I.

PROJECT DESCRIPTION
A. Problem to Be Addressed The California Institute for Regenerative Medicine (CIRM) seeks a publisher for an online, open-access journal focusing on translational aspects of stem cell research in response to insufficient and noncohesive coverage by scientific research journals of translational science in the fields of: stem cell science, stem cell-based regenerative medicine and tissue engineering, stem cell-based predictive toxicology, and cancer stem cell investigation. CIRM will subsidize the start-up phase of such an undertaking by a proven and established publisher offering a business plan that would allow the subsidy to be phased out within three years or less. B. Goals and Objectives CIRM believes that translational science, moving discoveries from the laboratory to the clinic, as it relates to stem cell therapies and regenerative medicine, will have many unique aspects not reflected in other avenues to therapeutic development and will likely have a smaller presence in existing research journals. Creating an open-access, peer-reviewed journal dedicated to the making these issues a priority will foster the acceleration of the entire field by allowing knowledge to be aggregated and shared more readily and by encouraging collaborations between stem cell biologists, clinicians and engineers. C. Scope of Services CIRM will subsidize startup costs for publication of an online journal focusing on translational aspects of: stem cell science, stem cell-based regenerative medicine and tissue engineering, stem cell-based predictive toxicology, and cancer stem cell investigation. The publisher will solicit, review and publish important manuscripts in the field, and also provide for rapid review and dissemination of negative data. There should also be provision for CIRM, with agreement from the editors, to provide periodic short articles on translational stem cell research. Editorial decisions shall be completely independent from CIRM. The editorial board and reviewers need to be independent from CIRM and from the publisher. The editorial board should be diverse with leading experts from stem cell research, clinical translation and engineering. The business plan must show an ability to be self-sustaining within three years via advertising, page charges, or other means. (If that business plan requires that the online journal be supplemented with a paid print version, CIRM will consider including that in the contact). The online journal’s first issue date should be within six months of the commencement of this contract.

II. PROPOSAL
A. Qualifications and Experience Discuss how your experience demonstrates your ability to successfully complete the Scope of Services. Describe your experience publishing peer-reviewed and/or online journals. Established in 1983, AlphaMed Press is the independent publisher of two international peer-reviewed journals published monthly: STEM CELLS® (entering its 29th year), and The Oncologist® (entering its 16th year). STEM CELLS is a premier publication devoted to the fast-paced and ever-changing field of stem and progenitor cell biology.

