{"id":1763,"date":"2017-04-07T12:00:02","date_gmt":"2017-04-07T16:00:02","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/compbiomed\/?p=1763"},"modified":"2017-04-07T12:00:34","modified_gmt":"2017-04-07T16:00:34","slug":"1763","status":"publish","type":"post","link":"https:\/\/www.bumc.bu.edu\/compbiomed\/2017\/04\/07\/1763\/","title":{"rendered":"BU Paves Way for MED Prof\u2019s $10M Plus Partnership with Industry"},"content":{"rendered":"

Monday, April 3, 2017
\nWritten by:\u00a0Sara Rimer\u00a0| Source: BUToday<\/a><\/p>\n

\"h_butoday_16-10090-AVISPIRA-026\"<\/a>
\nAs a pulmonary physician scientist, Avi Spira<\/a> is driven to get his breakthroughs in molecular biomarkers for the early diagnosis of lung cancer and chronic obstructive pulmonary disease (COPD) into clinical care. \u201cI\u2019m a doctor, I want to help people,\u201d says Spira (ENG\u201902), a School of Medicine professor of medicine, pathology, and bioinformatics. \u201cThe question is, how do you get these discoveries into patients? You have to work with companies and industry. How do you do that when you\u2019re an academic?\u201d<\/p>\n

With the support of BU President Robert A. Brown and BU\u2019s Technology Development (TD) office, Spira, director of the BU-Boston Medical Center (BMC) Cancer Center<\/a>, has spent much of the past eight years figuring out the answer to those questions. In 2007, he founded his own company to develop a relatively noninvasive molecular test for early detection of lung cancer<\/a>,\u00a0a test that grew out of Spira\u2019s research at BU. Getting the company off the ground, and running the large clinical trials needed to validate the test, meant raising millions of dollars in private funding.<\/p>\n

Spira says he and his partner, Jerome Brody<\/a>, a MED professor emeritus of medicine, had no clue about business. They blew their first meeting with venture capitalists by showing up with an 80-slide scientific presentation\u2014and no firm funding goal in mind.<\/p>\n

\u201cWe could tell within three minutes that no one in the room was listening,\u201d says Spira. Three minutes later, they were shown the door.<\/p>\n

\u201cBob Brown and TD have created an entrepreneurial culture that is very supportive of start-ups, as well as industry collaborations with our laboratory and others.\u201d \u2014Avi Spira<\/cite><\/p><\/blockquote>\n

They eventually raised more than $10 million in venture capital financing to run two successful clinical trials. In 2014, their company, Allegro, was acquired by a San Francisco molecular diagnostics firm, Veracyte<\/a>, which made an early lung cancer diagnostic test (PerceptaTM<\/sup>)<\/a>, based on Spira and Brody\u2019s biomarker, available for the first patients in 2015 (Medicare coverage recently became available for the test).<\/p>\n

\u201cJerry and I could never have done that on our own,\u201d says Spira. In recognition of his success with Allegro, he was named BU\u2019s Alexander Graham Bell Professor in Health Care Entrepreneurship. \u201cBob Brown and TD have created an entrepreneurial culture that is very supportive of start-ups, as well as industry collaborations with our laboratory and others.\u201d<\/p>\n

A different approach to collaboration<\/h3>\n

Spira has now entered into a promising partnership with Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson<\/a>, the pharmaceutical group of the New Jersey\u2013based health care giant, and the company\u2019s venture capital subsidiary, Johnson & Johnson Innovation\u2014JJDC, Inc.<\/a> Janssen is investing more than $10 million in Spira\u2019s research into biomarkers for the early detection of COPD and lung cancer. Spira views his collaboration with Janssen as part of an emerging new paradigm for how industry and academia can work together. In this new model, industry not only gets involved earlier in the disease, but also earlier in the initial discovery process.<\/p>\n

\u201cThe traditional model was one where academia did almost all of the discovery,\u201d he says. \u201cYou make a finding, figure out how to protect the intellectual property, and then try to license it to a pharmaceutical company or another partner, who will then hopefully move it into patients.<\/p>\n

\u201cThe challenge is that the initial discovery process is expensive and risky, and it\u2019s hard to know how to develop the technology and hand it off to someone else who is going to apply it to the clinic,\u201d says Spira, who started Allegro with Brody after failing to interest an existing company in licensing their biomarker discovery. \u201cPart of what Janssen is doing with my lab is becoming involved directly in the process as a partner from the very beginning. It\u2019s science done with application in mind at the earliest stages\u2014not science for science\u2019s sake.\u201d<\/p>\n

