Genotoxic Impurities: Join Us this Week!

Genotoxic Impurities must be detected, identified, and reported before clinical trial initiation to ensure patient safety and eventual drug approval, but every drug and process has a unique set of process impurities. To ensure drug approval, the industry has heavily invested resources to address the GTI concerns and stay compliant with limits of genotoxic and potential genotoxic impurities.

IIR's GTI seminar is the only US intensive day and a half event that brings together industry thought leaders, genotoxic carcenogenic white paper and FDA guidance authors to define regulatory concerns, build industry best practices, and reduce the need for individual judgment calls. This intensive format designed for you to walk away with a toolkit including everything you need to know about GTIs such as FDA and EU regulatory clarification, toxicology tools to assess GTI's, best practices in determining degradation products,validation criteria for low level impurities, and much, much more.

Event: http://bit.ly/6XeJTa
Agenda: http://bit.ly/5RQW0X
Registration: http://bit.ly/8IEVtW

December 3-4, 2009
Hyatt Regency
Princeton, NJ


Join the event that is building industry best practices for assessing GTI's, specifically focused on process chemistry, stress testing, regulatory concerns and analytical chemistry

Make sure your investment in resources to address GTI concerns are worth it, stay up-to-date with industry trends for limits of genotoxic and potential genotoxic impurities.

Ensure patient safety, clinical initiation and drug approval by learning to detect, identify, and report Genotoxic Impurities

Nothing can replace face to face time with industry peers. This event fosters brainstorming and idea exchange through interactive formats

Hear Current industry thought leaders discuss the validity of the current TTC Limit, where do you stand on the debate? Is the level of conservatism in the TTC approach too high for your drug to be allowed into clinical development?

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Complimentary Webinar: Insights and Perspectives from the FDA Public Hearing on the Use of Social Media

Insights and Perspectives from the FDA Public Hearing on the Use of Social Media and Internet for Health-Related Communications

Date: Wednesday, December 9

Time: 12:00-1:00PM EST

Space is limited.
Reserve your Webinar seat now at:
https://www1.gotomeeting.com/register/668144112

Please mention priority code: P1506W2TWITTERBLOG

About the webinar:
The FDA Social Media and Internet Public Hearing November 12-13, 2009 posed many questions for the pharmaceutical and biotech industries. Hear impressions of the event in a live interview with Jonathan Richman, Director of Business Development, Bridge Worldwide (Hearing Speaker) and Mel Halkyard, Global eCapabilities Director, Eli Lilly (Hearing Attendee) .

What You Will Learn:

* Potential policy and regulatory actions from the FDA as a result of the hearing
* Major obstacles and challenges presented by the industry due to lack of guidance
* Solutions suggested by the industry to address current issues with internet and social media

About the Speakers:


About the webinar:
The FDA Social Media and Internet Public Hearing November 12-13, 2009 posed many questions for the pharmaceutical and biotech industries. Hear impressions of the event in a live interview with Jonathan Richman, Director of Business Development, Bridge Worldwide (Hearing Speaker) and Mel Halkyard, Global eCapabilities Director, Eli Lilly (Hearing Attendee) .

What You Will Learn:

* Potential policy and regulatory actions from the FDA as a result of the hearing
* Major obstacles and challenges presented by the industry due to lack of guidance
* Solutions suggested by the industry to address current issues with internet and social media

About the Speakers:


Jonathan Richman, Director of Business Development
Bridge Worldwide
Author, Dose of Digital

Jonathan provides strategic direction and leadership for our clients with a concentration in healthcare. A big part of Jonathan’s role is helping solve clients’ business challenges by finding the right solutions among all of the many choices available to today’s brand managers. From social networking to relationship marketing to channels such as mobile and complex back-end technology platforms, Jonathan helps clients sift through the clutter and hype to find the best options for their brands.

Prior to joining Bridge Worldwide, Jonathan worked at AstraZeneca Pharmaceuticals for more than 11 years, holding positions in sales, training, sales leadership, and marketing in diverse disease areas including cardiovascular, oncology, asthma, and neuroscience.

Jonathan is a well-known and widely regarded thought leader in pharma digital strategy. He is the author of the popular industry blog, Dose of Digital, which provides insights on digital marketing in pharma and healthcare. It is one of the most read blogs of its kind and is one of the top marketing blogs according to the AdAge Power 150 (currently ranked at #133). Jonathan is a regular speaker at major pharma marketing meetings and conventions, including eight engagements scheduled for the second half of 2009 alone. He was also recently invited to speak at the FDA public hearings on social media in pharma; he was one of only sixty people given the opportunity.

Jonathan earned his Bachelor of Science degree in Molecular Biology from Tulane University. He earned a Master of Business Administration with a marketing concentration from the University of Phoenix.


Mel Halkyard, Global e-Capabilities Director
Eli Lilly & Company

Mel has over 18 years of pharmaceutical industry experience. She has spent the majority of her career leading transformational efforts to build or improve sales and marketing capabilities at Lilly. She has developed and implemented brand strategies in the US operations as well as globally. Most recently, Mel has been responsible for accelerating the development of global e-capabilities at Lilly, most notably launching a Global e-Center of Excellence which has been charged with the governance of the e-channel, including social media.

