Altasciences

In this issue, we dive into HAP studies, and the importance of an exert drug development solution partner in human abuse potential.

Click here to download a PDF, readable version of Issue 13: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue3_HAP_2022_v3.pdf

CHAPTERS:

- 00:08 — Section 1: The FDA Takes Steps to Limit the Misuse and Abuse of Prescription Drugs

- 08:59 — Section 2: Altasciences' Human Abuse Potential (HAP) Study Services

- 11:32 — Section 3: Our Study Design and Protocol

- 15:24 — Section 4: Tips for Designing a HAP Study

- 17:40 — Section 5: Case Study

- 24:06 — Section 6: Pioneering Ongoing Research

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, how to face bioanalytical challenges when evaluating the immunogenicity profile of protein-based therapeutic drugs, including:

• Challenges encountered in Anti-Drug Antibody (ADA) assays

• Information on when to use cell-based or non-cell-based assays to measure neutralization

Click here to download a PDF, readable version of Issue 8: https://www.altasciences.com/sites/default/files/2020-02/The%20Altascientist_issue8_ADAs_2020.pdf

CHAPTERS:

- 0:28-2:36 — Section 1: Introduction

- 2:36-5:08 — Section 2: Challenges Encountered in ADA Assays

- 5:08-6:32 — Section 3: How to Determine Cut-Point Evaluation for Oncology Clinical Studies

- 6:32-8:30 — Section 4: What to Do When the PEGylation of the Therapeutic Drug Masks Key Epitopes in the ADA Assay

- 8:30-12:08 — Section 5: Cell-Based or Non-Cell Based Assays to Measure Neutralization

- 12:08-13:45 — Section 6: Considerations for Choosing a Cell-Based Neutralizing Antibody Assay

- 13:45-14:46 — Section 7: Trusting Altasciences to Move Your Research Forward

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.

First-in-human (FIH) trials in the early phases of drug development represent a critical milestone in the approval of medicines. These trials allow sponsors to determine potential risks associated to the drug at each step of its development, and determine the safe dose range in the course of its clinical progression.

Click here to download a PDF, readable version of Issue 10: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue10_FIH_2022.pdf

CHAPTERS:

- 0:14 — Section 1: Introduction

- 2:16 — Section 2: Designing a Successful FIH Trial

- 5:57 — Section 3: Bridging the Gap from Preclinical to Clinical

- 8:19 — Section 4: Access to Patient Populations

- 9:26 — Section 5: Integrating Adaptive Designs in FIH Trials

- 15:26 — Section 6: Case Study

- 18:38 — Section 7: Choosing the Right CRO

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, discover how to plan your preclinical assessment for a successful regulatory submission, including:

• An IND checklist

• Preclinical program considerations

• Estimating timelines

Click here to download a PDF, readable version of Issue 11: https://www.altasciences.com/sites/default/files/2019-11/The%20Altascientist_issue11_0.pdf

CHAPTERS:

- 0:23 — Section 1: Introduction

- 1:28 — Section 2: Prepare a Checklist

- 3:38 — Section 3: Plan Your Pivotal Toxicology Studies

- 5:05 — Section 4: Frequently Asked Questions in Preparing Your Preclinical Studies

- 6:50 — Section 5: Small Molecules vs. Biologics

- 7:58 — Section 6: Species Selection

- 8:48 — Section 7: Formulation, the Test Article, and Bioanalysis

- 11:36 — Section 8: Pivotal Toxicology Studies

- 12:52 — Section 9: Safety Pharmacology

- 14:06 — Section 10: Genetic Toxicology

- 15:54 — Section 11: SEND Data

- 16:39 — Section 12: Selecting the Right CRO for You

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, explore antisense oligonucleotides, including:

• An overview of recent advances with hybridization-based assays to quantify antisense oligonucleotides in support of pharmacokinetic or toxicokinetic preclinical and clinical studies;

• Regulatory and bioanalytical considerations for these studies;

• Two case studies illustrating Altasciences’ capabilities and knowledge in the field.

