Current Issue - Q3 2019

The Networking Issue

Balancing Global & Local Considerations

Our third quarter edition features leading insights from key opinion leaders with findings specific to global and local concerns for clinical trials, manufacturing, and the supply chain; next-generation therapies and technologies; and drug development.

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Also in This Issue

Glocalization

Impacts of Glocalization on the Pharmaceutical Industry

Impacts of Glocalization on the Pharmaceutical Industry, Nigel Walker

Biosimilars

Is the U.S. Biosimilars Market Poised for Takeoff?

Is the U.S. Biosimilars Market Poised for Takeoff?; Haig Barrett

AAV Vector Production

Production of AAV Vectors Using Suspension Mammalian and Insect Cell Systems

Production of AAV Vectors Using Suspension Mammalian and Insect Cell Systems; Thermo Fisher Scientific, Richard Snyder

Clinical Trials

Managing the Complexities of International Clinical Trials

Managing the Complexities of International Clinical Trials, Yourway, Gulam Jaffer

Strategic Partnership

Growing With a Flexible, Collaborative CDMO

Growing With a Flexible, Collaborative CDMO; Grifols Recombinant Protein CDMO Services, Kim Berger, Paul Magreta

Orphan Drug Outsourcing

Customer Engagement and Information Sharing are Essential for Success in Orphan Drug Outsourcing

Customer Engagement and Information Sharing are Essential for Success in Orphan Drug Outsourcing, Grifols

Collaborative Culture

Tech Transfer and Scale-Up for Custom APIs Driven by a Collaborative Culture

Tech Transfer and Scale-Up for Custom APIs Driven by a Collaborative Culture; Albermarle Fine Chemistry Services

Cleanroom Solutions

Reducing Project Timelines with Integrated Cleanroom Solutions

Reducing Project Timelines with Integrated Cleanroom Solutions; Environmental Systems Corporation

Executive Compensation

Executive Compensation: Essential Factor in Private Equity Transactions

Executive Compensation: Essential Factor in Private Equity Transactions; Castleford Capital, Jeffrey Marlough

Tech Transfer

Realizing Technology Transfer in a Successful and Sustainable Manner

Realizing Technology Transfer in a Successful and Sustainable Manner; Joerg Zimmermann

Integration

True Integration is Integral to Providing One-Stop-Shop CDMO Services

True Integration is Integral to Providing One-Stop-Shop CDMO Services, Piramal Pharma Solutions

Semisolid Dosage Forms

Supporting Commercial Manufacturing of Semisolid Dosage Forms

Supporting Commercial Manufacturing of Semisolid Dosage Forms; UPM Pharmaceuticals

Containment

Meeting the Need for Higher Containment

Meeting the Need for Higher Containment; Servier

Facility Design Trends

New Trends in Tech Impacting Pharma Facility Design and Construction

New Trends in Tech Impacting Pharma Facility Design and Construction; CRB

Glocalization

Introduction: Glocalization

Glocalization: Introduction to the Networking Issue Feature

Worldwide Clinical Trials

The Relevance of Global Clinical Trials

Glocalization, The Relevance of Global Clinical Trials,

Glocalization

Glocalization of Drug Manufacturing

Glocalization of Drug Manufacturing

Glocalization

From Regulatory Convergence to Global Regulatory Harmonization

Glocalization of Drug Manufacturing

Global Network

Applying an Established and Continuously Upgraded Global Network for CDMO Services

Applying an Established and Continuously Upgraded Global Network for CDMO Services; Aspen Pharmacare

Cold Chain

Rigorous Quality Controls for Cold-Chain Drug Shipments

Rigorous Quality Controls for Cold-Chain Drug Shipments; Boyle Transportation

Globalizations

Internationalization of a European CDMO

Internationalization of a European CDMO; Doppel Pharma CDMO

Gut–Brain Axis

Harnessing the Gut–Brain Axis to Treat Neurological Disorders

Harnessing the Gut–Brain Axis to Treat Neurological Disorders; Axial Biotherapeutics

