Marie-Hélène Raigneau, Co-Chief Operating Officer The company selected Altasciences, a leading contract research organization (CRO) and contract development and manufacturing organization (CDMO), to guide them through the drug development journey.
Employing their integrated approach, Altasciences oversaw all operations of the clinical drug development process, including clinical monitoring, project management, biostatistics, TK bioanalysis, and medical writing. They also coordinated collaboration between different specialty functions using their proprietary communication and scheduling software, streamlining interactions internally and with Alzamend’s teams.
Altasciences conducted the multiple ascending dose (MAD) study to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions; to determine the maximum tolerated dose in healthy young and elderly study participants. Their partnership enabled Alzamend to proceed to the next step which was completing the clinical portion of Alzamend’s Phase IIA, MAD clinical trial for the treatment of dementia related to Alzheimer’s.
This is just one of the many successes achieved through Altasciences playing a pivotal role in a client’s drug development process. Combining expertise, advanced technologies, and a customer-focused mindset, the team at Altasciences is disrupting the traditional outsourcing model, particularly for small to midsize biopharmaceutical companies. They safely expedite development, eliminate silos and handoffs, and offer customized solutions through their carefully crafted integrated approach.
“Our unique model allows us to optimize efficiency and safely deliver substantial time savings without compromising the integrity of the drug development process,” says Marie-Hélène Raigneau, Co-chief Operating Officer at Altasciences.
Harmonizing Operations for Faster Results
Altasciences offers a full spectrum of drug development services using a proactive solution approach. The organization specializes in the early phases of drug development, from discovery to clinical proof of concept (and beyond). They employ approximately 2,000 employees across nine sites in the U.S. and Canada, as well as an office in the UK. Altasciences offers a wide range of services, including nonclinical studies, clinical trials, bioanalysis, regulatory affairs, formulation, manufacturing, and biometrics. The company effectively unites experts from various disciplines and phases of development to collaborate seamlessly and efficiently.
Quality and customer experience are top priorities for Altasciences, and operational integration plays a crucial role in achieving these objectives. Spearheading this approach is their program management team. Program managers act as the primary point of contact for clients, proactively managing timelines and ensuring swift action and effective mitigation of challenges. The objective is to effectively communicate client preferences, proactively communicate changes or challenges, and provide consistent and regular updates on crucial details. They also save clients from time-consuming contract negotiations with multiple vendors.
Altasciences’ ability to foster and support a cohesive and synergetic approach is largely powered by the vision to create a simple and easy one-stop solution for drug development supported by proprietary tools they have developed that facilitate effective teamwork and scheduling.
The team at Altasciences can plan your clinical program while your preclinical safety assessment is ongoing so that you can initiate your first-in-human trial as soon as you receive regulatory approval. For example, they can update your Investigator's Brochure while your IND-Enabling studies are in progress, or start first-in-human trials sooner by timing small-scale drug formulations with clinical conduct. Tools like Altasciences’ centralized scheduling planning system, empower program managers to oversee all project schedules, anticipate potential challenges, and make proactive adjustments.
Moreover, Altasciences’ proprietary Ask Albert tool provides a centralized repository of important client details, including historical study information, client preferences, and project objectives. The database eliminates the need for clients to repeat themselves or start from scratch when working with different teams, services, or phases within Altasciences. The company provides a unified experience where clients can benefit from working with a single, proactive team dedicated to safely accelerating their drug development journey.
Our unique model allows us to optimize efficiency and deliver substantial time savings without compromising the integrity of the drug development process.
Each of these elements collectively contributes to a client-centric, integrated approach, streamlining operations and allowing focus to remain on flexibility and innovation.
Each project Altasciences undertakes demands constant scientific and operational strategy to overcome complex obstacles, and safely expedite drug development. Renowned for their CNS expertise (substance abuse, depression, PTSD, and anxiety, etc.), and given the expanding body of research suggesting that psychedelics could treat CNS disorders, they expanded their offerings and established the necessary expertise to conduct studies with psychedelics for therapeutic use. In addition, they introduced pain models and procedures (e.g., CSF sampling), showcasing their dedication to improving their capabilities and meeting evolving client demands.
Architecting Advancements in Life Sciences
Altasciences was founded on the vision of transforming the outsourcing landscape in drug development. Operating in a fast and complex environment, they invest significant resources into strategizing ways to simplify the drug development process, as they understand improving operational efficiency and flexibility, as well as facilitating communication translates to superior service for clients.
The company recognizes that each client and project has diverse needs, including end-to-end support or targeted assistance for a specific service.
The secret to Altasciences’ success lies in their focus on customer experience, scientific and operational strength, comprising like-minded professionals with extensive drug development expertise and a firm belief that there is a better way to navigate this complex landscape.
“Altasciences focuses on the success of their clients by creating a place where employees embrace the excitement of driving novelty and making a tangible difference in patients' lives worldwide,” says Raigneau.
Altasciences’ crew of employees holds a collective understanding of their work's profound impact on global health, which fuels their motivation to be flexible and communicative, and therefore deliver high-quality results. Every team (all phases and services) collaborates closely with one another, with all scientific and operational teams reporting to two co-chief operating officers to avoid silos. Similarly, project successes are shared by the entire organization, with employees feeling a unified sense of achievement.
Altasciences takes pride in their involvement in the early stages of drug development, recognizing the significance of their contribution to the industry. “We contributed to approximately 10 percent of all successful FDA approvals in 2022 alone,” says Raigneau.
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Altasciences is a place where employees embrace the excitement of driving novelty and making a tangible difference in patients' lives worldwide.
Altasciences’ passionate workforce is backed by an internal culture that drives them toward triumph. Employees live and breathe the company’s core values of Customer Focus, Quality and Excellence, Integrity, Respect, and Employee Development; employees feel empowered and motivated to deliver the best possible experience for clients.
Matching the growing demand for their services, Altasciences is increasing capacity at existing nonclinical sites and expanding their bioanalytical lab infrastructures. They have set sights on expanding their operational presence in Europe, with the recent opening of an office in the UK. Equipped with the necessary resources, expertise, and connections, Altasciences is ready to fulfill any client demand, from nonclinical to clinical studies for a wide range of therapeutic indications.
The company is continuing to expand their CDMO operations, fueled by their partnership with Alladapt Immunotherapeutics. Having developed the formulation and manufacturing processes to meet their Phase I/II clinical trial needs, Altasciences has been contracted to continue the process with the construction of a new 53,000-square-foot building that will meet Alladapt’s Phase III and commercial requirements.
In a world where time and innovation are crucial, Altasciences is paving the way for groundbreaking advancements in drug development with their integrated, proactive approach, cutting-edge technologies, and a team driven by a collective vision. Pharmaceutical and biotechnology companies can rely on Altasciences to optimize their processes and safely bring better therapies to market faster.
