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54-649: Recipients of the award have included scholars, academic administrators, Nobel Prize winners, businesspersons, and public officials who have had a transformative impact on higher education and on society more broadly. The award is considered one of the most prestigious honors in higher education. Sue Desmond-Hellmann Amy Gutmann Timothy P. White Shirley Ann Jackson John L. Hennessy Diana Natalicio C. Judson King Robert M. Berdahl Philip Selznick Derek Bok Thomas E. Everhart Robert J. Brentano Lincoln Constance Ewald T. Grether Harry R. Wellman This award -related article

108-647: A Knowledge Network for Biomedical Research and a New Taxonomy of Disease", was described by Keith Yamamoto , Vice Chancellor for Research at UCSF, as "the most important National Academy of Sciences Framework Analysis since that advisory body recommended that the United States go forward with the Human Genome Project ". On December 17, 2013, The Bill & Melinda Gates Foundation announced that it had selected Desmond-Hellmann as its next chief executive officer. She assumed her role on May 1, 2014,

162-578: A second time that Avastin should no longer be used in breast cancer patients, clearing the way for the US government to remove its endorsement from the drug. The June 2011 meeting of the FDA's oncologic drug advisory committee was the last step in an appeal by the drug's maker. The committee concluded that breast cancer clinical studies of patients taking Avastin have shown no advantage in survival rates, no improvement in quality of life, and significant side effects. In

216-662: A significant benefit, the FDA's advisory panel recommended against the indication for advanced breast cancer. Genentech requested a hearing, which was granted in June 2011. The FDA ruled to withdraw the breast cancer indication in November 2011. FDA approval is required for Genentech to market a drug for that indication. Doctors may sometimes prescribe it for that indication, although insurance companies are less likely to pay for it. The drug remains approved for breast cancer use in other countries, including Australia. It has been funded by

270-655: A significant increase in overall survival vs bevacizumab alone on follow up analysis. In the EU, bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adults with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adults with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. In December 2010,

324-629: A three-year term on the Economic Advisory Council of the Federal Reserve Bank of San Francisco beginning in January 2009. She served on the corporate board of Affymetrix from 2004 to 2009 and on the board of Procter & Gamble in 2012–2013. After being invited to apply, on August 3, 2009, Desmond-Hellmann became the ninth Chancellor of UCSF, and the first woman to hold the position. Desmond-Hellmann became

378-657: Is Outlook Therapeutics Limited. Lytenava was approved for medical use in the European Union in May 2024. In March 2007, the European Commission approved bevacizumab in combination with paclitaxel for the first-line treatment of metastatic breast cancer. In 2008, the FDA approved bevacizumab for use in breast cancer . A panel of outside advisers voted 5 to 4 against approval, but their recommendations were overruled. The panel expressed concern that data from

432-612: Is a stub . You can help Misplaced Pages by expanding it . Sue Desmond-Hellmann Sue Desmond-Hellmann (born 1958) is an American oncologist and biotechnology leader who served as the Chief Executive Officer of the Bill & Melinda Gates Foundation from 2014 to 2020. In March 2024 she was elected as a board member of OpenAI. She was previously Chancellor of the University of California, San Francisco (UCSF),

486-482: Is a monoclonal antibody that functions as an angiogenesis inhibitor . It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A), in other words anti–VEGF therapy . Bevacizumab was approved for medical use in the United States in 2004. It is on the World Health Organization's List of Essential Medicines . Bevacizumab was approved in

540-424: Is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A). VEGF-A is a growth factor protein that stimulates angiogenesis in a variety of diseases, especially in cancer . By binding VEGF-A, bevacizumab should act outside the cell, but in some cases (cervical and breast cancer) it is taken up by cells through constitutive endocytosis. It also

594-674: Is also apparent in the European vs US trials of bevacizumab in colorectal cancer: Tyagi and Grothey, Clin Colorectal Cancer, 2006). As an anti-angiogenic agent, there is no mechanistic rationale for stopping bevacizumab before disease progression. Stated another way, the survival benefits achieved with bevacizumab can only be expected when used in accordance with the clinical evidence: continued until disease progression or treatment-limiting side effects. Another large European-based clinical trial with bevacizumab in lung cancer, AVAPERL,

