With new therapies and evolving science, the need to continually adapt the methods and capabilities of drug development to meet the changing demands is necessary. Early-phase studies have become increasingly more complex as there is more demand for early proof of concept explorations and the need to evaluate more data and endpoints in preliminary first-in-human studies. This is where Altasciences steps in with its cutting-edge solutions and services dedicated to early-phase drug development. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete program decisions.

Today, Altasciences is a unique player in the contract research organization (CRO) and contract development and manufacturing organization (CDMO) space thanks to its holistic approach to early-phase drug development. Unlike traditional CROs that may focus on one or a couple of steps in the process, Altasciences emphasizes a unified continuum, streamlining the journey from lead candidate selection to clinical proof of concept, and beyond. The company integrated preclinical research, clinical research, bioanalysis, drug manufacturing and formulation, with the option  for biotechnology and pharmaceutical companies to partner with Altasciences for one study, a package, or a program.

The company’s approach, termed Proactive Drug Development, aims to provide comprehensive solutions by integrating the various aspects needed for of early-phase drug development into a single platform. With this approach, Altasciences simplifies the outsourcing process for sponsors, enabling them to advance their molecules more efficiently. “We have established an alternative paradigm that removes operational silos and inefficiencies to allow data to flow seamlessly and efficiently between phases,” explains Steve Mason, Co-chief Operating Officer, Altasciences.

Central to Altasciences’ success is its robust project management, exemplified by a remarkable case study where the company shortened a sponsor’s start-up time from the standard 12 weeks to just 3.5 weeks. Through effective collaboration among cross-functional teams and the implementation of a dual project management structure across different time zones, Altasciences achieved rapid contract execution, regulatory document preparation, Institutional Review Board (IRB) approval, site initiation, participant recruitment, and database/eSource release. On a detailed note, the team assisted a company with an immediate need to conduct their required Phase I, multiple ascending dose (MAD) study for a regulatory filing. To meet their goals, it was essential that Altasciences shorten the start-up time (time from award to first dose) from a standard of 12 weeks to less than four weeks. Tasks to be completed during this immensely shortened timeframe included contract execution, regulatory document preparation, and Institutional Review Board (IRB) approval; preparation of documents and supply procurement for clinical, pharmacy, and laboratory procedures; site initiation and training; subject recruitment and screening; and clinical database/eSource release. The sharp focus on the early phase of the study allowed the team to meticulously review tasks and identify areas where time could be saved, thus completing every process faster and with the most efficiency. Collaboration among cross-functional teams allowed start-up tasks to be completed in parallel. Once the sponsor’s KPI was achieved, the team’s attention shifted to the remainder of the timeline, ensuring continued efficiency throughout the study’s duration.

Looking ahead, Altasciences remains focused on expansion and innovation. With the establishment of its first office in the UK in 2022, the company is poised to further expand its presence in Europe. Additionally, Altasciences continues to evolve its capabilities and methods, particularly in the realm of biologics, with a strategic focus on gene therapy, antibody, and cell-based therapies. By connecting with clients earlier in the drug development cycle and partnering with them throughout their journey, Altasciences aims to spearhead the future growth and success of the pharmaceutical industry.

Altasciences is not merely a CRO/CDMO but a transformative force driving change in the landscape of early-phase drug development. With its pioneering integrated approach, robust project management, client-centric focus, and commitment to innovation, Altasciences is revolutionizing the way sponsors can have their medicine and therapies developed, bringing better drugs to the people who need them, faster. “We are also constantly evolving our preclinical, clinical, bioanalytical, and formulation and manufacturing capabilities and methods to meet the changing demands of our clients and the industry,” concludes Chris Perkin, CEO, Altasciences.