Tagged with M

USA In 2020, the US FDA’s Center for Drug Evaluation & Research (CDER) approved 53 novel drugs, up from 48 in 2019, across a range of therapeutic areas, including the first treatments for COVID-19 patients.   The FDA’s Center for Biologics Evaluation & Research (CBER) is charged with approving new biologic…

Switzerland Belgian champion UCB’s global manufacturing head, Jacques Marbehant, talks candidly about managing a broad global manufacturing and supply chain through the COVID-19 pandemic, the talent challenges inherent in scaling up manufacturing capacity and scope, and why greater levels of both internal and external collaboration are crucial for the pharma industry…

China Dr Liang Schweizer introduces immunotherapy-focused biotech HiFiBiO Therapeutics, the main advantages of the company’s unique single-cell technology platform, its open innovation approach, experience with capital markets, and advice for other biotech leaders.   The traditional bulk analysis method is well-established and suited for diseases that are more homogenous, but cancer…

Dominican Republic The Association of Representatives, Agents and Pharmaceutical Producers (ARAPF), represents 65 companies in the Dominican Republic, including big pharma companies like Pfizer, Bayer, Roche, GSK, Nestlé, Sanofi and Novartis. Its president, Henry Suárez, reflects on the impact of the COVID-19 pandemic, the country’s objective to expand its social security system…

Singapore Dr Gideon Ho, co-founder and CEO of HistoIndex, shares the story of the company’s establishment in 2010, their proprietary technology to provide the world’s first stain-free AI-driven biopsy and tissue analysis focused on the diagnosis of fibrosis and cancer, and his thoughts on the Singaporean healthcare start-up ecosystem.   We…

USA Dr Maria T. Millan, president and CEO of the California Institute for Regenerative Medicine (CIRM), shares the Institute’s mission to advance basic and translational research in regenerative medicine in the State of California, their unique funding and operating model, and her perspective on the critical importance of investment in science…

Europe With Rare Disease Day falling on 28 February, PharmaBoardroom dedicates this month to exploring the global rare disease landscape, highlighting key trends and developments as well as profiling the most innovative global players in this space. We start the party off with five of the most promising clinical-stage biotech companies…

Global Advances in cell and gene therapies (CGT) are credited with thoroughly transforming medicinal science and creating an inflection point in the ability to treat and potentially cure many intractable illnesses. To date, however, accessibility to many of these game changing technologies remains limited, often due to high upfront sticker-prices and…

Switzerland A trained physician with several years of practice under her belt, Katharina Gasser then moved into clinical research as an investigator before joining the pharma industry in 2005. Now head of Biogen’s Swiss affiliate and chair of the executive committee of industry association Interpharma, Gasser cites her diverse background as…

Switzerland Alvotech – the biosimilars arm of Icelandic-headquartered generics player Alvogen – is positioning itself for future growth via a very different strategy to that of the Big Pharma players with biosimilar portfolios. Chief Commercial Officer Anil Okay, who sits in Switzerland, explains the four company traits that he believes will…

Switzerland Professor Susan M. Gasser, now director and group leader emeritus of the Friedrich Miescher Institute for Biomedical Research (FMI), shares the crucial aspects behind the FMI’s world-class reputation in basic research, her thoughts on the importance of public-private collaboration, and her perspectives on the European research ecosystem. Since February 1,…

Global Bayer’s Michael Levy casts his eye over the implications of the advent of cell and gene therapies on pharmacovigilance and patient safety.  Levy examines why these potentially revolutionary new therapies will necessitate a rethinking and adaptation of currently existing pharmacovigilance processes and activities.   While traditional medicines have, without a…