25 Jan

Solid Delays IPO, Discloses Duchenne Problems & Raises Rivals’ Hackles

Solid Biosciences was expected to ride gene therapy’s wave of recent momentum to an IPO this week. But the offering, possibly for more than $130 million, did not go off as planned last night, and the company revealed this morning that its most advanced drug candidate has been under FDA scrutiny since mid-November.

The gene therapy, SGT-001, is being developed to treat Duchenne muscular dystrophy, an inherited disease that affects boys, often robbing them of the ability to walk in their teens and killing them at a young age. Now that the FDA has approved its first-ever gene therapy,… Read more »

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25 Jan

BUILDING A LOW-CARBON, CLIMATE RESILIENT FUTURE: SECURE, CLEAN AND EFFICIENT ENERGY

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-LC-SC3-2018-2019-2020Pillar: Societal ChallengesPlanned Opening Date: Deadline: Thu, 30 Apr 2020 17:00:00 (Brussels local time)Modification Date: Thu, 25 Jan 2018Latest information: For topics LC-SC3-EE-1-2018-2019-2020 andLC-SC3-EE-6-2018-2019-2020 the threshold for the criteria Excellence and Impact will be 4. The overall threshold, applying to the sum of the three individual scores, will be 12. This will be applicable for the relevant call for proposals in 2018 and 2019 subject to the update of the H2020 Work Programme in summer 2018.

24 Jan

The Value of Academic-Industry Partnerships

Of particular importance for accelerating translational research and overcoming the challenging environment for bioscience innovation is advancing collaborations between industry and academia, as a means to both improving R&D productivity and reducing the costs of translating discoveries into new medical products.

That call for greater industry-academia partnerships reflects the unique nature of bioscience innovation when compared to other industrial sectors. For instance, not only is there a greater commitment by the bioscience industry to conduct internal R&D, there is also existing close ties between industry, clinical care, and  academic  communities  due  to  the  necessary  interface of  “bench  and  bedside”  required  for   biomedical innovation to move forward.

Two recent BIO reports affirms the stakeholder dynamics including a review of the economic impact of licensing of academic research to industry and a report on ways in the states that the biotech industry and academic research communities are crossing new frontiers of innovation.

Impacts on the US Economy

study released in June 2017 by BIO provided data on the importance of university/industry research and development partnerships to the U.S. economy. The study of university technology licensing from 1996 to 2007 shows a $187 billion dollar positive impact on the U.S. Gross National Product (GNP) and a $457 billion addition to gross industrial output, using very conservative models.

Before the passage of the Bayh-Dole Act in1980, inventions arising from the billions of taxpayer dollars invested annually in university research remained largely on laboratory shelves and were rarely commercialized because of restrictive patenting and licensing practices. This situation changed with passage of the Bayh-Dole Act, which allows university inventors to patent their discoveries and license them to commercial partners with maximum flexibility and limited federal bureaucracy.  As a result, the biotech revolution was born, turning inventions into products that are improving public health, cleaning our environment, and feeding the world.

Other key findings of the study include:

  • University-licensed products commercialized by industry created at least 279,000 new jobs across the U.S. during the 12-year period;
  • The annual change in U.S. GDP due to university-licensed products grew each year, illustrating that the impact of university patent licensing grows even more important each year.
  • The study was funded by BIO and the Association of University Technology Managers (AUTM) and headed by Dr. David Roessner, Professor of Public Policy Emeritus at the Georgia Institute of Technology.

Sponsored Research Engagement: Academic and Industry Principles

second BIO national report entitled Biotechnology-Research Engagement Opportunities: Eight Guiding Principles affirms that when biotechnology companies and universities work in tandem to push the frontiers of biotechnology based knowledge, they become a powerful engine for innovation and economic growth.

According to authors Peter M. Pellerito and Austin M. Donohue, academic and industry partnerships that work well have created strategic view of the value of R&D and commercialization merge the discovery-driven culture of the university with the innovation-driven environment of the biotechnology company.

But to make the chemistry work, each side must overcome the cultural and communication divide that can impair biotech industry-university partnerships and undercut their potential.

Principles                                                                                                                   

Guiding Principle # 1: Successful university-industry collaborations reflect an understanding of the mission and culture of each partner:

Successful sponsored research transactions require all parties – industry and academia – to identify the core mission of their organizations early in the process and defining the scope and focus of the proposed alliance.

