Melior Discovery FAQs
Regarding Interest in Specific Models
Q: Are the assays available and validated?
A: Yes. Beyond the 80 listed, and dozens of unlisted validated assays covering most therapeutic areas, Melior routinely engages in establishing and customizing new models.
Q: Can the study be conducted quickly and cost-effectively?
A: 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.
Q: Is there confidence that the scientific team can deliver reproducible, quality data?
A: 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.
Q: Is there flexibility in study design?
A: Yes. Melior scientists discuss the aims of an experiment with the partner and often incorporate suggestions not originally considered.
Regarding Longer Term Partnership
Q: How is an FTE arrangement with Melior Discovery more cost effective than conducting multiple independent projects with Melior?
A: If Melior is able to arrange a steady work flow over a period of time (1 year or more) then it is able to develop significant economies-of-scale which it can in turn pass on to our partners. The resulting cost difference results in large cost reduction for the partner.
Q: Why would a partner use Melior instead of hiring internally to support a program?
A: 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.
Q: What specific knowledge/ skills does Melior have?
A: Melior’s core competence, for which it has developed unrivaled capability, is with in vivo pharmacology and high throughput in vivo screening. Over the last eight years the Company 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, 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.
Q: What is the process for initiating a pilot “per project” arrangement and converting to an FTE arrangement?”
A: Following discussions with a partner to establish the general goals and scope of a pilot, Melior can provide the partner with a proposal for a specific body of work including specific 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
Q: How is Melior’s approach to drug repositioning a better direction for a pharma partners’ compounds than other approaches that are underway or have been proposed?
A: 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)
Q: Doesn’t phenotypic screen just uncover the off-target activities of a compound for which the compound has not been optimized? Doesn’t this leave a problem of: a) identifying what the target is and b)having to initiate medicinal chemistry efforts to find more potent modulators of that target?
A: No. About 90% of the instances of newly uncovered potential 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.
Q: Isn’t it an issue that animal models do not always translate well into the clinic.
A: No because:
- A) 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.
- B) The extent of this is therapeutic area dependent (e.g. Diabetes-- very good; Cancer-- very poor; )
- C) Candidates are not advanced based upon animal model data alone
Q: Isn’t it an issue that phenotypic screening in animal models is prohibitively expensive, time consuming and requires large supply of test article?
A: No. Melior’s theraTRACE® platform addresses these issues by 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 on another. We have accomplished this without compromising the quality of the animal models.
Q: How many compounds are expected to be new development candidates?
A: 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.)
Q: How long does it take for Melior to provide theraTRACE® results to a partner for potential new indications?
A: 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 compound is received.
If you have any additional questions, please don't hesitate to contact us at firstname.lastname@example.org to start the conversation.
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