Current Issue: Q1 2022

The Next-Generation Therapies Issue

Shifting the Biopharma Paradigm

Welcome to the first digital issue of the new Pharma’s Almanac, bringing our high levels of thought leadership into new spaces. This issue reflects an expansion of our editorial content, including regular columns from the Nice Insight and Pharma’s Almanac teams, in addition to some really illuminating Q&A interviews and articles on a range of innovative, forward-looking topics spanning drug discovery, development, and manufacturing. This issue includes some amazing contributors, so we hope you enjoy!

Also in This Issue

Column: M&A

Why the Big Shifts in Gene Therapy Investments? It’s Late in the Game

Nice Insight's Nigel Walker explains the current costly state of M&A activity within the cell and gene therapy sector.

Column: Clinical Trials

How Artificial Intelligence May Drive the Future of Clinical Trials

Nice Insight's Research Director James Grote discusses how artificial intelligence may result in greater efficiency across all facets of the clinical trial process.

Column: Regulatory Spotlight

New FDA Guidance on Real World Evidence/Real World Data

Editor in Chief David Alvaro discusses recent draft guidance published by the FDA to help sponsors successfully navigate the submission of applications leveraging real-world evidence.

Column: New Drug Watch

Alzheimer Drug Still Controversial

Cynthia Challener discusses ongoing questions about the rapid approval and continuing concerns regarding the safety and efficacy of Aducanumab, the first drug shown to reduce amyloid plaques for the treatment of Alzheimer’s disease.

Column: Technology

mRNA Technology: Is the Long Path Behind Leading to Endless Successes Ahead?

The Pharma's Almanac editorial team examines how decades of prior research, tremendous government funding, and unprecedented collaboration in the face of an urgent global health crisis made the success of messenger RNA (mRNA) vaccines against COVID-19 possible.

Column: Investment

2021 Was a Great Year for Biotech IPOs, Depending on When You Got Out

Pharma's Almanac's Danielle Alvarez expalins what investors need to know about this year’s cooler market and the lessons learned from 2021’s top earners.

Column: Regional

Expanding the Cell and Gene Therapy Ecosystem in Philadelphia

We explore the evolving cell and gene therapy hub in the Greater Philadelphia area.

Recombinant Antibody Production

HEK Cells vs. CHO Cells in Recombinant Antibody Production: What's the Better Choice

Zurich-based CDMO evitria AG provides a compact overview comparing HEK and CHO cell systems for recombinant antibody production.

Biotechs

10 Promising Biotechs Aiming to Transform Medicine

Many of today’s innovators are on a mission to go beyond ameliorating symptoms to actually address the underlying cause of an illness to offer a cure. Here, we highlight 10 standout organizations laying the groundwork for tomorrow’s breakthroughs by re-engineering how disease is treated.

Biomanufacturing

Unique Vector Expression Technologies for Boosting Protein Production in E. coli

Vectron’s CEO Trond Erik Vee Aune, Ph.D., discusses the founding and evolution of Vectron and the unique benefits of the company's vector evolution technology for microbial biomanufacturing.

Cell Culture

Changing the Future of Cell Culture and Accelerating Next-Generation Therapies

A.J. Mellott and Scott Leigh of Ronawk, discuss the development of a new 3D solution that enables easy growth of large quantities of cells of a consistent phenotype and their hopes for enabling significant advances in pharma manufacturing and beyond.

Gene Therapy Analytics

Overcoming Analytical Challenges for Gene Therapies

Jennifer Chadwick of ProtaGene discusses the analytical challenges that gene therapy developers face, from discerning what product qualities are critical attributes to the need for fit-for-purpose analytical methods for viral vectors that offer a combination of speed, sensitivity, and resolution.

COVID-19 Vaccines

Will the Second Wave of COVID-19 Vaccines Have the Improved Properties Needed to End the Pandemic?

Cynthia Challener explores the second wave of COVID-19 vaccines.

Process Validation

Streamlining Process Validation for Drug Substance Manufacturing

Juergen Utz, Ph.D., Gerhard Noessner, Ph.D., and Juergen Bank, Ph.D., of Fareva Excella discuss how developing robust processes from the outset by building broad and fundamental process knowledge minimizes future validation and revalidation work for drug substance manufacturing.

Investment

Global Investment Trends and Getting Noticed by PE/VC Firms

Iesan Tsai, of Asia-based investment firm Kiri Capital, explains what life sciences companies can do to get noticed by investors and her outlook on market timelines, investing after a pandemic, and the top trending technologies.

Sterile

Sterile Injectables Device and Packaging Trends

In this excerpt from Nice Insight's 2022 Sterile Drug Market Report & CDMO Pricing Study, Research Director James Grote discusses the factors to consider in the selection of device and packaging materials for injectable drugs.

Neurodegenerative Diseases

Pioneering Nanocatalysis to Revolutionize Treatments for Neurodegenerative Diseases

Clene’s President and Chief Executive Officer Rob Etherington discusses the company’s innovative technology and its potential to address the underlying causes of neurodegenerative diseases.

Solubility

The Limitless Potential of Thin Film Freezing

TFF Pharmaceuticals CEO Glenn Mattes discussed the potential of the company's Thin Film Freezing (TFF) technology for its own pipeline and beyond.