Click here to download a PDF, readable version of Issue 12: https://www.altasciences.com/sites/default/files/2020-11/The%20Altascientist_issue12_oligonucleotides.pdf

CHAPTERS:

- 0:35 — Section 1: Introduction

- 1:05 — Section 2: Recent Advances in Antisense Oligonucleotide Research

- 3:00 — Section 3: Regulatory Considerations

- 4:49 — Section 4: Bioanalytical Considerations

- 10:04 — Section 5: Case Study 1 — Resolving Issues with Matrix Effect

- 12:48 — Section 6: Case Study 2 — Stability of Antisense Oligonucleotide in Tissue Matrix

- 14:52 — Section 7: 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.

In this issue, we review complex considerations for the development of central nervous system-active drugs, including The Controlled Substances Act, preclinical and clinical data requirements, and additional assessments your program may need.

Click here to download a PDF, readable version of Issue 14: https://www.altasciences.com/sites/default/files/2020-08/The-Altascientist_issue-14_CNS_0.pdf

CHAPTERS:

- 0:24 — Section 1: Introduction

- 0:58 — Section 2: The Landscape

- 3:13 — Section 3: Drug Schedule and The Controlled Substances Act

- 6:39 — Section 4: Early Phase Preclinical and Clinical Study — Data Review

- 9:26 — Section 5: Significant Considerations for CNS Drug Development — Abuse Potential

- 11:07 — Section 6: Significant Considerations for CNS Drug Development — Physical Dependency and Withdrawal

- 14:01 — Section 7: Driving Impairment Assessment and Cognitive and Motor Function Effects

- 16:51 — Section 8: Additive Effects

- 14:40 — Section 9: Choosing a CRO for CNS Studies

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 how Altasciences maintained early phase research continuity during the COVID-19 pandemic.

Click here to download a PDF, readable version of this audiobook: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue15_Covid-19_2022.pdf

Business continuity, especially during times of uncertainty, is vital. Swift and decisive action to mitigate risk and support ongoing viability of activities is crucial. The COVID-19 pandemic challenges the strongest, most actionable plans, and they must be supported by consistent and clear communications.

Since the beginning of the pandemic, Altasciences has responded quickly and decisively with the goal of ensuring the safety of our teams, the animals in our care, the study participants, and business continuity for our clients. Thus far, there has been no viral outbreak at any of our sites thanks to all staff following precautionary guidelines, both state and provincial, and our own.

CHAPTERS:

- 0:08 — Section 1: Introduction

- 1:49 — Section 2: Employee Health and Safety

- 3:42 — Section 3: Participant Health and Safety

- 4:48 — Section 4: Animal Welfare

- 5:24 — Section 5: Travel Restrictions and Visitor Screening

- 6:38 — Section 6: Communication Strategy

- 7:50 — Section 7: Data and Research Integrity

- 9:19 — Section 8: 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.

In this podcast our special guest Dr. Michael Winlo, Managing Director at Emyria, talks about their unique programs and new patient care models. Emyria is a biotech company that brings together patients, clinicians, researchers, and medical innovators to develop data-driven, novel treatments for patients in need, including cannibidiol (CBD) formulations.

In this podcast, we uncover: the most important thing to know when developing your manufacturing program and what to look for in a consultant, and what to look for in a CRO/CDMO partner

In this issue, we explore microsampling applications, benefits, and considerations for preclinical, clinical, bioanalytical research, and review two case studies on the topic.

Click here to download a PDF, readable version of Issue 16: https://www.altasciences.com/sites/default/files/2020-12/The%20Altascientist_issue16.pdf

CHAPTERS:

- 0:07 ― Section 1: Introduction

- 1:44 ― Section 2: Microsampling Benefits in Preclinical Research

- 3:30 ― Section 3: Microsampling Benefits in Clinical Research

- 6:56 ― Section 4: Bioanalytical Considerations

- 8:32 ― Section 5: Case Study ― Anti-Epileptic Drug Monitoring: Sample Preparation Using Impact-Assisted Extraction

- 10:18 ― Section 6: Case Study ― Determination of Rituximab Using a Surrogate Peptide

- 11:43 ― Section 7: Regulatory Aspect

- 15:21 ― Section 8: Scientific Guidance

- 15:47 ― Section 9: Pharmacokinetic and Statistical Analysis

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.