Avid Bioservices Inc (CDMO)

[biopharm]

TransCelerate BioPharma Inc. Releases First Update on Risk-Based Monitoring of Clinical Trials Initiative, Yields Key Lessons and Training Materials

Jan 30, 2014

"Through piloting TransCelerate's RBM methodology, framework and tools, we have sought to manage clinical trial risks through identification, categorization and appropriate mitigation," said Rehbar Tayyabkhan, Executive Director at Bristol-Myers Squibb and RBM Project Lead for TransCelerate. "We have learned important lessons from our member companies and regulatory agencies on tools like the RACT (Risk Assessment and Categorization Tool), which will help companies identify and plan their risk mitigation strategies, and a focus group has been tasked with assessing the feedback and implementing changes to the tool. We also have received valuable feedback on our pilot study monitoring plans."

TransCelerate evolved from discussions at various forums for executive R&D leadership to debate current issues facing the industry, and examine solutions for addressing agreed-upon common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Medgenics, Inc., Shionogi & Co., Ltd. and UCB.

http://www.prnewswire.com/news-releases/transcelerate-biopharma-inc-releases-first-update-on-risk-based-monitoring-of-clinical-trials-initiative-yields-key-lessons-and-training-materials-242747271.html

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AbbVie ( oh soo close... may have been for the best )
AstraZeneca
Boehringer Ingelheim (partner of Avid)
Bristol-Myers Squibb (we know the story)
Eli Lilly and Company
GlaxoSmithKline (genecloner left the G.. )
Johnson & Johnson (subsidiary Janssen...)
Pfizer (Sierras favorite..where did Amy Schulman go? )
Roche Group ( many ex-Genentech at Peregrine..Garnick.etc)
Sanofi (docetaxel)

Additional members that have joined since the inception of TransCelerate include:

Allergan, Inc. (Brigitte Phan patent attorney..other PPHM ties)
Astellas Pharma Inc.
Biogen Idec
Cubist Pharmaceuticals
EMD Serono, Inc. (Merck KGaA, Darmstadt, Germany)
Forest Research Institute (Forest Laboratories, Inc.)
Medgenics, Inc.
Shionogi & Co., Ltd.
UCB (Belgium company, US headquarters outside Atlanta, GA)

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Now I know its controversial on which way Peregrine maximizes shareholder value, but a "hockey stick" enrollment could develop if Transcelerate realizes that "Bavituximab" targets a universal biomarker that could be used across the entire spectrum of oncology and beyond.... so who knows if anything develops here. Peregrine, being the smallest of all members, is welcomed into Transcelerate and only members of Transcelerate are able to combine their drugs with Bavituximab. This is one way that Transcelerate has a future...and could one way that the FDA gains public recognition... well should say public approval would increase.

I think its interesting that "Risk Based Monitoring" is discussed here and a BMS exec is part of it... and some form of remote monitoring was mentioned that would be part of "SunRise" Phase III NSCLC.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=88920042&txt2find=transcelerate

I'd also be just fine with Peregrine announcing a partnership with CALICO and $300 Million upfront cash to Peregrine to advance other Bavi clinical trials.