Lean LaunchPad for Life Science Entrepreneurs

Recently, Karl Handelsman, Founder, Codon Capital, talked about the Lean LaunchPad Entrepreneurship program, at www.bio2devicegroup.org event.  Handelsman, with Allan May (Managing Director at Life Science Angels), are instructors in the Lean LaunchPad for Life Sciences program at UCSF and also will be teaching at NIH, in the future.  Handelsman is the Therapeutics cohort and May is the Medical Device cohort.

It is a mistake to assume that pre-clinical programs are risky and they need to focus on easier low hanging fruit or they must take 10+ years and a billion dollars to create value, said Handelsman.  We have a duty to search for the path to unlock the value of the idea as industrially relevant innovation, and there are examples of biotech startups reaching that point in 18-30 months, said Handelsman.  Lean LaunchPad program teaches scientists and clinicians in startups to do a real world assessment of their idea or technology, before plunking down millions of dollars, in an idea.  Entrepreneurs receive training in determining their product’s market viability, regulatory risk, potential clinical utility, and also likely financing vehicles before making big dollar investments in research, design, and manufacturing.

English: Molecular graphics images were produced using the UCSF Chimera package from the Resource for Biocomputing, Visualization, and Informatics at the University of California, San Francisco (supported by NIH P41 RR001081). PDB rendering based on 1a8e. (Photo credit: Wikipedia)

Entrepreneurs need good operational models that build a context of value creation, said Handelsman.  Investors like value, not milestones.  “Investors want to invest money and they want to hear a business case, and operational milestones don’t get you there”,  stressed Handelsman.

Big things often have small beginnings and start with contributions from many small pockets.  Sharing the case of a company that started with collaboration and became the behemoth, Genentech,  Handelsman said, entrepreneurs need to start thinking about collaboration, not competition, and begin to look at models of collaboration that would create true value.  After all, strategic alliances built the Silicon Valley and there are many diverse and creative ways of creating partnerships.  Entrepreneurs need to talk with others and be really good listeners.

Successful entrepreneurs are not thoughtless risk takers, but approach problems in a disciplined way.  Value creation for therapeutics begins with thoughtful consideration of who would benefit from solving a certain problem; patients, payers, insurances companies or any other entity?  Once entrepreneurs can figure that out, they can go to a VC and explain the business case.  Value creation, after all, is not what entrepreneurs think or believe, but an idea or concept that gets external validation from the customer.  “Do not constantly worry about keeping the concept in the stealth mode, and talk to a lot of people”, advised Handelsman.  VCs do not count, they are not potential customers.  In the end, one could have a sexy product, but if it does not solve a pressing problem then it is not creating value.  Real answers to key commercialization questions, in the case of therapeutics, lie outside the lab, and entrepreneurs need to actively engage and talk with customers, partners, regulators and so on to figure out the value of their product.  Lean LaunchPad methodology therefore, helps to validate the product, before commercial strategy is considered, saving time, money, resources and in some cases, helping guide the change in the trajectory, for more meaningful outcome.

 

Diabetes & Cardiovascular Disease Risk Factors among South Asians Compared to other Ethnic Groups

Dr. Alka Kanaya talked about Diabetes and cardiovascular disease risk factors in multi-ethnic groups comparison studies, at a joint event hosted by  www.eppicglobal.org and  www.bio2devicegroup.org .  Dr. Kanaya is Professor of Medicine, Epidemiology, and Biostatistics at UCSF and a principal investigator in Mediators of Atherosclerosis in South Asians Living in America or MASALA study, for short.  Primary objective of the study was to research and understand the high incidence of diabetes and CHD among people of South Asian origin.

Kanaya first shared information on South Asians (will be referred here as SA) and then discussed the study results in the context of multi ethnic comparison.  Currently there are 3.4 M people from South Asia living in the US.  It is the second fastest growing racial/ ethnic minority in the US.  They constitute 20% of all Asians and 75% of them are foreign born.  Although there is little organized medical data on SAs, overall they have relatively lower body weight (BMI), have more central abdominal obesity, and experience higher rates of diabetes and indicate high risk of early heart disease.

MASALA study began in March, 2010 and constitutes a total sample of 906 people, between the ages of 40 and 84.  People with prior history of any cardiovascular disease, those in active cancer treatments, those planning to move out of the area in the next 5 years, and nursing home residents, were excluded.  Data collected included weight, height, waist, seated BP, Ankle-brachial index (ABI predicts the sevearity of PAD, peripheral artery disease), 2 hour OGTT (oral glucose tolerance test), abdominal CT, and several blood tests and extremely detailed questionnaires regarding family history and information about personal habits like alcohol, smoking, sleep, diet and exercise.

