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Health tech innovators pitch their business ideas to expert panel at BIO-Europe Spring®

The buzz steadily grew as the Health Tech Competition got underway on the last day of BIO-Europe Spring® March 22 in Barcelona. As delegates filed into the competition room, the energy was palpable.

What new trends would this preselected group of competitors bring to the global health tech stage? Which seed company would be awarded first prize for its innovation?

Moderator Xavier Olba of Biocat, the organization that coordinates and promotes the healthcare and life sciences sector in Catalonia,  introduced the expert panel of judges who would determine the final outcome:

Ignasi Costas, Partner, Head of Innovation and Entrepreneurship, Head of International Relations, RCD

Jorge Juan Fernández, Head of Academics, Moebio

Frederic Llordachs, Co-Founder, Partner and Global Business Development Manager, Doctoralia Internet SL

Montserrat Vendrell, General Partner, Alta Life Sciences

People who know about the health tech industry most likely understand that the location of this competition made perfect sense. Barcelona is home to the Spanish Federation of Healthcare Technology Companies (FENIN), a multi-sector federation made up of manufacturing, import and distribution companies and  healthcare technology and product associations that supply the vast majority of Spanish healthcare institutions. The city is also home base for Moebio, a collaboration between Biocat, Stanford University, La Caixa and Barcelona Activa focused on developing health entrepreneurs in Barcelona.

In addition, Barcelona has been the scene for million-funding rounds in digital health companies such as Galgo Medical and ClinicPoint, in addition to interesting mergers and acquisitions operations such as the DocPlanner fusion with Catalan Doctoralia.

Worldwide, digital health companies earned revenues of USD 16 million during 2015 and 2016. This financial success has boosted the sector to 40 digital health companies, and 200 medical technology companies, of which 94 develop innovative medical devices.

Additional startup accelerators MWC, G4A, and Health U are fueling the international fire for innovation in eHealth, medical devices, wearables and other healthcare applied technologies.

Representatives and companies participating in the Health Tech Startup Competition included:

  1. Ray G. Butler, CEO/Software R&D Manager, Butler Scientifics Product5: AutoDiscovery is an intelligent automated exploratory data analysis software that helps unveiling complex relationships hidden in the data files of your scientific experiments and clinical studies. http://www.butlerscientifics.com
  2. Laszlo Bax, Co-Founder and CEO, Braingaze Braingaze, founded in 2013, develops next-generation Mind Tracking Solutions that predict and identify personal behavior for clinical and commercial applications. http://www.braingaze.com
  3. Miquel A Bru, Co-Founder, Made of Genes One genome. Endless possibilities. The first marketplace of applications based on your genome. A new dimension in personalization. https://madeofgenes.com
  4. Francesc Martinez, Marketing Manager, Airmony By TBIOM Airmony is an innovative medical device which helps you improve your sleep. It’s a portable and autonomous CPAP, which impulses air to provide assisted ventilation to treat Obstructive Sleep Apnea Syndrome (OSAS). http://www.yourairmony.com
  5. Dr. Markus Wilhelms, CEO, MOWOOT The non-drug, non-invasive and no side effects solution for chronic constipation. https://www.mowoot.com
  6. Ignasi Heras, CEO, Transplant Biomedicals Transplant Biomedicals is a European company based in Barcelona aimed at developing novel medical strategies to improve organ, tissue and cellular preservation to overall enhance patients’ wellness. https://www.transplantbiomed.com/
  7. Xavier Raurich Fabregas, COO, MJN Neuroserveis We are a science research and engineering team developing high-technology innovative devices to predict epileptic seizures. http://mjn.cat
  8. Jordina Arcal, Co-Founder, HealthApp HealthApp was founded to improve medical assistance and the patient recovery process. By developing gamified apps, HealthApp engages patients in therapy and connects with healthcare professionals. HealthApp provides real time data and analysis to adjust treatment, actions and decisions for better care.  http://bcnhealthapp.com
  9. Xavier Guillem, CEO, Adan Medical Innovation Digital Epinephrine Management: The concept was born from daily clinical interactions between physicians and patients, based on their discomfort with current management of epinephrine auto-injectors, and with a continued effort has become a reality. http://www.adanmi.com
  10. Josep M. Escuer/Nuria Noguera, Managing Director/R&D+i Director, Qrem We offer the first lab-in-a-box device to perform a natural cure for osteoarthritis (OA) reducing 75% of the pain for more than 1 year. http://www.qrem-regenerative.com

