Dr. William J. Foster Joins Altasciences as Principal Investigator
LAVAL, QC, Canada (September 6, 2018) — Altasciences is pleased to welcome Dr. William J. Foster, MD, PhD, FRCSC, to the Altasciences family as Principal Investigator and Consultant on clinical trials. Dr. Foster, originally from the U.S.A., is a practicing retinal physician in Montreal, Canada, a Professor of Bioengineering, and a Member of the Institute for Regenerative Medicine and Engineering at Temple University in Philadelphia.
“Dr. Foster’s unique background in medicine, bioengineering and biophysics, along with his broad range of expertise in preclinical and clinical research, are an ideal complement to Altasciences as we grow and further develop new areas of specialization. His insight was instrumental in designing one of our upcoming first-in-human studies on an ocular product,” said Ingrid Holmes, General Manager, Montreal Clinical Operations, at Altasciences.
Holding an MD from Duke and PhD from Harvard University, Dr. Foster is a Diplomate of the American Board of Ophthalmology, a Diplomate of the American Board of Preventive Medicine in Clinical Informatics, a Fellow of the American Academy of Ophthalmology, and a Fellow of the Royal College of Surgeons of Canada. In addition to his clinical work, Dr. Foster does translational research to improve outcomes for patients with different retinal diseases, ranging from the application of high-tech polymeric compounds to the repair of retinal detachments and delivery of nanoparticle therapeutics to computational modeling of fluid flow in the eye during different diseases and treatments. He is the current Chair of the CME Committee of the Association for Research in Vision & Ophthalmology, and is a Grant Reviewer for the National Institutes of Health (NIH) Sensory Technologies Study Section.
“I’ve always been passionate about translational and early-stage clinical research. I look forward to working closely with the well-versed team of experts at Altasciences to help our clients in their efforts to enhance vision research that will ultimately lead to new therapies and methods for disease detection,” mentioned Dr. Foster.
Dr. Foster’s peer-reviewed publications are numerous and he has spoken at many national and international scientific conferences. He is on the editorial board of multiple publications, including PLOS One and Investigative Ophthalmology & Visual Sciences. Dr. Foster has been an investigator in a number of large, important clinical trials, funded by the NIH and pharmaceutical companies, in the field of diabetic retinopathy and other ocular diseases.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
ISSUE NO. 4 — Key Considerations for Biosimilar Clinical Pharmacology Studies
Biologics have become the fastest-growing class of therapeutic compounds, with seven of the top-10 selling drugs in 2023 being biologics, each exceeding sales of $10 billion USD. In 2022, biosimilars accounted for 13.7% of all spending on biologics, compared with the 8.9% in 2021.
Biologics have provided treatment options for people who suffer from some of the most serious medical conditions, such as cancer and genetic disorders.
A biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine. It enters the market subsequent to the patent expiration of a previously authorized version of a biologic. A biosimilar is approved only after showing that it is “highly similar” to an approved biological product, known as the reference product, in terms of structure, purity, potency, safety, pharmacokinetics, and in many cases, efficacy, with allowable minor differences.
In Issue 4 of The Altascientist, learn about the growing interest of biosimilars, and key considerations in pharmacokinetic (PK) studies, as well as:
- The rise of the biosimilar market
- The regulatory landscape
- How Altasciences puts biosimilars to the test
- Altasciences’ expertise in bioanalysis
- Key considerations for biosimilar clinical pharmacology studies
- Ensuring the continued success of biosimilar programs
Considerations and Study Challenges for Biosimilars
Early awareness of study challenges is crucial in running a successful early-phase biosimilar development program, and certain considerations must be taken into account before beginning a study.
Recruitment is often one the most challenging aspects of the biosimilar clinical trial process and can lead to trial delays if not managed effectively. The inclusion and exclusion criteria for healthy participants in a biosimilar bioequivalence study are often much stricter than a standard bioequivalence study on a small molecule.
Additionally, as a biosimilar product is not exactly the same as the reference product, there are also increased safety risks associated with the administration of the test product. Key safety considerations include immunogenicity, hypersensitivity reactions, and an increased risk for other adverse effects.
How Altasciences Can Support Your Biosimilar Drug Development
Bioanalytical considerations are another important factor. Unlike small molecule drugs, biologics exhibit a significant level of complexity which is driven by the fact that their production is dependent on a living system, such as a microorganism, a plant, or animal cells.
Altasciences supports method development, GCP/GLP-compliant biosimilar assay development validation, and sample analysis for PK and immunogenicity/anti-drug antibody (ADA) testing, and we are proud of our bioanalytical expertise with LC-MS/MS and ligand binding platforms . We provide support for all stages of drug development (discovery to preclinical to Phase IV) for both small and large molecules programs.
“Altasciences has the perfect mix of innovator and generic drug development experience, with a thorough understanding of the regulatory complexities involved in biosimilar clinical pharmacology studies. Companies developing biosimilars are collaborating with us because of our firsthand experience, distinctive recruitment strategies, and speed in conducting biosimilar clinical trials that require a customized approach based on the therapeutic indication and study-specific goals. Our expertise allows us to accelerate our clients’ biosimilar development programs so they can offer greater treatment options and more cost-effective medications to patients in need.”–Danielle Salha Senior Director, Global Immunology, Ligand Binding Assays
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Topical and Transdermal – Getting Under Your Skin
The skin is the largest organ of the human body, measuring 22 square feet, on average.
