Korea Korean Pharma company, Hanmi has won orphan drug status this week from the US Food and Drug Administration (FDA) for HM43239, a drug for the treatment of acute myeloid leukaemia (AML). The endorsement of FDA’s Orphan Drug Designation (ODD) — invented to smooth the development of therapies for life-threatening…
Innovation Patient groups oftentimes serve as the authority on a specific disease when it comes to advancing research. “Without patient perspective, there is no good medical product development,” Rachel Sherman, the FDA’s principal deputy commissioner proclaimed during her keynote at last week’s NORD’s Rare Disease & Orphan Products Breakthrough Summit.…
Brazil Cristina Dislich Ropke, CEO of Phytobios, a company that helps multinational and local companies turn Brazilian biodiversity into medicinal products, highlights the company’s exceptional perseverance in studying the Brazilian biodiversity at times when legal uncertainties threatened the development of this segment. She also expands on the drug development center founded…
Poland Mirosław Zieliński, president of the Polish National Forum for the Therapy of rare diseases (ORPHAN), the representative voice for 35 Polish rare disease associations, discusses the implications of the introduction of a national rare disease plan and the need to improve rare disease diagnostics. Furthermore, he highlights the importance of…
Switzerland Thierry Mauvernay, president and delegate of the board of Debiopharm, discusses the Swiss Group’s development over its 38 years of history, its unique business strategy, and how new trends such as personalized medicine and digitalization are being embraced moving forward. Our goal is not to become much bigger, but…
Indonesia Agus Heru Darjono, President Director at Metro Drug Indonesia, highlights the opportunities in the Indonesian Third Party Commercialization sector and emphasizes the importance of building the best team in order to successfully perform in an ever-changing market like Indonesia. Can you briefly speak towards the history as well as the…
Mexico Marco Cid, Director General of Investigacion Biomedica, shares how he successfully launched an innovative clinical research center (CRC) despite a challenging regulatory environment. He speaks about the inspiration behind his business model, the necessity of building a strong rapport with authoritative entities in the market, as well as fostering a…
Taiwan Peter Tsai, founder, CEO, and chairman of Orient EuroPharma (OEP), one of the leading groups of healthcare companies in Taiwan, provides insights into his strategic vision to double the group’s revenues within the next five years and nurture the long-term growth of the company he founded in 1982, while OEP’s…
Switzerland “Get it done! That is what CARBOGEN AMCIS is all about!” – The CEO of the Swiss drug development and commercialization services company elaborates on the company’s strong mindset and declares customer intimacy to be their unique selling point. CARBOGEN AMCIS celebrated its 10th year since joining the Dishman group.…
Taiwan Du-Shieng Chien, President & CEO of TaiRx, a Taiwan-based biopharmaceutical company focused on unmet medical needs, provides insights into the recent development of CVM 1118, a revolutionary cancer treatment targeting breakthrough mechanisms to tackle tumor development and the first drug of its kind to have already started clinical trials in…
Ireland Julie O’Neill, Alexion’s EVP for Global Operations highlights Alexion’s establishment of its Global Supply Chain headquarters in Dublin, Ireland, its investment in Athlone, her thoughts on the opportunities and challenges in the Irish pharmaceutical landscape, and her vision for Alexion. Alexion first established a manufacturing presence in Dublin, Ireland in…
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