Informa Agribusiness: Systematic Change Needed for U.S., China and the World to Benefit from Biotech Innovation

In 2017, U.S. farmers exported nearly $20 billion worth of agricultural products to China, and nearly two-thirds of those products involved biotech innovation. But a brand new study estimates that the economic benefits of the trade could have been higher, if not for China's persistent delays in approving imports of biotech crops.

This week, Informa Agribusiness Consulting Group (Informa) released the report The Impact of Delays in Chinese Approvals of Biotech Crops, quantifying the economic impact of China's delays globally, in the U.S. and in other major cultivating countries, including Argentina, Brazil and Canada.

And the economic impact is significant.

Informa estimates Chinese delays in biotech approvals resulted in U.S. farmers missing out on $5 billion in farm income growth from 2011-16. In that same time span, Informa calculates that China's delays prevented the U.S. economy from gaining nearly 34,000 jobs and $4.6 billion in wage growth, while also reducing potential gross domestic product (GDP) by $7 billion.

As Bill Tomson with Agri-Pulse notes in his piece on Informa's report, China's delays are, in part, the result of an "asynchronous" approval process:

"Whereas biotech seed companies can begin the approval process in several countries around the world at the same time to insure international acceptance, that's not possible in China. Despite repeated requests over the years, China continues to insist that it will not even begin the process until a cultivating country like the U.S., Brazil, Argentina or India first finishes the process."

And this unnecessary added requirement by China is not a matter of one or two years.

As Tom Polansek with Reuters notes in his piece on the Informa report, "companies such as Bayer AG, Monsanto Co, DowDuPont and ChemChina's Syngenta have been waiting as long as seven years for China to approve strains of soybeans, canola and alfalfa."

For the U.S., China and the rest of the world to benefit economically from biotech products, a long-term solution is needed. If China were to approve the current queue of products waiting to be accepted, it would only be a short-term solution. As a long-term solution, China needs to establish sound, predictable, science-based regulations to allow importation of biotech products into the country.

Looking at the next five years, Informa forecasts that if China were to establish a predictable, science-based approval process, the U.S. economy could see an increase of $4.9 billion in farm income, more than 19,000 jobs created, a $4.4 billion increase in wage growth and potential for a $7.3 billion increase in GDP.

BIO's CEO and President Jim Greenwood emphasized this point in his statement on the report, highlighting the need for "systematic change":

"The goal of the seed technology industry is to work cooperatively as a partner with the Chinese government to bring new production technologies to farmers around the world, including China. The outcome of this partnership will be an increase in global food security and greater economic activity in rural communities."

And as Greenwood notes, the Informa report concludes that China stands to gain from systematic change, including access to new technologies for feeding its own population as well as lowered food prices for Chinese consumers. 

BIO's Vice President for International Affairs Matt O'Mara says that the biotechnology industry is simply looking for a win-win solution for the U.S., China and the world, reiterating that for that to happen "Bottom line, we need a sound, predictable, science-based process and one that moves these products through in a reasonable time."

To view the full report, executive summary and methodology for the Informa report, click here.

To read more about the economic impacts of China's delays in biotech approvals, check out the news coverage from yesterday's report roll-out.

Reuters: China's slow approvals of biotech crops cost U.S. $7 billion, says industry group (Also published in New York Times and Agriculture.com)

Feedstuffs: Study finds crop values affected by approval delays

Informa: Chinese biotech approval delays stymieing growth in corn and soybean production

New Food: China's GMO trepidation has cost foreign exporters $8 billion

Industrial Biotechnology at 2018 International Convention

The 2018 BIO World Congress on Industrial Biotechnology is quickly approaching, but before the partnering begins in Philadelphia BIO will be focusing on industrial biotechnology at the 2018 International Convention in Boston, June 4-7, 2018.

Programming at BIO's International Convention will include sessions on Biofuels & Renewable Chemicals on Tuesday, June 5 starting at 11 a.m. Here's a rundown for what to expect for each program:

Advances in Renewable Chemicals

11 am – noon, Room 255, Level 2

Renewable chemical companies are using new techniques – including synthetic biology and automation – to rapidly move from initial target identification to production of a desired renewable chemical. Several renewable chemical companies will present new methods to improve efficiency and efficacy in renewable chemical manufacturing. Panelists include:

Moderator: Kevin Jarrell, CEO, Modular Genetics

Speakers:

• Stephan Herrera, VP, Evolva
• Jason Kelly, CEO, Ginkgo Bioworks
• John Shaw, President NA, Itaconix Corporation

Sustainable Aviation Fuel Taking Off!

