Future of BioPharma

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

noreply@blogger.com (Leah Kinthaert) — Mon, 14 Nov 2016 12:00:00 +0000

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!

Learn more about #BiotechWeekBoston

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

noreply@blogger.com (Leah Kinthaert) — Mon, 07 Nov 2016 12:00:00 +0000

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!

Learn more about #BiotechWeekBoston

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

noreply@blogger.com (Leah Kinthaert) — Mon, 31 Oct 2016 11:00:00 +0000

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

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

noreply@blogger.com (Leah Kinthaert) — Mon, 24 Oct 2016 11:00:00 +0000

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

FDA/CMS: New Administration, New Challenges?

noreply@blogger.com (Unknown) — Thu, 20 Oct 2016 15:57:00 +0000

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

Innovation Drives Biotech Week Boston

noreply@blogger.com (Leah Kinthaert) — Thu, 29 Sep 2016 11:00:00 +0000

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

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

noreply@blogger.com (Leah Kinthaert) — Mon, 26 Sep 2016 11:00:00 +0000

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?

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

noreply@blogger.com (Leah Kinthaert) — Mon, 19 Sep 2016 11:00:00 +0000

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.”

Learn more about #BiotechWeekBoston

Top 5 Ways to Innovate in Biotech

noreply@blogger.com (Leah Kinthaert) — Mon, 12 Sep 2016 11:00:00 +0000

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!

What exactly is #BiotechWeekBoston?

Download our New R&D Report (No Email Required)

INFOGRAPHIC: The Convergence Transforming Medicine

noreply@blogger.com (Leah Kinthaert) — Tue, 06 Sep 2016 11:00:00 +0000

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?

Download our New R&D Report (No Email Required)

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

noreply@blogger.com (Leah Kinthaert) — Thu, 01 Sep 2016 11:59:00 +0000

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!

What exactly is #BiotechWeekBoston?

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

noreply@blogger.com (Leah Kinthaert) — Wed, 31 Aug 2016 11:00:00 +0000

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".

What exactly is #BiotechWeekBoston?

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

noreply@blogger.com (Leah Kinthaert) — Tue, 30 Aug 2016 15:00:00 +0000

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.

What exactly is #BiotechWeekBoston?

Broad Institute's GTEx program ending, says Director

noreply@blogger.com (Leah Kinthaert) — Tue, 30 Aug 2016 11:00:00 +0000

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.

What exactly is #BiotechWeekBoston?

MIT's BioMAN Announces Global Initiative

noreply@blogger.com (Leah Kinthaert) — Mon, 29 Aug 2016 15:45:00 +0000

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?

Karp Lab: Biomedical Engineering and the Third Revolution in Biotech

noreply@blogger.com (Leah Kinthaert) — Mon, 29 Aug 2016 15:25:00 +0000

In the past decade, several scholars, led by luminaries such as Nobel Prize winner Phillip Sharp, have been talking about how the Cambridge/Boston biotech area has been at the epicenter of a third revolution in biotech. The first revolution we can trace to the beginnings of molecular and cellular biology. The second was a genomics revolution (much of it happening in Cambridge/Boston) with Sharp’s discovery of RNA splicing in 1977 and his founding of Biogen in 1978. Now Sharp and others see a third biotech revolution in a movement which is bringing together disciplines once seemed separate - such as engineering, computer science and the life sciences.

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 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 at Biotech Week Boston are excited by the possibilities that this new era of convergence 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. Nick begins his analysis of this exciting multidisciplinary movement in Boston with Jeff Karp, founder of Karp Lab. Associate Professor of Medicine at Harvard Medical School, Brigham and Women's Hospital, principal faculty at the Harvard Stem Cell Institute and Affiliate Faculty at MIT and the Broad Institute and board of advisors at TEDMED - MIT's Technology Review listed him as one of the top innovators in the world under the age of 35 in 2014.

We’re proud to feature world renowned innovator Professor Karp in our report “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs”. Karp Labs is “innovating at the intersection of medicine and science” with a firm belief that “innovation occurs at the interface of disciplines” and a focus on translational research. Click to download and read about Karp Labs’ contribution to this convergence phenomenon (no email address or registration is required).

We hope you enjoy Nick’s in-depth report. 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 this October. Jeffrey's talk is entitled "MSCs on steroids".

What exactly is #BiotechWeekBoston?

5 Women to Watch in Boston Biotech

noreply@blogger.com (Leah Kinthaert) — Mon, 22 Aug 2016 11:00:00 +0000

Less than five percent of the CEOs in Fortune 500 companies are women (just one is an African-American woman) but in Boston, several of the most influential biotech executives are women. Perhaps it is the fact that startups with at least one female founder simply perform better. To honor the accomplishments of these pioneering executives, here’s a snapshot at the contributions of five notable women to biotech in Boston.

Susan Windham-Bannister, President and CEO of Biomedical Growth Strategies and the Managing Partner of Biomedical Innovation Advisors

Susan Windham-Bannister was the first President and CEO of the Massachusetts Life Sciences Center where she oversaw a $1 billion investment to accelerate the growth of biotech in Massachusetts. A trail-blazer, she was the first African-American woman to lead a life sciences growth initiative of this scale. Named one of the 10 Most Influential Women in Biotech by the Boston Globe, Windham-Bannister took the reins at the Massachusetts Life Sciences Center in 2008 at a particularly difficult time in the US economy. Windham-Bannister turned this potential disadvantage into a creative force for opportunity, partnering with the private sector to, as a 2013 Northeastern University report found: “attract $3 in outside investment for every public dollar spent, turning just over $300 million in state funds into more than $1 billion worth of backing for the local life sciences sector.”

Susan Windham-Bannister will be the keynote for the Women’s Leadership Symposium and Dinner at part of our Biotech Week Boston event this October.

Mary Lynne Hedley, Ph.D. Co-Founder, President and Board Member, Tesaro

Named “Life Science Entrepreneur of the Year” by the New England Venture Capital Association this past spring, Mary Lynne Hedley Ph.D. has been rightly called a pharmacology pioneer as she has been developing cancer drugs since 1996. Hedley began her career as the co-founder of Zycos, Inc. (which later became MGI Pharma, then Eisai Co Ltd.) moving on in 2009 to become EVP of Operations and Chief Scientific Officer of Abraxis Bioscience. In 2010 Hedley co-founded (with partner Lonnie Moulder) Boston biotech Tesaro, an oncology-focused biopharmaceutical company. The first drug Tesaro brought to the market, called Varubi, manages the side effects of chemotherapy to alleviate suffering and therefore bring some normalcy to the lives of oncology patients. Tesaro is also developing cancer drug Niraparib which we wrote about here. Late last year, Don Seiffert of Boston Business Journal asked Hedley what it was like being one of a tiny minority of women in biotech. Hedley offered: “It’s probably like being a guy in biotech.” Relatively, that rings true – biotech is a tough industry for anyone, with 9 out of 10 companies that begin clinical trials unable to succeed in bringing those drugs to the market.

