One Health for the 21st Century

In remarkable ways, the embracing of the One Health concept over the last decade has resulted in a dramatic shift in the discussions, practices, polices and partnerships that link the health of people, animals and our shared environments. In part, One Health has benefited from many innovative, collaborative efforts well underway and years in the making.  In other ways, the efforts have been focused on improving on 20th Century approaches and meeting 20th Century goals rather than boldly leading us into the 21st Century.  While the movement has had positive effects, the challenge remains to expand stakeholder engagement in One Health and think more broadly about where opportunities for impact may lie.

One Health is not only about infectious diseases; non-transmissible diseases, the health of plants and animals, the quality of our water and air, and the safety of the environment in which we live, share, and depend all fit within the rubric. But since infections shared among animals and people account for nearly two-thirds of human infectious diseases, and the majority of these are from wildlife, “low-hanging fruit” for collaborative benefits can be found at the human/animal/environment interface of infectious diseases and even pandemics.  The environment and how we interact with it is key because we know that the leading drivers of disease emergence in humans result from activities such as land use change, food production systems, and trade and travel.  This reality reveals the need to embrace a wider range of civil society and private sector partners and indicates the valuable role that the biotechnology sector can play.

We now have the ability to predict where outbreaks are most likely to happen and under which circumstances, thus we can take action to reduce risk and mitigate adverse outcomes.  As with earthquakes, we can identify areas of higher risk, and we can engineer solutions to mitigate impact.

One Heath action requires the efforts of more than just policy makers, academics and practitioners. It is dependent on engagement, and often leadership, from civil society and the private sector.  Fire safety serves as good analogy.  Fire fighters don’t just put out fires, they engage the community in fire prevention.  School children are taught safety, buildings and products are designed and manufactured to be fire safe.  Companies sell smoke detectors and fire extinguishers to private citizens.  Data crunchers map out tax delinquencies as a predictor of arson.  Health in the 21st Century requires this same whole of society effort and requires the creation of opportunities for the inclusion and engagement of a wide range of actors to participate.  In essence, this is the heart of the One Health concept.

Dr. Karesh is scheduled to speak at BIO’s 2017 International Convention in San Diego on Monday, June 19, as part of BIO’s “One Health Day” programming.  This unique half-day session provides an opportunity for attendees to engage in discussions around the promises of One Health innovations to help us better heal, fuel and feed the world.

One Health for the 21st Century

In remarkable ways, the embracing of the One Health concept over the last decade has resulted in a dramatic shift in the discussions, practices, polices and partnerships that link the health of people, animals and our shared environments. In part, One Health has benefited from many innovative, collaborative efforts well underway and years in the making.  In other ways, the efforts have been focused on improving on 20th Century approaches and meeting 20th Century goals rather than boldly leading us into the 21st Century.  While the movement has had positive effects, the challenge remains to expand stakeholder engagement in One Health and think more broadly about where opportunities for impact may lie.

One Health is not only about infectious diseases; non-transmissible diseases, the health of plants and animals, the quality of our water and air, and the safety of the environment in which we live, share, and depend all fit within the rubric. But since infections shared among animals and people account for nearly two-thirds of human infectious diseases, and the majority of these are from wildlife, “low-hanging fruit” for collaborative benefits can be found at the human/animal/environment interface of infectious diseases and even pandemics.  The environment and how we interact with it is key because we know that the leading drivers of disease emergence in humans result from activities such as land use change, food production systems, and trade and travel.  This reality reveals the need to embrace a wider range of civil society and private sector partners and indicates the valuable role that the biotechnology sector can play.

We now have the ability to predict where outbreaks are most likely to happen and under which circumstances, thus we can take action to reduce risk and mitigate adverse outcomes.  As with earthquakes, we can identify areas of higher risk, and we can engineer solutions to mitigate impact.

One Heath action requires the efforts of more than just policy makers, academics and practitioners. It is dependent on engagement, and often leadership, from civil society and the private sector.  Fire safety serves as good analogy.  Fire fighters don’t just put out fires, they engage the community in fire prevention.  School children are taught safety, buildings and products are designed and manufactured to be fire safe.  Companies sell smoke detectors and fire extinguishers to private citizens.  Data crunchers map out tax delinquencies as a predictor of arson.  Health in the 21st Century requires this same whole of society effort and requires the creation of opportunities for the inclusion and engagement of a wide range of actors to participate.  In essence, this is the heart of the One Health concept.

Dr. Karesh is scheduled to speak at BIO’s 2017 International Convention in San Diego on Monday, June 19, as part of BIO’s “One Health Day” programming.  This unique half-day session provides an opportunity for attendees to engage in discussions around the promises of One Health innovations to help us better heal, fuel and feed the world.