Mesenchymal Stem Cells

The Exciting Growth Curve for hMSCs Must Be Facilitated by Manufacturing Advances

Demand for human mesenchymal stem cells (hMSCs) is increasing dramatically as numerous cell therapy, tissue engineering, and related products advance through clinical trials. Greater efficiency and productivity in GMP manufacturing will be essential to produce sufficient quantities of hMSCs at an acceptable cost for patients and payers.

Mesenchymal Stem Cells

Moving Beyond the Industrialization of MSCs

Tim Kelly, the new Chief Executive Officer at RoosterBio, discusses Rooster’s standardized stem cell product platforms that enable rapid clinical and commercial translation and its commitment to industrializing regenerative medicine supply chains to accelerate innovation.

Rare Disease Clinical Trials

Rare Disease Patients Benefit from Clinical Trial Flexibility

Francis Jones, Ph.D., Tim Rich, and Meredith McCumbee, experts in the Thermo Fisher Scientific Research Business supporting PPD Digital and Decentralized Solutions, discuss how digital and decentralized clinical trial solutions offer greater flexibility to benefit rare disease patients.

Excipients

Enabling Stable, High-Viscosity Injectable Drug Products with New Excipient Combinations

MilliporeSigma’s Tobias Rosenkranz and Sara Kalman discuss the new approach to viscosity reduction offered through the SAFC® portfolio's recently introduced Viscosity Reduction Platform.

Antibody Therapeutics

Developing New Antibody Therapeutics for COVID-19 and Beyond

Abpro’s CEO Ian Chan discusses the continuing role for new antibody therapeutics in the ongoing fight against COVID-19.

COVID-19 Vaccines

The Global Immunization Disparity

IPS's Komal Hatti analyzes the root causes of COVID immunization disparity at a global scale and how this inequity directly impacts rich nations and proposes potential solutions.

Oncology

Changing the Paradigm of Cancer Drug Discovery and Development with Plants

iBio's Martin Brenner and Randy Maddux; and oncology pipeline advisor Steven King discuss how they are recruiting creative scientific talent, pioneering new approaches, and leveraging iBio’s FastPharming System to deliver additional therapeutic options to the market.

Viral Vector Manufacturing

Optimizing Yields, Tech Transfer, and the Supply Chain for Viral Vector Manufacturing

Andrew Moreo and Lenore Giannunzio of Andelyn Biosciences, discuss some of the ongoing challenges in viral vector manufacturing, including optimizing yields, tech transfer, and the supply chain, and how Andelyn's unique experience and expertise can ensure program success.

Cell Therapy

Expanding Access to Cell Therapies with a Patient-Centric Focus

Amy Ronneberg, CEO of The National Marrow Donor Program® (NMDP)/Be The Match® and Be The Match BioTherapies®, shares her thoughts on current trends in the adoptive cell therapy space, the challenges the sector faces, and how Be the Match® is helping to facilitate further advances in the field.

Neurodegenerative Diseases

Uncovering New Drug Targets for Neurological Diseases

Cerevance’s Chief Executive Officer Brad Margus discusses how Cerevance's proprietary, Nuclear Enriched Transcript Sort sequencing (NETSseq) platform facilitates more informed drug development strategies for a variety of neurodegenerative disorders.

Viral Vectors

Smart Scale-Up: Expanding Viral Vectors With Microcarrier Bead Technology

Heidi Trusheim of IDT Biologika discusses scaling challenges in the development viral vector-based vaccines to combat coronavirus and other viral diseases.

Respiratory Diseases

Developing a Novel Anti-Inflammatory for Patients with Severe Asthma

Robert Clarke, Ph.D., CEO of Kinaset Therapeutics, discusses Kinaset's novel approach to developing inhaled therapeutics for respiratory diseases and the candidate advancing through early-phase clinical trials.

Oncology

Fighting Cancer by Focusing on Nuclear Export

Richard Paulson, President and Chief Executive of Karyopharm Therapeutics, disucsses their unique approach to cancer treatment that addresses a common mechanism of oncogenesis — dysregulation of nuclear export, as well as their therapeutic candidates.

Drug Discovery

Designing More Effective Therapeutic Proteins Using an Integrated Laboratory and Computational Platform

BIgHat Biosciences' CEO Mark DePristo, Ph.D., and CSO Peyton Greenside, Ph.D.discuss the founding of the company and its vision, the exciting initial success in a collaboration with Amgen, and where they see BigHat positioned in the coming years.

mRNA

Leveraging Existing Technologies with New Dedicated Facilities for mRNA Projects

Scott Doncaster,and Marc Sauer of BIOVECTRA discuss how BIOVECTRA's expansion into mRNA vaccine production and addition of a new biomanufacturing facility is a natural next step for the company, given its decades of success in chemical synthesis, biocatalysis, enzyme purification, microbial fermentation, and biologics manufacturing.

Leadership

Q: What’s the key to being a leader in the industry?

In this new roundtable at Pharma's Almanac, a terrific panel of subject matter experts explore the factors that make one a leader in the industry.

Milestones

Q: What important company milestone do you anticipate reaching in 2022?

In this new Pharma's Almanac roundtable, a panel of industry experts discuss the important milestones they anticipate their organizations reaching in 2022.

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
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