Global BioPharma, Inc.

Global biopharma company encourages education and awareness around a rare bleeding disorder. FORT LEE, N.J., Oct. 10, 2023 /PRNewswire/ -- Kedrion Biopharma, an international biopharmaceutical company specializing in the production and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, is proud to recognize the fourth Hereditary Factor X (10) Deficiency Awareness Day on October 10, 2023. This day helps bring awareness to a rare bleeding disorder, the patients it impacts, their challenges, and the treatments that can help. Continue Reading Factor X Day was launched on 10/1020 by U.K.-based Bio Products Laboratory (BPL). In 2022, Kedrion joined forces with BPL. The new Kedrion is a global player in plasma derivatives and rare disease medicines, employing more than 5,000 people worldwide. Kedrion Biopharma is proud to recognize the fourth Hereditary Factor X (10) Deficiency Awareness Day on October 10, 2023 Tweet this About one in a million people have hereditary factor X deficiency, which causes unusual or excessive bleeding or bruising, heavy menstrual bleeding in women, painful or swollen joints, nose bleeds, and bleeding gums. Although the disorder is ultra-rare, some patients with severe factor X deficiency could experience life-threatening complications like bleeding in the brain or stomach. Because symptoms vary, patients may suffer for years before being diagnosed. A simple blood test can determine whether someone has the disorder and can be treated with plasma-based treatments. John, one of the oldest known patients with severe hereditary factor X deficiency at age 51, says it best. "Since being diagnosed when I was a year old, I have had to go to the hospital about 150 times for transfusions of fresh frozen plasma to treat bleeds that were not controlled by themselves. As someone living with hereditary factor X deficiency, I want everyone to be more aware of this rare disease and why it is so important to get care and treatment." "We are excited for the first Hereditary Factor X Deficiency Awareness Day since Kedrion joined forces with Bio Products Laboratory in 2022," said Bob Rossilli, Chief Commercial Officer for Kedrion Biopharma. "With over 60 years of combined expertise across the United Kingdom, United States, and Italy, we are delighted to continue raising awareness for hereditary factor X deficiency and providing therapies to support patients, their caregivers, and families on the journey from diagnosis to treatment." Kedrion is committed to providing therapies for rare diseases to improve patients' health as they manage bleeding disorders like hereditary factor X deficiency. To learn more about hereditary factor X deficiency, visit . About Kedrion Kedrion Biopharma is a global biopharmaceutical company that collects and fractionates blood plasma to produce and distribute plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions like plasminogen deficiency, hereditary factor X deficiency, and hemophilia. Its portfolio of 37 life-saving products is distributed in over 100 countries. kedrion.com Contact Information: Sandy Sklareski Communications Manager [email protected] 551-255-6557 SOURCE Kedrion Biopharma

Wolves are fascinating creatures. They are intelligent, strong, and fierce. Many innovators are lone wolves. Many founders are as well. Sometimes the “lone wolf” moniker gets a bad rap, just as founders do. But the best of the lone wolf mythology is found in their independence, individuality, and a passion for a singular vision. These are the most universal and admirable traits of innovators and entrepreneurs. Yet the power of the wolf is found in the real world, not mythology. In the real world, the wolf relies on their pack to survive. In fact, their strategies for the hunt are based on group organization, and the wolf that finds himself alone finds himself hungry. In fact, wolves have been so successful as predators—and therefore feared—largely because they work together so well as a social unit. The notoriety of wolves as loyal, collaborative communicators led to the creation of the term “wolf pack mentality.” As Rudyard Kipling said, “For the strength of the Pack is the Wolf, and the strength of the Wolf is the Pack.” One way a founder can find their pack is by embracing Good Business Practices (GBPs). For the innovator and founder, their pack of trusted advisors allows them to traverse the precarious business landscape unscathed—particularly in the highly regulated world of MedTech. In today’s complex market, GBPs are wolf pack mentality at its best. Relying on them allows the pack to function well. It is not so much a rigid structure as it is a large stable of experts readily available to advise dynamically on strategy and quickly remove any short-term barriers—barriers that can hinder a much-needed product from making it to the patients who need it. With medtech companies often developing solutions for niche-specific clinical needs (read: underserved and/or underrepresented populations), the pack is not a nice thing to have; it is a “must” thing to have. It protects start-ups from failure and ensures that they have the best chance to bring their solutions to market for their benefit and for the benefit of the patients