Altasciences Acceleration Platform
By integrating regulatory strategy, nonclinical development, bioanalysis, manufacturing, and Phase I/II clinical execution from the outset, programs gain momentum through parallel execution instead of sequential handoffs. This integrated approach eliminates many of the traditional gaps and delays that occur between development phases, enabling faster decision-making, stronger continuity, and greater operational efficiency across the program lifecycle.
As a result, we can help reduce your drug development timelines by up to 40%, with the potential to move from first safety assessment to clinical proof-of-concept in as little as 18 months, compared to traditional industry timelines of approximately 27 to 51 months.
Keep scrolling to learn more about how it works.
Reimagining Early-Phase Drug Development
Early-phase drug development should move with clarity and momentum. By intentionally aligning the path from first safety assessment start through clinical proof-of-concept, we help sponsors reach meaningful clinical insight sooner, sometimes in as little as 18 months.”
— Marie-Hélène Raigneau
CEO, Altasciences
Why Acceleration Matters:
Changing the Trajectory of Your Molecule
In the high-stakes environment of early-phase drug development, the timing of a few critical milestones—like IND readiness, first-in-human dosing, and proof-of-concept (PoC) clinical data—can determine the trajectory of your entire program. The timing of these milestones directly influences valuation, financing strategy, and competitive positioning.
Speed was once just an operational efficiency, but now it is a strategic advantage. Programs that reach these milestones sooner gain measurable advantages:
- earlier access to capital
- earlier portfolio prioritization
- stronger investor confidence
- extended effective patent runway
- shortened burn rate to PoC
Traditional development models often suffer from "whitespace": the dead time between disconnected service providers and sequential handoffs. The Acceleration Platform eliminates this whitespace, so that you can reach your milestones sooner.
How the Platform Works: 4 Pillars of Alignment
To compress the timeline from first safety assessment to human clinical proof-of-concept, we synchronize four core workstreams:
1
Parallel Nonclinical and Clinical Planning
We don't wait for one phase to end before starting the next. Instead, regulatory positioning, safety assessment strategy, and clinical design evolve together. Translational modeling (PK/PD) is introduced early to define clinical starting doses while toxicology studies are still underway.
2
Embedded Bioanalytical Strategy
Bioanalytical method development begins alongside early PK and toxicology work, enabling clinical method readiness through earlier assay optimization, validation planning, and cross-functional alignment across nonclinical, bioanalytical, and clinical teams. This ensures assays are ready for both nonclinical interpretation and clinical endpoints on Day 1, preventing downstream delays.
3
Early Manufacturing and CMC Alignment*
By integrating formulation and manufacturing early, we ensure that GLP toxicology materials represent the intended clinical supply, reducing the need for time-consuming bridging studies.
*Applicable to small molecule programs
4
Continuous Program Leadership
Unified program management and scientific stewardship guides your molecule from nonclinical research through Phase I/Ib. This preserves institutional knowledge, establishes continuity, and ensures that nonclinical insights directly inform clinical conduct. With visibility on your entire early-phase drug development program, we can also anticipate and mitigate roadblocks before they become an issue, proactively clearing your path forward.
Faster by Design: The Tox-to-Trial Fast Track
By eliminating the traditional gaps between drug development phases, the Altasciences Acceleration Platform can significantly shorten the timelines from lead candidate to human PoC data by up to 40%. Through parallel execution of drug development activities, such as embedding regulatory, nonclinical, bioanalytical strategies with manufacturing and Phase I/II trials, we have the potential to reduce the time from first safety assessment to clinical proof-of-concept to as little as 18 months, versus industry standards of 27 to 51 months.
Achieving this level of momentum cannot be accomplished by simply working faster within individual functions/services. We’ve fundamentally shifted how development is structured, ensuring that critical scientific, regulatory, and operational decisions happen in total synchronicity from the start.
In the table below, we break down exactly how we save you time and resources by utilizing the Acceleration Platform in comparison to the traditional linear model of other CROs and CDMOs.
How We Can Get You From Safety Start to PoC in 18 Months
When the four pillars are applied, development accelerates through coordinated execution. Instead of sequential handoffs as is typical with most CROs, we can overlap key moments in the drug development journey to condense timelines.
Depending on your program design, molecule characteristics, and clinical strategy, we can accelerate your program from safety start to PoC in 18 months* by:
- Beginning regulatory planning during the safety assessment stage
- Streamlining preclinical safety studies (typically 4 to 12 weeks)
- Incorporating proof-of-concept into combined SAD/MAD protocol
*Actual timelines vary depending on molecule class, toxicology design, clinical strategy, and communication strategy.
