Euro Biotechnology

On Tuesday, June 5, 2018, BIO hosted its Food, Health and Environmental Future Day at the 2018 BIO International Convention.

Kicking off the half-day of panel discussions was USDA’s Under Secretary for Marketing and Regulatory Programs Greg Ibach, who discussed, among other topics, his agency’s focus to “put together a regulatory framework for today and tomorrow.”

Greg Ibach, USDA Under Secretary for Marketing and Regulatory Programs

Under Secretary Ibach provided candid insights into USDA’s rulemaking process for the National Bioengineered Food Disclosure Standard and asked industry to “engage and embrace” in the rulemaking process (due to end on July 3, 2018) to ensure a regulatory system that works across the food and agriculture industry, from small startups to large corporations.

Trace Sheehan, writer and producer, Food Evolution

Ibach’s remarks were followed by a keynote address from Trace Sheehan, writer and producer of the film Food Evolution. Sheehan focused on the need for honest, constructive dialogue on either side of the GMO and food innovation debates to drive public acceptance of new technologies.

Sheehan’s focus on constructive dialogue set the stage perfectly for the panel to follow, which included food companies and retailers discussing how they are managing the wave of innovation taking place in the industry and driving consumer acceptance.

Kevin Diehl, Director of Global Regulatory Seed Platform at Corteva Agriscience, noted many of the innovations being developed in the industry are to solve-real world challenges and drive sustainability, such as disease-resistant plants. All the panelists acknowledged, however, that while solutions to real-world challenges will help in driving consumer acceptance of new food technologies, the gap is significant. Even so, Jason Garbell, Senior Director for New Business and Alliance Development at Novozymes, said that food companies “can’t think about innovation as a turn off.” Tammy Lee, CEO and President of Recombinetics, added “science is the key to solving sustainability challenges.”

Following the two-part dialogue, the program shifted focus to the food and agriculture innovation taking place in the convention’s backyard: the New England region. Vermont’s Secretary of Agriculture Anson Tebbetts provided opening remarks before four panelists from the region spoke about their use of biotechnology.

Joanna Lidback, Dairy Farmer, Farm at Wheeler Mountain

Joanna Lidback, a dairy farmer from Vermont, spoke passionately about the role biotechnology has on her family farm, allowing her to produce products more efficiently and sustain her business. Lidback noted that biotechnology is not just for large food companies and that the innovations in food and agriculture allow family farms like hers to thrive.

Following the “Biotech in our Backyard” panel, the program shifted back to a national perspective with investment experts sharing their insights on the funding ecosystem in agricultural technology.

In the discussion, Roger Wyse with Spruce Capital Partners underscored Kevin Diehl’s point in the food innovation dialogue, noting many agtech investors are looking to fund companies that address major challenges.

Finally, to close Food, Health and Environmental Future Day, Jerry Flint, Vice President, Global Initiatives and Sustainability at Corteva Agriscience, hosted a fireside chat alongside Governor Dennis Daugaard of South Dakota and Governor Ricardo Rossello of Puerto Rico. Both governors spoke about their region’s investment in biotechnology and the promise it brings to the future of their economies.

“If you’re not paying attention to agriculture, you’re not paying attention to the economy,” said Governor Daugaard.

Right to Left: Governor Dennis Daugaard, South Dakota; Governor Ricardo Rossello, Puerto Rico; Jerry Flint, Corteva Agriscience

Governor Rossello added that while Puerto Rico is still recovering from Hurricane Maria, his region sees opportunity to further expand the economy through biotechnology. Governor Rossello noted that for every dollar his government invests in biotechnology, $5.36 comes back to the economy, representing a significant return on investment.

BIO’s 2018 Food, Health and Environmental Future Day included:

• Greg Ibach, Under Secretary for Marketing and Regulatory Programs, USDA
• Phil Miller, Vice President for Global and Regulatory and Government Affairs, Monsanto
• Trace Sheehan, Writer and Producer, Food Evolution
• Natalie DiNicola, President, DiNicola LLC (moderator)
• Tammy Lee, President and CEO, Recombinetics
• Kevin Diehl, Director, Global Regulatory Seed Platform, Corteva Agriscience
• Jason Garbell, Senior Director, New Business and Alliance Management, Novozymes
• Jane Andrews, Corporate Nutrition Manager, Wegmans
• Tony Freytag, Executive Vice President, Crunch Pak
• Doug Cole, Senior Manager of Marketing and Biotech Affairs, Simplot Plant Sciences
• Ron Stotish, President and CEO, AquaBounty Technologies (moderator)
• Al Kriz, Strategic Alliance Manager Trait Research & Genomics, Bayer LifeHub
• Victor Guzov, Lead, Protein Optimization and Evolution Team (POET), Monsanto
• Mark Cooper, Plant Manager, Scotts Miracle-Gro
• Joanna Lidback, Vermont dairy farmer, The Farm at Wheeler Mountain
• Aaron Schacht, Vice President, Research and Development, Elanco Animal Health
• Colin Steen, Managing Director, Syngenta Ventures
• Roger Wyse, Spruce Capital Partners
• Jerry Flint, Vice President, Global Initiatives and Sustainability, Corteva Agriscience (moderator)
• Governor Dennis Daugaard, South Dakota
• Governor Ricardo Rossello, Puerto Rico

