Issue Q4 2019

The Breakthrough Issue

The Promise and Challenges of Gene Therapy

Our fourth quarter edition features leading insights from subject matter experts covering a range of cutting-edge scientific topics, including microbiome therapy, biofabrication, cell and gene therapy, antibody–drug conjugates (ADCs), high-potency APIs, next-generation chromatography, personalized medicine and the increasingly complex “zoo” of multifunctional antibody and protein formats.

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Also in This Issue

Gene Therapy

Slow Progress and a Shaky Start—What’s Next for Gene Therapy?

Nigel Walker, Managing Director of That's Nice, provides an overview of the current state of the industry with regard to gene therapy, highlighing recent advances and ongoing challenges.

Oral Peptides

Advances in the Oral Delivery of Peptides

Health Bowers, Technical Business Director for Pharmaceutical Sciences, North America, at ABITEC, discusses recent advances in the oral delivery of peptides.

Microbiome

Supporting Commercialization of Live Biotherapeutic Products for Microbiome-Based Therapies

Mark Bamforth, founder and CEO of Arranta Bio, explains the establishment as the company as a CDMO dedicated to producing live biotherapeutic products for the treatment of microbiome-based diseases.

Clinical Trial Logistics

Expediting Clinical Trials with a Global Transportation Footprint and Clinical Packaging

Yourway President Gulam Jaffer explains how the company's integrated global courier network and clinical packaging services accelerate clinical trials.

Analytical Development

Solving Process Challenges Requires Flexibility to Explore Alternative Analytical Methods

A flexible approach to analytical methods is key to solving process challenges, according to Shaonly Saha, Analytical Development Scientist -- MS&T Analytical at Grifols Recombinant Protein CDMO Services.

Project Management

Adhering to Delivery Milestones

Julie Risdon, Business Director Pharma Solutions, and Megan Duffy, Program Manager, explain how Albemarle Fine Chemistry Services adheres to project milestones to ensure on time and in full delivery.

Commercial Manufacturing

Advancing Commercial Manufacturing from Orphan Drugs to Blockbusters

Associate Director of Manufacturing Tyler Ewald describes UPM Pharmaceuticals' support for commercial projects at all scales.

Quality Compliance

How a Quality Culture Contributes to Global Compliance

Ian Markwell, Vice President of Quality at Almac Pharma Services, relates Almac's successful completion of three regulatory inspections within two weeks and how that illustrates the company's commitment to quality.

Corporate Social Responsibility

Giving Structure to a Long-Term CSR Strategy

Servier has developed a comprehensive corporate social responsibility strategy with benefits to all stakeholders, explains CSR Director Vincent Minvielle.

Packaging

Advanced, Flexible Packaging Solutions to Meet Parenteral Product Demand

Growing demand for parenteral products led PCI Pharma Services to invest in a Center of Excellence for injectables packaging, according to Alex Weaver, Director of Engineering & HSSE, and Dave Christmas, Principal Engineer.

Ophthalmology

Tackling Genetic Eye Diseases with Novel RNA Therapies

ProQR Therapeutics is taking a novel approach to treating inherited retinal diseases with intravitreal RNA therapies, according to Founder and CEO Daniel de Boer.

Facility Design

Fast-Tracking Design and Construction to Save More Lives

Tim Tench, Senior Project Manager, discusses how CRB's OneSolution process fast tracks facility design and construction, reducing timelines to get novel medicines to patients more quickly.

Bispecific Antibody

Challenges of Manufacturing the Expanding Range of Bi/Multispecific Modalities

Bernie Sweeney, R&D Director Cell Expression Systems at Lonza Pharma & Biotech, provides an overview of the growing "zoo" of novel protein formats, including bi- and multispecific antibodies.

3D Bioprinting

Facilitating 3D Organ Printing with Plant-Based BioInks

Evolving 3D bioprinting technologies will soon facilitate the biofabrication of tissues and organs for transplant and other uses, according to Brian Berquist, Robert Erwin, and Tom Isett of iBio.

Purification

High-Productivity Membrane Chromatography to Enable Next-Generation Purification of Monoclonal Antibodies

Significant advances in the purification of monoclonal antibodies will be made possible by high-producutivity membrane chromatography technologies, explains Gary Skarja, Head of Membrane Chromatography R&D at MIlliporeSigma.

Gene Therapy

Introduction: The Promise & Challenge of Gene Therapy

An introduction to our feature on the promise and challenges of gene therapy.

Gene Therapy

Gene Therapy R&D Accelerates

The Nice Insight team highlights recent R&D innovations driving the field of gene therapy.

Gene Therapy

Overcoming the Manufacturing Roadblock

The rapid advancement of cell and gene therapies through clinical trials is creating an acute need for scalable production technologies.

Gene Therapy

Promise Amid Challenges: Logistics of the Cell and Gene Therapy Supply Chain

The growth of the market for gene and particularly gene-modified cell therapies is putting new demands on the temperature-controlled supply chain, explain the Nice Insight editorial team.

Personalized Medicine

Four Technology Trends Bringing Personalized Medicine to Life

My Personal Therapeutics Founder and CEO Laura Towart reviews some of the technologies driving personalized medicine.

