Immunotherapy, Bioinformatics, Devices: EPPICon 2017 Preview

 

One of the latest most talked about buzzwords in cancer treatment is “immunotherapy” where body’s immune system is used to wage a war against the cancer cells. Cancer cells divide rapidly than ordinary cells and manage to evade the immune system. The focus of a range of immunotherapies is to put body’s immune system on high alert so it can easily locate and destroy cancer cells.

This year, EPPICon (annual flagship conference at eppicglobal at www.eppicon.org) will focus on Immunotherapy, Bioinformatics, and Devices. Another recent buzzword, “bioinformatics” focuses on harnessing technological advances for management and analysis of data, for cancer immunology and immunotherapy.  The hope is that more reliable and comprehensive picture can emerge of tumor genomics landscape and that can point a way towards more effective personalized medicine.

Immunotherapy often involves delivery of a cocktail of immune drugs to awaken the body’s immune system and put it in a “ready” mode to get rid of the cancer cells. Implantable devices can be used to provide regular dosages of medication for several days or everyday for a few weeks and can be used to make localized delivery.  This convergence of technologies makes it an interesting time for treatment of cancer and other diseases.  

EPPICon, EPPIC’s all day conference will be held on Saturday, March, 25th at Crowne Plaza, Burlingame, CA and has a fabulous lineup of keynotes, speakers, and panels.

Morning keynote, Ira Mellman is VP of Cancer Immunology at Genentech and has an illustrious career in solving most profound health problems with strong research, grounded in science.  He spent 20 years at Yale University School of Medicine, prior to joining Genentech in 2007.  After the keynote, the conference program will continue with excellent speakers and panels with a special speed pitch session thrown in, where startups looking for funding will have an opportunity to pitch to a panel of investors and receive critical feedback, in real time. At the end of the day, 2017 “EPPIC Eleven” awards will be given out to chosen startups, from around the globe.

To register for the conference, please go to www.eppicon.org .

Digital Health Panel Preview – EPPICon 2015

EPPIC annual conference is on March, 28 and early bird pricing will end on Monday, March 16.  Here is a sneak peek at one of the panels.  

Technology is impacting health in interesting ways and many exciting innovations in digital health are expected to change how diseases are tracked, reduce inefficiency in healthcare delivery, reduce costs, improve access to healthcare, increase quality, save resources, and make medicine more personalized.  Digital health panel at EPPICon 2015 has diverse and interesting lineup of speakers.

Dr. David Persing, EVP, CMO, and CTO at Cepheid, had made an early resolve to have a positive impact on the world.  Guided by intellectual curiosity, while doing his pre-med, he discovered “the power of diagnostics”.  The company’s mission at Cepheid is to use the power of molecular diagnostics such that it would enable medical providers to identify and treat diseases early, increasing opportunities to improve patients’ survival and quality of life. Their cloud based platform, “The Digital Miasma” for monitoring of emerging infections earlier, is just launched and is in the implementation phase.

Panelist Deborah Profit is Director of Corporate Projects – Global Clinical & Business Operations for Otsuka Pharmaceutical Development and Commercialization.   OPC, is headquartered in Tokyo and is known for popular sports drink Pocari Sweat and energy drink Oronamin C.  OPC also developed Abilify, an approved drug treatment for certain mental illnesses, and as of 2013, annual sales of Abilify were over $8 billion a year, making it the highest grossing drug worldwide.  You would wonder what has that to do with digital health, until you consider the fact that patient non-compliance is one of the biggest challenges in many illnesses but specifically in mental illnesses.  Otsuka has recently made a deal with Proteus Digital Health for tracking medical adherence.  Proteus system includes sensor-enabled pills that embed intelligence into the pills so that their ingestion can be precisely tracked.  Personally, I am totally against drugs for mental illnesses, many of which do not work as expected; placebo effects are not well identified, clinical studies are often sponsored by drug companies and the list of side effects is daunting and being a psychologist, having seen side effects and heard them being discussed by my colleagues, I have developed absolute disgust for drugs for mental disorders.

Proteus “ingestible sensor” technology however, holds enormous promise for various indications, specifically for treatment and management of chronic conditions.  Otsuka plans to make use of Proteus Digital Health’s feedback system in its clinical R&D, presumably for its oncology products.