Results from MASALA study were compared to results on almost all similar measures with Whites, Latinos, African-Americans and Chinese populations in ongoing MESA study.  See the websites of MESA (www.mesa.nhlbi.org) and MASALA (www.masalastudy.org) studies to see many interesting details on several patterns that emerged.  Kanaya specifically discussed some patterns among South Asians when compared with other ethnic groups.

When adjusted by sex and age, South Asians had significantly high rates of hypertension.  However, there weren’t major or alarming differences in cholesterol.  One of the reasons could be that South Asians were overall more educated, from higher socio-economic background, and were more likely to be using statins and other cholesterol lowering drugs

Most alarming differences were observed in diabetes and pre-diabetes levels.  Almost 30% of men and almost 15% of South Asian women had Diabetes Mellitus, versus 20% or lower among other groups of men, and 13% or lower among other groups of women.  Nearly 37% of SA men and 29% of SA women had IFG (impaired fasting glucose indicative of pre-diabetes), compared to 20% or less for men and 13% or less for women from other groups.  When adjusted for many indicators including age, sex, cholesterol, triglycerides, hypertension etc., South Asians were significantly more likely to have type 2 diabetes.

When adjusted for age, sex, BMI, and waist and excluding those on diabetes meds, this high incidence of Diabetes Mellitus among South Asians seemed to be associated with higher levels of insulin resistance, lower pancreatic B-cell function, and (as confirmed by abdominal CT data) high amount of body fat around abdominal regions and in the liver.

Mercat de la Boqueria, fruits & vegetables (Photo credit: Wikipedia)

Among lifestyle factors, the high rates of DM (Diabetes Mellitus) among SA was attributed to poor diet with less fruits and vegetables and more Western diet (including pizza, pasta etc.), sweets, refined grains, and consumption of high animal based protein in the diet and low levels of exercise.  Considering that even on a relatively leaner body, South Asians carry more fat, the study concluded that guidelines for BMI should be lower for people of South Asian origin.

The study concluded that 75% of South Asians were overweight or obese using the recommended BMI cut-points in Asians.  Compared to other racial/ ethnic groups, South Asians were from higher socio economic status, had low smoking rates, and low to moderate alcohol use.  They also indicated very low physical activity, higher diabetes prevalence (specially among men), second highest prevalence of high blood pressure, and men have more coronary calcium than other groups.

A yoga class. (Photo credit: Wikipedia)

Some of the recommendations for South Asians from the study were, to know the risk factors, work towards ideal BMI goal (less than 23 kg/m2 for SA), remember waist size matters more than BMI, walk at least 30 minutes a day 5 days a week, avoid a diet high in animal protein and refined carbs, and then something interesting – do Yoga!

Kanaya also shared results from her PRYSMS study that assigned subjects with metabolic syndrome into two groups, one practicing Restorative Yoga (included lot of lying down and relaxing poses) and other, Stretching Exercises.  In 6 months, both groups improved their PA and calorie intake.  Favorable changes in the stretching group included, lowered triglycerides and improved mental health.  Restorative yoga group reduced and sustained weight loss and weight girth loss but not visceral fat area.  Finally, only yoga group indicated reduction of fasting glucose and overall favorable metabolic changes in the yoga group included lowering of fasting insulin, glucose, HbA1c and HDL.

One wonders if very determined focus on material wealth goes with more stress.  In any case, it shows once again that stress relief is a key for improved health.  This was a fascinating talk and was followed by Q&A and animated discussion.

Fiona Ma (Assemblywoman & Campaigner against Hepatitis B) to speak at Health Technology Forum Conference

Hepatitis B Virus (Photo credit: AJC1)

Hepatitis B (HBV) virus is a very common virus worldwide.   Approximately, 1.2 million people in the United States are affected by this virus.  Almost 350 million people worldwide, are living with Hepatitis B.  Many people with Hepatitis B are likely to be infected at birth or in early childhood, and due to lack of immediate attention, have developed a lifelong chronic infection.   Hepatitis B is a contagious liver disease that is commonly spread through blood, semen, or other body fluids.  Most people do not experience symptoms until it is too late.  The virus causes 80% of all liver cancers, if left untreated.  Hepatitis B can be prevented with vaccination.  And with immediate attention and monitoring with nutrition, fluids, and medical supervision, acute Hep B can also be effectively treated.

Fiona Ma, incumbent democratic candidate for State Board of Equalization, a reputed politician and a former member of the San Francisco Board of Supervisors, California State Assembly, is a tireless campaigner and spokesperson for “San Francisco Hepatitis B Free” campaign.  San Francisco has the highest concentration of Hep B in the country.  Ma herself learned that she had Hep B, when she was 22.  She acquired it from her mother, who had acquired it from her mother.  About 1 in every 10 Asian Americans, is infected with the virus.  Ma’s mother had developed liver scars and having caught that early, had it removed.