Life After Start-Up Stadium: SyntheX, Inc.

For the third year, the BIO International Convention will host the 2017 BIO Start-Up Stadium Empowering the Cutting-Edge Companies of Tomorrow, Today – an exciting and interactive experience where investors provide live feedback and judge 5-7 minute pitches presented by start-up biotech companies. The Start-Up Stadium accepts applications from early-stage companies with breakthrough technologies, and invites investors and state and regional affiliates to engage and explore mutual opportunities. Participating companies receive access to BIO One-on-One Partnering™ and educational sessions making their experience at BIO like no other.

Maria Soloveychik, Co-Founder and CEO of SyntheX, Inc.

This is the third in a series of guest blogs highlighting Start-Up Stadium success stories as told by former participants. Today we spoke with 2016 Alum, Maria Soloveychik, Ph.D., Co-Founder and CEO of SyntheX, Inc.

BTN: Can you tell us about your start-up?
SyntheX, Inc. is a San Francisco based therapeutics company founded in 2016. SyntheX utilizes its novel platform technology to select for peptides and create peptidomimetics to drug previously ‘undruggable’ targets, relying on the concept of synthetic lethality to treat cancer.

BTN: Was the Start-Up Stadium platform able to assist you in gaining visibility?
The Start-Up Stadium was an excellent platform for gaining visibility. You get to share your science and start-up with experts and investors in the biotech space AND receive valuable feedback and advice. We met great people in the audience and have even maintained relationships with a few judges.

BTN: Did you receive constructive live feedback at the Start-Up Stadium from stakeholders and subject matter experts?
I was asked several interesting questions regarding our platform and early assets. In their assessment, the panel made good suggestions in relation to alternative business models focused on licensing and partnering. They also provided great feedback on our deck and presentation style.

BTN: How have you implemented any feedback to achieve success and continued growth?
After Start-Up Stadium, the feedback received was incorporated into all presentations and meetings. I have also gone on to discuss various business model structures with advisors and experts in the industry – which later shaped our partnering meetings and internal work prioritization.

BTN: Were your BIO One-on-One Partnering™ meetings successful? Did they generate valuable connections with potential for meaningful partnerships?
The BIO One-on-One Partnering™ meetings were a major highlight of Convention! We had a very packed schedule, but had the opportunity to meet with big and mid-sized pharmas as well as CROs. These talks were excellent for understanding their interests and obtaining advice, as well as assessing a potential fit for a future partnership. We are actively communicating with several companies we met through partnering, and have established meaningful relationships with several CROs and fellow start-ups.

BTN: Although no longer eligible to participate in the Start-Up Stadium, will you be returning the 2017 BIO International Convention?
I would love to return this year, but unfortunately, there is a scheduling conflict for 2017. It is likely that we will attend the 2018 BIO International Convention. The BIO One-on-One Partnering™ meetings are such an excellent and organized way to meet with potential partners, and the events around the conference are a great collegial gathering of the biotech community.

About: SyntheX is a therapeutics company that disrupts cellular communication pathways to target proteins that are inaccessible via canonical screening technologies. We use a proprietary drug design approach and our in-vivo screening platform, ToRPPIDO, to identify compounds that disrupt protein-protein interactions (PPIs) – in a fast, efficient, and highly specific manner. We take advantage of synthetic lethality to develop compounds that target particular “Achilles’ heel” PPI in specific pathologies. We are currently developing inhibitors for a series of specific and previously undruggable targets. Our lead stabilized peptide inhibitor drugs, STX101 and STX105, block PPIs within the BRCA2 pathway, effectively mimicking a BRCA2 mutation and downregulating recombination. To learn more, visit: www.synthexlabs.com.

Life After Start-Up Stadium: SyntheX, Inc.

For the third year, the BIO International Convention will host the 2017 BIO Start-Up Stadium Empowering the Cutting-Edge Companies of Tomorrow, Today – an exciting and interactive experience where investors provide live feedback and judge 5-7 minute pitches presented by start-up biotech companies. The Start-Up Stadium accepts applications from early-stage companies with breakthrough technologies, and invites investors and state and regional affiliates to engage and explore mutual opportunities. Participating companies receive access to BIO One-on-One Partnering™ and educational sessions making their experience at BIO like no other.

Maria Soloveychik, Co-Founder and CEO of SyntheX, Inc.

This is the third in a series of guest blogs highlighting Start-Up Stadium success stories as told by former participants. Today we spoke with 2016 Alum, Maria Soloveychik, Ph.D., Co-Founder and CEO of SyntheX, Inc.

