Drug Development
An integrated drug development pipeline
(cGMP). 2016 also served as a reminder to spon- sors that all manufacturing facilities must be com- pliant with cGMP regulations to ensure approval of their application1. However, it could be argued that the industry’s ‘class of 2016’ highlights a drug development pipeline that’s not quite as robust as we thought. Indeed, even mainstream news outlets are report- ing on the status of the industry, particularly regarding the lack of new antibiotics and dementia drugs coming through. From a public health per- spective, this is a significant concern. Taking a lead compound successfully through pre-clinical studies, formulation development, reg- ulatory submission and into the clinic is not an easy task; the road to market approval is littered with discontinued drug projects. But now, more than ever before, it seems there is a real need to improve efficiencies in drug development to reduce timelines and costs to ensure the pipeline is fit for the future. Companies need to consider new approaches that will lead to timeline reduction so that drugs are more profitable to fund the next wave of treatments.
Combatting fragmented thinking in pharma
Set against a backdrop of squeezed global health- care budgets, increased regulatory complexity and an ongoing war on attrition, many pharmaceutical companies are reviewing how they approach drug discovery in order to reduce drug development timelines and ensure every dollar invested delivers maximum ‘bang for buck’.
Like many other industries dependent on the col- lective efforts of multiple teams made up of highly skilled specialists, the pharmaceutical industry has historically been vulnerable to a ‘silo’ mentality, characterised by ineffective inter-departmental communication and poor organisational efficiency. Of course, these silos are not there by design. Silo mentality typically develops as a result of poor
50
top-down management or flawed organisational structure. Perhaps teams have competing interests, or significant operational overlap. Ultimately, the outcome is the same: critical information and pro- cedural best practices do not flow freely between groups. This can lead to decisions being made based on incomplete or out-of-date information, often resulting in increased workloads, missed deadlines and outcomes that do not meet the desired goals or specifications. For the pharmaceutical industry, a silo mentality is highly problematic. For starters, fragmented thinking is a major source of workflow inefficiency and often results in the duplication of efforts. Not only does this result in wasted time and invest- ment, it can also throw up critical development challenges when issues need not have arisen. For example, performing poorly thought out pre-clini- cal toxicology studies using conditions chosen sim- ply due to departmental preference, rather than because of their relevance for the drug project as a whole, can unduly raise questions about product safety simply due to poor experimental design. While the duplication of data collection can be a waste of time, effort and resources, the absence of critical data can be terminal for a drug develop- ment project. Misunderstandings and oversights due to poor communication can lead to critical data simply being left off the list. When it comes to making decisions on project direction, without all the necessary data at hand, poor decisions can be made.
Bringing a medicine to market is a multidisci- plinary endeavour that relies on the cumulative efforts of individual teams in order to be successful. Few development challenges occur in isolation; the solutions adopted to fix one problem can have a sig- nificant impact on another. Efforts to improve drug molecule potency by tweaking the structure of an API, for example, can have significant implications for the formulation team. Without recognising the consequences of development decisions, fragmented
Drug Discovery World Winter 2017/18
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