English: California State Assemblywoman Fiona Ma (Photo credit: Wikipedia)

Fiona Ma will be giving keynote address at Health Technology Innovation Forum annual conference on May, 20 at Parc 55, Wyndham Hotel, SF.  The conference is focused on exploring pathways to sustainable health through various means including “best practices for globally underserved”, through “gamification” and “patient engagement”, and through “building resilient communities for better outcomes”.  Traditionally, this conference is heavily attended by physicians from UCSF, as well as entrepreneurs focused on healthcare breakthroughs.  Please register for the conference at http://www.healthtechnologyforum.com , as my friend, with the discount code “HTF14-FriendOfOrganizer” and send me your first & last name at wd_darshana at hotmail dot com, to get $150 off the price of the ticket.

 

Please note other upcoming events below – dates & deadlines.

1) Register for #TiEcon at link https://www.123signup.com/register?id=dbnfb&ref=4182698  as my guest & enter promo code tievalue to get $100 discount. If you are an entrepreneur, I would say this is the conference, you don’t want to miss.  Check out great agenda, top notch speakers & panelists on #IoT, #bigdata, #cloud, and #Healthcare tracks at http://www.tiecon.org.

3) Feel free to send me an email for any of these events at wd_darshana at hotmail dot com and you can follow my updates on Twitter @DarshanaN.  Also, do check out (in JOBS category on this blog), my job opportunities that include many Quality Engineering jobs in CA and MA and hot Software Embedded Engineer job and more.

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.

Jan Oldenburg from Aetna to Speak on Patient Engagement

Jan Oldenburg , a Vice President at Aetna and a nationally known expert in patient engagement, will participate in one of the twelve  panel discussions  at the upcoming  Health Technology Forum Conference on April 19, 2013 at the UCSF Mission Bay Conference Center in San Francisco.

Jan Oldenburg – transforming healthcare through digital patient engagement

Ms. Oldenburg will participate in the panel addressing the topic of “Patient Engagement for Care Improvement”.    Ms. Oldenburg is Vice President Patient and Physician engagement at Aetna and editor of  a recently published book – Engage: Transforming Healthcare through Digital Patient Engagement.   The questions Oldenburg and the panel will address, include:

• In this virtual age of lesser and lesser human contact, can technology be an enabler in creating dynamic partnership among patients, their families, and the providers of their healthcare?

• In a partnership model, who would establish the boundaries with regard to privacy, competent decision making, and ethical behavior, and ensure that they are respected?

Patient engagement has become a cornerstone today in discussions of accountable care.  Strong patient engagement will have its basis on physician patient partnership and that relationship will have to be grounded in confidentiality and clarity about mutual responsibilities.

Oldenburg has a passion for examining the use of technology to deliver patient engagement tools and solutions.  In addition to serving as the the editor of the  “Engage! Transforming Healthcare through Digital Patient Engagement”, she was selected to be a member of the Consumer Empowerment Workgroup (CEWG) of the Health IT Policy Committee (HITPC).  The HITPC makes recommendations to the National Coordinator for Health IT on a policy framework for the development and adoption of a nationwide health information infrastructure.  The Consumer Empowerment Workgroup (CEWG) is charged with providing recommendations on policy issues and opportunities for strengthening the ability of consumers, patients, and lay caregivers to manage health and health care for themselves or others.

In recent years, the rules of patient engagement have changed.   In a non-fiction book “The Immortal Life of Henrietta Lacks”, http://bit.ly/xrgzVM Rebecca Skloot discussed how cells retrieved from Henrietta’s cervical cancer, in 1951, have been the most widely used cells, have been bought and sold by the billions and have led to many discoveries and scientific insights.

These cells were taken without Henrietta’s permission and in those days no one talked about patient engagement or strived to create physician-patient partnership.  Recently, when Lars Steinmetz and his team published the genome of the HeLa cells, Steinmetz and his colleagues gave little thought that it could ignite a bioethical lightning rod.  But the descendants of Henrietta Lacks and other scientists and bioethicists were not pleased and they criticized Steinmetz’s decision to publish the sequence, noting that the HeLa cell line was established without Lacks’s consent and it may disclose genetic traits borne by surviving family members.

In addition to Ms. Oldenburg, other participants in the “Patient Engagement for Care Improvement” panel, will include Neil VerselLaura Esserman, Professor – UCSF School of Medicine  and Amy Tenderich, Editor-in-Chief, DiabetesMine.com, an online support and advocacy group for diabetics.  Neil Versel, HIT Journalist, Universal Media, will moderate the discussion.

