[Video] Ethnobridging Studies

 

Watch the Ethnobridging Webinar On‑Demand

Altasciences recently released a webinar on ethnobridging studies in which Dr. Affrime demonstrates how ethnobridging can help minimize time lags in development of drugs destined for Asian markets. Included are detailed case studies on how to include ethnobridging in your early clinical development plans to safely speed up worldwide regulatory approval.

Watch the Webinar On-Demand

To learn how Altasciences can assist you with your clinical research program,  contact us today!​​​​​​

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

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Marie-Hélène has been a leader in the drug development industry for close to 20 years.

Checklist for a Successful First-In-Human Trial

 

Planning Your First In Human Trial

Check out this issue of The Altascientist for your roadmap to successfully conducting FIH studies, including: 

  • Determining the necessary regulatory interactions 
  • Selecting the starting dose 
  • Designing the trial 
  • Planning for participant safety 
  • Identifying and mitigating potential risks 
  • Recruiting, educating, and retaining study participants
  • Planning resources and conducting the trial
     

Download issue

The Altascientist issue 18 - Planning you First-in-Human Clinical Trial

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

Making Sense of Antisense Oligonucleotides (ASOs)

 

ASOs — The Importance of Sensitive Bioanalytical Assays

Precise quantitation of ASOs helps you target the source of a disease’s pathogenesis. Chemical modifications of ASOs and advancements in drug delivery have improved drug stability and potency, reducing the requirements for quantity of drug per dose, and total number of doses.

Altasciences has expertise in the development of highly sensitive bioanalytical assays for the quantitation of ASOs in complex biological matrices such as eye, liver, or brain tissue, adapted to the different critical parameters of your preclinical or clinical study:

  1. The ability to quantitate ASOs to very low concentrations impacts calculation of half-life; more sensitive assays will produce more accurate readouts.
  2. Timepoints close to the end of the dosing cycle are expected to have lower concentrations in various tissues. Highly sensitive methods will produce the most accurate readings, allowing for an accurate PK profile even in late timepoints.
  3. Hybridization-based methods provide the best reported assay sensitivity and throughput, compared with other bioanalytical methods for ASOs. They are less time consuming, requiring little or no sample clean-up, and have been widely used for the quantitative analysis of ASOs to support both TK and PK regulated bioanalysis.

Take a deeper dive into our ASO capabilities and knowledge, and consult our two case studies, in the 12th issue of The Altascientist.

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

Safety Pharmacology Case Studies, Webinar On-Demand

 

You Won’t Want to Miss This Video!

Watch as, Dr. Michael R. Gralinski, CEO of CorDynamics, reviews the results of three GLP safety pharmacology validation studies.

The studies were conducted using telemetered dogs with well-characterized hemodynamic, electrocardiographic, and respiratory positive controls. All three studies demonstrated the ability to detect expected effects of positive controls with a high degree of reliability.

Watch video

The studies were conducted in Altasciences' purpose-built, isolated telemetry facility, with data review and interpretation by CorDynamics.

Speak with one of our experts today.

You may also be interested in: 
•    The Altascientist: Scientific Journal Issue 13 — Safety Pharmacology Studies, a Review
•    Fact Sheet: Safety Pharmacology
•    Webpage: Safety Pharmacology Overview and FAQs

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

Endpoints News: Canadian CRO Altasciences Kicks Off Client Manufacturing Expansion in Philadelphia

eBook – Monitoring Key Biomarkers of Immunomodulation

 

 

eBook: Key Biomarkers of Immunomodulations: Completement Factors and CytokinesAltasciences has published a new eBook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.

With the movement toward personalized treatments having immunomodulatory effects, monitoring complement factors and cytokines has become increasingly important to help prevent any unintended consequences that may arise from these new medications.

Contents include:

  • REVIEW: Complement Factors and Cytokines
  • SOLUTIONS: Biomarker Analysis
  • CASE STUDY: Comparing Cytokine Data to In-Life Parameters on Nonhuman Primates in Nonclinical Toxicology Studies
  • STUDY OUTLINE TEMPLATE: Nonclinical Study

Altasciences has been delivering excellence in bioanalytical services for over 25 years, and is fully equipped to analyze a comprehensive range of biomarkers to support your nonclinical toxicology programs. With over 260 scientists working in state-of-the-art laboratories and shifts running 24/7, as needed, our laboratory teams are able to process as many as 60,000 samples per month.

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.​​​​

Industry Expert Talks First-In-Human and Complex Clinical Trials

 

A Chat with Dr. Morelli

Altasciences has decades of experience designing, conducting, and reporting on early phase clinical trials. We have the scientific expertise and seamless operational processes to deliver quality data with speed and ease. 

Watch as Dr. Morelli, Chief Medical Officer, shares his first-hand experience and insight into Altasciences’ planning and conduct of your first-in-human, complex, and innovator clinical trials.

Quick Chat - Dr. Morelli

Want to know more? Speak with an expert about your FIH and other clinical research needs.

