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We invite you to a different conference experience. That's what you can expect from Clinical Leader Forum. Produced by and Life Science Leader magazine, Clinical Leader Forum is focused on bringing together a community that is committed to better trial outsourcing.

Hear our difference, from Clinical Leader Chief Editor and Conference Chair, Ed Miseta.




By Ed Miseta, Clinical Leader Chief Editor and Conference Chair

I was at a conference this past year listening to an executive from a big pharma company outline her involvement with a TransCelerate initiative. The speaker went into great detail about how the working group was established, what goals had been set, and how their work would impact the larger industry. The presentation ended and audience members had a chance to respond. At that point, an attendee stepped up to the mic, noted she was from a small pharma company, and asked how the initiative just detailed would help address the many challenges she faced every day running clinical operations within a company her size. Not surprisingly, it wouldn’t.

This is not an unusual occurrence. I attend a lot conferences and events each year focused on clinical trials. Almost all of the content revolves around high-minded topics. Risk-Based Monitoring? Check. Adaptive Trials? Check. TransCelerate Initiatives, Electronic Health Records, Big Data? Check. Check. Check. While those topics might be interesting for some, I speak to countless executives throughout the year who handle clinical ops for their companies. I always ask about their day-to-day challenges, their biggest struggles. I don’t know that I’ve ever heard anyone mention the lofty topics mentioned above. Their reality is much different. Their reality includes outsourcing trials and trying – to the best of short-staffed and underfunded situations – to manage this unwieldy process.

For the past year, I’ve tried to reconcile this disconnect in my mind. Every person I speak with has a set of challenges that aren’t getting addressed at any of the conferences I attend. I contemplated how to handle this situation. This space certainly doesn’t need another conference similar to what already exists. But, I wholeheartedly believe that professionals in the space would embrace a conference that truly speaks to their challenges. (How do a rate my CRO’s performance? How do I know if I’m getting my CRO’s A-Team? Who’s responsible for change orders? Should I choose a small or large CRO?)

That’s what I’m thrilled to announce: Clinical Leader is producing its first conference – Clinical Leader Forum. It’s focused on how small- and mid-sized pharma can run better clinical trials. How these companies can learn from large pharma. And, what large pharma can learn from their smaller counterparts. As one of our confirmed speakers recently mentioned to me, “There is a lot we can all learn from each other, regardless of whether we are big or small.” It’s going to be in Philadelphia on May 10-11, 2017. I can’t wait to meet members of the Clinical Leader community in person. If I’m going to bring the Clinical Leader community together, then I want to deliver a different experience. Here’s where I think my countless conversations with Clinical Leader readers were invaluable. They helped up me understand how Clinical Leader Forum should be different. Here’s what you can expect:

“Actionable Information” – What is it? Why should I care?
Time lost can never be found. If there’s one challenge faced by every clinical ops person I speak with, it’s that they’re constantly struggling to make more time. Stopping to consume any type of content means taking time away from your primary mission. Therefore, content MUST have real value. Internally, we refer this as Actionable Information. That’s what we strive to deliver in every article we write, and what you can expect in each session at our conference. You will have takeaways. You will scribble notes. You will have follow-up discussions and questions.

Presenters Deliver Expertise, Not Pitches
Solution providers and CROs are incredibly valuable members of the clinical trial ecosystem. But when these folks take the stage at conferences, they’re presentations are driven – at least in part – by self-interest. In some cases, sessions turn into outright sales pitches. “I felt like he was reading information off of his company’s website,” an attendee grumbled to me as we left a session at a recent conference. We hope many vendors and CROs will exhibit their latest products and services at Clinical Leader Forum. And, I encourage you to meet with them and learn how their offerings might help your company. However, don’t expect to see many of these folks on the stage. Instead, our speaker lineup will consist primarily of pharma executives who have struggled the same challenges you’re facing. Our presenter list includes some of my interview subjects and passionate experts. I’m thinking of people like Stephanie Petrone of Novartis, Deirdre Bevard of Nektar, Christine Pierre of SCRS, and David Slade from GSK. You’ll also hear from your peers such as Elizabeth Garner of Agile Therapeutics, Ramon Mohanlal of BeyondSpring Pharmaceuticals, Karen Brooks of Adare Pharmaceuticals, and Molly Rosano of Momenta Pharmaceuticals. You will hear the specifics from large and small pharma on how they solved vexing problems and overcame intractable issues.

Addressing YOUR Issues And Challenges
At its heart, Clinical Leader Forum is designed for executives engaged in the clinical trial process. When it comes to executing clinical trials, many do not have adequate resources and leverage, and cannot afford to throw money at CROs and gee-whiz technologies to make the problems go away. In many cases, the issues faced by these companies can be crippling. Clinical Leader Forum’s agenda addresses the most common challenges I consistently hear. Our session topics range from creating a CRO scorecard to affordable patient centricity to handling overruns and delays. Additionally, attendees will also hear from Dr. Roger Mills and his first-hand tribulations of a mid-sized pharma company bringing a medicine to market. I was so excited when he agreed to participate in Clinical Leader Forum.

I haven’t mentioned the networking opportunities (they will be substantial) or the food (it will be great) or the bar (it will be open). But, you get the idea. We are excited for Clinical Leader Forum. I hope you will be as well. I can’t wait to meet the Clinical Leader community face-to-face and hear about your challenges and successes. Visit the Clinical Leader Forum site to learn more about the conference. Or, contact me directly with any questions or suggestions.

I hope to see you there!

“Diversity is not something that happens by accident. It’s planned, so we need to start where we want to finish in mind. We want to give sites and sponsors any tools they need to help them do that.”
Marsha Henderson, assistant commissioner for women’s health at the FDA, speaking at the 2016 SCRS Global Site Solutions Summit in Boca Raton, Florida.

Ed Miseta, chief editor of and Chair of Clinical Leader Forum, writes about patient diversity in these articles:

Join us for Solving the Problem of a Diversified Patient Pool and continue the conversation during Clinical Leader Forum May 10 – 11 in Philadelphia. Confirmed panelists for this session include Fabian Sandoval, CEO and Research Director, Emerson Clinical Research Institute and Karen Brooks, Senior Director, Clinical Operations, Adare Pharmaceuticals.


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