3 – 4 pm, Room 255, Level 2

In May 2018, Boeing successfully flew the first commercial jet on 100 percent biofuel, flying from Seattle to Memphis and back. In this session, a panel of experts will discuss how biofuels are transforming the aviation industry and what the future holds. Panelists include:

Moderator: Todd Campbell, Development Advisor, CC: Clean Economy Works

Speakers: 

• Hank Krakowski, Director – Sustainable Aviation, Agrisoma Biosciences, Inc.
• Jim Macias, President and CEO, Fulcrum BioEnergy
• Chris Tindal, Assistant Director, Commercial Aviation Alternative Fuels Initiative

Designing Renewable Specialty Chemicals as Pharmaceutical Intermediates from Synthetic Biology

4:15 pm – 5:15 pm, Room 255, Level 2

Suppliers of active pharmaceutical ingredients (APIs) are looking to reduce cost and shorten time to market. As pharmaceutical manufacturers find their margins under pressure, they continue to look for ways to reduce cost through partnerships with industrial biotechnology companies that develop novel metabolic pathways to quality pharmaceutical intermediates. Panelists include:

Moderator: Brian Baynes, CEO, MODO Global

Speakers:

• Emmanuel Petiot, CEO, DEINOVE
• Christine Santos, CTO, Manus BIO
• Tom Stephenson, CCO, Zymergen
• Andrey Zarur, Ph.D., CEO, Greenlight Biosciences

In addition, BIO will be hosting a panel to discuss cellular agriculture and how Industrial Biotechnology is brewing protein! Panelists include:

Moderator: Vince Sewalt, Sr. Director, Product Stewardship & Regulatory, DuPont Industrial Biosciences

Speakers:

• Isha Datar, Executive Director, New Harvest
• Eric Schulze, VP. Product and Regulation, Memphis Meats
• Mike Selden, CEO, Finless Foods

For a full rundown of industrial biotechnology and other programming visit http://convention.bio.org/program/. For more information about the 2018 BIO International Convention visit http://convention.bio.org.

 

Countdown to #BIO2018-Four Days to Go!

In less than a week more than 16,500 people will descend on Boston to form partnerships and collaborations that could one day dramatically change our lives for the better. This year BIO will be celebrating its 25^th anniversary so its Convention is appropriately themed "Make History", a subtle reference to this historic milestone as well as the rich history of Boston.

Any veteran of BIO's International Convention can tell you: It's a lot.

There are keynotes, fireside chats, super sessions, breakout sessions, company presentations, partnering, a patient pavilion with 62 patient groups, a start-up stadium, an emerging innovators zone, international and state pavilions, hundreds of exhibitors-the list goes on. And don't forget Diana Ross!

What's the best way to navigate? First and foremost, make myBIO your best friend now.  You can download the app in the Apple or Google stores or use it on your computer. It is a great resource for everything happening at convention. (Note: myBIO is separate from BIO One-on-One Partnering). Here are some highlights to what you can do!

• View speakers or filter by interests
• View the full schedule and add events on the go
• View attendee list or filter by interests
• Browse companies and exhibitors, filter by interest or zone
• View the BIO Exhibition map
• Printable Schedule

Tip: Use the "filter" function for sessions, attendees, and companies. For more information and tips visit http://convention.bio.org/myBIO

There are three resources in our online Toolkit – feel free to browse the Onsite Guide, Education Grid, BIO Exhibition Map and Yelp Guide in advance of arriving onsite here.

