ファーマアクセスフレームワーク
ある国で承認された医薬品は、世界的に調和した承認システムがないため、承認されて世界中で利用できるようになるまでに何年もかかります。その結果、薬が自国に届くのを待っている間、患者は不必要に苦しんだり死んだりします。この変更が不可欠です。
したがって、Medebound HEALTHは、患者の地域の満たされていない医療ニーズを満たすために、世界中からの画期的な医薬品の導入を加速するよう努めています。
私たちの役割は、世界中で質の高いケアへのアクセスを拡大するという私たちの使命を果たすために、複数の手段を通じて患者に革新的なグローバル治療をもたらすことであると考えています。私たちは、あなたの薬にアクセスできないより多くの患者を助けることに関心のあるバイオテクノロジーおよびバイオ医薬品企業に連絡することを勧めます。
名前付き患者アクセス
私たちは、グローバルなバイオ医薬品企業と提携して、臨床KOLネットワーク、規制ライセンス、およびロジスティクス処理の専門知識を使用して、革新的な医薬品をアジア太平洋地域にもたらすことに専念しています。
このプロセスは、名前付き患者のインポートに基づいています。このインポートでは、患者は、厄介な状態を緩和するために自分だけに使用される少量の薬を入手します。 その結果、バイオ医薬品企業がこれらの新興市場で市場認可を取得するかどうかに関係なく、この方法でアジア市場にアクセスするための早期アクセスプログラムを開発および管理できます。私たちは、これらの新薬に対する個々の要求を管理するための専門知識、リソース、および技術を提供します
独占販売/ライセンス内
社内の専門知識とアジアの国際的な規制および法的枠組みに関する知識を利用することで、製薬会社が市場にアクセスできるように支援し、早期の収益を生み出すだけでなく、現実世界の証拠を提供することができます(RWE )地域の規制当局の承認に不可欠です。 AI対応の独自技術により、RWEへのアクセスを容易にします。 導入製品については、すべての臨床開発を主導します。 対象国で合法的に登録された後、国・地域の製薬会社と提携して商品化を図ります。
Asia Pharma Deployment Leadership
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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.
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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
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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.
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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.
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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.