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Forum Agenda

Wednesday, May 9, 2018

8:00AM

Breakfast & Networking

 8:00AM - 9:00AM

 

- Ed Miseta, Conference Chair and Chief Editor, ClinicalLeader.com

9:00AM

Welcome and Conference Chair Opening Remarks

 9:00AM - 9:15AM

 
9:15AM

Clinical Trials Are Broken. Here’s What We Need To Do To Fix Them

 9:15AM - 10:15AM

Panel discussion with SCRS, ACRO, ACRP, and APCR. Clinical trials are costly, time consuming, and at times very inefficient. Janet Woodcock of the FDA recently remarked that the clinical trials system is “broken” and there needs to be new ways to collect and utilize patient data. What can the industry collectively do to make the process better? This panel features experts on sites, investigators, clinical professionals, and CROs to discuss the efforts we can take to make trials more efficient. They will address four major problems plaguing clinical trials.

- Christine Pierre, President | Society for Clinical Research Sites
- Robert Hardi, President | Academy of Physicians in Clinical Research
- Jim Kremidas, Executive Director | Association of Clinical Research Professionals
- Doug Peddicord, Executive Director | Association of Clinical Research Organizations
- Greg Koski, President | Alliance for Clinical Research Excellence and Safety (Moderator)

10:15AM

Networking Refreshment Break

 10:15AM - 11:00AM

 
11:00AM

4 Successful Patient Recruitment Strategies You’re Not Using - And Why You Should

 11:00AM - 12:00AM

Every sponsor company has a problem that is common with all of the others: The industry seems to have too many trials and not enough patients. The patient recruitment problem has been around for as long as we have had clinical trials, and is not going away anytime soon. With technology advancements entering the clinical space and empowered patients taking charge of their healthcare options, how can you insure your trials recruit the patients you need? We have four experts willing to share a recruitment strategy that will help you get results.
This session will provide insights on how you can:

- Use social media and geo-targeting to locate patients
- Work with clinical partners and health service providers to find qualified participants
- Use social and digital listening to learn what patients want from your trial

12:00PM

Networking Lunch

 12:00PM -1:15PM

 
1:15PM

Are New Clinical Technologies Improving Your Trials Or Driving You Insane?

1:15PM - 2:15PM

If you work in clinical operations, you are likely subject to the daily calls and emails from vendors trying to get you to buy their latest technologies that will dramatically improve your clinical trials. Some technologies will actually improve the lives of patients and make your trials more efficient. Others will have a significant impact on your job without bringing any new innovation to your trials. So how do we know if a new technology will make your life better or create a nightmare for you to deal with?
In this session you will learn:

- How to best evaluate new technologies
- Which clinical technologies will make your job easier, and which can create more headaches than results
- How you can afford to purchase the technologies you need

2:15PM

Networking Refreshment Break

2:15PM - 3:00PM

 
3:00PM

They’re Doing What? How Poor Communication Can Sabotage Your Clinical Trial Execution

3:00PM - 3:50PM

You design your clinical trial protocol. You prepare your inclusion and exclusion criteria, as well as plans and manuals. And you deliver all of that information to your sites. But somehow the site personnel manage to execute your instructions incorrectly. Where is the communication breaking down and how can you correct it?
In this session you will learn:

- Why your consent form is confusing patients and investigators
- Why sites are simply overwhelmed with information
- How to listen to your sites and know if they are listening to you
- How to ensure your sites are properly adhering to your protocol
- How video, demonstrations, and simulations can eliminate staff confusion

3:50PM

Conference Chair Closing Remarks

3:50PM - 4:00PM

- Ed Miseta, Conference Chair and Chief Editor, ClinicalLeader.com

 
4:00PM

Networking Reception

4:00PM - 6:00PM

Thursday, May 10, 2018

8:00AM

Breakfast & Networking

8:00AM - 9:00AM

 
9:00AM

Conference Chair Opening Remarks

 9:00AM - 9:15AM

 

- Ed Miseta, Conference Chair and Chief Editor, ClinicalLeader.com

9:15AM

Keynote

9:15AM - 10:15AM

How to use leadership, people, and technology to fix a clinical development program that is quickly headed in the wrong direction. Mark Ridge turned around the clinical development program at CSL Behring and will tell you what was wrong, what changes were made, and what the results of those efforts have been.

- Mark Ridge, VP, Clinical Development Operations | CSL Behring

10:15AM

Networking Refreshment Break

10:15AM - 11:00AM

 
11:00AM

Am I Crazy Or Are They? Develop Stronger Contracts And Agreements For Partners

11:00AM -12:00AM

Have you ever had a conference call with a contract partner, hung up the phone and wondered if they are crazy or if you are? Did you not agree on who would perform that work? Did you not agree on a timeline? Did you not agree on what it would cost? So why do we now seem to be so out of sync? If you’re wondering if your partner has lost their minds, the odds are good that you both have.
In this session you will learn:

- How to avoid delays in your clinical trial agreements
- How to ensure nothing is left out of your trial agreements
- How a RACI chart can help alleviate potential issues

12:00PM

Networking Lunch

12:00PM - 1:15PM

 
1:15PM

Navigating the clinical process: What you need to know before you take the next step

1:15PM -2:15PM

Your molecule has shown positive results in pre-clinical studies. You are now ready to move into the clinical stage of your development efforts, and then progress from Phase 1 through Phase 3. Needless to say, your world is about to change. How do you know what challenges will await you, and how to best prepare for them? Our panel of executives who have navigated those waters will share their experiences and lessons learned.
In this session you will learn:

- How to expect the unexpected
- Who you can lean on for the expertise you need
- What you need to do, and when you need to do it
- How to identify partners that will get your study off the ground on time and on budget

2:15PM

Networking Refreshment Break

2:15PM - 3:00PM

 
3:00PM

Partnering with big pharma - Will you hit the jackpot or lose it all?

3:00PM -3:50PM

If you’re a small bio or pharma company and have a molecule that has shown success in Phase 1 or Phase 2, you need to start thinking about that upcoming Phase 3 trial. Phase 3 trials can be large, time consuming, and costly. Scaling up your efforts from Phase 2 to Phase 3 will be a monumental challenge for many companies. To get through the process, small sponsors will look to partner with a large pharma company to help them through the process. But that can be a challenge in and of itself. Sign a deal too soon and you may be giving away a lot of future value. Wait too long and you may end up with nothing.
In this session, our experts will help you:

- Determine the value of your asset
- Determine when is the best time to find a partner
- Know how to negotiate the best deal
- Find the right pharma partner
- Know where to go for guidance/p>

3:50PM

Conference Chair Closing Remarks

3:50PM - 4:00PM

- Ed Miseta, Conference Chair and Chief Editor, ClinicalLeader.com