PHILADELPHIA BIO, the flagship annual event in biomedicine and biotechnologies takes place in the Cellicon Valley on June 3–6 this year.


The new name - Cellicon Valley - has not yet established itself as such a familiar term as Silicon Valley, but the biomedical industry, booming across the Delaware Valley – the states of Pennsylvania, Delaware, and New Jersey – has offered some serious competition to the IT industry in California’s Silicon Valley as a place for innovation and investments. Cellicon Valley (from the word cell) is one of the main biomedical hubs in the world.

Philadelphia, where BIO-2019, the largest conference in the industry, takes place. Photo: Sk.ru

 

Some facts that reflect the scale of the event: 70 countries, over 7 thousand companies, 16 thousand participants, more than 1,800 exhibitors at the exhibition, 18 educational tracks and 220 presentations from companies in 25 therapy areas. Last year the BIO event entered the Guinness Book of Records for the largest number of partnerships at international conferences, with 46,000 one-on-one meetings; this year more than 50,000 such meetings are being planned. The conference program is structured in such a way that the entire first day is devoted to partnering opportunities; the official opening will take place only on Day 2 of the event.

A three-dimensional map of Philadelphia created at the Rowan University's Virtual Reality Center for the Pope's visit in 2015 was designed to guarantee safety during the Pontiff's stay.

The same center also designs three-dimensional maps of the human body, allowing the doctor to literally get inside the patient's body. Photo: Sk.ru 

   

In his video address James Greenwood, President and CEO of the Conference, mentioned that Philadelphia, also known as the City of Brotherly Love (not what you might have thought, just a word-for-word translation from Greek), was the first capital of America after the revolution. Today, though, another kind of revolution is taking place here: the revolution of cell and gene therapy.

During the days of BIO the population of Philadelphia increases by 16,000. Photo: Sk.ru

   

The symbol of Philadelphia is the Liberty Bell, but today a no less significant symbol is the CRISPR technology.

Content-wise, this conference discusses the influence of breakthroughs in genomics on patients’ lives. The talk will be not only about biomedicine however. One of the topics of discussion is politics and how it influences the industry. As the President and CEO of the conference said, “never before has science been so promising and politics – so challenging.”

Philadelphia has been known as the “city of brotherly love”.
But in what other cities would streets be named in honor of Health Sciences? Image: BIO

 

Now another motif that will be perpetually present in every discussion is money: never before has research in biomedicine been so ‘capital intensive’. In 2017 alone, a total of $165 billion US was spent on biomedical R&D worldwide. 

We will talk about this in a bit more detail below, but for now let us discuss why the Skolkovo Foundation continues taking its residents’ companies to BIO year after year.

“We would like Skolkovo startups to become global market players”

“It so happened that the system of compensating for health care and medicine services in the United States, “the richest in the world,” says Kirill Kaem, Senior Vice President of the Skolkovo Foundation for Innovations. “In the US the legislation is such that regulatory bodies or taxpayers do not get to select who to treat – one cancer patient or 10,000 people with influenza. The answer is: both. On the one hand, this makes the United States the most attractive market for developers and for testing new medications, but on the other it also poses certain threats for the health care system.”

“If we want Skolkovo startups to become global players, we will need to begin introducing them to key players on the American market at a very early stage, so that they could build strategic partnerships for the future that would allow them to gain access to the American market and international markets as well.

Being a permanent participant of BIO, Kirill Kaem remembers how three years ago the director of the American National Institute of Health (NIH) told the plenary session of the conference quite frankly, that medical research was a bubble ready to burst at some point in time because you just cannot spend more and more on health care. “This is what is happening now, in many ways due to technological reasons,” the Senior Vice President of the Foundation said. “Research and development are becoming increasingly more specialized; these medications are much more effective and less harmful for the patient. On the other hand, it is not only manufacturers of medications who now know more and more. Regulatory bodies improve the quality of testing of medications, and this in turn reflects on their prices. I do not know how the United States are going to resolve this problem in the near future, but for now the US is a real Klondike for startups. This concerns introducing medications onto the market, attracting money to developing new medications and clinically testing them. Since the FDA is one of the strictest regulatory bodies in the world, whenever the agency approves clinical testing or introduces a medication onto the market, many markets of the world automatically recognize the medication in question as being quite effective. And then, we must note that the American state has also been investing lots of money into health care. The annual budget for development of medications at various stages in the NIH – which is, in effect, state funding – is worth around USD 20 billion.

Kirill Kaem, Senior Vice President for Innovations, Skolkovo Foundation. Photo: Sk.ru

 

“If we really want Skolkovo startups to become global players – and pharmacology is a global industry – we will need to begin introducing them to key players on the American market at a very early stage, so that they could build strategic partnerships for the future that would allow them to gain access to the American market and international markets as well.

