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BioJournal - Drug and Market
Development Guides
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Assay Development and Technologies, 2nd Edition
300+ Pages, 45+ Exhibits, Including Assay Development Checklists & 2
Examples of Assay TroubleshootingThis Guide thoroughly evaluates
the capabilities, strengths, weaknesses, and expectations of leading
assays and assay technologies.
Assay development is often time consuming and frustrating. But
reliable, robust assays are key to every phase of pharmaceutical
development. D&MD's Assay Development & Technology, 2nd Edition
provides critical information to speed and simplify the development
and optimization of most technologies. This Guide eliminates the
tendency to "reinvent the wheel" by providing valuable tips that
incorporate the author's many years of hands-on experience in the
field.
This Guide provides the information necessary to select and develop
the appropriate assay for the task at hand, including:
> The most common and rapidly-growing assays in the drug discovery and
drug development industries.
> Charts and tables cut through the sales hype and facilitate
comparisons of different assay types.
> Tips and tricks learned over 15 years of professional experience and
collaborative work in laboratory assays.> The often neglected
topics of biological sample matrix and high-volume data analysis.
> Step-by-step instructions and checklists for assay optimization,
validation, automation, scale-up, and miniaturization.> Emerging
platforms, formats, and technologies for high-throughput screening (HTS)
and ultra-high-throughout screening (UHTS).
> Detailed comparisons of technologies designed to help scientists
determine the best format to meet their assay needs.> Lists of
instrument manufacturers and supply vendors-including original
references and historical developments, with resources for finding
detailed modern laboratory recipes.
The following professionals involved in drug discovery, screening,
lead generation, and assay technology will greatly benefit from this
Guide:> Directors, Lab Managers, Group Leaders, Senior Scientists,
Principal Scientists, Project Managers, Heads of Research &
Development, Quality Control Managers, and more
This Guide Will Answer the Following Questions:> How does a
scientist determine the best assay for a particular application?
> What questions must be asked and answered during assay development?
> What steps are involved in optimization and validation of an
assay?
> How can a scientist determine that an assay is fully optimized,
sufficiently validated, and ready for full-scale operation?> How
can controls be used to provide the earliest warning of assay
problems?
> How does sample throughput and assay miniaturization really affect
data quality and reagent consumption?
> Will migrating to a higher-density microplate format improve
throughput?
> How do state-of-the-art assay instruments fail during normal
operation, and what can be done to minimize failure and the impact of
failure on operations?> What universal considerations are
critically important for every assay?
Sep-06 Pages 282
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Life Sciences Mergers & Acquisitions (M&A)
by Enal S. Razvi, Ph.D. and Jonathan Burbaum, Ph.D.Published:
April, 2006
Recently, there has been an upsurge in the number of mergers &
acquisitions (M&A) in the life sciences space. According to D&MD's new
market analysis report, the life sciences space will continue to see
consolidation in 2006 and beyond.D&MD's Life Sciences Mergers &
Acquisitions (M&A): A Reference Guide Illustrating Recent Trends in
Life Science M&A market analysis report focuses on mergers &
acquisitions (M&A) in the general life sciences space. This report is
an excellent reference guide for the life sciences audience engaged
primarily in drug discovery and development.
The report includes information on the latest industry statistics on
recent life sciences merger and acquisition transactions in
biotechnology and medical devices, latest industry statistics on
initial public offerings (IPOs) and venture capital investing.
Specifically, key merger and acquisition transactions within the last
18 months in the life sciences tools space are presented and
characterized in this report to help readers spot growth trends or
define exit strategies.The authors of this report rely on
experience to define and illustrate key components of a merger and
acquisition transaction.
Companies seeking to contemplate a transaction should purchase this
report and use as a reference guide to evaluate opportunities. Analyze
this data to get a feel for the landscape and take the appropriate
steps to explore a merger and acquisition transaction.Buy this
report to:
> Utilize as a reference guide of Life Sciences M&A transactions. The
report is designed as a handbook for biotechnology firms especially
the smaller-sized ones who are potentially exploring an M&A
transaction, and seek to review the landscape.
> Examine a highly quantitative resource that provides the latest
statistics on the life science M&A space, IPO space and venture
capital (VC) financing space including statistics on pre- and
post-money values of IPO transactions (illustrating an exit option)
and compares these with M&A transactions as another exit option.
> Explore quantitative analysis and figures that illustrate the M&A
trends and can be used in investor, partnering, and board-level
presentations when discussing a potential M&A transaction.
> Gain exclusive statistics and analysis not available to the
general biotechnology community.
Questions answered:> What are the recent qualitative and
quantitative trends in life sciences M&A transactions?
> How is the IPO market compared to the M&A market as an exit
strategy?
> What factors to consider when contemplating an M&A transaction in
the life sciences space?
> What are the venture capital investment trends in life sciences
companies recently?Core opportunities addressed in the life
sciences M&A space:
> Small biotechnology companies need scale, and one way to achieve
this is via consolidation-mergers or acquisitions.
