Frequently Asked Questions
Regarding Interest in Specific Models
Yes. In addition to the 80 models featured on this website, Melior has validated dozens of additional models covering most therapeutic areas. Furthermore, Melior routinely engages with clients in establishing and customizing new models.
Yes. Melior can initiate most studies within days. We have more rapid turnaround than offshore providers. Pricing varies depending on the model and number of groups, and Melior provides significant discounts with increasing work.
Yes. Melior’s scientific staff is highly trained with an average of 8 years experience performing complex in vivo pharmacology studies. 100% of partners requiring additional work have returned for further studies; many have extended the collaboration by entering an FTE-based arrangement.
Of course. Melior scientists discuss the aims of an experiment with the partner and often incorporate suggestions not originally considered.
Regarding Longer Term Partnership
If Melior is able to arrange a steady workflow over a period of time then it is realizes significant economies-of-scale which it can, in turn, pass on to our partners.The resulting cost difference results in a large cost reduction for the partner.
Melior has brought Lean Manufacturing know-how to the biology bench as part of the Company’s core competence of in vivo pharmacology and high-throughput in vivo screening. Therefore, Melior is able to work more cost-effectively than a company which has not integrated the same level of process development to in vivo pharmacology. Moreover, a partner has much greater flexibility to reduce costs with Melior, as in vivo pharmacology needs or strategic priorities change.
Melior’s core competence, for which it has developed unrivalled capability, is with in vivo pharmacology and high throughput in vivo screening. Since our founding in 2005, Melior has evaluated hundreds of compounds through thousands of thousands of experiments representing many dozens of animal models. Much of this has involved partnerships with more than half of the top ten pharmaceutical companies.
Moreover, Melior has engaged many key opinion leaders (KOLs) representing specific therapeutic areas such as diabetes, Parkinson’s disease, NASH, fibrosis and lipodystrophy in order to become more familiar with current opinions regarding. treatment options and medical need in specific therapeutic areas.These KOLs assist in identifying the most appropriate, clinically translatable animal models that relate to these clinical areas.
Following discussions with a partner to establish the general goals and scope of a pilot, Melior can provide a proposal for a specific body of work including price and timelines. Upon successful completion of that pilot, at its option, the partner can transition to a “per FTE” arrangement.
Regarding Drug Repositioning and Phenotypic Screening
Melior’s approach is the only one that uses phenotypic screening with high quality, clinically translatable endpoints. There is a growing realization that phenotypic screening is an effective means for identifying new uses for compounds and, in many respects, more productive than “hypothesis-driven” approaches*.Moreover, animal models (as opposed to in vitro-based approaches) provide the highest quality of phenotype by virtue of interrogating a fully assembled biological system, as opposed to reductionist methods that use isolated cell or cell-based systems without the context of their normal physiological milieu.
*(Swinney, DC and J Anthony (2011).How were medicines discovered? Nat. Rev. Drug Discov. 10 (7), 508-519)
No. About 90% of the instances of newly uncovered indications are the result of on-target effects. Therefore, for a compound that is the product of modern-day medicinal chemistry, the compound has already been optimized for that target.
No because:
- Animal models remain the best predictor of clinical efficacy since, in a preclinical setting, they most faithfully recapitulate the complexities of assembled biological systems. This includes the presence of complete target systems, pharmacokinetic features, and dose-limiting events.
- The extent to which animal models have better or worse translatability is therapeutic area dependent (e.g. Diabetes — very good; Cancer — very poor ).
- Candidates are not advanced based upon animal model data alone.
No. Melior’s theraTRACE® platform addresses these issues by dramatically reducing the number of animals required, the FTE resource and the amount of test article to a fraction of what would be required compared to running the models independently of one another. We have accomplished this without compromising the quality of the animal models.
Based on Melior’s experience screening hundreds of compounds through theraTRACE®about 1 in 3 compounds have presented with potential new indications. This number is also consistent with literature precedent (e.g. Radley, D.C., Finkelstein, S. N., and Stafford, R. S. (2006) Off-label prescribing among office-based physicians. Arch Intern. Med 166 1021-1026.)
For an individual compound analysis Melior’s theraTRACE® is typically an 8-10 week process depending upon whether Melior first performs PK analysis and dose-finding studies for the partner. In a typical engagement where Melior is provided 10-20 compounds to screen through the platform, Melior would usually complete all analysis within 6 months from when the compound is received.
If you have any additional questions, please don’t hesitate to contact us at [email protected] to start the conversation.