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

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!

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!

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

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!

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!

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.

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.

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?

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?

Nabi BioPharm Begins Study on Nicotine Vaccine

Nabi Biopharmaceuticals announced that it is participating in an investigator initiated Phase IIb study to evaluate the safety and efficacy of NicVAX(R) (Nicotine Conjugate Vaccine) when co-administered with varenicline as an aid to smoking
cessation and relapse prevention. This study will be conducted by The Research
School CAPHRI of the Maastricht University Medical Center in Maastricht, The
Netherlands and will be funded primarily by The Netherlands Organization for
Health Research and Development and Maastricht University with Nabi providing
some additional support.

"In our proof-of-concept trial, NicVAX demonstrated that high levels of
anti-nicotine antibody in response to NicVAX immunization increases the ability
of smokers to quit smoking and remain abstinent," said Dr. Raafat Fahim,
President and Chief Executive Officer of Nabi Biopharmaceuticals.

For more on NicVax, please click here.

CCPM and Others Urge Congress to Fix or Drop Biologics Provisions

According to this post on Reuters many organizations including the CCPM, several hundred many Americans, experts from the medical and researhc community, economists, and thought leaders have joined together appealing to Congress to fix the 12 year market exclusivity for biologics or drop it altogether.

There has been an on-going battle on this topic, and Annette Guarisco, CCPM Chairman mentions:

"Finding the right balance between incentives for innovation and timely access
to care means that Congress needs to fix or drop the current biogenerics provision. We call on Congress to take this opportunity to truly constrain costs to benefit all health care purchasers, and override the lobby of the big pharmaceutical and biotech companies."

Perhaps now that the The Coalition for a Competitive Pharmaceutical Market has joined the fight Congress will begin to listen.

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.

Should the FDA be allowed to regulate e-cigarettes?

The LA Times looks at the current debate over e-cigarettes. This device allows smokers to get their nicotine fix through a small, smokeless electronic cigarette shaped device. The US FDA believes that they should be able to regulate them, as it can prove as a new gateway device to target teenagers who could be turned on to cigarettes by their use.

What do you think about this drug deliver device? While it may help millions stop smoking, it may introduce millions more to a new way of consuming nicotine. There are other things, such as lollypops, that contain nicotine, that are not regulated by the FDA, so why should this smoke-free device face FDA regulation?

Complimentary Webinar Archive Available: Overcoming the Challenges of Government Pricing, Compliance Reporting and Medicaid Rebate Processing

About the web seminar:
All pharmaceutical product manufacturers who sell to various agencies of the federal government and/or who participate in Medicaid, 340B, Medicare or other public sector reimbursement programs face significant requirements and challenges with respect to their government-mandated pricing calculations and compliance reporting processes. Huge penalties and fines can be levied for miscalculating or incorrectly applying the various government price types to government-contracted sales and/or for compliance reporting mistakes.

The Seminar will address the complexities and challenges associated with automating Government Pricing and Medicaid Rebate system(s) as well as the pros and cons of using a packaged-software approach versus a custom-development approach. An overview of a leading-edge enterprise solution, developed as a fully-integrated component of the SAP® Enterprise Resource Planning (ERP) System, will be presented, accompanied by a live software demonstration and followed by a Question & Answer discussion of the issues.

What you will learn:
• An appreciation of the historical and legal background and context for the government-mandated price calculations and compliance reporting requirements;
• An understanding of the various price types that must be calculated, used in sales transaction processing and reported under each corresponding government program;
• Why automating and managing these processes using a packaged solution, based upon a fully-integrated enterprise architecture, is the lowest risk and lowest Total Cost of Ownership (TCO) approach;

About the speaker:

Sanjay Shah, C.P.A., is the President/CEO and Chief Solution Architect of Vistex, Inc., a global SAP Software Solution Partner.

Prior to founding Vistex, Mr. Shah spent several years as a Platinum Consultant in SAP America’s Professional Services Organization and in SAP AG’s Product Development Organization. That experience provided him with a comprehensive and unique understanding of the functionality gaps in SAP’s “core” offering as well as SAP’s product development strategy. Mr. Shah also worked in finance/accounting management at a major global manufacturing company.

Complimentary Archived Recording

https://www1.gotomeeting.com/register/286708561

Should the FDA be sharing more about clinical trials?

According to the LA Times, the FDA could be providing more information about approved drugs with doctors and the public. While most of the information doctors use to prescribe medicine and information patients use to learn about the medicine, there's a lot of information that is left out about the drugs. The article points out a few cases in which the FDA doesn't share some of the road bumps that occurred in Phase III clinical trials, such as the drug being ineffective in some of the population.

What do you think? I think that the FDA should share all of the information they possibly can on a drug, and how the drug was accepted by different people's systems. If a drug barley passed the FDA approval, they should be required to share that too, as it could help doctors when prescribing it to individuals. Read the full article here.

