APR March 2024 - 30

» INTERVIEW
»
bioavailability, then we will likely need to develop an injectable
formulation. Key to success, however, is that we must consider ease
of use and compliance, in other words, the patient experience. Given
the success of GLP-1s, and the broad range of potential benefits to
patients, these therapies are likely to become very broadly accepted.
We will need to make delivery systems simple and robust to expand
to other targets.
We have all been hearing about the success of
GLP-1 and related therapies. These peptides
are good examples of how medicines have
become increasingly complex. While there
are oral versions, they have vanishingly
low bioavailability. What are the options
available to improve their delivery?
Certainly, the success of GLP-1 peptides is beyond expectation.
While there are oral formulations of these peptides, the
bioavailability is generally a few percent or less. Obviously, this
isn't ideal, and thus there is great need for improved formulations
that would enable increased oral bioavailability. Some approaches
being explored include novel lipids that may improve permeability,
but these are not likely to have a dramatic effect. There are some
interesting peptide designs, such as circular constructs that are
also showing promise. More likely, an optimization of chemistry,
formulation, solid dosage form, and process is required to maximize
oral absorption of peptides.
For injectables, what are some of the
challenges that you see and how
might we overcome them from a
drug delivery standpoint?
There are some really exciting opportunities for parenteral delivery
for both small and large molecules.
Some examples are high
concentration suspensions of antibodies to convert from IV delivery
to SQ. We are working on a spray drying approach to particle
design that really looks promising.
These delivery challenges
require substantial particle design and formulation optimization to
be successful, as well as integration with the delivery device. The
neat thing about this technology is that it is applicable to any drug
modality (protein, peptide, small molecule) that needs a very high
dose in a small dosing volume and requiring the use of suspensions.
I also think that oral permeability is such a daunting challenge that
we will see more innovative patient friendly SQ dosing systems be
developed as well.
The IRA has put a lot of pressure on small
molecules, and there is a debate over how
investment could be impacted in this space,
what are your thoughts here?
I think small molecules are here to stay since in many cases, for
example for intra-cellular targets and crossing the blood-brain barrier,
small molecules are in most cases the only practical approach for
achieving desired PK. I do think that in the short term the IRA will
cause a shift in investment in small molecules, but for the reasons I
just stated, I don't think it will have a lasting impact.
Given the need for rapid development
because of the 9-year exclusivity for small
molecules, how can the industry advance
drugs more rapidly to patients?
This is a good question. We are taking this very seriously and have
an approach we think could be beneficial. Essentially, assuming the
9-year window remains, we need to develop medicines much faster.
Thinking about the whole drug development process is required to
do this, including design and implementation of clinical trials, patient
selection, target selection etc., but also, we think that CMC can be
performed much faster as well. Our approach simply put is to provide
a commercially viable formulation and analytical path forward for first
in human studies. This avoids time consuming efforts that require
bio-equivalency studies and reformulation and enables collection of
data that supports QBD from the very beginning of CMC activities.
Dr. Smithey is the President, CEO and Co-founder of Serán BioScience.
Over his 30-year career, he has led multiple research and development
projects in a broad range of therapeutic areas.
His work has led to the
successful development of several novel medicines, including Tucatinib
(Tukysa®) for the treatment of metastatic breast cancer. Dr. Smithey
has extensive experience building entrepreneurial organizations that
embrace a strong science and engineering approach to solving unmet
need in drug development and biotechnology. Previously, Dr. Smithey
led a team at Bend Research (now Lonza®) directed at research and
development of novel pharmaceutical technologies, including the
industry leading spray-dried dispersion technology that is broadly in use
today. Subsequently, Dr. Smithey co-founded Agere Pharmaceuticals, a
specialty CDMO, which was acquired by Patheon in 2015. He is an inventor
in over 50 patent and patent applications in numerous technology and
therapeutic areas. Dr. Smithey obtained a Ph.D. in Quantum Information
and Optical Physics from the University of Oregon.
30 |
| March 2024

APR March 2024

Table of Contents for the Digital Edition of APR March 2024

Message from the Editor
Editorial Advisory Board
BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
An Interview with Dan Smithey, PhD President & CEO, Serán
FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
QC Corner - Enhancing Material and Equipment Availability in Production Isolators
BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
DRUG DELIVERY - Your Nails and You
DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
Event Preview - CPHI North America
Event Preview - Excipient World 2024
P.I.N. Points
Advertiser's Index
APR March 2024 - CoverTip01
APR March 2024 - CoverTip02
APR March 2024 - Cover1
APR March 2024 - Cover2
APR March 2024 - 1
APR March 2024 - 2
APR March 2024 - 3
APR March 2024 - 4
APR March 2024 - 5
APR March 2024 - Message from the Editor
APR March 2024 - Editorial Advisory Board
APR March 2024 - BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
APR March 2024 - 9
APR March 2024 - 10
APR March 2024 - 11
APR March 2024 - 12
APR March 2024 - 13
APR March 2024 - MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
APR March 2024 - 15
APR March 2024 - 16
APR March 2024 - 17
APR March 2024 - 18
APR March 2024 - FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
APR March 2024 - 20
APR March 2024 - 21
APR March 2024 - 22
APR March 2024 - 23
APR March 2024 - FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
APR March 2024 - 25
APR March 2024 - 26
APR March 2024 - 27
APR March 2024 - An Interview with Dan Smithey, PhD President & CEO, Serán
APR March 2024 - 29
APR March 2024 - 30
APR March 2024 - FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
APR March 2024 - 32
APR March 2024 - 33
APR March 2024 - QC Corner - Enhancing Material and Equipment Availability in Production Isolators
APR March 2024 - 35
APR March 2024 - BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
APR March 2024 - 37
APR March 2024 - 38
APR March 2024 - 39
APR March 2024 - Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
APR March 2024 - 41
APR March 2024 - MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
APR March 2024 - 43
APR March 2024 - Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
APR March 2024 - 45
APR March 2024 - 46
APR March 2024 - 47
APR March 2024 - DRUG DELIVERY - Your Nails and You
APR March 2024 - 49
APR March 2024 - 50
APR March 2024 - 51
APR March 2024 - DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
APR March 2024 - 53
APR March 2024 - 54
APR March 2024 - 55
APR March 2024 - FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
APR March 2024 - 57
APR March 2024 - Event Preview - CPHI North America
APR March 2024 - 59
APR March 2024 - Event Preview - Excipient World 2024
APR March 2024 - 61
APR March 2024 - P.I.N. Points
APR March 2024 - 63
APR March 2024 - Advertiser's Index
APR March 2024 - Cover3
APR March 2024 - Cover4
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