Wednesday, October 29, 2014

Text of Letter by Ellen Feigal on Her Resignation

Here is a copy of the letter that Ellen Feigal sent to her co-workers at the California stem cell agency earlier this week, announcing her departure.
"To my colleagues at CIRM:
"With some regret and after careful consideration, I have submitted my resignation as Senior Vice President of Research and Development at CIRM, effective November 10, 2014, in order to pursue other opportunities.
"It’s been an amazing four years.  I am proud of what’s been accomplished under my leadership for the research and development programs, none of which would have been possible without all of the contributions you each made, and was built on the foundation of science, education, training, basic biology and early translational programs of the previous 5 years. 
"The list of our accomplishments is indeed long, but let me highlight just a few.  When I began there were no operational development programs, and to date we have awarded over 27 disease and strategic partnership teams, 18 to move into the clinic, 8 already actively enrolling or ready to enroll patients, with a total of 10 expected to reach the clinic by the end of this year.
"In addition, there are more than 60 preclinical projects in the pipeline. I’m especially proud that our efforts have led to clinical trials reaching a broad range of patients with serious medical conditions including diabetes, spinal cord injury, blinding eye diseases, heart failure, cancer, sickle cell disease, beta-thalassemia, and HIV/AIDS.  With funding just approved Thursday for the first alpha stem cell clinics, CIRM and our investigators are well-positioned to reach the next level of progress – it will be an exciting time.

"I want to particularly thank the development team for the tremendous work of the hands-on management of the development projects – disease teams and strategic partnerships; the grants management team for handling the financial and business aspects of the projects; and our business development team for forging the substantive industry partnerships that will facilitate moving these projects towards commercialization.  Special thanks to our grants review officers for their expert handling of concepts and RFA solicitations and external peer review, in close collaboration with our science officers, and administrative support.
"I am proud to have created CIRM’s first external Clinical Development Advisory Panels.  These panels of multidisciplinary advisors served as a resource to our funded disease and strategic partnership team investigators in areas of preclinical, manufacturing, disease, stem cell biology, regulatory, clinical, and commercialization, to better position the disease and strategic partnership teams for success.
"I want to particularly thank the contracting officers and the legal office for their contributions to vetting the external advisors and ensuring all was done with due regard for COI and CIRM regulations; to science officers on the development team for the extensive discussions they held with the CIRM funded investigators to prepare the questions and issues to address --  your in depth knowledge of the projects and working relationships with the investigators greatly benefited the projects’ ability to progress. I forged a strong working relationship between CIRM and the FDA.  This included twice yearly webinars and yearly roundtables involving FDA, industry and academia to tackle regulatory issues on the product development pathway, and included CIRM scientific team input and participation in elucidating the topics selected for discussion; in addition, it included organizing in 2013, the first meeting of international regulatory authorities from the US, Japan, Europe, United Kingdom and Canada, and investigators from industry and academia, to discuss the regulatory pathways for stem cell treatments. Once again, the contracting office and administrative program support was instrumental in ensuring the webinars, roundtables and workshops proceeded smoothly, and the communications team facilitated the rapid dissemination of these sessions and white papers through CIRM’s public website.
"Over this time period, our repertoire of communications has steadily strengthened due to the direct efforts of our communications team – I have enjoyed working with the group in this critical component of CIRM’s mission.

"Our basic biology and early preclinical translational teams harnessed the engine of discovery to help increase our scientific understanding of diseases, stem cell biology, and how stem cells could function as tools for elucidating disease pathogenesis, target identification and drug discovery and as cellular candidates to fill the pipeline for the development projects – I want to extend my sincere thanks to the teams in their expert management of the CIRM funded investigator projects in these endeavors.

"We have invested in the future creating the next generation of researchers with our training programs – thanks again to the hard work of the teams managing these CIRM funded programs.
"Together – and by this I mean every single one of you – administrative and HR support teams, communications team, grants review officers, basic biology team, early translation team, development team, grants management, contracting officers, legal team, business development officers, financial officers, information technology team, and the leadership team of CIRM - I think we have accomplished a great deal. While there is much yet to be done, this is a good time for me to pursue other opportunities.  I am confident you will all continue to build on what has been accomplished.  I look forward to learning about CIRM’s successes in the future.' 

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