Cloud-based eClinical Systems – Myths, Challenges & Opportunities

Al Gicqueau, CEO & President at Clinovo talked about Cloud-based eClinical Systems to make clinical trial process more efficient and cost-effective, at www.bio2devicegroup.org event.

Cloud has been a big buzz word, significantly impacting the economy, in the last few years.  Cloud is growing 3X faster than traditional internet infrastructure, said Gicqueau.  Worldwide public cloud services market will total to over $73 billion, by 2017.  There is also simultaneous cloud-bashing.  According to Citrix research, majority of the Americans don’t understand it and over 51% think it has something to do with the stormy weather.  Most also believe they have never used it but over 95% of us have used cloud based services.

It is therefore important to understand what constitutes cloud based services.  There are 5 essential components of cloud based services.
Self Service, On Demand: Cloud based services are available, when the consumer needs them.  Further, for the most part  they are autonomous and the user can perform the actions without going through the IT department.  They are easy to use and on-site training will increasingly become a thing of the past.  Any training required has to be available on-line and has to be very short and for the most part the service has to be intuitive and should not require training.
Broad Network Access: Cloud based services provide a broad internet access.  For instance, consider gmail.  It can be accessed through desktop, laptop, tablet, smart phone etc.  Cloud based services enable an ability to easily synchronize information over multiple devices.
Resource Pooling: Amount of traffic over the internet is rapidly growing. Because of the distributed nature of the internet, there is no single point of measurement for total internet traffic.  But it is a fact that the total global IP traffic will pass the zettabyte threshold by the end of 2015.  By the year 2017, the total internet traffic is expected to reach 5.3 zettabytes.  To put it in perspective, if the 11 oz coffee on your desk equals one gigabyte, a zettabyte will have the same volume as the great wall of China!  Cloud based services enable customers to pool their resources and save cost.

Rapid Elasticity: In the world of internet activity there are lot of peaks and valleys.  Cloud can scale based on demand peaks, without incurring penalty for the period of low traffic.
Measured Service: Cloud offers and ability to pay as you go.  People can pay for the internet infrastructure as they pay for electricity.
Some of the examples of cloud based services include, SalesForce, Netflix, Gmail and Amazon.

Clinical Data Trends

Spiraling costs have been a grave concern in healthcare.  Typically, efficiency has not been very high in the area of healthcare. Costs of clinical trials is likely to increase even more significantly, in future, on account of increasing costs of medical research and changing and tightening regulations, among other things.  Increased costs for clinical trials will push the cost of drugs higher.  On the other hand, there is strong public criticism of higher costs of medicines and there is a lot of pressure on drug companies to contain costs.  Companies have pressure to cut the middle layers and manage clinical trials on their own.  Citing CISCRP (Center for Information & Study on Clinical Research Participation) study, Gicqueau said, currently, only 6% of clinical trials are completed on time, whereas 72% run late by over a month.

Compliance issues and regulations specified in 21 CFR, part 11, prohibit use of public cloud, for clinical data.  Clinical data has to be stored in a private cloud.  Clinovo’s ClinCapture is a cost-effective EDC (electronic data capture) system.  It is tailored to specific clinical studies teams and offers intuitive navigation and one-click access to routine functions.  It reduces time for data entry.  ClinCapture is also flexible and can be customized and deployed rapidly.  “We validate our software like medical devices are validated”, said Gicqueau.

Mobile is next major trend, as more data entries are happening through tablets and smart phones.  Tables are also very useful in remote regions of the world where cell phone reception may be spotty or non existent, where information can be easily synchronized later.  Data entries can also be structured  by getting patients involved.  Data integration is another big challenge.  Everyone hopes to make sense of the data and make meaningful use of the data.  However, making sense of the data and putting it to good use remains expensive.  Gicqueau said, meaningful data integration is another promise of the cloud.

Clinovo is launching CloudClinica, next generation, cloud-based eClinical platform.  With its easy to use, pay as you go platform, CloudClinica will eliminate IT dependency and allow small companies  to manage clinical studies in a sophisticated manner, without high level programming skills.  About 30% of cost and 60% of time associated with clinical trials is about data management, and almost 80% of clinical trials are still conducted on paper, said Gicqueau.  Paper has many pitfalls.  Paper can get lost, it is inefficient, there is challenge of mis-reading someone’s handwriting, it has regulatory risks and other hidden costs.  CloudClinica is FDA compliant and it can scale.