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The FDA approval of the first stem cell clinical trial of a therapy derived from human embryonic stem cells (hESC) offers a glimpse of the possible effectiveness of a technology that has been hailed for its medical promise but also one embroiled in political and ethical controversy. The potential of stem cells therapies and regenerative medicine is both provocative and unique, offering the distinct possibility of eventually repairing or replacing tissues damaged from disease, including certain cancers. A highly regarded journal directed and devoted to the development of translational medicine for stem cells will foster the proper growth and ethical development of this field. Recognizing this need, AlphaMed Press is poised to lead the way for STEM CELLS Translational Medicine to fill the gap in the existing stem cells journal spectrum. By helping speed expertly executed translations of emerging laboratory discoveries into legitimate clinical trials and bedside application, STEM CELLS Translational Medicine’s ultimate mission is to improve patient outcomes. AlphaMed Press has both a proven history of publishing high-impact articles, as well as access to and excellent working relationships with world-renowned stem cells experts. Our reviewer data base and manuscript review process is already in place, for a quick start of peer review and publication. For our STEM CELLS journal alone, our peer-review team processes over 1,300 manuscripts a year, with a submission to final decision time averaging 22 days. Throughout annual increases in submissions, the Journal has maintained its selectivity, earning an impact factor of 7.747 to place it in the top 3% of all high-impact peer-reviewed journals. AlphaMed Press can leverage and incorporate STEM CELLS Translational Medicine’s needs with its existing workflow proficiency with Manuscript Central for peerreview processing, Cadmus Communications for publication, and HighWire Press as its online host. B. Qualification of Staff Identify the staff that will be providing the services required by the proposal, including years and type of experience. By working closely together, the two journals will derive synergy from each other. STEM CELLS Editor and Associate Editors are listed here. Editor: Miodrag Stojković, PhD SPEBO Medical, Leskovac Human Genetics, Medical Faculty, University of Kragujevac, Serbia Dr. Stojković led the team that first announced derivation of pluripotent hESC from non-viable early human embryos that had stopped their cleavage. First published in STEM CELLS, these cells are now being used to better understand and fight debilitating diseases. He is also involved in derivation of cells with neural characteristics obtained from adult stem cells (ependymal) or hESC to treat spinal cord injury. Associate Editors: Majlinda Lako, PhD Newcastle University, UK Institute of Human Genetics Dr. Lako, Professor in Stem Cells Sciences at the Institute of Human Genetics, Newcastle University, focuses on understanding the critical pathways and factors that are involved in the maintenance of pluripotency, self-renewal, and differentiation of hESC. She is also involved in studies examining the derivation of hematopoietic progenitors from hESC and in studies of retinal and limbal stem cell characterization, differentiation, and transplantation and is a member of the International Stem Cell Initiative, a global collaborative effort to systematically characterize key features, genetics, and growth conditions of the many different hESC lines available worldwide. Her team implanted the first human ocular limbal stem cells. Mark Pittenger, PhD Johns Hopkins School of Medicine Pearl Lifesciences Partners Dr. Pittenger is Adjunct Assistant Professor at Johns Hopkins University and a consultant to businesses researching cellular therapies for regenerative medicine. He was previously Vice President of Research at Osiris Therapeutics, a leader in adult stem cell therapy, using MSC to

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repair various types of tissue. A cell biologist with a strong interest in the regulation of gene expression, regulatory pathways, cancer biology, and structural biology, his research on MSC includes their isolation and characterization, imaging, trafficking, differentiation, and engraftment, especially in models of myocardial infarction. Jan Nolta, PhD Stem Cell Research Program, University of California at Davis School of Medicine University of California at Davis Institute for Regenerative Cures Dr. Nolta, Director of the Stem Cell program at UC Davis, examines the recruitment of human adult and ESC to areas of tissue damage in immune deficient mice, with the aim of developing improved therapies for treating disease. She was a member of the University of Southern California team that succeeded in the first gene therapy trial to treat newborns for ADA deficiency; it shaped her career in translational medicine. Since then, she has specialized in translational, or bench-to-bedside science, and has been involved in 18 [change to many] clinical trials of gene and cell therapy. STEM CELLS Translational Medicine Editor: AlphaMed Press has a commitment from esteemed scientist-clinician Dr. Anthony Atala whose experience is reflected in a list of publications covering multidisciplinary aspects of basic stem cell research and translational applications of stem cells. Anthony Atala, MD Director, Wake Forest Institute for Regenerative Medicine Chair, Department of Urology, Wake Forest School of Medicine Dr. Atala heads the Institute of Regenerative Medicine, the world's largest such facility, where he and his staff are currently growing over 20 different tissues, including heart valves, kidneys, skin and muscle. With more than 20 years of experience, his main research focus is growing human tissues and organs to replace those damaged by disease or defect. He led the team that developed the first lab-grown organ to be implanted into a human. This well-respected physician is still a practicing surgeon and a long-standing member of the STEM CELLS Editorial Board. Associate Editor Candidates: Three experts in translational and regenerative medicine which use different types of growth systems and stem cells including biology and behavior of cancer stem cells and related drugs-models will be selected to join Dr. Atala in the leadership of STEM CELLS Translational Medicine. Hal Broxmeyer, PhD Scientific Director, Walther Oncology Center, Indiana University School of Medicine Leader, Hematopoiesis, Hematological Malignancies and Immunology Program, Simon Cancer Center, Indiana University School of Medicine Dr. Broxmeyer’s research interests include hematopoiesis in the context of normal and abnormal cell regulation as assessed in vitro and in vivo at the level of proliferation/self-renewal, differentiation, apoptosis and homing/migration of hematopoietic stem and progenitor cells. He is currently President of the American Society for Hematology and serves on the STEM CELLS Editorial Board. Doug Losordo, MD Director, Feinberg Cardiovascular Research Institute, Northwestern University Director, Program in Cardiovascular Regenerative Medicine, Feinberg School of Medicine, Northwestern University Dr. Losordo’s research focuses on angiogenesis/vasculogenesis; progenitor/adult stem cells; tissue repair/regeneration; vascular biology; and the effects of estradiol on vascular tissue. With more than 25 years of medical experience, he is currently Associate Editor of Circulation Research and serves on the editorial boards of Circulation, Vascular Medicine, and STEM CELLS.