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648-429: Is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. In the EU, bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in people who cannot receive platinum therapy, is indicated for the treatment of adults with persistent, recurrent, or metastatic carcinoma of

702-587: Is indicated for treatment of adults with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. In May 2020, the FDA expanded the indication of olaparib to include its combination with bevacizumab for first-line maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer

756-459: Is taken up by retinal photoreceptor cells after intravitreal injection. Bevacizumab was originally derived from a mouse monoclonal antibody generated from mice immunized with the 165-residue form of recombinant human vascular endothelial growth factor. It was humanized by retaining the binding region and replacing the rest with a human full light chain and a human truncated IgG1 heavy chain , with some other substitutions. The resulting plasmid

810-494: Is used as a first-line therapy . For age-related macular degeneration it is given by injection into the eye ( intravitreal ). Common side effects when used for cancer include nose bleeds , headache, high blood pressure, and rash. Other severe side effects include gastrointestinal perforation , bleeding, allergic reactions , blood clots , and an increased risk of infection. When used for eye disease side effects can include vision loss and retinal detachment . Bevacizumab

864-536: The Medicines and Healthcare products Regulatory Agency which had approved Lucentis but not Avastin for wet AMD, and their interest in ensuring that doctors do not use medicines off-label when there are other, approved medications for the same indication, and on the other hand, NICE in the UK, which sets treatment guidelines, and has been unable so far to appraise Avastin as a first-line treatment, in order to save money for

918-530: The National Health Service . Novartis and Roche (which respectively have marketing rights and ownership rights for Avastin) had not conducted clinical trials to get approval for Avastin for wet AMD and had no intention of doing so. Further, both companies lobbied against treatment guidelines that would make Avastin a first-line treatment, and when government-funded studies comparing the two drugs were published, they published papers emphasizing

972-661: The UC Berkeley Academic Senate. Desmond-Hellmann married Nicholas Hellmann in 1987. Avastin Bevacizumab , sold under the brand name Avastin among others, is a monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease . For cancer, it is given by slow injection into a vein ( intravenous ) and used for colon cancer , lung cancer , ovarian cancer , glioblastoma , hepatocellular carcinoma , and renal-cell carcinoma . In many of these diseases it

1026-482: The Arthur and Toni Rembe Rock Distinguished Professorship during her tenure. In 2011, Desmond-Hellmann co-chaired a National Academy of Sciences committee that recommended creating a Google Maps -like data network aimed at developing more diagnostics and treatments tailored to individual patients — a concept known as precision medicine . The so-called "knowledge network" would integrate the wealth of data emerging on

1080-423: The EU, bevacizumab in combination with paclitaxel is indicated for first-line treatment of adults with metastatic breast cancer. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adults with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. In certain kidney cancers, bevacizumab improves

1134-664: The English NHS Cancer Drugs Fund , but in January 2015 it was proposed to remove it from the approved list. It remains on the Cancer Drugs Fund as of March 2023. In 2015, there was a fierce debate in the UK and other European countries concerning the choice of prescribing bevacizumab or ranibizumab (Lucentis) for wet AMD. In the UK, part of the tension was between on the one hand, both the European Medicines Agency and

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1188-465: The FDA warned of the risk of developing perforations in the body, including in the nose, stomach, and intestines. In 2013, Hoffmann-La Roche announced that the drug was associated with 52 cases of necrotizing fasciitis from 1997 to 2012, of which 17 patients died. About 2/3 of cases involved patients with colorectal cancer , or patients with gastrointestinal perforations or fistulas . These effects are largely avoided in ophthalmological use since

1242-551: The NCCN Clinical Practice Guidelines for Oncology (NCCN Guidelines) for Breast Cancer to affirm the recommendation regarding the use of bevacizumab in the treatment of metastatic breast cancer. In 2011, the US Food and Drug Administration removed bevacizumab indication for metastatic breast cancer after concluding that the drug has not been shown to be safe and effective. The specific indication that

