Learn and Confirm Inc.
Regulatory Approval Made Simple

Regulatory approval is the crowning achievement for pharmaceutical research. It is one of the final challenges to attaining market entry. At this stage, pharmaceutical companies aim to capitalize on the information from their clinical studies and simplify for regulatory bodies the scores of pharmacokinetic and pharmacodynamic (PK/PD) data in terms of efficacy, safety and dosing regimen.

However, small to midsize companies often need to untangle a web of conflicting clinical study results to establish a compelling argument for a drug's efficacy. Without in-house expertise, this becomes nearly impossible.

Learn and Confirm Inc. emerges as a beacon of expertise to demystify research and statistical data and steer clients through the intricacies of drug development and regulatory approval to success. Leveraging its expertise in pharmacokinetics and pharmacodynamics, it conducts complex analyses using mathematical models and presents comprehensible information for clients and regulatory bodies.

“We work with aspects our clients deem complicated. Through advanced pharmacokinetics and pharmacodynamics, we better understand the efficacy and safety of drugs and make one simple story that explains everything,” says Murray P. Ducharme, president and CEO of Learn and Confirm.

Transforming Complex Data into Clear Narratives

Learn and Confirm caters to innovative pharmaceutical companies developing new drugs and biologics, and generic companies aiming to replicate them.

Its range of services are leveraged by many small to medium sized pharmaceutical company clients in clinical drug development worldwide, focusing on clinical pharmacology, scientific aspects of regulatory affairs, advanced PK/PD analysis, modeling and simulation, and reporting.

The company has extensive experience from its work on over 10,000 studies and numerous products, making it a valuable resource for clients seeking specialized expertise. Its modus operandi goes beyond routine analyses. Each case is treated as a distinct research endeavor, where a customized solution is provided to streamline complex clinical data. This approach stems from the understanding that simplicity of information enhances acceptance by regulatory agencies.

Even large pharmaceutical companies reach out to Learn and Confirm when expertise is needed to effortlessly bridge the medical, clinical, and statistical aspects of drug development. This can occur simply because they may have an expert clinical understanding of medicines and disease states, but are overwhelmed by the mathematical or statistical aspects of a drug's PK/PD behavior, or vice-versa.

Bridging this divide, Learn and Confirm emphasizes the importance of a clear message. Its insights and wealth of experience become invaluable for those lacking the resources and breadth of expertise to navigate complex regulatory and scientific challenges.

“We recognize the importance of the clarity of the message for both regulatory agencies and pharmaceutical company clients alike. It is crucial that both understand the work. We meticulously present the data in a more easily understandable format to achieve this,” says Philippe Colucci, Vice-President, Clinical Pharmacology and Operations.

Guiding Pharmaceuticals from Preclinical to Approval

Learn and Confirm takes a proactive approach to client engagement and ideally prefers to work with companies from the preclinical stage, guiding them through all phases up to regulatory submission. This collaborative strategy aims to streamline the development journey, helping clients reach their goals faster.

During the journey, it helps pharmaceutical companies address various challenges. For example, regulatory agencies have a keen focus on the lowest effective dosing regimen for a drug, which is not always easy to present in a convincing manner. Learn and Confirm employs advanced modeling and simulations, analyzing a client’s existing studies to determine the minimum effective dosing regimen. This process aids companies in addressing regulatory inquiries and refining their submissions.

It also engages in innovative problem-solving, proposing alternative paths when agencies ask questions and companies encounter roadblocks trying to address them. This is evident in its collaborations with generic clients, as regulatory agencies often require strict credible data, establishing their product is equivalent with the market reference. Learn and Confirm’s model-based analyses methods can establish whether complicated products such as Long Acting Injectables are equivalent to the market reference without launching additional time-consuming and costly clinical efficacy studies.

Another common scenario is adapting drugs for use in pediatrics, that have only undergone testing in adults. Leveraging the available safety, efficacy and PK data from adults and literature reviews, Learn and Confirm predicts optimal doses for pediatric use. This approach aligns with the company's commitment to optimizing drug development and addressing regulatory inquiries to secure approvals.

The company is often asked to uncover valuable insights from existing clinical data to prevent the need for additional studies. By strategically analyzing client datasets, it efficiently addresses specific questions, provides information on populations or conditions, and contributes to informed decision making. The approach results in significant cost reduction and has garnered appreciation for maximizing the potential of data resources.

It also offers valuable support during the regulatory submission process. Companies frequently receive inquiries from regulators during this process, either due to a lack of clarity or when the provided answers do not meet regulatory standards.

In these instances, Learn and Confirm helps rewrite the initial responses or enhance and refine existing answers to ensure they align with regulatory expectations, attributing to successful dossier submissions.

Over a Decade of Global Clinical Success

In its 13 years of operation, Learn and Confirm has amassed extensive experience. Its diverse clientele spans Europe, the U.S., India, Asia and Canada, among other jurisdictions. This global perspective, coupled with a distinct ability to bridge scientific and regulatory aspects, distinguishes the company in the pharmaceutical landscape. Its commitment to simplifying complexities, optimizing drug development, and facilitating regulatory approvals positions it as a trusted partner for pharmaceutical companies.

Drawing upon 30 years of industry experience, Dr. Ducharme leads Learn and Confirm with an unmatched quest for excellence. He continues to be highly involved in academia, directing doctoral and post-doctoral work in clinical pharmacology and leading young minds to greatness.

His fellow leaders include Corinne Seng Yue, vice president, a trained pharmacist specializing in clinical pharmacology and pharmacometrics. Philippe Colucci, another vice president, has over three decades of industry experience and specializes in clinical pharmacology and modeling.

The rest of the team comprises 12 dedicated scientists who actively engage in every project. The company operates with a novel and nimble approach in the pharmaceutical landscape and proudly maintains flexibility without unnecessary overhead. Its strength stems from its adaptability and responsiveness to regulatory needs, particularly when clients face tight timelines.

In-house research is conducted to stay ahead of the curve, contributing to the development of optimal drug development methods. It regularly publishes papers on state-of-the-art methodologies, in collaboration with regulatory agencies, and actively participates in international conferences, enhancing the company’s credibility and attracting clients who seek its expertise.

Over the years, Learn and Confirm has experienced gradual but consistent growth. The plan is to continue this trajectory with an openness to mergers, but only if a prospective partner brings synergy. The private entity is devoid of external pressures to pursue aggressive expansion. Instead, the primary focus is delivering exceptional clinical pharmacology service, modeling and simulation to pharmaceutical partners.

This distinctive approach positions Learn and Confirm as not just a service provider but as a partner for pharma companies invested in research-driven problem-solving, setting a standard in the eyes of regulatory agencies that requires no validation.

Website: http://www.learnandconfirm.com www.learnandconfirm.com
Contact info: Murray P. Ducharme at HYPERLINK
mailto: murray.ducharme@learnandconfirm.ca murray.ducharme@learnandconfirm.ca