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David Scadden, MD Director, Center for Regenerative Medicine, Massachusetts General Hospital Co-Director, Harvard Stem Cell Institute, Harvard University Dr. Scadden focuses on the regulation of the hematopoietic stem cell by its microenvironment or niche. Using a combination of genetics, imaging and pharmacology, the laboratory has defined key components of the niche and how stem cells traffic to and engraft the bone marrow. It has demonstrated methods of altering niche interactions that have resulted in two clinical trials in the use of stem cells to treat hematologic malignancies. He brings more than 30 years of experience and has served on the STEM CELLS Editorial Board. Editorial Board Candidates: Scientists with backgrounds in deciphering mechanisms of cancer stem cells, pluri/multipotency and targeted differentiation of stem cells, scale-up and engineering, trafficking, engraftment and assaying effects of stem cells under in vitro and in vivo conditions for the benefits of regenerative medicine and drug development will be solicited to served. Many who serve on the STEM CELLS Editorial Board will also be invited to serve on STEM CELLS Translational Medicine Board. Sajjad Ahmad, PhD Academic Clinical Lecturer, Institute of Human Genetics, Newcastle University Dr. Ahmad is a trained Ophthalmologist with a research interest in corneal epithelial stem cell biology, corneal tissue engineering and their clinical applications. Over the past six years he has developed an animal-free culture technique for corneal epithelial stem cells which have been used to successfully treat patients who are deficient in them. He has expertise in good manufacturing practice for corneal epithelial stem cells and in the translation of stem cell therapies and developed a method for culturing limbal stem cells. Victor Dzau, MD Chancellor, Health Affairs, Duke University President and CEO, Duke University health Systems Director, Molecular and Genomic Vascular Biology, Duke University Medical School Dr. Dzau’s laboratory studies the molecular and genetic mechanisms of cardiovascular disease and applied genomic and gene transfer technologies to develop novel therapeutic approaches, resulting in two of his discoveries being evaluated in clinical trials. He served as editor in chief for Physiological Genomics and Journal of Vascular Medicine and Biology and is a member of the STEM CELLS Editorial Board. Stanton L. Gerson, MD Director, Case Western Reserve Comprehensive Cancer Center and Ireland Cancer Center, University Hospitals of Cleveland Dr. Gerson’s research interests include stem cells and DNA repair, generating seven patents in gene therapy and cancer drug development that have been licensed to three companies. He is a member of the STEM CELLS Editorial Board. Joshua M. Hare, MD Director, Interdisciplinary Stem Cell Institute, Miller School of Medicine, University of Miami Chief, Division of Cardiology, Miller School of Medicine, University of Miami Dr. Hare is a pioneer in the use of stem cell therapy to repair heart damage. He conducted the first human clinical trial to test stem-cell based treatment for heart attack patients. Robert Lanza, MD Chief Scientific Officer, Advanced Cell Technology (ACT) Dr. Lanza’s research interests include embryonic stem cells and their derivatives. He was part of the team that cloned the world's first early stage human embryos for the purpose of generating embryonic stem  cells. Recently, Lanza was part of a team that reported a safe method for generating induced pluripotent stem (iPS) cells, creating them from skin cells by direct delivery of proteins, thus eliminating the harmful risks associated with genetic and chemical manipulation.

