Altasciences

Conducting ethnobridging studies locally, during Phase I, in the target population, can reduce drug development timelines by the number of years typically needed to complete clinical development in the target region, as compared with North America or Europe. A Phase I ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases II and III) without repeating Phase I development in that region and population.

Click here to download a readable, PDF version of Issue 24: https://www.altasciences.com/sites/default/files/2022-06/The-Altascientist_issue-24_Ethnobridging.pdf

CHAPTERS:

- 0:15 — Section 1: Introduction

- 1:15 — Section 2: Why Asian Ethnobridging?

- 4:22 — Section 3: The ICH E5 Guidance

- 5:34 — Section 4: The ICH E7 Guidance

- 7:48 — Section 5: Accelerating Asian Drug Development

- 10:32 — Section 6: Language Requirements for Global Clinical Trials

- 11:09 — Section 7: Altasciences' Expertise and Experience with Ethnobridging

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.

The movement toward personalized treatments with immunomodulatory effects has made testing biomarkers of immunomodulation increasingly important. Careful monitoring of complement factors and cytokines can help prevent any unintended consequences that may arise from these new medications.

In this eBook, Altasciences shares comprehensive information about including the testing of these biomarkers in your drug development program.

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

Click here to download a readable, PDF version of this eBook: https://www.altasciences.com/sites/default/files/2022-06/Key_Biomarkers_of_Immunomodulation.pdf

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.

The quality of trial data depends on a rigorous sample management process that safeguards the integrity of samples at every step, from initial specimen collection through bioanalysis, to post-study storage. A CRO partner that conducts both preclinical and clinical studies, and supporting bioanalysis, ensures continuity of processes, knowledge sharing, and a centralized location for long-term storage of all your samples.

Click here to download a readable, PDF version of Issue 23: https://www.altasciences.com/sites/default/files/2022-05/The_Altascientist_issue-23_Sample-Management_v3.pdf

CHAPTERS:

- 0:16 ― Section 1: Introduction

- 1:41 ― Section 2: Sample Collection and Storage Conditions

- 4:16 ― Section 3: Standardized Workflows for Risk Management and Chain of Custody Maintenance

- 5:54 ― Section 4: Stability Testing

- 7:34 ― Section 5: Laboratory Management

- 8:57 ― Section 6: Customized Processes

- 10:35 ― Section 7: Management of Bioanalytical Matrices

- 11:21 ― Section 8: Post-Study Sample Management

- 12:12 ― Section 9: Conclusion

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.

Innovation is the cornerstone of the work we do at Altasciences. When sponsor Tetra Bio-Pharma approached us to conduct a first-in-human test on their product, a cannabis extract being studied for use in breakthrough cancer pain, we collaborated with them on the ideal development plan, including clinical study design and bioanalysis, for the first whole plant cannabis extract following the drug pathway for approval.

Click here to download a readable, PDF version of Issue 2: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue2_Cannabis_2022.pdf

CHAPTERS:

- 0:08 — Section 1: Introduction to Cannabis-based Medicinal Products

- 1:33 — Section 2: Supporting Clinical Facts and Research

- 6:56 — Section 3: Altasciences' Experience and Innovative Approach to Cannabinoid Studies

- 8:10 — Section 4: Case Study — Safety and Tolerability Study on the World's First Cannabis Extract Being Developed as a Drug for Regulatory Submission

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.

Mandated by regulatory bodies the world over, the thorough and precise evaluation of a new drug’s cardiac effects is a critical element of new chemical entity development. Sponsors must submit all new chemical entities with systemic exposure to a dedicated thorough QT study (also referred to as TQT study) to understand the drug’s impact on ECG parameters and determine whether the compound prolongs the corrected QT (or, QTc) interval.

In Issue 9, we discuss global regulations, design, and timing of QT assessment, including a case study from a first-in-human clinical trial.

Click here to download a readable, PDF version of Issue 9: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue9_TQT_2022.pdf

CHAPTERS:

- 0:08 — Section 1: Introduction

- 1:50 — Section 2: Global Regulations

- 3:49 — Section 3: QT/QTc Study Design

- 7:01 — Section 4: Timing of Assessment

- 9:36 — Section 5: Case Study — First-in-Human Clinical Trial Involving QT Assessment

- 12:09 — Section 6: Cardiac Assessment Specializations

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.

With more than 6,800 FDA-approved drugs, many of which contain psychoactive or sedative pharmaceutical ingredients which could alter the ability to operate a motor vehicle, it is crucial to put in place a systematic effort to identify the drugs that increase the risk of motor vehicle accidents. This is a critical component in assessing drug risk and designing strategies to reduce this risk.