Clinovo had revenues of over $4 million in 2013 and raised $500,000 from business angels over the last few months to execute on their business strategy.   The company is profitable, and has 30+ clients that include Gilead, Roche and others.  Clinovo is now targeting small to mid-size companies, said Gicqueau.  Current market of $2.3 billion can be rapidly growing in the coming years.  MediData and Oracle are two dominant players but are relatively more pricey.    Clinovo’s CloudClinica will fill in the gap and broaden the use of eClinical systems and will empower and bolster the biotech, pharmaceutical, and medical device companies, said Gicqueau.  The event was followed by Q&A.

Neglected and Rare Diseases Panel

EPPICon 2014 (www.eppicglobal.org) will address the important topic of developing therapeutics for rare and neglected diseases.  So what are rare and neglected diseases?   Rare diseases are diseases that affect a small percentage of the population, most of them are genetic, and may be present throughout a person’s life.  In the United States, rare diseases are defined as those that affect fewer than 200,000 people.  About 7,000 diseases have been designated as rare and as many as one in ten Americans may suffer from a rare disease.  More rare diseases are discovered ongoingly.  Despite the growing numbers of rare diseases, the overall numbers are small and therefore they had not been a focus of research and many do not have treatments available.

Neglected diseases have also not been a focus of great deal of research and many of these diseases also lack viable treatment options.  These include tropical diseases like Tuberculosis and Malaria and affect over 1.4 B people, worldwide.  Often these affect the most vulnerable populations in the developing world, who lack access to basic sanitation, healthcare, and clean water.

A panel moderated by Roopa Ramamoorthi will discuss how companies and researchers can engage and bring forward cures for these diseases.  Rmamoorthi is an experienced scientist with extensive background in global health, drug development, biotechnology, bacteriology, and engineering.  As an Associate Director for Partnering and Scientific Affairs, at BioVentures for Global Health, Ramamoorthi leads the efforts to match researchers with pharma and other contributors, with an aim to accelerate product development for neglected tropical diseases like TB and Malaria.

Panelists include David Swinney, CEO of iRND3 (Institute for Rare and Neglected Diseases Drug Discovery).  Swinney has 20+ years of broad experience in preclinical drug discovery.  He founded his current non profit, in 2010, with a mission to help discover new medicines for rare and neglected diseases.  The equipment for its lab in Mountain View was donated by Roche, and three early stage drug discovery programs at iRND3 have focused on pediatric cancers and parasitic diseases.

Eric Easom is the VP of neglected diseases at Anacor Pharmaceuticals, and Vimal Srivastava, is VP or Product Development, at Ultragenyx Pharmaceuticals.  Anacor is focused on discovering, developing and commercializing novel small molecule therapeutics derived from its novel boron chemistry platform.  Ultragenyx is committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with an initial focus on serious and debilitating, metabolic genetic diseases. On the panel, they are likely to add the big pharma perspective regarding focusing on neglected and rare diseases.

Ponni Subbiah, MD has an extensive experience in global medical affairs and clinical development across multiple therapeutic areas in the pharmaceutical sector.  Currently, in the role of Global Program Leader, Subbiah is leading drug development efforts, at PATH, a nonprofit organization, with a bold vision for improving health, worldwide.  PATH seeks to blend the entrepreneurial side of the business and the scientific expertise of a research institution with on-the-ground experience of an international NGO.

Other interesting panels at EPPICon include, “Innovations in Clinical Development of Novel Agents” and “Point of Care Gold Rush – Hype versus Reality”.  Besides keynotes and networking opportunity, the conference will also feature a Speed Pitch session where entrepreneurs of early stage companies in the life sciences, are invited to give a five minute pitch about their technology and receive a quick feedback from a distinguished panel of VCs.

EPPIC is a volunteer driven organization, with a mission to promote networking, entrepreneurship, and mentoring for life science professionals.  All day EPPIC conference will be held at The Westin, San Francisco Airport, in Milbrae, CA, on March 29, 2014.  For more details and to register for the conference, go to www.eppicglobal.org .  Please note: Early bird registration is extended to March, 7.  EPPICon has an excellent lineup of great speakers and panels.  This is not a conference to miss for any life science industry professional.  Hope to see you there.

Critical Attributes in Leaders at Various Stages of Leadership Journey

EPPIC, an entirely volunteer driven, non-profit organization, found with a mission to create a forum to leverage entrepreneurship, mentoring, and networking opportunities in life sciences, celebrated its 15^th anniversary, at TiE office, in Santa Clara.  The event, sponsored by Genentech, was attended by 110 life science professionals, and served as an early introduction to 2014 Eppic Annual Conference, scheduled for February 1, 2014, at Westin, South San Francisco.  The agenda for this anniversary event included 3 excellent panels and concluded with a keynote by Ann Lee, Senior Vice President of Global Pharma Technology Development at Genentech/Roche.