Collaboration Unlocks Faster Drug Development
Acceleration is achieved through a strong, highly engaged partnership between Altasciences and you, the client; it’s how we unlock the full potential of speed together. From the outset, we align on expectations, milestones, and communication cadence, with a clear commitment to rapid review cycles and decisive feedback.
Our teams are structured to execute at pace, with the operational efficiencies and integrated strategies to move programs forward without delay. However, meaningful time savings depend on your ability to match that speed. Timely decisions, fast turnaround on deliverables, and proactive engagement are critical; these are what enable the Acceleration Platform to reach its full potential. We will build the fastest path forward, but it takes true partnership to move at that speed.
The Acceleration Platform
in Practice: Real-World Outcomes
Our integrated approach has delivered measurable advantages across various modalities for a multitude of sponsors:
- Small Molecule Program: With parallel planning, we enabled FIH dosing several months ahead of schedule, helping our client hit their corporate milestones earlier. Read the case study
- Monoclonal Antibodies (mAb): We achieved FIH readiness in approximately 13 months—nearly a year faster than the industry average. Read the case study
- GLP-1 Program: By coordinating execution, we ensured that our client’s complex biologic moved from safety assessment to clinical evaluation without avoidable lag. Read the case study
Everything You Need for Early-Phase Drug Development in One Place
A key component in accelerating your program’s timeline is the ability to work with one Drug Development Organization (CRO/CDMO) from lead candidate selection to clinical proof-of-concept. Our integrated solutions drive success at each milestone by designing a program that is tailored to your molecule and that unites laboratory sciences, nonclinical safety evaluation, formulation development, clinic-ready manufacturing, on-demand clinical pharmacy, and clinical pharmacology.
Not yet ready for the full Acceleration Platform experience? Rest assured that these early-phase solutions are available as standalone services or in combination with one another.
Get all your early-phase drug development needs filled by one partner:
Nonclinical Solutions
With four state-of-the-art nonclinical research facilities in North America, we offer a wide range of in vivo non-GLP and GLP safety assessments for small and large molecules in both rodent and non-rodent species to thoroughly evaluate your drug substances. Based on a custom-designed research program, we will conduct individualized nonclinical studies to ensure that your IND/NDA-enabling toxicology, safety pharmacology, and laboratory studies comply with global regulations.
Safety testing services include lead optimization studies, dose-range finding studies, preclinical pharmacology studies, PK/PD studies, cell and gene therapy development, pivotal toxicology studies, safety pharmacology studies, and more.
Clinical Solutions
As experts in early-phase clinical research, you can expect comprehensive solutions for first-in-human (FIH) trials, clinical pharmacology/NDA-enabling studies, and proof-of-concept. Our team will handle every aspect of your clinical development, ensuring seamless conduct from start to finish.
With deep expertise, timeline flexibility, and excellent enrollment results, we tailor our clinical services to suit your specific program requirements.
Bioanalytical Solutions
Benefit from comprehensive bioanalytical services, including assay and method, development, molecular biology, LC-MS, ligand binding assays (LBA), immunogenicity testing, biomarker analysis, microsampling, flow cytometry, and more, to support your journey from discovery through Phase IV. With three strategically located laboratories in Canada and the U.S. for seamless integration, we focus on delivering quality data for TK, PK, and PD analyses, critical for your nonclinical and clinical study progression.
Manufacturing and Analytical Solutions
We have formulated, tested, and/or manufactured nearly all pharmaceutical dosage forms on the market, including tablets, liquid- and powder-filled capsules, over-encapsulated capsules, nanomilled suspensions, creams, gels, powders, and terminally sterilized injectables.
Once we have formulated your drug product, our nonclinical team will evaluate its safety profile. Concurrently with these safety assessments, we develop reproducible and scalable manufacturing processes to prepare for commercialization, detailing the appropriate equipment and establishing relevant parameters.
Upon completion of safety testing and prior to beginning clinical trials, we will compile your nonclinical data, clinical trial protocols, and information about the manufacturing process to be included in your IND application.
CRO Services
Our approach synchronizes operational proficiency, medical insights, regulatory knowledge, and the resources of our nonclinical sites, wholly owned labs, clinical research unites, and manufacturing site. This integrated solution is designed to streamline and enhance your journey, providing an integrated early-phase pathway for accelerated drug development.
Complementary research support services include data management, biostatistics, clinical trial site identification and selection, clinical trial site management, clinical trial monitoring, scientific guidance and regulatory affairs, PK/PD/TK, project management, medical writing, and more.
Beyond Speed: Peace of Mind in Drug Development
In addition to expediting your timelines, the Altasciences Acceleration Platform reduces complexities and mitigates risk. We not only save you time and resources, but we also save you from unnecessary frustration.
Meet Your Milestones With Ease
With the traditional fragmented/linear model for drug development, sponsors often must carry the administrative burden of coordinating amongst multiple CRO and CDMO vendors. With Altasciences, you can stop being a coordinator and go back to being a drug innovator.