1296-932: The UCSF medical faculty during the HIV/AIDS epidemic in San Francisco, and worked on Kaposi's sarcoma . Beginning in 1989 both she and her husband, an infectious disease doctor, spent two years as visiting faculty at the Uganda Cancer Institute , studying and treating patients with infectious diseases and Kaposi's sarcoma in a project funded by the Rockefeller Foundation . She then spent two years in private practice. Returning to clinical research, Desmond-Hellmann became associate director of clinical cancer research at Bristol-Myers Squibb Pharmaceutical Research Institute. While there, she

1350-787: The US Food and Drug Administration (FDA) notified its intention to remove the breast cancer indication from bevacizumab, saying that it had not been shown to be safe and effective in breast cancer patients. The combined data from four different clinical trials showed that bevacizumab neither prolonged overall survival nor slowed disease progression sufficiently to outweigh the risk it presents to patients. This only prevented Genentech from marketing bevacizumab for breast cancer. Doctors are free to prescribe bevacizumab off label , although insurance companies are less likely to approve off-label treatments. In June 2011, an FDA panel unanimously rejected an appeal by Roche. A panel of cancer experts ruled for

1404-628: The United States in February 2004, for use in metastatic colorectal cancer when used with standard chemotherapy treatment (as first-line treatment ). In June 2006, it was approved with 5-fluorouracil-based therapy for second-line metastatic colorectal cancer. It was approved by the European Medicines Agency (EMA) in January 2005, for use in colorectal cancer . Bevacizumab has also been examined as an add on to other chemotherapy drugs in people with non-metastatic colon cancer. The data from two large randomized studies showed no benefit in preventing

1458-561: The United States. In July 2014, two pharming companies, PlantForm and PharmaPraxis, announced plans to commercialize a biosimilar version of bevacizumab made using a tobacco expression system in collaboration with the Fraunhofer Center for Molecular Biology . In September 2017, the US FDA approved Amgen's biosimilar (generic name bevacizumab-awwb, product name Mvasi) for six cancer indications. In January 2018, Mvasi

1512-579: The bogus drugs simple for medical providers. Roche analyzed three bogus vials of Avastin and found they contained salt , starch , citrate , isopropanol , propanediol , t-butanol , benzoic acid , di-fluorinated benzene ring, acetone and phthalate moiety, but no active ingredients of the cancer drug. According to Roche, the levels of the chemicals were not consistent; whether the chemicals were at harmful concentrations could not therefore be determined. The counterfeit Avastin has been traced back to Egypt, and it entered legitimate supply chains via Europe to

1566-462: The cancer from returning and a potential to cause harm in this setting. In the EU, bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adults with metastatic carcinoma of the colon or rectum. In 2006, the US Food and Drug Administration (FDA) approved bevacizumab for use in first-line advanced nonsquamous non-small cell lung cancer in combination with carboplatin/paclitaxel chemotherapy. The approval

1620-764: The cervix. Bevacizumab inhibits the growth of blood vessels, which is part of the body's normal healing and maintenance. The body grows new blood vessels in wound healing , and as collateral circulation around blocked or atherosclerotic blood vessels. One concern is that bevacizumab will interfere with these normal processes, and worsen conditions like coronary artery disease or peripheral artery disease . The main side effects are hypertension and heightened risk of bleeding . Bowel perforation has been reported. Fatigue and infection are also common. In advanced lung cancer, less than half of patients qualify for treatment. Nasal septum perforation and renal thrombotic microangiopathy have been reported. In December 2010,

1674-405: The clinical trial did not show any increase in quality of life or prolonging of life for patients—two important benchmarks for late-stage cancer treatments. The clinical trial did show that bevacizumab reduced tumor volumes and showed an increase in progression free survival time . It was based on this data that the FDA chose to overrule the recommendation of the panel of advisers. This decision

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1728-567: The company was acquired by Roche Pharmaceuticals . At that point her compensation was $ 8 million a year. From 2005 to 2008, Desmond-Hellmann served a three-year term as a member of the American Association for Cancer Research board of directors , and from 2001 to 2009, she served on the executive committee of the board of directors of the Biotechnology Industry Organization . She also served

1782-482: The drug is introduced directly into the eye thus minimizing any effects on the rest of the body. Neurological adverse events include reversible posterior encephalopathy syndrome . Ischemic and hemorrhagic strokes are also possible. Protein in the urine occurs in approximately 20% of people. This does not require permanent discontinuation of the drug. Nonetheless, the presence of nephrotic syndrome necessitates permanent discontinuation of bevacizumab. Bevacizumab

