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Category: Therapeutics

FDA issues guidance on conduct of clinical trials during the COVID-19 pandemic

Posted on March 23, 2020 by Jim Jordan

To Our Community,

The impact of COVID-19 on our personal and business lives has been, and will continue to be, significant. New guidance from the FDA specifically outlines how the virus will impact clinical trials, both those that are ongoing, as well as those yet to begin (“FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”).

The State of Pennsylvania Department of Community and Economic Development (DCED) is making resources available to help businesses through this uncertain time through its COVID-19 Resources website.

Being faced with so much unknown, this pandemic has caused disruption, stress, and fear. With the need for new vaccines and treatments, we in the life sciences are tasked with bringing the best and brightest minds together to find solutions. At the Pittsburgh Life Sciences Greenhouse, we are honored to be a part of this effort through our portfolio company, CytoAgents.

CytoAgents is working on an immunotherapy that is easily administered and cost effective, increasing its ability to make a positive global impact. With their oral treatment, the inflammation response that is triggered by a virus will be controlled more effectively. And unlike anti-viral medications, there is no risk of resistance or possibility of not working as the virus mutates. This is revolutionary and exciting, and it brings a sense of hope.

Please be careful, mindful of others, and adhere to the CDC guidelines.

 

Posted in Therapeutics, Uncategorized, Words of Wisdom, Portfolio CompaniesLeave a comment

Meet our Companies: Therapeutics Innovators in the PLSG Portfolio

Posted on July 8, 2019 by Jim Jordan

Meet our Companies: Therapeutics Innovators in the PLSG Portfolio

Healthcare is changing at a rapid pace and technology is one impetus behind the evolution. Organizations like the Pittsburgh Life Sciences Greenhouse have the privilege of supporting and nurturing the innovative companies that are propelling the industry forward into a new age. In our last blog, we took a closer look at the medical device companies we’re working with. We’d now like to introduce you to some the other companies in our portfolio. The organizations in this overview come from our Therapeutics category.

What is Therapeutics?

Simply put, therapeutics deals specifically with the treatment of disease. Several of the companies in our portfolio are currently in pre-clinical and clinical stages of product development. It’s exciting to walk with them on this journey of research, development and trialing their innovative treatments. The innovative entrepreneurs behind these companies are striving to treat a wide range of diseases and disorders.

Complexa

Complexa is a clinical-stage biopharmaceutical company focused on developing a new a new class of drugs to treat patients with severe and life-threatening fibrosis and inflammatory diseases. The company aims to create treatments that will prevent and repair tissue injury, as well as reverse fibrosis and inflammation.

Lipella Pharmaceuticals

Chemotherapy and radiation treatments may create their own collateral damage when used to treat cancer patients. Lipella Pharmaceuticals is developing products that can provide supportive care for cancer survivors with hemorrhagic cystitis. The company also has other urinary bladder conditions products in the pipeline.

Qrono

Qrono Inc, enables medications, patient adherence, patient outcomes and faster time-to-market using an innovative technology to create long-acting injectable formulations.

Sharp Edge Labs

This therapeutics company is developing small molecule drugs for genetic disorders of protein trafficking. The technology Sharp Edge Labs enables the dissection of each step in the lifecycle of a protein in order to better understand the trafficking of the target as well as defects in trafficking caused by mutation.

Cognition Therapeutics

Cognition Therapeutics (CogRX) is developing a small molecule therapeutics targeting the toxic proteins that cause cognitive decline associated with Alzheimer’s disease and related neurodegenerative diseases. Earlier this year, the company published clinical data from its Phase 1 trial of its drug Elayta in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

Knopp Biosciences

Knopp Biosciences seeks to discover, develop and deliver medicines to treat diseases that impose high costs on the healthcare system. Currently their research has led to an investigational compound in clinical development for immunological and hematological disorders, as well as discovery platforms directed to small molecule mediators of epilepsy and neuropathic pain.

Peptilogics

The early-stage biotechnology company Peptilogics is developing systemic anti-infective drugs called Engineered Cationic Antibiotic Peptides (eCAPs). Current pre-clinical data indicate that eCAPS may be effective in treating drug-resistant hospital-acquired infections.

These companies represent just one category of the PLSG portfolio. In addition to these innovative therapeutics companies, we also work with organizations that are shaking things up in the area of Medical Devices, Health IT, Diagnostics, and Bio Tools. You can learn more about those companies here.

Posted in Uncategorized, Portfolio Companies, TherapeuticsLeave a comment

Using Public Disclosures to Prevent Competitive Patents

Posted on August 15, 2018 by Alan West

When does disclosing a secret actually help the secret-keeper?  In the world of patents and patent protection, it can be a key strategy.

