Altasciences

In this issue, we will review the applications of PCR analysis for your gene therapy programs, and present two case studies. Click to read this audiobook: https://www.altasciences.com/sites/default/files/2023-10/the-altascientist-issue-37-pcr_4.pdf Gene therapy continues to accelerate through preclinical and clinical research arenas. These programs are developed with targeted and personalized medicines in mind. The goal of gene therapy is to safely deliver and incorporate a genetic alteration to restore or repair the protein of a missing or faulty gene. Preclinical assessments of gene therapies consider the general absorption, distribution, metabolism, and excretion of the drug, as well as data from tailored assessments to evaluate delivery and cell incorporation. Gene therapies require, by design and definition, DNA and/or RNA delivery and analysis. While most ongoing research involves gene therapies being delivered in vivo via adeno-associated viral (AAV) vectors, new in vivo delivery mechanisms are on the rise, such as other types of delivery vectors including lipid nanoparticles. CHAPTESR: - 0:05 — About Issue 37 - 1:20 — Introduction to qPCR, dPCR, and RT-PCR - 5:58 — Utility of qPCR, ddPCR, and RT-PCR - 8:19 — PCR Applications - 10:01 — Advantages and Applications - 17:45 — Case Study 1 - 20:20 — Case Study 2 - 22:47 — 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 the key considerations and regulatory guidance for nonclinical cell and gene therapy development, including expert approaches to mitigating complex challenges, improving study efficiency, and maximizing translational opportunities to first-in-human trials. CHAPTERS: - 00:07 — About This Audiobook - 01:57 — Introduction - 05:34 — Species Selection - 09:00 — Germline Mitigation Studies - 13:22 — Planning Your Nonclinical Studies - 14:44 — Case Study 1 - 17:18 — Case Study 2 - 19:08 — Conclusion Click here to read Issue 36: https://www.altasciences.com/sites/default/files/2023-09/The-Altascientist-Issue36-Cell-and-Gene-Therapy.pdf Traditional approaches modulate the course of disease but do not provide a cure, particularly in the case of monogenic diseases, which are caused by mutations in single genes that a person is born with. It is estimated that there are greater than 6,000 monogenic diseases, affecting over 350 million people worldwide. For these diseases, cell and gene therapy may provide hope for a cure. There are significant challenges associated with the successful development of these complex, leading-edge therapies. Challenges involved in the in vivo preclinical study of cell and gene therapies include understanding on- and off-target activity, immune responses, and other serious adverse events. All of these must be carefully monitored, rigorously assessed, and managed to the highest extent possible. 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 demand for HPAPIs has been increasing over the past decade, mainly driven by oncology research. The overall HPAPI market is predicted to reach $31.5 billion USD by 2029, with more than 25% of drugs currently on the market formulated with HPAPIs. In this issue, we examine the intricacies involved in manufacturing highly potent active pharmaceutical ingredients, herein referred to as HPAPIs. This examination of HPAPIs includes a review of the relevant guidance, classification systems, and safety processes. We also delve into how CDMO facilities, equipment, and processes for HPAPIs should be adapted to maximize safety and success for your development projects. CHAPTERS: - 00:08 ― Introduction - 01:35 ― Defining High Potency for an API - 03:47 ― Determining Exposure Potential - 05:47 ― Engineering Controls for HPAPI Manufacturing - 08:25 ― Regulatory Requirements for HPAPI Production - 14:22 ― Altasciences Case Study - 17:25 ― Conclusion Click here to read Issue 35: https://www.altasciences.com/sites/default/files/2023-08/The-Altascientist_issue35_HPAPI.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.