“The HealthTech Startup Competition brought together life science executives and digital health and medical technology innovators from all over the world, with the majority of startup companies representing the BioRegion of Catalonia,” said Dr. Albert Barberà, CEO of Biocat. “This life science segment has the opportunity for tremendous growth. I am sure the participants in the competition were deeply impressed with the BIO-Europe Spring attendees and enjoyed accessing such an international conference and coming face-to-face with delegates from all over the world.”

Transplant Biomedicals, Mowoot and Braingaze won first, second and third, respectively, in the competition. Transplant Biomedicals won EUR 5,000, four hours of mentoring from Alta Life Sciences and 10 hours of legal advice from RCD.

The Health Tech Competition was sponsored by Biocat, Catalonia Trade and Investment, Alta Life Sciences, and Rousaud Costas Duran (RCD) SLP.

Click here for more blog coverage of the activities held during BIO-Europe Spring.

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Report findings provide insight into technological innovations and trends in drug development

Knect365 Life Sciences has released a report offering unique insights into the awareness, perceptions and implementation of technological innovations in the drug development industry.

Based on a survey of their global database and 261 responses representing pharma, CROs and service providers split across North America, Europe and Asia, the report focuses on big data, cloud technology for EMRs, mHealth and patient-centricity.

The fascinating results provide a ‘state of the industry’ look at where these technologies are and where they are going, allowing professionals in the health sciences industry to better anticipate changes in their workplace.

The study found the primary benefit of big data to be increased efficiencies with the primary concern being cost of implementation. Big data practices are currently being utilized by nearly half of the industry, yet respondents in this survey indicate the quality of training received is only average (3.07 on a 5.0 scale).

Greater patient engagement and more successful patient recruitment are the top two benefits from implementation of patient-centric practices, yet cost is cited as the primary hindrance and/or concern regarding implementation. The most common ways to measure patient-centricity are patient engagement metrics and qualitative patient feedback.

Cloud technology for EMRs and mHealth technologies are still growing in their adoption by the industry, and it seems that data security concerns is the top obstacle to overcome. Respondents indicate that cloud technology for EMRs will have the greatest effect on increasing efficiencies while mHealth technologies allow real-time data acquisition and increased patient compliance.

Click here to download the report 

 

Innovative technologies and startup biotech companies are more important than ever to big pharma as their primary fuel source for drug and device pipelines. They are also a core focus of BioPharm America™, the leading US-based global innovation partnering event, September 26–27, 2017 in Boston. Learn more.

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Using Partnerships, Hua Medicine Brings Novel Diabetes Drug to Phase III

Li Chen, PhD, co-founded Hua Medicine (Shanghai) six years ago with Ge Li, PhD, founder of WuXi AppTec. The company soon in-licensed global rights to a GKA treatment for type 2 diabetes from Roche. Late last year, Hua announced positive results from the candidate’s proof-of-concept Phase II trial. The company also raised $50 million in additional capital during 2016 and has started US clinical development of the GKA candidate. Dr. Chen, who was previously CSO at Roche’s Shanghai R&D Center, talks about Hua Medicine and the contribution of the ChinaBio® Partnering Forum to China’s drug development ecosystem. The 2017 ChinaBio® Partnering Forum will be held May 31-June 1 in Zhuhai, China.

ChinaBio: Dr. Chen, Hua’s lead candidate is an oral GKA treatment for diabetes. It recently completed a Phase II trial in China. Can you tell us more about where you are with the candidate?

