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This Study Offers a Terrifying Revelation on the Future Cost of Cancer

This Study Offers a Terrifying Revelation on the Future Cost of Cancer | On Drug Development | Scoop.it
Cancer drug spending could approach $100 billion by 2018. - Todd Campbell - Health Care
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News & Events > Director's Corner Podcasts

News & Events > Director's Corner Podcasts | On Drug Development | Scoop.it

The Director's Corner is a podcast series featuring the director of FDA's Center for Drug Evaluation and Research and produced by CDER's Division of Online Communications.

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FDA takes lighter touch with new health IT guidance

FDA takes lighter touch with new health IT guidance | On Drug Development | Scoop.it
The FDA is giving further latitude to health IT under its jurisdiction with a pair of now-final guidances, which industry observers feel are friendly to innovation.
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FDA Law Blog: House Energy & Commerce Committee Releases 21 Century Cures Act Discussion Draft; The Nearly 400-Page Bill Includes More Proposals Than You Can Shake a Stick At!

By Kurt R. Karst – For months we have been waiting with bated breath for the promised January 2015 release of a discussion draft of legislation to implement the 21st Century Cures Initiative, which was launched in April 2014 by...
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Designing Better Drug Candidates - American Chemical Society

Designing Better Drug Candidates - American Chemical Society | On Drug Development | Scoop.it
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About CoSMoS | CoSMoS

About CoSMoS | CoSMoS | On Drug Development | Scoop.it
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Since 2003 a group of scientists and practitioners has gathered each year with the purpose of exchanging information in an effort to advance our interests in small molecule analysis.

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Medicine Gets Personal: How science is changing the way you receive care on Vimeo

It’s a new day in medicine. The computer-driven “genomic revolution” -- coupled with the growth of electronic and personal health records – is beginning to impact…
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Drug Discovery and Development in the 21st Century - YouTube

VICTORS FOR DISCOVERY: BIOMEDICINE AT MICHIGAN
LSI Annual Symposium May 15, 2014

"Drug Discovery and Development in the 21st Century"

Moderated by Alan Saltiel, PhD, Mary Sue Coleman Director of the Life Sciences Institute

Introductory Talk: "Making New Medicines: New Approaches to an Old Challenge," Tachi Yamada, MD
Chief Medical & Scientific Officer, Executive Vice President & Board Member, Takeda Pharmaceuticals

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FDA Law Blog: What Can FDA Do During Drug Inspections: Will FDA Apply Its New Guidance to Other Products?

FDA Law Blog: What Can FDA Do During Drug Inspections: Will FDA Apply Its New Guidance to Other Products? | On Drug Development | Scoop.it
By Jay W. Cormier & Anne K. Walsh – For managers and employees of drug facilities, the arrival of an FDA inspector can be an anxiety-producing experience. Adding to the understandable nervousness surrounding an inspection is FDA’s new statutory authority...
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View the 2014 IQ Symposium Speaker Presentations

View the 2014 IQ Symposium Speaker Presentations | On Drug Development | Scoop.it

2014 IQ Symposium - “Innovation Through Precompetitive Collaboration“

Terrence Tougas's insight:

The 2014 IQ Symposium - “Innovation Through Precompetitive Collaboration“ - took take place on October 9 at the Westin Hotel, Alexandria VA.

The Symposium Organizing Committee was proud to have as keynote speaker Dr. Bill Chin, Executive Vice President of Scientific and Regulatory Affairs at PhRMA. Dr. Chin has proven to be an outspoken advocate of precompetitive collaboration in pharmaceutical research:

From the dawn of time, the sharing of knowledge has been one of the main forces driving science and innovation. Yet, in recent decades, a propriety culture, which wrongly posits that all intellectual property must be restricted, has spread across the pharmaceutical industry and threatens to stall the engine that has given us so many valuable treatments. Pharmaceutical companies, together with with universities and government agencies, stand to gain much from reversing that trend and engaging in widespread collaboration early in the research process to expand foundational knowledge and create a shared infrastructure to tap it. [Munos and Chin, Science Translational Medicine, 2 December 2009]


Following Dr. Chin's keynote lecture, representatives of IQ Working Groups presented their achievements and successes in precompetitive collaborations:

  • Opportunities to Evolve Enabling Technologies Across CMC – Srinivas Tummala, Bristol-Myers Squibb
  • Non-Clinical to Clinical Translational Safety Database – Tom Monticello, Amgen and Vic Kadambi, Blueprint Medicines
  • Designation and Justification of API Starting Materials for New Chemical Entities – Margaret Faul, Amgen
  • The Potential of New Chemical Entities as a Victim of Drug Drug Interactions. – Tonika Bohnert, Biogen Idec
  • ICH Pharmaceutical Quality System Q10 Implementation – Steven Laurenz, AbbVie
  • Pediatric Clinical Pharmacology – Konstantina Vanevski, Bayer
  • Global Regulators and CRO's as Key Partners to Refine and Reduce Animal Use– Brian Berridge, GlaxoSmithKline and Donna Clemons, AbbVie
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Learn More About Medicines in Development for HIV/AIDS | PhRMA

Learn More About Medicines in Development for HIV/AIDS | PhRMA | On Drug Development | Scoop.it
In the United States, more than 1.1 million people are living with HIV and 15.8 percent of those are unaware they are infected, according to the U.S. Centers for Disease Control and Prevention (CDC). However, multiple medical advancements have taken place since 1981, when the CDC identified the first five cases of HIV/AIDS.
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Report: Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Disease Including Strategic Plan: Accelerating ...