Understanding a novel drug's PK and PD properties begins with nonclinical studies and evolves through early phase clinical trials. In this issue, we take a closer look at the collection and use of PK/PD data in early phase drug development. CHAPTERS: - 0:08 — Introduction to Issue 34 - 1:32 — Nonclinical Studies - 2:39 — IND Requirements and Translation to Clinical PK/PD - 5:37 — Translating Nonclinical Knowledge of PK/PD Analyses to Clinical Study - 8:51 — Case Study - 12:32 — Conclusion Click here to read Issue 34: https://www.altasciences.com/sites/default/files/2023-08/the-altascientist-issue-34-toxicokinetics-pharmacokinetics-and-pharmacodynamics.pdf Introduction on TK, PK, and PD Data: The understanding of a new drug's absorption, distribution, metabolism, and excretion (more commonly known as ADME) is critical to ensure that it is safe for human use. That understanding is achieved through collection and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data, which together account for approximately 25% of the contents of a drug package insert or label. The characterization of PK/PD effects starts with nonclinical toxicokinetic (TK) studies in animals. The purpose of TK studies is to define the chemical properties of the drug, including pharmacology and toxicology, and to assist in development of downstream clinical protocols. The necessary nonclinical studies are conducted before submission of Investigational New Drug (also known as IND) applications to the FDA or other global regulatory agencies, and deliver critical data used to set the parameters for future clinical trials. 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.

A consideration with a measurable impact on early phase clinical studies is the location where trials are performed; this is especially true for first-in-human trials. Conducting early phase clinical research on novel compounds in Canada can provide significant advantages versus other locations. CHAPTERS: - 0:43 — Introduction - 3:12 — Canadian Clinical Trials: Time and Cost Savings - 3:46 — CTA (Health Canada) vs. IND (FDA) - 5:17 — CTA: Health Canada vs. EMA - 7:52 — Regulatory Review Process Predictability - 10:19 — Business Efficiency Cost Savings - 11:28 — Clinical Trial Participants - 13:06 — FAQs - 18:43 — Why Altasciences? Read along with this PDF version: 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 the miniature swine as an option in small and large molecule studies. The choice of species for nonclinical safety studies is an important step in the drug development process. The species to be used is, to a large extent, dependent on the test article type and clinical indication. Existing regulatory guidance documents—combined with careful consideration of the characteristics of the drug being developed, guided by scientific, ethical, and practical considerations—help inform this key decision. The most common non-rodent species involved in nonclinical safety studies are nonhuman primates (also referred to as NHPs) and dogs. There is, however, an increasing body of evidence that supports the use of miniature swine as a viable non-rodent option for nonclinical safety studies. Chapters: - 1:09 — Introduction - 2:54 — Miniature Swine as a Viable Option for Nonclinical Safety Studies - 8:12 — Miniature Swine Size Considerations - 9:13 — Real-World Examples of Miniature Swine Use in Clinical Development - 10:28 — Species Selection Criteria and Processes - 13:10 — Case Studies - 22:09 — How Altasciences Can Help - 23:36 — Altasciences' Experience With Miniature Swine Studies

The different parts of the nervous system (or CNS for short), including the brain and spinal cord, and the peripheral nervous system, are important drug targets for many serious diseases affecting human health. As the body's processing center, the CNS is responsible for all functions of our bodies, including thoughts, emotions, memories, and behaviors. Unsurprisingly, drugs working on the CNS are subject to stringent regulatory requirements, and specialized safety assessments are often mandated. To confirm CNS activity without safety concerns, dedicated nonclinical and early phase clinical studies, with relevant endpoints and biomarkers, and supporting bioanalysis, are needed; and drug manufacturing must be carefully managed via rigorous handling and production processes. Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely sharing of data at every step of the drug development plan, and facilitate agile, flexible decision-making and planning. CHAPTERS: - 1:22 — Introduction - 3:53 — Preclinical Safety and Toxicity Testing of CNS-Active Molecules - 12:28 — Preclinical Case Study - 15:11 — Manufacturing CNS-Active Drugs for Trials and Commercialization - 21:48 — CDMO Case Study - 24:39 — Maximizing Early Phase Clinical Trials of CNS-Active Drugs - 34:02 — Clinical Case Study - 36:27 — Bioanalysis for CNS Drug Development (Preclinical to Phase IV) - 42:26 Altasciences' CNS Center of Excellence