Guiding Principle #2: Alliance management resources are essential:

Industry and university participants engaging in strong alliance management strategies devote resources, energy and attention to maintaining relationships and working together in an ongoing effort to facilitate productive, transparent outcomes to ensure sponsored research success.

Guiding Principle #3: Universities and industry participants should understand the objectives and benefits to each party that will result from collaborations:

Goals, objectives, and timelines for completion are essential for productive end results in partnerships; each party must understand and support the objectives and proposed research benefits of the other party.

Guiding Principle #4: Commitments in sponsored research agreements should ensure legal integrity and consistency:

Commitments contained in sponsored research agreements concerning future research results shall be consistent with all applicable laws and regulations and with any contractual obligations the University or biotechnology company may owe to others.

Guiding Principle #5: Parties should have a clear focus on each other’s licensing strategies:

Both industry and academia must commit to engaging in open and honest discussions to develop creative and effective licensing strategies that promote global access to innovation. The mutual goal should be an authentic partnership where each party understands the collaboration goals and objective of the other party and is committed to each party achieving success.

Guiding Principle #6: Parties should focus on streamlining negotiation protocols:

Universities and biotechnology industry should focus on the benefits to each party that will result from collaborations by streamlining negotiations to ensure timely conduct of the research and the development of the research findings.

Guiding Principle #7:  Negotiator training is essential:

In order to effectively navigate towards an overall success rate for the institution, all sponsored research officers, contract negotiators and licensing officers, and especially those early in their careers, must understand how each research collaboration with which they are engaged reflects forces in the larger world of biotechnology development.

Guiding Principle #8: Partnerships should work to lower the cost of transactional efforts:

Systematically reducing transactional costs should be a major combined effort of both the university and biotechnology industry sector. This includes broader efforts to engage interpersonally through these partnerships in order to lower communication barriers among participants.

From these two reports it is clear that as academic research institutions move in new and innovative multi-partner efforts, there is a new energy and focus in working to bring novel research into the public space and utilize the biotechnology industry continues to be a growing partner.

 

24 Jan

Boston Scientific Pumps $90M Into Heart Device Startup Millipede

human heart image (Credit: Depositphotos_2015 by © decade3d)

Boston Scientific is infusing medical device company Millipede with $90 million, an equity investment that comes with the option to acquire the startup outright.

According to the agreement, Marlborough, MA-based Boston Scientific (NYSE: BSX) must exercise its option to acquire Millipede before the startup completes its ongoing clinical trial for its heart valve repair device-as long as that trial meets certain undisclosed parameters. If the acquisition does not happen by the end of the clinical trial, which could wrap up by early summer, Santa Rosa, CA-based Millipede has the option to compel Boston Scientific to buy the rest of the… Read more »

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24 Jan

Research Headlines – Photocatalytic wastewater treatment in a new light

[Source: Research & Innovation] Olive oil, palm oil, seafood – for small producers of such goods, for example in rural parts of Asia, the cost of decontaminating wastewater to the required standard can be a heavy burden. EU-funded researchers have developed innovative photocatalytic technology to support them. Part of the work was carried out by a project partner in Malaysia.

23 Jan

NeuroPointDX Turns to Crowdfunding to Get Key Study Past Finish Line

Vials of blood

Autism is hard to diagnose-there’s currently no medical test to diagnose the disorder, and teams of experts typically make diagnosis decisions based on their assessments of patients’ behavior. NeuroPointDX aims to change that with a test that could potentially diagnose the condition by analyzing the metabolism of a child from a small blood sample.

NeuroPoint, a business division of Madison, WI-based Stemina Biomarker Discovery focused on diagnostics for neurological disorders, is now turning to the autism community to support its efforts to validate its blood test. The company is seeking to raise $50,000 or more through a new crowdfunding campaign. NeuroPoint… Read more »

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23 Jan

Research Headlines – Refining medical research methods for better results

[Source: Research & Innovation] Billions of euros are wasted ever year on research that is redundant, flawed, never published or poorly reported. The EU-funded project MIROR aims to reduce this waste and ensure money invested in medical research is well spent on achieving results that matter to people.

23 Jan

Combating Antimicrobial Resistance

Here’s a statistic you might not have known: an estimated 700,000 people die each year due to the growing number of infections resistant to treatment. Known as antimicrobial resistance (AMR), this “silent killer” and looming public health threat has severe social and economic consequences that could have a lasting impact on families, individuals and communities across the globe.