The next panelist, Dr. Marsha Rose Gillentine is Director of Biotechnology/ Chemical Group at Sterne Kessler Goldstein Fox, LLP and has intimate knowledge and understanding of patent litigation strategy in small molecules, ploymorphs, chemical synthesis, pharmaceutical formulations, methods of treatment, drug delivery devices, animal models, vaccines, polymers and more.  Her experience encompasses working with clients to implement lifecycle management strategies, specifically at it relates to personalized medicine patent portfolios.

Members of the Paris Medical Faculty (1904) André Chantemesse (1851–1919) Georges Pouchet (1833–1894) Paul Poirier (1853–1907) Georges Dieulafoy (1839–1911) Georges Maurice Debove (1845–1920) Paul Brouardel (1837–1906) Samuel Pozzi (1846–1918) Paul Jules Tillaux (1834–1904) Georges Hayem (1841–1933) Victor Cornil (1837–1908) Paul Berger (1845–1908) Jean Casimir Félix Guyon (1831–1920) Pierre-Emile Launois (1856–1914) Adolphe Pinard (1844–1934) Pierre-Constant Budin (1846–1907) (Photo credit: Wikipedia)

Jared Heyman is founder and CEO of CrowdMed, a brilliant innovative site that takes connected health to a whole new plane.  Often individuals afflicted with rare or neglected diseases, go from doctor to doctor, from pillar to post, just to accurate diagnosis and then they face whole set of new challenges for treatment.  CrowdMed is seeking to solve most challenging medical cases, worldwide, with speed and accuracy online, by harnessing the collective wisdom of the crowd.

The Digital Health Panel at EPPICon 2015, will be an exciting panel.  Agenda for the entire day looks very interesting and there will be plenty of opportunities for attendees to network and mingle with like-minded professionals.  The conference is on Saturday, March 28th at Santa Clara Convention Center, in Santa Clara, CA.  Early bird pricing has been extended till March, 16.  Please register for the event at the link http://tinyurl.com/o4cj3ow or from www.eppicglobal.org .

High Performance Computing Solution to Overcome Current Limitations in Mass Spectrometry

Jeff Peterson, Chairman at Veritomyx and CEO of parent company, Target Discovery, talked about how Veritomyx is focusing on convergence of high performance computing and state-of-the-art signal processing algorithms, to deal with the challenges encountered in identifying protein/isoform and metabolite biomarkers, due to limitations in mass spectrometry and supporting software.  The talk was in Sunnyvale, at event hosted by www.bio2devicegroup.org .

Modifications of proteins are responsible for exerting about 90% of the control of biochemical pathway changes. Accurate detection and validation of these changes offers hope for much stronger diagnostic insights into disease status and valuable treatment guidance decisions, enabling new effectiveness to advance the field of personalized medicine.  In turn, this is expected to help determine specific potential responses of therapeutic compounds in individual patients, allowing for more customized and successful treatment regimens.  Selection of properly validated therapies would save huge amounts of resources, money, and most importantly improve patient outcomes.

In the US, healthcare expenditure currently averages around $3T per year, said Peterson.  About 85% of that is spent on doctors, hospitals, ER, and end of life management.  Drugs make up only 12-15% of the total expenditure and diagnostics represent 2-3%.  The dawn of personalized medicine diagnostics now allows the right diagnostic to better select for the right therapeutic, and to minimize the patient’s descent into the chasm of other healthcare expenditures.  This paradigm shift is upending the value proposition in favor of newly recognized value in personalized medicine diagnostics leveraging overall healthcare expenditure decreases with improved outcomes.

A Shimadzu Ion Trap-Time of Flight mass spectrometer (center), HPLC-UV (left). (Photo credit: Wikipedia)

The search to find, identify and characterize new biomarkers across life science R&D efforts typically employs mass spectrometry.  In MS, ions from the unknown are accelerated and detected electro-magnetically, and software attempts to assemble puzzles of component ions into information identifying the unknown parent.  The output is typically analyzed in the form of a diagram, with X axis reflecting the masses of the individual ions, and the Y axis showing the  “relative abundance” of the ions detected.

 

However, current limitations in mass spectrometry, signal processing and identification algorithms often limit the availability of useful information.  Frequently, critical information remains hidden among overlapping peaks.  Overlapping peaks cause misdirection in mass and abundance results, delivering lower mass and abundance precision, and making it vastly harder or completely failing to correctly identify biomarker compositions.