> Many biotechnology companies are incapable of going public-their
focus, size, revenues, team, and core technology/capability is unable
to excite and sustain a public company. Therefore, one exit strategy
for these companies is to merge into another company or be acquired.
> Service providers-such as advisory companies, strategic planning
outfits, law firms-will find this reference guide valuable.
Chapter Summary
1 Executive Summary
2 Venture Capital Investment Trends in Life Science Companies3
Recent M&A Transactions in the Life Sciences Space
4 Qualitative and Quantitative Analysis of M&A in Life Sciences5
References and Further Sources of Information
Format: PDF
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Guide to US Reimbursement for Drugs, Medical Devices, and
Diagnostics
by Boston Healthcare
Securing FDA approval or clearance is not a guarantee of payer
coverage or payment for your novel drug or device. D&MD's Guide to US
Reimbursement for Drugs, Medical Devices, and Diagnostics is a
comprehensive review of how medical technologies secure payment from
private and public payers. The Guide examines coverage, coding, and
payment issues from private payer (HMO, PPO) and public payer
(Medicare, Medicaid) perspectives. The Guide is indispensable for life
science technology executives who are responsible for reimbursement
strategy, securing reimbursement, or assessing the value of a new
technology with reimbursement in mind. D&MD's Guide to US
Reimbursement for Drugs, Medical Devices, and Diagnostics will provide
insight to a wide audience of product managers, reimbursement
planners, business development executives, and CEOs.Key Benefits
> A comprehensive guide that provides key reimbursement concepts for
pharmaceutical, medical devices and the diagnostic industries, and
complements FDA regulatory knowledge to assist in market planning at
all levels of the product development cycle
> Updated CMS reimbursement news on guidelines and timelines in an
'actionable' format to aid in the marketability of products
> Details on CMS submissions for coding and coverage with charted
explanations on differentiating the need for new coding and its
integration into your marketing plan
> A strategic tool for successful 'in-house' reimbursement with
links to payment systems at the public level and turnkey solution for
monitoring policy
March 2006, Pages 140, FOormat PDF
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Guide to Business and Regulatory Strategies
Five years after the historic completion of the Human Genome
Sequencing Project, personalized nutrition and medicine are fields
evolving with an emphasis on discovering and researching biomarkers to
aid diagnoses. Specifically, clinical pharmacogenomics, theranostics,
and nutrigenomics are all examples of areas where diagnostic have
entered the arena of being used in conjunction with drug treatments
and nutrition recommendations. The availability of genome sequences
and biotechnology developments, such as clinical microarrays during
the last year, are driving the development of diagnostics. At the same
time, the technology is progressing, regulatory issues have to keep up
with the changes. The FDA approval of Affymetrix's AmpliChip at the
end of 2004 and beginning of 2005 as a 510K device rather than analyte
specific reagents reflects the changing landscape of genetic testing
regulation. Therefore, having examples and cases studies of business
strategies, business models, regulatory, and reimbursement issues are
extremely useful for learning and understanding the commercialization
process of diagnostics that are to be used in conjunction with
therapeutics.Report Overview
D&MD's Guide to Business and Regulatory Strategies: Companion
Diagnostic Products and Individual Therapies is a unique compilation
of historical companion diagnostic products, business models for
drug/diagnostic collaborations, education & marketing, intellectual
property, regulatory, and reimbursement information for those
interested in developing companion diagnostics, as well as stand-alone
diagnostics.This publication answers key questions such as:
> What are the US in vitro diagnostic regulatory guidelines?
> What are the in vitro diagnostic regulatory guidelines outside of
the US?
> Why is a diagnostic contract research organization (CRO) useful?
> What are main intellectual property issues to keep in mind?
> What is the difference between an ASR and a 510K?
> How can a company estimate the dollar value a companion
diagnostic can add to a therapeutic?
> Why companion diagnostic will not necessarily ruin a therapeutics
market?
> How a company can meet both commercial and non-profit goals?
> What does the FDA have to say about pharmacogenomics?
> What are the steps for validating a clinical assay?
Laura Ruth, Ph.D., has been an independent medical, science, and
technology writer and consultant. She has provided a wide range of
services to education, biotech, journal, and market research clients
for the past six years following a nine-year career as a biological
chemistry laboratory scientist. Her education, combined with her
experiences as a biological chemistry technician at Lawrence Berkeley
Laboratories and Syntex, allow her to cover a broad range of science,
technology, and policy topics. She has previously authored eleven
biotechnology market research reports for Business Communications
Company, Inc., Kalorama Information, and Cambridge Healthtech
Advisors. Other topics have included gene therapy, protein chips,
immunoassays, molecular diagnostics, drugs of abuse diagnostics, and
prion diagnostics for applications in industries such as clinical,
food, and biodefense. Laura Ruth holds a B.S. in chemistry from MIT
and a Ph.D. in biological X-ray crystallography from the University of
Pennsylvania.June 2006, Pages 155, Format PDF
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Good Manufacturing Practices 3rd Edition
A Guide to Good Manufacturing Practices 3rd EditionBy Alex D.
Kanarek, Ph.D.