BTN: Can you tell us about your start-up?
SyntheX, Inc. is a San Francisco based therapeutics company founded in 2016. SyntheX utilizes its novel platform technology to select for peptides and create peptidomimetics to drug previously ‘undruggable’ targets, relying on the concept of synthetic lethality to treat cancer.

BTN: Was the Start-Up Stadium platform able to assist you in gaining visibility?
The Start-Up Stadium was an excellent platform for gaining visibility. You get to share your science and start-up with experts and investors in the biotech space AND receive valuable feedback and advice. We met great people in the audience and have even maintained relationships with a few judges.

BTN: Did you receive constructive live feedback at the Start-Up Stadium from stakeholders and subject matter experts?
I was asked several interesting questions regarding our platform and early assets. In their assessment, the panel made good suggestions in relation to alternative business models focused on licensing and partnering. They also provided great feedback on our deck and presentation style.

BTN: How have you implemented any feedback to achieve success and continued growth?
After Start-Up Stadium, the feedback received was incorporated into all presentations and meetings. I have also gone on to discuss various business model structures with advisors and experts in the industry – which later shaped our partnering meetings and internal work prioritization.

BTN: Were your BIO One-on-One Partnering™ meetings successful? Did they generate valuable connections with potential for meaningful partnerships?
The BIO One-on-One Partnering™ meetings were a major highlight of Convention! We had a very packed schedule, but had the opportunity to meet with big and mid-sized pharmas as well as CROs. These talks were excellent for understanding their interests and obtaining advice, as well as assessing a potential fit for a future partnership. We are actively communicating with several companies we met through partnering, and have established meaningful relationships with several CROs and fellow start-ups.

BTN: Although no longer eligible to participate in the Start-Up Stadium, will you be returning the 2017 BIO International Convention?
I would love to return this year, but unfortunately, there is a scheduling conflict for 2017. It is likely that we will attend the 2018 BIO International Convention. The BIO One-on-One Partnering™ meetings are such an excellent and organized way to meet with potential partners, and the events around the conference are a great collegial gathering of the biotech community.

About: SyntheX is a therapeutics company that disrupts cellular communication pathways to target proteins that are inaccessible via canonical screening technologies. We use a proprietary drug design approach and our in-vivo screening platform, ToRPPIDO, to identify compounds that disrupt protein-protein interactions (PPIs) – in a fast, efficient, and highly specific manner. We take advantage of synthetic lethality to develop compounds that target particular “Achilles’ heel” PPI in specific pathologies. We are currently developing inhibitors for a series of specific and previously undruggable targets. Our lead stabilized peptide inhibitor drugs, STX101 and STX105, block PPIs within the BRCA2 pathway, effectively mimicking a BRCA2 mutation and downregulating recombination. To learn more, visit: www.synthexlabs.com.

#BIO2017: A Peek at Pavilions | Sub-Saharan Africa

Breaking Buzz is BIO’s newest blog series that reaches across the globe to bring you an insider’s preview into the hottest international and partnering trends coming to San Diego for the BIO International Convention.

The Fastest-Growing Continent You Thought You Knew

The African continent is currently home to seven of the world’s top-ten fastest-growing economies; and by 2050 (just 33 years from today!) is projected to represent 26% of the global population.

Let that sink in for a minute.

There are 54 countries within the continent which spans more than 11.7 million square miles – second only to Asia both in percentage of land on earth, and population; it is home to over 1.2 billion people many of whom are now referred to as the world’s fastest-growing middle class. And get this: World Economics, a research organization that measures global economic activity, reports that the African continent has surpassed Europe and the Americas in real GDP growth when measuring by continent, from 1961 to 2015.

So what’s a continent to do with so much potential? Breaking Buzz asked Jennifer Dent, President of BIO Ventures for Global Health (BVGH) just that and she says, it all starts at the BIO International Convention.

“We brought in the first African delegation to the Convention from Nigeria in 2014. The next year, six countries came, and we had the first Africa Pavilion. Last year in San Francisco we had 16 African countries present. But this year in San Diego we will have 24 countries from the African continent and upward of 30 delegates – and for the record, these aren’t just any delegates. The delegates at the pavilion have real authority, so expect action.”

She is referring to Ministry of Health officials and advisors representing several countries, Nigeria, Kenya, Tanzania, Côte d’Ivoire; and high-level decision makers from academic, non-profit organizations, and life science companies. Collectively they represent 24 of the African continent’s 54 countries and share a common mission: to engage biotechnology, pharmaceutical, and life science companies in meaningful initiatives, programs and partnerships to impact global health.