Katrine Bosley, Chief Executive Officer, Editas Medicine

In 2016, even the least scientifically minded among us cannot have missed the buzz about “CRISPR” technology. Katrine Bosley is at the front row and center of this pioneering technology as the CEO of Editas Medicine. This June Bloomberg called CRISPR “the genetic tool that will modify humanity” and Editas’ mission is to successfully use CRISPR to repair genes that cause mutations that cause a broad range of diseases. In 2014, when Bosley joined Editas, Alex Lash called her one of the “highest profile CEOs of the biotech scene” and her profile has only gotten higher since then. Bosley began her career at Alkermes, moved on to Highland Capital Partners, then Biogen, and then Adnexus (which was bought by Bristol-Myers Squibb). In her first CEO role, Bosley led Avila Therapeutics into a buyout from Celgene. Prior to Editas, from 2013-2014 she was an Entrepreneur in Residence at the Broad Institute. This May, Fast Company wrote: “Five years ago this was a medical pipedream…With an aggressive timeline and a giant war chest, the Editas CEO may be the first to treat genetic mutations using CRISPR technology…as soon as next year.”

Hannah Mamuszka, Founder Alva10

You may not have heard of Alva10 – yet – but I'll take a bet that you will soon. From stints at some of the most well known Boston based and Global biotechs - Organogenisis, Takeda and ArQule as a researcher and scientist - to almost twelve years as a Director of Pharmaceutical Alliances at Exiqon (previously Oncotech) and most recently VP of Business Development at Exosome, Hannah Mamuszka’s career “has evolved based on the intersections of biotechnology and business development”. The name of her new company Alva10 was inspired by Thomas Edison - whose middle name was, of course, Alva. Mamuszka explains: "Edison was an amazing inventor and thinker, who thought about challenges completely differently than everyone else at the time, and produced radically different results as a product of that thinking. With Alva10, we are emphasizing the value that diagnostics play in personalized, precision medicine, and approaching that value from a completely different perspective than anyone else (that I've seen) in the industry.” The diagnostics she is talking about can analyze “both DNA and RNA in a molecular liquid biopsy”. This ability to translate Big Data into “well validated, broadly distributed diagnostics that are valued in the healthcare system” Mamuszka says is key to precision medicine being realized.

Barbara Fox, Ph.D. Entrepreneur in Residence at Partners Innovation Fund

With a career spanning almost thirty years that started as a Professor of Medicine at the University of Maryland and led to her current role as Founder and CEO of Avaxia Biologics, Barbara Fox has honed her networking skills into a fine art, enabling her companies to compete and win in the highly competitive world of biotech. Prior to Avaxia, Fox was an Affiliated Entrepreneur at Oxford Bioscience Partners, before that President and Chief Scientific Officer of Recovery Pharmaceuticals (now Shire) - a company she founded that develops medicines for the treatment of addiction. Her first position after teaching was Senior Scientist at Immulogic Pharmaceuticals where she quickly moved from that role into Vice President of Discovery Research. At Immulogic Fox directed programs into vaccine development, allergy, autoimmune disease and substance abuse research.

We are pleased to have Barbara Fox speak at Biotech Week Boston’s Bioprocessing International Conference and Exhibition. She will be presenting “Funding a Therapeutic-Focused Company through Angels: The Good, The Bad and the Ugly”. Fox will also be a panelist for: ”How to Overcome the Funding Gap for Biotech Start-ups and Emerging Companies”. Fox will be joined by Joshua Speidel, Latham Biopharm Group and Ohad Karnieli of Karnieli, Ltd.

Got any more women in Boston biotech you think we need to write about? We’d love to share them with our audience so Tweet to us at @BiotechWkBoston. And don’t forget to check in every week for our Biotech Week Boston blog series. 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?

Boston’s ‘Neuro’ Network will Ignite Innovation

noreply@blogger.com (Leah Kinthaert) — Wed, 17 Aug 2016 11:00:00 +0000

We asked Martin Tolar, the Founder, President & CEO of Alzheon, Inc. what he thought Boston biotech would look like in 2050 earlier this week, and his response prompted us to invite him to contribute a blog post. What follows is Dr. Tolar's look into the future of biotech, specifically around neurodegenerative disorders.

By Martin Tolar, MD, PhD, Founder, President and CEO Alzheon, Inc.

Developing new medicines for neurodegenerative disorders is one of the most challenging areas of drug development that is pushing the new frontiers, and at last with the prospect of real breakthroughs on the horizon. Boston is one of the most active areas for research and drug development in neuroscience and neurodegenerative diseases. The Boston ecosystem that fuels biotechnology innovation includes a brain trust of experts in science, medicine and biotechnology collaborating for new ways to treat neurodegenerative disorders.

By the year 2050, the outlook is promising for new life-changing medicines to emerge from the Boston hub for these devastating diseases of the brain that represents some of the greatest challenges in human health, currently with very limited treatment options for patients: Alzheimer’s, ALS, Huntington’s, Parkinson’s diseases. We are on the cusp of bringing new medicines to millions of patients in need.

Let me predict some of the progress that will be made in Alzheimer’s disease, which is the key therapeutic focus for my company, Alzheon.

Biotech companies have already emerged in the land of the ‘giants’ of the big pharmaceutical companies who have traditionally carried out Alzheimer’s drug development, and companies in this region are poised to maintain their position through 2050 for being on the leading-edge of advancing some of the first medicines to Alzheimer’s patients.

In 2050 and beyond, Boston-area biotechs are poised to maintain their position on the leading-edge of bringing some of the first approved medicines to Alzheimer’s patients. Already Boston-area biotechs are among the companies with the most advanced Alzheimer’s drug candidates in Phase 3 clinical trials, and in particular Biogen has led local drug development in this therapeutic area. Biotech companies, including those from Boston, have emerged and earned their place in the ‘land of the giants’ of the big pharmaceutical companies who have traditionally carried out Alzheimer’s drug development.

