Current Issue: Q3 2020

The Outsourcing Issue

The Evolving Pharmaceutical Supply Chain

Our Q3 edition focuses on the evolution of outsourcing providers and innovations driving the future of healthcare. Experts from all facets of the industry discuss ongoing impacts from the COVID-19 pandemic, particularly to the supply chain, as well as topics spanning decentralized clinical trials, organ-on-a-chip technology, and increasing speed to the clinic.

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Also in This Issue

Cover story

Restarting a Manufacturing Campus and Revitalizing a Community

Federal Equipment Company's Vice President Adam Covitt relates the unique approach that FEC took to the acquisition of an entire pharmaceutical manufacturing campus in Huntsville, Alabama.

Nice Insight Overview

The Benefits of Expanding OSD Capacity

Nigel Walker analyzes trends in OSD drug forms and the importance of CDMOs in supporting complex API projects.

Equipment

Reshoring a Nation’s API and Pharmaceutical Production

Federal Equipment Company's Matt Hicks discusses the industry's efforts to simplify the supply chain, including reshoring U.S. manufacturing of APIs.

Microbiome CDMO

Extensive Experience Is Crucial to Speed to the Clinic and Market for Live Biotherapeutic Products

Arranta Bio CSO Aaron B. Cowley, Ph.D., explains how the company's extensive expertise in GMP tech transfer of LBPs can accelerate time to the clinic and the market.

Vaccine Distribution

Anticipating the Logistics of a COVID-19 Vaccination Effort

Boyle Transportation's Andrew and Marc Boyle and CSafe Global's Patrick Schafer assess the challenges ahead in the global distribution of forthcoming COVID-19 vaccines.

Leadership

A CEO’s Perspective: Positioning a CDMO for Significant Growth

New CEO Nick Green discusses his vision for Avid Bioservices' growth opportunities to take the company through the COVID-19 pandemic and beyond.

Parenterals

Trends Shaping the Dynamic Market for Parenterals

Grifols's Marga Viñes provides an overview of current trends impacting the market for parenteral drugs.

Integrated CDMO

Building an Integrated and Effective CDMO from the Ground Up

TriRx Chairman and CEO Tim Tyson reevaluates the responsibilities of different pharma stakeholders during pandemic times.

Recombinant Proteins

Innovation and Flexibility Drive Success During the COVID-19 Pandemic

The same culture of innovation and flexibility that drives the company is proving invaluable in dealing with the challenges of the COVID-19 pandemic, says Paul Magreta of Grifols Recombinant Protein CDMO.

Decentralized Trials

Facilitating the Full Spectrum of Decentralized Trials

Biorasi's Mamta Trivedi examines the increasing importance of decentralized clinical trials models through the pandemic and beyond and discusses Biorasi's approach.

Northern Ireland

COVID-19 and the Growing Need for Dual-Source Supply Chains

Northern Ireland is positioned to be an ideal location for second-source manufacturing of pharmaceuticals and medical devices, according to Kevin Holland, CEO of Invest Northern Ireland.

Decentralized Trials

Protecting Clinical Research and Patients Through Decentralized Trial Strategies

Alistair Davidson, Brittany Erana, and Rhonda Henry discuss PPD's commitment to decentralized clinical trial models and how they protect clinical research and patient safety.

Lipid Excipients

Successful Drug Development with Synthetic Lipids: Critical Aspects and Strategies

Shiksha Mantri, Ph.D., and Adela Kasselkus, Ph.D., of Millipore Sigma highlight the importance of high-quality reagents and production methods for lipid-based delivery systems.

Organ-on-a-Chip

Organ-on-a-Chip Technology Aims to Disrupt Traditional Drug Testing Models

Gustavo Mahler, Ph.D. and Jessica Davis of Dynamk Capital discuss the underlying innovations and extensive potential for application of organ-on-a-chip technologies.

Bioanalysis

How Bioanalysis Supports the Development of New Cell and Gene Therapies

The evolving cell and gene therapy modalities require similar innovation and transformation of bioanalytical methods, says Celerion's Timothy Sangster.

Pharma/Biotech Advising

Data-Driven Decision-Making Throughout the Pharma Life Cycle

AKDYS co-founders Stephan Kutzer, Ph.D., and Danielle Young discuss the importance of data- and science-driven decision-making across pharma operations.

Collaboration

Better Together: Collaborating to Simplify Complexities in Drug Development

Peter Soelkner, Managing Director of Vetter Pharma International GmbH, and Frank Mathias, Ph.D., CEO of Rentschler Biopharma SE explain how the two companies' new collaborative partnership provides new synergies to support customer projects throughout the life cycle.

