Current Issue: Q2 2022

The Cutting-Edge Therapies Issue

Cutting-Edge Therapies

The Pharma’s Almanac editorial team is very excited to present our Q2 digital issue. This issue includes new content from our team and our colleagues at Nice Insight, as well as a large number of incredible subject matter experts from across the pharma/biopharma ecosystem, including drug discovery and development companies, life science industrials, technology providers, and contract development and manufacturing organizations. The diverse selection of topics touches on a huge spectrum of topics, united by the central thread of innovations that are ushering in the future of the industry.

 

Also in This Issue

ADCS

Improving the Therapeutic Index of ADCs with a Peptide Linker Technology

Philipp Spycher, Ph.D. of Araris Biotech, discusses his company’s new peptide linker technology, which has been shown in preclinical studies to enable highly targeted delivery of payloads with minimal loss during circulation.

Column: Clinical Trials

CAR-T Study Shines New Spotlight on Clinical Trials Representation

Pharma's Almanac Editor in Chief David Alvaro, Ph.D., discusses a recent study exploring the failures of adequate representation in the clinical trials leading to the approval of CAR-T cell therapy products.

Column: M&A

Who's Left to Acquire in CDMO Biomanufacturing? A Select Few.

In his M&A column in our Q2 issue, Nice Insight's Nigel Walker explores factors impacting demand for CDMO services, how they are changing the M&A market, and some CDMOs that might be on the block for acquisition.

Column: New Drug Watch

New Drug Watch: A Validation of the ‘Twincretin’ Approach to Type 2 Diabetes

Pharma's Almanac's David Alvaro discusses Mounjaro, Eli Lilly's exciting new first-in-class type 2 diabetes drug.

Column: Investment

IPOs Have Not Recovered In 2022. When Will Biotech Bounce Back?

Pharma's Almanac's Danielle Alvarez discusses biotech IPOs thus far in 2022 and questions when we will see a return to past growth.

Column: Regulatory Spotlight

The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative

In this regulatory column, Pharma's Almanac's David Alvaro explores the recent FDA guidance on "Development of Non-Opioid Analgesics for Acute Pain."

NFTs

Digital Frontiers: What NFTs Can Do for Pharma

Pharma's Almanac's Danielle Alvarez discusses non-fungible tokens (NFTs) and a range of their possible applications in pharma.

Column: Supply Chain

Creating a More Resilient Pharmaceutical Supply Chain One Segment at a Time

Nice Insight's Strategy Director Tonia Becker lays out a roadmap for improving the resilience of the pharma supply chain in the wake of the COVID-19 pandemic.

Mental Health

Mental Health During a Global Pandemic

Nice Insight's Marc Technow discusses the special impacts the COVID-19 pandemic had on mental health.

Biotechs

10 More Biotechs Making Moves in 2022

The Pharma's Almanac editorial team shine a spotlight on 10 exciting biotechs.

Cell Therapy

Taking Adoptive Cell Therapies to the Next Level

Pharma's Almanac's Cynthia Challener provides a detailed overview of the next generation of cell therapies.

Unmet Needs

In which orphan spaces or unmet medical needs do you think we will see the next treatment innovations?

In this Pharma's Almanac roundtable, a panel of industry experts discusses the next hot orphan space or unmet medical need.

Industry Challenges

What do you consider the biggest challenge that the pharma/biopharma industry currently faces?

In this roundtable, a large number of SMEs explore the biggest challenges faced by the industry.

Quantum Computing

Quantum Computing will Transform Drug Discovery, Development, Manufacturing, and Supply Chain Management

Pharma's Almanac's Cynthia Challener explores the potential of quantum computing to transform all aspects of pharma.

API

Small Molecule API Market Trends

In this excerpt from Nice Insight's 2022 Active Pharmaceutical Ingredient (API) Market Report & CDMO Pricing Study, Research Director James Grote explores current trends in the small molecule API market.

Real-World Data

Real-World Data and Artificial Intelligence are Transforming Clinical Development

In this extended Q&A, Jeff Elton, Ph.D., Chief Executive Officer of ConcertAI, discusses the promise of real-world data and artificial intelligence in clinical research and the role ConcertAI is taking as an accelerator of evidence generation.

