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Shared Challenges. Shared Solutions.

Join us for a summit on modern-day clinical trial outsourcing.

If your clinical trial strategy involves outsourcing, you’ll face unique challenges that arise when coordinating your trial through a third-party. Clinical Leader Forum is all about sponsor-CRO partnerships and the issues that matter most to executives at small and midsize sponsor companies (or anyone who outsources).

8:00am
Registration, Exhibit Hall Open, & Networking Breakfast

Collect your badge at registration and head over to the catered breakfast spread to enjoy while you mingle with fellow attendees.

9:00am
Welcome & Conference Chair Opening Remarks

Ed Miseta, Chief Editor of ClinicalLeader.com, kicks off the morning with opening remarks.

9:15am
Clinical Trials Are Broken. Here’s What We Need To Do To Fix Them

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 executives from SCRS, ACRO, ACRP, and APCR. Don’t miss the opportunity to hear these experts 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
  • Patricia Leuchten, Founder & CEO | The Avoca Group
  • Doug Peddicord, Executive Director | Association of Clinical Research Organizations
  • Dan Milam, VP Global Engagement | Society for Clinical Research Sites
  • Greg Koski, President | Alliance for Clinical Research Excellence and Safety (Moderator)
10:15am
Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

11:00am
They’re Doing What? How Poor Communication Can Sabotage Your Clinical Trial Execution

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 effective communication of protocol
- how video, demonstrations, and simulations can eliminate staff confusion
- how to best manage your CRO and FSP communications

  • Mary Rose Keller, VP Clinical Operations | Heron Therapeutics
  • Leesa Gentry, Director | Otsuka America Pharmaceutical Development and Commercialization
  • Bari Kowal, Vice President, Global Head, Clinical Project Management & Operations | Regeneron
  • Carrie Melvin, Vice President | Clinical Operations TESARO
  • Laurie Halloran, President & CEO | Halloran Consulting Group (Moderator)
12:00pm
Networking Lunch

Lunch is served! Take the hour to fill up (if you haven't already!) and network with exhibitors and peers.

1:15pm
Are New Clinical Technologies Improving Your Trials Or Driving You Insane?

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?

In this session you will learn:

- how to best evaluate new technologies
- how to determine the cost/benefit of new innovations
- how to work with peers to ensure transparency
- how you can afford to purchase the technologies you need

  • Michael McKay, Global Trial Leader | Janssen Pharmaceutical
  • David Marquez, Clinical Research Site Manager | Clinical Trials of Florida
  • Rangaprased Sarangarajan, SVP & Chief Scientific Officer | BERG Health
  • Walter Boyle, Senior Director Biostatistics and Programming | Synteract
  • Gary Gentry, Executive Director | Cirrus Clinical Services (Moderator)
2:15pm
Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

3:00pm
4 Successful Patient Recruitment Strategies You’re Not Using - And Why You Should

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.

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

  • Mary Rose Keller, VP Clinical Operations | Heron Therapeutics
  • Maura Snyder, Director Patient Engagement Strategy | The Janssen Pharmaceutical Companies of Johnson & Johnson
  • Karen Correa, Senior Director Clinical Operations | Adare Pharmaceuticals
  • Michelle Berg, VP Patient Affairs and Community Engagement | Abeona Therapeutics
  • Rob O’Toole, Principal | OnPoint Consulting (Moderator)
4:00pm
Networking Reception

You're invited to join us for an open bar reception featuring heavy hor d'oeuvres, desserts, and live music!

8:00am
Exhibit Hall Open & Networking Breakfast

Collect your badge at registration and head over to the catered breakfast spread to enjoy while you mingle with fellow attendees.

9:00am
Conference Chair Day Two Opening Remarks

Ed Miseta, Chief Editor of ClinicalLeader.com, kicks off the morning with opening remarks.

9:15am
Keynote: Becoming a Sponsor of Choice

You realize your clinical development program is headed in the wrong direction. What steps can you take to quickly fix a potential disaster? How do leadership, people, and technology play into the solution? Mark Ridge is familiar with this scene. After all, six years ago he led the initiative to turn CSL Behring into a sponsor of choice. As Mark puts it, "We needed to clarify our internal processes, and our model of working with one single CRO was not working well. At the same time, we were upsetting long standing relationships with our investigators through insufficient interactions. I knew changes had to be made, and that the process would be a challenge, but patients depended on us to get the job done, so it was time to get to work."

  • Mark Ridge, VP R&D Project Management | CSL Behring
  • Ed Miseta, Executive Editor | Clinical Leader, Life Science Leader (Moderator)
10:15am
Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

11:00am
Am I Crazy Or Are They? Develop Stronger Contracts And Agreements For Partners

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? 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.

In this session you will learn how to speed study start-up by:

- avoiding delays in your clinical trial agreements
- insuring nothing is left out of your agreements
- creating more effective contracts and agreements
- creating RACI charts to alleviate potential issues

  • Débora Araujo, Associate Director Clinical Site Budgets and Payments | Boehringer Ingelheim
  • Sameer Tandon, Head Strategic Alliances and Customer Transactions | Novartis
  • Tina Grasso, Executive Director, Clinical Operations | Novartis
  • Brigid Siegel, Clinical Operations Executive
  • Amit Patel, CEO | Fiore Healthcare Advisors (Moderator)
12:00pm
Networking Lunch

Lunch is served! Take the hour to fill up (if you haven't already!) and network with exhibitors and peers.

1:15pm
Navigating the clinical process: What you need to know before you take the next step

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 have navigated those waters will share their experiences and lessons learned.

In this session you will discover:

- 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

  • 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

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

3:00pm
Partnering with big pharma - Will you hit the jackpot or lose it all?

Scaling up your efforts from Phase 2 to Phase 3 can be a monumental undertaking for many small bio or pharma companies. These sponsors will often 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. Our esteemed panelists are ready to share their big pharma partnering experiences.

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

  • Art Fratamico, Chief Business Officer | Galera Therapeutics
  • John Hubbard, Member of Board of Directors | Agile Therapeutics
  • Howard Johnson, SVP Corporate Development, 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

Impactful talks given by accomplished speakers that give the audience actionable ideas that can be taken back and used to manage risk and create effective management processes.

Michael McKay, GCDO Trial Leader | Janssen Research & Development

Interested in sharing your experience?

Clinical Leader Forum is looking for innovative executives with a passion for improving how clinical trial stakeholders do business together.

Join us at an upcoming Clinical Leader Forum Event.

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