With all your early-phase program handled by us, you can save time and energy by:
- Negotiating one contract that encompasses nonclinical, clinical, bioanalytical, and manufacturing services
- Receiving coordinated invoices, simplifying finances
- Having your studies overseen and coordinated by our dedicated cross-functional program managers who use a centralized scheduling system to actively monitor and manage your study for seamless transitions
- Reducing handoffs between phases by working with one drug development organization
Never Repeat Yourself Again
Have you ever found yourself repeating your study history, details, goals, and preferences at each new study phase or when you meet a new member of the study team? With Altasciences, those days are over.
Tell Us Once™ is our commitment to communication. We’ve built a proprietary database called Ask Albert that enables us to proactively share your preferences, requirements, drug information, and study results across all internal teams. As your molecule advances, so will your important information, ensuring that you never have to repeat yourself.
Our focus is on giving you an effortless journey, powered by timely information capture, proactive communication, and smooth transitions between phases and studies. Like we always say: You only have to Tell Us Once™, and we’ll take care of the rest.
Ready to Accelerate Your
Drug Development Program?
Reach clinical insight sooner with a partner designed for speed and scientific integrity.
Connect with an Altasciences expertRelated Resources
Optimizing for Success: How Sponsors can Overcome the Challenges in Early-Phase Drug Development
Faster by Design: Altasciences Acceleration Platform for Early-Phase Drug Development
Project Management: Where Science, Strategy and Operations Converge
One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
Accelerating Safety Assessment to PoC ~Six Months Ahead of Industry Norms for a Novel Incretin-Based Therapeutic
How Altasciences Launched a Phase I Study 70% Faster Then the Industry Standard
FAQs: Altasciences Acceleration Platform
What is the Altasciences Acceleration Platform?
The Altasciences Acceleration Platform is a synchronized, integrated framework designed to compress the timeline from preclinical safety assessment to clinical proof-of-concept (PoC). By replacing traditional sequential handoffs with parallel workstreams across nonclinical, bioanalytical, manufacturing, and clinical phases, the platform eliminates "whitespace" to accelerate drug development by 30 to 40%.
How long does it take to reach clinical proof-of-concept with Altasciences?
While typical industry timelines for reaching proof-of-concept (PoC) range from 2.25 to 4.25 years, programs utilizing the Altasciences Acceleration Platform can reach PoC in as little as 18 months. This speed is achieved through integrated SAD/MAD/PoC protocols and parallel regulatory planning.
What are the "Four Pillars" of Altasciences’ accelerated drug development model?
The platform is built on four core strategic alignments:
- Parallel Nonclinical and Clinical Planning: Starting regulatory and clinical design during toxicology studies.
- Embedded Bioanalytical Strategy: Developing assays that support both nonclinical and clinical endpoints simultaneously
- Early Manufacturing and CMC Alignment: Ensuring clinical supply is representative from the earliest safety stages.
- Continuous Program Leadership: Maintaining unified scientific stewardship from nonclinical research through Phase I/Ib.
How does Altasciences reduce the time between IND-enabling studies and first-in-human dosing?
Altasciences reduces this transition—the "Tox-to-Trial" track—by initiating regulatory dossier preparation and clinical site selection on Day 1 of toxicology studies. This synchronized planning ensures that first-in-human (FIH) dosing can occur immediately following IND approval, bypassing the typical inertial lag found in linear development models.
Why is drug development acceleration considered a strategic advantage for biotech companies?
Acceleration is more than operational efficiency; it is a financial and competitive lever. Reaching milestones like first-in-human (FIH) and proof-of-concept (PoC) sooner leads to:
- Earlier access to capital and higher company valuation.
- Extended patent runway, maximizing commercial exclusivity.
- Increased investor confidence through demonstrated program momentum.
Can the Altasciences Acceleration Platform be used for biologics and small molecules?
Yes. The platform has a proven track record across small molecules, monoclonal antibodies (mAbs), and emerging modalities. For example, Altasciences has helped monoclonal antibody programs reach FIH readiness in approximately 13 months—nearly a year faster than the industry average.
How is the Altasciences Acceleration Platform different from traditional CRO/CDMO models?
Traditional models operate through sequential handoffs across multiple vendors, often creating delays between development stages. Altasciences replaces this linear approach with a synchronized model where scientific, regulatory, and operational activities progress in parallel, reducing “whitespace” and enabling faster decision-making.
Does the Acceleration Platform compromise scientific rigor or regulatory compliance?
No. The platform is designed to maintain scientific integrity while improving efficiency. Streamlined study designs, early regulatory alignment, and integrated execution ensure that programs meet regulatory expectations while avoiding unnecessary delays or redundant work.