Dr. Chen: We expect our GKA candidate will be a first-in-class and, based on data from the Phase II trial, probably best-in-class oral type 2 diabetes treatment. The Phase II data is excellent, and we will be starting the Phase III trial later in 2017.  

ChinaBio: What’s next for the GKA drug after Phase III and, hopefully, approval?

Dr. Chen: Hua will be responsible for China commercialization and marketing. After approval, there are still a lot of things to do. We will need some way to identify patients with type 2 diabetes and then find an approach to them. Outside of China, we plan to co-develop and co-promote the drug there.

ChinaBio: You are also conducting clinical trials in the US.

Dr. Chen: Yes. The US is a very different market. In the US, the diabetic population takes metformin as a first-line treatment. So we administered our GKA treatment as an adjunct to metformin and the results were excellent. Because most China type 2 diabetics are treatment naive, we tested the drug as a monotherapy there. We saw excellent results in both countries.

ChinaBio: How does the ChinaBio® Partnering Forum fit into your strategy?

Dr. Chen: The most important role for the ChinaBio® Partnering Forum is to bring people together and allow our industry to develop. Most importantly, it brings investors together with innovators, entrepreneurs. For us, we are a small company, with about 30 to 40 people. We need a large community of 500 to 600 people in the medical and scientific communities to support our clinical research. The ChinaBio® Partnering Forum makes the community aware of us and helps us work with the larger ecosystem. It brings people together and provides an environment that allows the industry, all aspects of the industry, to develop.

ChinaBio: Are you in the hunt for additional drug candidates?

Dr. Chen: Our strategy is that, while we continue to develop and then launch our diabetes drug in China, we are talking to pharma partners and we open discussions about their potential portfolio molecules that Hua could license. In the future we would like to become a company that offers China market operations with partnerships in other regions. We could also co-promote products together outside of China.

There are several discussions underway currently. This is very exciting.

ChinaBio: Why does Hua adopt the China marketing/Ex-China co-promotion model?

Dr. Chen: Hua will do well marketing our own drugs in the China market because of our expertise and influence. Then, while we are working with partners outside of China for our drug development, we might also seek to license China marketing rights for their products. Using this model, both parties will be leveraging their strengths and partnering to benefit patients and the companies.

ChinaBio: What kind of partnering do you do in China?

Dr. Chen: We use a very innovative model here in China. We call it Collaborative Innovation. Hua has a strategic partnership with WuXi AppTec and its affiliated companies in the pre-clinical space, clinical development and contract manufacturing. Also we are working very closely with global CROs like TigerMed and dMed and a few others, working on clinical development and preparing for pharmacovigilance, monitoring and preparing for NDA approval. We have been working with over 30 partners in the areas of early discovery early development and commercialization/ manufacturing and then clinical development. Obviously, Hua will develop marketing skills through a partnership-based relationship.

ChinaBio: How did the GKA candidate perform in the China Phase II trial?

Dr. Chen: In the Phase II test, 268 diabetes patients received the treatment for three months on several different regimens. The efficacy was really great, lowering average HbA1c levels by 1.2%. The results were very significant with a p value of 0.01. Side effects were fairly benign — relatively little hypoglycemia for example — and in line with other oral type 2 diabetes treatments. It’s a good drug. Ours is the first successful trial of a GKA drug. Earlier versions caused hypoglycemia and often lost efficacy fairly quickly.

ChinaBio: When do you expect to put your GKA diabetes drug on the US market?

Dr. Chen: We have a plan for getting our partners ready in 2018-2019 and that’s where we will engage the US NDA trials. And then probably, it will take a few years to get through the trial and the drug will be ready to be launched around 2022-2023.

