BioPharma Today

Eliminating The Gap Between Innovation & Resources

The global healthcare market is broken and a key issue is the gap between innovators who need money and big players who have money but need innovation.

The Global Leaders is proud to host its 2nd annual healthcare forum on Tuesday, January 10th in San Francisco at the historic Marines’ Memorial Club. The theme for the 2012 event is “Eliminating the Gap Between Innovation & Resources.” The conference will focus on connecting CEOs and other senior executives with institutional investors and business development executives who can help bring the pieces together in a rapidly changing landscape.

• Matching innovation with capital
• How to mitigate risks; both financial and regulatory
• The future of healthcare in a changing global market

For a short video on the event and review the agenda at http://www.tgleaders-healthcare.blogspot.com/.  

Registration for the forum is at: http://tglhealthcaresymposium.eventbrite.com/?ref=ecount.

China: The New Land of Opportunity for Biopharma Companies?

The pharmaceutical and life sciences landscape is changing fast in China. There are close to 1,000 bio-related companies in China, and half were established in the last five years or so. Citi expects China’s pharmaceutical market to grow from its current level of $40 billion to $100 billion by 2015 and to $200 billion by 2020, which will make it the second largest in the world, passing Japan along the way.

Have You Joined Our LinkedIn Group Yet?

Did you know BioPharma Today has a LinkedIn group? To join, please visit: http://linkd.in/peGL7E. We hope to see you there!

Celebrating 30 years Of Biotechnology Innovation: From Diamond v. Chakrabarty To Today

This event co-sponsored by the U.S. Patent and Trademark Office, The Biotechnology Industry Organization and The Biojudiciary Project will celebrate the 30th anniversary of the issuance of the patent from the Supreme Court case, Diamond v. Chakrabarty, which held that subject matter derived from nature is eligible for patenting.

Last Chance To Register - The Hottest Asia Regulatory Issues For 2011

In this Dec. 16 "virtual" conference sponsored by PharmAsia News, Asia experts will discuss some of the hottest regulatory topics for 2011, including China healthcare reform, India IP protection, how to protect your supply chain, and clinical trial harmonization. Plus, learn the latest market trends and data from China, India and elsewhere in Asia from IMS.

New 2010 Report from The Rose Sheet

2010 Report On Global Efforts To Advance Cosmetics Regulation.

No, you're not paranoid. Regulators and legislators really are out to get you.

Fortunately, every cosmetics executive can be thoroughly prepared and armed against the coming onslaught of new safety regulations by reading "The Rose Sheet's" in-depth Special Analysis, 2010 Report On Global Efforts To Advance Cosmetics Regulation.

Just $199! Get this business-critical Special Report HERE.

China's Health Reform Will Dramatically Expand Healthcare Access

Representing nearly two-thirds of the world's population, this diverse region is expected to play a much larger role in the coming years to bringing innovative products to market.

Western biopharma companies are quickly realizing that Asia is a flourishing new market for their existing products and an inexpensive location to conduct clinical trials and manufacture them. Many companies are trying to gauge the short and long term benefits on the industry. 

Risk Evaluation and Mitigation Strategies Virtual Conference

Within three years the FDA has requested and approved 161 REMS. More than ninety REMS have been modified or approved in 2010 alone. Of those ninety REMS, thirty six included more elements than just the medication guide. If this year’s rate continued, five years from now, there would be more than 600 approved REMS. If the FDA required you to create a REMS, are you prepared?

Learn more about what this full day virtual conference will offer you!

Led by conference Chair Michael McCaughan, editor of The RPM Report and Founding Member of Prevision Policy LLC, this virtual conference will address the evolution of REMS and key challenges currently facing the industry. Through in-depth case studies you will discover lessons learned by pharmaceutical companies that have worked with the FDA to develop and assess their Risk Evaluation and Mitigating Strategies. 

By attending this virtual conference you will learn what requirements you must meet to ensure that your REMS are effective and satisfy FDA expectations. You will also get an exclusive opportunity to hear The RPM Report’s latest, just-published data on the trends in FDA’s use of the new Risk Evaluation & Mitigation Strategies.

Risk Evaluation and Mitigation Strategies Virtual Conference

December 15, 2010 * 10:00 AM EDT - 4:15 PM EDT

REGISTER TODAY!

Living in a Bipolar World Implications of FDA/CMS Collaboration from The RPM Report

If FDA approves your product ... is CMS on the same page?

If you think the answer is "yes," you haven't been paying attention. The truth is, the two agencies' agendas are almost entirely separate, and sponsors take either of them for granted at their peril.

But now an exclusive new report, Living in a Bipolar World: Implications of FDA/CMS Collaboration from The RPM Report, untangles the complicated threads of this looming problem and tells you exactly what you need to know to guide your product through the maze.

Just $399! Get this business-critical Special Report HERE.

IND Safety Reporting Requirements: Long Awaited Final Rule and Draft Guidance

New Drug Safety Reporting – Final Rule Goes Into Effect Soon! Are You Ready?
 
The final rule “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,” published in September, will go into effect in March 2011. The corresponding draft guidance, also published in September, outlines the new safety reporting requirements.