Alzheimer’s research from the Boston area will span the full spectrum of different treatment approaches for Alzheimer’s disease. New drug mechanisms for targeting Alzheimer’s will continue to emerge, and Boston researchers and biotech companies will continue to spur new frontiers for Alzheimer’s mechanisms. Amyloid-targeting is the most advanced drug development approach for Alzheimer’s, with more recent drug candidates following new science related to the role of tau protein in Alzheimer’s. Boston biotech companies will further advance the most well-established biology and mature learnings in the field of Alzheimer’s which offer the most near-term treatment possibilities. Drug candidates that target beta-amyloid, a pathway that is well-known to play a role in Alzheimer’s, are in Phase 3 trials with data on the near-term horizon, and two Boston-area companies, Biogen and Alzheon, have advanced drug candidates that target beta-amyloid.

Advances in Alzheimer’s drug development will be supported by new understanding of the genetics and sub-populations of Alzheimer’s disease, areas in which Boston’s world-class science and medical ecosystems will continue to make contributions. New insights about genetic markers for Alzheimer’s disease and deeper understanding about the underlying biology and disease progression are guiding better drug development and smarter targeting of patient sub-populations. Again, the Boston ecosystem is ideally suited to bring together scientific researchers, medical thought leaders, and biotech companies to rapidly translate new insights into drug development programs. For example, when clinical research showed that Alzheimer’s patients with the APOE4 gene have a higher risk and burden of disease, drug developers began to explore if patients in APOE4 sub-populations might be higher responders to certain drug candidates. Alzheon is proud to be a pioneer in applying a precision medicine approach to Alzheimer’s, by focusing our drug development on the APOE4 genetically-defined patients with Alzheimer’s.

At this moment in 2016, there is tremendous momentum in the field of Alzheimer’s disease. The ‘neuro network’ of industry, medicine and academia – in Boston and throughout the world – is emerging with greater knowledge about Alzheimer’s and other neurodegenerative disorders, which is driving better informed drug development. Our collective goal is to bring truly effective treatments to market that will change the lives of Alzheimer’s patients, as well as curbing the skyrocketing cost to society estimated at $1 trillion annually in the U.S. by the year 2050. As we look to 2050 and beyond, the future looks brighter than ever for achieving this goal and preventing devastation brought to patients and the impact on society.

You can see Martin Tolar at Biotech Week Boston's Partnerships in Clinical Trials event this October. Martin will present the opening keynote for day 2 of the event entitled "Innovation in Clinical R&D: Finding a Cure for Alzheimer’s". In this opening keynote Alzheon’s CEO will share the company’s drug development journey in neuroscience, as they innovate towards novel therapeutic solutions for Alzheimer’s Disease. Join us for insights on how innovation at Alzheon has been key in developing a promising pipeline of therapeutics in the clinic.

Please follow us on Twitter @BiotechWkBoston for more Boston biotech news and information, and don’t forget to check in every week for our Biotech Week Boston blog series. Biotech Week Boston is happening this October 4-7; you can learn more by clicking the link below.

What exactly is #BiotechWeekBoston?

Experts Predict what Boston Biotech Might Look Like in 2050

noreply@blogger.com (Leah Kinthaert) — Mon, 15 Aug 2016 11:00:00 +0000

This past July Karl Thiel wrote in Biospace: “Never has there been so much transformative technology, seemingly right around the corner… Hugely exciting new technologies like CAR-T, emerging technologies like CRISPR-Cas, and perhaps-ready-for-prime-time technologies like RNAi, gene therapy, and antisense all seem to be on the cusp of revolutionizing healthcare.” It’s hard to deny the fact that so many amazing groundbreaking biotechnologies have been developed, so quickly, in the past few years. If this growth rate continues there is really no telling what is on the horizon for biotech. I asked several experts in the Boston area – from biotech CEOs to bioengineers – what they thought Boston biotech would look like in 30 or so years.

Jeffrey Karp, Brigham and Women's Hospital and Karp Labs

In 2050, Boston’s population will have significantly swelled resulting from the booming biotech, medtech, and pharma industries, and new innovative colleges that have formed. People will be much more in control of their health than they are today - most people will have had their genome sequenced and will wear devices whose data will be used to minimize implications of the genome findings. Data from wearable devices will help promote lifestyle modifications to maximize health and be used by clinicians to tailor patient specific treatments. Life expectancies will continue to rise and quality of life past 65 will improve with regenerative therapies for hearing loss, cancer, and cardiovascular disease. This will in part be achieved through controlling stem cell populations inside the body with small molecules. People will also frequently visit stem cell infusion clinics for routine therapy for multiple diseases and tissue defects. The future is quite bright for Boston!

Catch Jeffrey Karp at Biotech Week Boston's Cell and Gene Therapy Bioprocessing and Commercialization event this October. Jeffrey's talk is entitled "MSCs on steroids".

Robert Langer, David H. Koch Institute Professor, MIT

I think in 2050 the Boston area will be the center of the biotech universe even more than it is today, and I expect we will see a host of new technologies including RNA therapies, nanotechnology, tissue engineering, gene editing and technologies that are not even on our radar screen today affecting the lives of billions all over the world.

Martin Tolar, MD, PhD, Founder, President and CEO Alzheon, Inc.

Boston is one of the most active areas for research and drug development in neuroscience and neurodegenerative diseases. The Boston ecosystem that fuels biotechnology innovation includes a brain trust of experts in science, medicine and biotechnology collaborating for new ways to treat neurodegenerative disorders.

By the year 2050, the outlook is promising for new life-changing medicines to emerge from the Boston hub for these devastating diseases of the brain that represents some of the greatest challenges in human health, currently with very limited treatment options for patients: Alzheimer’s, ALS, Huntington’s, Parkinson’s diseases. We are on the cusp of bringing new medicines to millions of patients in need.

You can see Martin Tolar at Biotech Week Boston's Partnerships in Clinical Trials event this October. Martin will present the opening keynote for day two of the event entitled "Innovation in Clinical R&D: Finding a Cure for Alzheimer’s".

C. Michael Gibson, Founder and Chairman of Wikidoc.org and Professor of Medicine at Harvard Medical School

Randomized clinical trials will no longer need to pay to build a new database for each trial and will not be using large number of nurses and doctors to identify and follow patients. Instead, national health databases will be used to identify patients with disease or those at risk of disease, and with the patient's consent they will be randomized to a therapy and followed using this database and a more limited number of nurses at centralized centers. Digital devices will collect and transmit data. Obviously, therapy will be much more highly targeted based upon genomics, proteinomics and other "ics."