We want to help patients and the current drug is not very effective. There have been a lot of drugs brought to market since insulin was developed 100 years ago. Insulin makes sure that people don’t die from diabetes. But look at the disease: it’s increasing. The current drugs do not cure people. New patients are diagnosed while the older patients are still there. Fundamentally, the community has not been able to target the cause of the disease, but they work to simply lower the blood glucose level to acceptable levels. Their drugs target symptoms, not the cause of the disease. That’s where our drug is different. It targets the underlying cause and that’s why the clinical benefit is so big [Ed. — Hua’s 4th-generation GKA targets a key enzyme (GK) that acts as a glucose sensor and regulates carbohydrate metabolism. It was designed to avoid the side-effects of previous generation drugs]. We can talk more about that as we complete our Phase III trials.

ChinaBio: We talked, back when you were just starting Hua, and you said it was the perfect time to start a China innovative drug company. Were you right about that?

Dr. Chen: Yes, I think so. Basically at that time we said we wanted to be the most innovative biotech company in China and be able to offer first-in-class, best-in-class drugs for patients worldwide in exciting therapeutic areas. We just did that.

And the other part I said was that in China the regulatory and financial environment would improve, and that has also taken place. In the last few years, the CFDA has put new policies in place encouraging innovation and enforcing quality of marketed drugs and clinical trials. They are bringing the whole process of drug discovery and innovation level up to the level of the US and Europe. I think that’s a major step forward and Hua benefits from that.

Also, also the investment community is very much involved in drug development. In 2016 a huge amount of investment was made primarily to China innovative drug companies, mostly coming from China-based venture and PE funds. Significant progress I’d have to say, and it seems like what we predicted six years ago is coming true.

ChinaBio: Dr. Chen, congratulations on Hua’s success so far and thank for your time.

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Q1 2017 – Advanced Therapies Make a Strong Showing Early in the Year

Guest post by Patricia Reilly, M.S., Head of Intelligence Alliances and Unification, Pharma Intelligence and Nancy Dvorin, Executive Editor, In Vivo

Advanced therapy companies started 2017 with a bang. One of the key events in Q1, following the passage of the 21st Century Cures Act, was the announcement that Humacyte received the first Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its Phase III human acellular vessel HUMACYL.

APAC deals are on the rise. Kite and Shanghai Fosun entered a joint venture to develop KTE-C19 in China. The venture will include profit sharing and an upfront payment of $40 million to Kite, milestones and sales royalties. Additionally, the deal includes an option for several other TCR therapies that could bring the total deal to more than $140 million. Molmed announced a $4.5 million agreement with TTY Biopharm for an exclusive license to commercialize Zalmoxis in select Asian territories. Caladrius has agreed to sell the remaining portion of holdings in its PCT subsidiary to Hitachi Chemical for $75 million with future potential milestone payments.

CRISPR and Casebia, its joint venture with Bayer AG, signed an agreement with Maxcyte for Maxcyte’s cell engineering platform to develop therapies for hemoglobin-related diseases and severe combined immunodeficiency. Allergan and Editas announced an agreement that would give Allergan the option to license five ocular programs from Editas’s gene-editing platform. Editas, which raised an $84.6 million FOPO in March, will receive an upfront payment of $90 million for the development of five candidate programs and will be eligible for milestone payments related to their program for Leber Congenital Amaurosis, a rare retinal degenerative childhood disease that leads to blindness.

Financings in a variety of forms continues to fuel this growing sector. Kite closed its $409.7 million public offering of common stock. Mustang Bio, a subsidiary of Fortress with a CAR-T therapy in Phase I for glioblastoma, raised $94.5 million in a private placement. Kadmon announced private placement equity financing this quarter as well, raising $23 million while BioTime and Biostage closed successful public offerings. Regenxbio sold 3.7 million shares of common stock for $75.9 million and Adaptimmune raised $60.1 million through the sale of 14.3 million ADSs. Cell Medica secured a $73.18 million Series C round. The company’s therapy baltaleucel-T is currently in Phase II for advanced lymphomas associated with EBV. Solid Biosciences raised $50 million in a Series C financing. Solid will use the financing to continue its focus on gene therapy programs for Duchenne muscular dystrophy. Exonics Therapeutics revealed that it will receive $5 million in seed money to move forward with preclinical research in Duchenne muscular dystrophy from CureDuchenne Ventures. Exonics hopes to use CRISPR/Cas 9 technology to identify and correct exon mutations that prevent the production of dystrophin.