As a rule, such contacts with potential buyers of the molecule or a formula are initiated at least five years before the transaction takes place. Company scouts begin monitoring interesting projects long in advance, and they are interested not only in how the molecule proves its effectiveness or safety; they monitor teamwork, publications on the problem, and new people joining the startup. And only after all these trials, years later, the company decides whether to finance the next several stages of development or not, and this process might take from 8 to 12 years. This is why we take our startups to BIO,” Kirill Kaem said.

It must be said here that Skolkovo already has startups that are moving along faster in the US than in Russia. For instance, Myrcludex B by Hepathera Company received the “breakthrough therapy” status from the FDA, which allows to fast-track the registration process of the medication in the US to treat hepatitis D. This is the first-ever medication that treats the previously untreatable Hepatitis D. It is also effective against Hepatitis B. The medication will be introduced on the Russian market by the end of 2019.

Skolkovo in the City of Brotherly Love


Co-creator of Alofanib, Ilya Timofeev Photo: RusPharmTech.

Just two weeks before BIO opened, the Ministry of Health of the Russian Federation issued a permit to hold clinical testing of safety and preliminary effectiveness of Alofanib, the first Russian-made targeted medication. Alofanib will be tested on stomach cancer patients who have already exhausted all standard treatment methods.

The medication was developed by Russian Pharmaceutical Technologies, RusPharmTech, and a Skolkovo resident company. With the help of the Foundation, the company created the first ever allosteric inhibitor of the fibroblast growth factor receptor (FGFR2).

“FGFR2 is present on cancer cells and helps tumors grow,” Ilya Timofeev, co-author of the product, told Sk.ru. “Alofanib binds with FGFR2 on the surface of the cell, and twists the receptor, which suppresses the FGFR2 activity. This action mechanism has been patented by RusPharmTech in Russia, the US, the EU, Japan and China. Preclinical testing results were published in the European Journal of Cancer, Medicinal Chemistry and Investigational New Drugs. These results testify to the need of further study of the medication in clinical research. Participation in BIO 2019 will allow the company to find an international partner for extended clinical trials worldwide.”


Kristina Zakurdaeva, Medical Director, Gero. Photo: Gero.

Another Skolkovo-based company, Gero, which is also taking part in the Philadelphia event, published a breakthrough piece in Scientific Reports a few days before the BIO Conference started. 

Researchers from this Skolkovo-based startup, Skoltech, MIPT and the University of Arkansas for Medical Sciences found a way to reuse the big data on how worm genes work, and discovered that the ageing of nematodes is a partially programmable process which could be interfered into with the help of drugstore medications.

“BIO is a great platform to build new and strengthen existing relationships with foreign partners,” says Kristina Zakurdaeva, Medical Director of Gero. “At the same time, it makes sense not to concentrate solely on partnering: the experience of previous years shows that useful contacts can be established during the educational program and at partnering events.

We need to pay attention not only to networking but also to supporting old relationships: many take time to form, and personal meetings still cannot be replaced with calls or correspondence. The success of an event, in my opinion, depends  on two key factors:

— Precise goals. To make sure you use the opportunity to the fullest, you must set your KPIs and your goals and plan your schedule in advance.

— Precise expectations. There are many meetings taking place, so at the very start it is essential to understand what it is that you are expecting from yourself and your partner during the meeting.

This year we will be working actively on a number of projects, so we are setting very diverse goals: to attract investments, to develop and strengthen partnership relations, find new collaborations.” 


Alexey Klyuchenovich, General Director, Target Medicals Company
Personal photograph.

T

This is not the first time Target Medicals have come to a BIO Convention. “We have taken part not only in this conference last year, but also in satellite conferences in Europe (Bio-Europe) and San Francisco (Biotech Showcase), where we also presented our new products,” General Director of the company Alexey Klyuchenovich told Sk.ru. “We believe that innovative enterprises should not just declare their presence once; they need to be in an ongoing dialogue with the industry, demonstrate their progress, meet new people and look for feedback from potential partners. In addition, being a small innovative company that outsources most of its research, we are constantly searching for contract research organizations that can offer more profitable conditions and a better quality-to-price ratio. This allows us to optimize our costs and expand the volume of the research we do,” he says.



Youssef Hesouani, co-founder and Managing Partner, 3DBioprinting. Photo: 3DBioprinting Solutions.

Another large and successful Skolkovo-based company, 3D Bioprinting Solutions, however, makes its debut at BIO this year. “3D Bioprinting Solutions is a truly unique company, since we conduct our experiments simultaneously in the field of regenerative medicine and in space aboard the ISS (the kind of research the pharmaceutical industry has been interested in for many decades). Additionally, we offer solutions for use of 3D fabric engineering constructs in development of new medications,” co-founder and managing partner of the company Youssef Hesouani said. “This is why we have great prospects for developing fruitful cooperation with research groups from around the world and companies that occupy leading positions in the sphere of biotechnology, pharmaceuticals and other related industries. BIO 2019 provides us an opportunity to maximize the effects of these meetings.” 