Published: July, 2006
Newly Revised to Include the Latest FDA Regulations
Scope of GuideD&MD's updated Good Manufacturing Practices
professional development guide provides pharmaceutical and biological
companies of all sizes with assistance in regulatory compliance. The
guide examines the new FDA Guidance for Industry documents and a new
amendment covering an exemption for investigational drugs in Phase 1
studies. The guide is addressed particularly to smaller sized
companies, perhaps those with their first new drug, working on this
extra challenge to their capabilities.
Analyzing the contents of the latest versions of the GMP rules laid
down by the USA, Canada and Japan, ICH, the EC and WHO, this guide
provides pharmaceutical and biological companies of all sizes with
assistance in compliance with these rules. The guide is addressed
particularly to smaller sized companies, perhaps those with their
first new drug, working on this extra challenge to their capabilities.
Questions Answered
> What drug products are covered by the cGMP regulations?
> At what stage in a drug's development do the cGMP regulations
become effective?
> How do we apply these regulations to our manufacturing operations?
> How do we ensure we will pass a cGMP inspection?
Target AudienceThis guide will prove beneficial to the following
professionals involved in Pharmaceutical, Biopharmaceutical and
Biological development and manufacturing:
> Heads of Manufacturing
> QA, QC
> Regulatory Affairs
> Product & Process Development Scientists
> Manufacturing Supervisory Staff
> QA Auditing Staff
> Validation Experts
> GMP Trainers
Jul-06 Pages 423 PDF Format |
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D&MD's Guide to Business Plan Writing, 3rd edition helps companies
in the life sciences industry create an effective business plan for
early and mid-stage stage business ventures. Businesses in the life
science industry, which includes biotechnology, agricultural
technology, pharmaceutical products, health services and medical
devices, face similar hurdles in the development of their businesses.
These challenges are often distinct from what is faced in other
non-life science based industries. |
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D&MD's Guide to Due Diligence in Life Science Transactions, 2nd
Edition provides a comprehensive overview on due diligence and a
proven path to success for professionals working in the life sciences
industry. This guide includes summaries of key investigation areas and
critical questions to ask during the due diligence process. Also
included are checklist tools readily employable in day-to-day business
operations. |
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D&MD's Guide to Good Clinical Practice, 3rd Edition updates the
regulations and their respective amendments since the 2nd edition was
published in 2005. The guide details the duties of the sponsors,
institutional review boards (IRB), investigators, and trial monitors.
Practical advice is given on the various mandates for achieving GCP
compliance. The templates of forms for study audits, data integrity
checks and IRB operations are included for the reader's access. |
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Drug regulatory agencies require pharmaceutical and
biopharmaceutical establishments to comply with Good Laboratory
Practice (GLP) and Good Manufacturing Practice (GMP) regulations.
D&MD's Guide to Good Facility Design, 2nd Edition examines these
regulations and details the means whereby a facility design that is in
compliance with them can be achieved economically and efficiently |
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D&MD's Guide to Good Validation Practice, 3rd Edition is devoted
to considering in greater detail the ways of complying with validation
requirements at all stages of drug research, development and
manufacture. The particular problems associated with the newer
biopharmaceutical products are given special consideration. To
complete this comprehensive guide to validation and its problems, full
texts are provided of the major guidelines issued by National and
International regulatory authorities, along with the relevant
abstracts from the GLP, GMP, and GCP regulations. Other references
include web sites for the retrieval of the text of regulations and
guidelines, a list of useful publications, and of some well-known
firms specializing in validation consulting. |
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D&MD's Guide to Good Laboratory Practice, 3rd Edition examines the
GLP regulations in the United States and other countries in detail,
and gives firm guidelines for compliance, using as a basis the GLP
requirements published in the U.S.A Code of Federal Regulations, Title
21, Part 58, 2006 Edition (21CFR58). The guidelines laid down by other
countries, especially members of the European Community, are based
upon guidelines developed by the Organization for Economic Development
(OECD) in 1980. Guidelines on safety testing and analytical methods
issued by the International Conference on Harmonization (ICH) are also
reviewed. Special attention is paid to the documentation and the
preparations for internal and external inspections and audits. |
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Regulatory bodies in the US, Canada, EU and Japan accept the CTD
document format when applying for IND and NDA approval. This
multiparty agreement, led by the ICH Harmonization, facilitates the
application process when multi-nation regulatory approvals are being
sought. The ground work and preparation of the CTD is critical since
it serves as the platform for regulatory filings. Module 3 of the CTD
focuses on Chemistry, Manufacturing and Controls (CMC) documentation
relating to substance and product quality. Providing the correct
information in sufficient detail in this section will reduce delays
and costs. |
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Recently, there has been an upsurge in the number of mergers &
acquisitions (M&A) in the life sciences space. According to D&MD's new
market analysis report, the life sciences space will continue to see
consolidation in 2006 and beyond.
D&MD's Life Sciences Mergers & Acquisitions (M&A): A Reference Guide
Illustrating Recent Trends in Life Science M&A market analysis report
focuses on mergers & acquisitions (M&A) in the general life sciences
space. This report is an excellent reference guide for the life
sciences audience engaged primarily in drug discovery and development. |
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