Belhaven Biopharma

Introducing a Seasoned Regulatory Leader to Belhaven! We’re pleased to announce that Lynn Gold, Ph.D., has joined Belhaven Biopharma as our new Head of Regulatory Affairs. Lynn brings with her 35 years of experience in the pharmaceutical industry, having worked across big pharma, specialty pharma, and pharmaceutical services. Before joining us, Lynn served as SVP of Regulatory Affairs at Impel Pharmaceuticals, where she was instrumental in the regulatory strategy for Trudhesa®, a drug-device combination for acute migraine. Her experience also includes a significant role as VP of Scientific and Regulatory Affairs at Camargo Pharmaceutical Services, where she focused on 505(b)(2) regulatory development strategies. Lynn’s expertise will be valuable as we advance our lead product, Nasdepi®, and explore new opportunities in emergency medicine. Her proven track record in managing global regulatory submissions and her in-depth understanding of drug-device combination products will strengthen our ability to bring life saving therapies to market efficiently and effectively. Lynn holds a B.S. in Chemistry from SUNY at Buffalo, a Ph.D. in Physical Organic Chemistry from the University of Rochester, and completed post-doctoral studies at Duke University. Please join us in welcoming Lynn to the Belhaven team. We’re confident that her leadership will be a strong asset as we move forward. #leadershipdevelopment #leadershipskills #healthcareprofessionals #leadershiptraining #healthinnovation #pharmajobs #newhire #teamgrowth #strategicgrowth #companynews #nextgen

Welcoming a Global Leader in Clinical Operations We’re pleased to announce that Freddy Byrth has joined Belhaven Biopharma as our new Head of Clinical Operations. With 30 years of experience managing clinical research across more than 30 countries in North and South America, Asia, Europe, and Sub-Saharan Africa, Freddy brings invaluable global expertise to our team. Freddy’s international experience aligns perfectly with Belhaven’s mission to make Nasdepi® accessible to patients worldwide, particularly those facing life-threatening allergies and limited access to healthcare. His background spans a range of clinical operations, from early-stage Phase 1 and rare disease studies to large-scale global Phase 3 trials. In his previous roles, including Senior Director of Global Clinical Operations at Nestle Health Science and North American Head of Global Clinical Operations for Aimmune Therapeutics/Nestle Health Science, Freddy has consistently delivered on complex clinical programs. Freddy’s extensive career also includes key positions at ClinTrials Research, Quintiles (now IQVIA), and GlaxoSmithKline (GSK), where he played a crucial role in global respiratory clinical operations. Freddy holds a Bachelor’s Degree in Biology from The University of North Carolina at Chapel Hill. Please join us in welcoming Freddy to the Belhaven team. We’re excited about the impact his expertise will help us achieve. #nextgen #leadershipdevelopment #leadershipskills #healthcareprofessionals #leadershiptraining #healthinnovation #pharmajobs #newhire #teamgrowth #strategicgrowth #companynews

Strengthening Belhaven’s Financial and Outsourcing Operations We’re excited to welcome Patty Williamson, MAC, as Belhaven Biopharma’s new Head of Finance & Outsourcing. With over 25 years of experience in biotech and pharma, Patty brings a wealth of expertise in financial management, contract negotiation, and clinical trial budgeting—skills that are essential as we continue to advance our innovative portfolio. In her new role, Patty will manage the day-to-day financial operations at Belhaven, supporting budgeting and forecasting activities across our portfolio. She will also oversee our outsourcing and contracting activities, ensuring that our partnerships and agreements align with our strategic goals. Patty’s extensive background includes significant roles at ClinTrials and IQVIA (then Quintiles), where she developed deep expertise in clinical trial services. Her experience also includes 16 years at Gilead Sciences, where she served as Senior Director and Head of Clinical Finance and Payments, supporting all phases of clinical trials and therapeutic areas. Patty’s work in developing budget and payment structures at Quintiles and her leadership in clinical finance at Gilead have made her a standout in the field. Patty holds a BA in English Literature from the University of Houston and a Master of Accounting from the University of North Carolina at Chapel Hill. Please join us in welcoming Patty to the Belhaven team. We’re confident that her leadership and experience will play a crucial role in our financial and operational success as we continue to innovate and grow. #leadershipdevelopment #leadershipskills #healthcareprofessionals #leadershiptraining #healthinnovation #pharmajobs #newhire #teamgrowth #strategicgrowth #companynews #nextgen

Our Team is Growing! Welcoming Eric Nickerson as Belhaven Biopharma’s Head of Quality! 🔔 We are excited to announce that Eric Nickerson has joined Belhaven Biopharma as our new Head of Quality. With 25 years of Quality Assurance experience in pharmaceutical and combination product organizations, Eric brings a wealth of expertise that will be valuable to our mission of innovating emergency medicine. Eric's background includes his role as Executive Director of Quality at Indivior, where he contributed to the development, FDA approval, and launch of Opvee® (nalmefene) Nasal Spray for opioid rescue. He has also led Quality functions at Radius Health and several other companies focused on late-stage clinical development and commercialization. Eric holds a BS in Mechanical Engineering and an MBA from Lehigh University. His expertise in nasal product development, Quality Management Systems, GMP compliance, and contract manufacturing QA will help drive Belhaven's mission of making lifesaving allergy medications accessible, effective, and user-friendly. Eric's leadership and experience will be crucial in ensuring that Nasdepi® meets the highest standards of quality and safety as we progress through clinical trials and towards market launch. Please join us in welcoming Eric to the Belhaven team. We are excited about the future and our continued commitment to improving patient outcomes. #newhire #qualityassurance #healthcareinnovation #emergencymedicine #epipenalternative #severeallergicreactions #companynews

