APR May/June 2022 - 27

« ROUNDTABLE
Considering the last two years and looking ahead,
what has the pharmaceutical industry learned and
how will it apply these lessons in the future?
Tillotson: Certainly, given the COVID-19 pandemic, the pharmaceutical
industry has learned a great deal over the past two years.
Initially, the
industry became quite agile formulating novel vaccines and delivery
technologies to meet the challenge. Subsequently, the industry has
had to adapt to certain outcomes resultant from the pandemic, such
as supply chain issues, rising raw material costs, and supply scarcity.
Overall, the industry has learned the value of agility and planning
in the face of every-changing conditions, to ensure supply of the
pharmaceutical goods and services that public health requires.
Dormer: Adherence to therapy is a driver for drug efficacy and should
be facilitated by designing products unencumbered by complex administration
procedures and cumbersome administration schedules.
The COVID pandemic further demonstrated the need and the value of
drugs that are simple and easy to take.
Social distancing and isolation are significant obstacles to therapy
adherence, especially for more vulnerable patients. It is therefore
crucial to design and develop products, such as controlled and
modified release medicines, that provide a simplified dosing schedule
to reduce dosing errors and enhance lifestyle compatibility for the
target patient population.
Bloder: I believe among the many learnings is that the pharma
industry has recognized the importance of supply chain functionality
and the profound impact it can have on the everyday lives, from lifesaving
vaccines to baby formula. We live in a fragile ecosystem and we
all can contribute each day to achieve its success.
Tiwari: While the pandemic in the last two years posed several
new challenges to the pharmaceutical industry, it also gave an
opportunity to reassess the status quo and innovate for providing
high-quality medicines with an unprecedented need and demand.
Besides strengthening the supply chain, other key learnings from the
pandemic for the pharmaceutical industry are:
Collaboration: The industry worked relentlessly to find novel treatment
modalities for prevention and treatment of COVID-19 by collaborating
and sharing information. Pfizer and BioNTech is a good example of
collaboration that brought mRNA vaccine. Collaboration and strategic
partnerships are expected to grow exponentially to address the needs
of the future pandemic.
Digital transformation and machine learning tools are getting
integrated into pharmaceutical manufacturing and research and
development for faster drug product development, control of
manufacturing processes, supply chain traceability and direct data
submission to regulatory bodies. BASF's virtual pharma assistant
tools for drug product development, regulatory product information,
interactive sustainability tool for its products and e-commerce are
good examples of digital transformation.
Innovation: In the area of drug delivery, classical drug delivery
approaches are being applied to improve the emerging therapeutic
modalities such as controlled release (initially developed for small
molecules) across the therapeutic spectrum. While technologies and
drug delivery strategies for new therapeutic modalities are being
adapted to improve the delivery of older drugs with repurposing
applications. Use of polyethylene glycol conjugation with proteins
first and then for improving delivery of small molecules latter is a good
example of innovation in drug delivery space.
Moody: If the past two years have taught us anything, it is that the
most important organizational resource is people. Well-qualified and
experienced people can adjust and adapt to changing paradigms in
communication, workspace, travel, and lifestyle in general. Resiliency
and flexibility are the new norms. Within the highly regulated
framework that we understand, companies must find innovative
ways to allow employees to do their jobs better and faster in a postpandemic
world. This includes using tools such as remote learning,
automation, enhanced communication platforms, and a general
openness to innovative ideas and change. As the pandemic recedes,
we all look forward to returning to something resembling normalcy.
But given our technological capabilities and what we have learned, it is
unlikely that things will ever go back to exactly the way they were. The
successful companies of tomorrow will be the ones that quickly adapt
and put the best tools in place to support their people.
Quinci: With the rapid development and commercialization of the
COVID vaccine, the pharmaceutical industry has learned how fast
innovation can happen. Moderna proved a relatively new entrant
can disrupt large pharmaceutical companies and bring innovation to
market quickly. BioNTech brought an entrepreneurial drive to their
partnership with Pfizer, helping to speed time to market with their
version of the vaccine. I believe the success of the COVID vaccines
raises the bar on what is an acceptable time to market and proves what
can happen when industry, regulatory agencies, and governments are
motivated and united behind a common cause.
More than ever, innovation is needed to develop improved drug
modalities and overcome longstanding therapeutic hurdles. For
example, novel controlled release technologies offer an opportunity
to address effectiveness and safety issues encountered with traditional
treatments. The overly risk-adverse mindset of the past doesn't have
to be the norm moving forward and long timelines that were once
accepted can be questioned as the industry takes on the challenges of
the future.
Siahboomi: The rapid increases in computing power and the
emergence of new capabilities in AI (Artificial Intelligence), virtual
modelling, automation, and data analytics, are accelerating the pace
of innovation not only for new chemical entity (discovery, but also for
drug dosage design. 3D printing technologies to manufacture solid
dosage forms is gaining momentum, allowing for complex designs
with regards to flexible shapes and precise release profiles. This
technology is still in development with some success in the nutritional
market and limited approvals in pharma.
The use of AI is already starting to have an impact through drug
discovery and bio-simulation that enables the pharmaceutical
industry to narrow down the most efficacious compounds, de-risk R&D
decisions, predict preclinical outcomes before human trials, reduce
animal testing, and therefore facilitate speed to market at a lower cost.
www.americanpharmaceutical.com |
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APR May/June 2022

