From Synlogic & Wyss Institute on the East Coast to Autodesk & UCSF on the West: A Look at Synthetic Biology in the US

The global synthetic biology market is supposed to reach $13.4 billion by 2019. A recent study from Transparency Market Research shows that Europe leads the world, while North America is the second largest market. Basically what synbio does is re-molds existing biological elements to create ones that do not exist in nature to make them cheaper, better or simply available to researchers for R&D when the real thing is not. You’ll see synthetic biology in biotech of course (the blog futurism.com actually says that “synthetic biology has become the backbone of biotechnology”), both in food production and healthcare; there are also uses for biosecurity, energy and the environment.

Synthetic biologists are often not biologists at all but can be chemists or computer scientists. In fact one of the industry’s biggest thought leaders, Andrew Hessel, is a Distinguished Researcher with software company Autodesk in their Bio/Nano Research Group, based out of San Francisco. With software companies such as Microsoft working to use DNA to store information, it would make sense that computer science also have a hand in designing and creating DNA. Hessel would like to push for a “new Human Genome Project based on synthetic biology” and feels that aiming for 2026 is a potential goal, if synthetic biology advances as quickly as the study of genomics has. (Andrew Hessel photo below from AndrewHessel.com)

Autodesk was also recently in the news for their work with Gen9 and Auburn University. A team of scientists comprised of these three organizations have synthesized sCAV2, an artificial virus that can "target and kill cancer cells while sparing healthy cells." Genetic Engineering News writes: "It’s important because it not only has immediate application in studies of canine cancer, it also promises to inform the development of human therapies."

Two of the places in the US where synthetic biology is hot are, not surprisingly San Francisco and the Boston/Cambridge biotech hub. University of California San Francisco was in science headlines a year ago “controlling stem cells with light” and this past September with their “cellbots” - engineered human immune cells that can locate diseased cells as well as deliver drugs. They are sure to continue to be at the epicenter of synthetic biology – as the National Science Foundation has just awarded them a $24 million dollar grant to create a new center called the Center for Cellular Construction. The UCSF website reports that: “researchers from San Francisco State University, Stanford University, UC Berkeley and IBM Research, Almaden” (IBM Watson) will all be part of the center.

Speaking of Stanford University, a professor there named Christina Smolke has “developed a method for synthesizing opiates from yeast”. BigThink blog reports: “Smolke expects to achieve poppy-free, commercial-scale production of opiates in a few years, and is now casting her attention towards other synthetic medicines, as well as a few inventions of her own, mentioning a non-addictive form of opium as one dream drug she’d like to see.”

Cambridge based Wyss Institute describes their research as: “seeking to transform engineering, medicine and the environment by creating new materials and devices using Nature’s design”. Popular Science just gave them their “Best of What’s New” Award for their Zika diagnostic system that uses synthetic biology to diagnose a patient in the field in just a few hours. The Wyss website describes how it works: “They freeze-dry synthetic gene circuits onto paper discs. These biomolecular circuits are activated when the paper is rehydrated with a droplet of sample fluid; the disc changes color to indicate a positive result for Zika virus, similar to the visual readout of a home pregnancy test. To validate their rapid Zika test, the team successfully identified strain-specific Zika in blood samples from infected monkeys as well in laboratory cell cultures infected with the virus.”

Another recent achievement by Wyss, specifically from George Church’s team, is solving the issue of the high cost of reading DNA sequences from genomes. Their website reports that they’ve: “developed a new electronic DNA sequencing platform based on biologically engineered nanopores”.

This past week, MIT Technology Review reported that Cambridge-based Synlogic had created "smart bacteria". Synlogic is the first to patent the live E. Coli Nissle bacterium modified to assimilate ammonia. The conundrum is that the EPA may have to be brought in, along with the FDA, for approvals here - as "no one is quite sure how to regulate a GM pill whose contents are both alive and likely to end up in toilet bowls".

Don't forget to follow Biotech Week Boston on Twitter for news on innovation in biotech and medicine. Each year passionate scientists and innovators converge on Boston to share ground breaking data, research and ideas - don't miss our next event in September 2017!

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At the Forefront of Cell Therapy in Boston: Oren Levy of Karp Lab

Oren Levy from Karp Lab gave an excellent talk called “MSCs on Steriods” last month at Biotech Week Boston. Oren's research focus is "investigating the roles of signal transduction pathways in hMSC physiological processes, specifically, the involvement of the JAK/STAT cascade in hMSC proliferation and osteogenic differentiation". His research also focuses on "hMSC homing and engraftment to various sites in the body". Karp Lab is located in the Cambridge/Boston Biotech Hub and works closely with Brigham and Womens' Hospital, MIT, Harvard Medical School and Harvard-MIT Health Sciences and Technology.

Levy started his discussion with this unfortunate fact - so common with so many potential biopharma cures being researched right now – that “MSCs clinical endpoints have not been met and there’s not a single approved FDA product”. He then also shared the impressive stat that “MSCs are used in 600 clinical trials worldwide”; with so much research happening right now, the industry is hopeful that some breakthroughs are on the horizon.

What are MSCs and Why Are They on Steroids? 

The NIH gives a good definition of MSCs on their website: “Mesenchymal stem cells (MSCs) are adult stem cells which can be isolated from human and animal sources”. MSCs are being studied for bone, cartilage, heart and blood vessel repair, as well as inflammatory and autoimmune diseases. Why are MSCs on steroids? If you check out their website, Karp Lab has a great sense of humor (and it’s an understatement to say the Lab’s work is “creative”) which makes sense that the title of the talk was playful. But in all seriousness, MSCs have the potential to be very powerful; researchers such as Oren Levy and Karp Lab have a real sense of urgency about getting MSC therapies to work. So much so that they embarked on a very ambitious project: with the help of Sanofi, Levy screened over 10,000 small molecules to improve cell targeting.