English: Isotopic pattern of an peptide. Mass spectrum recorded by Q-TOF mass spectrometer. Polski: Obwiednia izotopowa peptydu zmierzona przy pomocy spektrometru Mas Q-TOF (Photo credit: Wikipedia)

The “PeakInvestigator™” software from Veritomyx, helps enhance the quality of science, saving critical time and R&D resources.  PeakInvestigator typically triples the effective resolution and reveals and precisely deconvolves overlapping peaks that go unnoticed by current mass analyzers and software.

Precision problems in the data not only waste a great deal of time, but they can misdirect attention and decrease the effectiveness of R&D efforts.  Abundance and mass errors produce spurious biomarker candidates and incorrect isotopic ratios for peak identification, said Peterson.  The PeakInvestigator software delivers up to 10X improvements in mass and abundance precision across a wide dynamic range when deconvolving previously hidden overlapping peaks.

The PeakInvestigator is based on statistically robust and reproducible methodologies, said Peterson and it enhances identification of unknown proteins, peptides, and metabolites to improve the ability to correctly detect and validate biomarkers.  Further, it’s advanced signal processing algorithms automatically adjust for differences in instruments and tuning variations.  These algorithms provide adaptive baselining and signal-to-noise thresholding.  This easy to use software solution eliminates the need for manual estimation of centroiding parameters or visual inspection of data before processing.  When summing up the advantages, Peterson also added that PeakInvestigator is being designed to be 21CFR11 and HIPAA compliant.

For companies interested in PeakInvestigator software-as-a-service solution, it can be easily integrated into the existing workflow.  Their simple public application-programming interface (API) inserts directly into company’s existing mass spectrometry workflow.  While already validated workflow remains intact, the PeakInvestigator algorithms can be leveraged on the existing data.  Currently Veritomyx has launched Free Beta Services collaborations for its PeakInvestigator deconvolution and centroiding software.  Free Beta Services will allow collaborators to apply certain PeakInvestigator high performance computing capabilities to their own mass spectral raw datasets at no charge.   Please contact www.veritomyx.com for further information.

 

OneMedForum – San Francisco, 2014

The OneMed forum conference was launched in January of 2008, when economy was showing all signs of progressing to new heights, with an objective to showcase innovation in medtech.  The conference aimed to bring together the companies and investors, during the large influx of healthcare investors and executives, during the JP Morgan Healthcare Conference, in San Franciso.  Fast forward to 2014 and we are perhaps just emerging from one of the worst recessions; a downturn that hit the medtech sector more than any other industry segment.

This year, the location of OneMed Forum was changed and the venue was moved further away from the JP Morgan Conference.  Since the weather in SF was gorgeous, it was not a problem; but if the venue continues to be further away in future, and in the event of cold and rainy weather, it can have an impact and lower the attendance at future OneMed events.  This year also OneMed event seemed to be sparsely attended, although that appearance might also be enhanced because the meeting rooms were spread out on two different floors and there wasn’t a single spill out location for the participants to meet and network – another problem with the venue.

There was also a palpable difference between the JP Morgan conference and the OneMed Forum, this year, in terms of optimism.  While biotech and pharma sector is returning to pre-recession levels with a large number of IPOs and higher numbers of dollars raised, medical technology companies have yet to see significant investment dollars.  On talking with the participants, I heard a note of disappointment regarding low attendance from VCs and other investors, just like in the last few years.

However, despite slow pickup and staggering growth in the medtech sector, it is transforming and the companies are learning to operate more efficiently.  It is also recognized that healthcare is at a critical point and medical innovation will have to address some key challenges.  Various panels and speakers at the OneMed Forum, addressed the changing healthcare landscape and how the future of health and medicine will need to be shaped, in the coming years to address the key issues. 

Major Highlights

Personalized Medicine Panel discussed the promise offered by customized diagnosis and treatments, in lowering the cost and increasing effectiveness.  Panel sessions addressing the JOBS Act and the Affordable Care Act, explored the impact of the legislation on cost of care and access to care.  Companies and solutions that may be poised to offer effective healthcare solutions and may also present interesting investment opportunities were highlighted.  In somewhat grim medtech landscape, digital health is emerging as the hottest new trend, with much potential.  The Digital Health panel discussed the impact of Affordable Care Act in increasing information transparency and empowered consumers taking greater control of their health information.  The changing role of the patients/ consumers will require change in the healthcare delivery and transformation in the business model.

