KLIFO’s Post

Navigating Europe's complex landscape can be daunting for US biotech and pharma companies looking to launch a new #orphandrug. With 27 countries, 24 languages, and a host of different cultures, healthcare systems, regulations, and reimbursement mechanisms to navigate, that reputation isn’t unreasonable. However, there are several approaches to simplify the process. Discover advantages and disadvantages of the three main options for biotechs entering the European market: 👉 Out-licensing 👉 Going solo 👉 Partnering Explore more at: https://lnkd.in/eP6VsGjD #RareDiseases #OrphanDrugs #MarketAccess #Biotech

⛵ 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻: 𝗧𝗵𝗲 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲 𝗼𝗳 𝗢𝗿𝗽𝗵𝗮𝗻 𝗗𝗲𝘀𝗶𝗴𝗻𝗮𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗖𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀   Today in our fourth video in the series, we look at how important orphan designation is to innovative #biotech companies.   Smaller companies are often the originators of #orphanmedicines and rely on the designation as an important factor in reaching marketing authorisation for their medicine. It has been estimated that capping orphan designation at 7 years, as proposed by the commission could impact 1.9 million #raredisease patients.   ➡️ Find out more here https://lnkd.in/eHZMiaHU

Are you heading to Asembia's #AXS24 Summit later this month? Archbow's Subject Matter Experts and our colleagues from Valuate Health Consultancy and Entrée Health collaborated to create a checklist to help #marketaccess teams prepare for the conference. If you're attending, be sure to join us for a panel discussion on "Optimizing Market Access and Commercialization for New Biotech Product Launches." Details are on the last page of the PDF below. #pharma #biotech

The participation of our Market development lead Farzaneh Norouzi in #bioeurope was an opportunity to meet inspiring people and to reflect on many hot topics in the pharmaceutical sector. We have already mentioned the key learnings about #WomenHealthGap, but other trends discussed that need to be raised are the growing interest in #innovationandvalues among big Pharma’s and the impact of AI, data and #personalizedtherapies in the healthcare sector… Encountering Dr. Matthias Müllenbeck, MBA from Merck and Michael Palladinetti from Sanofi, a need has emerged to thoroughly reflect on the benefits that companies will gain from investing in #newtechnologies and platforms, considering both the importance of differentiation and achieving real value. In this sense, it is important to remain consistent as a company with its #values, without necessarily being blindsided by what is happening in the market. Finally, a captivating speech by Prabhu Velusami, MD of Johnson & Johnson, illuminated the shifting paradigm from assets to platforms and #datasets. The rise of #datacentric enterprises in life sciences emphasizes the crucial need for specialized roles within pharmaceutical companies, serving as integrators to effectively communicate the value proposition of new technologies. In an era of such massive change, it is even more important to stay ahead of the new trends and challenges that are redefining the pharmaceutical industry.  We thank all the speakers who participated in #BioEurope for the inspiring topics discussed and hope to have the opportunity to exchange ideas again.  Please feel free to contact us at: contact@elem.bio for any questions or interest in starting a partnership.

Ultimately, the goal of biotech leaders is to create an innovative product that brings medical value for patients. This cannot be achieved in a single step, and we help biotechs along the journey to reach that goal, structuring the drug development process into a series of clear and reachable value inflection points. Learn more about how we support our biotech clients or connect with our delegates onsite at #SwissBiotechDay: https://lnkd.in/dVAEZRKN #biotech #drugdevelopment

Check out this much needed discussion which is rarely found online. A very informative session by my brother Pratik Shingru, MD MPH PMP BCMAS on health tech, biotech, and pharma. It's rare to find guidance on transitioning to these fields, so don't miss it. And big shout out to RAJASHEKHAR ITTEDI for the great work! Link to the session is below :

I love this message from our Chief Science Officer Jaap V.! It makes clear that whether you have decades of scientific expertise or mid-career or an emerging star in your field, if you want to be part of a global organizational mission and advance public health, you have a place as a US Pharmacopeia Expert Volunteer. That is especially true if you are an expert in biologics. Led by one of US Pharmacopeia outstanding leaders Fouad Atouf, you can apply to be USP Expert Volunteer Committee or Chair in Biologics. We're looking for experts in peptides, proteins, complex biologics, vaccines, and more. Help shape standards that ensure the safety and quality of biological medicines. See below to apply to become a Volunteer Expert Committee or Chair of Biologics. 🧬 #USPVolunteers #Biologics"

At Sciensus, we excel in designing research protocols to capture real-world data, empowering biotech companies to make informed decisions throughout their orphan drug development lifecycle. Our comprehensive support spans: 👉 Clinical study design 👉 Funding submissions 👉 Market access initiatives 👉 Post-market studies 👉 Product evolution strategies Find out more here: https://lnkd.in/gVt-2y49 #RealWorldData #RareDiseases #PatientSupport #OrphanDrugs #PatientInsights #Biotech #Insights

🎙 Podcast alert | After Market Amplia CEO, Dr. Chris Burns, recently joined Susanna Nelson on the Proactive After Market podcast to share his personal insights on the state of drug development in Australia.  Drawing from his extensive experience in the field, including his role in the discovery of only the second Australian-discovered drug to receive FDA approval, they discussed the unique challenges and opportunities facing Australian biotech companies, the importance of fostering innovation, and the path towards successful commercialisation.    Reflecting on the challenges faced by Australian biotech in commercialising assets, Chris points to the need for more funding to support biotech companies through clinical trials and important value inflection points:      “I'd love to see funding schemes supporting companies doing commercially-focused research, and in particular, running clinical trials. There’s a number of funding schemes for academic or early-stage research, but we need those schemes to carry through and support companies as they get into the more expensive end of the process, which is running clinical trials.”    Have a listen 👉 https://lnkd.in/gsJxQ3-9     $ATX #Amplia #innovation #drugdevelopment #clinicaltrial #cancertherapeutics #biotech 

The most advanced regulatory processes for complex biological products have been put in place in many countries to provide appropriate regulatory oversight of biotherapeutic products in general, and similar biotherapeutics in particular. This process is still ongoing and requires regular updates to national regulatory requirements in line with scientific developments and up-to-date standards. For this purpose, strong knowledge of and expertise in evaluating biotherapeutics in general and similar biotherapeutic products, also called biosimilars, in particular is essential. Here, we discuss the World Health Organization’s international standard-setting role in the regulatory evaluation of recombinant DNA–derived biotherapeutic products, including biosimilars, and provide examples that may serve as models for moving forward with nonbiological complex medicinal products. A number of scientific challenges and regulatory considerations imposed by the advent of biosimilars are described, together with the lessons learned, to stimulate future discussions on this topic. In addition, the experiences of facilitating the implementation of guiding principles for evaluation of similar biotherapeutic products into regulatory and manufacturers’ practices in various countriesoverthepast10yearsarebrieflyexplained,withtheaimofpromotingfurtherdevelopmentsandregulatory convergence of complex biological and nonbiological products.