Growth in the number of clinical trials added to the positive signs of confidence in this sector.

There were over 800 trials at the end of 2016 with the greatest number in cell therapies currently in Phase II compared to a total of 630 trials in 2015. However, the news was not all good in Q1:  Juno’s Phase II Rocket trial for JCAR015 in ALL was closed after multiple holds because of patient deaths from cerebral edema. Juno and its partner Celgene have decided to move forward with several other treatments, including JCAR014 and JCAR017 that target B cell antigen CD19 and are being tested in other blood cancers. Juno is also looking to develop JCAR018, which targets CD22, and JTCR016, a T cell receptor product that targets WT-1.

To hear more on developments in the advanced therapies sector, and to meet and forge partnerships with decision makers from pharma, biotech and finance and patient advocacy groups, attend the Cell & Gene Exchange event taking place in Washington, DC, May 22–23, 2017.

 

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Rare Disease Foundation CEO cites collaboration, data sharing as keys to progress

An interview with Monica Weldon, President of Bridge the Gap – SYNGAP Education and Research Foundation

Houston-based Monica Weldon is a mother, wife, former teacher and a rare disease advocate who founded Bridge the Gap – SYNGAP Education and Research Foundation. The Foundation reflects her passion to serve, educate and raise public awareness about SYNGAP, a neurological disorder that causes intellectual disability and severe developmental delays. She has five children. Her son, Beckett, a fraternal twin, has the rare genetic disorder.

 

A defining moment

Beckett began to show symptoms at four months old, and at 14 months she thought he began having seizures. Initial tests showed no abnormality, but Weldon, a former teacher with a science background and a naturally inquisitive nature, had intuition that the reasons behind her son’s condition were genetic. The only way to determine SYNGAP1 is through genome, whole exome DNA, or any type of genetic panel test. After consulting 19 specialists, Beckett was finally diagnosed at the age of five when a genetics clinic gave them their answer. Beckett was the first patient diagnosed at Texas Children’s Genetics Clinic in 2012, and was one of only six known diagnoses in North America. At the time, Weldon could find just one published paper on the association of SYNGAP1 mutations with nonsyndromic intellectual disability (NSID).

Mutations in the SYNGAP1 gene are thought to be a relatively common cause of SYNGAP1-related nonsyndromic intellectual disability (NSID), yet patients are predominantly undiagnosed or misdiagnosed. “If parents do not continue to push for genetic testing to investigate the root cause of symptoms, we’re not going to be able to increase the diagnosis rate. It would have been so much easier if we had just started out with a genetic test,” said Weldon.

One study published in Neuron in 2014 suggests that there are tens of thousands of undocumented individuals carrying these mutations.

“I have a feeling that number is going to go up. The thing about this disorder,” said Weldon, “is that unless a child has something else paired with it, they progress at about a 50% rate.”

(more…)

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BIO-Europe Spring 2017 kicks off this week in Barcelona

BIO-Europe Spring® international partnering conference kicked off yesterday in Barcelona with an estimated 2,500 attendees representing executives from the life sciences, including nearly 200 delegates from the Catalonia region, according to Biocat CEO Albert Barbera. Anna Chrisman of EBD Group welcomed delegates to the event, followed by David Thomas of BIO, who reported on dealmaking and investment in 2016 in his BIO Industry Analysis. In general, 2016 saw an across-the-board slowdown for biotech for R&D stage financing and dealmaking in both the US and Europe, but despite the slowdown total investment values are still above average. And there were 26 IPOs last year including three CRISPR biotech companies whose genome editing technology may go to clinical trials in 2017. (more…)

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Report gives substance to fast-paced scientific discoveries in microbiome

Guest post by Eric de La Fortelle, Venture Partner at Seventure Partners

Microbes are everywhere, and apart from the occasional pathogen, they are a positive force for health maintenance. Indeed the ‘war on microbes’ of the last fifty years (antiseptics on skin, antibiotics in our bloodstream, food preservatives in our digestive system) largely contributed to the spread of chronic diseases in our societies.