Phillip Sharp, Ph. D. Koch Institute at MIT. Dr. Sharp won the Nobel Prize in Physiology or Medicine 1993 for the discovery of RNA splicing (in 1977) and founded Biogen in 1978.

Biotech in Cambridge and Boston will be thriving in 2050 having generated numerous treatments for Alzheimer's, Parkinson’s, better control of cancers, schizophrenia and depression. Delivery of medical care will continue to move from hospitals to more diverse settings and intense use of IT and engineering will individualize healthcare and reduce its cost.

Got any predictions for 2050? We’d love to share them with our audience so Tweet to us at @BiotechWkBoston. Don’t forget to check in every week for our Biotech Week Boston blog series. 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?

A Look at Three of Boston’s Biotech Disruptors: Christopher Viehbacher, Michael Pellini and Noubar Afeyan

noreply@blogger.com (Leah Kinthaert) — Mon, 08 Aug 2016 11:00:00 +0000

Disruptors are a special type of innovator who go outside the box and attempt to change preconceived notions and practices. If you take a look at the meaning of the word, “to disrupt” means to “rupture” or break apart, and essentially disruptors do this - discarding the old ways to bring in new ones. We might even take it a step further and look at as the commonly used root of "dis" which means to "do the opposite of" - and see the idea that disruptors are "fixers" essentially putting the pieces of something broken back together. Here’s a look at three disruptors in Boston Biotech who are revolutionizing traditional pharma to radically change the ways cures are being brought about for disease.

From all the stories that have been in the press about Christopher Viehbacher lately, you see a man who’s an extremely successful change agent that helped Big Pharma save billions. But dig a little deeper and you see a different Christopher Viehbacher, a person who is passionate about “bringing medicines to patients” without “distractions”. Joseph Haas from The Pink Sheet interviewed Viehbacher last year at BioPharm America™ and in the video Viehbacher comes across as fairly triumphant about having left his career in Big Pharma behind and invigorated by his current work as Managing Partner of Gurnet Point Capital and Executive Chairman of Boston Pharmaceuticals.

Interviewer Haas discussed how it’s a current trend that key executives in the industry are moving from Big Pharma to “small pharma” or biotech, and this theme was echoed throughout the entire conversation with Viehbacher. Viehbacher explained his thoughts on how he feels biotechs are simply a better model for efficiency: “There are dys-synergies of scale in this industry. As you get bigger you don’t necessarily get better. ... (Pharma) is an industry that has to reinvent itself all the time… Genzyme was an important tech investment for Sanofi, we weren’t really in biologics, we didn’t have a credible R&D base in the US. Building from scratch would have taken so long. Some of these acquisitions are not just product based but actually help you to shape the strategy of the company.”

Viehbacher explained what he sees as a big pitfall with many Big Pharmas – the inability to take risks: “What people forget about this industry – and that was particularly difficult to communicate in a big company - our business is inherently risky. If you don’t take risks, you will not advance. The question is ‘How do you manage the risk?’ That’s partly through a portfolio strategy… you need to be in multiple therapeutic areas, in multiple products. That means diversifying your sources of innovation, if you’re just betting on your own teams all the time you’re not necessarily going to come up with innovation. You have to mix sourcing of innovation from outside and from inside.”

He goes on to discuss the freedom given to biotechs versus the demands placed on Big Pharma: “You have to accept that some of the things you are going to do are not going to work out. I used to look at Regeneron, they would have Fidelity as a big investor, Sanofi had fidelity as a big investor – but it’s not the same Fidelity. And the expectations when you’re Big Pharma are buy backs on dividends. You’re a big cap company, they want you to have this predictability and sustainability of results. It became more difficult to take on risk and do innovation. In biotech there’s an assumption that this is risky and there’s an assumption that it’s going to take a while to see a payoff. Biotechs aren’t so concerned about quarterly earnings. That is one of the other reasons why I was quite happy to shift, if you really want to be involved in science and innovation you have to have patient capital and you can’t be on that treadmill of quarterly earnings. There will always be a role for biotech and big pharma but they really have to think about themselves in a complimentary way instead of a competitive way.”

How does Boston Pharmaceuticals disrupt? Well for one thing they have “no specific therapeutic area in mind” and focus on drugs targets that have already proven to have a benefit – and develop them with outside providers. Their site describes what they do well and simply: they acquire clinical stage molecules which they develop through clinical phases and then either partner and out license or keep and commercialize. The copy for the Gurnet Point Capital website strongly echoes Viehbacher’s disruptive vision: “We partner with life science leaders who have the vision and drive to transform their businesses. Those leaders are born risk-takers. Original thinkers with big ideas and bigger ambitions. Explorers who question the status quo. They are driven to succeed and are uncompromising in their quest to make things happen, even if the solutions aren’t easy or obvious.”

Michael Pellini is also a Big Pharma veteran who has transitioned to biotech. The President and CEO of Foundation Medicine, an organization that uses genetics to help select the right drugs to treat cancer patients, he and his organization are disrupting the siloed approach to cancer research to make cures happen faster and more effectively. He discusses his reasons for this disruption in a Pershing Square Foundation presentation last year.

Pellini begins: “Our aim is to democratize the precision medicine initiative and the work going on at academic centers around the US - not to be competitive with the academic centers – but let’s face it 85% of the patients in the United States never end up at Sloan Kettering, Weill Cornell or MD Anderson - they are treated in the communities around the United States.”

Pellini explains the need for what Foundation Medicine fundamentally does: “We extract information…we’re all building these databases that have to come together and they should absolutely not just come together inside my company or inside a medical center…they have to truly come together over time. (You need to combine) learning from the West Coast, Southeast, New York City, Boston, Hong Kong – because you’re going to see patients that are these snowflakes, tumors represented as snowflakes all around the world even the experts might not have seen enough of any one patient diagnosis to know exactly what to do with that patient. That issue is magnified many times over in the communities around the United States.” He emphasizes that “all data needs to be connected” and he urges the scientific community to “take the learnings from Silicon Valley.”

Moderna Therapeutics, a company co-founded by Noubar Afeyan, was given the distinction of being the #1 disruptor by CNBC last year, one of just a handful of non-tech companies in that list. Afeyan is the founder, Senior Managing Partner and CEO of Flagship Ventures, the firm that launched Moderna as well as several others. In fact, in his 30 plus year career, Afeyan has founded over 38 life science and tech startups, making him the perfect person to - know when and how NOT to start a start-up. An immigrant to the US at age 13, Afeyan credits being an immigrant as a big part of his success. He said to the Armenian Mirror-Spectator this spring: “What keeps you from innovating is being comfortable…If you’re an immigrant, then you’re used to being out of your comfort zone.”.