Table of Contents for the Digital Edition of APR May/June 2022

Message from the Editor
Editorial Advisory Board
CN Perspectives
Social Media Connections
BIOPHARMACEUTICALS - Long-Acting Injectable Suspensions
ROUNDTABLE - Controlled Release
QC CORNER - Affinity Approaches to Selective, Sensitive MS Assays
DRUG DELIVERY - Introduction to mRNA-LNPs, Their Manufacture and Future Perspectives
BIOPHARMACEUTICALS - A Next-Generation Workforce for Next- Generation Therapies Preparing for Cell and Gene Therapies
MICROBIOLOGY - Optimizing a Viral Testing Strategy
BIOPHARMACEUTICAL - Assuring Quality of Oligonucleotide APIs and DPs
FACILITY TOUR - Growing to Serve: Eurofins’ Portage, Michigan, Facility Expands to Offer New Capabilities and Services
VENDOR VIEWPOINT - Combining the Best of Both Worlds with Semi-Targeted Metabolomics
VENDOR VIEWPOINT - Method Changes for Bacterial Endotoxins Testing (BET): Steps to Follow for a Straightforward Process
An Interview with Tony Saavedra Sievers DataShare Elite Stoftware
Editor's Top Tech
MANUFACTURING - A Discourse on Pharmaceutical cGMP FDA Form 483 Trends: Why are We Re-Living the Same Issues Over the Last 23 Years?
Equipment Focus
MICROBIOLOGY - Cleaning and Disinfection: An Important Pillar of Contamination Control
P.I.N. Points
Advertiser's Index
APR May/June 2022 - Cover1
APR May/June 2022 - Cover2
APR May/June 2022 - 1
APR May/June 2022 - 2
APR May/June 2022 - 3
APR May/June 2022 - 4
APR May/June 2022 - 5
APR May/June 2022 - Message from the Editor
APR May/June 2022 - Editorial Advisory Board
APR May/June 2022 - CN Perspectives
APR May/June 2022 - Social Media Connections
APR May/June 2022 - BIOPHARMACEUTICALS - Long-Acting Injectable Suspensions
APR May/June 2022 - 11
APR May/June 2022 - 12
APR May/June 2022 - 13
APR May/June 2022 - 14
APR May/June 2022 - 15
APR May/June 2022 - 16
APR May/June 2022 - 17
APR May/June 2022 - ROUNDTABLE - Controlled Release
APR May/June 2022 - 19
APR May/June 2022 - 20
APR May/June 2022 - 21
APR May/June 2022 - 22
APR May/June 2022 - 23
APR May/June 2022 - 24
APR May/June 2022 - 25
APR May/June 2022 - 26
APR May/June 2022 - 27
APR May/June 2022 - QC CORNER - Affinity Approaches to Selective, Sensitive MS Assays
APR May/June 2022 - 29
APR May/June 2022 - 30
APR May/June 2022 - 31
APR May/June 2022 - 32
APR May/June 2022 - 33
APR May/June 2022 - 34
APR May/June 2022 - 35
APR May/June 2022 - DRUG DELIVERY - Introduction to mRNA-LNPs, Their Manufacture and Future Perspectives
APR May/June 2022 - 37
APR May/June 2022 - 38
APR May/June 2022 - 39
APR May/June 2022 - 40
APR May/June 2022 - 41
APR May/June 2022 - BIOPHARMACEUTICALS - A Next-Generation Workforce for Next- Generation Therapies Preparing for Cell and Gene Therapies
APR May/June 2022 - 43
APR May/June 2022 - 44
APR May/June 2022 - 45
APR May/June 2022 - MICROBIOLOGY - Optimizing a Viral Testing Strategy
APR May/June 2022 - 47
APR May/June 2022 - 48
APR May/June 2022 - 49
APR May/June 2022 - 50
APR May/June 2022 - 51
APR May/June 2022 - BIOPHARMACEUTICAL - Assuring Quality of Oligonucleotide APIs and DPs
APR May/June 2022 - 53
APR May/June 2022 - 54
APR May/June 2022 - 55
APR May/June 2022 - 56
APR May/June 2022 - 57
APR May/June 2022 - 58
APR May/June 2022 - 59
APR May/June 2022 - FACILITY TOUR - Growing to Serve: Eurofins’ Portage, Michigan, Facility Expands to Offer New Capabilities and Services
APR May/June 2022 - 61
APR May/June 2022 - 62
APR May/June 2022 - VENDOR VIEWPOINT - Combining the Best of Both Worlds with Semi-Targeted Metabolomics
APR May/June 2022 - 64
APR May/June 2022 - 65
APR May/June 2022 - VENDOR VIEWPOINT - Method Changes for Bacterial Endotoxins Testing (BET): Steps to Follow for a Straightforward Process
APR May/June 2022 - 67
APR May/June 2022 - An Interview with Tony Saavedra Sievers DataShare Elite Stoftware
APR May/June 2022 - 69
APR May/June 2022 - Editor's Top Tech
APR May/June 2022 - 71
APR May/June 2022 - MANUFACTURING - A Discourse on Pharmaceutical cGMP FDA Form 483 Trends: Why are We Re-Living the Same Issues Over the Last 23 Years?
APR May/June 2022 - 73
APR May/June 2022 - 74
APR May/June 2022 - 75
APR May/June 2022 - 76
APR May/June 2022 - 77
APR May/June 2022 - 78
APR May/June 2022 - Equipment Focus
APR May/June 2022 - MICROBIOLOGY - Cleaning and Disinfection: An Important Pillar of Contamination Control
APR May/June 2022 - 81
APR May/June 2022 - 82
APR May/June 2022 - 83
APR May/June 2022 - 84
APR May/June 2022 - 85
APR May/June 2022 - P.I.N. Points
APR May/June 2022 - 87
APR May/June 2022 - Advertiser's Index
APR May/June 2022 - Cover3
APR May/June 2022 - Cover4
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