FDA regulations and change resistance: Change management strategies to overcoming resistance
Operating in a regulatory-constrained environment of biotech and pharma, agility and the ability to adapt to change isn’t just a good idea—it’s essential. For Clinical Ops Leaders, it starts with two ingredients: A solid grasp of FDA’s rules and regulatory framework The ability of your organization to manage and adapt to changes in the regulatory […]
Accelerating data capture: How agile ways of working make an impact
Unless you’ve been living under a rock, you’ve heard of agile. And if you’ve sniffed around, you are probably looking for ways to apply agile in clinical operations. In this article, we will investigate how agility is bringing innovation to clinical operations data capture. We will focus on two areas: Building cross functional data management […]
The Ultimate Checklist for Streamlining Your Clinical Trials in 2024: A Leader’s Guide: Final Strategies
Welcome back to the second part of streamlining clinical your trials for 2024. In this last segment, we’ll uncover additional key tactics that leaders like you can employ to not only navigate the complexities of trial management but more importantly drive your projects towards envy-inducing success. 5. Learning From the Best, Don’t Reinvent the Wheel […]
Transform Your Pharma Leadership: Surprising Lessons from Industry Mavericks
Have you ever wondered how to ignite innovation within your team, attract innovative minds, or take your leadership approach to the next level? You wouldn’t be where you are if you didn’t at some level because this curiosity is shared by many key leaders, especially in the pharmaceutical industry, where innovation is the cornerstone of […]
The Ultimate Checklist for Streamlining Your Clinical Trials in 2024: A Leader’s Guide
The complexity of clinical trials can feel as daunting as the first time you held a Rubik’s Cube in your hand. Unlike removing the colored stickers to match, you don’t have to cheat to streamline your clinical trials. Here we provide you with a secret weapon… the ultimate checklist of 8 actionable processes that you […]
Accelerating drug approvals: When it positively, absolutely has to be there overnight
You know how it feels when you really need something quickly, like an important package? That’s what Fast Track is for in the world of drug development. It’s like express delivery for new medications. When a drug treats a serious disease and there’s nothing else like it, Fast Track helps it zip through the development […]
Beyond Buzzwords: Diversity as Pharma’s Strategic Game Changer
Think about the last time you encountered a truly diverse team – the new ideas and rich perspectives they brought to the table were likely something you still remember to this day like the smell of grandmother’s cooking. Diversity, Equity, and Inclusion (DEI) is a wonderful way to maintain this rich tapestry and encourage innovation […]
Partners in Innovation: How Collaborative Efforts are Reshaping Pharma R&D
R&D in the pharmaceutical sector is notoriously resource-intensive, in other words, it’s expensive! However, there’s a trend on the rise that may disrupt the status quo: collaborative innovation. By teaming up, stakeholders such as research institutions, startups, and industry giants are not just sharing the hefty R&D costs – they are transforming the landscape and elevating […]
Building Trust in Clinical Trials: The Key Role of Patient Advocacy Groups
For any clinical trial’s success, trust is non-negotiable. Patient advocacy groups are at the heart of this trust-building process, serving as vital connectors between pharmaceutical companies and participants. When industry leaders, from executives to managers, engage meaningfully with these groups, they’re not just ticking a box — they’re laying a foundation for transparency and trust […]
Why aren’t more physicians joining clinical trials?
Have you ever wondered why only a slim fraction of physicians are involved in clinical trials? Time: Consider the relentless time crunch physicians face, balancing patient care with their other professional commitments. Diving into clinical trials is like adding another hefty layer to an already full plate. Incentives: Without tangible rewards, be it financial, career […]
Agile pharma marketing: Teamwork principles
Collective Problem Solving: Encourage the whole team to engage in discussions on how to tackle challenges and develop strategies. This collective approach ensures a shared understanding and ownership. While specialization in tasks like data analysis, creative development, or regulatory compliance is necessary, it’s essential that all team members have a say in the overall strategy, […]
Efficiency in Oncology Drug Development: Navigating the Timeframe Dynamics
When we peel back the layers of drug development, focusing in on oncology, an unexpected narrative emerges: It’s commonly believed that developing cancer drugs is a marathon of complexity and time (or if you ask some people, the only marathon that matters). However, a closer look at the data reveals a compelling story: the journey […]
Navigating Participant Enrollment in Oncology Trials: A Comparative Analysis with Non-Oncology Trials
Let’s talk about a challenge that’s turning heads in the world of clinical trials, especially in oncology. Imagine you’re at the starting blocks, ready to launch a phase 2 trial, but here’s the catch: finding and keeping trial participants is a whole different game in oncology. In fact, out of all the hopefuls screened for […]
Fostering Innovation in Business: Defining the key challenges
Innovation stands as a cornerstone for growth and sustainability. It’s not just a buzzword; it’s a critical strategy for companies seeking to stay competitive and agile. This importance is echoed by business leaders globally: 84% of CEOs, agree that innovation is key to their company’s success. However, realizing the full potential of innovation is not […]
Agile pharma marketing: Agile team principles
Autonomous End-to-End Delivery Streams: Structure teams as mostly-autonomous units responsible for end-to-end delivery of marketing initiatives, from strategy development to execution and analysis. Equip teams with a diverse range of skills necessary for handling situations autonomously while ensuring they have the authority to act upon information promptly. This autonomy enhances the team’s ability to respond […]
Patient Retention in Oncology Clinical Trials: A Critical Challenge and Potential Novel Solutions
For every 10% increase in patient retention in oncology trials, a 1-2% increase in the success rate of the trial is experienced. Yet patient dropout rates in oncology trials are some of the highest, with some studies reporting rates of up to 50%1. At this metric, the cost to recruit and replace half of the […]
Making R&D transformation sustainable through leadership transitions
Sanofi recently announced new leadership for R&D. I’ll riff on this announcement to explore why the hire of a key executive ‘to continue the work of the departing key executive’, in the midst of a full on R&D transformation, is both critical and rare. First, let’s step back and familiarize ourselves with the basics of […]
Leveraging innovation to improve clinical study portfolio team dynamics and accelerate delivery
It goes without saying, our industry is extremely competitive. Each study in the pipeline represents billions of dollars at stake, and leaders constantly scan the horizon for innovative ways to shorten time to market and deliver therapies to patients faster. A culture of innovation, improved team dynamics, and an enhanced company culture can collectively accelerate […]
3 Tips to Integrate New ways of Working in Your Study Teams
We work in a complex industry, and the complexity is increasing. Some of the contributing factors are the looming economic uncertainties, ongoing geopolitical conflicts, and evolving workforce dynamics, Leaders are overwhelmed with the burden of keeping their teams motivated and focused to consistently deliver value to their organizations. To address these challenges and distractions, Leaders […]
Aligning competing Pharma R&D priorities
Bill, VP of Clinical Development, entered the room clutching a cup of black coffee. Noticing Charles’s evident distress, he took a deep breath. “Charles,” he began cautiously, “I sense you have concerns with our latest design.” Charles looked up, meeting Bill’s gaze. “Bill,” he replied, “it’s not the design per se. It’s the lack of […]