Investment in Innovation

Should You Choose a Commercial HPAPI Manufacturer for Your Clinical Program?

George Hlass, Senior Director of Business Development for APIs, and David Bastie, Commercial Project Coordinator at Fareva explain the strategic advantages of partnering with a commercial-scale CDMO from the start of HPAPI programs.

Antibody-Drug Conjugate

Fast-Tracking ADC Development and Commercialization

Business Development Manager Matteo Piazza explains how the PROVEO Alliance combines the strengths of AGC Biologics, Cerbios, and Oncotec Pharma Produktion to provide streamlined, integrated support for ADC programs.

Blockchain

Why the Industry Is Moving Toward Blockchain Technology

Nice Insight's Cynthia Challener provides a comprehensive overview of applications of blockchain technology in the pharma industry.

Plant-Based

Proprietary Protein Therapeutics with Clinically Improved Profiles

Protalix Biotherapeutics President and CEO Dror Bashan explains the company's unique plant cell-based expression system.

Alzheimer's Disease

The Self-Protein Challenge

Andrea Pfeifer, CEO of AC Immune, discusses novel immunological approaches to diagnosis and treatment of Alzheimer's disease.

Antibody-Drug Conjugate

Increasing the Potency of Antibody–Drug Conjugates

Novel linker technology may be critical to increasing the potency and effectiveness of ADCs, explains Philipp Spycher, Co-Founder and CEO of Araris Biotech.

Alzheimer's Disease

Innovating the Approach to Neurological Disease Treatment

Reducing neural overactivity may be key to preventing the progression of Alzheimer's disease, according to Michaela Gallagher, Founder and CEO of AgeneBio.

Cell Therapy

CD34+ Cell Therapy in Clinical Trials

Douglas W. Losordo, Executive Vice President, Global Head of R&D, and Chief Medical Officer of Caladrius Biosciences, discusses the promise of CD34+ cell therapies for cardiovascular disease.

CAR-T

Leveraging Natural Killer Cells as CAR-T Therapies

CAR-T therapies using natural killer cells have considerable potential to treat both hematological cancers and solid tumors, accoding to Filippo Petti, CEO of Celyad.

Immunology

Driving Drug Discovery Using Patients’ Immune Response

Purnanand Sarma, President and CEO of Immunome, explains the company's unique high-throughput approach to identify novel antibody-target pairs.

Ophthalmology

Innovative Therapies to Treat Rare and Underserved Eye Diseases

Ocugen Chairman, CEO and Co-Founder Shankar Musunuri discusses the company's approach to developing drugs for high-need ophthalmic diseases.

Photodynamic Therapy

Developing a Potential Cure for Bladder Cancer

Photodynamic therapy presents a novel approach to the unmet need for bladder cancer patients, says Shawn Shirazi, CEO of Theralase Technologies.

Generics Manufacturing

Supporting Rapid Equipment Procurement for Fast-Tracked Projects

A strategic partnership with a used equipment supplier can significantly reduce costs and time to equip a facility for a fast-tracked program, discusses Justin Kadis of Federal Equipment Company.

CRISPR-Cas9

CRISPR-Cas9 Milestones: The First In Vivo Clinical Trial Is Now Underway

Lydia Michaut, Scientific Officer at BioAgilytix, explains the significance of the first clinical trial using CRISPR-Cas9 gene-editing technology.

Translational Pharmaceutics

Measuring the Time and Cost Benefits of Integrated Product Development

Peter Scholes, CSO at Quotient Sciences, discusses the time and cost savings associated with their Translational Pharmaceutics offering, which integrates formulation, real-time manufacturing and clinical testing.

Strategic Partnership

Partnering for Success from Concept to Commercialization

RIchard Richieri, COO, and Magnus Schroeder, VP of Process Development at Avid BIoservices, discuss the advantages of choosing a single CDMO for the entire life cycle.

Fill Finish

Small-Batch Drug Development and Production Requires Flexible, Repeatable Fill-Finish Systems

Stephen P. Adams, Product Manager for Flexicon at Watson-Marlow Fluid Technology Group, discusses fill-finish solutions for small-batch drug products.

Plasmids

The Pivotal Role of Plasmid DNA

Robert Reames, Director of Technical Operations at Aldevron, provides an overview of the historical role of plasmids in drug development and their future potential.

Recruitment

Winning the War on Talent with Behavioral Interviewing

Behavioral interviewing is a critical tool in matching candidates and positions, according to Dave Kerns, Managing Partner at Key Corporate Services.

Drug Delivery

Bringing Novel Delivery Technologies to the North American Market

With a new facility acquisition, Labomar is fully entering the North American market, explains Founder and CEO Walter Bertin.

Technology

Q: What developing technologies do you believe will have the greatest impact on the biopharma industry in 2020 and beyond?

A range of experts speculate on the technologies likely to transform the industry in the coming year.

Technology

Q: What breakthrough technologies have had a transformative effect on your business this year?

This roundtable features SMEs discussing the most important technological breakthroughs of the past year.

Issue Q4 2019

The Breakthrough Issue

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

The Networking Issue

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Issue #3 | Volume #5 | Q3 2019
Issue Q1 2019

The Business Development Issue

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Issue #1 | Volume #5 | Q1 2019