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Forum Agenda

Wednesday, May 9, 2018

8:00AM

Registration & Exhibit Hall Open. Breakfast & Networking

 8:00AM - 9:00AM

 
9:00AM

Welcome and Conference Chair Opening Remarks

 9:00AM - 9:15AM

- Ed Miseta, Chief Editor and Conference Chair | Clinical Leader, Clinical Leader Forum

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.

- 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
- Christine Pierre, President | Society for Clinical Research Sites
- 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 - 12:00PM

There are some challenges that are common to all sponsor companies. Patient recruitment is one of them. With the increase in studies we have seen in recent years, 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 sponsors are in need of solutions that will help them overcome this hurdle and speed study start-up. 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 patient-centric recruitment strategies that will get results.

- Michelle Berg, VP, Patient Affairs & Community Engagement | Abeona Therapeutics
- Karen Correa, Senior Director Clinical Operations | Adare Pharmaceuticals
- Theresa Devins, Sr. Associate Director Clinical Operations | Boehringer Ingelheim
- Mary Rose Keller, VP Clinical Operations | Heron Therapeutics
- Dave Taylor, Sr. Dir., Head, Research Dept. | Inspire (Moderator)

12:00PM

Networking Lunch

12:00PM - 1:00PM

 
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 you know if a new technology will make your life better or create a nightmare for you to deal with?

- Walter Boyle, Sr. Dir., Biostatistics & Programming | Synteract
- Michael McKay, Global Trial Leader | Janssen Pharmaceutical
- Fabian Sandoval, CEO and Research Director | Emerson Clinical Research Institute
- Rangaprased Sarangarajan, SVP & Chief Scientific Officer | BERG Health
- Gary Gentry, Executive Dir. | Cirrus Clinical Services (Moderator)

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?

- Leesa Gentry, Director | Otsuka Pharmaceutical Development and Commercialization
- Mary Rose Keller, VP Clinical Operations | Heron Therapeutics
- Bari Kowal, Global Head, Clinical Trial Management | Regeneron
- Stephanie Petrone, Head, Clinical Operations | Loxo Oncology
- Laurie Halloran, President & CEO | Halloran Consulting Group (Moderator)

 

3:50PM

Conference Chair Closing Remarks

3:50PM - 4:00PM

 

- Ed Miseta, Executive Editor and Conference Chair | Clinical Leader, Clinical Leader Forum

4:00PM

Networking Reception

4:00PM - 6:00PM

 

Thursday, May 10, 2018

8:00AM

Registration & Exhibit Hall Open. Breakfast & Networking

8:000AM - 9:00AM

 
9:00AM

Conference Chair Opening Remarks

 9:00AM - 9:15AM

 

- Ed Miseta, Executive Editor and Conference Chair | Clinical Leader, Clinical Leader Forum

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. 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. Learn how you can make your operations more efficient while improving your CRO, FSP, and site relationships.

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

10:15AM

Networking Refreshment Break

10:15:00AM - 11:00AM

 
11:00AM

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

11:00AM -12:00PM

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. Stronger contracts and agreement will improve your relationship with sites, make for more effective CRO and FSP relationships, and help you become the sponsor of choice.

- D‌ébora Araujo, Associate Director Clinical Site Budgets and Payments | Boehringer Ingelheim
- Tina Grasso, Executive Dir., Clinical Operations | Novartis
- Sameer Tandon, Head Strategic Alliances and Customer Transactions | Novartis

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.

- Jeff Davidson, CEO | Keystone Nano
- Timothy J. Miller, President & CEO | Abeona Therapeutics
- John Maslowski, CEO | Fibrocell
- Christopher Schaber, President & CEO | Soligenix
- Martin Lehr | Co-Founder & CEO, Context Therapeutics (Moderator)

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.

- Art Fratamico, Chief Business Officer | Vitae Pharmaceuticals
- John Hubbard, Member of Board of Directors | Agile Therapeutics
- Howard Johnson, SVP, Corp. Dev., Alliance Mgmt., Program Mgmt. | Iovance Biotherapeutics
- Tony Meehan, SVP, Business and Corporate Development | VenatoRx Pharmaceuticals
- Michael W. Young, Principal | biomedwoRx: Life Sciences Consulting(Moderator)

3:50PM

Conference Chair Closing Remarks

3:50PM - 4:00PM

- Ed Miseta, Executive Editor | Clinical Leader, Life Science Leader (Moderator)