ICYMI: Insights from my time with Vicki Sato at BIO CEO & Investor Conference

At this week’s BIO CEO & Investor Conference the idea of saving the “best for last” certainly did apply. I had the great pleasure of moderating the final fireside chat with Vicki Sato, Chairman of Denali Therapeutics and Vir Biotechnologies, and co-Chair of Mayor de Blasio’s Life Sciences Advisory Council. Vicki’s career journey in the life sciences industry is as diverse as it is impressive, and she opened up to the audience about just a few of the successes and challenges she’s encountered along the way.

In case you missed it live, I’m sharing my top 3 takeaways from this raw and inspiring session:

The life sciences/biotech industry wouldn’t exist without people who are willing to take tremendous risk.

This industry has been built on taking major risks not only in science, but also from a business and financial perspective. A persistent belief in yourself that you can always do better and taking those tough challenges on, that while ridiculous to some, are equally irresistible.

Vicki’s current risk of choice? Getting involved with companies who are focused on some of the most complex healthcare challenges of our time, including Hepatitis C and Cystic Fibrosis. “If someone doesn’t take on these diseases we won’t improve the rate of progress against them… I feel I have a scientific and moral obligation to get involved.”

New York City is ripe for “irresistible risk taking” in this industry.

NYC is already a hub for biomedical innovation – an epicenter for academia, medical institutions and both private and public funding at your fingertips. 

The city and state are now providing incentives to keep healthcare innovation companies local, versus moving to the likes of Boston or Silicon Valley, and progress is being made a rate faster than ever to make the necessary adjustments to other perceived bottlenecks, such as challenging zoning laws and expensive rent.

All the more reason we are thrilled to be partnering with the state to open the doors to our JLABS @ NYC site in June of this year!

Diversity, in all senses of the word, is critical in this business.

Cultivating a culture of diversity and inclusion in the life sciences industry was a major topic at this year’s conference. Vicki highlighted that diversity certainly impacts the bottom line of business, emphasizing that in her experience it hasn’t been necessarily “in the labs” where we’re lacking. The challenge lies in maintaining that diversity at the management and board level, especially when it comes to gender disparity.

She highlighted that diversity of ALL kinds is impactful, beyond the traditional definition. Diverse management skills, such as the ability to raise significant quantities of funding on a sustainable basis, are also key when we think about influencing this industry.

It’s conversations like this that remind me why I’m so proud to be a part of a company that is passionate about these issues. While we’ve come a long way in NYC, it’s going to take banding together as a community to ensure we’re moving the needle and enabling this ecosystem to thrive.

Happy Valentine’s Day: Biotechnology is Good for the Heart

With today being Valentine’s Day and February being American Heart Month, there’s no better time to explore how biotechnology has benefited one of mankind’s most vital organs, the heart.

Question: When was the first American Heart Month? (read to see answer below)

On Valentine’s Day we may view the heart as a representation of love and joyfulness, but heart complications have plagued man for some time. According to the American Heart Association, in the 1960s more than half of the deaths in the U.S. were caused by cardiovascular disease. Today, heart disease is still the leading cause of death with more than 17.9 million people succumbing to the disease each year. In the future, that number is only expected to go up.

So, where does biotechnology come into play?  Well, as you probably are aware, one of the best nutrients to improve heart health is a type of fatty acid known as Omega-3. Omega-3s cannot be manufactured, so the best place to get them is through your diet. Using biotechnology, we can enhance Omega-3-rich foods to increase their availability and nutritional value.

Canola

Arguably one of the most popular oils at your local supermarket, canola oil is high in Omega-3 fatty acids. Coupled with the fact that the oil is widely used, canola oil is a common source of Omega-3s for many. Therefore, the availability of the canola plant is critical. So, to increase supply of the crop, scientists modified the canola plant to carry a trait that makes it herbicide resistant.  Before this intervention, the canola plant was highly susceptible to weeds. Farmers were forced to till the soil between yields to disrupt the growth of the weeds and protect the crops. By growing herbicide resistant canola, however, this tilling process in no longer necessary. This saves farmers both time and money and provides more time for the crop to reach its full yield potential, thus increasing crop yields and canola oil production. Because of biotechnology, canola oil is a food item that consumers can rely on to consume Omega-3s and improve heart health.

Soybean

Found in many products such as milk, oils and proteins, soybean is another popular crop that already has high levels of Omega-3 fatty acids. Thanks to biotechnology, however, scientists were able to increase the amount of Omega-3s in the crop. In 2009, the FDA ruled that soybeans modified to contain increased levels of Omega-3s are safe for human consumption and, as a result, could start serving as a substitute for other sources of the essential fatty acid.  Today, the crop is seen as a viable source of Omega-3s.

