Antibody–Drug Conjugates

92 Pages·2012·14.49 MB·English

The Drug Development FDA’s Perspective January 2012
Volume 36
PLUS: and Analytical Toolbox on Starting Materials
Number 1
The Authority on Drug Development & Manufacturing
PharmTech.com
Antibody–Drug
Conjugates
Looking ahead
to an emerging class
of biotherapeutic
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6 Pharmaceutical Technology JANUARY 2012 PharmTech.com
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January 2012 Volume 36 Number 1 ➲ On PharmTech.com
Issue extras
➲
Find additional interviews
from this month’s technical forum
on multilayer tablet technology
Pharmaceutical Technology is the authoritative source of peer-reviewed research and on PharmTech.com/multilayer.

expert analyses for scientists, engineers, and managers engaged in process devel-
Reader comment
opment, manufacturing, formulation and drug delivery, API synthesis, analytical
“Scientific facts should play a leading
technology and testing, packaging, IT, outsourcing, and regulatory compliance in the
role, but not an exclusive role, in de-
pharmaceutical and biotechnology industries.
termining what drugs are available to
whom,” in response to a blog post on
Cover Story: “Is HHS Using Scientific Standards?”
Read more conversations on our blog
Antibody–Drug Conjugates
r at blog.PharmTech.com
e 42 Looking Ahead to
v Free eNewsletters
o an Emerging Class of
c Visit PharmTech.com/enews for:
Biotherapeutic • ePT : Weekly eNewsletter keeps
e
by Amy Ritter
you current with industry news
h
t A successful antibody–drug conjugate requires and business notes.
n careful selection of the drug, antibody, and linker. • Sourcing and Management:
O Compositing by Dan Ward. A monthly eNewsletter to help
Images: Nick Koudis/Ingram Publishing/Getty Images you maintain a healthy supply
chain. The January issue pro-
Features vides an API market outlook.
• Equipment & Processing
Technical Forum Fda PersPecTives Report: Monthly reports on
48 Multilayer- 63 Designation of cutting-edge techniques and
technologies. The January edi-
Tablet Technology Regulatory Starting tion focuses on isolated robots.
Materials in the Manufacturing Most popular articles
Moderated by Rich Whitworth
and Stephanie Sutton of Drug Substances: • FDA–EMA Joint Manufacturing
Industry experts discuss formulation Impact on ANDA Review Time Inspections to Begin in 2012
and technical challenges in multilayer • FDA Warns Novartis of Violations
Barbara Scott, FDA
tablet manufacture. at Three Plants
The author describes how provid-
• Views from Pharma Leaders:
ing appropriate information about
A Year in Review and a Look Forward
Pharma ingredienTs the API in the Common Technical
52 Document can aid FDA’s review of an
Broadening the
abbreviated new drug application.
Drug Development and Departments/Products
Analytical Toolbox
Peer-reviewed research 18
In the Field
Patricia Van Arnum
26
In the Spotlight
A look at recent advances in FormulaTion develoPmenT
accelerating reaction discovery, 57 Assessing Tablet- 81 Pharma Capsules
inducing chirality and stereochemical
71
analysis, and nanotech applications Sticking Propensity Company Product
for protein elucidation.
Matthew P. Mullarney, and Service Profiles
Plus: Formulation Development Forum.
Bruce C. MacDonald, and Allan Hutchins 82
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The authors designed an upper 86
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Continued on page 10
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Columns
From The ediTor washingTon rePorT inside usP
12 28 67
Here’s to a Budget Crunch, Politics global Harmonization
year of Compromise Shape Policy Agenda opportunities and Challenges
Angie Drakulich Jill Wechsler Anthony DeStefano and Kevin Moore
The benefits of harmonization Pressure to approve new user fees To keep moving forward, the
may be on the industry’s wish list, but opens the door to action on drug Pharmacopoeial Discussion Group
buying into change is another story. shortages, prices, and regulation. needs industry participation.
ouTsourcing ouTlook
PharmTech Talk bio Forum
68
14 36 Contract Services for 2012
Cutting Prices Venture-Capital
to Save Sales Funding Falls Jim Miller
Erik greb Tracey T. Lefteroff Recent private-equity buyouts
Challenges remain, particularly for of CROs show the up- and
Copay coupons may help patients
early-stage biopharm companies. down-side for investors.
and drugmakers, but who ends up
holding the bag?
viewPoinT
Packaging Forum
88
agenT-in-Place 38 Innovations for 2012 Innovator Liability Still Not
16 Viable after Pliva v. Mensing
All Systems Slow Hallie Forcinio
Control, a Senior Compliance officer Packaging innovations boost Zach Hughes
productivity, meet regulatory
Technology may expedite requirements, and protect products. Recent legal decisions have
operations, but the absence of the further divided generic and
human element could cost dearly. brand manufacturer cases.
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