Here is the brief synopsis of the keynote.  Lee shared her own personal leadership journey and discussed the critical skills necessary at various stages of leadership for anyone following a similar career path.  During entry into the professional world, as a research fellow, it is critical to have technical expertise and grit to take the initiative and making contributions of value.  On the next step in the leadership journey, at the level of Director, one assumes greater share of managerial responsibilities and providing effective leadership to the teams.  At this time, hiring the best, becomes a critical responsibility.  As one progresses to Senior Director level, ability to communicate effectively with the seniors, becomes crucial.  This is a transition from technical mindset to be able to hone in on key points and communicate them effectively.  It also becomes important to focus on providing guidance and developing others as it is increasing not about you along, but increasingly it is about others in the team.  Lee emphasized that authenticity becomes critical as people will watch for congruence between what you say and what you do.  Greater self-awareness will enable greater authenticity, said Lee.  At VP and Senior VP level, one requires courage because one may be called on to make many tough decisions including work force reductions, killing a multi-million dollar project that may be eating up resources and so on.  Principle centered approach can effectively guide a person in making those critical decisions.  And just as one influences an organization with their decisions, organizational values also play a key role and guide the decisions, of its leaders.  For instance, Genentech takes great pride in being patient-centered company and decisions are often made after considering the impact on patients.  At this stage, leaders also have to focus on strategy and change and have to lead with a long-term vision, as opposed to fighting fires.   People look to the leaders for inspiration.  Mindfulness or daily meditation can help a leader be more effective, said Lee.

Lee then discussed Genentech/Roche’s commitment to diversity.  (In addition to recruitment for biotech and medical device companies, I also offer corporate trainings on diversity and global inclusion and in 2010, I did training for almost 400 Medtronic employees in India http://bit.ly/W33tZ2, and this part of Lee’s talk was very interesting to me.  Here is a link to my interviews http://bit.ly/ZpNwhN ).  Lee said that her company employs 2200 people, at 4 different sites, with a lot of functional diversity. Working across cultures is frequently challenging, because there is often distrust, preconceived notions, and logistics challenges, including ill timed phone calls, that exacerbate problems.  Instead of delving immediately into work, it is often more productive to set aside time for getting to know people and develop personal relationships, with team members at remote locations.  When working through preconceived notions and unmet expectations, it is important to maintain a balanced perspective and give credit for positive intent, and to seek to understand before being understood, said Lee.  Genentech/Roche has a commitment to increasing the number of women in the workforce and make opportunities for advancement, available to women.  However, it is not about quotas, said Lee.  A diverse workforce enhances and enriches the entire team and increases the diversity of thought, which in the end always leads to better problem solving, greater creativity and higher productivity, she said.

Lee also touched upon importance of work-life balance and flexibility in an individual and within an organization.  In the end, it is always about relationships.  Relationships with colleagues, allies, coaches, and sponsors are all different and need to be maintained differently.  For instance, coaches may talk to you but mentors talk with you and sponsors may talk about you, sometimes even when you are not present.  Summarizing and sharing the learnings from her own leadership journey, she said “be authentic, have greater self-awareness, and play to your strengths”.  Additionally, “you need to pursue your passion, do what you love, be resilient and face challenges head on”.  And finally, “remember that relationships matter and define your own path to fulfillment”, said Lee.

A sign at Genentech headquarters in South San Francisco, California. (Photo credit: Wikipedia)

EPPIC will host its Annual Conference on February 1, 2014 at the Westin in South San Francisco.  Mark your calendars for a great conference with excellent keynotes and panels on a variety of topics and watch out for preview blogs on the event.  Register early at www.eppicglobal.org, before the event gets sold out.

Bio-IT to Biotech: BioImagene & CellWorks Success Stories at EPPIC event

About EPPIC

The fusion of Biology and IT is likely to continue to revolutionize and optimize healthcare.  EPPIC, a premier organization started in 1998, from its inception, leveraged and blended existing Silicon Valley resource, in terms of pharmaceutical, biotech and IT professionals.  In the upcoming event, EPPIC will feature two of its prominent members who benefited greatly from the networking and mentoring opportunities available through EPPIC and have achieved great success with their Bio-IT companies.  EPPIC promotes networking, entrepreneurship, and mentoring for life science professionals, in additional to helping create US-India life science synergy.  The two success stories that will be featured in the upcoming event, not only received guidance and mentoring, but also found the funding.  They both were funded by Artiman Ventures.  Artiman has been affiliated with EPPIC and has strongly supported EPPIC, from inception.  Artiman Ventures invests typically in “white space” technology and are looking for technologies that integrate multiple disciplines and offer brand new revolutionary approaches to touch problems.