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Covance Partners with RBM to Extend Biomarker Offering

According to this article in outsourcing-pharma.com Covance will outsource biomarker activities to Rules Based Medicine, which is a US based laboratory group. Demand for biomarker services and the use of biomarker analysis in clinical trials has increased dramatically, and so this couldn't come at a better time.

Before the deal took place Covance had also begun building biomarker capacity. Under the deal RBM will apply its multi-analyte profile (MAP) technologies to projects being carried out by Covance's customers.

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EMEA Guideline on the Limits of Genotoxic Impurities

We've got some great new documentation available over at the Genotoxic Impurities website!

Here are the new reports available:
EMEA Guideline on the Limits of Genotoxic Impurities
FDA-GTI Guidance for Industry
Q & A on the CHMP Guideline on the Limits of Genotoxic Impurities

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Innovation in Science and Technology: A Critical Path to Addressing Global Health Inequities

Innovation in Science and Technology: A Critical Path to Addressing Global
Health Inequities
by Yun-Ling Wong

Download this presentation of the work being done by the Bill and Melinda Gates Foundation in developing worlds. Learn how the foundation is giving access to vital medicine and vaccines to the in the most need.

This is the global drug delivery partnerships meeting place, focusing on bringing together professionals seeking the latest strategies, industry updates, and networking opportunities to help position your company for a successful partnership/collaboration. Join us today on LinkedIn or Follow us on Twitter!

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Web Seminar: Technology Showcase Webinar: Explore the latest Drug Delivery Advancements in Solid Dosage Forms through Glide's SDI® Delivery

Date: Wednesday, December 2, 2009
Time: 12:00 PM - 1:00 PM EST

Reserve your Webinar seat now at:
https://www1.gotomeeting.com/register/707185768
Mention priority code P1578W1TwitterBlog

Featured Speaker:
Charles Potter, CEO
Glide Pharma

About the Webinar:
Glide Pharma has developed the Glide SDI (Solid Dose Injector) for injecting drugs and vaccines in a solid dosage form, without the need for a needle. The technology offers many benefits, such as drug stability and controlled release, and is suitable for self-injection of drugs in a home environment. The Glide SDI is patent protected and in clinical trials has been preferred to an injection with a standard needle and syringe.

The seminar will give an overview of the Glide SDI, its benefits and pipeline of product opportunities. Data will be presented demonstrating the utility of the technology together with plans for the commercialization of the Glide SDI. In addition, an overview of the competitive landscape for injection technologies will be provided.

What you will learn:
• An introduction to the Glide Solid Dose Injector
• The benefits of injecting drugs in a solid dosage form
• The market opportunities for a differentiated drug delivery technology
• The competitive landscape for injection technologies

This is the global drug delivery partnerships meeting place, focusing on bringing together professionals seeking the latest strategies, industry updates, and networking opportunities to help position your company for a successful partnership/collaboration. Join us today on LinkedIn or Follow us on Twitter!

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WSJ: Bristol-Myers Squibb Announces Split-Off Of Mead Johnson

The Wall Street Journal reports that drug giant Bristol-Myers Squibb Co. said on Sunday it would split off its Mead Johnson Nutrition Co. business so that it can focus on its bio-pharmaceutical business.

Under the terms of the deal, New York-based Bristol, which has an 83% economic interest in Mead, will give Bristol shareholders roughly $1.11 in Mead shares for each $1 in Bristol shares they tender. The ratio will be determined by a 10% discount to the daily volume-weighted average prices of Bristol-Myers Squibb and Mead Johnson common shares over a three-day period in early December.

New York-based Bristol said the deal, which it expects will be accretive to earnings per share beginning in 2010, is part of its divestment strategy that would allow it to transition from a traditional drug company into a biopharmaceutical company.

For more information about this story, please click here.

Bristol-Myers Squibb Announces Split-Off Of Mead Johnson

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New Bubble Gum Type Adhesive For Enhancing Drug Delivery in the Stomach

This article in Science Daily discusses how the reason why insulin can not be swallowed is because it doesn't survive the trip through the digestive tract, and because of this Tejal A. Desai from the University of California is looking to design new ways to deliver drugs orally that would help their absorption in the gut.

Tejal, working closely with a Bay-area biotechnology company, has designed devices that resemble spiny beads filled with drugs. The spines on the beads are filled with silicon and are designed to form an adhesive that covers the cell lining in the gut. This way, the drugs have a better shot of diffusing into the bloodstream. Tejal Desai will present shortly in her findings, what other methods of oral drug delivery will we see in the future?

This is the global drug delivery partnerships meeting place, focusing on bringing together professionals seeking the latest strategies, industry updates, and networking opportunities to help position your company for a successful partnership/collaboration. Join us today on LinkedIn or Follow us on Twitter!