Most entrepreneurs understand that an invention must be truly novel to receive a patent.  According to the U.S. Patent and Trademark Office (uspto.gov), an invention cannot be one that has been previously “patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.”

As an example, I once worked at a company that acquired a medical device patent from a physician.  The resulting product achieved rapid market penetration, and the physician inventor received substantial royalty payments – until a competitor discovered that the inventor had described the concept to a group of physicians during a Grand Rounds at a small hospital a few days before he had filed the patent.  As a result, the patent was invalidated, the competitor began marketing a look-alike product, and the company and inventor had to deal with the rather nasty legal business of all the royalties that had been paid.

You have to be especially cautious to not disclose a patentable idea to anyone before filing a patent, unless your audience has signed non-disclosure agreements in advance.  Otherwise, it is considered to be a “public disclosure,” even if it is to one person.

You can, however, use such public disclosures to your advantage.  Let’s say you are a start-up company with a patent covering your first product.  A common defensive patent strategy is to file additional patents covering improvements and line-extensions to your original patent – a tactic known as the “picket fence.”  In this way you create a “fence” surrounding your product, making it much more difficult for competitors to get around your patent.

These new patents are all subservient to your core patent in that they are offshoots of the original and cannot be independently practiced.  As a start-up company, however, you may not have the cash to file all these new applications.  A well-financed competitor, on the other hand, may decide to file patents covering improvements to your product as an offensive strategy.

By filing enhancements to your original patent, they can create bargaining chips to use with you to negotiate a cross license, giving them the right to your original patent in exchange for you to use their patents covering product improvements.  It is a common and effective strategy, but it’s crucial to realize that it can also undermine your company’s competitive advantage.

A simple way to avoid becoming fenced in by a competitor in this way is to publish a description of the improvement in a paper or on your website.  If you are not going to file a patent on the improvement, publicly disclose the idea so no one else can patent it.  In that case your product would still be protected by your core patent.

The Intellectual Property Pyramid Assessment©, a workbook published by the Pittsburgh Life Sciences Greenhouse, will soon be available to order on Amazon. To sign up to get more details please email info@plsg.com.

Posted in Medical Devices, Diagnostics, Portfolio Companies, Therapeutics, Biotechnology Tools, Uncategorized, Business Development, Health IT, Words of Wisdom, ConcentrationsLeave a comment

Why Invest in Nanomedicine? – Continuing the Discussion

Posted on January 16, 2018 by Marissa Kuzirian

By Marissa Kuzirian, Investment Manager, PLSG In collaboration with Fourth River Solutions

Innovations often require backing from those with the foresight to believe in them, and faith is required to overlook the risk associated with innovation. This is amplified in groundbreaking segments without much market validation. Such is the case today with nanomedicine, defined as the application of knowledge and tools of nanotechnology to the prevention and treatment of disease.

Investment activity in nanomedicine has been limited and unpredictable, primarily revolving around nanomedicine applications in oncology. Hesitation among investors may be attributable to the fact that nanomedicine is a non-product segment, meaning that technologies in this space need to be coupled with other attractive assets to provide a complete offering.

As nanomedicine tools and applications mature so will the investment opportunities.

Immunology and neurology are the next forefront of nanomedicine, as early-stage life science companies tackle new ways to approach autoimmune disorders and complicated CNS disorders such as Alzheimer’s and Parkinson’s disease. While investments in nanotechnology in immunology and neurology are still small and scattered, this may grow as nanomedicine enables effective therapeutics for previously intractable diseases.

Nanomedicine can be used as a tool to facilitate controlled release or delivery of therapeutics. This can be as simple as extended release formulations. However, as therapeutics move from blunt force inhibition or activation to a more sophisticated manipulation of endogenous signaling pathways, the question becomes: Can nanomedicine be a vital tool that enables this transformation?

Nanotechnology can deliver cargo to a specific tissue or act as the scaffold for complicated cellular signaling pathways. In this way, we can “tune” the release specifications for specific therapeutic applications.

Cell-therapies are popular because of their delicate and more endogenous manipulation of complex pathways, as compared with systemic administration of small-molecules therapeutics. But cell-therapy can be complex and difficult to control. Nanomedicine provides an opportunity to recapitulate cell signaling in a more precise, regulated fashion that may help mitigate the technical and regulatory complexities of cell-based approaches.

Nanomedicine may be in an early phase, but it is poised for a breakthrough. Risk is always present, as with any high-potential technology. Those with the faith to commit now, however, may be rewarded with significant returns.