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AstraZeneca Provides An Inside Look Into R&D Practices

AstraZeneca Provides An Inside Look Into R&D Practices | On Drug Development | Scoop.it
All of these categories of failure can be ascribed to a breakdown in scientific management and leadership. Scientists will naturally display exuberance about their programs and be convinced that they have discovered a major breakthrough. But it is the role of management to challenge the teams and, if necessary, make the tough decisions to end projects.
Reggie Saraceno's insight:

Click through to the Nature article for an in-depth view.

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PharmaVOICE | February 2015

PharmaVOICE | February 2015 | On Drug Development | Scoop.it
PharmaVOICE | February 2015
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"Re-Imagining the Future of the Life-Sciences Industry"

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Chemical & Engineering News Digital Edition - February 2, 2015 - Page 10-11

Chemical & Engineering News Digital Edition - February 2, 2015 - Page 10-11 | On Drug Development | Scoop.it
As the central print and digital source for global news of the chemical enterprise and instrumentation and life sciences marketplace, C&EN reaches the largest group of scientists in the world: the 161,000 members of the American Chemical Society. The scientific community has turned to C&EN for 85 years as a primary source of timely, accurate, and comprehensive news. C&EN leads the field in reporting on science & technology developments, business and industry news, education stories, government developments, international news, employment trends and other information of interest. C&EN has over 40 special weekly issues including detailed coverage of the pharmaceutical market, custom chemicals, specialty chemicals, fine chemical and intermediates, personal care, lab informatics, instrumentation market reviews, drug development, sustainability, life sciences molecules, drug discovery, and other important topics.
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FDA Law Blog: The 21st Century Cures Act: Putting Patients First, Literally and … Substantively (And FDA’s New Expanded Access Form)

FDA Law Blog: The 21st Century Cures Act: Putting Patients First, Literally and … Substantively (And FDA’s New Expanded Access Form) | On Drug Development | Scoop.it
By James E. Valentine* & Jim C. Shehan – The 21st Century Cures Act’s focus on patients is inescapable. Title I of this nearly 400 page bill is entitled, “Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process...
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Objectives « Bayes-pharma

Objectives « Bayes-pharma | On Drug Development | Scoop.it
Objectives
The practical implementation of Bayesian thinking into pharmaceutical research has been slow due to either important computational challenge, lack of Bayesian education in the bio-statistical community or reluctance of regulatory authorities on the usefulness of the Bayesian approach.

However, recent developments Clinical trials such as adaptive designs, in Non-Clinical, in Model Based Drug Development and in Health economics paradigms indicate the rising interest, added value and business impact of Bayesian applications.

The objective of the workshop is multifold:

- Present of some applied case studies in the clinical, non-clinical and CMC settings
- Highlight the participants about some success stories and impact of the Bayesian thinking
- Promote the Bayesian thinking and practices within the pharmaceutical industry.
- Underline the advantages of Bayesian modeling for science and business
- Offer opportunities for statisticians for reorientation within the changing environment of the (bio)pharmaceutical world.
- Show and update participants on the new numerical solutions making Bayesian statistics an easy journey.
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DNDi - Drugs for Neglected Diseases initiative - DNDi

DNDi - Drugs for Neglected Diseases initiative - DNDi | On Drug Development | Scoop.it
DNDi is an independent, not-for-profit product development partnership working to research and develop new and improved treatments - DNDi, Drugs for Neglected Diseases initiative, currently has representatives in Brazil, Democratic Republic of Congo, Kenya, India, Japan, and Malaysia.
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John Edson speaks at FutureCare 2013 on Vimeo

The era of personalized medicine is upon us and this trend has important implications for how we think about patients. In fact, we need to be designing meaningful…
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TEDxBoston - Dr Jay Bradner - Opensource Drug Discovery - YouTube

What does it take to bring a drug to a market? Join Dr. Derek Lowe, chemistry blogger for "In the Pipeline" and medicinal chemist for Vertex as he reviews th...
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7 Steps to Drug Discovery - YouTube

What does it take to bring a drug to a market? Join Dr. Derek Lowe, chemistry blogger for "In the Pipeline" and medicinal chemist for Vertex as he reviews th...
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The Human Element In Lab Informatics | October 20, 2014 Issue - Vol. 92 Issue 42 | Chemical & Engineering News

The Human Element In Lab Informatics | October 20, 2014 Issue - Vol. 92 Issue 42 | Chemical & Engineering News | On Drug Development | Scoop.it
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Optimizing Potency for Nevirapine: The Drug that Saved Children from AIDS - American Chemical Society

Optimizing Potency for Nevirapine: The Drug that Saved Children from AIDS - American Chemical Society | On Drug Development | Scoop.it
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IBM’s Watson Ushers in a New Era of Pharmaceutical Data-Driven Discoveries

IBM’s Watson Ushers in a New Era of Pharmaceutical Data-Driven Discoveries | On Drug Development | Scoop.it
IBM today announced significant advances in Watson's cognitive computing capabilities that are enabling researchers to accelerate the pace of scientific breakthroughs by discovering previously unknown connections in Big Data.
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