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Pfizer and Wyeth merger changes vaccine R&D structure

With the take over of Wyeth, vaccine research and development will be spread to other areas of the Pfizer and Wyeth facilities. There will be five major facilities looking to capture the research and development for the company including: Pearl River, NY, Cambridge, MA, La Jolla, CA, Groton, CT and Sandwich in the UK. Wyeth has been key in the vaccine development industry, which was appealing to Pfizer, as it's viewed as a steady revenue stream as developments allow scientists to find more way to prevent illnesses. Read more here.

This is the global drug delivery partnerships meeting place, focusing on bringing together professionals seeking the latest strategies, industry updates, and networking opportunities to help position your company for a successful partnership/collaboration. Join us today on LinkedIn or Follow us on Twitter!

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Glaxo Wins FDA Approval to Sell H1N1 Vaccine

NBC reports that Glaxo has won FDA approval to sell the popular H1N1 vaccine. The British company said on Tuesday the Food and Drug Administration had approved a modified version of its FluLaval seasonal flu vaccine containing the new H1N1 strain.

The green light clears the way for it to fill a order for 7.6 million doses from the U.S. government.

We, as always, would love to hear your thoughts.

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Investing in a small biotech

The Wall Street Journal's Venture Wire recently looked at what a corporate alliance could do for a small biotech company. In these times, it's important for a biotech to find a sponsor that aligns with its needs. These sponsors should both help provide the capital to advance the biotech's drugs and not compromise the value of the company. A key to being successful with the sponsor is to find someone within that company who will be your advocate, who also understands your technology. Read the full article here.

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Lilly Opens Biotech Center in San Diego

Eli Lilly and Company has opened a multi-faceted biotech center in San Diego aiming to discover and develop more biotechnology medications.

Laboratory Equipment reports that Lilly is moving its ImClone research headquarters (which specializes in developing cancer biologics) into a new biopharmaceutical research cluster in New York, and just one year after Lilly completed construction of its biotechnology R&D complex at its headquarters in Indianapolis.

"We're moving full speed ahead toward building a biotechnology powerhouse," says John Lechleiter, Lilly chairman/CEO. "The science, technology and talent at our new center in San Diego will help bring novel biotech medicines to patients faster and more efficiently, and reinforces Lilly's commitment and contributions to San Diego's burgeoning bioscience industry."

What do you think of Lilly's move out West? Will it be a step in the right direction for their bio offerings?

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Leverage your drug delivery with two webinars presented by DDP 2010

We're excited to deliver to you the most up to date information on drug delivery development . That's why we would like to extend this invitation to join us for the following COMPLIMENTARY upcoming webinars.

Glide SDI® – Injecting drugs and vaccines in a solid dosage form

Date: Wednesday, December 2, 2009
Time: 12:00 PM - 1:00 PM EST

Reserve your Webinar seat now at:
https://www1.gotomeeting.com/register/707185768
Mention priority code P1578W1TwitterBlog

Featured Speaker:
Charles Potter, CEO
Glide Pharma

About the Webinar:
Glide Pharma has developed the Glide SDI (Solid Dose Injector) for injecting drugs and vaccines in a solid dosage form, without the need for a needle. The technology offers many benefits, such as drug stability and controlled release, and is suitable for self-injection of drugs in a home environment. The Glide SDI is patent protected and in clinical trials has been preferred to an injection with a standard needle and syringe.

The seminar will give an overview of the Glide SDI, its benefits and pipeline of product opportunities. Data will be presented demonstrating the utility of the technology together with plans for the commercialization of the Glide SDI. In addition, an overview of the competitive landscape for injection technologies will be provided.

What you will learn:
• An introduction to the Glide Solid Dose Injector
• The benefits of injecting drugs in a solid dosage form
• The market opportunities for a differentiated drug delivery technology
• The competitive landscape for injection technologies

Leveraging Health: Driving Dividends through Value-Based Designs

Date: Thursday, December 3, 2009
Time: 2:00 PM - 3:00 PM EST

Reserve your Webinar seat now at:
https://www1.gotomeeting.com/register/215966568
Mention priority code P1578W2BlogTwitter

Featured Speaker:
Cyndy Nayer
Co-Founder and CEO
Center for Health Value Innovation

About the web seminar:
No matter how the reform legislation comes to pass, the ultimate outcomes must focus on health, productivity and economic improvement for the communities we serve. The Center for Health Value Innovation, through a grant from Takeda Pharmaceuticals, has prepared an overview of the levers of value-based design and a coordinated decision matrix for companies to consider as they revise their health plans for 2010 and beyond.

Through a suite of levers focused on prevention and wellness, chronic care management and care delivery, plan sponsors of all sizes, self-insured and fully-insured, can identify plan designs, incentives and disincentives that will shift populations to better health behaviors. How the plan sponsor chooses, and what questions are asked, is detailed in a forthcoming report. This webinar will frame the decisions and timelines for dividends in their companies and their communities.

What you will learn:
• What levers will drive better engagement of the consumer, the plan sponsor and the delivery system and result in improved outcomes?
• Where do we start? What if we are fully insured and cannot get integrated data—what do we do? What if we are a public entity, or working with unions, or operating under legislative barriers—is value based design still possible?
• What are reasonable expectations? What are the timelines for achievement and key messages for the C-Suite?
• How do we work with our vendors and health plans to promote, engage, and measure the outcomes?

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