Our Goal is to Improve Control Over Cell Fate 

Oren Levy mentioned two disease areas where his team was studying the use of MSCs: prostate cancer and multiple sclerosis. In fact, Levy mentioned that their multiple sclerosis study was about to be submitted for publication, so we have that to look forward to soon. For prostate cancer, the screening of the small molecules Levy’s team did with Sanofi comes into play. Levy discussed how they use “drug loaded MSCs to kill prostate cancer cells”. How they’re trying to make this happen is by “small molecule pretreatment to give MSCs the homing mechanisms they lack”. Essentially, they’re “using engineering strategies to improve MSCs targeting to tumor sites”. The combination of engineering and life sciences – bioengineering – is a major trademark of what Karp Lab does. Their website relates one of their mission statements: “Our lab firmly believes that innovation occurs at the interface of disciplines”. You can read an in-depth interview of Jeff Karp of Karp Lab produced by Biotech Week Boston and written by journalist Nick Paul Taylor here.

Don't forget to follow Biotech Week Boston on Twitter for news on innovation in biotech and medicine. Each year passionate scientists and innovators converge on Boston to share ground breaking data, research and ideas - don't miss our next event in September 2017!

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The Softer Machine: How Robots Are Filling Important Gaps in Global Healthcare and Biotech R&D

If you blink you will most likely miss some major design, invention or discovery in the robotics industry. The future is definitely here, and robots are becoming an inseparable (if sometimes unseen) part of our everyday lives, whether it’s in defense, manufacturing, biotechnology, caring directly for us, or used in and on our bodies.

The Co-bots are coming, and they're here to help
Robotics is set to be a $226 billion dollar industry by 2021, just 5 years from now. There are no statistics on exactly how much of that industry is healthcare related but there is some scattered research out there. For example, Medgadget tells us that surgical robotics systems will be a $6.4 billion dollar industry by 2020, and the exoskeleton robot market is to reach over $2 billion by 2021. Robotics and Automation News reports that “half of all surgeries in some countries are now done with robots.” Other aspects of healthcare using robotics include nursing and assistance to the elderly and those with disabilities. Biotech manufacturing uses robotics (IFR reports that by 2019, more than 1.4 million new industrial robots will be installed in factories around the world) and even biotech R&D has begun trying them out. The Financial Times reports how GlaxoSmithKline in the UK is using “co-bots to work side by side with scientists at research facilities.”

Robotics Looks to the Deep Sea for Biotech R&D
This past September MedTechPulse compiled a great slideshow “9 Ways Robots Are Getting So Much Better”. I recognized a few of these robots, as they had come out of the Boston/Cambridge biotech cluster – no surprise here. Research institutes such as The Wyss Institute in Cambridge, Massachusetts are creating their own robots, but they're not the kind that will clean your house. Instead, these robots have been created to stretch the limits of what we can accomplish in surgery, internal medicine and tissue engineering.

What Does an Octopus-Inspired Robot Do (And Why Create It)? 
This past summer Harvard University’s Wyss Institute created one of the cutest robots you’ll ever see, in the shape of an octopus. Their inspiration to create a robot using this shape was due to an octopus’ “ability to perform great feats of strength and flexibility, despite lacking an internal skeletal system”. The team at Wyss did a 180 on how robots are thought of (as made of hard components). What a soft robot can do is utilize "fuel" in a very different way. Softness also promises these benefits: “Soft robotic grippers are already being used to handle undersea structures in scientific research. One can easily envision soft robots being used to handle fragile objects such as crops, or even living beings. Internal medicine and wearable devices are also likely areas for future soft robots.” And did I mention that this robot was 3-D Printed?

Rat + Robot = Stingray
Wyss Institute’s Kevin Kit Parker, in his quest to eventually build a human heart, was inspired by the jellyfish and stringrays that he and his daughter saw at the New England Aquarium. Parker thought understanding more about the way they moved could give us a better understanding of the human heart. Parker mimicked the stringrays’ anatomy to create a soft robot (“gold skeleton sandwiched between two silicone layers”) with a difference. This robot incorporated 200,000 heart cells (from rat embryos). The plan was for these cardiac cells to do the work of skeletal muscles (which they did) powered by a virus and optogenetics. In their report, Science magazine joked that the stringray’s speed is ”quite pathetic by real stingray standards” but quoted Princeton engineer Alexander Smits to make a final point “we’re getting to the point where there really is a fusion between biology and engineering”.

Robot Doctors, Robot Nurses and “Carebots”
Nurses at Beth Israel Deaconess Hospital in Boston are using a humanoid robot designed by SoftBank robotics to help them with scheduling - which even for humans is a pretty daunting and complex task. Researchers at MIT showed the robot exactly how nurses were doing the scheduling, which involved complex, highly coordinated actions, and after training the robot succeeded in the tasks 90% of the time. Humber River Hospital in Toronto has taken it several steps further as North America’s first fully digital hospital; SiliconANGLE describes the scene at Humber River: “In the hospital, you will find robots mingling amongst human staff, with robots responsible for mixing the correct dosage of chemotherapy drugs, to transporting meals, medications, and linen”.

The Atlantic reports that doctors as well as nurses are being replaced by robots in countries where doctors are hard to come by. “In Brazil and India, machines are already starting to do primary care, because there’s no labor to do it,” says Robert Kocher, an internist, a veteran of McKinsey consulting, and a former adviser to the Obama administration. “They may be better than doctors. Mathematically, they will follow evidence—and they’re much more likely to be right.”

By 2025, Japan will have a shortage of 1 million caregivers for their aging population; to solve this issue Japanese companies are leading the world in the production of carebots. Emerging tech thought leader Alec Ross described the state of Japan’s carebots industry in a LinkedIn Pulse post earlier this year: “Japan already leads the world in robotics, operating 310,000 of the 1.4 million industrial robots in existence across the world…In 2013, the Japanese government granted $24.6 million to companies focusing on eldercare robotics. Japan’s prominent Ministry of Economy, Trade, and Industry chose 24 companies in May 2013 to receive subsidies covering one-half to two-thirds of the R&D costs for nursing care robots.”

