Drug Delivery Technology

77 Pages·2011·9.81 MB·English

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September 2011 Vol 11 No 7 www.drug-dev.com
IN THIS
ISSUE
INTERVIEW WITH
MACUCLEAR’S
CEO
PHILIP RALSTON
Beyond The
Headlines 18
Derek Hennecke
Functional
Excipients 22
João Correia
António Bica
Patient
Compliance 30
Steven Hamlen, MBA
Karen MacGregor, PhD
Zeta
Potential 2 50
David Fairhurst, PhD
Robert W. Lee, PhD
FEATURING
The science & business of drug development in specialty pharma, biotechnology, and drug delivery
Outsourcing
Trends 64
Fethi Trabelsi, Cindy Dubin Josef Bossart, Jennifer Brice
PhD PhD
Biologics, Self- Barath Shankar
Importance of Administration & DDEP Sales &
Phamacokinetic/ Patient Adherence: Prescription
Pharmacodynamic Creating a Lucrative Performance 2010, Development
SBtiousdiimesil aDru Crilningical HMaanrkde-Hteld Injection Hints of the Future Strategies 66
Development Andrew MacGarvey
AT LAST

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September 2011 Vol 11 No 7
PUBLISHER/PRESIDENT
Ralph Vitaro
[email protected]
EXECUTIVE EDITORIAL DIRECTOR
Dan Marino, MSc
[email protected]
CREATIVE DIRECTOR
Shalamar Q. Eagel
CONTROLLER
Debbie Carrillo
CONTRIBUTING EDITORS
Cindy H. Dubin
John A. Bermingham
Josef Bossart, PhD
Katheryn Symank
TECHNICAL OPERATIONS
Mark Newland
EDITORIAL SUPPORT
Nicholas D. Vitaro
ADMINISTRATIVE SUPPORT
Kathleen Kenny
Corporate/Editorial Office
219 Changebridge Road, Montville, NJ 07045
Tel: [phone]
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Ralph Vitaro Warren De Graff
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All editorial submissions are handled with reasonable care, but the publishers assume no responsibility for the safety
of artwork, photographs, or manuscripts. Every precaution is taken to ensure accuracy, but publishers cannot accept
responsibility for the accuracy of information supplied herein or for any opinion expressed. Drug Development &
Delivery (ISSN) 1537-2898 is published 9 times in 2011, January/February, March, April, May, June, July/August,
September, October, and November/December by Drug Delivery Technology LLC, 219 Changebridge Road, Montville NJ
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18 Beyond the Headlines: AstraZeneca, Pfizer,
“The comparability exercise for biosimilars
Asia & Strategic Alliances
should be very extensive at each step of the
Derek G. Hennecke continues with part 5 of his latest 6-part series on
development. Phase I PK/PD studies are a key how not to blow the recovery!
step in which innovative study designs and
26 DDEP Sales & Prescription Performance 2010,
rigorous methods should be used. They should
Hints of the Future
allow sensitive detection of any difference Josef Bossart, PhD, examines some key trends that defined 2010 and
between the innovator and the biosimilar, if tries to understand how these figures may impact business going
forward.
exists, in well-controlled testing environments
and standardized clinical conditions.” 30 New Data Shows Drug Delivery Has Positive
Impact on Patient Compliance
Steven Hamlen, MBA, and Karen MacGregor, PhD, outline the impact
of drug delivery formulation selection on cost to patients and our
healthcare system, therapeutic product profile performance, and
patient adherence to their prescription medication in a data-driven
case study.
34 Importance of Phamacokinetic/
Pharmacodynamic Studies During
Biosimilar Clinical Development
Fethi Trabelsi, PhD, highlights the importance of pharmacokinetics/
pharmacodynamics studies in the “similarity assessment” during
biosimilar clinical development.
40 MacuClear, Inc: Discovering & Developing
a Novel Solution for Dry Age-Related
Macular Degeneration
7
o Drug Development Executive: Philip Ralston, CEO of MacuCLEAR,
N
1 discusses his company’s unique, yet practical approach to treating
1
Vol Dry AMD.
1
1
0
er 2 50 The Zeta Potential & its Use in
b
m Pharmaceutical Applications - Part 2:
e
ept Measurement Techniques & Uses
S
y
er David Fairhurst, PhD, and Robert W. Lee, PhD, covered in part 1
v
Deli charged interfaces (in both polar and non-polar media) and
&
nt introduced the concept of the zeta potential (ZP). In this concluding
e
pm part 2, they discuss techniques to measure ZP and illustrate the utility
o
vel of its measurement.
e
D
g
u
Dr
p.34
6
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56 Biologics, Self-Administration & Patient
Adherence: Creating a Lucrative Hand-Held
Injection Market
Special Feature: Contributor Cindy H. Dubin heads up a roundtable
discussion with some of the industry's leading hand-held injection
companies to find out about what's driving the market, their
respective development projects, and where they see the sector
headed in the next few years.
64 Contract Research Outsourcing Market:
One of the Fastest Growing Segments in the
Pharmaceutical/Biotechnology Industry
Frost & Sullivan Analysts Jennifer Brice and Barath Shankar
Subramanian talk about competition in the growing CRO market and
the continued search for new growth and expansion opportunities as
pricing pressure continues to remain a major factor affecting
profitability.
66 Clusters’ Last Stand?
Andrew MacGarvey says clusters of businesses in the biotech
community have existed for many years, and while this has been a
boon for the human resources teams at these pharmaceutical and
biotech companies, it is not necessarily in the best interest of the
company as a whole, due to the innovation challenge it presents.
70 Biovista, Inc: Drug Indication Expansion &
Adverse Event Profiling as a Viable Business
Model
Executive Summary: Dr. Aris Persidis, President & Co-Founder of
Biovista, discusses how indication expansion (also known as drug
repositioning) practiced in a rational and systematic manner
“The market for prefilled syringes has achieved
7 generates a new kind of IP, innovation, market opportunity, market
o
N positive growth in recent years. In 2009,
1 barrier, and competitor differentiation.
1
ol an estimated 2 billion prefilled syringe units
V
011 were sold, and the market for that technology DEPARTMENTS
er 2 was estimated to be worth up to $2.5 billion,
b
m forming one of the fastest-expanding sectors in
e Market News & Trends . . . . . . . . . . . . . . . . . . . .. 12
pt
Se the pharmaceutical industry. Due to the
y Excipient Update . . . . . . . . . . . . . . . . . . . . . . . .. 22
er expanding use of biologic drugs and vaccines,
eliv The New Era of Functional Excipients: An Innovative
& D worldwide prefilled syringe technology market Approach in Dosage Form Design
ent revenue is expected to reach $3.9 billion in
pm Technology & Services Showcase . . . . . . . . . . .. 44
elo 2015.”
v
e
D External Delivery . . . . . . . . . . . . . . . . . . . . . . . .. 74
g
Dru Teachers
p.56
88
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