Migraine Therapy

Mimicking Environmental Enrichment for Migraine Therapy

Mimicking Environmental Enrichment for Migraine Therapy, Seurat Therapeutics,

Allergies

Developing a Microbiome-Based Treatment for Food Allergies

Developing a Microbiome-Based Treatment for Food Allergies; ClostraBio

Genomics Technology

Personalizing Cancer Treatment with Genomics Technology

Personalizing Cancer Treatment with Genomics Technology

Cannabinoids

Leveraging Biosynthetic Expertise to Access a Wide Portfolio of Cannabinoids

Leveraging Biosynthetic Expertise to Access a Wide Portfolio of Cannabinoids

Drug Development

Looking Beyond Current Treatments for CNS Diseases and Disorders

Looking Beyond Current Treatments for CNS Diseases and Disorders; VistaGen Therapeutics

Tumor Microenvironment

Focusing on the Tumor Microenvironment Leads to Novel Drug Targets

Focusing on the Tumor Microenvironment Leads to Novel Drug Targets

Bioprocessing

Facilitating Modern Bioprocessing with Real-Time Protein Titer Monitoring

Facilitating Modern Bioprocessing with Real-Time Protein Titer Monitoring; IDEX Health & Science, Kurt Pickle

Expression Systems

Choosing the Right Expression Platform for Biologics

Choosing the Right Expression Platform for Biologics; Nice Insight

Plasma Proteins

Sustainable Production of Plasma Proteins

Sustainable Production of Plasma Proteins; Evolve Biologics

Thermal Stability

Stabilizing and Protecting Biologic Formulations

Stabilizing and Protecting Biologic Formulations; LEUKOCARE AG

Oral Film

Expanding Access to Oral Thin Film Technology

Expanding Access to Oral Thin Film Technolog; tesa Labtec GmbH

Business Development

Strategizing for International Business Development

Strategizing for International Business Development; Sosna + Co.

FDA Guidance

Updating Ethical Guidelines for Cancer Clinical Trials

Updating Ethical Guidelines for Cancer Clinical Trials

Facilitating Acquisitions

Facilitating Pharmaceutical and Biotech Facility Acquisitions

Facilitating Pharmaceutical and Biotech Facility Acquisitions, PharmaBioSource, Inc.

Recruitment

Living in Canada’s Coastal Paradise

Living in Canada’s Coastal Paradise; BioVectra

Stem Cells

iPSCs: Moving from Drug Testing to Novel Cell Therapies

iPSCs: Moving from Drug Testing to Novel Cell Therapies; Stemson Therapeutics

Customer Centricity

Achieving Rapid Success with a Flexible, Client-Centric Approach

Achieving Rapid Success with a Flexible, Client-Centric Approach; Samsung Biologics

Capacity Utilization

Solving the Industry’s Capacity Utilization Problem

Solving the Industry’s Capacity Utilization Problem; TriRx

Fermentation

Supporting Customers with an Integrated Fermentation Offering

Supporting Customers with an Integrated Fermentation Offering; Olon Group

Innovation

Creating a Global CDMO Focused on Quality, Innovation and Happiness

Creating a Global CDMO Focused on Quality, Innovation and Happiness; SK Pharmteco

Lyophilization

Alternative Vial Designs to Reduce Lyo-Breakage Risk

Alternative Vial Designs to Reduce Lyo-Breakage Risk; SGD Pharma

Manufacturing Technology

Q: How does your company manage to provide local services/support while still efficiently managing global compliance?

Global Compliance, Roundtable

Novel Therapies

Q: What do you identify as the greatest advances that have been achieved in recent years with respect to harmonization of pharmaceutical regulations?

Roundtable, Regulatory Harmonization

Biologics

Northway Biotechpharma Celebrates 15 Years of Growth and Success

Northway Biotechpharma Celebrates 15 Years of Growth and Success

Issue Q1 2019

The Business Development Issue

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Issue #1 | Volume #5 | Q1 2019
Issue Q4 2018

The Innovation Issue

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Issue #4 | Volume #4 | Q4 2018
Issue Q3 2018

The Outsourcing Issue

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Issue #3 | Volume #4 | Q3 2018