Altasciences

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 — Your Drug Development Partner

- 0:53 — Uniquely Organized for Early Phase

- 2:46 — Scientific and Regulatory Consulting

- 3:38 — Parallel Processes

- 9:06 — Putting Participant Safety First

- 9:55 — 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.