What Does it Take to Successfully Execute Large, Global, Phase III Programs?

Syneos Health leaders reveal a proven method to thrive in this complex environment

Each year, the process of developing new drugs and new therapies for market becomes more and more complex. A diverse group of stakeholders including sponsors, CROs, regulatory bodies, patients, physicians & hospitals, ethics committees, vendors, etc., each have their own specific needs and requirements which need to be considered. A constantly changing environment with new regulations, new treatment options and competing investigational therapies compounds the issues further.

In addition, the complexity of managing a trial goes up exponentially when considering a large global study where geopolitics, differing regulatory requirements, cultural and language differences, variances in standards of care, socioeconomics and much more must be taken into consideration. It’s a challenge many clinical developers face in today’s global marketplace, but one that many times must be undertaken to access the limited patients available to meet enrollment targets.

So, what does it take to successfully execute a program of this nature? Clifford McIntosh, Vice President, Strategic Alliance Management, Syneos Health and Alexandria Wise-Rankovic, Ph.D., Senior Vice President, Clinical Development, CNS, Syneos Health, will break down some of the best practices and crucial elements for executing programs in this challenging environment.

Speakers

Clifford McIntosh, Vice President, Strategic Alliance Management, Syneos Health

Cliff has nearly two decades of clinical research experience, including seven years of senior level roles in operational delivery and oversight of clinical trials. He has managed the operational execution of multiple global Phase I – III trials in a variety of indications; provided operational oversight for more than 30 large Phase III global studies and programs, and overseen strategic development and launch of successful partnerships with large pharma and mid-size biotech companies. Cliff is committed to developing innovative solutions to mitigate risk and bring valuable therapies to patients.

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Alexandria Wise-Rankovic, Ph.D., Senior Vice President, Clinical Development, CNS, Syneos Health

Dr. Alexandria Wise-Rankovic is Senior Vice President of CNS Clinical Development atSyneos Health. Dr. Wise-Rankovic is an executive leader who has worked in clinical research for more than 25 years and brings a broad base of both industry and academic experience to her role. She is a licensed clinical psychologist with doctoral specialization in clinical neuropsychology. Alex’s clinical training and work history spans all ages and most indications in neurology, psychiatry, analgesia, and peri-operative procedure. She serves as a consultant to the scientific and pharmaceutical community, having served on advisory boards as a subject matter expert in schizophrenia.She has extensive clinical trial experience with the severe psychiatric population. In her current role, she represents Syneos Health’s CNS Business Unit as Customer Relation Executive (CRE) as a collaborator with pharmaceutical companies on program designs, strategic development, and governance. She provides operational oversight and direction to large, international, pivotal programs.

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