The quality of attendee is a direct reflection of recent findings reported by the World Bank who had this to say about Africa: Fostering public and private investment in infrastructure has become a priority to the African continent, [so] with well-targeted capital investments and policies fostering competitiveness and productivity, Africa’s larger and younger work force has the potential to transform the continent.

Jennifer Dent, President BVGH

“Think about what’s important to industry” says Dent; “they’re looking for growth opportunities in markets across the globe, and as the World Bank reveals, Africa has made considerable progress in its infrastructure development and emerging market status. While these countries have grown and prospered, however, so have non-communicable diseases like cancer and diabetes gown in prevalence; these aren’t just markets for anti-malarials and other anti-infectives anymore.”

To enter the African market, Dent stresses that partnerships will be critical to obtaining the in-depth knowledge of the continent’s infrastructure, politics, and disease landscape; that’s where the Convention comes into play and why she’ll be launching a new initiative in San Diego this year.

The African Access Initiative  will be launched on Wednesday at the BIO International Convention in San Diego; it is an integrated package of programs, activities, and partnerships designed to address the primary barriers to cancer treatment in Africa. The AAI will create new business models and tap into company products to establish access to cancer medicines and biologics. The program will augment the African Organization for Research and Training in Cancer which is furthering research relating to cancers prevalent in Africa and facilitating and supporting training initiatives in oncology for health-care professionals. AAI will also support leading cancer researchers dedicated to building clinical trial networks, and determining how genetics affect the types of cancer prevalent to the area.

Two groups from Kenya, incubator Villgro Kenya, and the Kenya National Innovation Agency whose Chairman Professor Reuben Marwanga will also be present, are both working toward the development of a better ecosystem to support innovation and innovators in the country.

“That’s a lot,” says Dent enthusiastically, “and we have just scratched the surface. There are many milestones being reached in Africa, and taking it all in can be a challenge; which is why we’re presenting a one-hour media event at BIO to overview each of the 24 countries and their primary areas of therapeutics.”

Jim Greenwood, BIO President and long-time Africa advocate will open the event at 10:45 on Tuesday morning, the first full day of the Convention. Also in attendance will be the European Commission’s Deputy Head of Unit, Health Directorate Dr. Philippe Cupers who will introduce the European and Developing Countries Clinical Trials Partnership.

The event will take place in the African Pavilion where you can visit 24 countries in one hour. No frequent flyer miles earned, but hey, what an efficient way to travel.

Filed under: Events, , , , , , , , , , , ,

#BIO2017: A Peek at Pavilions | Sub-Saharan Africa

Breaking Buzz is BIO’s newest blog series that reaches across the globe to bring you an insider’s preview into the hottest international and partnering trends coming to San Diego for the BIO International Convention.

The Fastest-Growing Continent You Thought You Knew

The African continent is currently home to seven of the world’s top-ten fastest-growing economies; and by 2050 (just 33 years from today!) is projected to represent 26% of the global population.

Let that sink in for a minute.

There are 54 countries within the continent which spans more than 11.7 million square miles – second only to Asia both in percentage of land on earth, and population; it is home to over 1.2 billion people many of whom are now referred to as the world’s fastest-growing middle class. And get this: World Economics, a research organization that measures global economic activity, reports that the African continent has surpassed Europe and the Americas in real GDP growth when measuring by continent, from 1961 to 2015.

So what’s a continent to do with so much potential? Breaking Buzz asked Jennifer Dent, President of BIO Ventures for Global Health (BVGH) just that and she says, it all starts at the BIO International Convention.

“We brought in the first African delegation to the Convention from Nigeria in 2014. The next year, six countries came, and we had the first Africa Pavilion. Last year in San Francisco we had 16 African countries present. But this year in San Diego we will have 24 countries from the African continent and upward of 30 delegates – and for the record, these aren’t just any delegates. The delegates at the pavilion have real authority, so expect action.”

She is referring to Ministry of Health officials and advisors representing several countries, Nigeria, Kenya, Tanzania, Côte d’Ivoire; and high-level decision makers from academic, non-profit organizations, and life science companies. Collectively they represent 24 of the African continent’s 54 countries and share a common mission: to engage biotechnology, pharmaceutical, and life science companies in meaningful initiatives, programs and partnerships to impact global health.

The quality of attendee is a direct reflection of recent findings reported by the World Bank who had this to say about Africa: Fostering public and private investment in infrastructure has become a priority to the African continent, [so] with well-targeted capital investments and policies fostering competitiveness and productivity, Africa’s larger and younger work force has the potential to transform the continent.