Boston as Robotics Hub
Along with the incredible 3-D printed and bioengineered robots that The Wyss Institute has given us this year, there is evidence that biotech hub Boston is also growing as a robotics hub. Tom Ryden, executive Director of Mass Robotics, describes the current vibe in Boston Business Journal earlier this month: “(Massachusetts robotics companies are) very open in sharing so they want to see all companies grow,” he said. “They realize it’s a ‘rising tide floats all boats’ type of thought…Not not only do we have some of the early companies like iRobot that really started this kind of revolution, but there are so many universities that have robotics programs or are doing robotics research in the Greater Boston area. That makes for a great idea generator, so it just kind of snowballed and built a great community.”

Last year CNBC reported that in Massachusetts: “more than 3,200 people (were) employed in the robotics industry. More than $200 million has been invested in Massachusetts robotics companies since 2008, and annual sales of robotics manufactured in state have topped nearly $2 billion.” The Mass Technology Research Council has an entire report devoted to “The Massachusetts Robotics Revolution” which you can download here.

Interested in hearing more about innovations in the intersection of bioengineering and medicine? Download our report here. And don't forget to follow Biotech Week Boston on Twitter for news on innovation in biotech and medicine. Each year passionate scientists and innovators converge on Boston to share ground breaking data, research and ideas - don't miss our next event in September 2017!

Learn more about #BiotechWeekBoston

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3D Bioprinting to Engineer Human Tissue: Wyss Institute's David Kolesky at Biotech Week Boston

The medical 3D printing market is expected to reach $983.2 million by the year 2020. What is the difference between medical and other 3D printing? Well to explain very simply, I will use a quote from Hod Lipson from ASME.org (Lipson is the author of  Fabricated: The New World of 3D Printing): “Unlike traditional 3D printing of plastics and metal where after you finish printing you have your part, with bioprinting it’s just the beginning. Even after you finish printing there is a long road ahead. You have to incubate the part, simulate its environment – it’s much more complicated.”

This month I was lucky enough to hear David Kolesky from Harvard University’s Wyss Institute discuss his team’s latest work on 3D bioprinting. The idea that we are beginning to be able to print human tissue is mind-blowing, and to hear details from someone in the forefront of this work was awe-inspiring.

Human Tissue Engineering: Challenges and Solutions
David Kolesky is part of a team at Jennifer Lewis' Research Group at the Harvard John A. Paulson School for Engineering and Applied Sciences (SEAS) and the Wyss Institute for Biologically Inspired Engineering at Harvard University who is working on engineering human tissue. In his talk at Biotech Week Boston on October 6, Kolesky focused on the team's work with engineering kidney tissue in particular. He described his team’s focus and some of their challenges: “(A human) kidney has a million nephrons, within the nephron we’re focused on the proximal tubule” and “(human) tissue is extremely difficult to mimic, because (of its) hierarchical structures that have a composite nature.” (You can see the tubule below, courtesy Wyss Institute.)

Stem-Cell Laden ‘Ink’ Becomes Living Tissue
Kolesky told the story of exactly how he was using 3D printing, specifically “bioprinting” to solve the challenges of vascularization. To someone not well versed in the latest discoveries it was fairly astounding – especially when he elucidated the use of “stem-cell laden ‘ink’ to build fully vascularized human tissue”. The materials they’re using are almost as fascinating at the engineered tissue: a hydrogel, which becomes “liquid when cooled” is the substance Kolesky and the Wyss Institute is using to make the bioprinting happen. With the methods he’s using, they are able to “keep these vascular networks perfusable for up to 45 days”. Their 3D printed proximal tubules actually contain living human cells and mimic many biological functions of nephrons.

How do they do that? Once the tubules are printed, they pump living kidney cells into them. After several days in the tubules the cells begin to function like the ones in our bodies. Cells in the tubules are “trained” by the chemistry of their environment to become and behave exactly like native kidney cells.

Researchers Can Now Study Real-Time Damage To Tubules
There are 60,000 people on a national waiting list for kidneys, and the CDC says that 1 in 10 American adults, more than 20 million people, have some level of chronic kidney disease. There is an urgent need for science to advance this research. The Wyss Institute is not only at the forefront of bringing us closer being able to engineer human kidneys in the future; with the current research researchers will actually be able to induce damage on these bioengineered tubules as if they were the real thing to study effects of drugs or toxins.

We Want a Synergistic Relationship with Biology
Kolesky closed his talk with the quote: ”We want a synergistic relationship with biology.” In fact Wyss Institute's Mission Statement is: "The Wyss Institute seeks to transform engineering, medicine and the environment by creating new materials and devices using Nature’s design principles".

Their team's paper:”Bioprinting of 3D Convoluted Renal Proximal Tubules on Perfusable Chips” was published in Nature Scientific Reports several days after Biotech Week Boston and gives more detail on Kolesky’s research. You can read the paper here.

Interested in hearing more about innovations in the intersection of bioengineering and medicine? Download our report here. And don't forget to follow Biotech Week Boston on Twitter for news on innovation in biotech and medicine. Each year passionate scientists and innovators converge on Boston to share ground breaking data, research and ideas - don't miss our next event in September 2017!

Learn more about #BiotechWeekBoston

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FDA/CMS: New Administration, New Challenges?

photo credit: @KimTweetsDC

For over 20 years we have been working hard on delivering you with first-hand insights into one of the most heavily-regulated industries in the world.

With recent debates over drug pricing, the FDA is faced with some challenges over regulation policies to ensure the healthy balance of big pharma companies on the market.

Here are the main three questions that are bugging the minds of the Top Biopharma Executives today:

• What does the future hold for the Affordable Care Act and health reform in the post-Obama landscape?
• What is the state of biosimilars in the US, and how these medicines may impact the cost curve for biologics as more reach the market and uptake becomes measurable?
[read an excerpt from the panel discussion with experts from Mylan, Pfizer and Momenta Pharmaceuticals “Biosimilars are here. Now what?”.]
• Transparency around pricing.

