Current Issue: Q3 2022

The Patient-Centricity Issue

Patient Centricity Across the Value Chain

The Pharma’s Almanac editorial team is very excited to present our Q3 digital issue, which features new content from our team and our colleagues at Nice Insight on a range of trending topics and from some truly remarkable subject matter experts from across the pharma/biopharma ecosystem, including drug discovery and development companies, life science industrials, technology providers, consultants, and contract development and manufacturing organizations. The featured articles address topics that span the biopharmaceutical value chain, threaded throughout with reminders to always consider the patient, throughout discovery, formulation, manufacturing, and beyond.

 

Also in This Issue

mRNA Manufacture

Platform Processes and End-to-End Capabilities Position Vernal Biosciences as a Critical CDMO Resource for mRNA Developers

Tonia Becker of Nice Insight discusses how Vernal Biosciences is leading innovation in end-to-end mRNA manufacture from development to clinical, with plans to expand capabilities to support commercial manufacturing and drive discovery.

Taste Masking Formulations

Formulating Flexibility with ActiMask® Taste Masking

Wayne Camarco and Donald Loveday discuss SPI Pharma’s innovative taste-masking technology to encapsulate API particles, the company’s relaunched Actimask® taste-masked ibuprofen product, and how their taste-masking formulation development services support product launches worldwide. 

Viral Vectors

Risk-Based Optimization of Viral Vector Processes Adds Real Value

Avid Bioservices' Elie Hanania, Ph.D., and Tatiana Mello explain the advantages of risk-based process optimization in viral vector manufacturing.

mRNA Manufacturing

Overcoming Bottlenecks in mRNA Manufacturing

Pierre Catignol of Samsung Biologics discusses how the company is applying the Power of One to mRNA, investing in a one-stop solution to facilitate the advance of customer mRNA molecules from the clinic to commercialization, including product and process development and characterization.

Antibiotic Resistance

Antibiotic Resistance: Advances in Understanding and Drug Development

Pharma's Almanac's David Alvaro, Ph.D., explores the significant challenges presented by the spread of antibiotic resistance and ongoing advances in development and clinical research to develop new, novel antibiotics.

Column: New Drug Watch

Potential Applications for Antisense Oligonucleotide Therapies Continue to Expand

Cynthia Challener of Pharma's Almanac explores the growth and innovation in the field of antisense oligonucleotide (ASO) therapy.

Cell and Gene Therapy

State of the Cell and Gene Therapy Market

Nice Insight's James Grote provides an updated snapshot of the dynamics in the cell and gene therapy market.

mRNA

Limitless Potential of mRNA Creates Tremendous Excitement Despite Uncertainties

Pharma's Almanac's Cynthia Challener, Ph.D., discusses the current dynamics in the mRNA sector, where significant interest and enthusiasm are tempered with uncertainty.

Precision Medicine

Examining the Potential of Precision/Personalized Medicine

Pharma's Almanac's David Alvaro re-examines the promise of precision and personalized medicine, exploring the progress to date and the work that remains to be done.

Column: Supply Chain

Reimagining the Pharmaceutical Supply Chain

Pharma's Almanac's Danielle Alvarez discusses some of the most pressing current challenges in the pharmaceutical supply chain and suggests solutions to overcome the disruptions.

Big Data

Leveraging Big Data, Artificial Intelligence, and Machine Learning for Drug Discovery, Development, Manufacturing, and More

Pharma's Almanac's David Alvaro explores the pharma industry's progress toward the Pharma 4.0 paradigm and the successful application of artificial intelligence, machine learning, and other big data approaches in transforming the industry.

Future of the Industry

What key indicators do you look at to predict the future of this industry?

In this Pharma’s Almanac roundtable, a panel of industry leaders explore the key indicators that they look at to predict the future direction of the pharmaceutical industry.

Sustainability

What is your plan to build a more sustainable business practice in the coming years?

In this Pharma's Almanac roundtable, a panel of SMEs discuss their plans to build more sustainable business practices in the coming years.

Transient Expression

Overcoming Limitations with Transient Protein Expression to Accelerate Development

In this Q&A, MaxCyte's Chief Scientific Officer Cenk Sumen discusses how extending the use of transient protein expression to later in development can allow developers to fail fast and confidently, thus accelerating program success.

Clinical Workflow Integration

How All Clinical Trial Stakeholders Can Collaborate as One Study Team

OneStudyTeam, a newly formed part of the Reify Health family, presents its cloud-based platform, StudyTeam. The company explains how StudyTeam brings the workflows of key clinical trial stakeholders onto a common platform and the potential of this technology to improve clinical trial enrollment.

Real-Time Monitoring

Raman Spectroscopy as a PAT Tool Advancing Biopharma Manufacturing

MilliporeSigma’s Stacy Shollenberger explains why Raman spectroscopy is particularly attractive as a process analytical technology (PAT) and discusses the significant advantages that it provides in optimizing product quality and monitoring molecular processes.

Digital Health Solutions

Beyond Drug Sales: Adding Value with Digital Health

Gérard Klop and Marcos Gallego Llorente of Vintura discuss untapped opportunities for pharma companies to embed themselves into digital health delivery via remote and hybrid care, smart devices and diagnostic tools, and other patient-centric solutions.

Biodefense

Supporting Biodefense Countermeasures with Strong Capabilities and Expertise

Brian O’Mara, Senior Director of Manufacturing Sciences and Technology at Scorpion Biological Services, discusses the U.S. biodefense efforts supported by the Strategic National Stockpile (SNS) and the broad expertise that makes Scorpion Biological Services an ideal biodefense supplier to the SNS.