1836-514: The first Chancellor drawn from outside academia. Her starting salary was $ 450,000 a year. In June 2010, one day after being questioned by The New York Times , Desmond-Hellmann sold her stock in the Altria Group , which owns Phillip Morris USA and other tobacco companies, and subsequently donated $ 134,000 to the tobacco control center at UCSF. She said that many of her holdings had been purchased on her behalf by her stockbroker and that she

1890-916: The first head of the foundation to be neither a former Microsoft executive nor a personal friend of the Gates', and the first physician. In 2017, Desmond-Hellmann became a member of the Prix Galien USA Committee, succeeding Roy Vagelos as Chair of that Committee in 2018. She is also Chair of the Prix Galien International and Member of the Prix Galien Africa Committee. In December 2019, Desmond-Hellmann announced plans to step down from her role as BMGF CEO "for health and family reasons". Mark Suzman will leave his role of BMGF president of Global Policy & Advocacy and chief strategy officer to become

1944-524: The first woman to hold the position, and Arthur and Toni Rembe Rock Distinguished Professor, and before that president of product development at Genentech , where she played a role in the development of the first gene-targeted cancer drugs, Avastin and Herceptin . Born in Napa, California , Desmond-Hellmann grew up in Reno, Nevada , as one of seven children. Her father worked as a pharmacist and her mother

1998-430: The hypothesis of Judah Folkman , proposed in 1971, that stopping angiogenesis might be useful in controlling cancer growth. It received its first approval in the United States in 2004, for combination use with standard chemotherapy for metastatic colon cancer . It has since been approved for use in certain lung cancers, renal cancers, ovarian cancers, and glioblastoma multiforme of the brain. In 2008, bevacizumab

2052-531: The lung. A subsequent European clinical trial, AVAiL, was first reported in 2009 and confirmed the significant improvement in progression-free survival shown in E4599 (Reck, et al. Ann. Oncol. 2010). An overall survival benefit was not demonstrated in patients treated with bevacizumab; however, this may be due to the more limited use of bevacizumab as maintenance treatment in AVAiL versus E4599 (this differential effect

2106-443: The molecular basis of disease with information on environmental factors and patients’ electronic medical records and would allow scientists to share emerging research findings faster, thereby accelerating the development of tailored treatments. It also would allow clinicians to make more informed decisions about treatments, reduce health care costs and ultimately improve care. The NAS report, titled "Toward Precision Medicine: Building

2160-566: The new BMGF CEO on February 1, 2020. In 2021, Desmond-Hellmann was appointed by President Joe Biden to the President’s Council of Advisors on Science and Technology (PCAST), co-chaired by Frances Arnold , Eric Lander and Maria Zuber . In March 2024, Desmond-Hellman was appointed to OpenAI's Board of Directors. In 2024 Desmond-Hellmann received the Clark Kerr Award for distinguished leadership in higher education from

2214-552: The progression free survival time but not survival time. In 2009, the FDA approved bevacizumab for use in metastatic renal cell cancer (a form of kidney cancer ). following earlier reports of activity EU approval was granted in 2007. In the EU, bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adults with advanced and/or metastatic renal cell cancer. Bevacizumab slows tumor growth but does not affect overall survival in people with glioblastoma . The FDA granted accelerated approval for

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2268-481: The risks of using Avastin for wet AMD. In March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Lytenava (bevacizumab gamma), intended for treatment of neovascular (wet) age-related macular degeneration (nAMD). The applicant for this medicinal product

2322-535: The treatment of recurrent glioblastoma multiforme in May 2009. A 2018 Cochrane review deemed there to not be good evidence for its use in recurrences either. In the EU, bevacizumab gamma (Lytenava) is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD). In 2018, the US Food and Drug Administration (FDA) approved bevacizumab in combination with chemotherapy for stage III or IV of ovarian cancer after initial surgical operation, followed by single-agent bevacizumab. The approval