who need them most. What good business practices (GBPs) look like Healthcare is in the business of helping people, often when they are at their most vulnerable. Patients put their lives in the hands of other people and companies that make the products that they use—often when they have no other choice. Within that lies a burden of responsibility. GBPs foster integrity, trust, and treating people the right way. In today’s climate, this is what investors, consumers, and employees are looking for. For most companies and medtech, in particular, GBP happens on multiple levels. On the micro level, it’s more prescriptive (i.e., regulatory best practices or good manufacturing practices). On the macro level, it’s expressed as a set of ethics and principles that govern a company’s conduct. It’s more than a statement of values or marketing strategy; it’s expressed in every decision a company makes and should include the following values. Honesty and transparency Companies that trust their partners and endeavor to be transparent come out ahead, particularly in the highly regulated markets. Companies that don’t often run into avoidable trouble. My team and I have also had to learn (sometimes the hard way) how to identify early on companies that follow GBPs. We’ve worked with our share of companies that lacked transparency in our partnership. This includes an experience we had with an inventor founder who had your typical lone wolf trust issues. Though his lone wolf-ism had created an exciting vision in terms of product and company, six months into our engagement with him, we found out his product didn’t work as presented and we had to pull the launch. If he had been honest with us from the start (instead of thinking he could fix it in time), we could have potentially worked with him to problem solve and to avoid what ended up being a failure. A good question to consider is: How does communication and information flow within the organization and outside of it? What information is provided and how forthcoming is it (i.e., are they sharing ten zipped folders or is it three documents)? Closely held or filtered information is a red flag and may be a sign of an immature leader or company. Takeaway: When it comes to transparency, finding alignment with partners as soon as possible eliminates risk. A culture of collaboration On the opposite end of the lone-wolf spectrum, you will find many companies who understand that operating with GBP is a real value-add. I recently worked with a company with a passionate leadership team who were not the founders of the technology that their company was trying to bring to market. It took them eight years to get FDA approval and because they had been so focused on approval, they were behind on their market access strategy. They asked us for help. After showing us their data and a productive give-and-take, they decided to expand their portfolio into other areas of focus, resulting in earlier approval on the tech and a more robust company. If they had continued unilaterally, they might have missed the opportunities that led to greater expansion of their offering and their company. Having a pack of internal advisors only gets a company so far. It is essential to be able to draw on the expertise of outside consultants and professional service providers. A good question to consider is: How does a company or founder respond to feedback? How willing is a founder to say: Tell me all the reasons this won’t work? Takeaway: Administrative complexity and regulation are systems of inertia, so having battle-tested partners can give you the competitive advantage when it comes to bringing a new product to market. Open-mindedness A challenge for founders and other lone wolves is self-reliance to a fault. No matter how innovative or brilliant a product, founder, or company is, blind spots are called blind spots for a reason. We all have them. Being open to outside ideas may not be the precursor of innovation, but it is the sustaining force—especially in healthcare. I’m not just talking the talk; I had to walk it, too, and I know how uncomfortable it can be. Eleven years ago, when I started my company, I sat down with an advisor and showed them my financials. It felt vulnerable, actually. What was coming? What didn’t I know? But by doing that and being open and trusting, I was able to get unstuck in areas I didn’t even know I was stuck in. It brought greater clarity and propelled me toward success. Consider: How open is this founder or company to new ideas? Are they willing to say, “I never thought of it that way”? Takeaway: When you’re open, doors open, and new opportunities are created. The benefits of GBP (especially for newcomers) There is a flood of new players in the healthcare space, particularly in the direct-to-consumer subscription models. That can be a good thing or a challenging predicament. Many of these players bring innovative thinking but often lack experience operating in the regulated environment of healthcare; this is where the risk is, and this is where GBP delivers its value in spades. When companies build a culture of openness, trust, and collaboration, it shows up in everything they do. It allows for greater innovation while avoiding unnecessary risk.

