Gedea Biotech AB

Gedea söker QA Director Är du vår nya kollega? Vi söker nu en QA Director till vårt trevliga team i Lund. https://lnkd.in/dr49RvKt

Gedea Biotech is developing a treatment for vaginal infections that actually works, meaning an effective, antibiotic free and safe treatment for vaginal infections that treats the infection and minimizes the risk of recurrence. Meet one of our colleagues, Sten Kornfält, Clinical Project Manager What is your role at Gedea? I have been with Gedea for five years now and I’m responsible for our clinical investigations. Together with the team at Gedea I plan and design the investigations, and when the clinical projects are ongoing, I also manage them together with our CRO (Clinical Research Orgionization). When the studies are completed, I’m involved in the evaluation of the results.   What previous positions have you had? I have long experience working with clinical trials at different CROs, both as a Clinical Research Associate and as Project Manager.   What makes your job particularly meaningful? BV and VVC are huge burdens for many women and our product will make a difference for them. The product is safe and helps the microbiome to restore in a natural way. To help document this product and make it available on the market feels very meaningful.   Is there anything that is frustrating and testing your patience in your work? Clinical investigations take a long time to complete, and there are a lot of hurdles. Solving the problems is however also stimulating.   What is the next milestone or achievement in your work at Gedea? Gedea Biotech has a comprehensive and ambitious clinical program. It is important for us that the advantages of our product are thoroughly documented. We also want to understand what is happening in the vaginal microbiome in women that have BV or VVC, and how our product may positively alter the conditions that have caused the infections. The next milestone will be the completion of NEFERTITI-2 study in bacterial vaginosis. 

Gedea Biotech is developing a treatment for vaginal infections that actually works, meaning an effective, antibiotic free and safe treatment for vaginal infections that treats the infection and minimizes the risk of recurrence. Meet one of our colleagues, Per-Ola Forsberg, Chief Financial Officer   How long have you worked with Gedea? I started quite recently so only from April this year What previous positions have you had? I have 30 years of experience in pharmaceuticals and biotech industry and previous assignments include roles such as CFO at Idogen, LIDDS, Lund University Bioscience and Probi. At Probi, I was for a time vice president, with responsibility for the company's business operations. I have previously also held positions such as controller at Rexam Beverage Can Fosie and Head of Administration at PolyPeptide Laboratories, a subsidiary of Ferring.   What makes you feel meaning in your work? To be part of a development company with the aim of improving people's health. I think, if we do not make these efforts, possible interesting products will never reach the shelf and become available to patients or consumers. It gives me an energy to be involved in driving development companies forward.   Is there anything that is frustrating and testing your patience in your work? Clinical results and optimal product design are both moving targets, since demands from the market can vary and change over time. We have to be on our toes to keep up with these changes to have a strong offer.     What is the next milestone or achievement in your work at Gedea? From my point of view, MDR approval and thus CE marking for Europe is the next big milestone for Gedea Biotech and along the way results in our ongoing clinical trial support these approvals.

By overlooking women-led ventures, we’re missing out on big economic gains. Rosario Dawson reminds us that when it comes to investing in women, the returns are big. 📈 A powerful conversation at this year’s Global Inclusive Growth Summit hosted by the Mastercard Center for Inclusive Growth. #GlobalIGS

Gedea Biotech is developing a treatment for vaginal infections that actually works, meaning an effective, antibiotic free and safe treatment for vaginal infections that treats the infection and minimizes the risk of recurrence. Meet Annette Säfholm, CEO of Gedea Biotech     I work as the CEO of Gedea since close to 8 years back. I was happy to join the team of founding reseachers already when Lund University Holding came in as the first investor.   What previous positions have you had?   Before joining the Gedea team, I worked with at Idogen AB- that developed an autologous cell therapy for treatment in hemophilia and transplantation and at Reccan Diagnostics – developing an ivd to diagnose pancreatic cancer at an early stage from a serum sample. I’ve also worked with project management in regional healthcare, as a publisher in medicine at Studentlitteratur and during my PhD with developing WNT Research’s peptide to inhibit cancer metastasis.   What makes your job particularly meaningful? Several times a month, frustrated, sad and desperate women contact us, telling us their story about having tried all products available on the market over and over again, and not being helped with their constant vaginal infections. I am deeply motivated by that we are making a change in the women’s health field, in shedding light on conditions which truly deserves better treatment alternatives.   I am also optimistic that the tools available today in microbiome and the brilliant research done by several groups in this field, eg Ina and Ravel, just to mention a few, will lead to a better understanding of the disease in the near future and with that improved possibilities to treat and prevent the diseases.   Is there anything that is frustrating and testing your patience in your work? It frustrates me to see that no breakthroughs has been made in treating vaginal infections for 40 years – women are still left with the same type of antibiotics and antimycotics as my mother’s generation used back in more than 40 years ago, with their limitations in side effects, recurrences etc. Women deserve better treatment alternatives than that and I hope Gedea will be able to contribute.   What is the next milestone or achievement in your work at Gedea? I look very much forward to reaching European approval and to teaming up with women’s health focused companies establishing partnership for launching the product and further regulatory development to reach approvals in regions outside of Europe.  

