Is Your Startup Company Developing a New Product? Only 3 Days Left to Register!

Join us for this must attend event as expert panelists share their tips on how to move your product from concept to commercialization. Learn what you need to know to develop diagnostic, medical device or digital health products for the healthcare, point of care and life science markets. Network with industry colleagues and checkout startup resources offered by exhibitors while enjoying craft beer & light snacks.

Sponsored by Molecular Diagnostics Consulting & Fallbrook Engineering

Panelists and topics:

Operations and Process Control
Marliese Bartz | Principal, Bartz Consulting

Marketing
Iryna Clark | Marketing Consultant, InceptPoint Consulting

Business Development
Madhushree Ghosh | Head, Alliance Management, Althea Dx

Patents and IP
Susan Gorman | Principal, Gorman IP Law

Funding
Martin Kleckner | Senior VP, SBDC TriTech

Regulatory
Mark Sarno | President, Vision Biotechnology Consulting

Don't miss this Nov 6th event! Click here to register. 

Digital Tech Meets Healthcare: Great Potential & New Challenges

Digital Tech Meets Healthcare: Great Potential & New Challenges
by Sylvia Norman, PhD, PMP

The Potential
We've all heard about wireless wearable devices that help you track physical activity, eating habits, sleep patterns and weight. Useful tools indeed. More recently though, wireless tech has broadened its focus to include the healthcare market. New digital health devices are being developed that help diagnose disease onset, monitor chronic diseases and improve quality of life for disabled and aging populations.

Here are some of my recent favorites:

The FingerReader - a team at MIT is developing this wearable audio device to help visually impaired individuals read printed or electronic text.

Google Diabetes Contacts - a contact lens being developed by Google and Swiss pharmaceutical company Novartis that will track glucose levels in diabetics.

PEEK Vision iPhone app - brings the ability to diagnose vision impairment to developing countries. This smartphone app scans for visual acuity and can be used to diagnose glaucoma, macular degeneration and cataracts.

The Lively Sensor - San Francisco based Aging 2.0 works with other companies to develop tech products for the elderly. The Lively sensor will help family caregivers remotely monitor whether an elderly parent has taken their daily medication and performed other important tasks.

A Digital Health Forum at the recent 2014 BIO International Convention highlighted the vast market potential for digital healthcare. Panelists discussed benefits like increased patient access to healthcare, decreased medical cost, increased patient engagement, improved chronic disease management and disease prevention.

The Challenges
The panelists also pointed out that this promising technology brings it's own set of challenges. Our healthcare reimbursement system, FDA regulatory policies, patient data management infrastructure and patient privacy policies are not ready for digital health. These factors combine to have a negative impact on both digital health innovation and the willingness of health providers to use new digital health technology. A recent blog article by Jean-Luc Neptune, MD provides an informative assessment of current roadblocks to digital health innovation.  

The Future
The convergence of tech and biotech to develop new digital health products has enormous potential to improve the healthcare industry for both patients and providers. Yes, there are many challenges ahead, but dialogues to address them are in progress. For example, possible alternative reimbursement models are being discussed. In June 2014 the FDA released draft guidance to decrease regulation of medical device data systems (MDDS). The FDA stated it "recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data." At a recent local regulatory event, Dr. Camille Nebekker, Division of Behavioral Medicine UCSD, discussed the ethical and regulatory challenges presented by digital health. She is currently working with IRB boards to help define and mitigate unique privacy issues for subjects enrolled in clinical trials utilizing digital technology. 

It's an exciting time for digital technology and healthcare. The convergence of these industries brings many new innovations and many challenges. Going forward let's remember this quote from Winston Churchill "the pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty."


Dr. Sylvia Norman is the Founder and Principal Consultant at Molecular Diagnostics Consulting.
Molecular Diagnostics Consulting Website
Molecular Diagnostics Consulting LinkedIn Company Page

Just Say Nay to the Naysayers

Just Say Nay to the Naysayers
by Sylvia Norman

"That will never work", "We tried that years ago", "You're wasting your time", "It can't be done". How many times have you heard these comments after presenting an innovative idea? Are they right? Maybe. Should we listen to them? NO! Well, at least not until we examine the real meaning behind the Nay.

