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Philadelphia 2017

May 10-11, 2017 | Hilton Philadelphia City Avenue


Exhibition & Sponsors

August Research

Clinical SCORE

Comprehend Systems

DrugDev

InSeption Group

Life Science Training Institute

OnPoint

Rho, Inc.


Agenda

Wednesday, May 10, 2017

Registration & Networking Breakfast

7:30AM

Welcome & Conference Chair Opening Remarks

8:30AM

Proven Strategies for Selecting the Right CRO for Your Trial

8:45AM

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, Chief Medical Officer & SVP, Clinical Development | Agile Therapeutics
  • Elspeth Carnan, Vice President of Service Provider Management | EMD Serono
  • Ed Miseta, Executive Editor | Clinical Leader (Moderator)

Networking Refreshment Break

9:45AM

How Top-Performing Pharma Companies Audit Their CRO

10:15AM

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 Managent & Clinical Operations | ImmusanT
  • Frances Grote, Director, Clinical Sourcing Advisory Services | Information Services Group
  • Kathryn Stiede, Head of Clinical Operations | Nimbus Therapeutics
  • Laurie Halloran, President & CEO | Halloran Consulting Group (Moderator)

Improve CRO oversight by implementing analytics and scorecards

11:00AM

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, Senior Director, Clinical Operations | Adare Pharmaceuticals
  • Sean Gharpurey, Executive Director R&D Strategic Business Improvements | Jazz Pharmaceuticals
  • Joe Martinez, former CEO, Center Point Clinical Services (Moderator)

Networking Lunch

11:45AM

Monitoring Strategies: How To Get The Most Out Of Your Sites And CRAs

1:00PM

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.

  • Theresa Devins, Senior Associate Director, Site Operations | Boehringer Ingelheim Pharmaceuticals
  • Greg Morosky, President | Square-1 Clinical Research
  • Dan Milam, VP Global Engagement | Society for Clinical Research Sites
  • Rob O’Toole, Principal | On Point Clinical Consulting (Moderator)

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

2:00PM

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

Delays, Overruns, And Quality Issues: Who’s To Blame?” (Sponsor/CRO Crossfire)

3:00PM

When issues arise during a trial, the finger pointing between a sponsor and CRO is not far off. This fun and lively, moderated debate – between a sponsor and CRO – will help you understand how common problems occur, the best way to quickly resolve them, and proven methods to ensure they don’t happen again.

  • Peter Benton, President and 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


Thursday, May 11, 2017

Registration & Networking Breakfast

7:30AM

Conference Chair Second Day Opening Remarks

8:30AM

Keynote: What I Would Do Differently: The Rise and Fall of Scios

8:45AM

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, Former Senior Director and Retired Clinical Lead | Janssen

Networking Refreshment Break

9:30AM

Your Trial Is Off The Rails, Here’s How To Put It Back On Track

10:00AM

Despite your best efforts and plans, sometimes a trial veers far off course.  When you reach this point, your next steps to rescue the study are critical as they will ultimately lead to success or failure.

  • Molly Rosano, Vice President of Clinical Operations | Nucana
  • Helen Kellar-Wood, Immunoscience Lead, Diversity & Patient Engagement | Bristol-Myers Squibb
  • Beth Harper, President | Clinical Performance Partners
  • Melissa Easy, Founder and President, SiteSmart | DrugDev (Moderator)

Solving The Problem Of A Diversified Patient Pool

11:00AM

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

  • Fabian Sandoval, CEO and Research Director | Emerson Clinical Research Institute
  • Karen Brooks, Senior Director, Clinical Operations | Adare Pharmaceuticals
  • John Whyte, Director, Professional Affairs and Stakeholder Engagement | FDA
  • Theresa Devins, Senior Associate Director, Site Operations | Boehringer Ingelheim Pharmaceuticals
  • Kathryn Ticknor, Senior Research Manager | Inspire (Moderator)

Networking Lunch

12:15PM

I Think My CRO Is Overcharging Me, But How Do I Know For Sure?

1:15PM

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 of Clinical operations | Ferring Pharmaceuticals
  • David Kim, Executive Consultant | Celeritas Solutions
  • John Hall, Director, Clinical Operations | Noveome Biotherapeutics (Moderator)

Networking Refreshment Break

2:00PM

Patient Centricity That Yields Results: How Others Are Getting It Done

2:30PM

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, Senior Director, Global Head Investigator and Patient Engagement | Johnson & Johnson
  • Michael W. Young, Principal | biomedwoRx: Life Sciences Consulting (Moderator)

The Future Of Clinical Trials: Are You Ready For New Technologies?

3:00PM

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.

  • Ramon Mohanlal, Chief Medical Officer | BeyondSpring Pharmaceuticals
  • Elise Felicione, Sr. Dir. R&D Operations Innovation | Janssen, Pharmaceutical Companies of Johnson and Johnson
  • Kelly Andrzejewski, Clinical Assistant Professor | University of Buffalo
  • David Slade, VP, Global Head, Clinical Development & Clinical Operations | Therakos, Inc.
  • Ed Miseta, Executive Editor | Clinical Leader, Life Science Leader (Moderator)

Networking Reception

4:00PM

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