May 27, 2021 12:00 UTC - Syndicate includes existing investors Vensana Capital and Amgen Ventures joined by new healthcare investor - Amgen Vice President of Research Philip Tagari, joins company’s board of directors CARLSBAD, Calif.--(BUSINESS WIRE)-- GPB Scientific, Inc., a developer of transformative cell processing technology for next generation cell and gene therapies, today announced raising an additional $18 million in capital as part of a previously announced financing, including commitments from existing investors Vensana Capital and Amgen Ventures, and from a new undisclosed healthcare investor. This financing will support expanded placements of GPB’s Curate™ Cell Processing System into partner facilities to enable optimized development and manufacturing in CAR-T and TCR programs, as well as development of the platform’s utility in additional types of cell and gene therapy applications. Conventional bioprocessing solutions for cell and gene therapies are challenged by cost, turnaround time, and scalability as well as suboptimal clinical performance characterized by limitations on cell therapy persistence, potency, adverse events, and applicability to various tumor types. The Curate system utilizes GPB’s proprietary Deterministic Cell Separation™ technology to deliver unmatched recovery, purity, and cell health impacting each of these challenges in bioprocessing for cell and gene therapies. In its first application, the Curate system has been optimized for T-cell isolation and associated downstream handling activities such as washing, concentrating, and exchanges in centralized and decentralized workflows. Additional applications will include optimization for stem cells and other cell types. Early data on GPB Scientific’s Deterministic Cell Separation process confirm substantial improvements in cost, target cell harvest time, and cell quality which enable the pursuit of advanced objectives across operational, clinical, and business-related areas of interest for therapy developers. In parallel with GPB’s progress on the development of the Curate platform, Phillip Tagari, Amgen’s Vice President of Research, has joined GPB Scientific’s Board of Directors. He commented, "The Curate system is poised to be transformative for cell and gene therapies. As the industry works to implement reliable, efficient, and cost-effective systems for the global deployment of these breakthrough medical treatments, GPB has devised an elegant yet powerful solution for cell separation, washing and concentration. The broad potential of this innovation aligns with Amgen's mission to partner with innovators in the fight against serious illness." "In order for cell and gene therapies to achieve their full potential, promising outcomes in hematological cancers that supported recent FDA approvals must be followed by improvements in manufacturing cost reductions, scalability and turnaround time for patients. Moreover, we hope to see continued advances in clinical impact against solid tumors and other indications for cell therapies. These advances will require creativity and execution from the drug developers, but in almost every case, can be aided by bioprocessing enhancements that yield more and healthier cells that are collected more efficiently,” said Justin Klein, M.D., co-founder and managing partner at Vensana Capital. "In a field where the process is the product, we believe GPB Scientific’s Curate Cell Processing System can confer a significant competitive advantage for cell and gene therapy companies and a much needed solution to scaling production to meet global demand." "We are pleased to see that our progress over the past year has been recognized by our existing partners and by new, important sponsors that share our vision for advancing therapies,” said Mike Grisham, CEO of GPB Scientific. “Our groundbreaking cell processing capabilities will enable next-generation medicines that are more consistently produced, at lower cost, for more patients and for additional conditions. We are proud to expand our efforts with this increased funding to deliver on our promise and to play our part in the enabling the development of new treatments for intractable disease.” About GBP Scientific GPB Scientific is a pioneering biomedical company realizing the promise of its Curate Cell Processing System. The Curate solution applies Deterministic Cell Separation (DCS™) technology, through a benchtop system and single-use cartridges that are currently optimized for T-cells. Designed with both manufacturing and clinical potential at the forefront, Curate™ delivers the scale and performance required to advance CAR-T and TCR applications beyond their limitations today. GPB works with leading biopharma and biotech companies, cancer centers, research institutes, and universities to advance the technology within and beyond this space, with future releases targeting additional cell types, use cases, disease states, and workflow paradigms. Learn more at or contact inquiries@gpbscientific.com About Vensana Capital Vensana Capital is a venture capital and growth equity investment firm dedicated to partnering with entrepreneurs who seek to transform healthcare with breakthrough innovations in medical technology. Launched in 2019, Vensana is actively investing in late development and commercial stage companies across the medtech sector, including medical devices, diagnostics, drug delivery, digital health, and tech-enabled services. Vensana’s investment team has a history of successfully partnering with management teams behind industry-leading companies including Cameron Health, CardiAQ, Cartiva, CV Ingenuity, Epix Therapeutics, Inari Medical, Intact Vascular, Lutonix, Neuwave Medical, Sequent Medical, Topera, Ulthera, Veran Medical Technologies, and Vertiflex. Learn more at About Amgen Ventures Established in 2004 as Amgen's corporate venture capital arm, Amgen Ventures identifies and invests in emerging companies and technologies to advance promising new medicines and solutions to healthcare's biggest challenges. Amgen Ventures has committed $625M to invest in biotechs focused on human therapeutics and drug discovery as well as MedTech, such as digital health platforms, data analytics, and value-based approaches. Learn more at