Your journey through #BIO2018 is your own but here are some highlights by day

Calls for change on anti-abortion law in Northern Ireland

Britain's leaders are facing increasing calls to take action to loosen abortion restrictions in Northern Ireland after the Republic of Ireland's vote in favor of doing so, but complex political realities make quick action difficult

Calls for change on anti-abortion law in Northern Ireland

Britain's leaders are facing increasing calls to take action to loosen abortion restrictions in Northern Ireland after the Republic of Ireland's vote in favor of doing so, but complex political realities make quick action difficult

Ebola vaccinations begin in rural Congo on Monday: Ministry

Ebola vaccinations begin in rural Congo on Monday, ministry says, as confirmed cases up to 35

Newborn Screening – How to Fill the Gap to End Diagnostic Odysseys

Many of the over 7000 rare diseases identified so far are not obvious at birth or may come with confusing, non-descript symptoms. Unfortunately, the currently available diagnostic algorithms are unsatisfactory. If a patient's condition remains undiagnosed, the miraculous and rapid advancements in pediatric rare disease therapies mean nothing. The truth is that some families search for more than ten years for the correct diagnosis, which often translates to irreversible damage or even death for pediatric patients. It is essential to find these babies and ensure that they live their healthiest life by receiving the care they need as early as possible.

The painful, costly and sometimes traumatic diagnostic odyssey that patients live through is a result of a few key factors. First, there are not enough newborn screening tests available. A good newborn screening test has a very low false negative rate, a low false positive rate and costs about $1.00. There are newborn screening tests for about 70 conditions available today. This falls well short of the 200 or so rare diseases that can affect newborns that have FDA approved therapies. Second, newborn screening is not consistent. While newborn screening is one of the most successful public health programs in the United States, each state decides what conditions to screen, creating inconsistencies. A baby can be undiagnosed simply because they are born a few miles away in another state that does not screen for a certain condition. While the promise of the Recommended Uniform Screening Panel (RUSP) is to standardize screening panels across states, each state has a different process for adding conditions to their state panel and for providing the resources for additional testing. Finally, outside of the US, there is a baby born every minute that goes undiagnosed because many countries have little or no public newborn screening program, even for conditions for which there are very inexpensive therapies.

A company located in Durham, North Carolina called Baebies, is in the business of advancing comprehensive newborn screening and pediatric testing. The company name comes with an extra "e," because it believes "everyone deserves a healthy start." Finding babies with rare disease using expanded newborn screening is the overarching goal of Baebies which sees the diagnostic odyssey as unnecessary and costly for patients and families. A discussion of how newborn screening reduces rare disease diagnostic odysseys will be held during the BIO International Convention: Newborn Screening: Ensuring All Babies Live Their Healthiest Lives, will be held on June 6 at 11 a.m. in Room 209, Level 2. The session is facilitated by Nicole Boice of Global Genes and the panel includes Richard West (me), representing Baebies, alongside Mark Dant of the EveryLife Foundation for Rare Diseases and the Ryan Foundation, Max Bronstein of Audentes Therapeutics, and Paldeep Atwal of genomeMedical. Let's move towards ending the diagnostic odyssey.

 

Richard West, Founder & CEO Baebies
With nearly 20 years of life science CEO experience, Richard leads the strategic direction for Baebies. Richard is currently on the board and executive committee of NCBIO, is a member of the Blackstone Entrepreneur Network, and serves on a number of private company boards. Richard is an Adjunct Professor at Duke University, where he teaches entrepreneurship. He has an Engineering degree from Duke University, an MBA from the University of West Florida and completed all requirements except dissertation for a PhD in management from the Peter F. Drucker Graduate School of Management.

On the President's Drug Cost Plan, Three Important Concerns

Part 1. Restricting access under Medicare Part D 

The Trump administration is out with its plan to lower the cost of prescription drug for America's patients. The plan rightly rejects the flawed schemes we hear regularly from pundits and the media - importation and direct government price negotiation in Medicare - that together would weaken the safety of our nation's pharmaceutical supply chain, reduce patient access and do little to lower costs.

The plan contains some positive ideas, such as encouraging value-based pricing agreements, fixing the flaws in the 340B drug discount program, limiting pharmacy gag clauses, and passing rebates through to patients in Medicare Part D and capping their out-of-pocket costs. However, buried in the details are proposals that could harm the ability of patients to get the medicines they need both now and in the future.

Today, BIO is starting a blog series that will highlight three proposals in particular that could pose significant challenges to patients. As the first in a three-part series, this blog will look at proposals in the president's drug pricing plan that would affect a popular prescription drug program for America's seniors.

Restricting access under Medicare Part D. 

The Medicare Part D prescription drug program has been a remarkable success for both seniors and taxpayers.

