ISSX 2021 North American Meeting: Tuesday, September 14, 2021


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Keynote Lecture: Janssen’s Effort in the Development of a COVID-19 Vaccine
Hanneke Schuitemaker, Janssen Vaccines and Prevention of J&J, Leiden, The Netherlands

In January 2020, when the genetic code of SARS-CoV-2 was published, Janssen started to work on a vaccine against COVID-19. A lead vaccine candidate, Ad26.COV2.S, was selected from 12 different spike protein designs, and leveraging the adenoviral vector platform. A single dose of this vaccine gave full protection in the lungs of challenge non-human primates and near complete protection in the nose. A first-in-human phase 1/2a study initiated in July 2020 and based on interim safety and immunogenicity results, a large (n=~44,000 participants) phase 3 efficacy study (ENSEMBLE), testing the protective efficacy of a single dose vaccine against moderate to severe COVID-19, was initiated in September 2020, in 8 different countries on 3 continents. End of January 2021, the primary analysis revealed the vaccine was safe and well tolerated, with an overall efficacy of 66% against moderate to severe COVID-19. A vaccine efficacy of >80% was observed against severe/critical COVID-19, with full protection against COVID-19 related hospitalizations and death, also in South Africa and Brazil where new SARS-CoV-2 variants of concern (B.1.351 and P2 lineage, respectively) were highly prevalent in COVID-19 cases in the trial. Ad26.COV2.S received Emergency Use Authorization from FDA in February 2021, conditional Marketing Authorization in EU and Emergency Use Listing from the WHO in March 2021, and conditional emergency use authorizations in countries worldwide.

Symposium 1: Latest Developments for Assessing the ADME of Biologics
Co-chairs: Dhaval Shah, University at Buffalo, Buffalo, New York, USA and Vittal Shivva, Genentech Inc., South San Francisco, California, USA

Disposition of Biologics is a very complex process, which depends on numerous drug and system related interactions. To facilitate the investigation of the key determinants responsible for the ADME of biologics, it is essential to develop novel analytical and experimental methods that can overcome the technical challenges associated with accurate and quantitative assessment of their disposition. Emerging techniques in this regard will not only help in establishing quantitative relationships between molecular properties and systemic exposure of biologics, but will also help in accurately characterizing and predicting the exposure of biologics at the site-of-action. In this session speakers will discuss novel state-of-the-art methods developed to assess the ADME of biologics.

Symposium 2: State of the Art Strategies to Enhance Brain Penetration of Small Molecules and Therapeutic Proteins 
Co-chairs: Marilyn Morris, University at Buffalo, Buffalo, New York, USA and Xiaoyan Chu, Merck & Co., Inc., Rahway, New Jersey, USA

The blood-brain barrier (BBB) and the blood-cerebrospinal fluid barrier (BCSFB) separate the brain and cerebrospinal fluid (CSF) from the systemic circulation, representing a barrier to the permeation of endogenous compounds and both small molecules and therapeutic proteins into the brain.  Drug transporters at the BBB and BCSFB are involved in the brain uptake and efflux of many drugs.  This symposium will 1) provide an overview of current knowledge and perspectives on roles of transporters at the BBB and BCSFB;  2) present novel in vitro, in vivo animal and clinical approaches applied in the elucidation and characterization of brain penetration, as well as clinical translation; and 3) provide an in-depth discussion of physiologically-based pharmacokinetic models to describe brain distribution and time course of therapeutic drugs and proteins, as well as the influence of dosing regimens and potential alterations with disease.

Symposium 3: Identifying Biotransformations of Next Generation Biologics
Co-chairs: Mark Cancilla, Merck & Co., Inc., Blue Bell, Pennsylvania, USA and Brooke Rock, Amgen, South San Francisco, California, USA

The increased complexity of biologic drug modalities has changed our understanding of their pharmacokinetic and metabolic assessment. The overall stability of a chemically modified or engineered proteins upon administration has been demonstrated to be linked to its efficacy. This session will focus on identifying biotransformations of complex biologics to further understand their metabolic fate as well as to aid in their design for the assessment of their therapeutic potential.

Symposium 4: Epigenetics in Drug Disposition and Drug Therapy
Chair: Ann Daly, Newcastle University, Newcastle Upon Tyne, United Kingdom

Epigenetics including DNA methylation, miRNA expression and histone modification contributes to the global gene expression including those relevant to xenobiotic metabolism and transport as well as disease processes including cancer. Though considerably progress has been made in this area, this is still a relatively poorly understood area with changes in epigenetic regulation due to disease and environmental factors of particular importance. Drugs that modulate epigenetic modification of gene expression are increasingly available and are especially relevant to oncology. This symposium will aim to cover both the drug disposition and drug discovery aspects of this area.