There is nothing new about Naysayers. They've been at it for a long time. You've heard the saying "There is nothing new under the sun." Well that was written thousands of year ago. If innovators had believed THAT, the agricultural, industrial, digital and biotech revolutions would never have happened. Luckily, innovators thrive on a good challenge and aren't easily discouraged. The idea for the first Apple computer was rejected 5 times by Hewlett Packard, but that didn't stop Apple co-founders Steve Jobs and Steve Wozniak. They pitched their idea to other companies, assembled their first computers in a garage and the rest is history.

The truth is, sometimes naysayers are right and our idea will fail, but sometimes they are wrong. So what is the best approach when faced with all this negativity? Just say nay to the naysayers, then take a look at the real meaning behind their words. It may be true that some version of your idea was tried in the past. But so what? Did it fail because there wasn't a market for it? Maybe that's changed. Maybe there's a niche market that was never explored. Has new technology been invented that will make it work now? Did the idea fail for lack of funding or because it didn't align with corporate goals? Did it languish for lack of persistence? These are all good questions to ask yourself. They'll help turn the negative into a positive motivation. They'll help you focus on the important questions and maybe even shed light on new inspiration.

In a recent interview, our society's most prolific innovator called on the biotech industry to find innovative breakthroughs in clean energy, access to vaccines, cures for cancer, diabetes, Alzheimer's and other diseases Richard Branson BIO 2014 Interview. Oh and by the way, he mentioned a $20M prize for extracting carbon out the earth's atmosphere to help control climate change. Now that's a clear call to action! In his keynote speech Richard Branson challenged the audience to "innovate in everything you do." A clear call to make creative, positive changes in every aspect of our lives -  professional and personal. So next time you encounter a naysayer, just say NAY then go out and INNOVATE.

New Priorities for Biotech in the Global Market

New Priorities for Biotech in the Global Market
by Sylvia Norman, PhD, PMP

Dr. Trevor Mundel, President of the Global Health Division, Bill & Melinda Gates Foundation provided an inspiring start to the 2014 BIO International Convention forums on Emerging Opportunities in Global Markets. In a plenary session interview with journalist David Brancaccio, he discussed the soon-to-be released 2013 Global Burden of Disease Study. The study focused on the 70 poorest countries of the world and identified infectious diseases (TB, malaria, HIV, childhood pneumonia, etc.) as the highest priority for disease prevention and treatment. Dr. Mundel said that in spite of technological advances in vaccines and diagnostics, mosquito netting for beds remains the most cost-effective intervention against malaria. Why? Current vaccines and diagnostics for infectious diseases do not address the developing countries market need for low-cost products, distribution and long-term ambient temperature shelf life.

When asked for a list of the Gates Foundation's top priority biotech products, Dr. Mundel responded:
1) an infection control surveillance device that detects if a person in the room has an infectious disease
2) biomarkers for predicting risk of preterm birth

Poor return on investment (ROI) is frequently cited as a reason for not developing products for use in developing countries. David Brancaccio and Dr. Mundel said that every day 20,000 children die of treatable diseases. The majority of these occur in developing countries where infectious diseases, not diabetes or cancer are the primary cause of disease-related deaths. With a statistic like that, isn't it time for our Biotech industry to realign our priorities and broaden the definition of ROI?

Check out the BIO Buzz Center interview with Dr. Mundel for more information on how Biotech can help prevent deaths from treatable diseases in developing countries.

Biotech Opportunities in Emerging Markets - 2014 BIO Updates

Biotech Opportunities in Emerging Markets - 2014 BIO Updates
by Sylvia Norman, PhD, PMP

One of the highlights of the 2014 BIO International Convention in San Diego June 23-26, 2014 will be the forums on Emerging Opportunities in Global Markets. Marketplace Morning Report host David Brancaccio will kick-off the program with an interview of Dr. Trevor Mundel, President of the Global Health Division, Bill and Melinda Gates Foundation. The 3 day program includes half day sessions on China's biotech industry, Russia's pharmaceutical industry and the biotech/pharma landscapes in Brazil & India. Additional sessions on emerging markets in Africa and the Middle East, updates on patent & regulatory policy trends and trade agreements will round out the schedule.