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Posted in Medical Devices, Therapeutics, Biotechnology ToolsTagged Nanomedicine

Getting a Handle on Nanomedicine

Posted on December 11, 2017 by Marissa Kuzirian

By Marissa Kuzirian, Investment Manager, PLSG In collaboration with Fourth River Solutions

Imagine a market valued at $135 billion, yet still considered too immature in which to invest. A market that deals in products invisible to the naked eye, yet which can yield incredible advances in human health. That market is known as nanomedicine.

Defined as the application of knowledge and tools of nanotechnology to the prevention and treatment of disease, nanomedicine features applications such as biosensors, tissue engineering, diagnostic markers, and therapeutics. The promise of nanomedicine for the healthcare industry includes enabling personalized medicine, permitting clinical protocols to become more efficient, providing targeted delivery mechanisms and formulations that can cross the blood brain barrier, and enabling novel implant surfaces that can avoid infections.

The nanomedicine global market is currently valued at $135 billion and is projected to increase to $212 billion, $287 billion, and $365 billion by 2020, 2025, and 2030 respectively. These figures derive from the current development pace of products awaiting FDA approval and the major impact of the market associated with anticancer therapies.

Despite this growing global market, investors have held back from committing dollars to nanomedicine to date because the field remains in its infancy and the field somewhat ill-defined. At this point, most activity, technologies, and delivery systems have centered in and around oncology to treat cancers.

North America has captured 45% of the total market, with Europe and Asia Pacific following, at 35% and 15%, respectively. Industry watchers anticipate North America to continue dominating the market for the next five years, while the European market is expected to see the fastest growth rate due to an extensive product pipeline portfolio, an improving regulatory framework, and an increase in European Commission innovation initiatives.

In the U.S., the FDA is still determining how best to evaluate and regulate nanotechnology and as this comes into focus, investors are likely to become more keen to engage.

The truth remains, nanomedicine represents an incredibly diverse marketplace of opportunity and advancement, featuring a variety of products that can be segmented in multiple ways. It has the potential to significantly impact the field of life sciences for generations. Look for additional articles from the Pittsburgh Life Sciences Greenhouse and Fourth River Solutions exploring the future of nanomedicine.

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Posted in Therapeutics, Biotechnology Tools, Medical DevicesLeave a comment

Advances through the Triple Aim

Posted on June 13, 2017 by Marissa Kuzirian

The “Rule of Three” helps organize thoughts and communicate complex ideas simply.  Think “…of the people, by the people, for the people…” or “I came, I saw, I conquered.”  People like to think and act in sets of three.

The Institutes for Healthcare Improvement used this principle to develop its “Triple Aim” approach to optimize health system performance.  The Triple Aim, which has become one of the central tenets of the Affordable Care Act, comprises:

  • Improved Quality of Care
  • Better Outcomes
  • Lower Costs

While these goals may sound obvious and seem simple to meet, many times the ideas that are easiest to say can be the most difficult to achieve.  PLSG hosted a panel discussion during Life Sciences Week, featuring leaders from Knopp Biosciences, Pinney Associates, Attune Pharmaceuticals, and Cognition Therapeutics.  The panel focused on discussing how pharmaceutical innovations can coexist and thrive under the tenets of the Triple Aim.  Some of the ideas generated and discussed during the event included:

Patient-centric development is rising. In one example, a drug designed to treat pediatric epileptic seizures is using patient surveys to understand the degree of side effects parents are willing to accept if the drug otherwise performs well.  This patient-focused development enables companies to bring treatments to the market that positively affect patients with minimal unaccepted risks. (Serves Triple Aim goal of Improved Quality of Care)

Pharmaceutical companies can drive better outcomes for patients by moving away from blockbuster drugs that target huge populations, but that commonly have deleterious side effects.  Instead, these companies should focus on pharmaceutical subsets of patients with clearly defined disease pathways, which would allow for more effective and safer drugs.  Molecular diagnostic innovations can also help pave the way for targeted precision medicine therapeutics. (Serves Triple Aim goal of Better Outcomes)

Innovation is expensive, so lowering costs is difficult.  Innovation that allows patients to control more of their own health care, however, will be important in lowering costs.  Integrating strong patient advocacy groups can help support early-stage development of high-quality, cost-reducing solutions.  (Serves Triple Aim goal of Lower Costs)

Each of these examples represents important changes in the pharmaceutical industry, affecting development of new ideas, research to refine them, testing to improve them, and commercialization to find markets for them.

