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European Biopharmaceutical Review
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| Convergence therapies have been defined as “the combination in a single product
of device and pharmaceutical and/or biological therapies” and have been referred
to as the medical device industry’s “most promising opportunity ever” (1). There is
no denying that this area holds the potential for delivering major benefits, not just
in regard to better treatments, but also significant financial reward to successful
developers of combination products. However, before leaping into this space it
is important for device companies to recognise the increased technical and
commercial challenges that are faced when developing this type of product. How
can device companies learn from the experiences of early pioneers in this field,
develop a strategy that is able to see past the core science and focus on delivering
the full business package necessary for commercial success? This article explores
some of the opportunities and challenges (technological, regulatory and marketing)
in developing device strategy through to implementation. |
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Based at PA Consulting’s Technology Centre
in Cambridge, Stephen Blatcher is a chartered
Mechanical Engineer who specialises in
material selection, component design and risk
management activities for surgical products
and processes. Whilst at PA, Stephen has
helped many companies develop innovative products and
processes with particular emphasis on the multidisciplinary skills
necessary for delivering combination products such as drug
eluting implants and biotherapeutic delivery devices. Stephen
has also undertaken a number of studies to understand the
technologies required to commercialise combination surgical
products and regenerative therapies.
Ian Rhodes is a member of PA’s Management
Group World Wide and leads the technology
group. His background is in the design and
development of new products, processes and
services, primarily within the healthcare and
medical industries. Ian has become widelyrecognised
for bridging the gap between commercial/business
development/strategic issues, and the implementation of
engineering/operations. He has led and provided input to a
number of due diligence assignments within the sector. Ian has
an MBA from the London Business School and more recently
was the founding CEO of Aegate Ltd, a PA venture company
which he led for the first two and a half years of its growth
and development.
Dr Angus Forster is a Principal Consultant at PA
Consulting Group, Cambridge, UK. He earned
his PhD in Pharmaceutics and BPharm from
Otago University, New Zealand. Angus has
been involved in the Pharmaceutical industry
for over 10 years and has experience in Drug
Development, Pharmaceutical Manufacturing Technology and Drug
/Device combination products. He has published over 15 articles
and presented at a number of pharmaceutical conferences on the
subject of solid dispersion formulation and characterisation.
Jennifer Vondran is an Analyst in the
Global Technology Group of the PA
Consulting Group. Jennifer’s interests include
biocompatible materials, drug delivery
design and development, tissue engineering,
medical device product development and
risk management, and nanotechnology. Prior to becoming
an analyst, Jennifer completed a dual BS/MS degree in
Biomedical and Materials Science and Engineering from
Drexel University in Philadelphia. Her research was recently
published in the Journal of Applied Polymer Science.
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News and Press Releases |
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Catalent Invests $175 Million to Expand Manufacturing Capabilities and Capacity at Winchester, Kentucky
SOMERSET, N.J. – May 19, 2022 — Catalent, the global leader in
enabling biopharma, cell, gene and consumer health partners to optimize
development, launch, and supply of better patient treatments across
multiple modalities, today announced that it has commenced a $175
million project to expand its flagship U.S. manufacturing facility for
large scale oral dose forms in Winchester, Kentucky. Two new buildings,
expected to be completed by January 2024, will add 107,000 square feet
to the site’s manufacturing footprint.
More info >> |
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White Papers |
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Clinical Trials in Emerging Markets: Goldmines or Landmines?
Pharm-Olam, LLC
Over the past decade, biopharmaceutical companies
have increasingly turned to emerging markets as a way
to reduce clinical trial costs and timelines. Areas such
as Eastern Europe, India, and Latin America—with their
ready population of treatment naïve patients—can be an
answer to the intense competition for patients seen in
developed markets. Many of the countries within these
regions may now be considered as “emerged” countries
but yet, conducting trials in these regions does require
some special attention and expertise. Before deciding to
conduct studies in these areas, companies should have a
full appreciation for the ethical, medical, regulatory, legal,
and operational hurdles that must be surmounted for
success. Here we highlight a number of those issues and
offer our recommendations for how sponsor companies
can deal with them effectively.
More info >> |
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