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Forum Agenda

Wednesday, May 10, 2017


Breakfast & Networking

 7:30AM - 8:30AM


Welcome and Conference Chair Opening Remarks

 8:30AM - 8:45AM


Proven strategies for selecting the right CRO for your trial

 8:45AM - 9:45AM

Selecting the right CRO might be the most critical decision facing pharma executives. The right choice will let you sleep at night and speed your trial to a successful conclusion. The wrong choice could sink the effort before it even gets off the ground. With thousands of CROs to choose from, how do you find the one that is right for you? This session will provide you with proven and effective strategies for making the right choice.

- Deirdre BeVard, VP, Development Operations | Nektar Therapeutics
- Elizabeth Garner, CMO & SVP, Clinical Development | Agile Therapeutics
- Elspeth Carnan, VP, Global Head, Service Provider Mgt. | EMD Serono
- Ed Miseta, Executive Editor | Clinical Leader, Life Science Leader (Moderator)


Networking Refreshment Break

 9:45AM - 10:15AM

Sponsored by
Halloran Consulting Group

How Top-Performing Pharma Companies Audit Their CRO

 10:15AM - 11:00AM

Your long and tedious CRO selection process is over, and your study is finally underway. Now you are faced with questions about the best way to audit your CROs and the trial it’s conducting. Some of those questions include: Is the data being collected according to protocol? Can you ensure the data is accurate? What’s the best way to view the data without being overwhelmed? How should you begin to analyze the data?

- Anita Treohan, Director, Program Management & Clinical Operations | ImmusanT
- Frances Grote, Director, Clinical Sourcing Advisory Services | Information Services Group
- Kathryn Stiede, Head, Clinical Operations | Nimbus Therapeutics
- Laurie Halloran, President & CEO | Halloran Consulting Group (Moderator)


Improve CRO Oversight By Implementing Analytics and Scorecards

 11:00AM - 11:45AM

How do you evaluate your CROs performance? There are concrete measures and methods to determine if your CRO is on track and leading your clinical trial to a successful conclusion. Discover the best ways to evaluate your CROs performance as measured by quality, regulatory, timeliness, and other key factors.

- Karen Brooks, Sr. Director, Clinical Operations | Adare Pharmaceuticals
- Sean Gharpurey, Exec. Dir., R&D Strategic Business Improvements | Jazz Pharmaceuticals
- Joe Martinez, Former CEO | Center Point Clinical Services (Moderator)


Networking Lunch

 11:45AM -1:00PM


Monitoring strategies: How to get the most out of your sites and CRAs

1:00PM - 2:00PM

Just because your trial hasn't embraced risk-based monitoring doesn't mean monitoring shouldn't be a concern for you. Sites often place too much attention on large pharma clients and CROs at the expense of smaller pharma companies. Learn strategies to monitor your partner, including site monitoring tactics, monitoring CRA performance, and improving connections with sites and CRAs.

- Theresa Devins, Sr. Associate Director, Site Operations | Boehringer Ingelheim Pharmaceuticals
- Dan Milam, VP, Global Engagement | Society for Clinical Research Sites
- Greg Morosky, President | Square-1 Clinical Research
- Rob O'Toole, Principal | OnPoint Clinical Consulting (Moderator)


Finding And Evaluating CRO Partners: Lessons From A Decade of Market Research

2:00PM - 2:30PM

Detailing the prevailing drug development outsourcing models used by large and non-large biopharmaceutical companies. ISR will outline the processes by which drug companies evaluate potential contract research organizations (CROs) in one-off scenarios and longer-term partnerships. The ideas and strategies conveyed in this session are based on a decade of market research that has chronicled the evolution of these relationships from purely tactical purchasing of “hands and feet” to highly strategic relationships with integrated teams, connected technologies, and swapping of staff.

- Kevin Olson, CEO, Industry Standard Research


Networking Refreshment Break

2:30PM - 3:00PM


Delays, overruns, and quality issues: Who’s to blame?

3:00PM - 4:00PM

This lively, moderated debate between a sponsor and CRO will help you understand how common problems occur, the best ways to quickly resolve them, and methods to ensure they don’t happen again.