Salmon

Researchers have already made progress on improving other sources of Omega-3s, such as meats and seafood, using biotechnology. One example is the salmon, a well-known source of Omega-3s. Through biotechnology, researchers have created the AquAdvantage salmon, which grows to market size faster than conventional salmon. Once this fish hits the market, the supply of the nutrient-rich fish will likely increase, resulting in another heart-healthy food that consumers can rely on.

With the rate of heart disease not slowing down, we’ll need to continue looking at ways to improve crops, like canola and soybean, and meats and seafood, like salmon, to ensure we maintain a steady supply of Omega-3-rich foods.

Answer: In December 1963, then-President Lyndon Johnson proclaimed February as American Heart Month. The following February (1964) marked the first recognition of American Heart Month, which has been recognized every year since.

Needle Tilting Mid-Session For Puma Biotechnology (PBYI) As Shares Move 8.73%

Shares of Puma Biotechnology (PBYI) have seen the needle move 8.73% or 5.38 in the most recent session. The NASDAQ listed company saw a recent bid of $67.03 on 826983 volume. Some investment professionals believe that a great way to find, study, and invest in equities without getting …

The Art of the Biotech Deal at BIO CEO & Investor Conference

Professionals from all areas of biotechnology convened for the 20th annual BIO CEO & Investor Conference held at New York’s Marriott Marquis February 12th and 13th. Looking for deals, partnerships and collaborations, attendees participated in BIO One-on-One Partnering™, networked, listened and learned during a busy two days.

As one of the largest investor conferences focused on established and emerging publicly-traded and select private biotech companies, the event drew an enthusiastic group ready to make deals and find the right partners to move innovation to the marketplace. The key relationship-building was reflected in the 2,700 individual meetings that took place during the conference, scheduled through the partnering system.

We talked with several attendees to get their take on the conference

Things were very busy at BIO’s buzz center where interviews with thought-leaders focused on breakthrough technologies and the investment climate for biotechnology.

There was no shortage of twitter activity underscoring the impact of this event.

#BIOCEO18: Paradigm Shift Creating New Opportunities in China

The past few years have been a time of tremendous change in the world’s second largest market for biopharmaceuticals: China. What these changes mean for biopharmaceutical companies looking to break into the market – or find a new potential source of investment capital – was the subject of a lively panel at the opening day of the 2018 BIO CEO and Investor Conference in New York.

Moderated by BIO Executive Vice President for International Affairs Joseph Damond, the panelists included:

  • Alex Jung, Managing Director, Parthenon-EY, Ernst & Young LLP
  • Michael Keyoung, MD, PhD, Managing Director and Head of North America, C-Bridge Capital 
  • Yuwen Liu, Founding Partner, BOHE Angel Fund; former Chairwoman & CEO, Suzhou Industrial Park Biotech Development Co. Ltd. (BioBAY)
  • Hummer Mars, Executive Director, China Group, Global Investment Banking Division, NYIC
  • Kimberly Nearing, Managing Director, Head of Life Sciences, Cedrus Group
  • Dan Zhang, MD, Chairman, Fountain Medical Development

BIO’s Damond summed up the shift in his opening remarks:

“One of the things we’ve been following a lot in the past couple of years is the fact that China has been doing a lot to reform its regulatory and drug approval regime from one that is under-resourced and lagged tremendously from approval dates in the US and Europe to one that is better resourced and more aligned with regulatory practices in the developed world. And this is part of China’s goal of developing the right conditions to do drug development in China.”

As Kimberly Nearing of the Cedrus Group noted, “Western companies that are sitting on the sidelines to see what’s going to happen in China, this might be the impetus to start including China in their plans. We hear from a lot of clients, and rightly so, that the value of their assets to potential partners in China just increased because of the reduction in development time.”

C-Bridge Capital’s Michael Keyoung observed that the changes have meant a shift from focusing on me-too products to true innovation. “If you’ve followed China in the last 5 years, there’s a big dynamic shift in the past 2 years… if you’re a VC investor you invested in a different type of Chinese biotech company these past 3-4 years,” said Keyoung. “You were focused on fast followers and a different type of drug development. Now with the change of regulation, you really have to focus on innovation.”

The panelists had a few pieces of advice for those looking to break into the Chinese market. First, do your homework. Ms. Nearing stressed the importance of thorough due diligence with any potential partner, and spelling out in lengthy and explicit detail the division of labor and decision-making structure for partnerships.

Several panelists also advised finding the right strategic advisor who can guide through the complex Chinese landscape, where a clear understanding of the regulatory and investment landscape is paramount for success.

Read more coverage of the 2018 BIO CEO & Investor Conference.

