Partnerships in Drug Development: Are you building a successful relationship?
How to create and maintain partnerships throughout the drug development process
Location: West in Exton, PA
Date: Friday November 18, 2016
Time: 7:30am networking breakfast followed by panel discussion from 8:15 to 9:30am
Panelists:
Katherine High, Co-Founder, President and Chief Scientific Officer – Spark Therapeutics
JeanMarie Markham, Founder, President & CEO – Clinlogix
Amy Furlong, Executive Vice President of Cardiac Safety and eClinical Insights – ERT
Moderator:
Jen Baysarowich, Senior Associate, Pharmaceutical and Life Sciences R&D Advisory – PwC
Who Should Attend:
· Individuals interested in becoming involved in a strategic partnership with a CRO or CMO in the next 12 to 18 months
· Biotech, pharma, medical device or diagnostic companies planning a clinical trial
· Individuals who have secured a CRO and CMO and the relationship has not been successful
BIOS
Katherine High, Co-Founder, President and Chief Scientific Officer – Spark Therapeutics
Dr. Katherine High completed clinical training in internal medicine and hematology. The initial focus of her faculty career was the development of novel therapeutics for the treatment of bleeding disorders. Her pioneering bench-to-bedside studies of gene therapy for hemophilia and for a rare form of congenital blindness using adeno-associated virus (AAV) vectors provided some of the most convincing proof-of-concept studies in gene therapy. Prior to joining Spark Therapeutics, Dr. High was an Investigator of the Howard Hughes Medical Institute and held an endowed chair at the University of Pennsylvania School of Medicine. She served as the director of the Center for Cellular and Molecular Therapeutics at The Children’s Hospital of Philadelphia, served a five-year term on the FDA Advisory Committee on Cell, Tissue and Gene Therapies and is a past-president of the American Society of Gene & Cell Therapy (ASGCT). She was recently elected to the Faculty of Pharmaceutical Medicine of the Royal College of Physicians (London). She received her A.B. in chemistry from Harvard University, an M.D. from the University of North Carolina School of Medicine, business certification from the UNC Business School Management Institute for Hospital Administrators and a master’s degree from the University of Pennsylvania.
JeanMarie Markham, Founder, President & CEO – Clinlogix
As the founder of Clinlogix, LLC, JeanMarie Markham, RN, CCRA, is an inspiring leader who seeks to continually drive the field of Clinical Research Services forward. She has over twenty-five (25) years of experience in the industry. In 1990, JeanMarie founded Markham & Associates to provide regional Clinical Monitoring and Investigator Management services to the Industry. She developed a national platform of experienced Clinical Research Associates to provide clients with regionally based clinical monitoring services in multi-therapeutic areas for the biopharmaceutical and medical device industries.
In 1999, JeanMarie founded Clinlogix, a Clinical Research Service Organization, with the mission of providing exceptional service and resources to the industry as a whole by assisting them to meet unmet medical needs and improve quality of life and health. Through diligent planning and superior execution, Clinlogix guides and manages projects, through the clinical development process expediently. Requisite project management of experienced resources produces high-quality clinical trial data while managing cost effectively. Loyal clients can attest to the delivery of this vision, demonstrated by Clinlogix early adaptation of electronic data and safety management, optimization of eClinical tools bundled with process management to leverage and create effective strategies. JeanMarie is an active member of ACRP, DIA, RAP’s, AWE, SCDM and SQA.
Amy Furlong, Executive Vice President of Cardiac Safety and eClinical Insights - ERT
Amy Furlong is the Executive Vice President of Cardiac Safety and eClinical Insights at ERT – a developer of technology solutions used by pharmaceutical companies to capture safety and efficacy data during new drug development. Since joining the company in <YEAR> she has held several senior roles building the company’s global operations team, including Senior Vice President, Regulatory Compliance and Chief Operating Officer.
Upon joining ERT, Amy immediately recognized the need for a formalized Quality Assurance process related to the company’s services to support clinical drug development. She single-handedly pushed management to back her ideas of implementing a QA process that included medical device and computer validation of ERT’s electronic electrocardiogram (ECG) system. That process is still in place and has become the foundation of a very intricate QA program that is trusted by pharmaceutical companies around the world. The impact of her efforts was huge, considering that for the past three years, over 50% of the new drugs approved by U.S. FDA have utilized ERT’s technology solutions to capture critical safety and/or efficacy data during clinical development.
Amy earned her BS and MS in Biology/Pharmaceutical Sciences from Temple University.
Jen Baysarowich, Senior Associate, Pharmaceutical and Life Sciences R&D Advisory – PwC
Jennifer Baysarowich is an experienced consultant in PwC’s Pharmaceutical & Life Sciences R&D Advisory Services practice with over 10 years of experience.
At PwC, Jen’s current experience includes:
Leading an initiative to expedite study start up at a global biotechnology company, including design of a new operating model for country and site and site selection and novel site budgeting and contracting processes to create efficiencies and reduce cycle times across the start up process
Lead the design and execution of cross-functional training to educate the R&D organization of a global pharmaceutical company on utilizing centralized business processes to enable strategic reporting and decision making
Supported the design and implementation of a new strategic outsourcing model for a global biotechnology company, with a redefined governance structure, streamlined contracting model and defined key performance indicators and metrics to drive accountability and measure efficiencies
Led a workstream to define a novel contracting model for a CRO strategic alliance partnership to reduce sponsor oversight and empower both partners to think and work more creatively
Prior to joining PwC, Jen spent over 2 years managing the externalization of biological basic research in support of drug discovery within the Strategic Operations department at Merck Sharp and Dhome. Jen was responsible for managing the external research portfolio across a diverse group of therapeutic areas at contract research organizations (CRO) and academic institutions, leading partner relationship management to drive process improvements, performing competitive analysis to identify preferred suppliers, and optimizing processes for secure data exchange and metrics tracking. Jen also brings 5 years of experience in R&D supporting drug discovery for cardiovascular diseases. Jen holds a Master’s Degree in Biochemistry from McMaster University where she studied enzyme kinetics and antibiotic resistance.