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Opening Welcome Remarks & Keynote Lecture: Janssen’s Effort in the Development of a COVID-19 Vaccine
Recorded 09/14/2021
Recorded 09/14/2021 Opening Welcome Remarks 24th North American ISSX Meeting Co-chairs: Raymond Evers, Johnson & Johnson, Spring House, Pennsylvania, USA and Joseph Balthasar, University at Buffalo, Buffalo, New York, USA Janssen's Effort in the Development of a COVID-19 Vaccine Hanneke Schuitemaker, Janssen Vaccines and Prevention of J&J, Leiden, The Netherlands In January 2020, when the genetic code of SARS-CoV-2 was published, Janssen started to work on a vaccine against COVID-19. A lead vaccine candidate, Ad26.COV2.S, was selected from 12 different spike protein designs, and leveraging the adenoviral vector platform. A single dose of this vaccine gave full protection in the lungs of challenge non-human primates and near complete protection in the nose. A first-in-human phase 1/2a study initiated in July 2020 and based on interim safety and immunogenicity results, a large (n=~44,000 participants) phase 3 efficacy study (ENSEMBLE), testing the protective efficacy of a single dose vaccine against moderate to severe COVID-19, was initiated in September 2020, in 8 different countries on 3 continents. End of January 2021, the primary analysis revealed the vaccine was save and well tolerated, with an overall efficacy of 66% against moderate to severe COVID-19. A vaccine efficacy of >80% was observed against severe/critical COVID-19, with full protection against COVID-19 related hospitalizations and death, also in South Africa and Brazil where new SARS-CoV-2 variants of concern (B.1.351 and P2 lineage, respectively) were highly prevalent in COVID-19 cases in the trial. Ad26.COV2.S received Emergency Use Authorization from FDA in February 2021, conditional Marketing Authorization in EU and Emergency Use Listing from the WHO in March 2021, and conditional emergency use authorizations in countries worldwide.
You must register to access.
Latest Developments for Assessing the ADME of Biologics
Recorded 09/14/2021
Recorded 09/14/2021 Disposition of Biologics is a very complex process, which depends on numerous drug and system related interactions. To facilitate the investigation of the key determinants responsible for the ADME of biologics, it is essential to develop novel analytical and experimental methods that can overcome the technical challenges associated with accurate and quantitative assessment of their disposition. Emerging techniques in this regard will not only help in establishing quantitative relationships between molecular properties and systemic exposure of biologics, but will also help in accurately characterizing and predicting the exposure of biologics at the site-of-action. In this session speakers will discuss novel state-of-the-art methods developed to assess the ADME of biologics. Co-chairs: Dhaval Shah, University at Buffalo, Buffalo, New York, USA and Vittal Shivva, Genentech Inc., South San Francisco, California, USA
You must register to access.
State of the Art Strategies to Enhance Brain Penetration of Small Molecules and Therapeutic Proteins
Recorded 09/14/2021
Recorded 09/14/2021 The blood-brain barrier (BBB) and the blood-cerebrospinal fluid barrier (BCSFB) separate the brain and cerebrospinal fluid (CSF) from the systemic circulation, representing a barrier to the permeation of endogenous compounds and both small molecules and therapeutic proteins into the brain. Drug transporters at the BBB and BCSFB are involved in the brain uptake and efflux of many drugs. This symposium will 1) provide an overview of current knowledge and perspectives on roles of transporters at the BBB and BCSFB; 2) present novel in vitro, in vivo animal and clinical approaches applied in the elucidation and characterization of brain penetration, as well as clinical translation; and 3) provide an in-depth discussion of physiologically-based pharmacokinetic models to describe brain distribution and time course of therapeutic drugs and proteins, as well as the influence of dosing regimens and potential alterations with disease. Co-chairs: Marilyn Morris, University at Buffalo, Buffalo, New York, USA and Xiaoyan Chu, Merck & Co., Inc., Rahway, New Jersey, USA
You must register to access.
Identifying Biotransformations of Next Generation Biologics | Mark Cancilla | Brooke Rock | Amita Datta-Mannan | Anton Rosenbaum
Recorded 09/14/2021
Recorded 09/14/2021 The increased complexity of biologic drug modalities has changed our understanding of their pharmacokinetic and metabolic assessment. The overall stability of a chemically modified or engineered proteins upon administration has been demonstrated to be linked to its efficacy. This session focuses on identifying biotransformations of complex biologics to further understand their metabolic fate as well as to aid in their design for the assessment of their therapeutic potential.
You must register to access.
Epigenetics in Drug Disposition and Drug Therapy | Ann Daly | Joseph McClay, Ph. D | Philip Lazarus, Ph.D. | Baitang Ning
Recorded 09/14/2021
Recorded 09/14/2021 Epigenetics including DNA methylation, miRNA expression and histone modification contributes to the global gene expression including those relevant to xenobiotic metabolism and transport as well as disease processes including cancer. Though considerably progress has been made in this area, this is still a relatively poorly understood area with changes in epigenetic regulation due to disease and environmental factors of particular importance. Drugs that modulate epigenetic modification of gene expression are increasingly available and are especially relevant to oncology. This symposium will aim to cover both the drug disposition and drug discovery aspects of this area.
You must register to access.