Help is on its way. Recent discoveries of the biological mechanisms behind the elegant symbiosis of microbes and higher species (including man) jumped from the laboratory to the popular press in a matter of months, contributing to a rapid surge of interest in the topic. These academic discoveries are being rapidly translated from academic research to biotech companies developing products for functional nutrition, clinical nutrition, over-the-counter therapeutics and prescription drugs. These products take many forms: live bacteria administered orally or even intravenously; bacteriophages acting as highly specific antibiotics, but also the more classical pharmaceutical tools of small molecules, peptides and antibodies peptides. Understanding microbiome biology can also lead to diagnostic insights and products.

The rapidly-increasing number of startups developing products in this field operate at the interface between nutrition and drug discovery, and navigate novel regulatory paths. Many of the economic actors, while they recognize the potential of those novel product category, hesitate to commit resources early, preferring to wait for the first clear successes.

Seventure Partners is an acknowledged leader for venture investment in microbiome-based products, largely via its EUR 160 million Health for Life Capital investment fund. Using its strategic insights in this field, it authored a new report entitled “The human microbiome : A new protagonist in managing human health.“ This short read (22 pages, many figures) is aimed at the generalist economic decision maker. It gives an overview of the field, including quantitative analyses, and through interviews with a broad range of thought leaders in the field, aims to understand the key questions for future value creation : how to turn these fast-paced scientific discoveries into useful products, and what is the substance behind the current hype.

The report will be released at BIO-Europe Spring® 2017 in Barcelona this week during the program panel “Key considerations in microbiome partnering” moderated by Mike Ward of Informa Pharma Insights and featuring panelists Michel De Baar, Executive Director, BD&L, Infectious Diseases & Vaccines, Cardiovascular & Metabolic Diseases at MSD; Eric De La Fortelle; Xavier Aldeguer Mauté, Co-Founder and Medical Advisor at Goodgut; and Mariona Serra-Pagés, CEO at Goodgut.

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2016 – A Year in Review for Advanced Therapies

Guest post by Patricia Reilly, M.S., Head of Intelligence Alliances and Unification, Pharma Intelligence | Informa and Nancy Dvorin, Executive Editor, In Vivo

The past year saw intensifying dialogue on how to assess the value of and properly price therapeutics poised to cure diseases with a single dose, thus making drug pricing the major healthcare story of 2016. Stakeholders in the regenerative medicine space are preemptively laying the groundwork for the day when more of these products are approved and discussion of their cost-benefit analysis surfaces. With over 800 clinical trials involving regenerative medicine ongoing, and more than 60 trials in Phase III, this time will be approaching quickly. (more…)

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Stirring the Pot for Entrepreneurship in European Tech Transfer

Guest post by Luke Timmerman, founder and editor of the Timmerman Report, and a regular contributor to Forbes and STAT News.

The science in many parts of Europe is first-rate. No one disputes that. But yet the biggest emerging biotech business stories in the world pop up regularly in the U.S. That’s been true for a long time, and it’s been true lately with messenger RNA therapies, CRISPR-Cas9 genome editing, and deep DNA sequencing for early cancer detection, to name a few big ideas. (more…)

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World RARE Disease Day shines a light on rare disease community

Tomorrow is the 10th annual World RARE Disease Day. Various activities are taking place all over the United States as well as countless locations around the world.

World RARE Disease Day is an annual observance held on the last day of February to raise awareness for rare diseases, in hopes of improving access to treatments and medical representation for individuals with rare diseases and their families.  Global Genes is one of the leading rare disease patient advocacy organizations worldwide and a consistent supporter of this important day of awareness.  Since 2009, Global Genes and hundreds of patient advocacy organizations around the world have engaged in awareness raising activities developed by Global Genes in support of World Rare Disease Day! (more…)

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