Translational Science Is the Key to the Success of the Clinical Research

PLEASANTON, Calif., Dec. 5, 2023 /PRNewswire/ — In Q2 2023, Amador Bioscience, a next generation CRO focusing on translational science and early clinical development, announced the addition of Dr. Lorin Roskos to the Board of Directors. Dr. Roskos has also taken on the roles of Chief Scientific Officer (CSO) and President of Clinical Quantitative Pharmacology. 

Dr. Roskos: Former Vice President of R&D at AstraZeneca has over 30 years innovative drug R&D experience.

Dr. Roskos is a highly esteemed leader in the field of science and a pioneer in the pharmaceutical industry. He is among the world’s first pharmacometricians to explore and advocate for the concept of ‘translational science’. His career spans over 30 years, during which he has amassed extensive experience in research & development, and management within top-tier pharmaceutical companies.

Following the completion of his PhD in Pharmaceutics from the University of Washington, Dr. Roskos has made significant strides in his field. Over the course of his career, he has published approximately 200 original research papers, reviews, and book chapters, he has been granted 9 therapeutic patents as well. His work spans a wide range of specialist areas which include clinical pharmacology, pharmacometrics, systems pharmacology, translational medicine, and GXP-compatible bioanalysis. Furthermore, his research covers a diverse array of medical fields such as oncology, respiratory diseases, autoimmune disorders, inflammatory conditions, cardiovascular diseases, renal disorders, metabolic diseases, and infectious diseases.

Dr. Roskos brings over 30 years of R&D and management experience from his tenure at major multinational pharmaceutical companies and innovative biotech firms, including AstraZeneca, Eli Lilly, Amgen, and Exelixis. His involvement extends to more than 50 IND pipelines and the development of approximately 20 new drugs. In the 1990s, while serving at Amgen, Dr. Roskos initially created the ‘pharmacokinetics-pharmacodynamics mechanism model’, such as the Hematopoiesis Transit Model and antibody-antigen interactions, including the target-mediated drug elimination model, the model for the absorption of large molecule drugs through the lymphatic system following subcutaneous injection, and the tumor growth inhibition model. These mechanism models served as the foundation for using pharmacometrics in rational biopharmaceutical development.

When serving as the Vice President of R&D at AstraZeneca, Dr. Roskos’s leadership spanned across global clinical pharmacology, bioanalysis, biomarker, and translational science departments. He also held the position of Sr. VP at Exelixis, where he led the work of clinical pharmacology, bioanalysis & biomarkers, translational science and toxicity, pharmacology, drug genomics, bioinformatics, and translational medicine. Prior to joining AstraZeneca, Dr. Roskos had significant roles at Eli Lilly, Amgen and Abgenix as the Senior Director leading and managing the clinical pharmacology and toxicology departments.

In Amgen, people described him as “Skywalker”, a bright super achiever.  His charisma and competence have earned him the admiration of both his superiors and colleagues.

Translational Science Is the Key to the Success of the Clinical Research

Amador offers comprehensive one-stop services, including clinical pharmacology, bioanalysis and biomarker research, clinical research, and regulatory affairs. Among these, Amador’s robust capabilities in clinical pharmacology and translational science play an indispensable role. These strengths, which Dr. Roskos has consistently emphasized during his decades of work in drug research, are integral to Amador’s success.

“Clinical pharmacology, an essential discipline in recent developments, is the most crucial sector to focus on if one has to be named, for optimizing dosage selection and administration,” emphasized Dr. Roskos.

Phase II clinical trials, approved and regulated by the FDA, are increasingly emphasizing dose control. This involves considering the balance between therapeutic efficiency and toxicity, weighing the benefits and risks. However, within the framework of actual clinical development, it’s not just a scientific and technological challenge. It also imposes stringent demands on statistical capabilities, such as data analysis.

Dr. Roskos holds the view that translational science and clinical pharmacology are intrinsically linked. The accurate identification of populations benefiting from a drug can only be achieved through the integration of these two fields. This approach forms the cornerstone and foundation for the successful development of innovative drugs.

Transitioning a drug from preclinical to clinical stages necessitates advanced expertise, meticulous operational steps, and seasoned professionals. As a result, many clinical trials stumble during Phase 1, a stage often dubbed the ‘valley of death’ in the realm of innovative drug development. Translational science serves as a bridge between ‘laboratory research’ and ‘clinical research’, with a focus on patients and diseases. It delves into the scientific rationale and operational foundation for each phase, from problem identification to the establishment of appropriate therapeutic methods.

Given the progression of basic science and the constraints in conventional route of drug discovery, the demand for basic science knowledge in the development of innovative drugs has expanded in both volume and scope. Fundamental research scientists at the forefront often lack extensive clinical experience. Therefore, translational science can serve as a guiding discipline to comprehend drug development.

Is the disease mechanism clear? Do in vivo and in vitro models corelate with the disease and aid in target validation? Are there suitable biomarkers that indicate disease onset and progression, as well as drug efficacy? How should a clinical trial be designed to validate a concept?

AstraZeneca categorizes translational science into the “5R” principles, emphasizing that drug development should take account five aspects: the right target, the right tissue, the right safety, the right patient, and the right commercial.

