Emerging Biopharma: Designing Smarter, More Predictable Clinical Trials

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation,
  • Wednesday, March 25, 2015

For biotech companies, success can be transformational. But the path is often paved with unique challenges, including constrained budgets and limited internal resources.

For emerging biopharma companies, the path to success can be paved with significant and sometimes unforeseen challenges that may not be present for large pharma.

Combine these unique challenges in a risk-averse regulatory and financial environment – where stakeholders have an increased focus on evidence and investment viability – and it becomes essential for emerging biopharma companies to do everything they can to get it right the first time.

Quintiles experts will discuss practices that will help emerging biopharma companies design smarter trials to put their products on a more predictable path to success.

Key Topics include:

  • Mitigating risk and achieving more predictable outcomes in early development– How PK/PD modeling and simulation can be used to develop scenarios that allow for more informed benefit / risk / value assessments
  • Achieving optimal trial design by balancing risk, time, and cost – Combine various data sources, real-world evidence, and technology to build in predictability and prototype cost and time scenarios
  • Generating predictability for stakeholders – Utilize scenario-driven strategies to make the most effective use of funds, develop more informed go/no-go decisions, and achieve a more robust proof of concept

This 45 minute presentation will be followed by a 15 minute Q&A session.

Free registration is open now – We look forward to the opportunity to share insights and discuss with your further.


Seth Berry, PharmD, Director, Clinical Pharmacokinetic / Pharmacodynamic Modeling & Simulation, Quintiles

Dr. Berry is Director of Clinical Pharmacokinetic / Pharmacodynamic (PK/PD) Modeling and Simulation in the Quintiles Advisory Services Group. He has a PharmD from the University of Missouri-Kansas City, School of Pharmacy, a 2-year Post-Doctoral PK/PD Fellowship with the University of North Carolina, and a 2-year Pharmacometrics Fellowship with the Center for Drug Development Science, Georgetown University (now at the University of California – San Francisco).

Since joining Quintiles in 2004, Dr. Berry’s extensive experience in Model-Based Drug Development includes Population PK/PD modeling and simulation along with Clinical Trial Simulation to optimize dose selection and study design. Dr. Berry is also a high performance computing and personalized medicine application expert with strong backgrounds in NONMEM®, S-Plus®, and R. Dr. Berry has numerous publications and presentations in the pharmacometrics discipline, while also mentoring PK/PD students and fellows, providing workshops, and training seminars.

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Laura Marquis, Vice President and Global Head, Emerging Biopharma, Quintiles

Laura Marquis is vice president and global head of Emerging Biopharma at Quintiles, a position she was appointed to in 2014. In this role, she is responsible for strategy and delivery of the work Quintiles performs for its emerging biopharma customers worldwide. A bioPharmaceutical industry veteran with more than 20 years of clinical research experience, Marquis has held a number of leadership positions at Quintiles, including the development and management of global strategic partnerships with services in Clinical Development, Consulting and Commercial. Prior to joining Quintiles in 2007, Marquis held various positions at Pharmaceutical companies and bioPharmaceutical services providers in clinical operations, including corporate training, project management and strategic partnerships. In addition to her Quintiles responsibilities, Marquis is the board chair of the Carolinas Raleigh Chapter of the Cystic Fibrosis Foundation. She also is a board member of Leadership Triangle and a mentor with the RTP Chapter of the Healthcare Businesswomen’s Association. Laura received her bachelor’s degree with honors in psychology from the University of California at San Diego.

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Cara Willoughby, Senior Director, Infosario Design Delivery Lead, Quintiles

Cara Willoughby has 17 years of Pharmaceutical industry experience in clinical program planning and reporting, interpretation and application of global regulations, medical writing, preparation of marketing applications, and the development of novel clinical research technology solutions. She has held leadership positions and consulted on a variety of strategic transformation and modernization initiatives across clinical development, where she has developed expertise in process improvement, Lean Six Sigma, and organizational change management. Additionally, she has four years of experience leading and influencing the development of clinical trial and healthcare data interchange standards through CDISC and HL7. Cara was previously employed at Eli Lilly and Co. and was a founding member of Semio, a strategic partnership between Lilly and Quintiles that led to the development of what is now known as Infosario® Design. Cara joined Quintiles in 2011 and currently leads the Infosario® Design Delivery Team.

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Who Should Attend?

  • Senior level executives from biopharmaceutical companies
  • Chief medical and scientific officers from biotech companies
  • Biotech investors, including venture capital and private equity
  • Therapeutic area clinical development heads
  • Clinical development program leaders or managers
  • Procurement/outsourcing managers

Xtalks Partner


Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of bioPharmaceutical development and commercial outsourcing services. With a network of more than 32,000 employees conducting business in more than 100 countries, we helped develop or commercialize all of 2013’s Top 100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit http://www.quintiles.com/.

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