What is the difference between school-based and community-based mass drug administration (MDA)? Which are you?
School-based MDA is the administration of MDA drugs to school-aged children while at school. As long as most treatment in an MDA program is school-based, blister-packaging is less of a concern. Problems however are that only children are covered, and many countries have significant percentages of children who are not enrolled in school. Also, not all children who are enrolled regularly attend school. Community-based MDA includes house-to-house distribution, distribution from a health facility or other central location, or a combination of the two. We primarily do community-based MDA, and blister packaging suits this model.

Are your MDA medicines direct or indirect?
We do direct MDA and make medicines that are to be given directly to patients. In indirect MDA, the drug is added to food, such as the fortification of salt.

What countries are candidates to use triple therapy for lymphatic filariasis MDA?

Any country with lympatic filariasis without loa loa and onchocerciasis or other contraindications. Patients with loa loa co-infection should not be treated with ivermectin without consulting an expert on loiasis due to the risk of a fatal encephalitic reaction. Patients with onchocerciasis should not be treated with DEC because of a severe hypersensitivity reaction to released filarial antigens, damaging skin, eyes, and leading to cardiovascular collapse. Countries like Nigeria with both loa loa and onchocerciasis should use albendazole alone for lymphatic filariasis MDA.

Why are you blister-packaging?
The usual approach to mass drug administration is for tablets to be distributed from shared bottles on ordinary folded paper without labels or instructions. As a result, patients have a lack of trust and effective coverage is poor in many areas. No publicly traded company is going to spend the money required to develop and take to market highest-quality preventive medicines with improved packaging for global health.

How serious is vitamin A deficiency in children?
In addition to blindness and associated mortality, Vitamin A deficiency can also cause abnormal lung development, anemia, diarrhea, infections, night blindness, and stunting.

Bend Biomedical has four primary MDA targets. Are there other good targets for MDA?

Yes, there are three other main MDA targets: azithromycin for under-five mortality, trachoma, and yaws; praziquantel for schistosomiasis, foodborne trematodiases, and taeniasis; and dihydroartemisinin-piperaquine (DHA-PPQ) for falciparum malaria. But there are lingering questions about all three. 

--Azithromycin for trachoma and yaws is currently being donated, however no drug company is donating azithromycin for under-five mortality. Giving azithromycin to infants in sub-Saharan Africa can reduce under-five mortality by nearly 75%. There is concern though about the development of drug resistance by other bacteria that are killed by azithromycin. Also, it is about 60 cents a dose, so it is expensive compared to other MDA drugs.

--At-risk adults are frequently left out of schistosomiasis mass drug administration, because treatment and monitoring efforts with praziquantel have typically focused on children. WHO’s new guidance recommends treatment of all ages when the prevalence is greater than 10%, however, the quantity of donated drug is limited and may not be sufficient to achieve this goal.

--There are now two new vaccines for malaria that are moderately effective. Donors may still need to complement these vaccines with a combination antimalarial drug like DHA-PPQ or something newer to reach elimination in some areas.

Is Bend Biomedical for real?
Yes, you can see a timeline of our progress here.

What is a World Health Organization (WHO) "prequalified generic?"
WHO prequalification of medicines is a service provided by WHO to assess the quality, safety and efficacy of medicinal products. Only essential medicines qualify. The five-step process includes invitation, dossier submission, assessment, inspection, and decision. Countries are expressing a preference for WHO prequalified generics for MDA.

Where do you manufacture your medicines?
Our plans are to make DEC, IVM, and ALB in India; Vit A in Canada and USA, and BPG in USA.

What are CMOs and do you use them?
A CMO is a contract manufacturing organization. We use them when it makes sense. CMOs are the norm for pharmaceutical manufacturing. Today, 70% of pharmaceutical companies outsource their manufacturing.

Are you going to ship to the main WHO warehouses in Geneva and Manila?
Yes, but if the government or organization prefers the shipments to go straight from the CMO to warehouses in country, that might be more cost effective.

Do you have any endorsements?
Yes, and we are seeking more. Dr. Sitikantha of Kolkata, India, is on our Board of Advisors. He wrote, “Mass Drug Administration coverage remains an important indicator in elimination of Lymphatic Filariasis… Drugs should preferably be distributed in blister packs to increase acceptance.” More recently Coach Mike Krzyzewski, Duke University, wrote us: "I applaud you and your team for the work you are doing. It will help so many people around the world, especially in regions that do not receive this type of aid... I wish you and your team the very best."

Do you think someone could put azithromycin in soft gel caps for infants? Would it cost less than the dihydrate formulation?
Soft gel caps would be less expensive by far and easier to make and distribute to infants. Azithromycin in capsules are already on the market but not tailored to infants, meaning it has not been developed with flavoring and in special gelcaps (what are sometimes called tiny plastic bladders by UNICEF).

Can’t we already get these medicines for free from Big Pharma?
Many countries can still access medicine donations in bottles. However, as companies move to restrict their donations (either to areas with prevalence above a defined threshold or to low-income countries and away from middle-income countries), certain countries and organizations wish to procure their own medicines and prefer blister packaging. Bend Biomedical provides the medicines in this type of packaging while following the World Health Organization guidelines for MDA.

Why don't EISAI, GSK, MSD, Catalent, NutriCorp, etc. donate in blister packs?
They have been approached and are not interested. Because medicines in bottles are being supplied to governments and organizations at no cost, the makers are unwilling to change the packaging or otherwise improve products; they are also reluctant to allow products to leave their direct control to be blister-packaged elsewhere. The original donors of our mass drug administration medicines, EISAI, GSK, and MSD, have been bearing the world's treatment burden of these diseases for 35 years.

Who are the manufacturing partners you have lined up, and for which projects?
All of our CMOs are very large, tier-one manufacturers, and we have current mutual non-disclosure agreements in place.

What do you mean by "using appropriate dosage forms, packaging, and languages" in your products?
We believe, especially for community-based mass drug administration, that the dosage form (tablets, chewable tablets, capsules, liquids, etc.) should be familiar to, and suitable for, the recipients based on location and age. In most cases the appropriate packaging is drugs in blister packs. Labels and instructions should be included in languages that patients can read.

What specifically do you mean by age-appropriate drug formulation?
Sometimes pills are too big for children. To prevent choking, tablets are commonly crushed before administering them. In some cases though it doesn't work well, and the preferred form would be dihydrates as liquid or in soft gel caps that can be opened with scissors or nail clippers and the liquid squeezed into the child's mouth.

Why are you making "single-drug" blister packs?
Although drug combinations on blisters are convenient, sometimes they are not practical. Single-drug blister packs are what the doctors on the ground are calling for. Single-drug packs also make a lot of sense and give us an opportunity to look at different markets, e.g., ivermectin for scabies or strongyloides or in combination for trichuris. It does seem like single-drug ivermectin is being used in cocktails against many diseases.

What are asymptomatic reservoirs?

They are persons with inapparent infection but capable of transmitting the pathogen to others. Asymptomatic reservoirs are sometimes called passive or healthy "carriers." They never experience symptoms despite being infected. Thus the need for mass drug administration to treat everyone, especially when diagnostics are not feasible.

Are blister packs more environmentally friendly than pills in bottles?

Blister packs are regarded as the more environmentally-friendly option. They are child-resistant and reduce plastic use by more than 80%.

What languages will be provided on your labels and instructions?

Right now we are planning versions in Hindi, Swahili, and Arabic.

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