BIO Publishes Report on Pain Meds

12, 2018, the Biotechnology Innovation Organization (BIO) published a report on the opioid addiction problem in the United States. The report, which analyzed a decade of innovation and investment in the treatment of pain and addiction, states that more research and clinical development are needed.

Chapter 8: Building the Brand – Today’s Homeowner

Danny with Anchors from American Morning Headquarters on The Weather Channel

Danny shares stories about his many media appearances over the years and how he built upon the TV show to create a multi-media brand.

Are We Ready to Unleash the Promise of Gene Editing?

An opinion column on AgWeek.com looks at the promises of gene editing and the questions that still remain about the regulation and acceptance of such technologies.

Those two factors could determine whether the United States will nurture the potential for breakthroughs in the areas of human health, animal health and food production or lag behind other countries who are eager to harness gene editing’s potential.

Sara Wyant, president and founder of Agri-Pulse Communications Inc. authors this piece with contribution from Agri-Pulse’s Ed Maixner:

The process of producing better food, protecting the environment and improving animal health is advancing at a seemingly breakneck pace.

These advancements are driven in part by new scientific discoveries, genetic research, data science, enhanced computational power and the availability of new systems for precision breeding like CRISPR – an acronym for Clustered Regularly Interspaced Short Palindromic Repeats.

“We use the term ‘gene editing’ rather loosely” in the world of science, said Bernice Slutsky, senior vice president for the American Seed Trade Association. At its core, gene editing is “plant breeding innovation,” she said. “Plant breeders have always used a range of tools – a toolbox of different disciplines.”

With the new techniques, they are “doing the same things that breeders have always done, but very precisely,” she said.

The outcomes possible with different types of gene editing today might have seemed impossible just a few decades ago. And now, these new opportunities have strong implications for both producers of crops and livestock, as well as consumers. Consider just a few of the possibilities:

  • New breeds of livestock and poultry could be genetically engineered to no longer be susceptible to widespread disease outbreaks, like pigs resistant to Porcine Reproductive and Respiratory Syndrome Virus (PRRSv), which can cost hundreds of millions of dollars annually.
  • Cover crops that naturally improve soil health can be developed to grow in more diverse climates, improving environmental sustainability, water quality and animal nutrition.
  • Dairy cows can be bred without horns, removing the need for cows to endure the polling (horn removal) process.
  • Fruits and vegetables could be engineered to resist browning, extending their consumer appeal and reducing food waste.

Indeed, the science is moving so rapidly that some are wondering if producers, consumers and regulators will ultimately be able to understand and embrace the changes.

As history demonstrates, new advancements in breeding have almost always been controversial – even though safety or environmental risks have not been proven.

It’s important to always remember that, “science and innovation always outruns law and policy. These ethical and moral questions are not new,” said Bill Even, CEO of the National Pork Board who also owns a farm in South Dakota. “They arise every time a new technology emerges.”

“I would have these same discussions when I worked at Pioneer,” Even recalls about some of the Iowa-based seed company’s early research aimed at improving corn yields. “When Henry Wallace pioneered the use of hybrid seed corn in the 1920s, there were all sorts of people saying, ‘the sky is falling,’ ‘you’re messing with God,’ and this is ‘not the natural way things should happen.’ There was all this fear mongering. Now, it’s viewed as one of the most successful improvements in agriculture and modern history. And people assume it’s natural and they welcome it.”

Kevin Folta, who chairs the Horticultural Sciences Department at the University of Florida in Gainesville, agrees.

“It is critically important that everyone in agriculture becomes rapidly conversant in this technology, as it already has been a game changer,” he notes “If these technologies are delayed because of misunderstanding, we will lose many opportunities to bring improved varieties to the field and better fruits and vegetables to consumers.”

One important thing to keep in mind: These new gene-editing tools are much different than genetically modified organisms or GMOs, that activist groups have given such a bad rap.

“We’re very excited by the potential for gene editing, and not only against PRRS … a devastating disease to the industry,” says veterinarian Dan Kovich, speaking for the National Pork Producers Council.

“In the future, looking to other applications for disease resistance, prevention, management – all sorts of traits – I think the potential is there (for gene editing) traits that can have an impact on animal welfare, reducing need for antibiotics,” he says. “This is very different from the (genetically modified organisms) that people have talked about in the past.”

With gene editing, no genes from foreign species are introduced.

“I think there are very sound reasons why the marketplace will be accepting of this technology. This is a very precise technology, working within the genome of the pig. It’s not transgenics,” he says. So, he says, NPPC is “just really excited about where this can go.”

Gene editing is akin to cutting and pasting text within a document, explained Jennifer Doudna, professor of molecular and cell biology and chemistry at the University of California, Berkeley, at a recent conference on gene editing.

