At BioDuro, early-stage engagement typically begins with assigning a project manager upon receipt of an RFP. This person coordinates internal efforts to collect detailed responses from the relevant scientific and operational teams. The compiled information is reviewed, validated, and shared with the biotech partner. These discussions often continue as needed to clarify scope, address technical considerations, and ensure alignment on feasibility and expectations.

BioDuro supports biotechs during lead optimization by contributing to compound design, synthetic route development, biological evaluation, and DMPK profiling. In addition, our platforms with catalyst screening, photochemistry, flow chemistry and library synthesis enablement allows for rapid problem solving to move projects forward. 

Single site location for cross-functional collaboration between discovery chemistry, biology, and pharmacokinetics allows for reduced cycle time and timely data generation, allowing for rapid decision-making. This integrated approach, with a single project manager POC, also enables efficient progression from lead optimization to preclinical candidate selection, including the ability to conduct in vivo PK and PK/PD studies when appropriate.

Involving a CDMO like BioDuro at the stage of preclinical candidate selection is often beneficial. This is the appropriate time to introduce the compound to the process development and pre-formulation teams, who can begin evaluating manufacturability and formulation strategies. Early involvement helps reduce later-stage risks and supports a smoother handoff into IND-enabling studies.

When a discovery-stage molecule is introduced with minimal data, BioDuro’s technical teams assess whether additional characterization is needed. Common activities include solubility profiling, salt and polymorph screening, and evaluation of other physical properties. These steps help determine appropriate formulation strategies. Early pre-formulation and formulation screening also enable execution of in vitro and in vivo studies, which are critical at this phase of development.

BioDuro has developed integrated capabilities across discovery chemistry, biology, and DMPK to facilitate a seamless progression from hit validation through to candidate selection. At the point of preclinical candidate nomination, our process and formulation development teams are brought in to begin planning for scale-up and downstream development. This structured handoff allows for continuity across project stages. In one representative program, over 400 compounds were synthesized and tested within 16 months using this integrated workflow.

BioDuro manages resource planning by assigning dedicated project teams to each biotech partner. These teams include scientific staff, group leaders, and directors who are aligned with project needs and timelines. We have multiple sites for chemistry where clients can locate their teams along with needed analytical teams. 

If integrated support across chemistry, biology and DMPK are needed, we have two sites enabled for cross functional collaboration. Each of these sites can support multiple clients with dedicated labs for IP security.

Having a large and experienced scientific workforce allows for flexibility and scalability while maintaining delivery standards across concurrent programs.

Timeline projections at BioDuro are based on scientific assessment and past experience. If risks are identified—such as potential delays from complex chemistry or external shipping issues—clients are informed early, and backup strategies are discussed. Open and ongoing communication is central to this process. The goal is to work collaboratively with biotech/pharma partners to manage uncertainties and maintain alignment throughout the project lifecycle.

BioDuro maintains transparency through regular updates, including weekly meetings, detailed written reports, and ad hoc discussions when needed. Teams operate with a strong sense of ownership and responsibility. All scientific activities are recorded in lab notebooks and electronic systems in accordance with regulatory expectations. Internal QA audits and client inspections are routinely conducted to ensure traceability and compliance throughout the development process.