MAY 10-11, 2017 AT THE HILTON PHILADELPHIA CITY AVENUE

CLINICAL LEADER FORUM

DAYS
Hours
Minutes
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WHAT ARE YOUR BARRIERS TO A FAST & EFFICIENT CLINICAL TRIAL?

Vetting partners. Contract negotiations. CRO monitoring and audits. Delays, overruns, and quality issues.

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 mid-sized sponsor companies (or anyone who outsources).

VENDOR SELECTION

With limitless CROs to evaluate, how do you find the right match? Ask questions of other sponsors about their strategies for selecting outsourcing partners for trials.

PERFORMANCE MONITORING

What is a performance scorecard and how do you use it? Learn methods to assess your CRO and how to get the most out of your sites and CRAs.

PATIENT ISSUES

How can you meet the FDA’s demands for a diversified patient pool? Find out what the FDA requires of trial sponsors and how you can exceed expectations.

CLINICAL LEADER FORUM
MAY 10-11
HILTON PHILADELPHIA CITY AVENUE

30+ SPEAKERS

Michelle Berg, VP Patient Advocacy | Abeona Therapeutics
Paulo Moreira, VP Global Clin. Ops. & External Innovation | EMD Serono
Stefan Schwabe, EVP, Head of R&D | Supernus Pharmaceuticals
Mike Collins, Head of Global R&D Vendor Mgmt. | Alexion
Guy Bolton, VP Clinical Operations | Ferring Pharmaceuticals
Molly Rosano, VP Clinical Dev. Operations | Momenta Pharmaceuticals
Gerri Henwood, President & CEO | Recro Pharma
Deirdre BeVard, VP Development Operations | Nektar
Elizabeth Garner, CMO & SVP Clinical Dev | Agile Therapeutics
Ramon Mohanlal, CMO | BeyondSpring Pharmaceuticals

VIEW ALL

Christine Pierre

Founder & President
SCRS

Christine Pierre

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Deirdre BeVard

VP Development Operations
Nektar

Deirdre BeVard

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Fabian Sandoval

CEO & Research Director
Emerson Clinical Research Institute

Fabian Sandoval

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Stephanie Petrone

Exec. Dir. Medical Operations
Novartis

Stephanie Petrone

view profile

Forum Agenda

Wednesday, May 10, 2017

7:00AM

Breakfast & Networking

 7:00AM - 9:00AM

 
9:00AM

Opening Remarks

 9:00AM - 9:15AM

 
9:15AM

Proven strategies for selecting the right CRO for your trial

 9:15AM - 10:00AM

With thousands of CROs to choose from, how do you find the one that is right for you? Learn proven strategies for making the right choice, including preparing a list of candidates, vetting techniques, evaluating vendor presentations, and conducting effective site visits.

- Deidre BeVard, VP Development Operations | Nektar Therapeutics
- Elizabeth Garner, CMO & SVP Clinical Development | Agile Therapeutics
- Paulo Moreira, Global Clinical Operations & External Innovation | EMD Serono
- Ed Miseta, Executive Editor | Clinical Leader, Life Science Leader (moderator)

10:00AM

Networking Refreshment Break

 10:00AM - 10:45AM

 
10:45AM

How Top-Performing Pharma Companies Audit Their CRO

 10:45AM - 11:20AM

Get advice for auditing your CROs and your trial, including answers to questions like: 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?

- Frances Grote, Director, Clinical Sourcing Advisory Services | Information Services Group
- David Kim, Executive Consultant | Celeritas Solutions
- Kathryn Stiede, Head of Clinical Operations | Nimbus Therapeutics
- Laurie Halloran, President & CEO | Halloran Consulting Group (moderator)

11:25AM

Improve CRO Oversight By Implementing Analytics and Scorecards

 11:25AM - 12:00PM

There are concrete 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 CRO’s performance as measured by quality, regulatory, timeliness, and other factors.

- Karen Brooks, Sr. Director, Clinical Operations | Adare Pharmaceuticals
- Sean Gharpurey, Exec. Dir. R&amp:D Strategic Business Improvements | Jazz Pharmaceuticals
- Greg Fiore, CEO & President | Fiore Healthcare Advisors (moderator)

12:00PM

Networking Lunch

 12:00PM -1:15PM

 
1:15PM

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

1:15PM - 1:50PM

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
- Christine Pierre, Founder & President | Society for Clinical Research Sites
- Rob O'Toole, Principal | OnPoint Clinical Consulting

1:55PM

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

1:55PM - 2:30PM

This session will detail the prevailing drug development outsourcing models used by large and non-large biopharmaceutical companies. In addition, the session will outline the processes by which drug companies evaluate potential contract research organizations (CROs) for us 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.