Two years ago Afeyan gave an inspiring talk to a group of scientists at Imperial College in London, and interestingly enough his talk was less about scientific innovation than it was about the business aspect of how to make scientific discoveries successful. Afeyan opened his talk with the affirmation that the most important innovation in the last fifty years wasn’t the internet, biotherapeutics or even genome sequencing but “startup ventures” as an entity. Afeyan makes this point: “Startup ventures are a fairly new phenomenon. When I was at MIT in the mid-1980s there was maybe one company every year of any note that was being created.”

He goes on to describe his experience of founding multiple startups, and offers the idea that startups as the way they are now will radically change. Afeyan is at the epicenter of that change with his organization Flagship Ventures: “Flagship ventures asks the question, can you think systematically about innovation, instead of doing it when it comes to you or when an opportunity is presented. Venture Labs is an institutional attempt to create first of their kind companies around technologies developed to solve a problem – not around advancement of science.”

Please follow us on LinkedIn at our company page or on Twitter @BiotechWkBoston for more Boston biotech news and information, and don’t forget to check in every week for our Biotech Week Boston blog series. Biotech Week Boston is happening this October 4-7; you can learn more by clicking the link below.

What exactly is #BiotechWeekBoston?

How Venture Philanthropy is Helping 5 Boston Biotechs Develop Cures

noreply@blogger.com (Leah Kinthaert) — Mon, 01 Aug 2016 11:00:00 +0000

Researching and developing lifesaving medicines can take as long as 15 years and the costs are high – recently estimated at $2.6 billion by the Tufts Center for the Study of Drug Development. Venture capital can be hard to get, especially in the early stages of the drug pipeline. Broadview Ventures summed up the situation in their Venture Philanthropy in the Healthcare Marketplace report: “Venture capitalists are risk averse. NIH is retracting. Big Pharma is refocused on marketing and commercialization, as the productivity of R&D declines. This widening translational gap threatens to strand promising products and cures.”

Luckily venture philanthropy is increasingly fulfilling those financial needs with important bridge funding. And where once philanthropies focused on funding academic and institutional research, more and more are beginning to take a look at biotech companies, and essentially helping to build those bridges from bench to bedside in order to expedite the delivery and approval of life saving therapeutics. Chris Colecchi of Broadview Ventures was quoted in their report: “Venture philanthropy can disrupt the status quo with fewer dollars than people think. Modest amounts of money can fund early stage research in that translational space.” Indeed their research shows that 51% of the funding that venture philanthropies are giving focuses on the preclinical stage of development, a “key unmet need in the funding landscape”. But just exactly who is funding medical research, and what research are they funding? Here are examples of five Boston biotechs who are working with patient advocacy foundations to develop cures.

Five years ago the Juvenile Diabetes Research Foundation (JDRF) stepped in to help Boston biotech Selecta Biosciences develop a vaccine for type 1 diabetes, specifically a therapeutic which would prevent the autoimmune response that causes type 1 diabetes. Since JDRF’s inception, JDRF has contributed more than $2 billion to T1D research and is currently funding 50 human clinical trials of potential T1D therapies. Selecta’s ability to begin this research with the help of JDRF’s funding led them to the success they have now; just this June they raised $70 million in an IPO. Selecta describes their technology as being: “designed to communicate precise instructions to the immune system and to expand the use of vaccines to immunotherapies that enable a new generation of biologic therapies to treat autoimmune diseases, allergies, and cancer.” You can learn more about JDRF grants and the work they do here.

Akashi Therapeutics is unusual in that it was founded not by VCs but by nonprofit disease advocacy groups for the main purpose of developing a cure for Duchenne muscular dystrophy. Duchenne is a disease which affects about 300,000 people a year, primarily boys, and leads to progressive decline in muscle function and early death. Akashi Therapeutics was founded in 2010 – known then as Dart Therapeutics - and by 2014 it had raised $2.5 million dollars from 25 different patient advocacy groups. One of those groups was CureDuchenne. Akashi has had to suspend an experimental treatment called HT-100 for Duchenne following the tragic death of one child who was being given a high dose of the drug. (You can get an update from their CEO Marc Blaustein here where he talks about next steps for the HT-100 study.) Early this year CureDuchenne’s president and CEO Debra Miller spoke with Boston Business Journal about the situation: “We are confident that the team at Akashi will be able to isolate the problem soon. Anti-fibrotic drugs are needed, and CureDuchenne will continue to fund a research pipeline so that we can treat all aspects of this devastating disease.” CureDuchenne is currently funding 10 clinical trials and 7 preclinical studies as well as the Center for Duchenne Muscular Dystrophy at UCLA. You can apply for a research grant directly on their website here.

Early this year The Boston Globe described The Cystic Fibrosis Foundation and their then President Robert J Beall as having “pioneered” the model of “venture philanthropy”. In fact, The Cystic Fibrosis Foundation have invested a great deal of their resources in the Boston area: with early investment in Vertex Pharmaceuticals, a current alliance with Shire PLC and their own research lab in Bedford, Massachusetts. Late this spring Boston’s Editas Medicine made an exciting announcement – that The Cystic Fibrosis Foundation would be giving them up to $5 million for their research on CRISPR/Cas9 based medicines. CFF’s press release says that in 2015 they: ”gave approximately $15 million in grants to nearly 50 scientific laboratories to fund CF research on emerging technologies such as gene editing, gene delivery and stem cell research.” Learn more about CFF research awards here.

Last year Emulate was awarded a grant from the Michael J. Fox Foundation to apply the company’s “organs-on-chips” for the investigation of drug candidates for Parkinson’s disease. Organs on chips basically simulate the real thing for testing, to give more predictive data as well as a deeper understanding of both drug and disease. This funding led to Emulate eventually raising $28 million in a Series B Round this past March, as well as partnerships with both Merck and Johnson & Johnson. The Michael J. Fox Foundation website shows recent grants to Boston’s own MGH and MIT, and their press says they have funded more than $600 million in research to date fundamentally altering the “trajectory of progress toward a cure” for Parkinson’s disease. You can learn more about MJFF grants here.