Jennifer Dent, President BVGH

“Think about what’s important to industry” says Dent; “they’re looking for growth opportunities in markets across the globe, and as the World Bank reveals, Africa has made considerable progress in its infrastructure development and emerging market status. While these countries have grown and prospered, however, so have non-communicable diseases like cancer and diabetes gown in prevalence; these aren’t just markets for anti-malarials and other anti-infectives anymore.”

To enter the African market, Dent stresses that partnerships will be critical to obtaining the in-depth knowledge of the continent’s infrastructure, politics, and disease landscape; that’s where the Convention comes into play and why she’ll be launching a new initiative in San Diego this year.

The African Access Initiative  will be launched on Wednesday at the BIO International Convention in San Diego; it is an integrated package of programs, activities, and partnerships designed to address the primary barriers to cancer treatment in Africa. The AAI will create new business models and tap into company products to establish access to cancer medicines and biologics. The program will augment the African Organization for Research and Training in Cancer which is furthering research relating to cancers prevalent in Africa and facilitating and supporting training initiatives in oncology for health-care professionals. AAI will also support leading cancer researchers dedicated to building clinical trial networks, and determining how genetics affect the types of cancer prevalent to the area.

Two groups from Kenya, incubator Villgro Kenya, and the Kenya National Innovation Agency whose Chairman Professor Reuben Marwanga will also be present, are both working toward the development of a better ecosystem to support innovation and innovators in the country.

“That’s a lot,” says Dent enthusiastically, “and we have just scratched the surface. There are many milestones being reached in Africa, and taking it all in can be a challenge; which is why we’re presenting a one-hour media event at BIO to overview each of the 24 countries and their primary areas of therapeutics.”

Jim Greenwood, BIO President and long-time Africa advocate will open the event at 10:45 on Tuesday morning, the first full day of the Convention. Also in attendance will be the European Commission’s Deputy Head of Unit, Health Directorate Dr. Philippe Cupers who will introduce the European and Developing Countries Clinical Trials Partnership.

The event will take place in the African Pavilion where you can visit 24 countries in one hour. No frequent flyer miles earned, but hey, what an efficient way to travel.

Filed under: Events, , , , , , , , , , , ,

BIO 2017 Innovation Zone Company Snapshot: NuvOx Pharma

The next big medical breakthrough may start in a small business with a big idea. Recognizing the potential and promise of early-stage companies for addressing unmet medical needs, the BIO International Convention will once again host the Innovation Zone on the exhibit floor of the San Diego Convention Center, June 19-22. Eighty emerging companies will showcase biotechnology breakthroughs in drug discovery, diagnostics, and other therapeutic platform technologies.

The Innovation Zone was created through a partnership with the National Institutes of Health (NIH) and the National Science Foundation (NSF) with the intent to group Small Business Innovation Research (SBIR)-funded companies together on the exhibit floor of the BIO International Convention. The SBIR program provides U.S. federal funding to small businesses engaged in research and development with demonstrated potential for commercialization. Companies are rigorously vetted through the NIH and NSF SBIR review process prior to receiving the funding.

Today we spoke with Innovation Zone exhibitor, John McGonigle, Business Development Associate at NuvOx Pharma, which is supported by NIH’s SBIR program.

BTN: What is your company’s lead product or technology?
NuvOx Pharma is developing a nanotechnology platform of therapeutics to treat life-threatening diseases characterized by hypoxia. The Company has clinical programs in cancer (Phase II), stroke (Ib/II) and sickle cell disease (Phase Ib).

BTN: How has the NIH’s SBIR program helped your company grow?
The NIH’s SBIR program has been instrumental in the development of NuvOx Pharma. For example, our oncology program was started by an NCI SBIR Phase I grant to help us reformulate an EMEA approved ultrasound contrast agent as a stable emulsion for oxygen delivery.  A Phase II NCI SBIR grant supported IND enabling animal studies, and helped us show that the drug can raise tumor oxygen levels to make tumors more sensitive to radiation therapy. We completed a Phase Ib/II clinical trial in brain cancer, and the FDA has allowed our IND for a Phase II clinical trial in this indication. We have applied to the NIH for a Phase IIb SBIR Bridge Award, which would match investor funds to support the Phase II clinical trial. In addition, the Company has received Phase I SBIR/STTR grants to develop nanotechnology products for heart disease (endocarditis and myocardial infarction) and cancer (pancreas and breast).

BTN: What are the upcoming milestones and long-term priorities for your company?
Long term, we recognize that hypoxia can be life-threatening in many medical conditions, including some of the biggest killers in the world such as cancer, stroke and heart attack. We intend to save lives by using our nanotechnology to deliver oxygen to hypoxic tissue more effectively than red blood cells. We have animal data showing improved outcomes in cancer, stroke, myocardial infarction, sickle cell disease, hemorrhagic shock, and traumatic brain injury.