In this issue, we describe the numerous benefits of incorporating a stable isotope labelled internal standard for quantitative liquid chromatography-mass spectrometry, and detail recent advances in MS technology. Several case studies are presented, which exemplify novel bioanalytical workflows that are required to meet the challenges faced in both non-clinical and clinical development, across a variety of drug classes. - 0:42 Introduction - 5:33 The Case for Stable Isotope Labelled Internal Standards for LCMS Quantitation - 8:34 Recent Innovations in Mass Spectrometry - 15:38 Case Study: Dried Blood Microsampling - 17:14 Case Study: Anti-Epileptic Drug Panel - 19:17 Case Study: COVID-19 Neutralizing Monoclonal Antibody - 21:16 Case Study: Differential Mobility Spectrometry (DMS) - 23:49 Case Study: Bioequivalence - 26:22 Case Study: Oligonucleotides - 33:57 Conclusion Click here to download a readable, PDF version of Issue 13: https://www.altasciences.com/sites/default/files/2022-12/The-Altascientist-issue-30-LCMS.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.

In this issue of The Altascientist, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program. Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population. In this issue: - 0:19 Introduction - 1:01 Protocol Development - 2:49 Data Management - 9:07 Statistical Support - 10:49 Analysis and Reporting - 13:28 Conclusion Click here to download a readable, PDF version of Issue 29: https://www.altasciences.com/sites/default/files/2022-12/The-Altascientist-issue-29-Data-Journey.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.

Liquid-filled hard-shell capsules are a popular formulation for oral solid delivery of chemical drugs and nutraceuticals. Often selected for drugs with poor solubility and/or poor bioavailability, liquid-filled hard-shell capsules also have applications in a number of other situations, including specific benefits during early phase clinical development. In this issue of The Altascientist, you will hear about: • 0:57 — Applications of liquid-filled hard-shell capsules • 5:32 — The production process • 8:13 —The role of excipients • 9:54 — Other advantages of liquid-filled hard-shell capsules • 11:04 —Case study Click here to download a readable, PDF version of Issue 28: https://www.altasciences.com/sites/default/files/2022-10/The-Altascientist_issue-28_LFCs.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.

Podcast—Nonclinical Considerations When Developing An Ophtalmic Drug by The Altascientist

PODCAST—Key Considerations As You Move From Discovery To Preclinical To Clinical by The Altascientist

EPISODE #27 - Podcast: The Many Faces of Drug Use — Episode 3 by The Altascientist

In this podcast our special guest Dr. Don Chace, Capitainer, talks about some of the most pressing drug development topics.

Drug development in the ocular space has specific challenges. In this audiobook, we explore how an end-to-end solution can facilitate a path to Phase 2, and we do this by breaking down the entire pathway by solution. Click here to read a PDF version of Issue 27: https://www.altasciences.com/sites/default/files/2022-09/The-Altascientist_issue-27_Ophthalmic_1.pdf CHAPTERS: - 0:54 — Section 1: Introduction - 3:01 — Section 2: Prototype Development, Formulation, and Manufacturing - 8:10 — Section 3: CDMO Case Study - 10:40 — Section 4: Preclinical Research - 17:38 — Section 5: Preclinical Case Study - 23:30 — Section 6: Bioanalysis - 32:32 — Section 7: Phase I Clinical Research - 37:02 — Section 8: Clinical Case Study - 40:42 — Section 9: Phase II to Commercialization 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.