- Peter Benton, President & COO | Worldwide Clinical Trials
- David Rodin, CEO | Amici Clinical Research
- Stefan Schwabe, EVP, Head of R&D | Supernus Pharmaceuticals
- Michael Harte, President | The Harte Group (Moderator)


Networking Reception

4:00PM - 6:00PM


Thursday, May 11, 2017


Breakfast & Networking

7:30AM -8:30AM


Conference Chair Opening Remarks

 8:30AM - 8:45AM


Keynote - What I would do differently: The rise and fall of Scios

8:45AM -9:30AM

Dr. Roger Mills’ career in life sciences has spanned 47 years and has included serving as medical director of the advanced heart failure/cardiac transplant program at the University of Florida, cardiologist at the Cleveland Clinic, VP of medical affairs for Scios (a J&J company), and senior director, clinical lead at Janssen Research and Development. Dr. Mills’ recently published book Nesiritide – The Rise and Fall of Scios, details his experiences at Scios during the company’s attempt to bring the heart failure drug Nesiritide to market after claims it might cause kidney failure and death. Mills will also discuss mistakes made along the way, what could have been done differently, and what you can learn from his experience.

- Roger Mills, Sr. Dir., Clinical Lead (Retired) | Janssen


Networking Refreshment Break

9:30AM -10:00AM


Your trial is off the rails: Here’s how to put it back on track

10:00AM -11:00AM

Despite the best plans, sometimes a trial veers off course. Learn how to determine if your study needs to be rescued, what team is responsible for study rescue, when to rescue (and when to bail out), and who to turn to when all else fails.

- Molly Rosano, VP, Clinical Operations | NuCana
- Beth Harper, President | Clinical Performance Partners
- Helen Kellar-Wood, Immunoscience Lead, Diversity & Patient Engagement | Bristol-Myers Squibb
- Melissa Easy, Founder & President, SiteStart | DrugDev (Moderator)


Solving the problem of a diversified patient pool

11:00AM -12:15PM

The FDA is demanding clinical trials represent a wider spectrum of patients. Sponsors are struggling to meet this requirement. Find out what the FDA is actually asking of clinical trial sponsors and discover techniques that will diversify your pool of trial participants.

- Fabian Sandoval, CEO & Research Director | Emerson Clinical Research Institute
- Karen Brooks, Sr. Director, Clinical Operations | Adare Pharmaceuticals
- Ola Akinboboye, Medical Director | Laurelton Heart Specialists PC
- John Whyte , Dir., Professional Affairs and Stakeholder Engagement | FDA
- Theresa Devins, Sr. Assoc. Dir, Site Ops, Strategic Alliance Dev. | Boehringer Ingelheim
- Kathryn Ticknor, Senior Research Manager | Inspire (Moderator)


Networking Lunch

12:00PM -1:15PM


I think my CRO is overcharging me, but how do I know for sure?

1:15PM -2:00PM

You’re not an expert at negotiating sponsor/CRO contracts. But you still need to sign one and be able to put a correct valuation on your trial. Hear strategies to determine pricing factors for your trial, whether fixed-versus-variable pricing is best for you, and how to avoid getting nickel and dimed to death by your vendor.

- Darlene Panzitta, President | DSP Clinical Research
- Guy Bolton, VP Clinical Operations | Ferring Pharmaceuticals
- David Kim, Executive Consultant | Celeritas Solutions
- John Hall, Director, Clinical Operations | Noveome Biotherapeutics (Moderator)


Networking Refreshment Break

2:00PM -2:30PM


Patient centricity that yields results: How others are getting it done

2:30PM -3:15PM

Patient centricity is a hot button topic that is not going away anytime soon. True centricity involves hearing the voice of the patient and taking the additional step of getting it involved in your trial design. Doing so correctly will allow you to design trials that are friendly to both patients and sites, while also allowing you to improve the rates of recruitment and retention. In this session, learn how some of your peers at small- and mid-sized companies are successfully making patient centricity a reality.

- Michelle Berg, VP, Patient Advocacy | Abeona Therapeutics
- Stephanie Petrone, Executive Director, Medical Operations | Novartis
- Katie Mazuk, Sr. Dir., Global Head Investigator & Patient Engagement | Johnson & Johnson
- Michael W. Young, Principal | biomedwoRx: Life Sciences Consulting (Moderator)


The future of clinical trials: Are you ready for new technologies?

3:15PM -4:00PM

Wearables, social media, adaptive trials, risk-based monitoring, eTechnologies, big data, and electronic health records. These are just a few of the technologies and movements that will transform clinical trials. But, what does this mean for small- and mid-sized pharma companies? Understand the innovations that demand your company’s attention today, and will determine the success of your trials in the future.

- Kelly Andrzejewski, Clinical Assistant Professor | University at Buffalo
- Ramon Mohanlal, Chief Medical Officer | BeyondSpring Pharmaceuticals
- Elise Felicione, Sr. Dir. R&D Operations Innovation | Janssen
- Ed Miseta, Executive Editor | Clinical Leader, Life Science Leader (Moderator)