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Posted in Therapeutics

Life Sciences Equals Economic Development

Posted on May 26, 2017 by Jim Jordan

Life Sciences drives economies, and for western PA it is one of our best contributors to economic development in the form of generating wealth and jobs. Just look at the math.

The term “life sciences” can include biotechnology, pharmaceutical, diagnostic, medical devices, and health care IT products – which make up approximately 40% of health care spending. And our nation’s health care system is projected to be $3.2 trillion by the end of the year. When you do the math, that’s $1.3 trillion in life sciences.  And that’s just the U.S.

In short, success in the life sciences is necessary for prosperity in a region, state, or nation.  We’re not talking about a subjective observation.  This statement comes via cold, irrefutable, objective calculations.  The economic impact of the life sciences industry is simply too big to ignore and too important not to invest in heavily.

Our local universities attract nearly $1 billion of federal funding each year to the region. That means if we were a state, the economic impact of western Pennsylvania’s federal funding for life sciences research alone would rank us among the top 12 states in the country.  That sounds big, and it is.

Lastly, the PLSG and its central role in fostering and advancing the life sciences in this region would not be in possible without foundation support.  Funding from regional foundations can be directly linked to an annual increase in Pittsburgh-area life sciences startups from three companies in 2002 to more than 12 today.  While we always would like to see more funding to support the innovation coming from our universities and entrepreneurs, the fact remains that our local foundations have been invaluable in moving the needle higher.

A high level of cooperation among investors, foundations, university researchers and technology transfer offices, local entrepreneurs, and organizations like PLSG is essential for success.  We must all focus on the same result – to generate economic prosperity, increased jobs, and a higher quality of life for our families, all through a stronger, more vibrant, and ever-expanding life sciences presence across this region.

Posted in Health IT, Venture Capital Perspective, Medical Devices, Diagnostics, Therapeutics, Biotechnology Tools, Capital Investment Programs, Investment Growth Programs, PLSG News, Business Development

It All Starts with An Idea

Posted on May 15, 2017 by Marissa Kuzirian

by Marissa Kuzirian, Investment Manager

Any project begins with an idea, the kernel of a concept that you hope pops into something bigger, something better.

The same holds true for those involved in the life sciences.  A new treatment or device or biochemical breakthrough begins with a simple idea.  It might be to ease patients’ suffering, or to make a surgeon’s task easier and more effective.  It could be any number of things.

And, in more instances than one might surmise, that idea could come from a personal experience or connection.  Take the case of PECA Labs, run by founder Doug Bernstein, as one example.

PECA Labs, begun in 2012 as a Carnegie Mellon University and University of Pittsburgh spin-off, focuses on pediatric and cardiovascular surgical devices.  Its proprietary MASA valve greatly lessens the likelihood of reconstructive surgery later in life for newborns with rare congenital heart defects, like the one suffered recently by the infant son of late-night host Jimmy Kimmel.

Bernstein had a great motivator for delving into research and development of these devices in particular – he had been born with the same kind of congenital heart defect.

“My life was saved, shortly after being born in Los Angeles, by a pediatric cardiac surgeon,” explained Bernstein.  “I only survived because a surgeon had been flown in when another baby, born at the same time, had a congenital heart defect.  When the doctors realized that I needed the same attention, they called the airport and had that surgeon come back to the hospital before flying off.  He saved me, which was so unbelievably lucky because there weren’t many surgeons who could perform that procedure then.

“When I had the opportunity to conduct research and start a company dedicated to addressing this issue, I was eager to do it,” Bernstein continued.  “I had the technical experience, passion, and drive, but right out of school, no business experience. If not for the PLSG and the one-to-one help, guidance, and perspective received from the Executive In Residence program there, we could never have advanced to where we are today.”

And it all started with a simple idea – to save and improve the long-term lives of babies born with the same heart defect Bernstein had.

Posted in Business Development, Health IT, Concentrations, Medical Devices, Diagnostics, Therapeutics, Biotechnology Tools

Just the Facts – Speaking the Language of Funders

Posted on May 1, 2017 by Diana Cugliari

In just about any TV police drama, detectives have a way of cutting through the clutter when interrogating a witness – they want just the facts.  In other words, don’t waste time on irrelevant information or pumped-up descriptions.  Eliminate distractions.  Just the facts.

Startup entrepreneurs can take this same advice when approaching funding sources.  Hopeful business owners may not be as confident in building a case, so a flashy PowerPoint presentation gets assembled to cover their tracks.  Or maybe they overemphasize or underplay the wrong aspects of their pitch, missing the mark in the end.  The potential for disappointment can be enormous.

It helps to speak the language of the people and organizations writing the checks.  Here’s why.