2376-579: Was an English teacher. She graduated from Bishop Manogue High School in 1975. She earned a bachelor of science degree in pre-medicine and an M.D. from the University of Nevada, Reno and received her residency training at UCSF, where she served as chief resident. She is board-certified in internal medicine and medical oncology, and also holds a master's degree in public health from the University of California, Berkeley School of Public Health . Desmond-Hellmann served as an associate adjunct professor of epidemiology and biostatistics At UCSF. She joined

2430-570: Was approved for breast cancer by the FDA, but the approval was revoked on 18 November 2011 because, although there was evidence that it slowed progression of metastatic breast cancer, there was no evidence that it extended life or improved quality of life, and it caused adverse effects including severe high blood pressure and hemorrhaging. In 2008, the FDA gave bevacizumab provisional approval for metastatic breast cancer, subject to further studies. The FDA's advisory panel had recommended against approval. In July 2010, after new studies failed to show

2484-477: Was approved for use in the European Union. In February 2019, Zirabev was approved for use in the European Union. Zirabev was approved for medical use in the United States in June 2019, and in Australia in November 2019. In June 2020, Mvasi was approved for medical use in Australia. In August 2020, Aybintio was approved for use in the European Union. In September 2020, Equidacent was approved for use in

2538-563: Was based on a study of the addition of bevacizumab to carboplatin and paclitaxel . Progression-free survival was increased to 18 months from 13 months. In the EU, bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adults with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel,

2592-566: Was based on the pivotal study E4599 (conducted by the Eastern Cooperative Oncology Group), which demonstrated a two-month improvement in overall survival in patients treated with bevacizumab (Sandler, et al. NEJM 2004). A preplanned analysis of histology in E4599 demonstrated a four-month median survival benefit with bevacizumab for people with adenocarcinoma (Sandler, et al. JTO 2010); adenocarcinoma represents approximately 85% of all non-squamous cell carcinomas of

2646-438: Was lauded by patient advocacy groups and some oncologists. Other oncologists felt that granting approval for late-stage cancer therapies that did not prolong or increase the quality of life for patients would give license to pharmaceutical companies to ignore these important benchmarks when developing new late-stage cancer therapies. In 2010, before the FDA announcement, The National Comprehensive Cancer Network (NCCN) updated

2700-564: Was reported in October 2011 (Barlesi, et al. ECCM 2011). First-line patients were treated with bevacizumab plus cisplatin/pemetrexed for four cycles, and then randomized to receive maintenance treatment with either bevacizumab/pemetrexed or bevacizumab alone until disease progression. Maintenance treatment with bevacizumab/pemetrexed demonstrated a 50% reduction in risk of progression vs bevacizumab alone (median PFS: 10.2 vs 6.6 months). Maintenance treatment with bevacizumab/pemetrexed did not confer

2754-463: Was the project team leader for Taxol . In 1995, Desmond-Hellmann joined Genentech as a clinical scientist. She was named chief medical officer the following year, and in 1999 became executive vice president of development and product operations. From March 2004 through April 2009 she was president of product development, playing a role in the development of two of the first gene-targeted therapies for cancer, Avastin and Herceptin . She left after

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2808-552: Was too busy to oversee all her investments, although she had included the stock on her financial disclosure statement. In January 2012, Desmond-Hellmann proposed changing the relationship between UCSF, a health sciences university, and the University of California . She proposed creating partnerships between UCSF and private pharmaceutical corporations and other sources of funding, in order to increase its revenues and resolve its projected financial instability. Desmond-Hellmann served as UCSF Chancellor until March 2014, holding

2862-564: Was transfected into Chinese hamster ovary cells which are grown in industrial fermentation systems. Bevacizumab is a recombinant humanized monoclonal antibody and in 2004, it became the first clinically used angiogenesis inhibitor. Its development was based on the discovery of human vascular endothelial growth factor (VEGF), a protein that stimulated blood vessel growth, in the laboratory of Genentech scientist Napoleone Ferrara . Ferrara later demonstrated that antibodies against VEGF inhibit tumor growth in mice. His work validated

2916-429: Was withdrawn was for the use of bevacizumab in metastatic breast cancer, with paclitaxel for the treatment of people who have not received chemotherapy for metastatic HER2-negative breast cancer. In February 2012, Roche and its US biotech unit Genentech announced that counterfeit Avastin had been distributed in the United States. The investigation is ongoing, but differences in the outer packaging make identification of

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