Phase to Phase - The Guide to Drug Development
Sponsored by Thermo Fisher Scientific and PPD, experts will present innovative strategies in outsourcing discovery that allows small companies to focus on their core discovery needs and frees them up from both a capital and manpower investment.
In this session hear from experts on rare disease clinical development.
- Regulatory benefits when developing a rare disease drug or device.
- The importance of natural history data in rare indications.
- Patient-centricity and other operational aspects of rare disease clinical trials.
Speakers:
- Edress Darsey, Executive Director, Pediatric Development Strategy, PPD, part of Thermo Fisher Scientific
- Kaitlyn Huff, MSc,RAC, Senior Director, Regulatory Strategy, Strategic Development Consulting, PPD, part of Thermo Fisher Scientific
- Susan McCune, MD, Vice President, Pediatrics & Clinical Pharmacology, Rare Disease and Pediatric Center of Excellence, Medical Science and Strategy, PPD, part of Thermo Fisher Scientific and former Director of Pediatrics, FDA
- Moderator: Danko Dominis, MD, PhD, Regional Medical Officer, PPD, part of Thermo Fisher Scientific
Speaker Bios:
- Susan K. McCune, MD
- Dr. McCune is a scientifically driven, motivated, customer-focused Vice President in the Pediatrics and Rare Diseases Center of Excellence of GPD with more than 35 years of clinical care (pediatrics and neonatology), research, and regulatory experience. Her depth of experience consists of regulatory consulting for all phases of pediatric trials including the review of study protocols and analysis of data submitted to the FDA. Her additional experience includes pediatric clinical pharmacology, biomarker development, international pediatric cluster activities with EMA, Health Canada, PMDA, and TGA, patient focused drug development, rare diseases, pediatric ethics, pediatric extrapolation, and research development/bench science.
Dr. McCune is focused on broadly supporting pharmaceutical development across Rare Diseases & Pediatrics, including delivering expert knowledge and guidance in Early Development and Biomarker assessment to a diverse collection of clients. Dr. McCune’s ongoing medical and operational expertise augments the work that PPD is committed to executing on behalf of clients in order to exceed their needs and contribute meaningfully to the development of transformational rare and pediatric therapies. Dr. McCune is focused on value centered delivery based on her expertise in pediatrics, neonatology, clinical pharmacology, and biomarker development.
Dr. McCune holds a bachelor’s degree in Biochemistry from Harvard University and an MD from George Washington University. She is Board certified in Pediatrics and Neonatology.
- Dr. McCune is a scientifically driven, motivated, customer-focused Vice President in the Pediatrics and Rare Diseases Center of Excellence of GPD with more than 35 years of clinical care (pediatrics and neonatology), research, and regulatory experience. Her depth of experience consists of regulatory consulting for all phases of pediatric trials including the review of study protocols and analysis of data submitted to the FDA. Her additional experience includes pediatric clinical pharmacology, biomarker development, international pediatric cluster activities with EMA, Health Canada, PMDA, and TGA, patient focused drug development, rare diseases, pediatric ethics, pediatric extrapolation, and research development/bench science.
- Kaitlyn Huff, MSc, RAC
- Over a decade of experience spearheading regulatory development strategies and leading cross-functional teams to generate high-quality deliverables. Responsible for optimizing regulatory strategy from early concept through post-marketing commitments including complex health authority negotiations, expedited pathway assessments, technical document strategic inputs. Comprehensive product development experience (drugs, biologics, devices) with special interest in ATMP. Considerable therapeutic area understanding across hematology/oncology, cardiovascular, dermatology, gastroenterology, immunology/rheumatology, infectious disease, metabolic and endocrine disorders, neuroscience, and ophthalmology. Regulatory Affairs Certificate (RAC) - US Development. MSc in Integrative Pharmacology from Michigan State University, BS in Biochemistry with Food Science Minor from University of Missouri
Refund/cancellation policy: This program is offered free of charge. As such refunds are not applicable. Questions: Contact Lauren Boyle, [email protected]