WHAT IT TAKES — Central Nervous System (CNS) Clinical Trials
Biopharmaceutical companies developing new CNS products can face special obstacles.
Selective Quantitation of 1,3-Propanediol in Dog Plasma Using Differential Ion Mobility Spectrometry
ISSUE NO. 3 — Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs
Originally published June 2018 / Updated April 2022
Prescription drugs, including opioid analgesics, are an important component of modern pain management; however, along with their euphoric effects comes an increased possibility of misuse and abuse—all of which can lead to addiction, overdose, or death.
The FDA has undertaken many efforts to help clinicians
manage this widespread issue by instating guidelines
to better understand the abuse potential of new
drugs, and ensure drugs currently on the market are less likely to be abused through the use of abuse-deterrent formulations (ADFs). The FDA guidance, Assessment of Abuse Potential of Drugs, states that a broad range of CNS drugs require human abuse potential (HAP) studies, also known as human abuse liability (HAL) studies, to evaluate the abuse liability of drugs in development, and to determine the relative risk of abuse before a drug comes to market.
In Issue 3 of The Altascientist, we look at the intricacies and key considerations involved in conducting these sensitive HAP studies, including:
- FDA’s steps to limit the misuse and abuse of prescription drugs
- human abuse potential study solutions
- study design and protocol
- a case study
Human Abuse Potential Study Designs
HAP studies are clinical pharmacology studies and play a key role in the overall abuse potential assessment of a new chemical entity (NCE). As per the FDA’s guidance, Altasciences’ HAP studies are conducted with participants who have experience with recreational drug use in the same pharmaceutical class as the NCE, or with drugs with similar psychoactive properties.
Psychedelics are gaining interest for treating psychiatric illnesses. Altasciences’ experts can guide a clinical development strategy to evaluate safety, pharmacokinetics, and pharmacodynamics. With a team recognized in pharmacology, addiction, and regulatory services, we can help build your target product profile and clinical development plan, ensuring comprehensive studies and data early to support regulatory milestones and FDA meetings.
Abuse potential evaluation is also required to evaluate novel formulations designed to specifically reduce or deter abuse of a drug. According to the National Center for Drug Abuse Statistics, 16 million, or 6% of Americans over the age of 12, abuse prescription drugs every year. In addition, many individuals misuse their prescription medications by tampering with the formulation. The FDA has worked to address this problem by encouraging the development of abuse-deterrent formulations (ADFs) for opioids and other drugs that are associated with a high risk of abuse.
These products are formulated with properties expected to meaningfully deter certain types of abuse and/or make abuse more difficult or less rewarding. This allows patients who are in chronic pain to have appropriate access to drugs, such as opioid analgesics, with significantly less risk of abuse through unintended routes, such as intranasal insufflation or injection.
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IBS? Don’t Despair – There are Options!
IBS is the name doctors have given to conditions characterized by cramp like abdominal pains, bloating and bouts of diarrhea and/or constipation. According to an article in Nature, it affects hundreds of millions of people — around 11% of the global population has IBS, with a higher prevalence in North America. As a result, there is a significant need for treatments.
As part of Irritable Bowel Syndrome (IBS) awareness month, we wanted to provide you with insight into potential IBS treatments.
Patient Centricity — taking care of our most valuable asset!
“Patient centricity” is the process of designing a service or solution around the patient; more specifically, it is collectively defined as “Putting the patient fi
Because who Doesn’t Love a Quiz!
ISSUE NO. 2 — Revolutionizing Traditional Medicine With Cannabis-based Medicinal Products
Cannabis, one of the oldest and most commonly used drugs in the world, is derived from the cannabis sativa plant and contains hundreds of active ingredients. These include the most abundant active constituents, tetrahydrocannabinol (THC), which is the primary psychoactive component of cannabis, and cannabidiol (CBD) which has therapeutic effects but less psychoactivity.
Research has shown that these constituents interact with various systems in the body where cannabinoid receptors are located, leading to a range of therapeutic effects within the central nervous system and its periphery.
Though it has become difficult to conduct clinical research involving cannabis, Canada became the first country in the G20 to introduce a legal framework regulating the use of cannabis by adults for non-medical purposes, creating a large-scale natural experiment that the world continues to study.
In Issue 2 of The Altascientist, we explore the science, therapeutic potential, and regulatory considerations for cannabis-based medicinal products, including:
- Supporting clinical facts and research;
- Altasciences’ experience and innovative approach to cannabinoid studies; and
- a case study on the safety and tolerability of the first cannabis extract developed for regulatory submission.
Altasciences’ Innovative FIH Cannabis Research
Altasciences remains a champion of innovation, and when Tetra Bio-Pharma sought a partner for their first-in-human (FIH) study of a cannabis extract for breakthrough cancer pain, we collaborated to design a comprehensive development plan. This included clinical study design, bioanalysis, and regulatory strategy for the first whole-plant cannabis extract to follow the drug approval pathway.
Our expertise in cannabinoid research, along with our specialized bioanalytical capabilities and purpose-built facilities, ensured rigorous safety and efficacy assessments to support the drug’s advancement.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.