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!

The Ambitious Goal of Harmonizing Global Biobanking

Biobanks have become an essential tool for advances in genomics and biotechnology.  Access to large specimen collections with associated patient genotypic and phenotypic data is especially important to biomarker discovery for cancers and genetic diseases.  There are numerous biobanks in existence, but no internationally-accepted governance process is currently available to standardize the many ethical, legal and social implications (ELSI).  Some of these issues include ensuring high quality samples and  data, appropriate patient consent, secure de-identification & storage of patient data and standardized practices for patient phenotype characterization.  Harmonization of biobanking operational procedures and policies is key to the ability to share specimens and associated data (1). 

Patient Privacy and Consent Issues

While there is general consensus on the need to address the issue of patient privacy, there is a general lack of consensus on implementation.  The “broad consent” model has been adopted by many biobanks in an attempt to solve the problem of making samples available for multiple projects.  However, some experts argue these are not really informed consents since aims of future projects cannot be specified (2).  Broad consents leave patients vulnerable to loss of control over their biological samples and so may result in decreased donor participation.  A “dynamic consent” model has been proposed which would allow donors to extend or revoke consent for new projects via a web-based system (2).

Ownership of samples is a hotly debated issue with the most well-known examples being the cases of Henrietta Lacks and John Moore.  In the US, the debate has centered on whether donated samples can be viewed as property (3).

Ursin et al. (4) provide an enlightening glimpse of how study patients perceive privacy and consent.  Their focus group results revealed that patients are primarily concerned with self-determination (control), harm, respect, freedom, confidentiality and discretion.  The most interesting insight was that patients view consent as the expectation that their sample will be treated with respect.

Securing Data-Linked Sample Information

The ability of biobanks to share patient data between multiple studies requires absolute assurance that sensitive patient information is protected. This includes secure de-identification methods as well as secure storage of genotypic and associated phenotypic data.  Tracker detection, anonymization of data sets and statistical blurring of query results are proposed technical strategies for preserving donor anonymity while allowing access to biobank information systems (5).

Progress in Global Biobanking Harmonization

Progress towards the goal of harmonization has been accelerated in Europe by initiatives funded by the European Commission.  These harmonization projects include Promoting Harmonization of Epidemiological Biobanks in Europe (PHOEBE), Biobank Standardisation and Harmonization for Research Excellence in the European Union (BioSHaRE-EU) and the International Society for Biological and Environmental Repositories (ISBER).  The BBMRI (Biobanking and Biomolecular Resources Research Infrastructure) consortium was formed to improve accessibility and interoperability of existing European biobank collections.  This consortium consists of 54 members with 225 associated organizations (mostly biobanks) from over 30 countries (http://bbmri-eric.eu/).  The preparatory phase of BBMRI is complete and implementation under the European Research Infrastructure Consortium (ERIC) is scheduled to begin in 2014.  Harris et al. (6) provide a comprehensive review of biobanking infrastructure, bridging and harmonization efforts in Europe.  Numerous other international organizations and initiatives are already in place to aid in the development of global biobank harmonization (1).  Although global harmonization of biobanking remains a daunting task, recent progress made by international organizations and initiatives suggest this ambitious goal is attainable.

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Welcome to our blog.  Our goal is to provide weekly updates about  regulatory compliance issues, legislation, technology breakthroughs, biotech/pharma mergers & acquisitions and any other news that impacts the molecular diagnostics community. This will be open forum for exchanging ideas and news important to molecular diagnostics products.  Looking forward to hearing from you!