Back in 2012, Constellation Pharmaceuticals began a partnership with The Leukemia & Lymphoma Society (LLS) to “advance the development of a novel BET inhibitor.” LLS provided $7.5 million in funding for their Phase I trial. Since then Constellation has established an alliance with Genentech and gone on to get $55 million in financing from venture capital. Their website describes why they develop drugs that target epigenetic function: “Our research has shown that when epigenetic regulatory events occur aberrantly, the proteins that regulate these events can become drivers of disease. Inhibiting these targets with novel agents promises to be a powerful avenue to develop important treatments serving unmet medical needs.” LLS invested a total of $67.2 million in cancer research last year. You can learn more about partnering with LLS here.

Please follow us on LinkedIn at our company page or on Twitter @BiotechWkBoston for more Boston biotech news and information, and don’t forget to check in every week for our Biotech Week Boston blog series. Biotech Week Boston is happening this October 4-7; you can learn more by clicking the link below.

What exactly is #BiotechWeekBoston?

5 Boston Biotech Breakthroughs We Could See in 2017

noreply@blogger.com (Leah Kinthaert) — Mon, 25 Jul 2016 11:00:00 +0000

Early this year, Tufts Center for the Study of Drug Development reported that “developing new drugs has become more complex and more expensive than ever.” What is increasing the cost? For one, Tufts CSDD reports, “a typical Phase III protocol now entails an average of 167 procedures” which is 60% more than it was just 16 years ago in 2000. With statistics like these it’s not surprising that 9 out of 10 companies that begin clinical trials never bring a drug to market. However, even with these odds biotech companies are persevering and in some cases thriving, especially in Boston’s Biotech Hub. Boston is a hotbed of discovery and innovation, with startups attracting VC investment and Big Pharma organizations like Merck building new labs here even as they cut teams in other parts of the country. Right now Boston has several promising drugs in the pipeline, with Phase III studies completed and FDA approvals on the horizon. Read about five success stories we could see coming out of Boston biotechs in 2017.

According to their data, Sarepta Therapeutics' drug for Duchenne muscular dystrophy (DMD) “Eteplirsen” has been effective in a Phase III clinical study. Because DMD is both rare and serious, Sarepta has been a candidate for a sped up review process from the FDA, however as Robert Weissman from the Boston Globe recently reported an “influential advisory committee” has recommended “to reject its experimental treatment”. Sarepta’s March press release explains: “The FDA has granted Eteplirsen Priority Review status, which is designated for drugs which provide a treatment where no adequate therapy exists. The FDA also granted Rare Pediatric Disease Designation to Eteplirsen, as well Orphan Drug Designation and Fast Track Status.” What does Eteplirsen do? Sarepta explains: “The underlying cause of DMD is a mutation or error in the gene for dystrophin, an essential protein involved in muscle fiber function. Our investigational therapies for DMD are designed to skip an exon in the dystrophin pre-m RNA to enable the synthesis of a functional shorter form of the dystrophin protein.” UPDATE: Boston Business Journal reported the morning of September 19, 2016: "More than six months after its original deadline to make a decision, the U.S. Food and Drug Administration has granted accelerated approval to the first drug in the U.S. that can slow the progression of Duchenne muscular dystrophy."

The action date for FDA review was late May, but the FDA requested more data from Sarepta in June. Sarepta explained the dire need for a Duchenne cure, and how they could potentially meet that need, in their March press release: “It is estimated that Duchenne muscular dystrophy affects approximately one in every 3,500 – 5,000 boys born worldwide, with 13% of people with the disease having mutations addressable by Eteplirsen/exon 51 skipping.” This potential for a cure gives new hope for those affected by this disease, a hope which has been increasingly channeled into activism. Fierce Biotech reported last month that: “Hundreds of patient advocates, patients and families turned out to give their raucous support for an approval during the (FDA) panel review and vote.” In addition, the Washington Post reported that families whose sons have taken Eteplirsen have documented the “apparent halt in their sons' decline” on Facebook and YouTube. Note: since this article was written, biotech Santhera was set back by potentially three years by the FDA decision for them to run another Phase III study for their Duchenne’s drug. The jury is out on how this decision will affect Sarepta’s chances. Matthew Herper of Forbes had this to say on Twitter right after that decision: “I don’t think there is any read-through from Santhera to Sarepta.”

Back in 2013, Robert Weissman reported on this devastating Boston biotech setback: “It took Aveo Pharmaceuticals Inc. seven years to develop a much anticipated kidney cancer drug (Tivozanib). Federal regulators needed only about four hours to crush the company’s hopes.” Three years later, after a corporate restructuring (the SEC has threatened to ban three of its former executives), loss of Biogen and Astellas as research partners, a rebrand as Aveo Oncology and then gain of $17 million in funding, Aveo has given the go ahead from the FDA to begin a Phase III trial of Tivozanib for renal cell carcinoma. What does Tivozanib do? Aveo’s website describes it as: “a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off-target toxicities.” Why blockade VEGF? Aveo explains: “vascular endothelial growth factor (VEGF) pathway plays a significant role in angiogenesis, which is critical in cancer”. With perhaps lessons learned from how they work with the FDA, success may be on the horizon for this drug, eagerly awaited by patients and patient advocates.

In partnership with NSGO (Nordic Society of Gynaecological Oncology), Tesaro just had the first successful Phase III trial of a PARP inhibitor Niraparib (NOVA) for ovarian cancer. Tesaro’s NDA and MDA submissions “are planned for Q4 2016”. Niraparib (BRAVO) is also in a Phase III trial for the treatment of breast cancer. One of the youngest companies of the five on our list, founded in 2010, it is also one of the most successful, with a commercial drug for chemotherapy side effects called Varubi, a $500 million deal with Janssen for commercial use of Niraparib for prostate cancer, and plans to add 100 employees by the end of the year.

Paratek Pharmaceuticals’ website describes their efforts as “working to change how bacterial infections are treated.” Having just received positive results in Phase III trials for Omadacycline, they are poised to fulfill that promise. Paratek believes that Omadacycline will solve a great deal of the issues with the bacterial resistance doctors are increasingly dealing with. Paratek says that Omadacycline is “Active against drug resistant pathogens, including methicillin-resistant Staphylococcus aureus, penicillin-resistant and multi-drug resistant Streptococcus pneumonia da, and vancomycin-resistant Enterococcus species.”

