Monday, February 12, 2018

#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.

Marijuana's 4/20 holiday tied to rise in fatal car crashes

Marijuana users' April 20 holiday is linked with a slight increase in fatal U.S. car crashes

Friday, February 9, 2018

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.

 

Wednesday, February 7, 2018

Give It a Shot – Protect Yourself from the Flu

Everyday it's a new headline. The numbers keep rising. No, we're not talking about the latest lottery jackpot. We're talking about one of the worst flu seasons in nearly 10 years. But it's not too late to protect yourself with a flu vaccine – and here's why you should:

"The negatives of a flu shot are almost nonexistent, and significant side effects are very rare. Even in an ineffective year, the benefits greatly outweigh the harms. The [CDC] estimates that 9 million to 36 million people become ill with the flu each year in the United States. Somewhere between 140,000 and 710,000 of them require hospitalization, and 12,000 to 56,000 die each year," the New York Times reports.

This messy flu season is not only impacting individuals and families, though. Businesses across the nation can expect to see billions of dollars in lost productivity as a result of employees falling ill. One recent estimate predicted that 11 million Americans will fall ill this season, at a cost to their employers of over $9 billion in sick leave.

As we've pointed out before, vaccines have tremendous societal value, responsible for saving more than 730,000 children over the past 20 years in the U.S. Another study found that the vaccination of children born in the United States in 2009 is projected to generate $184 billion in lifetime social value – or about $45,000 per child.

If you're still not convinced, data from the CDC confirms the benefits of getting a flu shot. In fact, it's estimated that number of flu hospitalizations prevented by vaccination during the 2015-2016 season was more than 70,000, while over 5 million cases of illness were prevented. And if you're wondering how widespread influenza is in your state or region of the country, check out this map for details.

While every flu season is slightly different, getting vaccinated is still the best way to prevent a few sick days on the couch or a trip to the hospital. As flu season continues on its path of destruction, help protect yourself and those around you by getting vaccinated.

Monday, February 5, 2018

340B Drug Discount Program At-A-Glance

In 1992, with the support of the biopharmaceutical industry, Congress created the 340B Drug Discount Program to help uninsured and vulnerable patients gain access to affordable prescription drugs. Over the years, however, there have been growing signs that this program has expanded well past the intent of Congress and that patients may not be seeing the benefits they deserve.

Just last month, the House Energy and Commerce Committee published a review of 340B concluding that the program has grown far beyond its original scope, leading to growing problems with accountability and transparency. And building on these findings, a new study in the New England Journal of Medicine offered fresh evidence that 340B functions almost entirely as a source of revenue for hospitals, rather than as a benefit for vulnerable patients.

In our latest infographic, we dive into the current state of 340B, highlight areas that are in need of reform, and showcase expert viewpoints on the issue.

To view the full infographic, click here.

Friday, February 2, 2018

Super Bowel: GMOs Make for a Super Party Spread

In honor of the big game this Sunday, I thought we would look at how biotechnology, specifically GMOs, have benefited some of the foods that are sure to be part of many Super Bowl party spreads. Whether you're rooting for the Philadelphia Eagles or the defending champion New England Patriots, we can all thank biotechnology for ensuring we're not hungry come halftime.

Cheese

From nachos to queso dip to cheeseburgers, cheese will be a staple at most Super Bowl parties this weekend. And as we touched on briefly before the Thanksgiving holiday, we can thank GMOs for allowing us to indulge in this popular snack item:

While most people don't think of GMOs when they think of cheese, much of our cheese is made using biotechnology. Enzymes known as "rennet" are a critical part of the cheesemaking process. Years ago, the only source of that rennet was the lining of calf stomachs; however, biotech stepped in to help make the cheesemaking process more humane. Researchers used biotechnology to create genetically modified (GM) bacterium and yeast cells to produce rennet, which in turn could be used in making cheese. Between 80 to 90 percent of hard cheese made in the U.S. is made using GM rennet!

Unless you plan on extracting rennin from the lining of a calf's stomach, you'll are relying on GMOs for that cheese board at your Super Bowl celebration.

Tortilla Chips

What pairs well with any queso dip? Chips. More specifically, tortilla chips. Party guests may claim they're full by the end of the first quarter, but I guarantee they'll continue munching on chips until the Lombardi trophy ceremony.

Of course, the main ingredient in tortilla chips is corn, which is one of the most common crops benefiting from biotechnology. To meet demand for the crop, farmers plant corn that has been genetically modified to be resistant to damaging insects and tolerant of commonly used herbicides.   What many people don't know is that genetically modified corn can also be disease resistant. As noted in an article on Livestrong.com, this type of corn may actually be safer than non-GMO corn for human consumption:

Another benefit of GMO corn is described in an International Council for Science, ICSU, report cited by the "Public Library of Science-Biology." Corn bioengineered to carry disease resistance genes from naturally resistant plants contain lower levels of mycotoxins, substances produced by fungi growing on insect-infested, non-GMO corn crops. Myxotoxins are potentially carcinogenic to humans.

Therefore, not only does biotechnology allow for higher yields of the crop, it also safeguards against cancer causing substances.

Hamburgers and Hotdogs

Cheese and chips are good for munching throughout the game, but your guests will start to grow hungry without some type of protein.

Whether you are serving hamburgers or hotdogs, the livestock that led to that burger patty or sausage link most likely fed on some type of GM crop. According to GMO Answers, more than two-thirds of GM corn and half of GM soybeans are used for livestock feed. And much like GM crops, GM animal feed does not pose any risks to a person's health. Even so, if there are a few people at your viewing party who refuse to eat GM foods, you can assure them that the hamburgers and hotdogs are actually GMO free:

Over one hundred scientific studies have found no difference in the productive performance or health of livestock that have been fed genetically engineered feedstuffs, and they found no presence of genetically engineered DNA or proteins in the milk, meat or eggs from animals that have eaten genetically engineered feed.

So, whether you're whipping up some Philly cheesesteaks, classic New England Franks & Beans or some simple chips and salsa, remember to thank biotechnology for that super party spread.

Thursday, February 1, 2018

How Stonyfield Could Have Gotten It Right on GMOs

The uproar following yogurt maker Stonyfield Farm's recent Facebook video ad featuring elementary school-aged girls perpetuating GMO myths was widespread. Within hours, hundreds of consumers, farmers and scientists condemned the brand for spreading misinformation and fearmongering.

GMO Answers has posted a new blog post to their Medium page talking about the video, and how the entire incident could have been handled better.  Here's what a company SHOULD do:

  1. Lead with science & facts.Don't exploit consumer knowledge gaps. GMOs are safe!
  2. Inform consumers, don't fearmonger.The Stonyfield video ended with the statement, "It's important to know what's in your food." That's correct. So rather than exploiting their knowledge gaps, food companies have an opportunity to help educate, using science-based information and facts.
  3. Be open to skeptics & open dialogue.Whether discussing organic, conventional or GMO foods, it's important to acknowledge consumers' concerns and communicate with fact-based, open dialogue - banning adverse, but constructive feedback isn't the answer.

Let's be open to joining these conversations - even the tough ones.

If you have questions or need a resource, GMO Answers is here to help you understand GMOs and make informed food choices. We can also connect you with farmers, scientists and other biotechnology experts who can answer your questions about GMOs.