There is tremendous value in standardizing and sharing data: organizations across the globe that are using CDISC standards produce faster, more efficient research, and pave the way for more breakthroughs that amplify the power of data, in both the short- and long-term. To download a readable, PDF version of Issue 26, click here: CHAPTERS: - 0:17 — Section 1: What is CDISC? - 2:00 — Section 2: The Power of Standardization - 4:56 — Section 3: Client Consideration for Nonclinical and Clinical Data Standardization - 8:58 — Section 4: Case Study — Realized Efficiency - 12:15 — Section 5: Case Studies — Legacy Data Conversion - 13:31 — Section 6: Focus on the Future - 15:11 — Section 7: Altasciences' Capabilities 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 structure of an early phase drug development pathway is not set in stone. In fact, certain studies that are generally considered Phase 1 do not have to be conducted before Phase 2 commences. Conversely, some studies that are typically done in Phase 2 can be advanced into a Phase 1 combined protocol to have access to key data earlier in the program. Early Phase 1 studies have become increasingly complex, in order to gather comprehensive data related to safety and drug pharmacology. Having early access to trial results and data helps inform decisions later in the development journey, can support funding opportunities, and help solidify the overall plan around sound data. Partnering with a CRO team that has the knowledge and experience to design each program according to the sponsors' needs, considering flexibility to perform specific analyses early (in Phase 1) or later (Phase 2 and beyond) is ideal. Experts will incorporate and analyze early signals that point to specialized analyses being included or waived, and the development pathway is structured to maximize efficient timelines and budget. CHAPTERS: - 0:08 ― Section 1: Introduction - 1:30 ― Section 2: Timing of Early and Clinical Pharmacology Studies - 4:01 ― Section 3: Development Program Optimization - 7:52 ― Section 4: Scenarios - 16:31 ― Section 5: Summary 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.

We recently 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 provide insight into several areas: • The significant challenges companies encounter when conducting preclinical and Phase 1 studies • The unique difficulties of transitioning from preclinical to first-in-human studies • The specific capabilities and expertise executives look for in their CRO partners Listen to this audiobook to hear the results of this survey. Click here to download a readable, PDF version of this eBook: https://www.altasciences.com/sites/default/files/2022-04/Biopharma-Dive-Playbook_One-integrated-solution_web.pdf CHAPTERS: - 0:16 — Section 1: Introduction - 1:39 — Section 2: The Drug Development Journey and the Benefits of Outsourcing - 3:03 - Section 3: Real-World Insights from Our Biopharma Executive Survey - 6:08 — Section 4: Altasciences Offers Solutions - 10:34 — Section 5: The One-Stop Solution 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 eBook, we present Altasciences' comprehensive, multi-service solution for your first-in-human trials that extends beyond the clinic. Click here to download a readable, PDF version of this audiobook: https://www.altasciences.com/sites/default/files/2021-12/FIH_solution_ebook_2021.pdf CHAPTERS: - 0:10 — Section 1: Your Drug Development Partner - 0:42 — Section 2: Uniquely Organized for Early Phase - 2:29 — Section 3: Scientific and Regulatory Consulting - 3:19 — Section 4: Parallel Processing - 7:49 — Section 5: Putting Participant Safety First - 8:38 — Section 6: We Deliver on Our Promise 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.

Advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials. This eBook provides a high-level overview for the preclinical component of your drug development program. Click here to download a readable, PDF version of this eBook: https://www.altasciences.com/sites/default/files/2022-02/Nonclinical_Safety_Testing_Guide.pdf Contents of this audiobook: - Planning Your Pivotal Toxicology Studies - Small Molecules vs. Biologics - Species Selection - Program Study Outlines - Timing - SEND Compliance - Selecting the Right CRO for You 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.

Liquid-filled, hard-shell capsules offer a number of advantages over tablet and other solid oral dosage forms. Listen to this eBook to discover how LFCs can help accelerate your drug development program. Click here to download a readable, PDF version of this eBook: https://www.altasciences.com/sites/default/files/2022-03/Altascience_Biopharma_Playbook_FNL_v2.pdf CHAPTERS: - 0:10 — Section 1: Introduction - 1:39 — Section 2: How Liquid Filling Works - 3:53 — Section 3: Logistical Advantages - 7:38 — Section 4: Improved Applications for Challenging APIs - 9:44 — Section 5: Customization Options and Marketing Opportunities - 10:34 — Section 6: Essential Capabilities in Manufacturing 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.