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Jane S. Lebkowski, PhD Senior Vice President, Chief Scientific Officer, Regenerative Medicine, Geron Corporation Dr. Lebkowski leads a human embryonic stem cell program and is responsible for all of its research, preclinical development, product development, manufacturing and clinical development activities. She has also coordinated preclinical investigations of gene-therapy approaches for treatment of cancer, cardiovascular disease and nervous system disorders, and directed vector formulations and delivery development. She has also served on the STEM CELLS Editorial Board. Nicolas L’Heureux, PhD Co-Director of Cell and Regenerative Medicine, Saint Joseph’s Translational Research Institute Chief Science Officer, Cytograft Tissue Engineering Dr. L’Heureux’s research interests are concentrated in cell-based therapies and personalized medicine in the vascular field but also include pediatrics, neuroregeneration, orthopedics and vascular networks. He has focused most of his efforts on developing autologous small diameter blood vessels and his team has led to the first and only clinical use of tissue-engineered blood vessels under arterial pressure. Paolo Macchiarini, MD, PhD Head and Chairman, Hospital Clínic de Barcelona, University of Barcelona Professor of Surgery, University of Barcelona in Spain Professor of Surgery, Hannover Medical School Dr. Macchiarini's research interests include extended surgery for lung, esophageal, and mediastinal tumors; adult and pediatric tracheal surgery; lung and heart-lung transplantation; pulmonary endarterectomy; (bio)artificial lung; and experimental research, education, training. Dr. Macchiarini performed the first adult stem cell grown trachea transplant in 2008. The first successful operation on a child followed in March 2010. Teruo Okano, PhD Professor and Director, Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University Dr. Okano’s research interests involve the use of intelligent biomaterials for research applications in various fields such as tissue engineering, drug and gene delivery, green chromatography, microfluidics, and cell-based on-chip assays. His research group has successfully modified the temperature-responsive polymer, poly(N-isopropylacrylamide) (PIPAAm) onto ordinary polystyrene tissue culture surfaces by controlling its thickness and nanostructure. He currently serves as an Associate Editor for the Journal of Biomedical Materials Research, Bioconjugate Chemistry, and Tissue Engineering. He is also a member of the editorial boards for the Journal of Controlled Release, Drug Targeting, and Advanced Drug Delivery Reviews. Rocky S. Tuan, PhD Director, Center for Cellular and Molecular Engineering, Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine Executive Vice Chairman for Orthopaedic Research, University of Pittsburgh Dr. Tuan’s research focuses on the utilization of adult stem cells in the regeneration and/ or restoration of diseased or damaged musculoskeletal tissues. He is a member of several professional societies, including the Society for Physical Regulation in Biology and Medicine and the Tissue Engineering Regenerative Medicine International Society. He is the Editor-in-Chief of Birth Defects Research; Part C – Embryo Today and Stem Cell Research and Therapy.