Funders are looking for indications – as strongly and clearly conveyed as possible – that a startup business is more than just a good idea, because an idea is just that.  It doesn’t make money yet.  It’s not real yet.  And it’s not going to get any funding yet.

Funders are looking for certain criteria before they will commit.  Is the business in an industry they typically fund?  Is the financial “ask” within a suitable range to generate the returns the funder expects?  Can the business win in its competitive space, and why, and how?  Can the business prove that others believe in it as much as the entrepreneur?  What has been done already, before receiving additional capital, to prove commitment to the concept – such as development of a working prototype, sales achieved to date, and hiring key talent?

Funders are looking for the right fit.  The business must appeal to some inherent, many times unspoken, intangible that’s important to the funder.  It could be a shared interest in the field that the business addresses, or the markets it will serve, or maybe a personal connection of being fellow alumni of a university.  The business seeking funding certainly must offer tangible, measurable, objective evidence that it’s worthy of financial support.  But the funder also needs to feel good on a subjective level about the decision.

The Pittsburgh Life Sciences Greenhouse works with startup entrepreneurs seeking early-stage funding.  We’ve seen presentations that worked and those that didn’t.  Bottom line – lose the extraneous stuff.  Stick with just the facts.

Posted in Therapeutics, Biotechnology Tools, Business Development, Health IT, Medical Devices, Diagnostics

Private vs Government (Public) Funded Medical Device and Therapeutic Development

Posted on September 13, 2016 by Hank Safferstein

A perfect, unflawed system in any business sector is virtually unachievable, and the biotechnology and therapeutics industries are no exception. Although we are innovating and making strides to end what were once thought of as incurable diseases, we still do not have one single agreed upon way of funding the research and development of drugs and medical devices.

Week after week, new devices and drugs are approved by the FDA, but where does all the money that funds these life science investments come from? Part of it comes from government grants through the National Institute of Health. More specifically, $32.3 billion annually is awarded through nearly 50,000 grants reaching over 300,000 scientists throughout the country. The rest of the estimated $117 billion comes from industry, foundations and other private sectors. And although $117 billion sounds like a lot of money, it only accounts for 0.7 percent of the gross domestic product while the healthcare industry provides 17 percent of the nation’s economy.

A recent U.K. government review stated that the future of research and development funding should be done through the government itself. With a backing from former Goldman Sachs chief economist Jim O’Neill, not only did the research say that it should be funded this way, but that those who don’t participate should be fined. Although this may seem like a good idea, there are many reasons why our current system benefits both private and government industries.

Government Funding Only

A government funded only system sounds like a good idea, but in reality it may take away the drive that pushes many to support the industries. If all of the industry’s money was distributed this way, research studies that may have not gotten a significant amount of money to use would then be awarded funds. Although this may seem like a win-win situation, it would create a much less competitive industry. You would no longer need to be the best, most precise researcher possible, because quite frankly you’d never be given a deserved reward for the service provided.

Private Funding Only

On the other hand, a system regulated only by private funding would be equally detrimental. One good thing that it would create is competitiveness. The best and the brightest would be rewarded for their work, but would they strive to help the next generation like they do now? It would create an industry run by the wealthiest, only trying to help them get richer and solve only their problems. Poverty in our world has already been one of the leading factors of the spread of disease, and if the research and development went private, this issue would only grow substantially. Each newly developed life science products could become a monopoly, similar to what happened when Martin Shkreli, former CEO of Turing Pharmaceutical, hiked up prices on his company’s drug, Daraprim, an antiparasitic commonly used to treat HIV patients. The government side of the industry is what keeps the private in check, just as congress is designed to do for the president.

Finding Balance

The key to addressing the seemingly intractable diseases of our time is to strike the appropriate balance between public and private financing.

For Government, there is simply too much focus on academic science and not enough on small business, one of the major engines of innovation in the drug and device sector.  For example, only a very small fraction of the total NIH funding goes to small businesses through SBIRs, STTRs, UO1s and RO1s.

From the private investment side, while angel investors have stepped up to the plate to fund innovation, venture and strategics have moved away from the risk and created huge funding gaps that, in the end, only hurt them in the long term through a complete loss of innovation in the pipeline.

So how do government and private funders pivot to drive research and development forward? Government funding needs to expand their effort towards funding the science beyond the bench. The private sector funding also needs to modify their investment models to allow for the risk in investing to the research. If both sides are able to support the translational process on the road to commercialization than more funds will become available to life sciences companies thus incentivizing them to research and develop life saving solutions to the public.

Hank Blog Image 2

 

Posted in Business Development, Medical Devices, Therapeutics

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