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Oct 8, 2014 · Individualizing Medicine 2014: Day Three Recap

The final day of the Individualizing Medicine 2014 Conference kicked off with one of the pioneers of genomics taking the stage. Having founded the Baylor College of Medicine Human Genome Sequencing Center in 1997, Richard Gibbs led one of the five main groups that completed the Human Genome Project. Gibbs discussed his past, present and future work at Baylor, and the impact clinical exome sequencing has had on genetic research. He has been active in Mendelian disease discovery, and discussed the limitations created by lack of sample size.

Munir Pirmohamed, M.B., Ch.B., Ph.D., the National Health Service Chair of Pharmacogenetics in the United Kingdom, presents his research on pharmacogenomics at Individualizing Medicine 2014.

Munir Pirmohamed, M.B., Ch.B., Ph.D., the National Health Service Chair of Pharmacogenetics in the United Kingdom, presents his research on pharmacogenomics at Individualizing Medicine 2014.

“We have lots of good machines. We have a lot of good infrastructure. But we have a limitation of samples.”
— Richard Gibbs

Bringing an international perspective to the conference, Munir Pirmohamed, the National Health Service Chair of Pharmacogenetics in the United Kingdom, presented his work on using genomics to improve the safety of drug therapy. He opened with both a caution and a challenge: “We need to be much more clever in how we use genomic evidence in drug therapy. Genetic factors are important in identifying and limiting adverse drug reaction.”

Pirmohamed’s work in the UK and with the European Commission’s Eu-Pact has covered a broad spectrum of genomics, including work on relating genomics to drug dosing and drug choice. It has also included extensive work with the U.K.’s electronic health records, the European version of electronic medical records.

“Rare diseases will require a worldwide collaboration. No one place has enough cases to build effective studies.”
— Munir Pirmohamed

From the Oregon Health and Science University, Christopher Corless discussed the advantages and limitation of next generation sequencing in clinical cancer diagnostics. The problem is, he said, how do we provide knowledge with the data?  “Everyone can sequence. The issue is how we deal with the data.”

He issued a challenge to the conference audience: it’s critical to enhance and aggregate information on clinical genomics into a database; and we need to turn that data into knowledge.

Still excited from her San Francisco Giants winning the National League Division Series, moderator Ceci Connolly used a baseball metaphor for the conference’s final speaker. “Batting cleanup” was Peter Jones, Research Director and Chief Scientific Officer at Van Andel Institute. His talk on the cancer epigenome focused primarily on his discoveries on the effects of 5-azacytidine on DNA methylation. This led Jones to ask the question: how stable is the human epigenome? So, he and his team designed a study with patients who have had their bladders removed and a new bladder surgically inserted. The neobladder study showed the epigenome can change 5 percent a year, and each neobladder adopted a unique epigenome.

We are “at the tipping point for epigenetic therapies in cancer,” Jones said.

As he has done each day of the conference, Alexander Parker, Associate Director of the Mayo Clinic Center for Individualized Medicine, offered a recap of the day — this time for the entire conference. He left the 750 attendees with a sense of “hope.” But it was “hope” with a twist.

“I hope you leave here today upset,” Parker said. “I hope you’re frustrated.  I hope you’re really ticked off.  And I hope you’re motivated to change things.

“I hope you’re asking, ‘Why aren’t their more projects like the BEAUTY Project? Why aren’t we doing this kind of work in other cancers?’
— Alexander Parker

“I hope you’re asking, ‘Why are drug costs so high? And why don’t we understand more about the genome?’

“And I hope you’re asking, ‘Why aren’t we doing whole genome sequencing on everyone?’”

Oct 7, 2014 · Individualizing Medicine 2014: Day Two Recap

Day two of the Individualizing Medicine 2014 Conference dispelled any notion of a conference on genomics being a gathering of humorless, stuffy scientists talking about the minutiae of genetic alphabet soup. Bob Dylan and Fifty Shades of Grey, Clint Eastwood and Dr. Seuss were intermixed in with informative talks that centered on the power of pharmacogenomics, the future, and challenges of the field.

Ceci Connolly, managing director of PwC's Health Research Institute, kicks off day two of Individualizing Medicine 2014: From Promise to Practice

Ceci Connolly, managing director of PwC’s Health Research Institute, kicks off day two of Individualizing Medicine 2014: From Promise to Practice

Moderator Ceci Connolly introduced the morning’s first speaker, Mayo Clinic’s Richard Weinshilboum, M.D., as “an icon in individualized medicine.” In a fun, dynamic presentation, Dr. Weinshilboum referenced Dylan, “that great poet from Hibbing, Minn.,” when setting the stage for his talk on pharmacogenomics. “‘The times they are a changin’,’” Weinshilboum said.

