BioPharmaWorks a preferred partner in drug discovery
Headquartered in Southeastern Connecticut,BioPharmaWorks brings in-depth and broad education and experience across multiple disciplines to bear on drug discovery. The goal is to work as collaborators with our partners, pioneering medicinal solutions to address unmet medical needs. BioPharmaWorksdelivers a soup-to-nuts approach to drug discovery. Our consulting serves to align and guide research direction, with the goal to pioneer and develop unique intellectual property for further advancement. We execute by managing an extensive CRO network, applying our highly specialized expertise to solutions with our partners. With over 300 years of combined experienced at the world’s leading pharmaceutical company, our post-Pfizer scientists remain active members of the global scientific community, working together and with partners to create positive contributions in the field of pharmaceutical science.
Get in touch
Progress and a better life is within reach. Let’s collaborate. There is no limit to what we can discover together.
Email Us ▸
consultancy services and drug development
ADME AND DMPK
We apply our extensive experience in pharmacokinetics and drug metabolism to support our clients’ discovery programs. This involves defining near and long-term project objectives related to the identification of NCEs possessing the appropriate predicted human efficacy and pharmacokinetic properties. We work with a network of CROs able to assess the absorption, distribution, metabolism and excretion characteristics of compounds of interest. We then optimize compound properties for a particular indication.
INDICATIONS DISCOVERY AND SYSTEMS BIOLOGY
We use our extensive experience in pathway analysis to validate molecular targets of interest to our clients, using a variety of proprietary and public resources. We research MOA to discover new indications for novel or existing client compounds as well as to uncover possible adverse effects of leads at an early stage. We identify appropriate CROs, suggest assays for efficacy and toxicity, and provide expertise in interpreting the results. We can analyze drug targets plus preclinical and clinical data of small molecules and biologics in the portfolios of companies and academic institutes for our clients. Together with other colleagues in the company, we conduct patent search and analysis to establish patentability, residual patent life and potential commercial value of client projects.
LEGAL AND INTELLECTUAL PROPERTY
BioPharmaWorks understands our clients’ variable needs to identify + protect their intellectual property and other associated legal issues. Whether the program be first in field, unraveling literature in a crowded area or dealing with regulatory issues, we have the experience to identify the strategy to move your project forward.
Our clients realize that legal costs can be among the largest expenses for supporting a new program. Arbitraging these substantial costs of securing IP, we access skilled database searchers, prepare technical documents that our clients can take to their own Patent Attorneys or use law firms we have relationships with to cost effectively progress a research program. Whatever your goals are, we can provide the technical support to draft documents that enable valuable IP.
MEDICINAL CHEMISTRY
Medicinal chemistry is at the heart of our effort with most clients. We aim to understand our client’s objectives and work with them-defining a drug discovery screening funnel required for efficient program progression. Clients often bring screening results and lead compounds to begin the journey and we provide a thorough literature review to define new targets and provide plans to optimize activity and medicinal properties with predictive tools. Often the biological target is the only starting point, and we aim to identify novel IP to develop into drug candidates. Working with a number of CROs with broad capabilities, we manage compound synthesis, initial property assessments and behavior in metabolism assays to create a database of compound characteristics. Structure-activity relationships (SAR) are gathered and we work directly with clients as the journey progresses and compounds are optimized for development
PRODRUG EXPERIENCE
Frequently, issues with drug exposure at specific tissues necessary for therapeutic action is compromised by metabolic effects. In such cases it may be possible to study and develop a prodrug of the active ingredient. The prodrug, after administration, is designed to be metabolized into a pharmacologically active agent that reaches the therapeutic target + provided the desired efficacy. Our long and extensive experience with prodrugs allows us to rapidly assess prodrug option to improve how a medicine is absorbed, distributed, metabolized, and excreted (ADME). This is often necessary to improve bioavailability when a drug itself is poorly absorbed from the gastrointestinal tract or to avoid drug interacts with cells or processes that are not intended target. Over 15% of currently available medicines are prodrugs, making this expertise a key facet to many projects we encounter with our work.
NEUROPHARMACOLOGY
Our combined experience in discovering and developing drugs for Central Nervous System (CNS) disorders makes BPW an ideal partner for overseeing CNS projects. We provide a team of experts with deep knowledge and understanding of issues specifically associated with CNS drug development. We provide specialists in chemistry, ADME, preclinical models, in vivo microdialysis and clinical statistics. In addition, we will work with appropriate CROs to support projects and move them forward.
PRECLINICAL AND CLINICAL STATISTICS
We apply our expertise + experience in pharmaceutical statistics to provide support to drug discovery and development projects from preclinical, through all clinical phases, and including regulatory submission. Areas of support include design and analysis planning for preclinical and clinical studies, clinical development plans, analysis and interpretation of study data, statistical evaluation of interim safety and efficacy results. In addition we provide membership in independent data and safety monitoring boards (DSMBs) plus due diligence evaluation for investment and in-licensing decisions.
PROCESS DISCOVERY AND DEVELOPMENT
We provide scientific oversight for the development of API syntheses + develop strategies for initial scale-ups (GMP or non-GMP) with appropriate vendors. BPW helps with the quality audits of the GMP vendors. We evaluate the control impurity profile of the API and set specifications at every stage of development. In addition, we qualify impurities in tox. We support polymorph screening efforts and shore up the IP strategy with polymorphs. We also can write the CMC section for the IND and establish the strategy for early or late formulations and recommend appropriate vendors. We support clinical trials by ensuring appropriate flow of supplies to clinical sites in US and elsewhere and provide Pharmaceutical Sciences risk assessments for potential licensing deals.
STRUCTURAL BIOLOGY
We use our extensive experience in structural biology as applied to drug discovery to help clients in different ways. We work with CROs either in the US or overseas to execute structure projects for clients. Whether for a totally new target or one that has been solved before, we can work with the clients and the CRO to design constructs, apply appropriate purification and crystallization strategies, and obtain novel structures of their protein targets bound to lead molecules. We also apply our knowledge of structure-based drug design to help clients use existing structural information to guide their chemistry design. In addition, we provide guidance for the successful execution of biophysical assays such as SPR, MST or TSA for fragment screening campaigns.