Pharmaceutical Access Framework
A medicine that is approved in one nation takes years to become approved and available worldwide due to an absence of a globally harmonized approval system. As a result, patients suffer or die needlessly while waiting for the medicine to reach their country. It is imperative that this change.
Therefore Medebound HEALTH strives to accelerate the introduction of breakthrough medicines from all over the world to meet patients' local unmet medical needs.
We see our role as bringing innovative global treatments to patients through multiple vehicles to fulfill our mission of expanding access to quality care across the globe. We invite biotech and biopharma companies interested in helping more patients who have no access to your medicines, to contact us.
Tech-Enabled Named Patient Program with RWE
We are dedicated to partnering with global biopharmaceutical companies to bring innovative medicines to the Asia Pacific using our expertise in clinical KOLs network, regulatory licenses, and logistics handling. The process is based on a Named Patient Program, in which patients acquire small amounts of medicine that will be used only for themselves to alleviate a troubling condition. As a result, we can manage an early access NPP program for biopharmaceutical companies to gain access to the Asian market through this method, regardless of whether or not they wish to obtain market authorization in these emerging markets. We provide the expertise, resources and, we have a technology platform to assist the Real World Evidence (RWE) to manage each and every individual request for these new medicines.
With access to our in-house expertise in Asia-specific regulatory and legal frameworks and our large network of KOL physicians and hospitals in Asia, US or EU-based pharmaceutical companies can get our help to register their products for local regulatory approval, in conjunction with the named patient program supply via appropriate regulatory channels.
With our multi-lingual data-acquisition proprietary technology, we facilitate continuous RWE collection and key metrics evaluation. For the in-licensed products, we will lead all the clinical development. Once it is legally registered in the target country/region, we will partner with national/regional distributors for commercialization.
Asia Pharma Deployment Leadership
What is a Tech-Enabled Named Patient Program?In cases where biopharmaceutical companies lack the bandwidth or expertise to get their innovative medicines approved in other countries, a Named Patient Program can make their medicines available internationally. This process, a widely accepted practice for many pharmaceutical companies, enables healthcare professionals across the world to request new medicines, for patients who have no other treatment options available to them in their own countries. As part of the Personal Importation Process, the patient submits all the necessary documentation, including passport and medical information, to make a request for a small amount of medicine. We refer to our "Access as Services" program as "Tech-enabled Named Patient Program," and that means we not only handle the logistics of international shipment, custom clearance, storage and distribution, but also assist pharmaceutical companies in gaining market access that will generate early revenue for them, as well as provide them with the real-world evidence (RWE) necessary for local regulatory approval.
What are the advantages for companies of conducting a Named Patient Program in Asia?There are many advantages for biopharma companies with a newly approved medicine to discuss with us to set up a Named Patient Program: - Managing unsolicited patient requests for drugs in an ethical and regulatory controlled manner - Building a stronger network of KOLs and future advocates by exposing physicians in new markets to your products - Providing benefits to patients suffering from conditions, including some that can be life-threatening. - Generating additional revenues in countries that allow you to charge for drugs supplied on a named patient basis - RWE acquisition based on Asian demographics which accounts for 25% of the world population
Can pharmaceutical companies provide drug to patients in any country?Companies can provide drugs to patients in any country in which they have not yet received marketing authorization. This includes countries in which a company plans to seek marketing approval, as well as those countries in which a company does not plan to seek marketing approval. With a properly established Named Patient program, we help navigate the complex regulatory landscape, especially in Asia countries, and manage the shipment, customs clearance, and delivery to treating clinics. Asia is a huge, rapidly growing and attractive market that is hard to ignore. Building a reputable early entry program with a US-based partner with a significant local presence is essential. We invite biotech and biopharma companies interested in helping more patients who have no access to your medicines, to contact us.
How can I introduce Medebound HEALTH to a biopharma company?We can share introduction materials or schedule a demo to learn more about our full range of offerings.
Why choose Medebound HEALTH to be your partner in Asia?With access to our in-house expertise and knowledge of international regulatory and legal frameworks in Asia, we will be able to help pharmaceutical companies gain market access which will not only generate early revenue for them but also provide them with real-world evidence (RWE) crucial to local regulatory approval. In addition to relationships with top hospitals, KOLs and Government agencies, Medebound HEALTH also partners with largest rare disease consortium, and this year, signed an agreement to help their hundreds of thousands rare disease patients source the latest medicines –both approved and not-yet-approved. In the past, we have successfully imported and supplied of unlicensed medicines in oncology, neurology and rare diseases into the Asian region. Please contact us to learn more. Medebound HEALTH has established its brand presence in Asia by contracting with the Asia’s largest insurance firms, and global Fortune 500 companies. Its services have covered worldwide members touching millions of lives, bringing new hope to patients who would otherwise have to travel abroad for care.