ContraFect Corp’s Post

Greetings LinkedIn network, Unexpectedly losing your job sucks, obviously...(none the less when you find out while on conference travel where you have been professing the scientific achievements of your company in its fight against antimicrobial resistance). Receiving no severance hurts but such is life in biotech. Losing your team sucks too...My experience with my CF team colleagues was great from top to bottom and across all groups. They were diligent, inspiring, and supportive. Team chemistry is indeed priceless. Being said, the biggest disappointment in this situation is the loss of hope for current and future patients who are still in need of treatments that are not yet developed. We had promising molecules in the clinic and more on deck and it seems they will be abandoned. On the same day I was let go, I picked a buddy up from the airport and asked for the normal life updates. He said he just lost a friend due to sepsis from a drug resistant microbe. It seemed cosmically twisted given the timing of the situation. I write this post to my LinkedIn network and colleagues as a plea that if you or someone you know works in this space, or is in a position to influence funding, support, or legislation, please keep up the fight. Keep the conversation going on the need to for the advancement of treatment against drug resistant microbes. Don't let the bugs win! p.s. If you need a toxicologist, call me. Stay well everyone!

Hey Everyone! Big News!! I'm beyond excited to kick off something special today – the launch of Pharma Catalyst! This isn't just another page; it's a space where we can dive deep into everything pharmacy-related and geek out together! 💊 So, what's on the agenda? Well, think of this as your go-to spot for: - Staying in the loop with the latest industry buzz, - Navigating those regulatory waters like a pro, - Getting the lowdown on meds so you can make informed decisions, - Unpacking clinical stuff in a way that makes sense, and - Boosting your career game with some killer advice. Together, we're going to spark ideas, push boundaries, and maybe even shake things up a bit! But hey, that's the fun part, right? I can't wait to hear your thoughts and share some awesome insights with you all. Don't forget to hit that like button, drop a comment, and spread the word – the more, the merrier! Here's to new beginnings and endless possibilities! Catch you in the comments! Cheers, Pharma Catalyst #PharmaCatalyst #Pharmacy #NewBeginnings

There are two types of biotech leaders. Email response from a CEO of a preclinical biotech yesterday morning: "We're in preclinical so quality isn't a concern for us right now". 🙄 Chat with a founder of a similar sized preclinical biotech yesterday afternoon: "We want to bring in quality early as we don't want to have problems in GMP as we scale". ✅ When CEO's and Founders integrate quality early in development, whether it be through consultants or full time quality head, you're avoiding issues AND unnecessary costs later down the line when you scale. You're catching the problem early before it causes irreparable damage.

The biopharma sector is in the midst of huge change. New approaches to leading and managing product development need to emerge and the requirement for project managers to build networks, engage cross functionally and find new constellations will become more evident. In advance of our Mannaz open event on June 14th, Pete Harpum and I put some thoughts together on what this change might mean for the industry and how the sector might need to adapt as a response. https://lnkd.in/eMXuPyin

In other words: Quality by Design

Product development plans should align with your goals, budget, and resources. . At Facet, we specialize in: . . ·      working exclusively with small organizations including commercial and non-commercial start-ups, academic developers, health care specialty centers, and physician-innovators ·      nimble, innovative, and entrepreneurial “right sized” regulatory strategies ·      securing special regulatory assets (e.g., orphan designation, breakthrough therapy designation) to progress development and add business value ·      providing reliable and trusted practical and strategic support, not simply process related advice or corrective guidance #biopharma #regulatoryaffairs #productdevelopment Bob Keith Ken VanLuvanee Lisa Jenkins VanLuvanee

After experiencing a number of challenges internally during the year, eventually the C-Suite, SVP's, VP's & Global Heads of Biotech and Pharma may need solutions to counteract them. The biggest villain is procrastination but everyone wants to save time...can you help them take action with some of their issues? - Building frameworks for overall development plans. - Accessing supportive integrated technology platforms for their trials - Complexity of scientific data across the organisation scattered across locations and formats from small teams on standalone projects. - Integrating contextual and fact based external data from collaborations and CRO's. - Minimising the burdens of study participation for patients and their families - Moving away from mixed vendor models to simplify operations to contain costs. - Analyzing high-throughput screening data - Overcoming patient barriers with mistrust, stigmas of participation and inadequate communication being mentioned. - Succession of project managers and CRA's Proventa International - Save the dates and get in touch to see who's confirmed so there is no blind leap of faith! Understand the problems, provide the solutions and lay foundations for partnerships. Less than 20 days to go... #pharma #biotech #cro #newjersey #clinicaltrials #ClinicalResearch #bioinformatics #IT #DrugDiscovery #Biology #MedicinalChemistry #Proventa #thoughtleadership #LifeSciences #drugdevelopment #decentralizedtrials #diversityandinclusion #DEI #healthcare

Navigating the regulatory aspects of the healthcare industry, especially with the rapid emergence of artificial intelligence, remains a complex challenge due to the lack of a comprehensive regulatory framework. In the next episode of The Doc Suit , Sharan Jhaveri △🦦🎙️ and I will explore the various regulatory issues that startups and businesses encounter in this evolving landscape. Join us as we unpack these challenges and discuss strategies for navigating them effectively.

After experiencing a number of challenges internally during the year, eventually the C-Suite, SVP's, VP's & Global Heads of Biotech and Pharma may need solutions to counteract them. The biggest villain is procrastination but everyone wants to save time...can you help them take action with some of their issues? - Building frameworks for overall development plans. - Accessing supportive integrated technology platforms for their trials - Complexity of scientific data across the organisation scattered across locations and formats from small teams on standalone projects. - Integrating contextual and fact based external data from collaborations and CRO's. - Minimising the burdens of study participation for patients and their families - Moving away from mixed vendor models to simplify operations to contain costs. - Analyzing high-throughput screening data - Overcoming patient barriers with mistrust, stigmas of participation and inadequate communication being mentioned. - Succession of project managers and CRA's Proventa International - Save the dates and get in touch to see who's confirmed so there is no blind leap of faith! Understand the problems, provide the solutions and lay foundations for partnerships. Less than 20 days to go... #Pharma #Biotech #CRO #Boston #ClinicalTrials #ClinicalResearch #Bioinformatics & #IT #DrugDiscovery #Biology #MedicinalChemistry #Proventa #ThoughtLeadership #LifeSciences #DrugDevelopment  #Decentralizedtrials #Diversity #DEI #Healthcare

"Fit for Purpose" That's how we referred to our Translational Research and Early Clinical model at Takeda. We were transforming early phase clinical into a more lean, Innovative, Engine, To determine safety and proof of mechanism early. And often. This meant the old model or later phase model didn't work for us. Governance needed to be faster. Protocol creation needed to be faster (with quality), and our CRO model needed to fit. Not all CROs are created for fast, innovative development. Is your CRO agreement fit for your purpose? Is it too complex for your needs in early stage development? Is your CRO the right fit? Are you clear on how long systems and changes take to adapt to your needs? I do. My strategic advisory and oversight model is fit for your purpose too. And, it's customized to your needs. Not a one size fits all. Because you and your asset are unique. Let's connect.