Redefining Early Stage Development
Redefining Early Stage Development
Redefining Early Stage Development
At BDD we have over 25 years’ experience developing, manufacturing and clinically testing pharmaceutical products. We offer a single point solution to get phase I clinical data faster by eliminating unnecessary steps that cost our clients time and money.
We call this Lean Clinical Development™
Lean Clinical Development disrupts and streamlines the traditional early drug development approach, accelerating timelines and reducing waste. Bringing together phase-appropriate development with “just in time” manufacturing and clinical agility, we deliver the fastest path to phase I data providing you with a competitive edge. As a combined site, CRO and GMP manufacturing facility, BDD offers a responsiveness and adaptability that larger CROs can’t match.
BDD has 25 years experience in drug delivery, developing advanced formulations to optimise therapeutic outcomes.
Our formulation capabilities span from simple capsule/tablet dosage forms for rapid clinical evaluation to complex modified-release profiles using techniques like hot melt extrusion and our proprietary OralogiK technology.
BDD offers flexible GMP Manufacturing for early-stage clinical trials. We provide cost-effective, rapid GMP manufacturing of small batches of clinical trial supplies and matching placebo.
For clinical studies performed through our Lean Clinical Development pathway, we offer our clients just-in-time manufacturing, eliminating the need for lengthy stability programmes and accelerating time to first dose.
We have been conducting Phase I clinical studies for more than 20 years. With industry leading recruitment rates and integrated CRO and site service, BDD’s processes are designed to streamline the clinical pathway, reducing costs for our partners.
Our unique mix of medical and scientific staff means that we approach studies differently. Bringing together our in-depth knowledge of formulation development and biopharmaceutics ensures a sound scientific basis for every study.
BDD has over 25 years of success conducting early-phase confirmatory clinical trials.
Established in 1999 by scientists, BDD has consistently placed great science at the forefront of everything we do.
BDD has a superb track record of reliability, supporting clients from formulation through to the clinic, with hundreds of satisfied partners.
BDD’s Lean Clinical Development™ approach significantly accelerates traditional development pathways.
For decades, BDD has built a robust and effective database of volunteers and patients, achieving an industry-leading 80.2% screening-to-enrolment rate. With BDD, your study starts on time.
“As a biotech start-up company, we knew we had to lean heavily on BDD’s expertise and disciplined processes to navigate the complexities of MHRA regulatory submission, manufacture radiolabeled material, manage complexity of a combination product, and the execute a meaningful, 5-way crossover, PK/PD study. The seamless team dynamic and expertise at managing critical vendors, while communicating clearly and with precision throughout truly set them apart. After more than 35 years of running Phase 1 trials, I can confidently say this team ranks among the best in the Phase 1 space.” – David Skarinsky – SVP Clinical Development
“We cannot thank this team enough for all the hard work that led us to this point! The flexibility, the promptness, the communication. One of the best sites we’ve worked with, a truly cohesive team.” – Kiana Robinson – Project Manager
“With industry leading scientific expertise in clinical imaging and drug product design, BDD was an ideal partner for early stage clinical evaluation of complex drug products and implementation of new imaging approaches.” – Matt Burke – Vice President, Technical Operations & Product Development.
Formerly Senior Director, Head of Drug Delivery and CMC Leader at GSK
“We are happy to collaborate with BDD Pharma – their technology as well as integrated setup for early exploratory clinical testing is a great match for us and allow us to advance our Parkinson´s disease program towards patients.” – Anders Brandt Elvang – Chief Business Officer
“BDD was able to think out of the box in approaching some unusual formulation challenges in our development program. We were able to work interactively with BDD to get our new drug formulation program off the ground.” – Thomas Jozefiak – Chief Scientific Officer
“Cingulate appreciates BDD’s collaborative approach which consistently takes into consideration our priorities. This has allowed us to progress our clinical program for our ADHD clinical candidate. We certainly can recommend BDD for anyone seeking a reliable partner.” – Laurie Myers – Chief Operating Officer
BDD Completes Successful Dosing of all Patients, on Schedule, in Head-to-Head Clinical Study of Investigational Subcutaneous Furosemide (SQIN-Furosemide)