SynBio: unlocking the commercial potential of a new bioscience industry

Posted: 8 August 2017 | | No comments yet

An exclusive column from the ABPI’s Magda Papadaki about the implications of synthetic biology for the pharmaceutical industry…

DNA Strand

Despite its early stage, the volume of ongoing work to link breakthroughs in basic synthetic biology with promising applications underscores its considerable potential to generate both transformative tools and products. ABPI Head of Manufacturing Innovation Dr Magda Papadaki discusses how these advances can be harnessed for patients worldwide….

Biotechnology has evolved over the last 30 years from a futuristic vision of better genome analysis and advanced chemical engineering to an industry staple. Thanks to ongoing technology optimisation in molecular and cellular biology as well as synthetic chemistry, engineering and computing, among a wealth of other disciplines, applying bioengineering approaches is faster, cheaper and more accurate than many could have imagined.

In the biotechnology arena, no advance has seen as rapid a development as synthetic biology (or SynBio). From new bioprocesses to test medicines and chemicals, novel biological methods for the production of chemicals and biofuels to replace fossil fuels, or even make new nature-inspired materials, synthetic biology holds the key to the next wave of innovation in those technology forward areas that make the UK a world-leader in innovation.

Even now, the successes in synthetic biology are just scratching the surface of potential breakthroughs but, as is usually the case with cutting-edge sectors, investment enthusiasm comes with unrealistic timelines for commercialisation; particularly true within the long-timelines of product development in the life-sciences arena.

SynBio faces threats of funding deficits on all sides largely because of its disruptive nature.

SynBio faces threats of funding deficits on all sides largely because of its disruptive nature.

With its applicability already starting to pick up, SynBio has been putting global biomedical systems to the test to address persisting scientific and technological unknowns, as well as build experience around the scientific and financial models needed to embed them into standard practice.

For potentially disruptive, yet not fully deciphered, technologies to fulfil their therapeutic and market potential, collaboration will be a game-changer. Scientists, health systems, businesses and government must hold hands to share scientific risks, facilitate development and maturation of solutions, provide financial support mechanisms and promote a more connected environment for innovation.

Support from consortia

During a remarkably small window of time, national and global consortia linking government, academia and industry, such as the EU Innovative Medicines Initiative (IMI) or the UK’s network of Catapults, have become an important operational alternative for the biopharmaceutical industry, addressing challenges that exceed the capacity of single organisations. It is with support from these organisations that SynBio can flourish.

As we learn more about the hardest to treat diseases: blood cancers, haemophilia or type-1 diabetes, SynBio is increasingly attractive as an avenue to develop curative products. CAR-T therapies, gene therapies and cell therapies are still in their clinically effective infancy. Open innovation will be increasingly important in turning these amazing advances into positive patient outcomes.

Echoing the growing demands to bridge the gap in innovations reaching society, the time is now to learn from the global space of open innovation, as well as a number of emerging development pathways, and set the foundations for a future strategy that can smooth the journey to technology development, prototyping and adoption.

Ultimately, the UK needs a joined up system with the right fiscal environment, support from highly skilled scientists, multi-stakeholder innovation including with the NHS, clear regulatory guidelines and education which lay the groundwork to a positive uptake environment, and a new generation of innovation leaders, to deliver the successes that SynBio promises.

About the author

Dr Magda Papadaki is Head of Manufacturing Innovation for ABPI and shares responsibility for the Medicines Manufacturing Industry Partnership (MMIP). Before joining ABPI, Magda was a Lead Technologist for the Innovate UK Regenerative Medicine program, looking after the development and commercialization of new cell and gene therapy products, as well as novel tools and platforms.

A stem cell and gene therapy scientist by training, Magda combines experience of over a decade in research, with regulatory and business experience in the EU and US. Her specialization includes the development of adaptive pathways and partnerships to reshape the development, manufacturing and adoption of breakthrough treatments and was member of the global consortium developing the Adaptive Licensing paradigm in MIT, Boston, MA. Magda has worked extensively in the global space of public-private partnerships, including the EU Innovative Medicines Initiative (IMI) and the US/FDA Critical Path initiative.

Her industry experience was with Novartis, as DRA and QA/QC Director for Greece and Cyprus. She holds a PhD in Gene Therapy and Stem Cells, an MPhil in Bioscience Enterprise from the University of Cambridge, UK and MSc in Pharmacology from the University of Oxford, UK.