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Michelle LeRoux Williams, PhD Chief Scientific Officer, Osiris Dr. Williams’ research has led to the development of Osteocel, the world’s first commercially available stem cell product, as well as the advancement of the Chondrogen program from preclinical testing through human clinical evaluation. The above is a proposed list of associate editors and board members with whom AlphaMed Press already has exemplary working relationships. STEM CELLS Translational Medicine staff will include the two science editors, who are shared with STEM CELLS. A managing editor and editorial coordinator will be recruited for the California Editorial Office to handle manuscript screening, document collection, author correspondence, and production preparation. Journal staff will be selected with the utmost care and consideration. The editorial team will be familiar with translational science, stem cells, stem cell-based regenerative medicine and tissue engineering and/or cancer stem cells. C. Comparable Projects Provide a brief list and description of similar types of comparable projects successfully undertaken within the last three years. Provide relevant samples of your work. The Oncologist This 16-year-old Journal has undergone significant changes within the past three years, still managing to increase revenue, readership and impact. The focus of these changes was to embrace the possibilities of digital media and new technologies. In the most difficult economic time since the great depression, AlphaMed Press responded to these environmental shifts by changing the journal’s revenue model from a grants-supported model to a profitable ads-supported model using print, web and mobile Apps. Additionally, we incorporated aggressive marketing strategies to foster Journal recognition and increase advertising revenue. We developed mobile Apps to decrease the time from publication to the reader – also giving physicians worldwide access to content on-demand. We spent significant effort re-branding The Oncologist to balance the focus of the print journal with the online version and the Apps. Finally, we implemented new manuscript submission and peer review management systems to handle a 300% increase in article submissions. We plan to use these same strategies and the same revenue model to transition STEM CELLS Translational Medicine from a subsidized start-up to a self-sustaining journal. We have the necessary processes and systems in place to facilitate accelerated peer review and publication of critical papers. We are constantly evaluating both internal systems and the publishing industry itself for trends and data that help us evolve and improve. The Oncologist is the second highest ranked peer-reviewed cancer medicine journal in readership recognition (PerQ Report, December 15, 2010). Global Thought Leaders The Oncologist has created a podcast platform that features recognized thought leaders in oncology and hematology. This podcast series provides critical insight for physician scientists and oncology practitioners in the trenches across the globe and in an on-demand format. This content is also available as video and mobile CME, which allows physicians to access the most current research and also complete their continuing medical education requirements. Beginning year two, AlphaMed Press plans to do the same for STEM CELLS and STEM CELLS Translational Medicine, including CME for manuscript reviewers. D. Business Plan AlphaMed Press has been publishing in the field of stem cells and regenerative medicine for 29 years. Although this field has grown significantly over the last several decades, it still only encompasses a small subset of researchers. AlphaMed is fortunate to have long-standing relationships with today’s foremost stem cells scientists, many of whom serve on the STEM CELLS Journal board. These globally recognized thought leaders will contribute their expertise to the launch, direction and future of STEM CELLS Translational Medicine.

