Helena Tewolde’s Post

Last week Patrizia Cavazzoni announced her retirement as director of CDER. AgencyIQ provides an in depth analysis of what this decision means for industry moving forward.

🚨 What CDER Director Patrizia Cavazzoni’s retirement means for FDA Dr. Patrizia Cavazzoni, CDER's Director, announced her retirement effective January 18, marking the end of an era in drug regulation. This comes at a pivotal moment for the life sciences industry: - PDUFA negotiations start this summer ($1.61B in funding at stake) - Key senior FDA departures creating leadership vacuum - Organizational changes across multiple FDA centers - Upcoming administration transition CDER's next leader will inherit both immense opportunity and unprecedented challenges. With a $2.2B annual budget authority and oversight of most pharmaceutical regulation, they'll shape the future of drug development and approval processes. #RegulatoryAffairs #FDARegulation #Pharma #RegulatoryPolicy #LifeSciences #Leadership

Our New York partner Shireen Barday recently discussed the corporate governance dilemma created by the drug ruling in a decision from the Court of Appeal of the State of California in Gilead Sciences Inc. v. Superior Court, involving Gilead's alleged delay-for-pay business practices, which has drawn significant outcry from all sides.   The public is outraged that Gilead may have delayed the commercialization of a safer drug to maximize profits from the drug it already had on the market. However, businesses in the life science space are outraged that a court in California has upended the well-settled common law rule that a manufacturer can only be held liable for customer injuries if its product was defective in the first place.   The decision, affirmed once on appeal — and now in front of the California Supreme Court — seems to hold that, where a pharmaceutical company has a drug in its pipeline that is safer than another drug it presently has on the market, the company has a duty to commercialize the competing drug with all deliberate speed if there is any indication that the competing drug might be safer or better.   Read the Law360 article below, or via: https://lnkd.in/eH3rGezG   #PallasPartners #LifeSciences #Pharamaceuticals

Revolution begins with questions and answers drive change. I am beyond honored to share that our research has been awarded the Best Research Award at the Research Symposium on Revolutionizing Trends in Pharmacy Practice: Advancements and Future Trends. This recognition is a testament to the relentless curiosity and teamwork that drove our study. Our research, titled "Regulatory Inflection Points: A Quantitative Analysis of FDA Drug Recalls and the Impact of Transformative Policy Changes," sheds light on how pivotal FDA policy changes have reshaped drug safety and quality over the past decade. By identifying the critical junctures where regulation meets practice, we aim to provide actionable insights for the pharmaceutical industry to ensure compliance, innovation, and patient safety. This journey was far from a solo effort. I extend my deepest gratitude to my supervisor, Hina Rehman Ansari, whose wisdom and guidance were invaluable, and to my dedicated team, whose hard work and shared vision made this possible. This achievement is not just a recognition of our past efforts it’s a call to continue revolutionizing pharmacy practice for a safer, more innovative future. #PharmacyResearch #DrugSafety #RegulatoryAffairs #Teamwork #PharmaceuticalExcellence

Hello Good People of LinkedIn, Recently, I've been diving deep into the end-to-end drug development process. This journey has led me to regularly update myself with the latest FDA guidelines and explore their comprehensive website. During my research, I came across a fascinating document detailing case studies of 22 drugs that failed at various stages of clinical trials. These case studies are a stark reminder of the complexities and challenges inherent in drug development. 💡 Key Takeaway: The failure/divergence from expected results of these drugs not only represents a significant financial loss for the companies involved but also impacts their reputation and future research directions. Each failure, however, provides invaluable lessons that drive innovation and improvement in the industry. Attached the same here go through it if you are interested! #ContinuousLearning #DrugDevelopment #FDA #ClinicalTrials #Pharma #Innovation

🌟 We Did It Again! 🌟 Achával Porcario San Juan is proud to be Recommended in Healthcare, Pharmaceuticals & Biotech - Regulatory Law by Leaders League for 2024. A special shoutout to Melisa San Juan for her exemplary work in the healthcare and biotech sectors, which has significantly contributed to this recognition. Thank you to our incredible team for their hard work and dedication, and to our clients for their trust and support. We look forward to continuing to serve with excellence! #HealthcareLaw #BiotechLaw #RegulatoryLaw #LeadersLeague #APSLaw

I am thrilled to have completed the "Prescription Drug Regulation, Cost, and Access: Current Controversies in Context" course from Harvard University. This course has been a valuable journey, deepening my understanding of the intricate issues surrounding drug regulation, affordability, and patient access. The knowledge I’ve gained will not only enhance my skills in regulatory affairs but also allow me to contribute more effectively to the ongoing conversations and solutions in the pharmaceutical industry. I am excited to apply these insights to make a meaningful impact in my field!

Big Pharma is once again under scrutiny. In Louisiana, a recent court ruling protected the 340B program, ensuring that hospitals in low-income areas can continue to provide essential medications at discounted rates. Meanwhile, the industry braces for the "patent cliff," which threatens significant revenue losses as patents expire, prompting a strategic shift towards smaller-scale products. Furthermore, over 800 brand-name drugs have seen price hikes this year, fueling ongoing debates about drug affordability and the ethical responsibilities of pharmaceutical companies. These issues highlight the complex interplay between profit, innovation, and public health.

In the pharma world, innovation and accessibility go hand in hand. But have you ever wondered how pharma companies strike this balance? Meet #patents and market #exclusivity. Patents grant Pharma companies exclusive rights to produce and sell new drugs, vital for recouping the massive costs of research and development. Market exclusivity, on the other hand, provides additional protection, ensuring other companies can't sell similar versions, even after a patent expires. Understanding these concepts sheds light on how drug development and accessibility intersect. Patents incentivize investment and reward innovation, while market exclusivity extends protection, paving the way for more accessible medications. #Pharma #Innovation #Patents #MarketExclusivity #Accessibility #DrugDevelopment #Healthcare

"The Fall of the Big Pharma Empire: Uncertainty Ahead" The pharmaceutical industry is facing a significant challenge in the coming years - the expiration of many lucrative drug patents. This "patent cliff" is creating uncertainty for big pharma companies as they grapple with the loss of market exclusivity for some of their top-selling products. Once these patents expire, generic versions can enter the market, leading to steep declines in sales for the original branded drugs. The loss of patent protection is a major threat to the business models of large pharmaceutical companies. They have become accustomed to enjoying years of monopolistic pricing power that allows them to recoup their substantial innovative startup's bought. But with generics flooding in, they will face intense competition and pressure on pricing. This patent cliff comes at a time when the industry is already facing other challenges, such as increased regulatory scrutiny, public backlash over high drug prices, and difficulties in bringing new innovative treatments to market. The combined impact could significantly disrupt the financial outlooks and growth prospects for many big pharma players. To weather this storm, many pharma companies have tried to pivot towards digital buying skills and attracting professionals without understanding how tech companies behave and what public healthcare needs from technology but also forgetting what patients need ahead. The next few years will likely separate the pharmaceutical winners from the losers as the industry navigates this period of heightened uncertainty, and we are already seeing how some stocks are losing shine. #PharmaIndustry #GenericDrugs #BigPharmaChallenges #InnovationInHealthcare #DigitalTransformation #HealthTech #HealthcareInnovation