There’s just one week left before Xconomy’s latest biotech event, “What’s Hot in Seattle Biotech.” Don’t let the clock run out while you can still save some cash on a ticket.

Next Tuesday, June 12, we’re bringing together some of the Emerald City’s top life science entrepreneurs, scientists, and investors to discuss the strengths and challenges of Seattle’s life science community. Don’t wait to register-our Procrastinator’s Special ends soon and it’s your last chance at a discount.

Speakers include:

• Leen Kawas, CEO, M3 Biotechnology
• Harlan Robins, Co-founder & Head of Innovation, Adaptive Biotechnologies
• Desney Tan, General Manager,

… Read more »

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[Source: Research & Innovation] EGVIA (the European Green Vehicles Initiative Association) is organising #EVinthegrid2018 workshop, whose aim is to highligh challenges and potential solutions for a large scale uptake of electro-mobility in European cities and peri-urban areas.The overall programme will roll out as follows:
9.30 Opening 10.00 Electric Vehicles: challenges and opportunities for the grid 11.45 How to integrate electromobility in cities and peri-urban areas? 14.00 The automotive perspective: EGVI projects presentation15.45 Panel discussion: how to solve the “chicken and egg” problem of the uptake of electromobility in Europe?Several EU-funded research project presentations will enable participants to get an holistic view on this key challenge for the European Union’s decarbonisation.
Don’t miss it and join us!

#EVinthegrid2018

When Good Morning America co-anchor Robin Roberts was diagnosed with cancer in 2007, she took her mother’s advice to “make your mess your message,” and connect with her audience as she was treated for and recovered from her disease. For those without the resources and platform that she had, “I needed to be their voice and show them the journey,” Roberts recalled during the Tuesday morning keynote session at the Biotechnology Innovation Organization’s international convention. 

Roberts, an award-winning broadcast journalist and author, and a survivor of breast cancer and myelodysplastic syndrome (MDS), was interviewed in a wide-ranging discussion by BIO president and CEO James Greenwood.

Roberts repeatedly credited her family and her faith for her personal and professional successes. Her father was a Tuskegee Airman – one of the storied group of World War II African-American fighter pilots – and her mother was appointed to the Mississippi state board of education, later becoming its chairwoman. The family focus on education was “less about the ‘three Rs,’” she quipped, and more about the three Ds – “discipline, determination, and d’Lord.”

Roberts also colorfully described her early career – it included a stint as a country music DJ on AM radio and a gig as a weekend sports anchor paying $5.50 per hour – and later highlights including interviewing President Barack Obama on the subject of marriage equality, and her emotional coverage of the aftermath of Hurricane Katrina, during which she set out for the Gulf Coast when the storm’s great damage became evident. “I couldn’t go on the air until I found my family,” she said (and when she did, her mother ordered her back to her television crew).

A personal thank you from #BIO2018 keynote speaker @robinroberts to the #biotech community pic.twitter.com/lpsPxdmxTM

– BIO Intl Convention (@BIOConvention) June 5, 2018

Living proof 

Before his conversation with Roberts, Greenwood told the story of Ashanthi De Silva, who was born in 1986 with two broken copies of a gene that makes a protein called ADA. This meant she had severe combined immune deficiency, and “by age four, she was slipping away,” he said. But De Silva’s doctor knew of a team of scientists at the National Institutes of Health who were pioneers in applying genetic engineering to human health. She became first patient in the world to receive a gene therapy. Twenty-eight years later Ashanthi remains on enzyme replacement therapy but leads a full and normal life.  “This is the power of biotechnology” says Greenwood. 

As he advocated for strong policies to support the continued development of the biotechnology industry Greenwood dotted the line from De Silva’s treatment through to more recent breakthroughs, including the approval in 2017 of the first gene therapies in the US – Novartis’ cell therapy for a kind of pediatric leukemia, Kymriah, Gilead Sciences’ cell therapy for aggressive lymphoma, and Spark Therapeutics gene therapy for inherited retinal diseases, which can prevent children with a particular genetic mutation from going blind.