Do these topics keep you up all night as well?

Be the first one to learn the updates directly from CDER and CMS right in the heart of DC, the political epicenter of the United States at the 11th Annual FDA/CMS Summit.

Some of the themes to be discussed at the Summit include:

• An overview of regulatory and policy news;
• Regulatory & reimbursement expertise from KaloBios Pharmaceuticals Inc., FDA, REGENXBIO, Aimed Alliance, Acorda Therapeutics, Beth Israel Deaconess Medical Center, and many others;
• The state of biosimilars and revisions to BSUFA;
• Drug Development Innovation including regulatory strategies of pandemics such as Ebola and Zika.

For the full range of topics download the brochure here.

Join an open dialog over the industry issues with other health care professionals from the FDA and CMS regulatory agencies, including Janet Woodcok, Gerald Dal Pan and John Jenkins at the FDA/CMS Summit, this December, 14 – 15th in Washington, DC.

As a valued member of our community you can register with a special discount of $100 OFF the current rate using this code: PFDA16SOCIAL.

Secure your spot and the best rate here.

Stay tuned:

Twitter: @healthcarebiz ; #FDACMS

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Innovation Drives Biotech Week Boston

Innovation is driving our first ever Biotech Week Boston, where the heart, technology, and business of science converge. We just announced that two of our much-anticipated keynotes will speak. And we're partnering with one of the most respected tech news journals in the US - Xconomy for another first - our 1st ever Innovation Summit.

Keynote speakers announced this month are technology super-veteran, Steve Wozniak, the co-founder of Apple Inc., and former big pharma research and development veteran, Dr. Toni Hoover, the director of the Bill & Melinda Gates Foundation. Biotech Week Boston is bringing together more than 3,000 of the world’s leading scientists, executives and technologists at the Boston Conference and Exhibition Center, Oct. 4-7, 2016.

Hoover will kick-off Biotech Week Boston day two with her keynote presentation, “Harnessing Science, Technology and Innovation to Improve Global Health,” on Thursday, Oct. 6, at 9:30 a.m. Wozniak will headline the day three festivities with a keynote Q&A, “Innovation and Customer Centricity,” taking place on Friday, Oct. 7, at 9:15 a.m. “I look forward to sharing insights on the future of technology and innovation at this event in Boston next month,” expressed Steve Wozniak, Co-Founder, Apple Inc. “I think the audience will be surprised by some of the stories I am excited to share.” These luminary thought leaders will join more than 350 international speakers flying in for the inaugural Biotech Week Boston conference.

Our Innovation Summit happens on October 7 and will feature world renowned researchers from Memorial Sloane-Kettering Cancer Center and RoosterBio as well as a panel discussion on: "Innovations and Technology to Drive Improvements in Healthcare Delivery".

“I am happy to welcome Biotech Week Boston and its thousands of attendees to the City of Boston,” says Boston Mayor Martin J. Walsh. “Boston is renowned as one of the top biotechnology hubs in the country thanks to our talented workforce and world-class research and development centers that help foster a thriving innovation sector. I send my best wishes to the organizers and all partners involved for another successful event."

Learn more about #BiotechWeekBoston

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Focus on Women Innovators in Boston Biotech: Dr. Rosana Kapeller & Alison Silva

Last month we blogged about five women to watch in Boston biotech and got an incredible response. In a country where less than five percent of the CEOs in Fortune 500 companies are female it's good to know that women in leadership is such a popular topic. Or perhaps our blog was popular because the Boston area women we profiled are making international biotech news, regardless of their gender. This month - as we gear up for our first ever Biotech Week Boston where we celebrate biotech innovation in the Boston area and around the Globe - we'd like to take a look at two more women innovators in the Boston area. This time we posed the questions: "Why are there so many women innovators in the Boston area" and "Why do women-founded startups perform better than all male ones?"

Dr. Rosana Kapeller, CSO Nimbus Discovery and Scientific Advisor, Atlas Venture

Innovator is a very fitting way to describe Dr. Rosana Kapeller, the Chief Scientific Officer at Nimbus Discovery and scientific advisor to Atlas Venture. Why fitting? Well first of all the very work that her company Nimbus Discovery does is at the cutting edge of biotech. Luke Timmerman recently described Nimbus' work as "changing the fundamental mode of drug discovery".  Dr. Kapeller also has taken it upon herself to do a research study to draw attention to the small number of women executives represented in biotech. Kapeller reported the stats she uncovered in an article for Life Science VC last fall called Biotech Circa 2015 AD: Where Are the Women? Even in the most innovative small biotech companies, Kapeller found that just 8% of board members were female. Kapeller also uncovered the fact that only 10% of CEOs were women.

Alison Silva, President & Director, Critical Outcome Technologies and Co-Founder, The Orphan Group

Do a search for Critical Outcome Technologies (COTI) and you won't find local press buzzing about them just yet, but newly appointed Director of COTI and President of Synlogic Therapeutics Bharatt Chowrira made sure to let us know that is about to change: "Although COTI may not be a household name in the Boston Biotech area, it's just a matter of time with Alison Silva at the helm!" President and Director of COTI, Silva was a co-founder and COO of Chowrira's company Synlogic.

What Critical Outcome Technologies is doing is quite ground-breaking; they use computer science and machine learning to develop drugs. Their CEO Wayne Danter described what they do to Canada's Financial Post: "So that much of what the traditional drug discovery process would do occurs in a wet lab and is very expensive; most of our work initially is done in computer simulations so that we’re able to develop candidates very quickly."

Biotech Week Boston spoke with both Dr. Rosana Kapeller and Alison Silva to ask them what they thought about women and innovation, here's what transpired:

Biotech Week Boston: "Although women are only 5% of the Fortune 500 CEOs, there are a great deal of women leaders in Boston biotech. Do you have any thoughts on why that is the case?"