Innovation in emergency healthcare hinges on sustainability. Our device partner, Aptar, received their fourth consecutive EcoVadis Platinum status, placing them in the top 1% of over 125,000 companies assessed. This showcases their leadership in environment, labor and human rights, ethics, and sustainable procurement. Aptar's expertise in developing combination products and packaging has been instrumental in creating Nasdepi®, making it both highly effective and environmentally responsible. Their commitment to transform people's everyday lives aligns greatly with Belhaven Biopharma’s mission to provide innovative and impactful healthcare solutions to life-threatening allergies. Congratulations to Aptar and their team (Alex Theodorakis and Badre E. Hammond) on this remarkable achievement. We are excited to continue our partnership and drive forward the future of emergency healthcare. Read more about Aptar’s achievement here: https://ow.ly/ZamC50RQ3LU #Sustainability #Innovation #Healthcare #Partnership #EcoVadisPlatinum #Nasdepi #DryNasalPowder

We are on the verge of a significant breakthrough in treating severe allergies—achieving quicker, more efficient results without the use of needles. It was an honor to share these important findings at Respiratory Drug Delivery (RDD) 2024, alongside my colleagues, Philip Kuehl, Bill Wargin and Brian Taubenheim. Our latest study explores a new approach to anaphylaxis treatment: nasal dry powder epinephrine versus the traditional EpiPen® auto-injectors. 🔬The main takeaway from our study is that nasal delivery of dry powdered epinephrine offers a faster, more effective response in treating anaphylactic reactions compared to the traditional EpiPen® auto-injectors. This could significantly improve emergency treatment for anaphylaxis, a life-threatening condition. Here are our key findings: - Rapid Effectiveness: The nasal (IN) administration achieved maximum plasma concentrations within 5 minutes for all tested subjects, in stark contrast to the traditional intramuscular (IM) method via EpiPen®, where most subjects reached maximum concentration much later. - Increased Drug Exposure: The area under the concentration-time curve (AUC), which indicates the total drug exposure over time, was significantly higher for the nasal delivery method. This suggests that not only does the nasal route deliver epinephrine faster, but it also maintains an effective concentration for a longer duration compared to the EpiPen®. - Potential for Better Patient Compliance: The nasal delivery method, being needle-free, could potentially improve patient compliance, especially among those with needle phobia or difficulty with self-administration techniques. Our study not only challenges existing paradigms in allergy treatment but also opens the door to safer, faster, and more user-friendly options for those at risk of life-threatening allergic reactions. I’ve attached our full poster from RDD if you’d like to take a closer look. Stay tuned for more exciting updates on our research towards revolutionizing emergency allergy treatment. #RDD2024 #HealthcareInnovation #AnaphylaxisTreatment #MedicalResearch #BioPharma #PatientCare

Job Posting Alert: It has been brought to our attention that an unknown recruiter is fraudulently posting positions for Belhaven on LinkedIn. This is the second instance of this happening that we are aware of. We have reported these positions to LinkedIn. Belhaven will announce on this page and our website when open positions are posted. Please be cautious when giving out your information.

Thankful for the opportunity to be profiled locally. Belhaven is proud to be a portfolio company of the North Carolina Biotechnology Center. Their support has been vital as we advance our first product through development.

For decades, the fear of needles has been an all-too-familiar concern, especially for those with allergies who face the prospect of using an EpiPen. The anxiety associated with intramuscular injectables has been a significant hurdle in delivering immediate epinephrine. Since the early 1990s, the process has remained unchanged, leaving many dreading the thought of needle administration. It’s these concerns that have led to an alternative over a decades old injection treatment. We created Nasdepi to address a longstanding concern for many individuals— the fear of needles. For those facing the prospect of using an EpiPen due to allergies, this fear has been a constant companion. Nasdepi is a Dry Powder Nasal Epinephrine that is designed for pain-free nasal administration. It’s an intuitive device with not only faster onset action but simple and pain free to use. Can you relate to the dread of needles? Feel free to share your thoughts in the comments or send me a message if you'd like to learn more about Belhaven Biopharma's development of Nasdepi. #needlefree #allergycare #patientcomfort #healthcareinnovation #painfree

Accessibility to medicine is a huge issue worldwide. In the US, many are fortunate to have access to emergency medications that they can carry or are available from first responders.  This is not the case in most other countries.    Many emergency medicines require administration through a needle, which could be a shot or IV.  In the case of epinephrine and anaphylaxis, diagnosed patients (25% that have attacks were not) may carry an autoinjector for self-administration.  Autoinjectors are expensive, complicated, and have a short shelf-life.  Other conditions need to be treated by trained first responders using needles.  These drugs may not be available due to expense and take valuable time to prepare and administer during an emergency.  It is these challenges to accessibility that led to our formulation of a nasal powder delivered by an easy to use, carry, and store single-use device that outperforms expensive autoinjectors. Belhaven’s nasal dry powder formulation platform provides a patient friendly, economic solution.  The first of these underserved life-threatening conditions we are addressing is anaphylaxis, a severe allergic reaction often triggered by medications, insect stings, or food.    In addition to increasing accessibility, Belhaven’s nasal powders are demonstrating treatment advantages over liquid injectables and nasal sprays. More accessible, easier to administer, and superior performance…there is a lot we are excited to offer to patients.  Our Nasdepi (Nasal Dry Powder Epinephrine) program is in clinical trials and we will share more information soon. Have any of you experienced similar accessibility challenges? I'd be interested to hear your insights and experiences in overcoming these barriers. #MedicineAccessibility #HealthcareInnovation #EmergencyMedicine #PatientCare #PharmaceuticalAdvancements