In recent years, economic woes, political turmoil, regulatory compliance issues and allegations of misconduct have seemingly dimmed the once bright prospects of investing in emerging biotech/pharma global markets. Or maybe not. Just last month Sequoia Capital announced a $530 million investment fund intended to benefit healthcare and technology startups in India: India Tech and Healthcare Startups Investment. In April 2014 the formation of the Brazilian Industrial Biotech Association (ABBI) was announced. This new trade association collaborative between Brazil and leading global biotech companies & institutions has the goal of promoting interaction between stakeholders, policy makers and the public to improve Industrial Biotech R&D funding, regulatory policy and patent legislation. Global partnering with China biotech/pharma and recent US facility expansions to other Asian countries is on the increase.

The 2014 BIO convention program on emerging markets and daily International Market Briefings provide a great opportunity to learn the current status of global market biotech/pharma collaborations. The Exhibit Hall International Pavilions and hospitality receptions will provide welcome opportunities to network and explore synergies between businesses. Stay tuned this week as I explore opportunities to bring global collaborations to my business.

LONGEVITY - Genetics, Diagnostics and a Good Attitude

LONGEVITY – Genetics, Diagnostics and a Good Attitude

This week my mom will be celebrating her 100^th birthday. Relatives and friends will be arriving from all over the country to help her celebrate this momentous occasion. It seems like we hear of people reaching this milestone fairly frequently, but it still has the power to amaze. People who don't even know my mom have asked me to relay their heartfelt congratulations. The most amazing part is that my mom doesn't think she’s “old”. In her mind, she’s at least 20 years younger. Mom keeps up with current events, plays cards, makes new friends and remembers things I've long forgotten. In fact, until 3 years ago, mom was living by herself on a farm, gardening and mowing her lawn. Good health, a sharp mind and a willingness to keep learning new things – isn't that what we all hope for in our senior years?  But how do we make sure we attain that? Can we somehow avoid the diseases that plague many senior citizens e.g. Alzheimer's, Parkinson's, Type 2 diabetes, strokes, heart disease and cancer? Or are we at the mercy of our family genetics?

Recently, we've been hearing a lot about 2 research projects addressing these questions by utilizing advances in genetics and medicine to look for clues to longevity - The Human Longevity, Inc project and The 90+ Study.

The Human Longevity Inc project  - Dr. J. Craig Venter recently announced the goal of his new company, Human Longevity Inc.(HLI), is to sequence the genomes of over 40,000 individuals per year to identify ways to live longer and healthier lives. HLI co-founder Dr. Peter Diamandis apparently agrees with my mom's view of her age, declaring "100 will become the new 60".

The 90+ Study - The University of California, Irvine 90+ Study compiled physical, cognitive and questionnaire data from 1600 retirement community residents over the age of 90. In a recent interview, Dr. Claudia Kawas revealed a few surprising results e.g. taking vitamins didn't contribute to longer life, moderate alcohol consumption (2 drinks/day) increased longevity, exercising just 15 minutes per day and keeping socially active also contributed to extended life expectancy. The 90+ Study has been granted an extension to include PET and MRI scan experiments to study Alzheimer's and other forms of dementia in this population.

How will sequencing genomes and PET/MRI scans help unlock the secrets to longevity? Understanding the genes and biological pathways contributing to diseases like Alzheimer's, Parkinson's, Type 2 diabetes, strokes, heart disease and cancer will help physicians find more effective ways to diagnose and treat these diseases. Molecular diagnostics and personalized medicine will play a primary role in this effort by providing medical tests that physicians can use to monitor the health of aging patients and determine the best course of prevention or treatment of age-related diseases.

It's important to keep in mind that advances in longevity genetics, diagnostics and medicine won't translate into eternal youth anytime in the near future. We can still expect to acquire certain diseases, gain weight, move slower and look older as we age. That's where the good attitude comes in. Mom wakes up every day looking forward to what new surprises and challenges life will bring her. In fact, I'm sure that attitude is at least partially responsible for her longevity. Happy 100th Birthday, Mom!