Therapeutics
Raising the bar on the BIOLOGICS potential
In the quest for safe, efficacious and profitable therapies, pharma research is changing. There is continued pressure to fill the drug pipeline and, at the same time, globalisation of personalised medicines is complex, expensive and requires a significant time commitment. With budgets being tight and time scarce, outsourcing has become more common. Additionally, risk, perception and regulation have limited the adoption of biologics, biosimilars and biobetters, as small molecules and synthetic drugs have been the traditional therapeutic standard. Fortunately, innovative biological therapeutic tools and technologies are now proven to be viable, highly effective, low risk and safe. The strides made to reduce therapeutic toxicity, increase patient safety and enhance efficacy, along with the increased financial ROI for biologicals, have provided the foundation and the right incentive for pharma moving toward these therapies. Several other factors, such as automation, are imperative to the success as they bring particular benefits to streamline the path towards better biologicals development, production and regulatory body approvals, including parallel development of companion diagnostics. The time is right; the technologies are ready and the rewards are sweet.
T
argeted biological therapies have trans- formed pharmaceutical research and treat- ment. Of all therapies, including chemical- ly-derived small molecules and synthetic drugs, biological drugs produced by living systems repre- sent the largest class of drugs currently under development by the biotechnology and biopharma- ceutical industries1. Despite the fact that small molecule drugs still continue to dominate the majority of the US Food and Drug Administration (FDA)-approved therapies, advances in technology and increases in our knowledge of subcellular pro- cesses in relation to multiple disease states have exponentially increased biomarker identification and therapeutic targets for protein-based biologics.
Drug Discovery World Summer 2017
Over the last decade, global economic decline has driven the pharmaceutical industry to re-evalu- ate its business model and revise discovery process- es. This has created a large paradigm shift in the way pharma approaches drug discovery. New ther- apeutic entities (NTEs) have been on the decline, however pressure remains to fill the ever-increasing drug pipeline in order to remain competitive. Globalisation of personalised medicine is emerging as a major consideration. Pharma is now focusing on expanding scientific exploration with better tar- gets and more efficacious therapies, while still find- ing ways to emphasise big profits for shareholders. Outsourcing arose as a consequence of pharma companies thinking differently about time and
By Dr Michael Mouradian
45
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72