Spira\u2019s research on biomarkers for the early detection of COPD and lung cancer is part of his work within DECAMP (Detection of Early Lung Cancer Among Military Personnel)<\/a>, a US Department of Defense\u2013funded consortium of researchers at military facilities and veterans\u2019 hospitals that Spira leads as principal investigator.<\/p>\n

As part of the Janssen-funded effort, Spira\u2019s team will also study how the immune system behaves in the development of lung cancer and determine whether approaches that boost the immune system have the potential for stopping the progression to disease. The team will also evaluate the molecular and radiological features in the airways and lungs of hundreds of smokers to identify biomarkers that can pinpoint individuals who are likely to develop COPD.<\/p>\n

\u201cI\u2019m very encouraged about Dr. Spira\u2019s partnership with Janssen Research & Development,\u201d says Brown. \u201cWe\u2019re committed to fostering efforts\u2014such as this one\u2014that quickly translate research into effective therapies and diagnostic tools. Industry support is critical to translating the results of our research into better health care.\u201d<\/p>\n

Janssen is additionally supporting Spira\u2019s collaborations with scientists Mary Reid<\/a> and Samjot Dhillon<\/a> at Roswell Park Cancer Institute<\/a>, in Buffalo, N.Y., to develop a precancer genome atlas <\/a>(PCGA). The PCGA would provide comprehensive genomic profiling of premalignant lesions for lung cancer and identify the key molecular pathways that lead pre-cancer lesions to progress to invasive and lethal lung cancer. The National Cancer Institute<\/a> is helping to expand this work by providing an additional investment for the PCGA in collaboration with Steven Dubinett<\/a>, a University of California at Los Angeles professor of medicine and molecular and medical pharmacology. Finally, with Janssen and James Hogg of the University of British Columbia, Spira and Marc Lenburg<\/a>, a MED professor of medicine, are working to identify new therapies and therapeutic targets that can reverse or stop the progression of COPD-related lung pathologies.<\/p>\n

The traditional model for working with industry, where a company comes in toward the end of the academic discovery process, \u201cis very dependent on federal funding of the early discovery work, which is very competitive, and is probably not sufficient to take advantage\u201d of today\u2019s vast scientific opportunities and potential, says David Coleman<\/a>, Wade Professor and chair of the MED department of medicine. The new model that Spira and BU have embarked upon with Janssen is one that has been discussed by many people in both academia and industry in the last few years, Coleman says.<\/p>\n

\u201cI think this is a very important model to find new and productive ways for academia and industry to successfully develop products that contribute to public health,\u201d he adds.<\/p>\n

Partnerships for progress<\/h3>\n

As a research university, BU helped generate Spira\u2019s breakthroughs in the lab, as well as his partnership with Janssen, says Mike Pratt<\/a>, TD interim managing director. \u201cOur community of innovators and portfolio of discoveries are accessible,\u201d he says. \u201cThis open access enables innovators like Avi by giving them the freedom to be creative and to form partnerships with key stakeholders that share their vision for treating disease.\u201d<\/p>\n

As part of its collaboration with Spira, through JJDC, Johnson & Johnson Innovation is providing an equity investment into Metera Pharmaceuticals, a company that Spira founded in July 2016 with two MED colleagues, Lenburg and Joshua D. Campbell (ENG\u201912)<\/a>, a MED assistant professor of medicine. They hope to develop a diagnostic to identify patients who show early signs of possible COPD and a drug that could potentially treat and even reverse the disease (and perhaps other lung diseases as well). With this financial backing, Spira can bypass the usual financially driven venture capitalists, at least in the early stages.<\/p>\n

\u201cThis is a really nice model for more efficient drug development and commercialization,\u201d Spira says. \u201cWe don\u2019t have to go out and raise traditional venture capital, which is challenging, is primarily focused on financial returns, tends to look for later-stage molecules, and already comes with ties. JJDC is getting involved very early and helping us to advance this important program due to their primary strategic goal of bringing medicines to patients. What\u2019s exciting is that we get industry guidance early in the process, in areas such as designing and developing a drug and clinical trials, expertise that we don\u2019t have within academia. These are things drug companies do well. We get access to that knowledge base while getting to remain actively involved.\u201d<\/p>\n

Janssen\u2019s $10 million research collaboration in Spira\u2019s work on early detection and intervention in lung cancer and COPD is part of the company\u2019s ambitious, multipartner effort to move from what it calls disease care to health care. Called the Disease Interception Accelerator (DIA)<\/a>, the partnership is also focusing on type 1 and gestational diabetes, cataracts and presbyopia, perinatal depression, and cancers of the cervix, mouth, and throat caused by human papilloma virus. The goals are to find biomarkers for the earliest signs of disease and to develop affordable diagnostics as well as therapeutics to stop an individual\u2019s progression to disease.<\/p>\n