• The program cost $349 billion less over 10 years than initially expected;
• Average premiums dropped 3% in 2018 to less than $34 per month; and
• Hospital admissions for seniors have also dropped by 8%.

It's no wonder then that nearly 90% of seniors are satisfied with the program.

Medicare Part D generally covers medicines that patients buy at a retail pharmacy and take themselves. The private health plans administering the Part D program are required to provide at least two drugs for each class of drugs that exists. Then there are six "protected classes" of drugs for patients facing particularly devastating diseases like cancer, HIV and mental illnesses. Health plans are required to cover "all or substantially all" medicines that fall within these protected classes.

Current policies help provide seniors and people with disabilities with choices, and more choices means more competition that can lead to lower costs. However, under the Trump administration's proposal, health plans would only be required to provide one drug per class, down from the current requirement of at least two. The administration may also eliminate some of the protected classes altogether. These changes would leave doctors and patients with fewer options, forcing beneficiaries to pay more if the medicines their doctors prescribe aren't covered.

Health plans would also be allowed to increase the use of so-called utilization tools – such as "step therapy" or "prior authorization." These bureaucratic hurdles are already far too common, and while these "tools" may help insurers protect their bottom line, they also bury doctors in paper work and make it harder for patients to get the right medicines at the right time. 

The nation's biopharmaceutical innovators support taking steps to strengthen the Medicare Part D program. That effort should focus on lowering seniors' out-of-pocket costs and ensuring they have broad access to the medicines they need.

Stay tuned for the second part of this three-part blog series, which will look at proposed changes to the Medicare Part B program.

Six deals for Saturday: $21 wireless headphones, $55 4K Roku and more - CNET

Here are a few of the top tech deals we think are worth checking out this weekend.
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2017 Rosalind Franklin Award Recipient: CRISPR has the potential to address important challenges

As we've covered here before, gene editing holds tremendous promise in advancing modern agriculture. And it's not hard to see why. With gene editing tools like CRISPR, researchers have the capability to engineer plants to be, amongst other things, better for the environment, more nutritious and disease-resistant.

BIO's 2017 Rosalind Franklin Award for Leadership in Biotechnology recipient Vonnie Estes is an agtech innovation consultant who is tuned into the current conversations happening at farms and agricultural businesses across America. And a lot of those conversations revolve around the new gene editing technology.

In a blog for Ag Funder News, Estes entertains the question: Should You Be Using CRISPR for Your Ag Business? In addressing this question, Estes starts by outlining the "number of challenges" that must be addressed before CRISPR becomes widely adopted, including the regulatory landscape:

One of the biggest restrictions to the global commercial use of gene editing is uncertainty around regulation. The USDA just ruled it would not regulate plants that could otherwise have been developed through traditional breeding techniques, as long as they are not developed using plant pests. This is a good start, however, there are a limited number of improvements that can be made within these criteria. If Agrobacterium is used as a delivery method or a greater number of genes are edited - which will be needed for complex traits - it will be considered GMO and more highly regulated. Most crop genetics and food production companies operate globally: shipping seeds, plant materials, or final foods worldwide. The EU has not yet ruled if gene edited crops fall under the genetically modified organism rule, although there is some indication that may change. Until this is clear, many crop genetics companies will not risk the potential trade barriers of using gene editing technology.

Vonnie Estes, Agtech Innovation Consultant

Estes then goes on to note that because of the contentious debate around GMOs and the public's confusion around the difference in the science behind the two technologies, gene editing will be susceptible to similar pushback. However, Estes believes the younger generation of consumers will be receptive, especially if the benefits are clearly defined and explained:

Consumers are more likely to accept the technology if they get a direct benefit, such as better taste or higher nutritional value. Food producers are right to be cautious, but I'm hoping the younger, tech-savvy, more demanding food consumers will be accepting of gene editing technology.

Nevertheless, the potential for the technology to solve some of the world's food challenges is encouraging and the science community is enthusiastic:

As the world's population rapidly approaches eight billion, modern food production methods will need a radical transformation. Gene editing can certainly help meet that challenge of production, along with making food more flavorful and nutritious. The path to widespread usage is currently complicated – from the science to consumer acceptance. But with the tremendous enthusiasm of the research community, gene editing technologies will improve rapidly along with the all of the techniques and technologies needed to support crop use.

Read Vonnie Estes full piece at AgFunderNews.com.