Click here to download a readable, PDF version of Issue 1: https://www.altasciences.com/sites/default/files/2022-03/The-Altascientist_issue1_driving_2022.pdf

CHAPTERS:

- 0:07 — Section 1: The FDA Finalizes Drug-Impaired Driving Guidance

- 2:39 — Section 2: Driving Simulation Testing and CNS Side Effect Specificity

- 5:26 — Section 3: Cognitive Studies with State-of-the-Art Driving Simulator

- 7:08 — Section 4: Case Study — Clinical Study Planning Challenges of Driving Studies

- 10:12 — Section 5: A Second Case Study — Driving Assessment of Filbanserin (Addyi)

- 12:42 — Section 6: Regulatory Recommendations and Requirements

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.

In this issue, we explore key considerations for biosimilar clinical pharmacology studies. Biosimilars are usually given the same indications as the originator drugs but with reduced development cost, which translates to a lower market price, making them more accessible and affordable to patients.

Click here to download a readable, PDF version of Issue 4: https://www.altasciences.com/sites/default/files/2020-02/The%20Altascientist_issue4_Biosimilars_2020.pdf

Issue 4 was originally published in print in September 2018.

CHAPTERS:

- 0:20 — Section 1: The Rise of the Biosimilar Market

- 3:36 — Section 2: Regulatory Landscape

- 8:04 — Section 3: Altasciences Puts Biosimilars to the Test

- 12:41 — Section 4: Experts in Bioanalysis

- 16:32 — Section 5: Key Considerations

- 23:30 — Section 6: Ensuring the Continued Success of Biosimilar Programs

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.

Metabolic disorders can take many forms, with obesity and diabetes being the most common. The worldwide prevalence of obesity has nearly tripled between 1975 and 2016. Once considered a high-income country problem, obesity is now on the rise even in low- and middle-income countries. Overall, about 13% of the world’s adult population was considered obese in 2016. Of that 13%, 11% were men and 15% were women. In that same year, it was estimated that 41 million children under the age of 5, and 340 million children and adolescents aged 5 to 19, were considered overweight or obese.

Click here to download a readable, PDF version of Issue 5: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue5_Metabolic_2022.pdf

Issue 5 was originally released in print in 2018.

CHAPTERS:

- 0:09 — Section 1: Current State of Metabolic Disorders

- 2:21 — Section 2: Ask the Expert — A Q&A with Altasciences' Ingrid Holmes, VP of Global Clinical Operations

- 5:40 — Section 3: An Epidemic Still on the Rise

- 7:53 — Section 4: Case Study

- 11:52 — Section 5: A Hidden Threat — Nanalcoholic Fatty Liver Disease

- 15:27 — Section 6: Recruitment Process and Patient Access for NASH Studies

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.

Hybrid medicines are drugs based on a generic molecule and have a different route of administration, format, strength, or indication from the original reference product. They require re-approval for market authorization, partly based on data from the original reference medicine, and partly on data from new clinical trials on the modified version.

Click here to download a PDF, readable version of Issue 6: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue6_505B2_2022.pdf

CHAPTERS:

- 0:08 — Section 1: An Introduction to Hybrid Medicines

- 1:41 — Section 2: Some Applicable Categories of Drugs for Hybrid or 505(b)(2) Pathways

- 5:06 — Section 3: Hybrid or 505(b)(2) vs. Generics

- 6:21 — Section 4: Choosing a Drug Candidate

- 9:30 — Section 5: Case Study — Achieving a 505(b)(2) Regulatory Approval

- 10:40 — Section 6: Case Study Continued — Study Methods

- 14:40 — Section 7: Case Study Continued — The Results

- 16:22 — Section 8: What Sets Altasciences Apart

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.

In this issue, we discuss effective pharmaceutical therapies. Specifically, understanding the intrinsic and extrinsic factors that alter exposure to limit adverse effects and maximize treatment response.

Click here to download a PDF, readable version of Issue 7: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue7_DDI_2022.pdf

CHAPTERS:

- 0:18 — Section 1: Introduction

- 1:48 — Section 2: Key Factors to Consider in the Course of Drug Development

- 9:41 — Section 3: Drug Interactions and Guidances for Marketed Drugs

- 12:06 — Section 4: Partnering with Altasciences for Your Drug Interaction Studies

- 13:52 — Section 5: Case Study — Drug-Drug Interaction

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.