ArQule is currently in two Phase III trials for Tivantinib to treat hepatocellular carcinoma, the most common type of liver cancer, in partnership with Daicchi Sankyo and Kyowa Hakko Kirin. The National Cancer Institute gives a great explanation of what exactly Tivantinib does: ”Tivantinib binds to the c-Met protein and disrupts c-Met signal transduction pathways, which may induce cell death in tumor cells overexpressing c-Met protein or expressing constitutively activated c-Met protein.” In more layman’s terms, it’s a “kinase inhibitor” a type of research in which ArQule specializes, having “eight kinase inhibitors into human clinical trials with a ninth about to enter the clinic.” In late June ArQule was featured by Zack’s Investment Research Firm with the call to action “Forget Valeant, Invest in These Attractive Stocks Instead.”

Two Boston biotechs that may not have an impending breakthrough, but are looking fairly certain (if anything is certain in this biotech world) to have success by 2020, are Alnylam and Boston Biomedical. Andrew McConaghie raved about Alnylam this June in Pharma Phorum, saying it was: “one biotech company which is tipped to deliver on huge expectations, thanks to a rigorous approach to validating its science.” Alynlam proposes to have three drugs approved and another ten in the pipeline by 2020. Alynylam’s core focus is RNAi therapeutics, and Pharma Phorum describes their pipeline as: ” based on targets in the liver, but covering a broad range of diseases; rare genetic diseases, cardiometabolic conditions and hepatic infectious diseases, such as hepatitis B.”

Boston Biomedical’s Napabucasin was just granted Orphan Drug Designation from the FDA in the treatment of gastric cancer this June. Orphan Drug status is given to: “Drugs that are not developed by the pharmaceutical industry for economic reasons but which respond to public health need.” Boston Biomedical is currently in Phase III trials for this drug, which inhibits cancer cell pathways by targeting the STAT3 pathway.

Please follow us on LinkedIn at our company page or on Twitter @BiotechWkBoston for more Boston biotech news and information, and don’t forget to check in every week for our Biotech Week Boston blog series. Biotech Week Boston is happening this October 4-7; you can learn more by clicking the link below.

What exactly is #BiotechWeekBoston?

Gene Editing in CHO Cells

noreply@blogger.com (Unknown) — Fri, 17 Jun 2016 15:06:00 +0000

The team behind Cell Line Development & Engineering event have recently produced an exclusive whitepaper titled "Gene Editing in CHO Cells". Below you will find a brief summary of the whitepaper and download the complete whitepaper now.

Whitepaper Summary:

Recently, several exciting advances in CHO cell line engineering have received significant media and research attention due to efforts in genome sequencing, systems biology, and bioinformatics combined with the relatively new field of targeted gene editing platforms. Three key gene editing technologies have been at the forefront of the recent developments in CHO cell line engineering. Early efforts to introduce targeted site specific edits to the CHO genome focused on implementing the zinc finger nucleases (ZFNs) and the transcription activator-like effector nucleases (TALENs). The ZFN platform has been successfully deployed in a variety of post translational modification applications aimed at increasing specificity of recombinant protein production, but the efficiency of this platform can be limited in mammalian cell lines.

The clustered regularly interspaced short palindromic repeats associated 9 (CRISPR/Cas9) targeted gene editing system has recently exploded onto the research scene in almost every organism. This targeted gene editing platform allows for the creation of multiplexed edits in a single cost-effective step with a specificity previously unachievable in the genome editing arena. This complex is composed of short guide RNAs (sgRNAs) and a CRISPR-RNA that form a site specific construct that is complimentary to the target DNA, which introduces a double stranded DNA break upon binding. Repair of the break site by endogenous enzymes then creates a highly specific change to the DNA which can be customized for a variety of applications.

These advances in genome editing have helped enable high-throughput development of CHO cell lines that can be utilized as economically viable commercial expression vectors. The CRISPR/cas9 gene editing system has shown to be an extremely useful tool for customizing the metabolic pathways of CHO cell lines for use in biopharmaceutical production. One of the most useful applications of this exciting technology has been the creation of multiplexed targeted knock out screening systems. Previously, knock out experiments had to rely on mutagenesis, drug knock out, or media screening to identify the effect of a mutation on a desired cell type. These methods are inefficient and sometimes lead to less desirable off-target effects. It is now possible to develop very large gene knockout libraries to be targeted by CRISPR/cas9 using bioinformatics software specific to this platform.

Customizing metabolic pathways in CHO cell lines is of paramount importance for developing “cell factories” capable of biopharmaceutical production. Reducing the energy expenditure associated with mitochondria production and oxidative metabolism is one approach that has been shown to increase the efficiency of the cell by directing metabolism towards production of the target product. Modulating these pathways has traditionally been accomplished using interfering RNAs, but the specificity of the CRISPR/cas9 platform offers another tool with which researcher can customize the energy profile of CHO cell lines destined for biopharmaceutical production.

Future efforts in the field will be focused on increasing the efficiency of the CRISPR/cas9 system, as this platform is poised to become the model for the majority of biopharmaceutical development. Currently, 60 to 70% of all biopharmaceutical production is accomplished with recombinant mammalian cell lines, and this market share is expected to grow. Multiplexed editing efforts will also continue to increase the rate at which specific customizable CHO cell lines can be produced, as this process is highly critical to increasing the rate at which CHO cell line engineering moves forward.

Download the Complete Whitepaper

Innovative Development Strategies and Applications for Bispecific Antibodies

noreply@blogger.com (Unknown) — Fri, 10 Jun 2016 12:00:00 +0000

The team behind the Next Generation Protein Therapeutics Summit have recently produced an exclusive whitepaper titled "Innovative Development Strategies and Applications for Bispecific Antibodies". Below you will find a brief summary of the whitepaper and download the complete whitepaper now.