Taking the stage, De Silva received the morning’s loudest ovation as a living embodiment of biotech innovation. She urged patients and patients’ families to “look at my story and see anything is possible.” With patients now at the forefront, telling their own stories, she said, “please have hope, be your own advocate, and please, never give up.” 

BioGENEiuses

They keynote also featured the 2018 International BioGENEius Challenge finalists. “Some day you’re going to be working for these kids,” joked Greenwood. One of those high schoolers was awarded the grand prize. Ontario, Canada eleventh grader Sajeev Kohli’s project “recruiting endogenous proteins for site-specific transport: a novel workflow for gene carrier design” earned him the $7,500 award, as judged by a panel of industry and academic experts.

Portola Pharmaceuticals (NASDAQ: PTLA) CEO Bill Lis is retiring from the South San Francisco, CA, drug developer. Lis will also retire from Portola’s board of directors. The company said Lis will remain with the company through Aug. 1, and then step back into an advisory role. John Curnutte, Portola’s executive vice president of research and development, and Mardi Dier, chief financial officer, have been appointed interim co-presidents while the company searches for a permanent successor.

Lis joined Portola in 2008. His retirement follows the FDA approval last month of andexanet alfa (Andexxa), a treatment to reverse the effects of blood… Read more »

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Houston biotech Aravive Biologics is going public through a reverse merger with Versartis, a Menlo Park, CA-based company whose lead drug failed a clinical trial last year.

Under the deal, Versartis and Aravive shareholders will each own about 50 percent of the combined company, according to a press release. Aravive will get Versartis’s (NASDAQ: VSAR) NASDAQ listing. Jay Shepard, Versartis’ president and CEO, lead the combined company, which will be based in Houston. The transaction is expected to close during the second half of the year, pending approval by shareholders of each company.

IPOs are the typical path for… Read more »

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[Source: Research & Innovation] The ScienceCampus Halle and the BioEconomy Cluster Central Germany cordially invite you to the 7th International Bioeconomy Conference in Halle an der Saale from June 6 – 7, 2018.
The motto of the conference will be “Bio meets Economy – Science meets Industry”. The event, which was first held in 2012, is one of the most important dates of the bioeconomy in Germany. H
ere internationally renowned representatives from science and industry meet to intensively and productively exchange ideas on the latest research findings, innovations and market developments.

(left to right) Associate Counsel and Director, Intellectual Property Policy Melissa Brand, USPTO Director Andrei Iancu, Deputy General Counsel and Vice President Hans Sauer

This afternoon USPTO Director Andrei Iancu delivered remarks at the BIO International Convention’s Intellectual Property Track opening plenary. During the well-attended session, Director Iancu addressed a key policy priority for BIO – reform within the Patent Trial and Appeal Board (PTAB).

Last month, the USPTO signaled an intention to replace the broadest reasonable interpretation (BRI) standard for construing unexpired patents with the same standard used in Federal district courts and the International Trade Commission – a turn of events BIO views favorably.

According to Iancu, he is looking for more efficiency within this system. It remains to be seen what that will look like, however a positive outcome will certainly mean an overall reduction of IPR claims.

Director Iancu also went on to address his concerns relating to lack of clarity when it comes to patent eligible subject matter under 35 U.S.C. 101.

BIO has long shared these concerns and looks forward to opportunities to contribute to constructive reform efforts. Clarification of patentability criteria and improvements of the PTAB will enhance American biotech innovators ability to compete on a level playing field.

Eli Lilly won regulatory approval for its rheumatoid arthritis drug Friday, nearly 14 months after the FDA rejected the once-daily pill due to safety concerns. But the approval comes with limitations that will likely hamper Lilly’s ambitions to turn the drug into a blockbuster seller.

The regulatory nod covers only the lower of the two doses of baricitinib (Olumiant) that Lilly (NYSE: LLY) hoped to bring to the market, which reduces the number of patients eligible for the new rheumatoid arthritis (RA) treatment. The drug’s label carries a black box warning-the FDA’s strictest notification of health risks associated with… Read more »

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As Amgen approached an FDA decision last month for its migraine-prevention treatment, concern mounted that the drug would come at premium. In setting a price thousands of dollars less than expected, Amgen has won over one of the pharmaceutical industry’s fiercest drug price critics.

The non-profit Institute for Clinical and Economic Review (ICER) assessed the effectiveness and value of the Amgen (NASDAQ: AMGN) drug erenumab (Aimovig) and other new migraine drugs, and concluded in an updated report that erenumab offers value to patients in the price range of $3,700 to $5,300 per year. After the FDA approved erenumab last… Read more »

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