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

June 2022

Our Altascientists are hard at work, whether it’s on your drug development projects, or producing insightful scientific resources to share their knowledge with you. Catch up on what you may have missed, or revisit some highlights from the last three months.

The Drug Development Journey

A Message from Our CEO to You
Each quarter, Chris Perkin reflects on the past, present, and future of Altasciences.

News: Altasciences Receives CRO Leadership Award in All Five Categories!
Each year, Clinical Leader and Life Science Leader team up with ISR Reports to determine award recipients by assessing 50 CROs on more than 20 performance metrics in ISR’s annual Quality Benchmarking survey. This is the seventh time Altasciences has been recognized.

eBook: One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
In conjunction with Biopharma Dive, Altasciences conducted a survey of over 143 biopharmaceutical executives to gain real-world perspective on the challenges they face, and shed some light on what motivates them to choose one CRO over another. The results are in.

Blog: The Impact of Social Factors on Drug Development
Drug development exists within the context of interrelated social factors that impact its norms and practices. This dynamic has a long history: in ancient Greece, learning to treat illnesses and injuries with medical remedies based on a growing understanding of physiology depended on a broader philosophical shift in society favoring logic over superstition – a transformation that continues to form the basis of modern-day science.

Preclinical Services

Five New Scientific Posters Presented at SOT 2022:

Clinical Services

Blog: Five Facts About Psychedelics for Mental Health
With an evolving regulatory environment easing some of the barriers to research, there is new hope for the development of potential treatments. Here’s what we know so far about psychedelics for the treatment of mental health illnesses.

Quick Chat: Experts in Complex Clinical Trials (with Dr. Morelli, MD)
Dr. Morelli, Chief Medical Officer at Altasciences, shares insight and first-hand experience in how we conduct your complex clinical trials, such as first‑in‑human and innovator studies.

On-Demand Webinar: Inside the Pharmacodynamic Toolbox
In this webinar, you will explore the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy evaluation of a CNS-active drug in early clinical trials. Presented by Altasciences’ Dr. Beatrice Setnik, PhD, Chief Scientific Officer, and Dr. Denise Milovan, Neuroscientist and Clinical Neuropsychologist.

On-Demand Webinar: Ethnobridging in Phase I Clinical Trials
In this webinar, Mel Affrime, PharmD, Executive Vice President of Translational Medicine at Altasciences, presents a strategy for enhancing asset value and accelerating global drug development.

Manufacturing and Analutical Services

Quiz: Test Your Knowledge of Liquid-Filled Capsules
Liquid-filled capsules offer several advantages over other solid dosage forms, but how much do you know about this alternative dosage form?

Case Study: Rapid Development of a Liquid-Filled, Hard-Shell Capsule Formulation of Cannabidiol
We partnered with Emyria to present the challenge of developing several oral formulation candidates for CBD from scratch for a new over-the-counter product in Australia.

Podcast: Episode #24 ― The Importance of a CDMO Consultant
Hosts Teresa Johnk (Biopharma Connections) and Michael Stenberg (Altasciences) chat with Dr. Daniel Levy, Owner and Principal Consultant at DEL BioPharma, to uncover key considerations for putting together your drug development and manufacturing program.

Quick Chat: Manufacturing and Handling Your Highly Potent APIs and Controlled Substances (with Ben Reed)
Not every CDMO is able or equipped to formulate, manufacture, analyze, and handle your highly potent APIs and controlled substances. Ben Reed, General Manager of CDMO Services, describes how Altasciences has both the equipment and expertise for all your highly potent API project.

Bioanalytical Services

eBook: Key Biomarkers of Immunomodulation ― Complement Factors and Cytokines
The movement toward personalized treatments with immunomodulatory effects has made testing biomarkers of immunomodulation increasingly important. In this new eBook (also available as an audiobook), we share comprehensive information about including the testing of these biomarkers in your drug development program.

Poster: Parallelism Challenges When Using Commercial Kits for Biomarker Quantitation
Presented at AAPS National Biotechnology Conference, this scientific poster describes the challenges and mitigation strategies we observed for three different biomarkers, demonstrating that different approaches are required for each one.

Research Support Services

Scientific Journal: Issue 23 — Robust Sample Management for Reliable Study Results
The quality of your trial data depends on a rigorous sample management process that safeguards the integrity of your samples, from initial specimen collection through bioanalysis, to post-study storage. Issue 23 (also available as an audiobook) delves deeper into sample management.

Unboxing Video: What’s Inside Altasciences’ Clinical Sample Collection Kit?
Our sample management kits provide all the materials necessary for accurate, efficient, and safe preparation, collection, and shipment of clinical samples from trial sites to bioanalytical laboratories.

Blog: Q&A with Dr. Nicole Maciolek — Setting Up Your Clinical Research for Success
To understand the value of research support services for your program, we sat down with Dr. Nicole Maciolek, PhD, Vice President of Research Services at Altasciences, for a quick Q&A period.

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