A total of 18 Skolkovo-based startups take part in BIO, says Kamila Zarubina, Director for Acceleration of the Foundation’s Biomed Cluster. “This is the largest ever delegation from Skolkovo at BIO,” she says. “We will hold two educational sessions, and have our own stand, which will present new products developed by Skolkovo residents.

 


Kamila Zarubina, Director for Acceleration of the Foundation’s Biomed Cluster. Photo: Sk.ru.

One session is dedicated to collaboration between development institutions in BRICS countries. Kirill Kaem, Senior Vice President for Innovations at Skolkovo will be the keynote speaker at this session. In particular, he will talk about Skolkovo acceleration programs. First row speakers will include two of our startups: Hemopharm and Target Medicals. Both companies have cooperated successfully within the industry, received industry grants, participated in accelerator programs, and have taken part in several BIO events.

The second session is held within the framework of the Country Innovation Hub. This session will allow participating countries to talk about their investment capabilities. Kirill Kaem will serve as a keynote speaker at this session as well.

Skolkovo does not need to pay a cent for taking part in this session: we won the competition and got a great slot, on the first day of the conference, June 4,” Kamila Zarubina said.

What Would Louis Pasteur Says About ‘Anti-Vaxers’?

This BIO conference takes place at a surprising moment, when at the time when better medications and biotechnologies appear every day, developed countries still experience bouts with epidemics of diseases that seemed to have been conquered a long time ago. Measles is back to the US, France, Russia and dozens of other countries. In America, the most serious outbreaks of the disease have been registered in four geographical locations: in Brooklyn, New York, home, among others, to the community of Orthodox Jews; in Washington State on the other side of the country among members of the Russian-speaking community, in Minnesota among immigrants from Somalia, and in Ohio among the Amish, CNN reported. These communities are quite different, but they all have the same background cause: they are all ‘anti-vaxers’, people who consciously choose not to vaccinate.

Quite obviously, this is not a medical problem per se; however, physicians and biotechnologists have to deal with it in one way or another.

These problems, Kirill Kaem says, must be discussed at BIO.

“On the one hand, this might be related to lack of literacy among the general public; in Russia we do have such tendencies,” the Senior Vice President of Skolkovo said. “But then there are more fundamental reasons: they do not concern the concrete case with measles, but instead concern other diseases we thought had been eradicated. New waves of diseases have to do with resistance to antibiotics, while large pharmaceutical companies do not find it profitable to develop new antibiotics.”

“Contacts with potential buyers of the molecule or a formula are initiated at least five years before the transaction takes place. Company scouts are interested not only in how the molecule proves its effectiveness or safety; they monitor teamwork, publications on the problem, and new people joining the startup. And only after all these trials, years later, the company decides whether to finance the next several stages of development or not, and this process might take from 8 to 12 years. This is why we take our startups to BIO.”

A short while before the BIO event opened, a conference in Helsinki introduced the results of a global study conducted by two UK universities in 72 countries, which found that major rivers have been contaminated with antibiotics. Antibiotics in river water were found in 65% of locations where samples were taken. According to the authors of the research project, such contamination poses a direct threat of an epidemic of resistance to antibiotics. Some 10 million people may die before 2050 from this condition, a UN study said. 

Why are these problems important for BIO? “The BIO conference is the conglomerate of large pharmaceutical companies, research institutions and the state; this is why the participants in this event can define quite precisely the problems that worry the society, and declare these problems for the entire conglomerate, including the state,” Kirill Kaem says. “Measles is one such problem.” Last year at BIO many participants talked about the problem of opioid dependence. This is a major problem for the United States. Its existence was recognized at BIO, where a call for action was made, aimed at manufacturers of non-opioid analgesics. This call for action obviously confirms that the state is ready to pay for non-opioid analgesics to help bring down the wave of dependence.

Another storyline that was discussed at BIO was the major social problem of rising prices for medications. Just 3 or 4 years ago, a gigantic wave of black PR - negative reports - hit pharmaceutical companies. They were called greedy abusers of patients who charged gigantic amounts for medications. The participants at the BIO conference that year put forth considerable efforts to explain how much it cost to create new medications, why they are getting more expensive every year, and why regulatory barriers are becoming more expensive as well. This helped bring down the negative wave somewhat.

Obviously, if we get Louis Pasteur level questions asked – to vaccinate or not to vaccinate, and if this is indeed a serious problem, the BIO event can include discussions on this topic and special keynote speeches, too.