Business


References 1 Accenture Report. High Performance Drug Discovery: An Operating Model For A New Era. https://newsroom. accenture.com/subjects/resear ch-surveys/new-drug- discovery-model-can-drive- pharmaceutical-biotech- pipeline-and-growth-says-new- accenture-research.htm (2001). 2 Naylor, S, Culbertson, AW and Valentine, SJ. Technology: Bane or Bonanza for the Pharmaceutical Industry. Drug Discov. World. Fall Edition: 51- 57 (2007). 3 Gartner Consulting. Technology Hype Cycle. https://www.gartner.com/en/re search/methodologies/gartner- hype-cycle. 4 Haeckel, SH. About the Nature and Future of Interactive Marketing. J. Interactive Marketing 12: 63-71 (1998). 5 Rogers, EM. Diffusion of Innovation. 4th Edition, Free Press, New York (1995). 6Thong, R. Bioscience Platform Companies and Their Lifecycle. SciTechStrategy. http://scitechstrategy.com/2015 /01/bioscience-platform- companies-and-their-lifecycle/ (2015). 7Thong, R. Everything You Need to Know About Biotech Business Models. LabTech.eu. https://labiotech.eu/features/yo ung-biotech-business-models/ (2018). 8 Gade, D. Ego, ambition, and turmoil: Inside one of biotech’s most secretive startups. StatNews. https://www.statnews.com/201 6/09/13/moderna-therapeutics- biotech-mrna/. September 13th, (2016). 9 Fidler, B. Moderna Ends Venture Experiment, Dissolves Four Startups. Xconomy. https://www.xconomy.com/bos ton/2017/09/14/moderna-ends- venture-experiment-dissolves- four-startups/ September 14th, 2017.


that used to be the biotech companies of the past.”13 Afeyan suggested also that due to the complex


structure of the Moderna PD3 approach, it is more appropriate to “…think of Moderna not as one company, but as an assemblage of five or 10 differ- ent companies. If you look at how many drugs they have in the clinic, it’s about 10 times more than most other biotech companies at this stage”13. Such assertions strongly suggest that PD3 strate- gies can help facilitate increased valuation of such companies. Although, it should not be overlooked that Moderna does now possess a robust mRNA DDD pipeline in prophylactic and cancer vaccines, immuno-oncology, regenerative and systematic therapeutics. This consists of 21 mRNA drug can- didates in preclinical (10), Phase I trials (10) and Phase II trials (1)14. However the company still does not have any successful products currently on the market in patients. We believe that the valua- tion of Moderna dramatically increased from $2.5 billion up to $7.5 billion (pre-money) mostly in part due to the platform capabilities. As can be seen in Table 1, the pre-money valuation of Moderna was estimated at $2.5 billion in August 2016. This was followed in early 2017 by the com- pany highlighting the component parts of the plat- form11 followed shortly thereafter by validation of the platform12. The subsequent valuation of the company skyrocketed to $7.5 billion (Table 1). Coincidence, or a reality-based phenomenon of PD3 companies? Moderna Therapeutics has experienced a roller-


Continued on page 43 42


coaster ride since its formation eight years ago. It has enjoyed meteoric financial success, in associa- tion with a plague of criticism. The company has clearly articulated the potential of its mRNA plat- form and has developed the beginnings of an early- stage, but burgeoning, pipeline of drug candidates. In return, investors have rewarded the company with a staggering valuation. Some have argued that such a valuation is unsustainable. We are not so skeptical. Moderna has clearly demonstrated the power of its PD3 capabilities and has set new stan- dards for valuation considerations. However, we would also note that the current Board and Management team members have demonstrated an ability to define new paradigms as well as learn from past mistakes. In the latter case this is epito- mised by the changed behaviour of CEO Stephane Bancel. Back in 2016 he was the focus of a highly- critical article predicated on a series of issues asso- ciated with Moderna. Last year he was voted an EY Entrepreneur of the year, and Moderna was voted in the top 25 ‘best places’ to work in the


Cambridge area. All of this combines to suggest an IPO is on the near horizon for Moderna Therapeutics.


Conclusions The pharmaceutical sector failed to adequately implement TTPs into the DDD process. This has led to a stagnation of productivity as defined by ‘flat’ annual FDA NME/NTB approvals (Figure 1). In part this was due to a lack of understanding on how to optimise the choice of which technology/platform should be selected. More recently, a number of companies, including Moderna Therapeutics, have defined a new paradigm associated with the co-development of the PD3 model. It could be that indeed we were right in our 2007 assertion that a more focused and integrated implementation of TTPs should result in a significantly-improved output of thera- peutic drug products2. We simply picked the wrong implementers! Moderna and others have demonstrated that the


implementation of a PD3 approach can significant- ly drive company valuation. The initial case studies appear to suggest that, in good part, this is fuelled by an innovative and validated platform. Although the complexities of such efforts should not be underestimated and an experienced and flexible management team is of vital necessity in order to produce drug candidates that fill the company pipeline. It is clear that the new paradigm driven by PD3 efforts is here to stay. The unresolved ques- tion is can such an approach finally drive the DDD process out of the mire it has been stuck in for sev- eral decades? For example is the uptick in produc- tivity for 2017 (highlighted in Figure 1) just a part of the annual yo-yo effects of NDA/BLA filings and NME/NTB approvals or are PD3 efforts starting to have an impact? Only time will tell!


DDW


Dr Urban A. Kiernan is a Co-Founder, CEO and Board Director of


iMetabolic Biopharma


Corporation (iMBP), a biopharmaceutical compa- ny that is developing platform-engineered, preci- sion medicine drugs for the treatment of obesity- related diseases. He has almost 20 years of indus- trial experience in the biotechnology and life sci- ences fields. In the past he served as a Global Business Development Manager within the Laboratory Consumables Division of Thermo Fisher Scientific (Waltham, MA). In 2017 he founded iMBP and subsequently devoted all of his full-time efforts to company endeavours. He previ- ously served as the Director of Biomarker


Drug Discovery World Fall 2018


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