A panel addressing “reimbursement strategy after the affordable care act”, discussed impact of medicare payment rules on medtech and hospital markets.  The panel also discussed trends in coverage and payment for newly emerging molecular diagnostic tests.  One key advice from the panel was that thinking upfront about the reimbursement strategy will be increasingly more important for companies with new, innovative products.  A panelist also suggested that during clinical trials, companies can also think about reimbursement and instead of doing only what may be required by the FDA, if they can also collect reimbursement data then they would come out ahead.  During innovation, the companies should relentlessly focus on disease management, and that would lead to them to appropriate and effective reimbursement strategy, advised the panel.

Financing and IPO issues were addressed in various panels.  One interesting panel on Crowdfunding discussed a handful of portals that are beginning to raise some capital for emerging growth companies.  One investor who was attending the panel, later told me, that it is too early to give an opinion on what kind of success this strategy would yield, but he had some grave concerns.    AdvaMed CEO’s Unplugged Panel featured some of top leaders of the MedTech industry, who shared their insights on key challenges facing the industry.  Stuart Randle, CEO of GI Dynamics advised startups to focus on crucial healthcare issues including obesity.  He also advise companies to pursue capital intensive strategy, and at least initially sell products outside the US.  Scott Brooks, CEO of Regenesis Biomedical, advised startups to get good legal and regulatory counsel early on.  Patrick Daly, CEO of Cohera Medical was optimistic about the future of MedTech.  “IPOs are coming back, M&A is picking up, and dollars are rolling in, big companies have record levels of cash, and I feel positive”, he said.

One of the most prolific financiers, Bill Hambrecht gave a keynote address.  Hambrecht has over 500 IPO’s to his credit that include seed level funding in nascent industries.  Although I did not attend the keynote, I heard some highly positive comments from an attendee.  Steven Burrill, who has been at the helm of innovation in healthcare and shares and who regularly shares his insights through his annual reports, gave a second keynote.  Again, I missed the address but both keynotes were major highlights of the event.  Throughout the conference, over 800 emerging companies gave presentations.  Following the presentations, partnering and breakout sessions gave the opportunity for conference delegates to meet the CEO’s of these companies.

Although it may seem hard to believe, it appears that now the MedTech sector has nowhere to go but up.  The industry has learned some hard lessons, the companies are lean, operating with greater efficiency, spending cash wisely, and instead of hawking next new technology, they are focused on key problems facing the healthcare industry, and on providing effective solutions.  If the healthcare providers are not eager to incorporate some of the solutions, then it will happen out of necessity.  It will become incumbent upon the healthcare industry to implement solutions offering greater ROI in terms of improved health and lower cost.  Healthcare providers will be looking for solutions that provide digital and point of care diagnosis and health monitoring and treatment options and solutions from personalized medicine and genomic health.  Let us stay tuned for some cool innovations from the MedTech sector in 2014.  Senior Analyst at Wells Fargo, Larry Biegelsen has also observed that not only acceleration in healthcare spending is expected in 2014 but there are number of other tailwinds including, “emerging technologies and emerging markets contributing more to growth and a more industry-friendly FDA, which should lead to faster approval times for medical devices”.   

 

“Solving the Challenges of DNA Sequencing for Molecular Diagnostics” talk by Stefan Roever, CEO, Genia Technologies

Stefan Roever (www.geniachip.com) began his talk (at http://www.bio2devicegroup.org) by affirming that in the future, without a doubt, molecular diagnostics will be dominated by DNA sequencing. Sequencing will be everything, said Roever. Using the blood test analogy, where when RBC count is needed, the physician might likely order a comprehensive profile, similarly in future, complete sequencing might be ordered. The high cost however, remains a big challenge. At the current cost of $50K to $100K for a sequencing instrument, the Molecular Diagnostics (MDx) industry cannot scale to support the vision of personalized medicine by complete gene sequencing. Without scale, there is little standardization as the existing companies use many different platforms. The existing DNA sequencers utilize a complex workflow and rely on complicated optics or amplification, which does not lend themselves to clinical utility.