Gedea Biotech is developing a treatment for vaginal infections that actually works, meaning an effective, antibiotic free and safe treatment for vaginal infections that treats the infection and minimizes the risk of recurrence. Meet one of our colleagues, Annamaria Bontidean, student assistant   What’s it like to be a student assistant at Gedea? I am a student assistant with a strong biomedical background. I started working at Gedea at the start of 2024, eager to gain insights into the life sciences industry and join an innovative company with a focus on women’s health. This medical area has been a passion of mine for many years, driving my academic and professional pursuits.   What is the next milestone or achievement in your work at Gedea? Looking forward, I am excited to continue working with this amazing team alongside my master’s in bioentrepreneurship to learn more about advancing healthcare solutions, fostering innovation, and contributing to groundbreaking projects that improve women’s health globally.

Gedea Biotech is developing a treatment for vaginal infections that actually works, meaning an effective, antibiotic free and safe treatment for vaginal infections that treats the infection and minimizes the risk of recurrence.   Meet one of our colleagues, Anna-Karin Areskog, QA/RA Director What is your role at Gedea? I am consultant from QAdvis AB, working at Gedea Biotech as QA/RA Director since beginning of 2023. I started at Gedea 2022 as project lead of tech transfer, and has worked with both pharmaceuticals and Medical Device as a consultant since 2013 within validations, QA and RA.   What previous positions have you had? QMS, GMP, ISO standards, regulations, IVDR and MDR is my everyday life and I also hold courses in some of these areas. What makes your job particularly meaningful? Or testing your patience? The satisfaction for me is to see that the developed products reach the market, the innovations for new and updated products may help and make it easier for so many people. At the same time, the frustration becomes great when it turns out that something is not what it seemed to be or that the documentation needs to be supplemented even thought it was perfect from our perspective.   What makes your job particularly meaningful? Gedea gives me faith that women with bacterial vaginosis will become symptom-free without antibiotics. I am now looking forward to, after summer and vacation, the challenges to complete the product and documentation for CE-mark and release to the market.

Gedea Biotech is developing a treatment for vaginal infections that actually works, meaning an effective, antibiotic free and safe treatment for vaginal infections that treats the infection and minimizes the risk of recurrence. Meet one of our colleagues, Sten Kornfält, Clinical Project Manager What is your role at Gedea? I have been with Gedea for five years now and I’m responsible for our clinical investigations. Together with the team at Gedea I plan and design the investigations, and when the clinical projects are ongoing, I also manage them together with our CRO (Clinical Research Orgionization). When the studies are completed, I’m involved in the evaluation of the results.   What previous positions have you had? I have long experience working with clinical trials at different CROs, both as a Clinical Research Associate and as Project Manager.   What makes your job particularly meaningful? BV and VVC are huge burdens for many women and our product will make a difference for them. The product is safe and helps the microbiome to restore in a natural way. To help document this product and make it available on the market feels very meaningful.   Is there anything that is frustrating and testing your patience in your work? Clinical investigations take a long time to complete, and there are a lot of hurdles. Solving the problems is however also stimulating.   What is the next milestone or achievement in your work at Gedea? Gedea Biotech has a comprehensive and ambitious clinical program. It is important for us that the advantages of our product are thoroughly documented. We also want to understand what is happening in the vaginal microbiome in women that have BV or VVC, and how our product may positively alter the conditions that have caused the infections. The next milestone will be the completion of NEFERTITI-2 study in bacterial vaginosis. 

Gedea Biotech AB is based in Lund, Sweden meaning we will celebrate Swedish Midsummer on Friday, June 21st. Pickled herring, strawberries, outdoor activities and the midsummer pole are key ingredients. We wish all colleagues and partners a happy Midsummer, wherever you are!

THE WOMEN’S HEALTH GAP Research in women’s health primarily focuses on diseases with high mortality, overlooking diseases leading to disability. Many gynecological conditions are neglected because research and investment focuses on saving lives rather than adding healthy years to lives. As pointed out in the report by McKinsey Health Institute: “In all, when tackling women’s health, the solution is not to divide more slices of one pie: it’s to make more pie.” At Gedea Biotech AB, we know that many women spend years, literally, with recurring vaginal infections and even more time worrying about the next episode of BV or fungal infection. Our aim is to decrease years spent with debilitating gynecological conditions. Source: Closing the women’s health gap: A $1 trillion opportunity to improve lives and economies by McKinsey Health Institute and World Economic Forum https://lnkd.in/gfP-2Vsa #femtech #closingthegap #womenshealth #gedeabiotech #innovation #amr