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: - 0:08 — Section 1: Introduction - 2:01 — Section 2: Key Factors to Consider in the Course of Drug Development - 9:04 — Section 3: Partnering with Altasciences for Your Drug Interaction Studies - 10:33 — Section 4: Case Study — Drug-Drug Interaction - 17:47 — Section 5: Challenges and Solutions 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 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.

In this issue, we discuss how to maximize drug formulation for first-in-human clinical trials. Click here to download a PDF, readable version of Issue 17: https://www.altasciences.com/sites/default/files/2021-05/The-Altascientist_issue17.pdf The main objective of first-in-human trials is to determine the starting dose of a new drug, one that is low enough to provide minimal to no safety and toxicity risks, and allows the highest dosage and benefit for the intended trial. The manufacture of the drug product for clinical trials is of critical importance, as the formulation, manufacturing, and assessment of a drug candidate during first-in-human trials can be contributing factors in whether the drug safely provides the correct dosage and, ultimately, gains regulatory approval. Decisions made during early phase development, when the compound is being used in a clinical research setting, provide significant learnings for its progression through later phase research. Integration is key − ensuring that information gathered at the clinic is efficiently incorporated into the manufacturing process is a major contributor to the goal of achieving marketing approval. CHAPTERS: - 0:15 ― Section 1: The Key Role of Formulation in Drug Development - 3:45 ― Section 2: Formulation - 7:25 ― Section 3: The Impact of Formulation on Subject Safety - 10:09 ― Section 4: A Pharmacy Case Study ― Supporting Regulatory Approval - 11:43 ― Section 5: Manufacturing Case Study ― Mission Impossible to Possible - 13:20 ― Section 6: Integrating to Maximize Chances for Success - 14:36 ― 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 safety pharmacology guidelines and practices. Click here to download a PDF, readable version of Issue 13: https://www.altasciences.com/sites/default/files/2020-06/The%20Altascientist_issue13.pdf Safety pharmacology studies are defined in the International Conference on Harmonization (known as the ICH) S7A guidance as “those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.” In other words, they are a set of tests focused on potentially adverse effects of pharmaceutical or biological agents, differing from traditional toxicology studies as they are typically concentrated on a single organ or physiological system. CHAPTERS: - 00:16 — Section 1: Key Considerations for Safety Pharmacology Studies - 4:35 — Section 2: Core & Supplemental Studies - 12:07 — Section 3: Species Selection - 13:15 — Section 4: Number of Animals - 14:06 — Section 5: Routes of Administration - 14:29 — Section 6: Dose Level Selection & Duration - 15:55 — Section 7: Supplemental Studies (aka Follow-Up Studies) - 18:09 — Section 8: Safety Pharmacology Endpoints on Traditional Toxicology Studies - 20:04 — Section 9: Safety Pharmacology Studies May Not be Necessary - 20:45 — Section 10: Choosing a CRO for Safety Pharmacology Studies - 21:40 — 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 explore the challenges associated with Schedule I therapeutic development. Click here to download a PDF, readable version of Issue 19: https://www.altasciences.com/sites/default/files/2022-03/The%20Altascientist_issue%2019_CNS%20Hallucinogens_v4.pdf Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics and entactogens, both of which are Schedule I, is beginning to demonstrate potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status. CHAPTERS: - 0:00 — Section 1: Introduction - 4:40 — Section 2: Research Site Requirements Associated with Development of Schedule 1 Drugs for Therapeutic Use - 8:01 — Section 3: Required Preclinical Studies - 10:30 — Section 4: Formulation, Manufacturing, and Analytical Considerations - 13:02 — Section 5: Required Clinical Studies - 18:27 — Section 6: Specialized Clinical Assessments - 20:19 — 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, learn about the validation of immunogenicity assays to support nonclinical and clinical studies, including different purposes and challenges. Click here to download a PDF, readable version of Issue 20: https://www.altasciences.com/sites/default/files/2021-11/The-Altascientist_issue-20_Immunogenicity-Assays.pdf Regulatory guidelines