Biopharm Regulatory Reform Summit

Biopharm Regulatory Reform Summit

December 2-3, 2009 - Washington, DC

Impending legislation coupled with new FDA initiatives, leave many companies wondering what to expect as we head into 2010. Biotechnology and Pharmaceutical corporate decision-makers are seeking guidance on what they can do now to protect their business model in the short term and ensure its sustainability in the long term. The BioPharm Regulatory Reform Summit, held in Washington D.C. on December 2nd & 3rd, brings together the FDA, the Biotechnology Industry Organization, the Agency for Healthcare Research and Quality and other senior industry executives to create a strategic action plan for 2010 to effectively respond to healthcare reform and the changing political and economic landscape.

Event Site: http://bit.ly/4EUQd0
Brochure: http://bit.ly/16q73f
Registration: http://bit.ly/2BOKUb

PanThera Biopharma wins $1.6 million contract for botulism antidote research

Honolulu Advertiser reports today that The Department of Defense has been awarded a one-year, $1.6 million contract to Honolulu-based PanThera Biopharma for research into a small molecule antidote to treat botulism, the company announced today.
Advertisement

Medical countermeasures against botulism are biodefense priorities for protecting both military and civilian populations against bioterrorism, PanThera said on its Web site.

PanThera said its objective is to create a medical solution that is affordable, easy to use and store for stockpile.

Merck Extends Galapagos Discovery Deal

According to this article in Fierce Biotech Merck has decided to extend its research collaboration with Galapagos. The agreement earlier this year called for Galapagos to be responsible for the discovery and development of small molecule candidate drugs for atherosclerosis therapies. This extension shows Merck's commitment to fighting both cardiovascular and metabolic diseases. Read the full article here.

Mark McClellan, Carolyn Clancy, and Jim Greenwood to Keynote

Impending legislation coupled with new FDA initiatives, leave many companies wondering what to expect as we head into 2010. Join the Biopharm Regulatory Reform Summit as Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA discusses the challenges in establishing a regulatory pathway for biosimilars. Quality, patient safety, and efficacy are all primary issues the FDA must focus upon in the review and approvals for these complex biologics. Dr. Kozlowski addresses these issues in addition to comparative effectiveness and factors to consider for drug development plans for products in the pipeline. Bring home regulatory insights to challenges with defining “biosimilars” and their scope, biosimilars’ regulatory pathway, and the latest on comparative effectiveness.

Don’t miss the keynote presentations from Mark McClellan, Senior Fellow, Director of the Engleberg Center for Healthcare Reform, Carolyn Clancy, MD, Director, AHRQ, and Jim Greenwood, CEO, BIO.

Join the Meet and Greet session with Jacquelyn White, Director, Office of Strategic Operations and Regulatory Affairs, CMS

In an era of personalized medicine, IIR’s Biopharm Regulatory Reform Summit provides a unique opportunity to interact with industry thought leaders focusing exclusively on the true downstream effects of reform on how biopharm does business. Join senior leadership for two days to create actionable strategies to respond to reform, protect profitability, and deliver patient driven care for pharmaceutical, biotech and medical device executives.

2009 Faculty Highlights
• Dr. Mark B. McClellan, Senior Fellow, Director of the ENGELBERG CENTER FOR HEALTHCARE REFORM
• Carolyn Clancy, MD, Director, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
• Jim Greenwood, CEO, BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO)
• Joseph Antos, Health Adviser to the Congressional Budget Office, AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH
• D. Bruce Burlington, MD, Pharmaceutical Product Development and Regulatory Affairs, Independent Consultant, former Executive Vice President Business Practices and Compliance, WYETH
• Jane Galvin, Managing Director, Regulatory Affairs, BLUE CROSS BLUE SHIELD (BCBS)
• Julie K. Letwat, JD, MPH, Government and External Affairs, TAKEDA PHARMACEUTICALS AMERICA
• Amy Miller, PhD, Director, Public Policy, PERSONALIZED MEDICINE COALITION
• Les Paul, MD, Vice President, Clinical and Scientific Affairs, NATIONAL PHARMACEUTICAL COUNCIL (NPC)
• Ian D. Spatz, Principal, ROCK CREEK POLICY GROUP and Senior Advisor, MANNATT HEALTH SOLUTIONS, formerly, Vice President, Global Health Policy, MERCK
• Dan Todd, Executive Director, Health Policy, EMD SERONO
• Myrl Weinberg, President, NATIONAL HEALTH COUNCIL
• Jacquelyn White, Director, OFFICE OF STRATEGIC OPERATIONS AND REGULATORY AFFAIRS, CMS

3M opens new Drug Delivery Plant in Singapore

3M, who is looking to capitalize on the growing amount of biomedical research taking place in Asia, has opened their first drug delivery R&D facility in Singapore. They're looking to contribute to the biomedical research already going on in the region, as well as partner with biotech companies who they can work with to leverage their worldwide connections. Read the full article 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!