Amgen’s Post

Are you in the Life Sciences Eco-system and in the GTA? Here is an event to look into!

Lots of great things happening at UBC; let's connect at Asembia and talk about your patient access needs. -https://hubs.li/Q02rj16m0 #PatientsFirst #Asembia24 #Pharma #PatientSupport

Excited to be representing Rho at #octeastcoast this year! As the clinical trial landscape transforms, I'm eager to showcase Rho's strategic solutions that can chart the course for your successful drug development journey. Are you attending OCT East Coast? Let's connect and discuss how Rho's expertise can help you navigate the complexities of clinical trials and achieve your development goals faster. Comment below or send me a DM!

▪ It was great to catch up with old friends and colleagues, seeing them now in these positions of influence, hugely successful careers, taking ownership, protecting our two-legged and four-legged public. ▪ It was great to connect with FDA in this relaxed setting - instead of during an inspection or regulatory meeting! 😉 ▪ It was also great to meet folks for the first time! The networking opportunities were great, though I did miss quite a few of you! A few take-aways: 🔹 Basic, fundamental GMP issues continue to be seen by FDA across the industry, despite the tools, technology, resources, policy, guidance documents, history of observations, warning letters and enforcement, training, industry groups. 🔹 Bare feet in an ISO-classified suite?!?! 🔹 FDA’s Top Ten Issues cited in 483s have not really changed over 20+ years; rankings have shifted up or down, but it is still the same things 🔹 Similarly, DI (data integrity) is not a new concept. As Dr. Cavazonni said, “Get away from paper.” 🔹 “Reading an SOP is not training” – Alonza Cruse 🔹 “The battle is won and lost at the Supervisor level” – Kevin O’Donnell, (HPRA) 🔹 Have we forgotten about the patient? Have we forgotten who the patient is? Do we not realize we are The Patient? 🔹 “Cost of Quality” Why do we use this term? Why don’t we ever speak of the Cost of HR? The Cost of Supply Chain? of Technical Services? 🔹 Leadership sets the tone: it is the determiner of success. 🔹 Leadership is responsible for issues – whether they know it, or not. 🔹 Training, training, training. Real, intentional, training. Designing your org to be effective over the product life cycle should be your goal, not just for the next quarter’s results. Isn’t there a company out there that can help with this? 🔷 Eliquent – from thought to finish 🔷 Christie Bielinski; Karin Baer; Ileana Barreto-Pettit; Linda Evans O'connor;William (Al) Kentrup; Gerard (Jerry) Greco; Donald Ashley; Grace McNally ; Barbara Clendenen; Carmen C. Araujo; Elaine Shannon; Magaly Aham, MSc, RAC-US; Christina M. Mazzella; Domenic Veneziano; Sumaiya Reza; Zhenzhen Liu; Arlene Wolny; Arie Menachem; Saundrea Munroe; Jerome Chal; Maria McCaffrey; Cathy Burgess; Beth Weinman; Greg Levine ; Darrin Schellin; Brendan Carroll; Ben Wolf; Anthony Fanucci, PharmD, JD; Quality & Regulatory Network; Alonza Cruse; Michelle Toro, ASQ CQA, CSQP; Judy Zdanowicz; ELIQUENT Life Sciences; Eliquent Japan, Inc; Eli Shani; Ori Landau; Kimberly Garko; Jenna McCarthy

Dr. Jörg Duschmalé, board member of Roche, with a 128-year-old family business ownership, presented at our recent High Performance Board sessions IMD. Learn more about the program here - https://bit.ly/49XnCfP As the youngest board member at Roche, one of the largest pharmaceutical companies globally, Dr. Duschmalé emphasised that the governance structure, with the founder’s family ownership, is a key success factor. In a challenging environment, such as an aging population and a growing burden of chronic diseases, family ownership allows for a longer-term approach, rather than focusing on short-term gains. “It is easy to cut R&D, but with our transgenerational view, we choose to do the right things now within the company for the future.” In response to a question on how to prepare for being a board member in family businesses, Dr. Duschmalé expressed appreciation for a less predefined process. It gave him flexibility to approach responsibilities in various ways, especially considering his background as a chemist. Without this freedom, he might have felt constrained by the family legacy. “Be honest, be humble, and be yourself.” With this philosophy, Dr. Duschmalé’s insights illuminate the essence of serving as a board member across diverse governance environments. #imdimpact #highperformanceboards #imdboardcenter #corporategovernance #familybusiness 

Leveraging 6 decades of microbiology knowledge to impact human health and safety in pharmaceuticals, nutraceuticals, food, and cannabis to further amplify the support and impact to the cannabis industry:  https://lnkd.in/gCHYBvzJ #cannabisindustry #cannabismicrobiology #humanhealth #consumersafety #productsafety #cannabisscience

Throwing it back to November's COG West Coast meeting where Oranee Daniels MD shared her experiences outsourcing an early-phase clinical trial to Australia. Check out the key takeaways from her talk on the blog post linked below! #australia #clinicaltrials

Nice to be back on the conference scene and seeing so many familiar faces. If you are here, come and see us for a chat on how we can support the Bioanalysis and Biomarker needs for your clinical trial. #clinicaltrials #clinicalresearch #bioanalysis #COGUK

Congratulations to Dr. J. Jean Cui! With #lorlatinib's PFS reached more than 60 months (the PFS not reached yet, some estimated it could reach 10 years or more) and #repotrectinib's PFS reached 35.7 months, Jean's creativity (she designed both of the two FDA approved #oncology drugs) is helping transform deadly late-stage #cancer into manageable disease for ALK and ROS1 positive #NSCLC. More to come! https://lnkd.in/g4pSvZyC

Thank you for the opportunity to share my journey in entrepreneurship! I had a full table each session and shared my love of LaunchNet Bob Sopko GiveBackHack and Seachange. I also shared with the grad students and postdocs some of the big takeaways I took from my time at CWRU. 1) Get involved with the Postdoc Association and Grad student organizations and get experience in different board settings, including things like Faculty Senate. That helps you prepare for being in those board rooms as you move up in your career. 2) You are learning how to fail and pivot and keep going. Everyday is a new opportunity to try again. 3) Create your own opportunities. I curated an event called Postdocs on the State capitol just so we could go to Columbus and get the experience of talking to our local legislature. Those connections and experiences help me still today. 4) You may not see the end product, but you know you made an impact...however small...along the way. 5) If you stick to your values, you'll know what you need to do and how to stay true to yourself. I love what I am doing and am grateful for all my experiences in grad school, my postdoc, and as an entrepreneur. It also doesn't hurt that I almost died 3 times last year so I don't really have the same level of worry as others on the small stuff.