Drug Discovery Productivity at Enveda —Biotech Innovation with Big Pharma Efficiency

“Most drug discovery projects follow a standard life cycle (left). Any slow step will slow down the entire process, resulting in drug discovery productivity losses.  Efficiency gains must address the rate-limiting steps.”

Most drug discovery projects follow a standard life cycle (left). Once the initial project goals are defined, biologists build assays that can reproducibly evaluate compounds (agonists, antagonists, inhibitors, etc.) in accordance with the project goals.  Unoptimized leads are identified from various sources, such as synthetic compound libraries or natural products, and are subsequently optimized until they meet clinical candidate criteria.  This lead optimization (LO) work becomes a drill, where biologists and chemists work together to simultaneously optimize multiple parameters (right).  One can think of this drill as a three-step iteration cycle of data generation, new ideas, and synthesis of new chemical entities (NCEs).  The speed in which this repeating iteration cycle can be completed will always align with the speed in which a new clinical candidate can be delivered.  There are no shortcuts and the iteration cycle time is simply the sum of the steps:  Ttotal = T1 + T2 + T3.  Any slow step will slow down the entire process, resulting in drug discovery productivity losses.  Efficiency gains must address the rate-limiting steps.  Let’s analyze each step.

• T1:  The time it takes for a team of scientists to review new biological data, generate a hypothesis/idea and design a new compound(s) to test the hypothesis.  In my experience, this is always the fastest step (hours to days).
• T2.  The time it takes a chemist to go into the lab and prepare the new compound.  This is dependent on factors such as compound complexity, number of synthetic steps and availability of starting materials and intermediates (days to weeks).
• T3.  The time it takes from compound delivery to the generation of new biological data.  Depending on the duration of the assay and overall throughput, this is often the rate limiting step (weeks to months).

“Big Pharma leverages the advantage of having most, if not all the steps performed within their organization.  Alternatively, it is common for smaller companies to experience significant efficiency losses due to multiple hand-offs to contract research organizations (CROs).”

In addition to the actual times associated with each step, significant productivity losses occur when steps are contracted.  Big Pharma leverages the advantage of having most, if not all the steps performed within their organization.  Alternatively, it is common for smaller companies to experience significant efficiency losses due to multiple hand-offs to contract research organizations (CROs), especially in T2 (synthesis) and T3 (new biological data).  Negotiations, shipping and priority conflicts within the CRO can cause significant delays in iteration cycle times.  Additionally, real time strategy changes and course corrections are more difficult when CROs are doing specific contracted work.  At Enveda, we have a tremendous advantage because all chemistry and most biology, including in vitro and in vivo testing,  is done by Enveda full time employees (FTEs) in Enveda labs – something few startups can boast of.  Thus, our research proceeds without delay and real-time strategic and tactical priorities are managed internally to support the rapid generation of new data.  Furthermore, our employees work within a cross functional team of familiar colleagues to achieve the goals of the company together.

“At Enveda, we have a tremendous advantage because all chemistry and most biology, including in vitro and in vivo testing,  is done by Enveda full time employees (FTEs) in Enveda labs – something few startups can boast of.”

CROs are and will remain a vital part of the drug discovery process for many organizations, small and large, including Enveda.  That said, in the critical parts of the drug discovery optimization drill, significant productivity gains are realized without hand-offs.  At Enveda, our leadership realized this from the beginning and built our infrastructure accordingly, to maximize efficiency in the delivery of our goals.