He took the audience through the days of pharmacogenetics, therapy given one drug at a time—“That is so yesterday”—to today’s pharmacogenomics, looking at the whole genome, and predicted a future of pharmaco-omics, in which the whole range of “omics” combine to deliver better patient care. This “therapeutic revolution” has brought us to the point where we’re scanning the genome to try to cure, even prevent diseases.

“The future is not around the corner. It’s now.”
— Richard Weinshilboum, M.D.

A representative from the pharmaceutical industry, Lon Cardon, focused his talk around four main points: pharmacogenetics, drug repositioning, target validation, and electronic medical records. Target validation was the key point of his presentation. A late-stage failure, Cardon explained, which is where most of the failures occur, can take 12 years and costs $1 billion.

“We need to do a better job earlier with better target validation,” Cardon said. He challenged the genomics community to help the industry develop better drugs faster.

Lawrence Lesko, a former official with the FDA, talked about the critical role drug labels play informing the health care community. Lesko highlighted some of the recent history FDA drug labeling and how recent changes have started to include appropriate genomic information.  Today, Lesko contents, “The regulatory framework for PGx in labels is mature, multifaceted and more transparent with many drugs.”

With his experience directing the Vanderbilt DNA databank BioVu, a discovery resource that includes more than 175,000 samples linked to an electronic medical records (EMRs), Dan Roden talked about the role of EMRs in assisting genomic research and leading to discoveries not possible through conventional means. A leader in linking genes to diseases through EMRs, Roden elaborated on how a biobank of large data is the perfect tool to make new discoveries.

“People think this will give them answers in black or white. It’s not about black or white.  It’s all about Fifty Shades of Gray.”
— Dan Roden, M.D.

The afternoon started with three breakout sessions, including a lively talk on the controversial topic of predictive genomics. A Mayo Clinic researcher, a Direct-To-Consumer advocate with 23andMe, and an academician discussed the future of predictive genomics, the needs, the pitfalls, the costs. Other breakout sessions focused on genomics in cardiovascular disease, and clinical bioinformatics.

Rebecca Nagy brought to the IM Conference audience a first-hand look at the problems and challenges facing the genomic counselor. Genetic counseling is now becoming more genomic counseling. She talked about scope, approach and process that this change is dictating. The future is changing the role of the counselor, Nagy explained, but as we work out the process, “we have to make sure there’s not a lot of collateral damage for the patient in the process.”

The afternoon ended with a look at one of the true successes of genomic medicine: The Breast Cancer Genome Guided Therapy, known at the BEAUTY Study. Mayo Clinic’s Drs. Matthew Goetz and Judy Boughey explained the successes of the project and how they’re beginning the follow-up study, BEAUTY II.

After an exciting day looking at the future and power of genomics, hearing about the challenges, and being challenged to overcome the obstacles, people left the day knowing, as Tom Petty said, “Waiting is the hardest part.”

The 2014 Individualized Medicine Conference concludes tomorrow, October 8, which promises to be a last, exciting day of taking genomic medicine from promise to practice. If you’re unable to attend, follow along on Twitter at #CIMcon14.

Oct 6, 2014 · Individualizing Medicine 2014: Day One Recap

Gianrico Farrugia, M.D., Director of the Mayo Clinic Center for Individualized Medicine, took to the stage Monday morning to welcome nearly 500 attendees to the Individualizing Medicine 2014 Conference.  This third-annual genomics conference promises a practical approach to helping medical professionals discover and integrate genomics technology into routine patient care.

“We know we need to incorporate genomics into patient care. We have a moral obligation to bring genomics to the practice, and we have a moral obligation to do it right.”
—Gianrico Farrugia, M.D.

Clifford Hudis, M.D., immediate past president of the American Society of Clinical Oncology (ASCO), delivered the keynote address by challenging the participants to reexamine how we define value in cancer care. If the practitioners don’t, others will. He highlighted how the current way cancer drugs are developed and priced is not sustainable, that there is no relationship between cost and value.  Dr. Hudis predicted that changes are coming.

“Whether we’re for or against it, pressure is building in U.S. policy circles for the federal government to take action regulating the cost of drugs and technologies. Increasing access is crucial, yet thwarting innovation is a real concern.”
—Clifford Hudis, M.D.

Several informative presentations followed. Geoffrey GinsburgDuke University, offered a look at the future of genomics, and how we now have the opportunity to use genomics throughout the lifetime of a patient, in effect, from womb to tomb. Noninvasive Prenatal Tests (NIPT) is a success story in genomic medicine. Diana W. Bianchi, Tufts Medical Center, discussed how genomic testing has revolutionized prenatal screening for aneuploidy in a very short time.