In the 25 years of her cell biology and biochemistry career, she has “never seen science moving at the pace it is moving right now,” and she sees gene editing as generating much of the stampede.

Nevertheless, gene editing will have to jump huge policy hurdles – both domestically and internationally – before results of such plant and animal breeding show up on farms, in fields and in food stores.

Plant breeders must currently seek regulatory approval from the U.S. Department of Agriculture. Animal breeders must seek approval from the Food and Drug Administration, which requires new animal varieties to be tested as a “drug.” They are watching carefully to see how new regulations evolve and ultimately, how consumers accept these new products of precision breeding.

At the same time, a number of scientists, consumer and food safety advocates want to see the U.S. and world governments lump gene editing in with​ transgenic genetic alterations and regulate it as just another type of ​genetically modified organism​​. That would ​almost surely ​ensure years of testing and approval for each product – dramatically running up the costs to produce these innovative new gene-edited products commercially.

 

Is Organic Really Better? 4 Food Myths Debunked By Science

Victor Tangermann writes for Futurism on myths and misconceptions about the food we chose to eat every day. Do foods labeled “organic” actually make us healthier? Are they free of pesticides? Should we be afraid of pesticides in the first place? What about GMOs?

Many studies have shown that just because a food is labeled “organic,” that doesn’t mean it was grown without pesticides (more on that later). In any case, scientists note that limiting the consumption of fruits and vegetables for fear of pesticide use could be much worse for consumers’ health than inadvertently consuming a little bit of pesticide.

“My biggest concern is that a lot of these reports may [produce] a negative effect in that they may discourage people from consuming what are perfectly healthy, conventionally-produced [non-organic] fruits and vegetables,” Carl Winter, food toxicologist at the University of California, Davis and member of the Institute of Food Technologists, told Futurism. “While everybody wants to do what they hear is the right thing, they could be doing themselves more harm than good in the long term.”

Here are four common, pervasive myths about GMOs and organic foods. Understanding what the science says can help consumers ensure that they choose the food that will best keep them healthy:

Myth 1: Organic Food Is Safer Because It Doesn’t Touch Pesticides

Organic foods, by definition, can’t have had synthetic fertilizers or pesticides applied to them for three years before they are harvested. But just because a crop fits the definition of organic doesn’t mean it’s totally free of pesticides or fertilizer residue.

USDA organic certification allows for natural substances such as pheromones, vaccines for animals, and a limited number of natural pesticides as well. A 2005 market trends survey by Whole Foods found that more than 70 percent of consumers bought organic food to avoid pesticides.

Myth 2: Organic Food Is Healthier

Since the U.S. government began regulating organic products in 1990, proponents have claimed that eating organic food makes us healthier. That claim, as difficult as it is to nail down, is ultimately misleading.

After analyzing 240 studies about the nutritional value of organic food, the authors of a 2012 review study published in the Annals of Internal Medicine concluded that they “[lack] strong evidence that organic foods are significantly more nutritious than conventional foods.”

Myth 3: GMOs Are Dangerous to Eat

There is no trustworthy evidence that any GMO-derived food poses health risks to humans. If anything, genetic modifications make crops safer for agricultural workers (genetic tweaks make crops more resistant to damage from insects and viral infections, so plants need fewer pesticides) and even make them more nutritious, bringing a healthful variety to more people worldwide. According to the WHO, no foods available today based on genetically modified crops have been shown to have a negative effect on human health in the countries in which they have been approved.

Myth 4: GMOs Are Bad for the Environment

A 2016 study found that GMOs actually reduced the amount of pesticides needed to raise the same amount of maize compared to crops that didn’t use GM strains of maize engineered to resist pests. Another 2014 study found that genetically modified crops had a 22 percent greater yield than non-GM varieties. More food per square meter could mean that less land is needed worldwide for agriculture, leaving more habitats undisturbed or allocating more land for natural reserves or wildlife corridors. Plus, many GMO crops need less water than organic or non-GM varieties, which will help feed everyone in a warmer world.

Scientists are still not completely sure if GMOs are better for the environment than other types of crops. But they at least demand fewer resources than organic crops.

At the end of the day, “organic” food isn’t a bad option. And neither are GMOs. But consumers should make their food choices based on science, not hearsay. Many myths persist around the risks of GMOs and the benefits of organic foods. But one thing is clear: eating fruits and vegetables is the most important thing, no matter if they’re organic or GMO.

 

Puma Biotechnology (PBYI) Price Target Cut to $146.00

Puma Biotechnology logo Puma Biotechnology (NASDAQ:PBYI) had its price target cut by investment analysts at Citigroup from $164.00 to $146.00 in a research note issued on Wednesday, January 24th. The brokerage currently has a “buy” rating on the biopharmaceutical company’s stock. Citigroup’s …

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