Client:

‍Academic spinout developing novel biologics for treatment of pulmonary diseases.

Problem:

‍The company had many preclinical programs in parallel. They needed guidance on how to prioritize them, select lead indication and execute effectively on a limited budget with aggressive timelines.

Solution:

We formed a project-focused team of experienced drug developers, regulatory,CMC/manufacturing advisors, and project managers. The team developed a detailed, custom drug development plan (PDP) to IND. The client engaged us on a monthly retainer basis to then execute on that plan through our network of vendors. We also assisted the company in meeting with the FDA for the pre-IND meeting.

Results:

By engaging Radyus on a monthly retainer basis ensured wholistic product development planning and effective execution of the novel therapeutic modality. The company is now entering IND-enabling studies.

Related Radyus Services:

‍+ Product development plan (PDP)

+ Monthly FTE retainer model

+ Pre-IND meeting coordination

+ Regulatory and manufacturing advisory

Client:

Biotech company developing orally delivered enzymes for metabolic diseases.

Problem:

Company had an asset efficacious in several metabolic diseases. They needed to prioritize and focus their funds, while maximizing the company value. The company was also actively fundraising and needed clear indication prioritization to attract the right investors, while insuring competitive advantages in the market.

Solution:

We took a systematic approach to indication prioritization by developing a target product profile (TPP) for the lead asset. We conducted in-depth interviews with physicians, payors and investigators in the areas of interest to inform our analysis.

The TPP also provided clear use of proceeds for the next clinical stage of development and informed the experimental roadmap to preclinically validate new claims identified in the TPP.

Results:

The TPP helped formulate clear product development strategy, select lead indication and best position the company for fundraising.

Radyus Related Services:

+ Target product profile

+ Indication selection

+ Fundraising strategy

‍

Client:

Academic spinout developing novel drugs for oncology.

Problem:‍

Given the early stage of the company, client was mostly funded through grants and had a limited budget for R&D. Their recent grant was awarded for two animal studies, but with the proposed experimental protocols and their own CRO reach-out, the client was getting quotes three times greater than what the grant would cover.

Solution:

‍Radyus team worked to first modify these two experimental protocols in such a way that the scope of work was reduced, but the critical data to be collected was preserved. We modified the number of animals, the number of test samples and the dosing schedule.  Then, we reached out to our preferred subcontracting labs for quotes. We have over 2,000 specialty labs in our proprietary database and can do a custom RFP for each project. We identified a lab that could execute both studies under the modified protocols.  We also negotiated  a volume-based discount, enabling us to fit the client’s budget.

Result:

Radyus was able to work creatively with the client ona limited budget and execute both animal studies.

Radyus Related Services:

+ Experimental protocol development

+ Budget-conscious planning

+ Vendor reach-out and management

+ Project management

Client:

‍Venture-backed, preclinical stage immuno-oncology company

Problem:

‍Company in-licensed a portfolio of novel monoclonal antibodies but had limited knowledge on the signaling pathway modulated by the antibodies and had no internal expertise in designing in vitro assays to select for efficacy. The company needed to evaluate the antibody portfolio for efficacy in a new in vitro assay to select a smaller cohort of lead antibodies.

Solution:

We conducted scientific diligence to investigate the mechanism of action of  novel antibodies and identify best downstream biomarkers. We then developed protocols for in vitro assays to test efficacy and select a smaller cohort of lead antibodies. We also identified vendors and project managed execution of efficacy experiments. Finally, we informed the next round of critical experiments towards selecting the lead clinical candidate.

Result:

Scientifically and strategically driven product development to accelerate lead candidate selection.

Radyus Related Services:

+ Custom immunoassay development

+ Scientific consulting

+ Lead candidate selection