Patrick GeraghtyCEO of Florida Blue, outlined the innovative policies that Florida Blue is bringing to the healthcare community, and challenged the attendees to rethink the future of healthcare is about packaging the right answer in a way that meets people where they are, how they want to receive it.

The afternoon brought a number of breakout sessions, including a lively conversation on the current state of reimbursement for genomic testing, trends in ethical and social issues for genomic research, and personalized medicine for hematological cancers. Gloria Petersen, a researcher and a biobank manager at Mayo Clinic, talked about the challenges and obligations, the goals and obligations of running a biobank.

Paul J. HergenrotherUniversity of Illinois at Urbana-Champaign, offered a detailed look at procaspace-3 activation for pet therapy, and how this relates to a forthcoming human clinical trials. Hergenrother confirmed that the dogs were veterinary patients in need of aggressive cancer treatment, not lab animals.

The 2014 Individualized Medicine Conference runs through October 8, and promises to be an informative and exciting look at the present and future of genomic medicine. If you’re unable to attend, follow along on

Oct 5, 2014 · Individualizing Medicine 2014: Pre-conference Session, The Physician's Odyssey

Mayo Clinic physician Timothy Curry and genomics scientist Matthew Ferber paired up to set the stage for the Individualizing Medicine 2014 Conference with opening remarks at the pre-conference session, an “Introduction to Genomic Medicine for Practitioners.”  They detailed how genomic medicine is now making the transition from technological marvel to bedside practice for physicians.

Timothy Curry, M.D., center, and Matthew Ferber, Ph.D., left, kickoff Individualizing Medicine 2014: From Promise to Practice at the Mayo Civic Center in Rochester, Minn.

Timothy Curry, M.D., center, and Matthew Ferber, Ph.D., left, kickoff Individualizing Medicine 2014: From Promise to Practice at the Mayo Civic Center in Rochester, Minn.

“Genomics isn’t just the future,” Dr. Curry said.  “Genomics is now.”

Over 150 people attended this introductory conference for practitioners, a preliminary session to Mayo Clinic’s third annual conference on genomic medicine.  The international audience received a tutorial in the fundamentals of genetic principles and were offered a primer on how genomics is making the rapid transition from promise to practice.

Three case studies—in oncology, pharmacogenomics, and diagnostics—detailed the physician’s odyssey in applying genomics to day-to-day practice.  Physicians, genetic counselors, pharmacists, and bioethicists provided attendees with insights and first-hand patient stories on how the science of genomics is being applied to clinical practices.  The three case studies demonstrated how practitioners are using genomic medicine to improve the quality of treatment for patients.

“This is truly a team approach to medicine,” Dr. Curry said.  “It is how we are bringing individualized medicine to the patients.”

The 2014 Individualized Medicine Conference begins tomorrow, October 6, and promises to be an informative and exciting look at the present and future of genomic medicine. If you’re unable to attend, follow along on Twitter at #CIMcon14.

Jan 14, 2014 · Pursuing Future Ventures in Biomarker Discovery

mss_0001287359Five business students from around the state have immersed themselves in our Biomarker Discovery Program where they are conducting commercial assessments of Mayo Clinic discoveries in cancer diagnostics. These students, who work with the Center for Individualized Medicine and Mayo Clinic Ventures, conduct a semester-long evaluation of molecular discoveries that could help oncologists better diagnose and treat T-cell lymphoma. These assessments include a summary of current diagnosis and treatment options, risks associated with current options compared to those with biomarker diagnostic schemes,  evaluation of possible tests, and viability of a biomarker detection scheme in a cancer diagnostic market (i.e. desirability, cost effectiveness, utility, and market size).

Cancer diagnostics represents an explosive market, with some segments expected to more than double in value each year, according to a recent report from market forecaster Transparency Market Research.

mss_0001287362

“The total global annual market for next generation cancer diagnostics was $776 million in 2010, and is growing at a compound annual growth rate of 47 percent, to reach a forecast market size of $5.3 billion in 2015,” according to the report.

The students complete their assessments with a final project that earns them course credits at their university or college, and provides valuable information for our intellectual property managers in Mayo Clinic Ventures, who seek to help bring discoveries from around Mayo Clinic to patients and providers around the world. The Mayo Innovation Scholars Program started in 2006 and forces students to tackle real-world problems at the intersection of science, medicine and business.

mss_0001287366Final components of the student portfolio include:

  1. Recommendations for a business pursuit regarding the biomarker after validation.
  2. Recommendations for a test that is marketable.
  3. Recommendations about the available market and customer base for the validated biomarker and potentially a developed test for the biomarker.
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