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 discuss how to plan for your first-in-human clinical trial.

Click here to download a PDF, readable version of Issue 18: https://www.altasciences.com/sites/default/files/2022-03/The%20Altascientist_issue%2018_FIH_v9.pdf

A first-in-human clinical trial is a significant milestone in the development of a potential new drug in that it will be the first opportunity for a drug development sponsor to evaluate the impact of their new chemical entity or biologic in humans. Typically, first-in-human trials with compounds intended for treatment of diseases other than cancers or certain rare non-malignant diseases are conducted using healthy normal volunteers, unless there is an ethical concern (such as known toxicity) in administering the investigational drug to an otherwise healthy population.

CHAPTERS:

- 0:00-2:50 ― Section 1: Introduction

- 2:50-3:48 ― Section 2: Selecting the Starting Dose

- 3:48-7:34 ― Section 3: Designing the Trial

- 7:34-12:36 ― Section 4: Planning for Subject Safety

- 12:36-15:18 ― Section 5: Identifying and Mitigating Potential Risks in Trial Conduct

- 15:18-17:16 ― Section 6: Recruiting, Educating, and Retaining Study Participants

- 17:16-20:23 ― Section 7: Planning Resources and Conducting the Trial

- 20:23-end ― Section 8: Conclusion

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