Short term, we have several major milestones coming up in the next year. We are on track to start the Phase II clinical trial in oncology this fall.  We have an active Phase Ib/II clinical trial in stroke and we should have the first randomized data from that trial within the year.  We are on track to start a Phase Ib clinical trial in sickle disease this summer.  The NHLBI has recently funded a study in heart attack in pigs, which could provide the data needed to file an IND for a clinical trial in that indication.

BTN: What do you hope to gain out of your participation at the 2017 BIO International Convention?
We are seeking investors to help us develop our drug assets and corporate partners to help us develop our nanotechnology products.

BTN: Tell us something about your company that investors might not know…
$100M was spent developing the core technology for a diagnostic indication – as an ultrasound contrast agent.  It was used in 2,200 patients, and approved in Europe, but never marketed due to competitive pressures. NuvOx was formed to reposition the technology for its oxygen delivery ability. We have devised new formulations with the support of the NIH.  We have tested the nanotechnology products in multiple models – oxygen delivery and/or therapeutic effect has been shown in 26 peer-reviewed publications, many of which were supported by NIH funding, in particular by the NCI and NHLBI.  We have expanded the IP – and have 5 patents issued, 1 patent allowed and 12 patents pending.  The FDA regulates the technology as a Biologic, allowing 12 years exclusivity for a first in class indication – and we are the only technology in clinical trials in our class.  We would like to thank the NIH for its forward-thinking and continued support.  Feel free to stop by NuvOx Pharma’s kiosk in the NIH’s Innovation Zone at BIO San Diego if you would like to learn more.

BIO 2017 Innovation Zone Company Snapshot: NuvOx Pharma

The next big medical breakthrough may start in a small business with a big idea. Recognizing the potential and promise of early-stage companies for addressing unmet medical needs, the BIO International Convention will once again host the Innovation Zone on the exhibit floor of the San Diego Convention Center, June 19-22. Eighty emerging companies will showcase biotechnology breakthroughs in drug discovery, diagnostics, and other therapeutic platform technologies.

The Innovation Zone was created through a partnership with the National Institutes of Health (NIH) and the National Science Foundation (NSF) with the intent to group Small Business Innovation Research (SBIR)-funded companies together on the exhibit floor of the BIO International Convention. The SBIR program provides U.S. federal funding to small businesses engaged in research and development with demonstrated potential for commercialization. Companies are rigorously vetted through the NIH and NSF SBIR review process prior to receiving the funding.

Today we spoke with Innovation Zone exhibitor, John McGonigle, Business Development Associate at NuvOx Pharma, which is supported by NIH’s SBIR program.

BTN: What is your company’s lead product or technology?
NuvOx Pharma is developing a nanotechnology platform of therapeutics to treat life-threatening diseases characterized by hypoxia. The Company has clinical programs in cancer (Phase II), stroke (Ib/II) and sickle cell disease (Phase Ib).

BTN: How has the NIH’s SBIR program helped your company grow?
The NIH’s SBIR program has been instrumental in the development of NuvOx Pharma. For example, our oncology program was started by an NCI SBIR Phase I grant to help us reformulate an EMEA approved ultrasound contrast agent as a stable emulsion for oxygen delivery.  A Phase II NCI SBIR grant supported IND enabling animal studies, and helped us show that the drug can raise tumor oxygen levels to make tumors more sensitive to radiation therapy. We completed a Phase Ib/II clinical trial in brain cancer, and the FDA has allowed our IND for a Phase II clinical trial in this indication. We have applied to the NIH for a Phase IIb SBIR Bridge Award, which would match investor funds to support the Phase II clinical trial. In addition, the Company has received Phase I SBIR/STTR grants to develop nanotechnology products for heart disease (endocarditis and myocardial infarction) and cancer (pancreas and breast).

BTN: What are the upcoming milestones and long-term priorities for your company?
Long term, we recognize that hypoxia can be life-threatening in many medical conditions, including some of the biggest killers in the world such as cancer, stroke and heart attack. We intend to save lives by using our nanotechnology to deliver oxygen to hypoxic tissue more effectively than red blood cells. We have animal data showing improved outcomes in cancer, stroke, myocardial infarction, sickle cell disease, hemorrhagic shock, and traumatic brain injury.

Short term, we have several major milestones coming up in the next year. We are on track to start the Phase II clinical trial in oncology this fall.  We have an active Phase Ib/II clinical trial in stroke and we should have the first randomized data from that trial within the year.  We are on track to start a Phase Ib clinical trial in sickle disease this summer.  The NHLBI has recently funded a study in heart attack in pigs, which could provide the data needed to file an IND for a clinical trial in that indication.