focusing on immunogenicity assays for clinical studies are not all applicable to nonclinical requirements and their unique challenges. While we have a full understanding of regulatory requirements for clinical studies, the lack of regulatory documents addressing the particular needs of nonclinical immunogenicity studies has contributed to less consensus on appropriate immunogenicity testing strategies and validation parameters. This, by extension, has led to different approaches being adopted by the drug development industry. CHPATERS: - 0:00 — Section 1: Introduction - 1:04 — Section 2: Challenges and Goals - 3:31 — Section 3: Validation of Immunogenicity Assays for Nonclinical Studies - 10:45 — Section 4: Validation of Immunogenicity Assays for Clinical Studies - 20:42 — Section 5: 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, learn about terminal sterilization of pharmaceutical products. Click here to download a PDF, readable version of Issue 21: https://www.altasciences.com/sites/default/files/2021-12/The-Altascientist_issue-21_Terminal-Sterilization.pdf There is growing demand for sterilization of small-molecule parenteral products, including heart medications, eye drops, analgesics, and antibiotics, as well as common intravenous solutions such as glucose, potassium, and saline. Many such products are used by medical professionals in hospitals, and to ensure patient safety, the drug products and related instruments and materials are sterilized at manufacture. This ensures there are no microbial contaminants like fungi or bacteria present when the product is used. CHAPTERS: - 0:00 — Section 1: Introduction - 1:12 — Section 2: Terminal vs. Aseptic Sterilization of Pharmaceutical Products - 5:41 — Section 3: Terminal Sterilization Methods for Pharmaceuticals - 9:03 — Section 4: Validation Steps - 13:11 — Section 5: Material Changes - 14:12 — Section 6: Method Selection - 15:01 — Section 7: Why Terminal Sterilization - 16:31 — 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, discover how nanomilling can improve the solubulity and bioavailability of your drug. Click here to download a PDF, readable version of Issue 22: https://www.altasciences.com/sites/default/files/2022-02/The-Altascientist_issue-22_Nanomilling.pdf A crucial feature of drug development is bioavailability, defined as “the ability of a drug to be absorbed and used by the body.” For a drug to be bioavailable, it must first be soluble, meaning able to be dissolved, especially in water. Many drugs on the market today are poorly water soluble, and patent extensions or 505(b)(2) new patents become possible for formulation improvements delivered via nanomilling. CHAPTERS: - 0:00: Section 1 — Introduction - 0:47: Section 2 — Solubility Classifications - 2:33: Section 3 — Overcoming Solubility Challenges - 3:51: Section 4 — The Benefits of Nanomilling - 4:53: Section 5 — How Nanomilling Works - 6:00: Section 6 — Maximizing Formulation - 8:15: Section 7 — Case Study - 11:14: 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.

Drug addiction is a devastating condition that affects the quality of the user and their families. In this podcast series, we explore the behaviors of individuals who abuse opioids and stimulants, and learn about their patterns of use and motivations to compel them to continue using these drugs through a series of candid interviews with opioid and stimulant recreational drug users. In this episode, "Chasing the Dragon — A Series of Candid Interviews with Opioid and Stimulant Recreational Drug Users", moderated by Dr. Beatrice Setnik, CSO, and featuring Dr. Debra Kelsh, psychiatrist and Principal Investigator at Altasciences, we provide a unique perspective around the behaviors of opioid and stimulant drug abuse. Throughout the episode, Dr. Kelsh and Dr. Setnik will offer commentary on key moments from the interview with a drug user. Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients' projects to help support educated, faster, and more complete early drug development decisions. Altasciences' full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: https://www.altasciences.com/

EPISODE #22 - The Next Trip, Developing the 2nd generation of psychedelics for medical indications by The Altascientist

EPISODE #21 - The Many Faces of Recreational Drug Use by The Altascientist

Overcoming Challenges and Building a Successful Company: Dr. Gautam Ghatnekar, CEO of FirstString Research, shares his secrets to raising capital, recruiting and retaining talent, and overcoming the challenges of getting medicines to the market.