When Mohan Uttarwar first conceived of his idea for BioImagene, he discussed his idea with Nagesh Mhatre, one of the founders and board member at EPPIC and Partner at The Angel’s Forum, Halo Fund.  Mhatre did not see merit in the idea, but Uttarwar did not quit.  With constructive feedback and mentoring, Uttarwar refined and polished his idea and the rest is history – as you can see below.  Similarly, Pradeep Fernandes, President and co-founder of CellWorks Group Inc. credits his success largely to the mentoring and networking opportunities he received, through EPPIC.  Fernandes spent most of his career in the semiconductor and software algorithms domain and was a relative novice to the life science industry.  However, valuable mentoring, along with his insightful application of his software expertise to solve life science industry challenges, led to the success he has achieved today.  Go to www.eppicglobal to register for the event below.

BioImagene

Recently Roche forked over $100 million to acquire BioImagene, Inc., a privately held company, in the emerging field of digital pathology.  What is digital pathology and why it is poised for growth?  The new technologies in the realm of digital pathology enable capture, information, analysis, sharing, and storing of information, including patients’ tissue samples, with greater efficiency and lower cost.  Moreover, unlike the analog age of glass slides, where pathologists frequently did the analysis and sent the information over to the physicians in charge of patient care, the pathologists today are increasingly involved in treatment decisions.  New and sophisticated tools greatly enable better and more accurate diagnosis.  BioImagene offered digital pathology application software iScan, a family of automated digital scanners, along with unique image viewing input device called the iSlide.  Additionally, the hardware and software came with a rich menu of Companion Algorithms, to help arrive at better decisions.  Mohan Uttarwar, founder and CEO of BioImagene will be speaking at EPPIC event on Monday August, 5.

Uttarwar is a serial entrepreneur, with 25+ years of experience in high-tech and bio-tech area.  He was co-founder and CEO of Roamware Inc., a leading wireless roaming software company; was founder and CEO of SoftPlus, a leading provider of eCRM software for telecom carriers around the world; and had co-founded and served as CEO of Digital Tools Inc., a leader in enterprise project and resource management software.  SoftPlus was acquired by US interactive for $360 million, in March, 2000.  Uttarwar is now founder and CEO of  OncoMDx/Core Diagnostics  Lab that focuses on Cancer Diagnostics both in US and India. It does translational research to come up with Lab Developed tests for patients stratification using novel bio-markers (personalized medicine) and early detection of Cancer, with a goal to connect any patient from any part of India, for second opinion, from any expert in USA. It has been funded by Artiman Venture (who also funded BioImagene).

     Mohan Uttarwar

CellWorks                                                                 Pradeep Fernandes

CellWorks Inc., founded by experts in software and semiconductors, recently received $10+million series B round at the end of 2012, with Sequoia Capital leading the round.  They had closed a $7.5 million in Series A, funded by Artiman, in 2009.  Pradeep Fernandes, President and Co-founder of Cellworks, spent most of his career prior to Cellworks in semiconductor world.  He was VP and GM of Synthesis Solutions at Cadence Design Systems, which acquired Get2Chip in 2003 and under Fernandes’s leadership, Get2Chip became one of the most externally recognized and fastest growing product in Cadence’s product lineup.  Prior to Cadence, Fernandes served on executive teams at TriQuest Design Automation and CyberX.

CellWorks is designing novel therapies, using proprietary dynamic and responsive disease models.  Scientists at CellWorks mine vast repositories of known information about drugs, protein interactions and genetics to predict the outcomes in humans.  Thus integrating biology and computing, the focus is to dramatically reduce spending for developing new therapies.  Each year, an estimated $100B is spent worldwide, for pharmaceutical R&D.  The cost for development of each new drug?  A staggering $1 to $4 billion!  Don’t miss the chance of to hear how CellWorks has created a pipeline of validated therapies for RA and Oncology in record time of 6 months, from computer to validations, using their proprietary platform.

The event is on Monday August, 5th from 6 to 9 pm at The Westin, San FranciscoAirport in Milbrae.  Go to www.eppicglobal.org for more information and to register for the event and to sign up to become a member.