Speed to Clinic

Leveraging Experience to Reduce Timelines for IND-Enabling Activities

Muctarr Sesay and Andrew Majdoch discuss how GBI's end-to-end capabilities, from RCBs to manufacturing, including fill/finish and stability studies help clients simplify the development process and reduce both costs and project timelines.

CDMO

Asymchem: Leading with Technology

Asymchem's Mark McLaws, James Gage, and Stephen Hu explain Asymchem's strategy as an early adopter of new technologies at the forefront of practical manufacturing advances and how the company makes prophetic investments in capabilities even before clients inquire about them.

Pharma 4.0

Applying an Advanced Pharma 4.0 Perspective to Design the Facility of the Future

In this Q&A, a panel of experts from Wheeler Bio and from their design–build partner CRB discuss the Pharma 4.0 model and their collaboration to advance it to build a transformative new facility.

Diversity and Inclusion

Five Ways to Embed Truly Diverse and Inclusive Patient Engagement into Pharma’s DNA

Kirstie Turner of Page & Page and Partners shares ways to improve diversity and inclusion in patient engagement focused around authentically, consistently, and honestly embedding patient centricity into your company’s DNA.

Plant-Inspired Drug Discovery

Unlocking the Therapeutic Potential of Plant-Inspired Minimum Essential Mixtures

Andrea Small-Howard, Ph.D. discusses how Gb Sciences' AI-enabled platform mines plant species for new drug molecules and mixtures that can serve as therapeutic alternatives to opioids for the treatment of chronic pain.

Cosmeceuticals

Cosmeceuticals Are Here. When Will Regulations Catch Up?

Ameena Pathan of That’s Nice breaks down the cosmeceutical sector, exploring the regulatory complexity and the implications of the sector’s meteoric growth and tackling the biggest question: how can cosmeceuticals deliver on the promises made to consumers?

Theranostics

Theranostic Manufacturing Solutions

GBI's CSO Muctarr Sesay, Ph.D., discusses how theranostic bioconjugates work, their significant market potential, and challenges and their solutions during development and manufacturing.

Drug Discovery

Enabling Seamless Workflows for Small Molecule Drug Discovery

In this Q&A, Melanie Nelson, Ph.D., Senior Solutions Architect at Dotmatics, discusses the Small Molecule Drug Discovery Solution the company developed to help enhance insights and innovation, improve productivity and collaboration, and drive operational efficiency during drug discovery.

Multispecific Antibodies

Optimized Multispecific Antibody Design, Development, and Manufacturing

Na Li, Ph.D., of Sino Biological and Yue Liu, Ph.D., of Ab Studio Inc. discuss how their companies are leveraging artificial intelligence, computer-aided antibody design, and traditional antibody development technologies to accelerate the development and manufacture of multispecific antibody candidates.

Patented Production Strains

Adding Value with Patent Protection for Novel, Tailor-Made Bacterial Production Strains

Vectron Biosolutions CEO Trond Erik Vee Aune, Ph.D., discusses the exclusive licenses that Vectron currently grants to customers for the specific E. coli strains developed for their programs and how the company will soon offer customers the option of patenting the strains for further protection.

Clinical Data Integration

Decentralized Clinical Trials: the Future is Now

Raj Indupuri, CEO of clinical data software and services provider eClinical Solutions, discusses evolving challenges with clinical trial data, the solutions the company offers, and his insights into the future of interoperable digital systems in pharma.

Cell Therapy

Targeting Cancers by Leveraging the Biology of Gamma Delta T Cells

In this Q&A, TC Biopharm Chief Executive Officer Bryan Kobel discusses the tremendous potential of gamma delta T cells and the approach TC is taking to their development.

Life Science Industrials

Life Science Industrials Are Key to the Growth of the Biopharma Industry

Dynamk Capital's Reinhard Vogt discusses the strong growth prospects for life science industrials and the dynamics of the market.

Electronic Documentation

Duplicated Document and Data Creation Must Stop!

Remco Munnik of Iperion - a Deloitte business discusses the importance of streamlining electronic documentation practices for medical products in the EU in this article, adapted from his talk at Amplexor Life Sciences' BE THE EXPERT 2022 conference.

Contamination Control

Contamination Control Strategies for the Manufacture of Conventional and Next-Generation Biologics

Rolf Hansen, Ph.D., Chris Berridge, and Donald Singer of Ecolab discuss contamination concerns in biomanufacturing and contamination control strategies.

RNA

Closing the Developability Gap for RNA Therapeutics and Vaccines with a Fit-for-Purpose Analysis Kit

Susan Darling and Quincy Mehta of SCIEX discuss how a new, fit-for-purpose RNA analysis kit is helping researchers overcome some of the key development hurdles for RNA therapeutics.

Cloud Regulatory Compliance

Cloud Control: Maintaining Compliance as Regulated Apps Move Off Premise

Dr. Thierry Dietrich, Ph.D., of pharm@dviser discusses ensuring regulatory compliance at different levels of cloud use in this article, adapted from his talk at Amplexor Life Sciences’ BE THE EXPERT 2022 conference.

Issue Q4 2020

The Innovation Issue

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Issue #4 | Volume #6 | Q4 2020
Issue Q3 2020

The Outsourcing Issue

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Issue #3 | Volume #6 | Q3 2020