Whitepaper Summary:

The phenomenal growth of the bispecific antibody arena has culminated in 60 unique constructs, more than 30 in clinical development, and two on the market as therapeutics for a wide variety of cancer types and numerous diseases/disorders. Bispecific antibodies are specially engineered antibodies which simultaneously bind to two different epitopes on the same antigen or different antigens, increasing selectivity and effectiveness. [1]

The focus in incorporating bispecific antibodies within oncology applications has been in either blocking multiple and redundant signaling pathways involved in oncogenesis or redirecting immune effector cells to be in close proximity to tumor cells. In non-oncology applications, a major developmental effort has gone into blocking pro-inflammatory cytokines.[2, 3]

Despite successes in development there are some critical hurdles to overcome and there is a need for innovation and improvement. Manufacturability issues such as low expression yields and product instability/short half-life have hindered development. Challenges lie in the need for rapid discovery of lead bispecific antibodies with optimal selectivity for their targets, and a need for rapid purification techniques. Adverse effects from immunogenicity, mainly caused by a “cytokine storm,” can stifle clinical trials.[3]

Development efforts have provided some solutions to these hurdles. Researchers at Eli Lily are using mathematical modeling parameters to make predictions about how engineered antibody properties will affect binding to cell surface antigens, ultimately optimizing developability. [4]Another novel strategy involves monitoring target/ligand binding of bispecific antibodies through surface plasmon resonance (SPR), which allows users to view the dynamics of bispecific antibody binding and dissociation events with two targets. [5]

The short half-life of scFv-based bispecific antibodies is a major drawback compared to that of IgG-like bispecific antibodies. Successful half-life extension, and in some cases, recycling, has been achieved by attaching a variety of components: PEG chains [6], human serum albumin, and Fc fragments [1]. In another novel approach, human mesenchymal stromal cells (MSCs) can be genetically modified to produce and secrete bispecific antibodies that accumulate near tumors continuously throughout the lifetime of the patient.[7]

A plethora of unique applications are being investigated for bispecific antibodies. One is in delivery of therapeutic antibodies across the blood-brain barrier for neurological conditions. [8]Another innovative application involves engaging bispecific antibodies to deliver drug, nanoparticle or radiolabel payloads to tumor sites. [1]Bispecific antibody-based immunoassays are being developed for diagnosis of patients with various infectious diseases: SARS, hepatitis B, tuberculosis, as well as E. coli infections. [9]Another application involves tackling the rising threat of antibiotic resistance through specially designed constructs effective against antibiotic resistant bacteria such as Pseudomonas aeruginosa. [10]

This exciting and fast moving arena includes many creative design formats, and innovative solutions for numerous development and manufacturing issues. There are still many unmet needs, but the field is bound to yield many more successes.

Download the Complete Whitepaper

Fan, G., et al., Bispecific antibodies and their applications. Journal of Hematology & Oncology, 2015. 8(1): p. 1-14.
Spiess, C., Q. Zhai, and P.J. Carter, Alternative molecular formats and therapeutic applications for bispecific antibodies. Mol Immunol, 2015. 67(2 Pt A): p. 95-106.
Spasevska I, D.M., Klein C, Dumontet C, Advances in Bispecific Antibodies Engineering: Novel Concepts for Immunotherapies. J Blood Disord Transfus 2015. 6(243).
Rhoden, J.J., G.L. Dyas, and V.J. Wroblewski, A Modeling and Experimental Investigation of the Effects of Antigen Density, Binding Affinity, and Antigen Expression Ratio on Bispecific Antibody Binding to Cell Surface Targets. J Biol Chem, 2016.
Karllson, R., Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity. Biopharm International, 2015. 28(10): p. 38-45.
Kontermann, R.E., Strategies for extended serum half-life of protein therapeutics. Curr Opin Biotechnol, 2011. 22(6): p. 868-76.
Aliperta, R., et al., Bispecific antibody releasing-mesenchymal stromal cell machinery for retargeting T cells towards acute myeloid leukemia blasts. Blood Cancer Journal, 2015. 5: p. e348.
Couch, J.A., et al., Addressing Safety Liabilities of TfR Bispecific Antibodies That Cross the Blood-Brain Barrier. Science Translational Medicine, 2013. 5(183): p. 183ra57-183ra57.
Byrne, H., et al., A tale of two specificities: bispecific antibodies for therapeutic and diagnostic applications. Trends Biotechnol, 2013. 31(11): p. 621-32.
DiGiandomenico, A., et al., A multifunctional bispecific antibody protects against Pseudomonas aeruginosa. Science Translational Medicine, 2014. 6(262): p. 262ra155-262ra155.

Creating New Pathways for the Development, Translation, and Delivery of Immunotherapies

noreply@blogger.com (Unknown) — Fri, 03 Jun 2016 14:47:00 +0000

The team behind the Next Generation Protein Therapeutics Summit have recently produced an exclusive whitepaper titled "Creating New Pathways for the Development, Translation, and Delivery of Immunotherapies". Below you will find a brief summary of the whitepaper and download the complete whitepaper now.

Whitepaper Summary:

The last decade has seen substantial growth of immunotherapy treatments for cancer. The new immunotherapies have produced exciting results in terms of response rates to treatment for certain cancers, such as melanoma, which have been refractory to treatment, once substantial metastasis has occurred. The US Food and Drug Administration (FDA) has approved several antibodies against immune checkpoint inhibitors based on the encouraging results in clinical trials. Other types of immune therapies are also being developed which may also be useful in the treatment of cancer.

New antibody/cytokine fusion proteins, anti-CD 137 monoclonal antibodies (mabs) for stimulating cells of the immune system, more refined uses of cytokines in immunotherapy treatments, cancer vaccines, use of genetically engineered T cells to specifically target tumors, new techniques in stimulating the innate immune system and combinations of immunotherapies have great potential for being effective treatment options for cancer treatment in the future.

Challenges, however, remain to perfect these therapies for use in the clinic for cancer treatment. The nature of these challenges are scientific, clinical and regulatory. Scientific challenges include defining the appropriate tumor types for an appropriate immunotherapy, the conditions under which various cells of the immune system would be activated and determining how best to manipulate them to allow for maximum tumor cell destruction, finding better ways to circumvent cancer cell suppression of immune cell responses and using new techniques to prevent or ameliorate the nonspecific injury to normal tissue that can occur as a side effect of immunotherapeutic treatment.

Clinical challenges include ensuring there is adequate quality control in manufacturing process to supply the agent in pure enough form for clinical trials, obtaining enough patients that meet inclusion criteria, designing clinical trials that will yield adequate information to assess the safety and efficacy of the treatment and defining appropriate endpoints for a cancer clinical trial to effectively interpret clinical data gained from the clinical trial.

Regulatory challenges can occur at multiple levels for companies or entities trying to gain FDA approval for their immunotherapy technique or product. These challenges can be at the preclinical level, clinical or manufacturing levels. Adherence to regulations governing Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices can be problematic when trying to take immunological reagents or cellular treatments from the research laboratory to the cancer treatment clinic.

Despite the challenges when conducting research and treatment with immunotherapies, the intense level of research and data being generated with immunotherapies for cancer will ensure that a wide variety of new therapies will be possible in the coming years.

Download the Complete Whitepaper

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