A thoughtfully designed translational pharmacology strategy is especially crucial in bridging the gap between preclinical and clinical stages. This involves a deep understanding of the exposure-response relationship in animal models for drug pharmacology and efficacy, the exposure-safety relationship in toxicity studies, and the appropriate bioanalytical method to transition from animal studies to clinical trials. This information can be leveraged in designing Phase I trials, including determining the starting dose, dose escalation steps, projecting the effective clinical dose, and comprehending the expected safety range and risks.

In his interview, Dr. Roskos specifically emphasizes the importance of precision and effectiveness in drug therapy, as well as the exploration of risk-benefit balance. This implies that to improve the success rate of clinical trials, we need to carefully consider two questions. Firstly, can the drug precisely and effectively treat the disease? Secondly, does the potential safety concern of the drug impact the exploration of the therapeutic dose?

Based on it, before initiating clinical trials, scientists should first calculate the feasibility, dose requirements and safety range based on the results of in vitro testing systems and animal study data. For various drug modalities, such as small molecules, antibodies, and cell therapy, the success rate of this pipeline in human trials can be calculated, derived, and determined from array of data related to dose gradient, dosing frequency, therapeutic benefit, safety range and others obtained from actual preclinical experiments. Appropriate tools, such as AI algorithms and statistical modelling, are utilized for this purpose.

After the pre-evaluation, the next challenge is to identify suitable patients for clinical trials. This is particularly crucial for cancer treatment, as the individual variations among patients can significantly influence the final treatment outcome. Studying the drug’s preclinical study data compared with the patient’s clinical diagnosis data can help to find specific patients who are suitable for the therapy, and further refine the patient group for clinical trials. The patient analysis not only increases the success rate of current clinical trials, but can also prevent unnecessary studies on patients who are not suitable for this treatment. After all, for patients in urgent need, time is far more precious than money.

It’s important to emphasize that the key to translational science is the courage to say ‘no’. As a tool for decision‑making, translational science is underpinned by theoretical foundations and empirical data. It focuses on identifying potential safety risks, ineffective explorations, and resource wastage during clinical trials through early‑stage calculations, statistics, and evaluations, to facilitate the advancement of drug pipeline along the right trajectory.

With biotech companies thriving, it’s crucial for CROs to understand their clients’ needs and ensure all activities comply with regulations.

With the advancement of human genome mapping and a deeper understanding of pathological biology and molecular disease studies, more effective therapies have been developed in recent decades.

In the realm of tumor immunotherapies, inhibitors such as PD-1 and PD-2 have made significant breakthroughs in combating multiple cancers. The trend of combination therapy is increasingly prevalent. ADC drugs, with their stability, safety, tolerability, and dosage advantages, are attracting numerous pharmaceutical companies to invest and strategize in this field, leading to remarkable progress.

However, for solid tumors, metastatic cancers, and others, in most cases, current therapies can only extend survival rather than provide a complete cure. Therefore, there are still many unmet clinical demands in future drug development, making it a challenging endeavor.

Years ago, new drugs were primarily developed by major biopharmaceutical companies such as Merck, AstraZeneca, Eli Lilly. However, the current landscape has seen a rise in the entry barrier for the divided pharmaceutical competition track, leading to a thriving global biotech industry. As a result, CROs have become dispensable in launching more new drug pipelines.

Given the rise of differentiation in aspects such as targets, modes of action, indications, therapies, regulations and laws, the implementation challenges for CRO teams are growing exponentially. The only way to be a preferred CRO for Biopharma in future competition is to stay abreast of the latest scientific studies, understand the real needs of clients, and maintain control over the quality of deliverables.

“Drawing on an advanced understanding of translational science, cutting-edge techniques, and extensive experience in areas such as QCP, bioanalysis and biomarker, and regulatory affairs, Amador Bioscience can accurately pinpoint and scientifically address the challenges in drug development. They offer practical strategies and clinical plans, establishing themselves as a CRO capable of providing full services for clients,” Dr. Roskos shared in the interview. “This is a significant reason why I decided to join them”.

Now, Amador Bioscience, already equipped with comprehensive CRO solutions and global strategies, will be further empowered with the addition of Dr. Roskos’s extensive 30-year experience in new drug development. Dr. Roskos can address any unexpected events that may arise during any stages from drug development to commercialization, thanks to his experience with over 50 IND pipelines, approximately 20 NDA drugs, and his cooperative involvement with global regulatory agencies such as the FDA and EMA.

Based on his empirical experience in drug development and the comprehensive application of expertise, Dr. Roskos will use his multifaceted insights into the pharmaceutical industry to guide Amador Bioscience towards a future that is higher, greater, and stronger.

Amador Bioscience
Amador Bioscience is a science-driven translational & clinical research CRO with established sites in USA, China and Europe.

As a leading partner for successful biopharmaceutical research and development, Amador Bioscience offers a comprehensive range of services, including translational sciences, clinical pharmacology, bioanalysis & biomarkers, regulatory strategy & submissions, and clinical research adhering to global standards. We excel in formulating and executing development strategies from pre-IND all the way to NDA/BLA/MAA submissions.

Our scientific methodologies to select the right target, right patient & right dose, and our global adoption of rigorous quality standards, serve to substantially enhance the efficiency and success rate of novel drug development endeavors.

For more information:
www.amadorbioscience.com
Email: [email protected] 
Phone: (800) 803-0150

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SOURCE Amador Bioscience