For information on the other panel discussions and speakers at the conference and to register, please go to:http://www.healthtechnologyforum.com/conference/health-technology-conference-2013/

Platforms for the Underserved – Health Tech Forum Innovation Conference, April 19, 2013 at UCSF, CA (Preview)

In the upcoming conference on April 19, 2013 and Code-A-Thon preceding the conference, Health Technology Forum, www.HealthTechForum.com is trying to push the envelope on creating new applications and technologies for hospitals and for getting information on tiny devices.  The aim of such applications and devices is to make healthcare information and treatments available to people with the greatest need.  Health Technology Forum Innovation Conference on April 19th, 2013 at UCSF, Mission Bay Conference Center, has a theme of “Platforms for the Underserved”.  Here is a preview of some of some of the panels and speakers.

Dennis Boyle, a partner and one of the founding members of IDEO will share examples and case studies about IDEO’s work around the world.  Armed with a mission to “make high-tech simple”, Boyle tackles design challenges to find ways to get information into and out of tiny devices.  IDEO’s current project, a QWERTY keyboard made with foldable fabric, in collaboration with a British company, Elekson is an example of how technology is transforming our ability to send and receive information.

How can better communication through connected healthcare model help improve patient care in the hospitals?  This will be discussed in a panel comprising of Five Bay Area Hospital CMIOs.  I would also like to see this panel discuss how the IT infrastructure will enable the hospitals to provide value based care with fee-for-performance mindset.  Additionally, I am looking for this panel to explore how technology may enable hospitals to lower readmission rates and control infections.  Studies indicate that community based care transitions programs can help lower hospital readmission rates, particularly for patients afflicted with chronic diseases.  I would welcome an opportunity to hear what plans hospitals have to leverage current strides in remote patient monitoring apps and devices so that patient’s vital signs including blood pressure and weight, biometric data including pulse oximetry and blood glucose levels as well as disease signs and medication and diet adherence can be monitored to couple it with reform driven community care to help lower hospital readmission rates.

Other interesting panels will address issues regarding patient engagement, challenges of harnessing big data and analytics, use of robotics in life sciences, and an opportunity to hear from Bay Area VCs on the funding scenario for Medical Device and Biotechnology companies.

See my earlier blog at http://bit.ly/ZsUggs for information on some of the other panels and register for the conference at www.healthtechnologyforum.com .

Technology Making Quality Healthcare Accessible to Those Most in Need – HealthTech Forum Conference – April 19, 2013 – Preview

Access to quality healthcare across the world is not consistent and to many it is simply not available.  Many of these people live shorter and highly constrained lives.  In fact, unavailability of adequate health care is presumed to be the primary cause of premature deaths of 100 million women, reported missing, worldwide.  Statistics are equally staggering regarding higher mortality among infants and children, on account of lack of medical care.  This is true even in more developed countries.  Health Technology Forum Innovation Conference, www.HealthTechForum.com on April 19th, 2013 at UCSF, Mission Bay Conference Center, will explore innovations in healthcare technology that is making healthcare more accessible to those in need of quality care.  Here is a preview of some of some of the panels and speakers.

Social media is offering a whole new platform that is enabling communities and patients to be actively engaged in their own health.  The access to information makes the patients feel more empowered and knowledgeable.  However, participation on social platforms also raises HIPAA issues and other legal challenges.  Representatives from Bay Area’s prominent law firms will join in, on a panel, moderated by Renne Berry, Founder and CEO of goBeMoRe, about current issues relevant to digital media law and healthcare.

A panel moderated by Suneel Ratan, CEO and Founder of Care Architecture will explore the concept of using technology in caring for dual eligibles.  Plans often called “dual” or “dual eligible” are designed for people who qualify for both Medicare and Medicaid at the same time. These plans include all Medicare Part A (hospital stay) and Part B (doctor visit) benefits and Part D prescription drug coverage. For people with limited incomes, these plans may offer better health care coverage than Original Medicare and a separate Part D plan.  Those who are dually eligible for both Medicare and Medicaid have a higher probability of complex chronic conditions, as well as mental health issues.  They have a higher probability of being institutionalized or are at a risk of being so.  They also account for a larger share of Medicare and Medicaid spending.  The panelists will discuss the role that “connected health” technology might play in healthcare programs for dual eligible individuals.  All such initiatives will need to begin with understanding the lifestyle, challenges, and characteristics of these individuals.  Additionally, the panel will discuss the recent successful model that has been pioneered by the VA and how it can be scaled.

I will be sharing information on other panels and excellent keynotes.  To register for the conference, go to www.healthtechnologyforum.com Early bird price is available if you register before tomorrow, March, 15.