Genia uses standard semiconductor technology that can enable massively parallel, single molecule DNA sequencing, that is highly accurate. Genia’s key proprietary innovations around the nanopore allow single molecules of single stranded DNA, to move through the pore slowly, so the sequence can be measured accurately. This single molecule, electrical, real-time analysis can be done without the need for complicated optics, labels, amplification, or fluidics. There are therefore, no amplification errors and it is better for rare event detection, like infectious disease. Genia’s technology also offers the ability to re-read. Genia’s key proprietary innovations, its automated bilayer pore setup, allows for scalability and ease of use. Also Genia’s IC achieves 30fA noise preference so the sensor itself is truly transformative and allows very small electrical signals (~0.2 pA current levels) to be seen high above the noise floor. This is a key challenge that many other nanopore companies are currently struggling with. The data shows that with highly accurate analog electronics and clever data analysis techniques, single base discrimination is possible, and adequate SNR can be reached to perform DNA sequencing. Genia’s mission is to “unify Moore’s Law with biotechnology to make genetic information universally available”, said Roever. By developing a true integrated circuit on standard semiconductor process technology, Genia is hoping that it will revolutionize the world of DNA sequencing.

Wish List in Open Letter to TiEcon 2012 (www.tiecon.org) Planning Committee

Dear TiEcon Organizers:

 

You have kicked off the planning for TiEcon 2012, with continuing goal to deliver the best TiEcon ever.  Successfully year after year, you have delivered a conference that is vibrant with opportunities for professionals, looking to advance their careers, staying connected with their peers, looking at staying in touch with the emerging trends, and looking for access to angels and VC community.  Year after year, you have exceeded the goal to deliver the best TiEcon, by adding new and exciting offerings, like TiE50, TiE Expo and more, by attracting the best and most sought after speakers and panels, and by keeping the enormous volunteer pool engaged, with exciting volunteering opportunities.  It is perhaps the only conference where hundreds of volunteers often spend hours toiling in the trenches, and then claim to get more out of this conference than at any other conference.

 

So what is going to be the focus this year?  Well, we have our wish list.  Readers, please leave comments about what you wish to see at this year’s TiEcon.  We hope to see more discussion on social media and where will be next disruption in social media.  Television has always been inherently social activity.  People gathered around the tube when TV was just introduced and friends still gather around the tube to enjoy sports events like Super Bowl, Academy Awards, and movies.  Will there be re-socializing television by integrating it with social media.  Is Pinterest the next big thing in social media?  Even in it’s “by invitation-only” beta phase, the company has attracted 7 million plus visitors and is driving more traffic to company websites and blogs than YouTube, Google+, and LinkedIn combined.  With growing cybercrime with huge and costly implications for corporations, how will we enhance network security?  Besides managing new and emerging systems, how will companies protect data and information?

 

Will TiEon focus on Energy and Life Science industries?  Despite the major Soyndra fiasco, we would like to see some discussions on solving energy challenges? Apparently, there are huge potential advantages to making cheap fuel from seaweed or macro-algae and Bio Architecture Lab inBerkeleyis currently building huge seaweed farms.  It remains to be seen how it will scale.  Will there be discussions on electric cars with durable and long lasting battery, even on harnessing solar power more effectively, and other potential breakthroughs to deal with the energy challenges.  I will absolutely love to see some serious focus on Life Science industry.  Some of the current major buzz words are the new frontiers of synthetic biology, wireless devices, and the continuing interest though not much progress in personalized medicine (with the exception of Herceptin and recent launch of Zelboraf).  Scientists will be heavily focusing on understanding the brain, and perhaps mapping the brain by zooming in on single neurons (brain has billions of them).  Understanding breakdowns within the neurons will enable targeted gene therapies, besides the current focus of personalized medicine, in oncology.

 

And finally, what new and innovative ways will the TiEcon enable entrepreneurs and other dedicated professionals to come together and leverage what each has to offer, to mutual advantage?  Each year, TiEcon has responded to the external opportunities and challenges with new offerings like extended and serious focus on Women’s Forum to encourage and ensure women professionals’ participation at TiEcon 2011, Outer Realm sessions at 2010 TiEcon, to challenge perceptual boundaries in technological, marketing, and cognitive realm and allow for cross-functional collaboration, Business Bootcamp sessions in 2009 to provide hands-on tips to the entrepreneurs, during the fledgling economy, and so on.  Now in 2012, the economy is on the path to gradual recovery but uncertainty and funding challenges linger.  We have high expectations that TiEcon 2012 will give yet again a positive boost to the professionals to follow their dreams, and offer sessions and strategies with tools and techniques, to enable them to achieve their dreams.  Readers, please leave comments about your wish list.

 

And friends, I have also heard some great info regarding best price offer for TiEcon 2012 that will be offered and will be valid only on February 21 and 22.  Stay tuned to my tweets and postings and I will share any news I get soon and don’t forget to register at http://www.tiecon.org.