Cell and Gene Therapy Analytics

Accelerating the Development of High-Quality Cell and Gene Therapies with Comprehensive, In-house Analytical Support

Hui Chen, Ph.D., Vice President of Analytical & Quality Control and Gene Therapy at Porton Advanced, discusses the company’s unique analytical capabilities for supporting viral vector and plasmid DNA manufacturing.

Rare Diseases

Staying Agile to Bring Therapies to Patients with Rare Diseases

In this Q&A, Amryt’s President Americas Sheila Frame discusses the company’s dedication to transforming the lives of patients with rare diseases, including acromegaly, epidermolysis bullosa, lipodystrophy and homozygous familial hypercholesterolemia.

Immuno-Oncology

Tuning the Myeloid Compartment with a Best-in-Class CDMO

Alicia Levey and Kiren Khanduja of Pionyr Immunotherapeutics discuss the basis for selection of Lonza to meet Pionyr’s goals to rapidly develop a third lead candidate from the start and to scale-up manufacturing of two clinical-stage immuno-oncology treatments after tech transfer.

Cell Therapy

Fighting Solid Tumors by Targeting Neoantigens in a Personalized Manner

Mark Shlomchik, M.D., Ph.D., co-founder and Chief Scientific Officer at BlueSphere Bio, discusses how the company’s new platform technologies enable the rapid development of effective personalized T cell receptor (TCR) T cell therapies for the treatment of solid tumors.

Liver Disease

Tackling Liver Disease with a Multimodal Cyclophilin Inhibitor

Robert Foster, Pharm.D., Ph.D., CEO of Hepion Pharmaceuticals, discusses the history of cyclophilin inhibitors and Hepion's candidate drug, rencofilstat/CRV431.

R&D

Driving Further Innovation by Integrating a Decentralized R&D Network

Olon’s Senior Vice President of Research & Development Giorgio Bertolini, Ph.D., discusses the company's creation of a major new global research and development (R&D) hub at its headquarters in Rodano, Italy.

mRNA Delivery

New Polymer-Lipid Delivery System for mRNA

Evonik's Andrea Engel, Ph.D., and Philipp Heller, Ph.D.,m discuss the development of charge-altering releasable transporters (CARTs), polymeric delivery vehicles that capable of delivering many types of nucleic acids and potentially other negatively charged biomolecules that complement lipid nanoparticle delivery.

Cell Therapy

A PODular Therapies-as-a-Service Approach To Fundamentally Change the CAR-T Cell Therapy Landscape

aCGT Vector is developing disruptive technology that is poised to transform the way CAR-T and other autologous cell therapies are manufactured, locating PODular “GMP-in-a-POD” distributed manufacturing systems in cancer centers of excellence.

Regenerative Medicine

NFTs Are Bringing the Regenerative Medicine Community Together

RoosterBio is leveraging NFT technology as a means to build an engaged community of members who look to them for both regenerative medicine expertise and putting themselves ahead of the NFT curve.

Digitalization

Reducing Time to IND, Increasing Quality, and Building Trust through Shared Data

Representatives from start-up development company Wheeler Bio and its digitalization partners, DataHow and Synthace, discuss how their collaboration will help Wheeler gain deeper insights into its processes more quickly and accelerate the time to IND for its customers.

Plasmid DNA

Translating Three Decades of Experience in Plasmid DNA Into Customer Success

Richter-Helm’s Kai Pohlmeyer, Ph.D., and Thilo Kamphausen, Ph.D., discuss the company’s upcoming expansion in Bovenau, Germany, how pDNA manufacturing is differentiated from more conventional biomanufacturing, and how to ensure and test for the highest level of quality.

Ophthalmic

Transformative Early and Patient-Centric Treatments for Retinal Diseases

OcuTerra Therapeutics, with their lead compound OTT166, is seeking to enable earlier and more patient-centric intervention for diabetic retinopathy.

Viral Vector Manufacturing

Approaching Viral Vector Manufacturing With an Emphasis on Quality and Design

Avid Bioservices' Atef Khezri and Chris Berger discuss how Avid's long quality and compliance track record and purpose-built viral vector manufacturing facility will extend Avid’s unparalleled dedication to quality into the cell and gene therapy sector.

