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药品准入框架
由于缺乏全球统一的审批系统,在一个国家获得批准的药物需要数年时间才能在全球范围内获得批准和使用。结果,患者在等待药物到达他们的国家时遭受不必要的痛苦或死亡。这种改变势在必行。
因此,Medebound HEALTH 努力加快从世界各地引进突破性药物,以满足患者当地未满足的医疗需求。
我们认为我们的角色是通过多种工具为患者提供创新的全球治疗,以履行我们在全球范围内扩大获得优质护理的机会的使命。我们邀请有兴趣帮助更多无法获得您的药物的患者的生物技术和生物制药公司与我们联系。
指定患者访问
我们致力于与全球生物制药公司合作,利用我们在临床 KOL 网络、监管许可和物流处理方面的专业知识,将创新药物带到亚太地区。
该过程基于命名患者导入,在该过程中,患者获得少量药物,这些药物仅用于自己以缓解令人不安的状况。 因此,我们可以为生物制药公司开发和管理通过这种方式进入亚洲市场的早期准入计划,无论他们是否希望在这些新兴市场获得市场授权。我们提供专业知识、资源和技术来管理对这些新药的每一个请求
独家经销/许可
凭借我们对亚洲国际监管和法律框架的内部专业知识和知识,我们将能够帮助制药公司获得市场准入,这不仅可以为他们带来早期收入,还可以为他们提供真实世界的证据(RWE ) 对当地监管部门的批准至关重要。凭借我们支持人工智能的专有技术,我们促进了 RWE 的访问。 对于授权产品,我们将主导所有的临床开发。 一旦在目标国家合法注册,我们将与国家/地区制药公司合作进行商业化。
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.
O U R V I S I ON
There should be no geographical barrier to accessing innovative medicine for patients
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