care providers to know the source for prescription drugs.

kypd

Verify that Your Wholesale Drug Distributor is Licensed in Your State

map

https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm281446.htm

For more information about Sentry’s pharmaceutical licensing, registration and international compliance program, contact Sentry via email or by phone at 1-866-757-7400.

For more information: https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm

DoD | Human Trials Begin for Army-Developed Zika Vaccine

By Cheryl Pellerin, DoD News, Defense Media Activity / Published Nov. 8, 2016

A clinical trial began yesterday at the Walter Reed Army Institute of Research, where 75 participating healthy adults were vaccinated with a Zika virus vaccine that the institute’s scientists developed earlier this year, Walter Reed officials announced today.zika

Laboratory-confirmed Zika virus disease cases reported to ArboNET by state or territory as of Nov. 2, 2016. ArboNET is a national surveillance system for arthropod-borne virus diseases in the United States, such as those from ticks and mosquitoes.

The Phase 1 trial will test the safety and immunogenicity — the ability of the vaccine to trigger an immune response in the body — of the purified, inactivated Zika virus vaccine called ZPIV. The vaccine is being tested at WRAIR’s Clinical Trial Center in Silver Spring, Maryland.

“The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials,” Army Col. (Dr.) Nelson Michael, director of WRAIR’s Military HIV Research Program, or MHRP, and Zika program co-lead, said in a statement.

Efficacy refers to the vaccine’s ability to demonstrate a health effect when tested in a clinical trial.  “All of this,” he added, “was done in 10 months.”

Dr. Kayvon Modjarrad, Zika program co-lead and associate director for emerging infectious disease threats at WRAIR’s MHRP, said the Army was able to move so quickly in developing, manufacturing and testing a Zika vaccine “because of its extensive experience with this vaccine platform and longstanding investments in the understanding and mitigation of flaviviruses like yellow fever, dating back to the founding of WRAIR.”

DoD Zika Response

WRAIR officials say this study is part of the Defense Department response to the ongoing Zika outbreak in North and South America and Southeast Asia.

For service members, there are concerns about infection during deployment and travel, but also in the continental United States, where most military installations are concentrated in southern states. There, climate conditions and mosquito populations favor Zika transmission, WRAIR officials say.mosquito

Zika virus is transmitted to people primarily through the bite of an infected Aedes species mosquito — Aedes aegypti, shown here, and Aedes albopictus. The same mosquitoes spread dengue and chikungunya viruses. The mosquitoes typically lay eggs in and near standing water in things like buckets, bowls, animal dishes, flower pots and vases. They prefer to bite people and live indoors and outdoors near people. Mosquitoes that spread chikungunya, dengue, and Zika are aggressive daytime biters, but they can also bite at night. Mosquitoes become infected when they feed on a person already infected with the virus. Infected mosquitoes can then spread the virus to other people through bites. CDC photo by James Gathany

As of Nov. 2, according to the Centers for Disease Control and Prevention, 149 cases of Zika infection were confirmed in the military health system, including four pregnant service members and one pregnant family member.

Zika infection during pregnancy, CDC says, can cause a birth defect of the brain called microcephaly and other severe fetal brain defects.

Other problems have been detected among fetuses and infants infected with Zika virus before birth, such as defects of the eye, hearing deficits and impaired growth. And reports have increased about Guillain-Barré syndrome, an uncommon sickness of the nervous system, in areas affected by Zika, CDC says.

But even Zika infections without symptoms “can lead to severe birth defects and neurological complications,” Zika study principal investigator Army Maj. (Dr.) Leyi Lin said, adding, “A safe and effective Zika vaccine that prevents infection in those at risk is a global public-health priority.”

Zika and Other Flaviviruses

Flaviviruses like Zika are found mainly in mosquitoes and ticks and cause widespread morbidity and mortality worldwide. Other mosquito-transmitted viruses that are members of the flavivirus genus include yellow fever, or YF, dengue fever, Japanese encephalitis, or JE, and West Nile viruses, according to the CDC web page.

“We want to assess the safety and immune response of the ZPIV vaccine in JE and yellow fever YF vaccine recipients because these vaccines may alter the response to the ZPIV vaccine,” Lin said.

“Uniquely,” he added, “illness as a result of natural infection from JE, YF or Zika could be more severe when prior flavivirus infection or vaccination exists. Our study assesses co-vaccination to learn how to reduce risk when protecting against circulating flaviviruses.”

This is important for service members who are vaccinated against other flaviviruses and then stationed in or deployed to areas where Zika is becoming endemic, WRAIR scientists say.

Zika Vaccine Platform

WRAIR’s inactivated flavivirus vaccine platform was the same technology the institute used to create its Japanese encephalitis vaccine, licensed in 2009.

An earlier preclinical study found that rhesus monkeys vaccinated with ZPIV developed a strong immune response and were protected against two strains of Zika virus.

The National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing and is sponsoring the conduct of this trial.

WRAIR, NIAID and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, have established a joint research collaboration agreement to support the vaccine’s development.

The Pilot Bioproduction Facility at WRAIR manufactured the ZPIV vaccine being used in Phase 1 clinical studies, and the Army recently signed a cooperative research and development agreement to transfer the ZPIV technology to Sanofi Pasteur to explore larger-scale manufacturing and advanced development. BARDA recently awarded a six-year contract to Sanofi Pasteur to further develop this vaccine to licensure, according to the WRAIR release.

Other ZPIV Trials

WRAIR’s ZPIV candidate also will soon be part of an NIH trial that began in August. The NIH vaccine contains DNA that instructs volunteers’ cells to make certain Zika proteins that then illicit an immune response. As part of that study, WRAIR’s ZPIV vaccine will be given to volunteers as a booster after they receive the NIH DNA vaccine, WRAIR officials say.

Three more Phase 1 trials using ZPIV are scheduled to begin this year, the WRAIR release noted:

— St. Louis University researchers, through the NIAID-funded Vaccine and Treatment Evaluation Units network, will examine the optimal dose of the vaccine to be used in larger studies.

— Beth Israel Deaconess Medical Center and Harvard Medical School researchers will evaluate the safety and immune response from a compressed vaccine schedule.

— The Ambulatory Center for Medical Research, part of Ponce Health Sciences University in Puerto Rico, will examine the vaccine’s safety and immune response in participants who have already been naturally exposed to Zika or dengue viruses.

The WRAIR trial that began yesterday is sponsored by NIAID and funded by the Army and the Defense Department.

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