CRISPR RNPs

CRISPR RNPs and the Future of Cell and Gene Therapy

Thomas Lynch, Ph.D. discusses the potential of CRISPR RNPs for cell and gene therapy and Aldevron's manufacturing capabilities.

Supply Chain

Introduction: The Evolving Pharmaceutical Supply

The Pharma's Almanac editorial team discusses how the COVID-19 pandemic has aggravated existing issues with the pharmaceutical supply chain.

Feature Story

The COVID-19 Pandemic Magnifies Pharmaceutical Supply Chain Issues

The Pharma's Almanac editorial team discusses how the COVID-19 pandemic has aggravated existing issues with the pharmaceutical supply chain.

Feature Story

The Growing Importance of Local Manufacturing and Nearby Outsourcing Partners

Our editors explore the increased demand for local manufacuturing and outsourcing partners during the pandemic.

Feature Story

Rethinking the Global Pharmaceutical Supply Chain Post-COVID-19

We attempt to anticipate the long-term changes to the pharma/biopharma supply chain following the resolution of the COVID-19 pandemic.

Design Logic

The Integrated Service Offering Driving Yourway

The Nice Insight team explains the creative thinking behind That's Nice's rebranding of Yourway to support its reconfiguration into a full-service premium biopharma courier and clinical trials logistics organization.

Design Logic

Experience to Solve Your Microbiome Challenges

Nice Insight highlights the creative work underlying the development of the Arranta Bio brand.

Dietary Supplements

An Economic Update on Natural Health and Cannabis Products during COVID-19

Sosna + Co.'s Erica and Adam Sosnowski highlight the impact of the COVID-19 pandemic on natural health and cannabis products.

The Future of Healthcare

How Is SPI Pharma Evolving its Business Model to Meet the Future of Healthcare?

SPI Pharma continues to prioritize the qualification and validation of alternative sources –– a strategic objective invaluable to enable them to face a supply chain risk from China that grew into a global pandemic.

The Future of Healthcare

How Is Dynamk Capital Facing the Future of Healthcare?

How Is Dynamk Facing the Future of Healthcare?

The Future of Healthcare

How Is Sanaclis Evolving its Business Model to Meet the Future of Healthcare?

Being able to provide end-to-end clinical trials solutions and services enables SanaClis to become more of a partner, ensuring that a study reaches its next phase or market authorization.

The Future of Healthcare

How Is Polpharma Biologics Evolving its Business Model to Meet the Future of Healthcare?

Polpharma Biologics has always sought to function as a partner in drug development, so they not only offer fully integrated discovery to commercial supply services but clinical, regulatory, and IP support.

The Future of Healthcare

How Is TriRx Pharmaceutical Services Evolving its Business Model to Meet the Future of Healthcare?

TriRx is building additional capabilities to service the full supply chain, including the acquisition of materials, a broader capability of dosage forms, and additional supply chain services.

The Future of Healthcare

How Is FEC Evolving its Business Model to Meet the Future of Healthcare?

New equipment technologies will need to be developed to keep manufacturing costs manageable for existing and future products., but for now, the industry will need to rely on existing manufacturing equipment and facilities.

The Future of Healthcare

How Is SGD Pharma Evolving its Business Model to Meet the Future of Healthcare?

SGD Pharma maintains its focus on customers by taking a Global Account Management approach and aligning different models and processes with their relevant needs.

The Future of Healthcare

How Is Globyz Evolving its Business Model to Meet the Future of Healthcare?

Globyz Biopharma Services is investing in facilities and temperature-controlled capabilities to become a leading one-stop shop for global comparator sourcing.

The Future of Healthcare

How Is Pii Evolving its Business Model to Meet the Future of Healthcare?

Going forward, manufacturing companies should be able to reliably produce small batches of highly complex, potent drug formulations for smaller but better-understood patient populations.

The Future of Healthcare

How Is Avara Pharmaceutical Services Evolving its Business Model to Meet the Future of Healthcare?

Avara is currently focused on their existing network and core capabilities of oral solid dose and sterile manufacturing services across the Americas and Europe.

The Future of Healthcare

How Is Arranta Bio Evolving its Business Model to Meet the Future of Healthcare?

Arranta Bio has more than 10 years of experience in manufacturing challenging LBPs, including species that clients may be skeptical about being able to produce.

The Future of Healthcare

How Is Yourway Evolving its Business Model to Meet the Future of Healthcare?

The Yourway team is aligned in their commitment to better the lives of patients and embrace every project with the utmost dedication regardless of its size or scope.