BTN: What do you hope to gain out of your participation at the 2017 BIO International Convention?
We are seeking investors to help us develop our drug assets and corporate partners to help us develop our nanotechnology products.

BTN: Tell us something about your company that investors might not know…
$100M was spent developing the core technology for a diagnostic indication – as an ultrasound contrast agent.  It was used in 2,200 patients, and approved in Europe, but never marketed due to competitive pressures. NuvOx was formed to reposition the technology for its oxygen delivery ability. We have devised new formulations with the support of the NIH.  We have tested the nanotechnology products in multiple models – oxygen delivery and/or therapeutic effect has been shown in 26 peer-reviewed publications, many of which were supported by NIH funding, in particular by the NCI and NHLBI.  We have expanded the IP – and have 5 patents issued, 1 patent allowed and 12 patents pending.  The FDA regulates the technology as a Biologic, allowing 12 years exclusivity for a first in class indication – and we are the only technology in clinical trials in our class.  We would like to thank the NIH for its forward-thinking and continued support.  Feel free to stop by NuvOx Pharma’s kiosk in the NIH’s Innovation Zone at BIO San Diego if you would like to learn more.

#BIO2017: A Peek at Partnering | SPARK

Breaking Buzz is BIO’s newest blog series that reaches across the globe to bring you an insider’s preview into the hottest international and partnering trends coming to San Diego for the BIO International Convention.

Perfecting Translation

Stanford’s translational research program, SPARK, is only 11 years old yet already has funded and supported 148 past and current projects, helped launch 24 start-ups and has had over 30 patents licensed. Spark lays claim to a 62% success rate; measured when a project enters into human clinical trials, or is licensed to a start-up or existing company.

With those kind of stats it’s no wonder Mahima Agochiya, Business Development and Program Manager for SPARK was besieged with meeting requests at last year’s BIO International Convention within BIO’s One-on-One Partnering™ system.

SPARK’s remarkable program – a partnership between Stanford and volunteers from the biotechnology, pharmaceutical, and healthcare investment industries – offers support to an average of 12-15 new projects each year.

Mahima Agochiya PhD, MBA
Business Development and Program Manager
SPARK Translational Research Program at Stanford University School of Medicine

Breaking Buzz sat down with Mahima to chat about the 69 meetings she and her colleagues attended in three days during the BIO International Convention in San Francisco, and asked about her strategy for partnering success.

We know SPARK is a Translational Medicine Program based out of Stanford School of Medicine that seeks partnerships with industry to help translate its projects, and is entering into its second year attending BIO. What kind of partner are you looking for this year?

SPARK is agnostic to indication so we are not limited to specific areas of therapeutics. We generally look for companies that are interested in early stage start-up funding or licensing; or both. The assets/ projects that we are looking to partner with this year are novel, address an unmet clinical need, and are at a stage where they ready for the next step.

There are thousands of companies in the BIO’s One-on-One ™ system representing tens of thousands of assets. How did you narrow it down to 69 meetings?

The first thing I do is add filters. We are mostly interested in companies that license at early-stage since our projects are preclinical at the most, so my go-to filters are “licensing” and “early-stage” for example. I then send out a lot of meeting requests. Perhaps it was because last year was only the first year that SPARK attended BIO, and my first year too, but I was very surprised by the number of invitations we got from other companies. It helps a lot to belong to a university that has a great reputation scientifically and I think people were curious about us, given our success rate.

Can you tell us about that success rate?

SPARK has a 62% success rate on all projects we take in. So far we’ve spun out 24 start-ups; eight licenses to biopharma; four tech transfers without license, and 31 clinical trials – 10 without license. To date we have provided education, mentorship and funding to 148 projects and hundreds of students.

Last year SPARK had 35 projects (assets) that you presented during partnering meetings at the Convention. Did any of those materialize into a licensing opportunity?

Yes! Last year resulted in at least one successful partnership that I will be able to talk about at the Convention this June, and we have ongoing negotiations with other companies we met, most of whom we’ll meet with again in San Diego. BIO provides a great opportunity to get to know new companies and share experiences with them. I think it might be hard to walk away with nothing.

What’s your advice to people new to the Partnering system?

Don’t have a script ready. Instead, open with a clear and concise statement saying exactly what you’re looking for. A half-hour isn’t long enough to delve into details, but rather to quickly ascertain if there is a viable partnering opportunity; so keep the conversation direct at opening, then very flexible. Also, provide all of your materials on a USB. SPARK’s assets are detailed, each on a single page, in one file given on a single USB drive.

Besides partnering meetings, what else is on your Convention calendar?