Bioanalytics

The Bioanalytical Development Journey

Scorpion Biological Services' Director of Analytical Development Nick Raja, Ph.D., explains the process of bioanalytical development from inception through qualification and validation.

mRNA

The Intersection of mRNA Biology and Artificial Intelligence is Yielding Unique mRNA Drug Candidates

Anima Biotech's Yochi Slonim explains how Anima's unique technology can accelerate the discovery and development of small molecule drugs targeting mRNA translation, transport, and relocalization.

Biomanufacturing

A Next-Generation Baker’s Yeast Biofoundry Presents Transformative Potential for Biomanufacturing

Phenotypeca's Keith Williams discusses how the company is combining breeding and rational engineering technologies to rapidly generate next-generation strains of Saccharomyces cerevisiae that optimize biomanufacturing, reducing cost and time to market for drug developers.

Regulatory Compliance

Addressing Regulatory Challenges for Ophthalmic Combination Products

Jeff Tremain and Ania VanDyke discuss the new regulatory requirements for ophthalmic formulations designed for administration as eye drops and the importance of partnering with a full service provider experienced in meeting complex compliance requirements.

Biomanufacturing

The Smart Approach to Preclinical Development for Bacterially Expressed Biologics

Vectron Biosolutions CEO Trond Erik Vee Aune discusses some of the primary challenges face in the manufacturing of biotherapeutics and explains how Vectron's E. coli technology can help developers overcome many of them.

Intranasal Vaccines

Increasing Safety, Efficacy, and Global Equity with Intranasal Vaccines

BlueWillow Biologics Chief Executive Officer Chad Costley, M.D., discusses the historical development of mucosal and intranasal vaccines and their advantages over intramuscular delivery.

Advanced Excipients

How the Developability Classification System and Advanced Excipients Enable the Formulation of Poorly Soluble APIs

Daniel Joseph Price, Ph.D., Strategic Marketing Manager for the SAFC® portfolio of solid formulation excipients at MilliporeSigma, explains how the Developability Classification System is enabling the development of better excipients for poorly soluble compounds and simplifying the formulation process for these challenging APIs.

Critical Care

Bringing Novel Solutions to Market for Unmet Needs

Citius Pharmaceuticals is developing novel medical solutions that address specialized needs for which no products are on the market, from a prescription hemorrhoid treatment to a solution for salvaging infected catheters

Mesenchymal Stem Cells

A Media Platform for Cost-Effective and Scalable 2D and 3D Bioreactor MSC Expansion

RoosterBio’s media platform for culturing mesenchymal stem cells (MSCs) reduces the time and cost limitations while generating billions of MSCs. Our Scientific Editor in Chief examines how this platform enables cell therapy companies to profitably bring their novel treatments to patients at a reasonable price.

Aseptic Processing

Unique Manufacturing Challenges Associated with Sterile Eye Ointments

Tim Schuetter, Site General Manager at AbbVie, discusses the unique challenges of ophthalmic ointment manufacture and the importance of experienced manufacturing partners with specialized capabilities in the aseptic processing of these unique products.

Vaccine and Cell & Gene Therapies

Expanding Manufacturing Capacity to Meet Market Demand for Vaccines and Cell and Gene Therapeutics

Prof. Dr. Ulrike Fiedler, Chief Commercial Officer at IDT Biologika, explains the drivers of IDT Biologika's recent notable investments in greater capacity and capabilities across the board, and what might be coming for the industry and the company in the near future.

Data Mapping

Adding Dimensionality to Data Mapping for Higher-Level Analysis

Zachary Pitluk, Ph.D., Vice President, Life Sciences and Healthcare, explains how Paradigm4’s innovative technology is elevating companies to unique, first-in-class players and enhancing data cohesion.

Recombinant Antibodies

Taking a Customer-Focused Approach to Custom Antibody Development and Manufacturing

Amy Sheng, Rob Burgess, and Lillith Elmore of Sino Biological discuss the company's extensive experience developing processes for the production of all types of antibodies and how it continues to invest in more technologys to meet the evolving needs of the marketplace.

Bioprocessing

Better Bioprocessing Efficiency Through Centralized Orchestration

Aniruddha Bose of MilliporeSigma examines how intensified bioprocessing technologies, together with software, automation, and analytics, will help advance the industry through its digital transformation.

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