Alison Silva: "I believe innovation is fundamental to any successful biotech venture, and Metro Boston is an innovation hub. Biotech in Boston fosters merit based, gender neutral advancement, so women who are innate motivators and leaders tend to gravitate and thrive here. The combination provides a natural environment for women to be leaders in the biotech sector. On a personal level, as someone who has worked for both start-up and Fortune 100 companies, I feel more natural in a smaller, fast-paced growth environment where my passion for diversity and opportunity is most embraced.

In discussing this topic with colleagues, spurred on by the recent appointment of Emma Walmsley as GSK’s new Chief, some at the table wonder why these positions receive press focused on gender and not purely the merit that these women clearly possess being placed in such significant positions. It’s a point made in support of the growth of the meager 5%, when it’s clear by female leaders whose footsteps we are following in, that the path is becoming more defined, accepted and most importantly appreciated. I argue that is still comes down to balance and choice. Women may have the desire to take their careers to a certain professional level, however may not be willing to fully accept the lifestyle choices of, in the case of this question, a Fortune 500 CEO-ship. I believe and am hopefully optimistic that we are entering an era during which some of the extraneous and self-imposed demands are being pressure tested and companies are diligent in finding balance for all of their employees."

Dr. Rosana Kapeller: "I am not so sure this statement is completely correct. Although women CEOs in biotech comprise more than 5% as compared to Fortune 500 CEOs (About 10% +/- 4% depending on the year), they are still the minority. What you see in biotech though is an increase in women in leadership positions mostly as CSOs and CMOs, which I find quite interesting (could these be considered “soft areas”?)  According to my own research, which is supported by a broader and more robust research by Liftstream, here are the numbers: Women comprise about 26% of all leadership positions in Biotech; 17% CSOs, 24% CMOs as compared to 10% CEOs and COOs. CFOs and CBOs fall in between CSOs and CMOs numbers.

I think the higher number of women CMOs reflects what is happening in medicine overall, where more women and less men are enrolling into medical schools, since medicine is no longer a career of choice for men. On the positive side, I think the increase in the number of women in leadership positions in biotech is due to several factors. It reflects the overall increase in the numbers of women in the biotech workforce. There an increase in women role models: this is the first time in the industry that women can emulate other women who got there before them. Before this generation of women, they needed to emulate their male counterparts to “make it". I am part of the “transition” generation and have seen an increase in the number of women leaders that I can emulate towards the later part of my career.

Women are making it into leadership positions due to the support these women are receiving from trailblazers like Vicki Sato (former President of Vertex and currently a Professor at Harvard Business school), Deborah Dunsire (formerly CEO of Millennium and Forum), and Carol Gallagher (formerly CEO of Calistoga and now a partner at NEA), just to name a few. I firmly believe in ‘like hires like'.

Lastly, men are starting to appreciate what women bring to the table and feel less uncomfortable with the differences in leadership and management styles. I think in the next 5-10 years we will continue to see an increase in women in leadership positions in biotech, and we will eventually see it leveling off between 30-40%. You may ask, why not 50%, since women comprise 50% of the population? To be honest and this is my personal opinion, women may not be willing to put up with all the “pressure" required to be a CEO. And I am not talking about the hard work, innovation, team building, financing etc. I am talking about the amount of time one has to spend playing the politics of the job. And, whatever happens in the workforce women still do most of work/worrying on the home front. So when you put these two pieces together, you may find that it is a life choice, not a career choice and women may opt out of it." 

Biotech Week Boston: "Startups with at least one female founder perform better, do you know why that may be the case?"

Alison Silva: "I have seen many women, many friends, thrive in a start-up environment - a dynamic stage where strong organizational skills, adaptability and an ability to be fearless yet pragmatic are critical success factors. The intensity of this pace lends itself well to leaders with inherent multi-tasking skills, a collaborative nature and an instinctive drive to motivate others. These are common, foundational traits in many women and they are infinitely synergistic to a start-up environment. Additionally, I believe a fundamental success factor in the early days of a start-up is the corporate culture, which must be designed upfront and consistently nurtured to breed creativity, productivity, direction and camaraderie. Tying all of these aspects together within a small team is a challenging task, and I believe many of our female leaders in biotech have a unique understanding of what it takes to bring out the best in their team and make the endeavor successful."

Dr. Rosana Kapeller: "Yes, it is all about PEOPLE. This is what make companies succeed or fail. Women in principle are more collaborative and caring. They have a knack for recruiting and retaining talent as, most women, are willing to make the effort of understanding the different needs of the team members. They can be incredible motivators, and at the same time require a level of commitment and integrity that serves the company well. They are cheer leaders by nature. They are more willing to hire a “diverse” work force… find the best person for the job regardless of gender, race, etc. They are not afraid to make decisions, but consider all the angles before making a hasty decision. They can play the “contrarian” and will often have a different view of the needs of the company and elicit a conversation. A woman will not be another “yes man” and that is very beneficial in leadership teams. Of course this is a generalization and there are exceptions to the rules, but overall I find this to be the case.

Women are as good as men in innovation. Not sure why men are thought to be more innovative then women. I always worked on cutting edge science and so do most of my female counterparts. I think this is still an unconscious bias. Two of my favorite current innovators are Jennifer Doudna and Sangeeta Bhatia. Of course we can also go back to Marie Curie, Rita Levi-Montalcini and Rosalind Franklin..."

Interested in learning more about the experiences of women in biotech leadership? Join us at the Women's Executive Leadership Dinner which will feature Susan Windham-Bannister, President and CEO Biomedical Growth Strategies and Christina Bodurow, Ph.D., Senior Director, External Sourcing Medicines Development, Lilly.

Biotech Week Boston is a hub for life sciences, technology, and business and fosters cross-disciplinary interaction and collaboration to break down silos and spark change. Biotech Week Boston will showcase the most comprehensive science and innovative technologies while fostering partnerships to unlock the full potential of what science and business can achieve. Learn more by clicking the link below.