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AlphaMed Press is in the unique position of being able to launch STEM CELLS Translational Medicine’s inaugural issue by April 2011, if granted CIRM support by February. CIRM’s subsidy would provide the financial support to establish the key administrative foundation and funds necessary to position this new journal for success. STEM CELLS, with its focus on top-tier manuscripts dealing with fundamental stem cell molecular and cell biology and physiology, receives more than 1,300 manuscript submissions each year, accepting only 17 percent of those. With about four new manuscripts received each day, many of those not selected for publication are simply more translational in nature covering topics such as the translation of hESC/iPSC and cancer stem cells into bona fide clinical trials), rather than basic science. STEM CELLS Translational Medicine will address this gap by providing the publication bridge between stem cells and clinical trials. The STEM CELLS Science Editors, distinguishing between the two journals, will identify high quality manuscripts that are more appropriate for STEM CELLS Translational Medicine. Those authors will then be offered an opportunity to submit their work to STEM CELLS Translational Medicine. The top hESC/induced pluripotency stem cells, cancer stem cells/clinical trials, and clinical applications manuscripts currently not published by STEM CELLS will be submitted for expedited review by STEM CELLS Translational Medicine within seven days and, when accepted, will be published online within 14 days and indexed in PubMed within four days. STEM CELLS will provide a steady pipeline of high impact papers during the initial phase of STEM CELLS Translational Medicine’s development, as we cultivate its awareness and a brand through a global “call for papers” campaign and concise reviews invitations. In addition, to foster work in the field of stem cells and regenerative medicine, the Journal will present the STEM CELLS Translational Medicine Young Investigators Award to the young researcher, serving as the principle author, whose paper in STEM CELLS Translational Medicine is judged to be the most important by the Journal’s Editorial Board jury. Also, STEM CELLS Translational Medicine will use the international reach of its Board and networks to encourage researchers to publish data from their negative clinical trials to and rapidly share results that others could find valuable to their applications. If appropriate, STEM CELLS Translational Medicine proposes to accompany such papers with a commentary by an Editor, explaining the significance of the study and placing the results into context. Other editorial content in the Journal will include case studies from CIRM (modeled on Massachusetts General Hospital case studies in the New England Journal of Medicine) and invited and proffered commentaries on topics such as Biosimilars. STEM CELLS Translational Medicine will leverage social media (Facebook, Twitter, etc) to encourage collaboration among researchers, clinicians and engineers and to create a dialogue that will consolidate cell-based translational work and create a synergistic community within academia, the biotech industry and regulatory bodies. In addition, STEM CELLS Translational Medicine will be represented at several key meetings, including the Translational Regenerative Medicine Forum and the International Society for Stem Cell Research Annual Meeting. Other methods of marketing the Journal include print advertisements in conference programs, email campaigns, and collaborations with biotech clinics and numerous stem cells societies. STEM CELLS Translational Medicine expects to publish an average of 180 manuscripts per year, with an average of 15 manuscripts per month, including periodic short topics from CIRM. Outside of traditional publishing, AlphaMed Press brings to the table the unique knowledge and experience of producing professional podcasts featuring key opinion leaders and thought-provoking roundtables. Using this technology, STEM CELLS Translational Medicine can develop a series of online videos that deal with methods or clinical processes, as a service to the field. Video Podcasts of roundtable discussions can also be used to highlight important issues or feature premier stem cells institutes and laboratories, building a greater sense of community. These podcasts will also be available on the STEM CELLS Portal (www.StemCellsPortal.com), giving them a greater reach in the research community. We plan to mobilize broad national and international scientific and non-scientific communities, promoting discussions on all aspects of stem cell applications, including advertisement of stem cell products and rapidly developing pharmaceutical applications.

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AlphaMed Press can utilize its Application platform and structure to broaden the readership of STEM CELLS Translational Medicine. We have included a brief demonstration of our iPad HD App and Proof of Concept PDFs with this proposal. An App for STEM CELLS Translational Medicine will provide a dynamic venue to access STEM CELLS Translational Medicine journal content and podcasts ondemand. We envision STEM CELLS Translational Medicine to be a unique peer-reviewed, online journal, covering stem cells biology, tissue engineering and regenerative medicine, using resourceful translation and commercialization of stem cells research. An online format will accelerate publication and facilitate the development of a mobile application for the journal, making it easily accessible from routinely-used mobile devices, allowing busy physicians and researchers to retrieve articles quickly and conveniently. The Boards believe it essential to produce a print version of STEM CELLS Translational Medicine to be circulated to key institutions and researchers to build the awareness and recognition of the Journal at the outset.  Being an open access journal, STEM CELLS Translational Medicine will require the CIRM subsidy for the first three years. As the STEM CELLS Translational Medicine name becomes recognized as an essential source for translation of stem cell therapies and regenerative medicine, the Journal will be able to sustain itself through publication fees and advertising (see attached budget). E. California Editorial Offices STEM CELLS Translational Medicine’s two Science Editors are based in Palo Alto, California. Lucy Rasmussen, Sc.D., Senior Research Scientist, Department of Medicine, Division of Infectious Diseases (retired) is currently a member of three Stanford Institutional Review Boards, including the combined IRB/SCRO panel and the SCRO advisory committee. Catherine Bessette, PhD, is a graduate of UCLA with a degree in biomedical engineering with a focus on stem cells.

III. Enclosures
A. Proof of Concept PDFs B. Budget C. Sample Issues of STEM CELLS and The Oncologist D. STEM CELLS Translational Medicine proof of concept App on the iPad, including other examples of AlphaMed Press Apps

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