\u201cThis is a really nice model for more efficient drug development and commercialization. We don\u2019t have to go out and raise traditional venture capital, which is challenging, is primarily focused on financial returns, tends to look for later-stage molecules, and already comes with ties.\u201d
\n\u2014Avi Spira<\/cite><\/p><\/blockquote>\n

With Janssen\u2019s support, Spira will expand on his DECAMP project and test hundreds of high-risk smokers to identify biomarkers that predict who will eventually develop lung cancer and COPD. The study will also work to discover whether there are biomarkers that can be used to guide current and future therapeutic approaches.<\/p>\n

Advances in genomics and bioinformatics have made Janssen\u2019s DIA project possible, and Spira\u2019s groundbreaking work in both fields\u2014as well as his focus on early detection of disease and his extensive network of scientific collaborators\u2014helped bring him to the company\u2019s attention. \u201cWe\u2019re trying to find the Avis of the world to work with,\u201d says Benjamin C. Wiegand<\/a>, DIA global head. \u201cHe\u2019s a phenomenal visionary. He loves health care challenges. He\u2019s working with researchers around the world\u2014leading microbiome experts, some great pulmonary researchers\u2014and because he can articulate his vision, he brings others along with him. He\u2019s building his ecosystem and we\u2019re glad to add him to our ecosystem as well.\u201d<\/p>\n

Spira first connected with Janssen in 2012, when Patrick Branigan, a senior research scientist at the company, heard Spira\u2019s talk on COPD research at the American Thoracic Society <\/a>annual meeting. Branigan then invited Spira to meet with Janssen\u2019s COPD and oncology teams in Philadelphia. \u201cMost of the research and development in Big Pharma is focused on people who are already sick,\u201d Spira says. \u201cWhat got me aligned with Janssen is that they\u2019re interested in disease prevention and disease\u2014a word I love\u2014interception. In the lung cancer space, a lot of companies are developing very effective drugs that keep you alive longer with late-stage disease. That\u2019s very important, but I would argue that we should be focusing earlier in the disease process. Prevention is always better than cure. Janssen was very clear that this vision was aligned very well with our lab.\u201d<\/p>\n

One of the tasks ahead for Metera is figuring out how to move from these interesting data to a true drug in a precision medicine way, Spira says. \u201cPart of it would be to generate novel drug-like molecules and effectively deliver them to the lung,\u201d he says. \u201cIt\u2019s very challenging. Janssen has the expertise in how to do this and we have been very fortunate to work closely with world-class scientists, like Chris Stevenson<\/a> at Janssen, who have been instrumental in moving compounds toward the clinic.\u201d Stevenson leads the DIA COPD team at Janssen.<\/p>\n

Reversing the risk<\/h3>\n

Spira, who practices at BMC, says his experience managing patients with advanced lung cancer and COPD helped spur his focus on translational research into ways to diagnose disease as early as possible. Lung cancer, which is the leading cause of cancer deaths in the United States and around the world, is extremely difficult to diagnose, and by the time most people exhibit symptoms, the cancer has metastasized. \u201cAs a physician, by the time I see patients with either COPD or lung cancer, the vast majority of them have late-stage disease and it is too late for a cure,\u201d Spira says.<\/p>\n

\u201cWe don\u2019t want to treat people at the end of the disease. We want to catch it early or even prevent it. That\u2019s what our lung cancer test is about. It applies to COPD, too, we believe. This is a disease we need to prevent. We need to get people before they get the disease and then intercept and reverse the risk.\u201d<\/p>\n

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Monday, April 3, 2017 Written by:\u00a0Sara Rimer\u00a0| Source: BUToday As a pulmonary physician scientist, Avi Spira is driven to get his breakthroughs in molecular biomarkers for the early diagnosis of lung cancer and chronic obstructive pulmonary disease (COPD) into clinical care. \u201cI\u2019m a doctor, I want to help people,\u201d says Spira (ENG\u201902), a School of […]<\/p>\n","protected":false},"author":11679,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/posts\/1763"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/users\/11679"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/comments?post=1763"}],"version-history":[{"count":9,"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/posts\/1763\/revisions"}],"predecessor-version":[{"id":1772,"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/posts\/1763\/revisions\/1772"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/media?parent=1763"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/categories?post=1763"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/compbiomed\/wp-json\/wp\/v2\/tags?post=1763"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}