What exactly is #BiotechWeekBoston?

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What President Clinton or President Trump Will Mean for Biotech and Pharma

This past June, a STAT news article described the current presidential race as between a "policy wonk and a 'black box'" in other words Clinton's track record shows somewhat elaborate strategies that haven't always been successful while Trumps' views on biotech are "an almost complete mystery". Of the two Clinton is probably perceived at the most knowledgeable in regards to the biotech industry, STAT wrote: "Even Clinton’s conservative critics don’t doubt her knowledge — but they object to her proposed solutions, including her plan to crack down on drug prices, which they say fails to appreciate the financial risks biotech investors have to take." Regardless of Clinton's reputation of cracking down on drug prices, Boston Business Journal has reported that the majority of political contributions from biotech executives in the Boston area have been for Clinton (not a big surprise in a blue state).

Get an expert, up-to-the-minute view on what Clinton and Trump will mean for biotech and pharma at Biotech Week Boston's STAT Panel Discussion: President Clinton or President Trump: What Our Next President Will Mean For Biotech and Pharma this October. This panel will feature: Rick Berke, Executive Editor of STAT; Dylan Scott, Washington Correspondent at STAT; Damien Garde, National Biotech Reporter at STAT; Mason Tenaglia, Vice President at IMS Institute for Healthcare Informatics; David Meeker, Executive Vice President and Head of Sanofi Genzyme; and Kathleen Weldon Tregoning, Senior Vice President, Corporate Affairs at Biogen.

For a sneak peak, here's what Mason Tenaglia, Vice President of IMS Institute for Healthcare Informatics had to say in Pharmaceutical Executive about the challenges facing pharma from increased scrutiny due to the elections: “Due to the increased presence of pharmacy deductibles, patients are being exposed to the ‘raw, naked’ price of mainstream drugs like insulins, LABA, DPP4, and others.” This leads to the situation where “the pharmacy passes these on at ‘full price’ when the payer probably is getting a 40% rebate,”... 2016 “might be the year when all pricing heuristics disappear and pharma companies lower their list prices for new launches while holding back on rebates to the payers.”

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Top 5 Ways to Innovate in Biotech

Everyone likes to talk about innovation, but how can you stop simply talking about and start driving real innovation in biotech? We looked at some of the most ground-breaking, silo-busting movers and shakers around to bring you the "Top 5 Ways to Innovate in Biotech".

• #1 Diversity is not just good business, it makes for good science. People who grew up in the same parts of a country and went to similar schools often have comparable approaches to solving problems. As such, homogeneous groups of these individuals tend to get stuck on problems at the same point. Diverse teams, in contrast, come at problems from lots of different angles, enabling them to find creative solutions. Jeffrey Karp, Principal Investigator and Founder of Karp Lab populates his clinic with scientists from around the world: “We’ve had people from over thirty different countries,” he said. “I think this has been important because people in different places, they have different ways of thinking, different ways of solving problems.”

• #2 Hire Outside the Life Sciences. Traditionally distinct disciplines such as engineering, mathematics, computer science, chemistry, physics and the life sciences are increasingly coming together to advance the management and prevention of disease in the US. Tufts Allen Discovery Center, UCSF, Caltech, U of Illinois at Urbana-Champaign, ICES at U Texas at Austin, Carnegie Mellon and U Pittsburgh, Johns Hopkins Biomedical Engineering, Duke and U of Michigan, The Wyss and the Broad Institutes are examples of organizations combining either elements of computer science or engineering with the life sciences into their various programs. Jeffrey Karp of Cambridge’s Karp Lab has worked with heart surgeons, mechanical engineers, polymer chemists, and a fiber optics expert. Karp creates an environment designed to make the most of everyone’s capabilities, specifically by minimizing overlap in expertise. “When people get together to brainstorm, everybody can bring something unique,” Karp said. “Everybody feels validated, everybody’s motivated because they’re the only ones who can bring that particular perspective or expertise.”

• #3 Balance competitiveness with valuable data sharing. Stacy Springs, Biomanufacturing Program (BioMAN) and executive director of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) at the MIT Center for Biomedical Innovation (CBI), has the recipe for successful collaboration between industry, government and academia when it comes to biotech: “truth, transparency, and trust. Setting the ground rules and understanding how you want to work together is definitely very helpful.” CAACB brings together more than 20 leading drug product and equipment companies, such as Amgen, Biogen, Genentech, and Sanofi Pasteur, to gather confidential information on viral contamination. Such contaminations are too rare for any individual company to have enough data to develop best practices, but, by pooling resources at the neutral forum of MIT CBI, companies can learn from their collective experience.

• #4 Go outside science for your brain trust. When Kristin Ardlie’s team at Broad Institute’s Genotype-Expression Program (GTEx) was formed, there simply weren’t enough samples for the breadth and scale of the sequencing program envisaged for that organization. They realized they needed to look into sourcing samples from people who had died recently to alleviate their tissue supply bottleneck. But this created a whole new set of ethical and legal questions. So what did GTEx do? GTEx established a separate wing of ethical and legal experts. Not only did this solve the issue of having enough samples, it also turned GTEx into an unusually broad, multidisciplinary initiative that, through an ethical, legal, and, social issue substudy, has driven advances in fields far beyond genetics. Notably, the substudy has supported the development of best practices and training resources for people who have to ask grieving families to donate tissues. It has created an invaluable dialogue between biospecimen specialists, ethicists, geneticists, and the families of donors. GTEx has also opened up the data to scientists outside of the consortium and holding outreach meetings with the wider community. Through these and as-yet-unstarted analyses, the data derived from years of work and sacrifice by the families of donors, ethicists, legal experts, biospecimen specialists, geneticists, and others will continue to yield scientific discoveries.