Writing for Life Science Leader, Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) points out that while the United Nations and the World Health Organization recognize AMR as serious concern, it is not as visible as other epidemics, which explains why the general public is often unaware of the issue at hand.

“AMR does not have the recognizable “face” of disaster. It is not a train crash, an ecological disaster, or a disease epidemic such as Ebola or Zika scaring all of us. It is more of a silent killer,” Cueni notes.

“People only fully realize its consequences when they or a member of their family suffer from a bacterial infection which proves resistant to treatment.  From a health community perspective, AMR has crept up on us over a period of time where we perhaps complacently believed we had effectively dealt with any number of established diseases and could now save our attention for a few new ones.”

And from a dollars and cents point-of-view, AMR could have a crippling effect on the global economy and in local communities who might not have the means to combat such an epidemic. As Cueni explains:

“The economic impact of AMR is huge – estimates are of $100 trillion lower GDP on a global level. Given these figures, it is actually quite astounding that the emerging consensus on the need for sustainable pull incentives to encourage long-term investment in AMR R&D has not moved from talk to action. Progress on this front is urgent. There is need for open-minded conversations amongst all of the key stakeholders, including international organizations, governments, the public health community, civic society, and the private sector.”

The global biopharmaceutical industry is committed to doing our part to tackle this serious issue. The AMR Industry Alliance a cross-sector coalition of 101 companies from across the industry was formed to fight and overcome antimicrobial resistance. Members including biotech, diagnostics, generics and research-based pharmaceutical companies and associations have committed to sharing information and jointly reporting on four key areas: R&D, appropriate use, access to treatment, and reducing the impact of manufacturing on the environment. And findings from their first progress report shows that they are doing just that:

  • In 2016, 22 Alliance members invested at least $2 billion in R&D to counter AMR;
  • Approximately 250 biotechnology companies across the globe are investing in innovative R&D approaches – both antibiotic and non-antibiotic – and are focused on developing powerful drugs and novel tactics to fight against AMR;
  • More than two out of three Alliance companies surveyed with marketed AMR products, have strategies, policies or plans in place to improve access to their AMR-relevant products; and
  • The Alliance is appealing to policy makers to draw from the evidence provided in this report and invites stakeholders to work more systematically with the life sciences industry, to find sustainable solutions to tackling antimicrobial resistance.

To read the full op-ed, click here.

To learn more about the AMR Industry Alliance, click here.

22 Jan

4 Things Millennials Should Know (and Love!) About Food and Farming

One of the things that we at GMO Answers emphasize is finding common ground. In this time of polarization, with all the fractious discussions online and in the news, we sometimes forget that we actually have more in common with each other than some may think. Whether it’s politics, religion, money, or yes, even the weather, it can seem like there’s nothing we can agree upon.

But when you look what we care about, and what we value, deep down, we’re not so different after all. Take the case of GMOs. People on both sides of the issue really just want the same things: safe, affordable, healthy food that is good for farmers and for the environment. It’s really that simple.

In a new Medium post for GMO Answers, millennial Laura Rutherford explains just how much millennials, known for their love of food, and farmers, also known for their love of food, have in common.

We both want the same things – healthy, real food that is the highest quality possible for ourselves and our families. We both want to not only preserve, but improve our environment with safe and sustainable farming practices that will ensure a safe food supply for generations to come. Both farmers and millennials love the environment and understand the value of the land. It is in farmers’ best interest to be good stewards of the land because they often pass it down generation after generation, and often live on the land where they farm.

To read the rest of Laura’s blog post, please visit the GMO Answers Medium page. And visit the GMO Answers website if you have further questions about GMOs.

22 Jan

BioCryst, Idera Plan Merger in Tie-Up of Rare Disease Drug Developers

BioCryst Pharmaceuticals and Idera Pharmaceuticals have struck a deal to combine into a single company focused on treatments for rare diseases.

The stock deal announced Monday calls for each share of Research Triangle Park, NC-based BioCryst (NASDAQ: BCRX) to be exchanged for 0.50 shares of the new company. Idera (NASDAQ: IDRA) shareholders will get 0.20 shares of the new company for each Idera share. When the merger closes, BioCryst shareholders will own 51.6 percent of the combined company, and Idera shareholders will own the remaining 48.4 percent.

The new company, which will be renamed after the merger closes, will… Read more »

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