On Monday from 11:30 – 4:30, SPARK will team up with partners from Massachusetts, Quebec, Philadelphia, San Francisco Bay Area, Oslo, UK Golden Triangle, Catalonia, and the Paris Region to present cutting edge innovations in oncology at the 6th International Cancer Cluster Showcase. Each cluster will present their oncology pipelines in compact 20-minute presentations, so it’s the perfect opportunity to learn about the latest innovations and a great precursor for partnering meetings on Tuesday, Wednesday, and Thursday.

Why did you get an MBA eight years after getting a PhD in cancer research?

The two degrees are actually a perfect combination. After finishing my PhD I did about eight years of basic science which was very rewarding, but also a little heartbreaking because I never saw the work translated. That’s what made me do the MBA – now I get to see all the cool science and get to see them translate – at Stanford University no less. How perfect is that?

Life After Start-Up Stadium: ViRAZE

For the third year, the BIO International Convention will host the 2017 BIO Start-Up Stadium Empowering the Cutting-Edge Companies of Tomorrow, Today – an exciting and interactive experience where investors provide live feedback and judge 5-7 minute pitches presented by start-up biotech companies. The Start-Up Stadium accepts applications from early-stage companies with breakthrough technologies, and invites investors and state and regional affiliates to engage and explore mutual opportunities. Participating companies receive access to BIO One-on-One Partnering™ and educational sessions making their experience at BIO like no other.

Rajiv Khosla, CEO and Co-Founder of ViRAZE

This is the second in a series of guest blogs highlighting Start-Up Stadium success stories as told by former participants. Today we spoke with 2015 Alum, Rajiv Khosla, Ph.D., CEO and Co-Founder of ViRAZE.

BTN: Can you tell us about your start-up?
ViRAZE is an emerging biotechnology company utilizing a patented high throughput screening (HTS) technology to discover and develop new small molecules to treat viral diseases. Our initial emphasis is on viral dermatology diseases that have unsatisfactory treatment options.

BTN: Was the Start-Up Stadium platform able to assist you in gaining visibility?
ViRAZE, a University of Pennsylvania PCI company, was an inaugural presenter at BIO 2015. We presented in front of a “stadium” of about 30 people, plus three seasoned judges. The increased awareness resulted in post-presentation interaction with BioPharma companies and service providers interested in learning more – some of which are proving fruitful today.

BTN: Did you receive constructive live feedback at the Start-Up Stadium from stakeholders and subject matter experts?
For a fledgling company, the benefit of presenting to professionals who provide meaningful critique, and constructive feedback was invaluable. BIO’s Start-Up Stadium is a must do if you are a recent University spin-out or newly emerging Biotech company.

BTN: How have you implemented any feedback to achieve success and continued growth?
Encouraged by our positive experience in 2015, we returned in 2016 and actively engaged using BIO’s One-on-One Partnering™ and Business Forum. This year, ViRAZE was nominated as a “Technologies of Tomorrow” company in the Buzz of BIO competition. Yet another opportunity to raise awareness and potentially secure additional partnerships for ViRAZE.
BTN: Were your BIO One-on-One Partnering™ meetings successful? Did they generate valuable connections with potential for meaningful partnerships?
From my Business Development career in corporate Pharma, BIO One-on-One Partnering™ was the stimulus for at least 65% of licensing deals that our Pharma company consummated. The efficiency enabled ViRAZE to meet with 30 potential partners in the span of three days. Some of these meetings have led to ongoing discussions as well as due diligence to further explore a partnership deal!

BTN: Although no longer eligible to participate in the Start-Up Stadium, will you be returning the 2017 BIO International Convention?
We will be in San Diego – wouldn’t want to miss out on BIO’s Partnering program!
If you are a Biotech company looking to partner-out your asset or a Pharma company seeking to partner-in for your pipeline: the Start-Up Stadium, BIO One-on-One Partnering™, and annual BIO International Convention are essential events in your annual plans.


About: ViRAZE has a proprietary drug discovery platform, which exploits the proteins necessary for DNA replication as novel drug targets, to discover and develop first-in-class small molecules to treat viral diseases. ViRAZE has a lead program for the first and only FDA approved topical drug product to treat the skin disease, Molluscum contagiosum. The program recently secured a $3 million NIH grant for certain IND-enabling studies. ViRAZE is actively seeking investors and partners to file the IND. To learn more, visit: www.viraze.net.

About today’s guest: Rajiv Khosla has had an extensive career in the BioPharmaceutical industry, with experience in Europe, Asia, and the Americas. His most recent corporate stint was VP BD Biovail; since then he has been CEO and Board member at emerging Biotechs, and now a co-founder of ViRAZE