• #5 Get your superhero on. Sometimes it takes a far-fetched idea to solve a problem; a picture of Spiderman in an article on a colleagues’ desk at MIT gave Jeffrey Karp of Karp Lab the wild idea to develop a surgical patch that was degradable, elastic and transparent (inspired by Spiderman's sticky hands and a gecko's sticky feet). Karp Lab has used everything from porcupine quills to jellyfish tentacles as the basis for a breakthrough. From Karp Lab’s bioinspiration to recent discoveries about the microbiome and advances in T-Cell therapy, the jury is out on whether future generations will look back on the 21st century as a time of technological advances or a time when science brought us closer to harnessing the innate power of our own bodies as well as those of the natural world. 

We hope you enjoyed our Top 5 List! We are proud to say that three innovators featured in this Top 5 article will be speaking at Biotech Week Boston this October 2016. You can catch up with Jeffrey Karp’s newest discoveries and research at Biotech Week Boston's Cell and Gene Therapy Bioprocessing and Commercialization event. Jeffrey's talk is entitled "MSCs on steroids". Stacy Springs will be on a panel entitled "Industry-Academia Collaboration in Translational Research and Biomanufacturing of Next Generation Biologics at the Bioprocess International Conference and Exhibition. And Kristin Ardlie will discuss GTEx Data and Analysis at Biorepositories and Sample Management.

We also invite you to download “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs" to get more detailed information on the types of innovations Ardlie, Karp and Springs are working on. The report is free and no email address or registration is required - so go ahead and share the link!

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INFOGRAPHIC: The Convergence Transforming Medicine

We at Biotech Week Boston are excited about a new era of biotech convergence that we're in right now. More and more labs are inviting what were once considered strange bedfellows - computer scientists, engineers, chemists, physicists, life scientists and others - to come together in the quest for novel ways to fight illness. We’ve created an infographic on this phenomenon, inspired by work done by MIT's convergence research as well as our new report: Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs.

Click for full size

We hope you enjoy our infographic. We are proud to say three innovators featured in this infographic will be speaking at Biotech Week Boston this October 2016. You can catch up with Jeffrey Karp’s newest discoveries and research at Biotech Week Boston's Cell and Gene Therapy Bioprocessing and Commercialization event. Jeffrey's talk is entitled "MSCs on steroids". Stacy Springs will be on a panel entitled "Industry-Academia Collaboration in Translational Research and Biomanufacturing of Next Generation Biologics at the Bioprocess International Conference and Exhibition. And Kristin Ardlie will discuss discuss the newest GTEx Data and Analysis at Biorepositories and Sample Management.

We invite you to download our infographic. It's free and no email address or registration is required.

What exactly is #BiotechWeekBoston?

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New Report: Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs

The area in and around Boston, Massachusetts is as dense with world-renowned scientific experts as anywhere on earth. Here, in an area a little larger than one square mile, researchers from Harvard University, Massachusetts Institute of Technology (MIT), and a multitude of biotechs and Big Pharmas are driving the evolution of the technology and business of science. In doing so, research teams are increasingly looking to share data, research, and ideas.

Collaboration has always been key to science, but, as researchers have taken on ever-more complex projects, the need to work with people from different disciplines, backgrounds, and organizations has increased. Such collaborations run counter to the secretive, ego-driven, or financially-motivated sides of science, but have nonetheless taken root, even in for-profit fields, as organizations have realized the value of expanding the breadth of their internal expertise while looking outside of their walls for collaborators. We at Biotech Week Boston are excited by the possibilities that this new era of collaboration can bring to biotech. We’ve asked writer Nick Paul Taylor (Nature, Fierce Biotech, Regulatory Focus) to report on several innovators who are contributing to this convergence of disciplines and ideas here in Boston.

In this report, Nick looks at three people: "who have embraced the collaborative, multidisciplinary ethos and, in doing so, have influenced science, business, and the lives of patients to a far-greater degree than would have been possible through an isolationist approach. Their goals are diverse. One is working to improve drug availability in low and middle-income countries through the advance of biomanufacturing. Another is looking to nature for answers to biomedical problems that blight the lives of patients. Our third is coordinating a global campaign to unlock the secrets of the genome."

Nick continues: "What links the three researchers is not the type of science they do, but the way they do it. Each is an example of what scientists, particularly in hotspots such as Boston, can achieve when they are open to the sharing of data, research, and ideas."

We hope you enjoy Nick’s in-depth report. We are proud to say that all three innovators featured in this report will be speaking at Biotech Week Boston this October 2016. You can catch up with Jeffrey Karp’s newest discoveries and research at Biotech Week Boston's Cell and Gene Therapy Bioprocessing and Commercialization event. Jeffrey's talk is entitled "MSCs on steroids". Stacy Springs will be on a panel entitled "Industry-Academia Collaboration in Translational Research and Biomanufacturing of Next Generation Biologics at the Bioprocess International Conference and Exhibition. And Kristin Ardlie will discuss discuss GTEx Data and Analysis at Biorepositories and Sample Management.

We invite you to download “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs.” The report is free and no email address or registration is required - so go ahead and share the link!

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From bench to bedside: Stacy Springs and the BioMAN program connect theoretical concepts to real world application

In 1978, there were just 30 patents granted for biopharmaceuticals. Now biologic drugs make up more than 28% of all pharmaceutical sales - $41.7 billion in 2013. MIT CBI’s BioMAN program is focused on translating all of the research into successful manufacturing, so theoretical concepts can be turned into real world applications. They do this by bringing together thought leaders from across the biopharmaceutical industry including manufacturers, vendors, the FDA and academia. They also leverage the MIT research they have access to in order to advance new technologies as well as assess the global landscape.

This year MIT put out a report called “Convergence: The Future of Health” which states: “Convergence comes as a result of the sharing of methods and ideas by chemists, physicists, computer scientists, engineers, mathematicians, and life scientists across multiple fields and industries…it needs to be applied to help solve many of the world’s grand challenges.” To that we can add - as scientific discoveries progress collaboration between the academic world, the government and manufacturers is key to solving these challenges. That is what BioMAN was set up to do.