Supply Chain Risk

The Precarious Pharmaceutical Supply Chain: To Reshore or Not to Reshore – Part 1

In the first part of a series, Haig Armaghanian explores the challenges the COVID-19 pandemic has brought to the pharmaceutical supply chain and the issues surrounding attempts to reshore U.S. manufacturing.

Microphysiological Systems

Accelerating Drug Development with Microphysiological Systems (MPS)

Altis Biosystems co-founder Nancy Allbritton discusses how microphysiological systems, like Altis's RepliGut, enable more efficient and cost-effective drug discovery and development.

M&A

Lessons Learned from the Ground Floor of Life Science Advising

Nice Consulting's Guy Tiene relates some of the insights gained through his experience assisting pharma companies in mergers and acquisitions.

M&A

The Business of a Pandemic: Mergers and Acquisitions During COVID-19

Nice Insight's Nigel Walker discusses the inherent challenges in conducting M&A activity during a pandemic

Over-the-Counter Conversions

Avara Pharmaceutical Services: Achieving Successful OSD Rx-to-OTC Conversions

Patrick Hatem relates Avara's experience with successful conversions of drugs from prescription to over the counter forms at their Aiken facility.

Research Insights

Approved Therapeutics for a Novel Pandemic: Drug Repurposing to Treat COVID-19

Nice Insight's Research Director TJ Ladage provides an overview of efforts to repurpose existing, approved drugs to combat COVID-19.

Skin Models

Overcoming Skin Assay Challenges with Living Human Models

Founder and CEO Pascal Descargues, Ph.D., explains how Genoskin's living human skin models provide better translation of preclinical findings than animal models.

Medical Devices

Investing with a Focus on Medical Devices and Digital Health

Medevice Capital President Cécile Real discusses the how Medevice works as both an investment firm and a business development partner to its portfolio companies.

Clinical Supply

Getting Your Biologic to Clinic Faster and More Efficiently

Ann McMahon and Pamela Barton relate how an integrated supplier like Catalent can help clients get biologics to the clinic faster and more efficiently.

Endocannabinoid System

Realizing the Promise of Therapeutics Targeting the Endocannabinoid System

The endocannabinoid system is a ripe source of drug targets for a range of indications, according to Artelo Biosciences, Inc. President, CEO, and Director Gregory Gorgas.

Vaccine Development

The Advantages of Implementing Plant-Based Vaccines

Sylvain Marcel, Ph.D., Robert Erwin, and Brian R. Berquist, Ph.D., discuss how iBio's FastPharming plant-based production system, along with its VLP and LicKM platforms, are well suited to the accelerated development of vaccines.

Plasma Proteins

Therapeutic Potential of Novel Plasma Protein Production Technology

David Holliday, DMS, and Mark Krause of Evolve Biologics discuss an alternative plasma protein production technology that promises to further unlock the therapeutic potential of plasma proteins.

Cell & Gene Logistics

Standardizing Best Practices for Transporting Cell and Gene Therapies

Mark Sawicki and Robert Jones of Cryoport walk us through recently updated ISO guidelines seeking to standardize best practices for the storage and transportation of cell and gene therapies.

Peptide Drugs

Transforming the Treatment of Ocular Diseases and Cancer with Peptide Drugs

Theresa Heah, M.D. describes how AsclepiX Therapeutics' takes a unique approach to computational biology and rational drug design to uncover candidate treatments to restore homeostasis in ocular diseases and oncology.

Thin-Film Freezing

Enhancing Drug Delivery with Thin-Film Freezing Technology

President, CEO, and Director Glenn Mattes discusses TFF Pharmaceuticals unique thin-film freezing (TFF) technology and how it addresses both solubility and storage and handling issues for parenteral drugs.

Post COVID-19 Supply Chain

Q: How are you rethinking your supply chain and operational fitness in light of the COVID-19 pandemic?

A panel of SMEs discusses how the industry is restructuring supply chains in response to the COVID-19 pandemic.

Roundtable

Q: What steps is your company taking to address drug pricing issues?

Industry experts discuss possible steps to address drug pricing issues.

Issue Q2 2020

The Next-Generation Issue

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Issue #2 | Volume #6 | Q2 2020
Issue Q1 2020

The Executive Issue

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Issue #1 | Volume #6 | Q1 2020
Issue Q4 2019

The Breakthrough Issue

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Issue #4 | Volume #5 | Q4 2019
Issue Q3 2019

The Networking Issue

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Issue #3 | Volume #5 | Q3 2019