- Kevin Olson, CEO, Industry Standard Research

2:30PM

Networking Refreshment Break

2:30PM - 3:15PM

 
3:15PM

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

3:15PM - 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
- Mike Collins, Head of Global R&D Vendor Management | Alexion Pharmaceuticals
- Bari Kowal, Head of Clinical Trial Management | Regeneron Pharmaceuticals
- Stefan Schwabe, EVP, Head of R&D | Supernus Pharmaceuticals
- Michael Harte, President | The Harte Group(moderator)

4:00PM

Networking Reception

4:00PM - 6:00PM

 

Wednesday, May 11, 2017

7:00AM

Breakfast & Networking

7:00AM -9:15AM

 
9:15AM

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

9:15AM -10:15AM

Dr. Roger Mill’s book, Nesiritide – The Rise and Fall of Scios, details his experiences at Scios as VP of Medical Affairs during the company’s attempt to bring the heart failure drug Nesiritide to market after claims it might cause kidney failure and death. Dr. Mills will discuss mistakes made along the way, what could have been done differently, and what you can learn from his experience.

10:15AM

Networking Refreshment Break

10:15AM -10:45AM

 
10:45AM

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

10:45AM -11:20AM

Despite the best plans, sometimes a trial veers off course. Learn how to determine if your study needs 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 Development Operations | Momenta Pharmaceuticals
- Beth Harper, President | Clinical Performance Partners
- Melissa Easy, Founder & President, SiteStart | DrugDev (moderator)

11:25AM

Solving the problem of a diversified patient pool

11:25AM -12:00PM

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
- Richard Tsai, VP Marketing | Inspire (moderator)

12:00PM

Networking Lunch

12:00PM -1:15PM

 
1:15PM

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

1:15PM -1:50PM

You may not be an expert at negotiating contracts, but you need to 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 by your partner.

- Darlene Panzitta, President | DSP Clinical Research
- Guy Bolton, VP Clinical Operations | Ferring Pharmaceuticals
- David Kim, Executive Consultant | Celeritas Solutions

1:55PM

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

1:55PM -2:30PM

True centricity involves hearing the voice of the patient and getting it involved in your trial design. Doing so will allow you to design trials that are friendly to patients and sites, while allowing you to improve recruitment and retention. Learn how others sponsors 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
- Richard Tsai, VP Marketing | Inspire (moderator)

2:30PM

Networking Refreshment Break

2:30PM -3:15PM

 
3:15PM

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. What do these transformative technologies mean for small- and mid-sized pharma companies? Understand the innovations that will determine your trial’s success in the future.

- David Slade, US Asthma & Biologics Lead | GlaxoSmithKline
- Ramon Mohanlal, Chief Medical Officer | BeyondSprings Pharmaceuticals
- Elise Felicione, Sr. Dir. R&D Operations Innovation | Janssen
- Ed Miseta, Executive Editor | Clinical Leader, Life Science Leader (moderator)

EXHIBITS & OTHER SPONSORSHIPS AVAILABLE FOR SERVICE PROVIDERS

Download Prospectus
 

Forum Sponsors

 

Early Bird Industry Pass

For end-users to the pharma industry (sponsors with pipelines, consultants). Full program.

Rate expires March 15.


REGISTER NOW

$ 399

Industry Passes for Groups

For end-users to the pharma industry (sponsors with pipelines, consultants).Full program.

Rate valid for teams of 2+.


REGISTER NOW

$ 299

REGISTRATION IS OPEN

Passes to the Clinical Leader Forum in Philadelphia are all inclusive - conference sessions, exhibit hall access, and networking are included. The program is fully catered with an exceptional spread.

To reserve an industry pass, your company must be an end-user to the pharma industry. We define end-users as pharma/biopharma companies, biotechs, and consultants. We will decline all registrations that do not meet this criteria.

Service providers that wish to attend should contact us for details on sponsorships.



Registration & Lodging