We at Biotech Week Boston have asked writer Nick Paul Taylor (Nature, Fierce Biotech, Regulatory Focus) to report on several innovators who are contributing to this convergence of disciplines and institutional boundaries here in Boston, and Nick reports on the work Stacy Springs  is doing at BioMAN Institute. At BioMAN Stacy is the Director of the Biomanufacturing Program and Executive Director of the Consortium on Adventitious Agent Contamination in Biomanufacturing. We’re proud to feature her in our report “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs”. BioMAN “fosters a collaborative research environment that brings together thought leaders from industry, the government/FDA and academia.” Click to download and read about Stacy Springs and MIT’s CBI BioMAN program (no email address or registration is required).

We hope you enjoy Nick’s in-depth report. You can catch up with Stacy Spring’s newest research at Biotech Week Boston's Bioprocess International Conference and Exhibition event this October. Stacy will be on a panel entitled "Industry-Academia Collaboration in Translational Research and Biomanufacturing of Next Generation Biologics".

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How the Broad Institute’s GTEx uses a multidisciplinary approach to translate research into medicine

MIT’s new report “Convergence: The Future of Health” states: “Convergence comes as a result of the sharing of methods and ideas by chemists, physicists, computer scientists, engineers, mathematicians, and life scientists across multiple fields and industries. It is the integration of insights and approaches from historically distinct scientific and technological disciplines. Convergence is a broad effort across the sciences that will play a crucial role in many fields of endeavor. As noted above it needs to be applied to help solve many of the world’s grand challenges.”

We’ve asked writer Nick Paul Taylor (Nature, Fierce Biotech) to research several innovators who are contributing to a multidisciplinary convergence right here in Boston. The paper is entitled: "Convergence in Boston: How Multidisciplinary R&D is driving bench to bedside breakthroughs".

Nick reports on what the Broad Institute, specifically in their Genotype-Tissue Expression (GTEx) project, is contributing to understanding disease in their work with genomics. Genomics has, since its earliest days, been a multidisciplinary field. The sequencing, analyzing, and contextualizing of genomes necessitates the input of experts from a broad range of backgrounds. Nick spoke with Kristin Ardlie, Ph.D., the Senior Research Scientist, Director of GTEx at the Broad Institute of MIT and Harvard. The GTEx project started in 2010 “with the goal of creating a comprehensive atlas and open database of gene expression and gene regulation across human tissues.” Nick explores Kristin Ardlie and the Broad Institute’s work to discover how and why the field of genomics needs to draw on a diversity of skills and disciplines to handle the myriad of tasks involved in understanding inherited susceptibility to disease.

We hope you enjoy Nick’s in-depth report. You can catch up with Kristin Ardlie and The Broad Institute’s Genotype-Tissue Expression projects newest research at Biotech Week Boston's Biorepositories and Sample Management event this October. Kristin will discuss GTEx Data and Analysis.

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Broad Institute's GTEx program ending, says Director

The GTEx Project has announced that “GTEx, in its current form, is nearing the end.” The GTEx Project was launched in 2010 to create a data resource and tissue bank for scientists to study how genomic variants may affect gene activity and disease susceptibility. GTEx was set up in response to a boom in genome-wide association studies (GWAS) and subsequent sharp increase in knowledge of the links between genetic variants and human diseases. On one level, knowledge of these variants marked a major advance in our understanding of the root causes of disease and, by extension, our ability to treat or prevent them. However, with most of the GWAS variants not coding for proteins, the molecular mechanisms through which they lead to the development of diseases were poorly understood. This is where GTEx came in.

GTEx program may transition, in some form, into an international project 

Nick Paul Taylor recently interviewed Kristin Ardlie, director, biological samples platform at The Broad Institute of MIT and Harvard where she made this exclusive announcement. Ardlie gave some indication of what might happen to the program. “There are several groups that would like to continue and expand the project and the sampling,” Ardlie said. “Our particular project won't be continuing, but there's a lot of interest in pushing a continued project forward, maybe internationally. We've had one meeting already.” announced Ardlie.

For the full interview with Ardlie download the complete report by journalist Nick Paul Taylor here: “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs”. No email or registration is required.

We hope you enjoy Nick’s in-depth report. You can catch up with Kristin Ardlie and The Broad Institute’s Genotype-Tissue Expression projects newest research at Biotech Week Boston's Biorepositories and Sample Management event this October. Kristin’s will discuss GTEx Data and Analysis.

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MIT's BioMAN Announces Global Initiative

MIT's Center for Biomedical Innovation Program(BioMAN) has announced a new global health initiative. BioMAN’s mission is to “develop new knowledge, science, technologies and strategies that advance the manufacture and global delivery of high quality biopharmaceuticals”.

Stacy Springs, who has been Director of the program since 2008, recently spoke with Nick Paul Taylor: “We have a new global health initiative that hasn't really been publicized yet,” Springs said. “It is very much focused on the different ways we need to think about ... making biologic medicines available and accessible to middle and low-income patients around the world.”

In discussions with the Bill and Melinda Gates Foundation and PATH 

Stacy Springs elaborated on the initiative: “We certainly have been engaged in discussions with the Bill and Melinda Gates Foundation, with PATH, and others about our goals,” Springs said. The Gates Foundation is among the organizations already working to drive down the cost of manufacturing, but its focus is limited to drugs against its target diseases. Springs’ nascent initiative is broader in scope. It may, for example, look at ways to improve the availability of insulin around the world.

For the full interview with Springs download the complete report by journalist Nick Paul Taylor here: “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs”. No email or registration is required.

We hope you enjoy Nick’s in-depth report. You can catch up with Stacy Spring’s newest research at Biotech Week Boston's Bioprocess International Conference and Exhibition event this October. Stacy will be on a panel entitled "Industry-Academia Collaboration in Translational Research and Biomanufacturing of Next Generation Biologics".

What exactly is #BiotechWeekBoston?

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