Navigation of Key Regulatory Information for Efficient Life-cycle Management of Regulated Product and Application in SINGAPORE

Jul 26, 2017

Developing an innovative healthcare product (a drug or a biologic, or a medical device) from the proof-of- concept stage to the marketing stage is an expensive and complex process. It involves many years of research and development work. To save time and money in bringing products to market, product development activities should be conducted in accordance with the related regulatory requirements. These requirements can update development activities and help you to manufacture a product that meets the regulatory standards of your targeted jurisdiction(s) – that is, a quality product that is safe and effective for its intended use. Dr Balamuralidhara V., ...

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CpG OligonucleotideTherapeutics– A History Lesson for CRISPR?

Jul 26, 2017

When we look at the emerging and likely future battles being fought to establish dominance in the emerging field of CRISPR technologies, it may be too easy to conclude that one has no frame of reference to help understand what the conclusion will likely be. However, as Harry S Truman said; “There is nothing new in the world except the history you do not know”. There have, of course, been many emerging technologies that have been subject to an IP land-grab. One such instance that we will look at in this article relates to CpG oligonucleotides. Craig Thomson, Patent Attorney ...

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The North of England – An Internationally Recognised Health and Life Science Ecosystem

Jul 26, 2017

The North of England’s profile as a hub of health science has been on an impressive trajectory over the past five years. With some of the most illustrious health science institutions in the world. Analysis funded by the Northern Health Science Alliance (NHSA), and conducted by the think tank IPPR North last year, shows that the health and life science economy in the north is worth over £17 billion to the UK economy, over £10 billion of which is contributed by private sector life science companies. Suzanne Ali-Hassan, Business Development Manager for the Northern Health Science Alliance, discusses the health ...

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Safety and Regulatory Solutions to Address the Needs of Small and Medium Biopharmaceutical Companies

Jul 26, 2017

Small and medium-sized enterprises (SMEs) are often faced with the challenge of having limited resources which can impact their ability to seamlessly move products through the pipeline from clinical development to launch and post-marketing activities. This is further exacerbated by the growing complexity of regulatory requirements and significant pressure companies face to get their products to market as quickly as possible – balancing these two requirements can be virtually impossible. In this white paper, Dr Chitra Lele, Chief Scientific Officer at Sciformix Corporation, looks into the safety and regulatory solutions at biopharmaceutical companies. ...

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Change Management

Jul 26, 2017

The life sciences industry is currently facing unprecedented turmoil. Peter Muller of Schlafender Hase outlines five trends pharma companies will need to weather in 2017, and the considerations needed for smooth adaptation. The life sciences industry is in a state of flux for a whole series of reasons, which can largely be traced back to shifting market dynamics and growing regulatory rigour. ...

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