Personalised Medicine
Figure 1: Hurdles for personalised medicine development across various therapeutic classes
Therapeutic area impacted
Neurodegenerative diseases [Parkinson’s, Alzheimer’s] Schizophrenia, depression, other psychological disorders Breast cancer
Leukaemias/haematological cancers Other cancers/oncology HIV infection/AIDS
Cardiovascular diseases Drug toxicity/adverse drug reactions Large hurdles need to be addressed
79% 59% 19% 35% 48% 51% 60% 50%
Hurdles are not that high
21% 41% 81% 65% 52% 49% 40% 50%
l OncoType Dx21™ from Genomic Health [offered under CLIA exemption as a means for patient stratification based on probability of recurrence of breast cancer and for guiding chemotherapeutic regimens] l MammaPrint™ from Agendia [US FDA approved as a means for patient stratification based on probability of recurrence of breast cancer] l EGFR-targeting therapeutics: Vectibix®, Erbitux® [US FDA approved]
Source: Select Biosciences Industry Report
platforms for companies to engage with them. Later in this article, we will focus in brief on the steps involved in such newly-introduced proce- dures, an outline of data package required towards gaining formal regulatory acceptance of biomark- ers into drug development strategies and as tools in companion diagnostics.
As part of its industry analysis, Select Biosciences has assessed the various challenges in the development of personalised medicine-based therapeutics. There are hurdles – technical, legal, regulatory, commercial and socio-political – that need to be addressed in the context of personalised medicine and these hurdles serve as challenges to the industry. Figure 1 classifies the various thera- peutic areas potentially addressable by person- alised medicine according to hurdles that need to be addressed as part of personalised therapeutic development. In our industry analyses, we have deployed market surveys of worldwide industry participants as a means to map the qualitative and quantitative market metrics. By looking at the dis- tribution of participants from the market respon- dent pools, we can address how a given parameter distributes across the industry. The percentages in Figure 1, for instance, reflect the position of the respondent pool vis-à-vis various therapeutic areas – and we observe that in the three areas where the hurdles are not that high – ie breast can-
86
cer, leukaemias/haemato-logical cancers, and across the oncology space, current product offer- ings are already on the market. Cancer person- alised medicine is therefore at the leading-edge of the broader personalised medicine marketplace. As part of our industry tracking, we have also evalu- ated the macro challenges that exist in the person- alised medicine space – these impact the field broadly rather than being restricted to a given dis- ease/therapeutic class. Figure 2 presents the data (the size of each bar is proportional to the pene- trance of that particular challenge into the person- alised medicine industry community). As can be observed, there are three major messages from these data: [a] Unclear regulatory considerations (from the EMA and FDA) are a challenge to the personalised medicine industry development; [b] In many cases it is difficult to associate diseases com- prehensively with molecular markers; and [c] Biomarkers do not exist for characterising/stratify- ing patient populations. More details on the afore- mentioned guidance from the regulatory authori- ties, presented later in this article, seek to address the concern voiced by the personalised medicine community and begin to offer a more structured platform for overcoming the regulatory concerns of the community. The difficulty to associate dis- eases with molecular markers/biomarkers that exist and the paucity of such markers is an area of
Drug Discovery World Summer 2010
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 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92