“On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion. This number incorporates the cost of failures – of the thousands and sometimes millions of compounds that may be screened and assessed early in the R&D process, only a few of which will ultimately receive approval.” - Pharmaceutical Research and Manufacturers of America
BioPharma companies operate in a world of challenges including rapidly changing competitive landscape, increasingly complex requirements from patients, payors, providers and new and sometimes conflicting regulations. Demands for innovative therapies at lower costs fuel research, development and commercial activities. Join long-time biopharma executives as they share strategies and tactics to mitigate risks and increase the likelihood of therapeutic and market success for new drugs. Learn more about the impact of healthcare economics, navigating FDA regulations, conducting clinical trials, and transforming to a commercial mindset for product launch.
5:30 p.m. – 6:30 p.m. – Registration, Networking, Appetizers, Opening Remarks
6:30 p.m. – 7:30 p.m. – Panel Discussion
7:30 p.m. – 8:00 p.m. – Audience Q&A, Networking
Sharon Ayd, Ph.D., MBA
Chief Executive Officer, Ayd BioPharma Consulting Group
Sharon Ayd, Ph.D., MBA, is currently the primary owner and Principal Consultant at Ayd BioPharma Consulting Group. She is a biopharmaceutical industry veteran with 30-years’ experience in commercializing Branded/Novel, Specialty, Rare, Generic and Biosimilar drugs and has a proven record of value creation for companies by leading international drug programs from discovery to clinical evaluation through regulatory approval, launch and life cycle maintenance. She also has diverse corporate experience in startups to mid-size companies to Fortune 100/Multinational corporations around the globe, with revenue from <$100M to >$10B.
- Building Commercial Pipelines: Maintains awareness of FDAs changing regulations and effectively interacts with the Agency. Has ~100 drug approval to her credit.
- Building New/Expanding Core Business: Created business strategy, organization structure and operations for new therapy/technology from acquisition (pre-revenue)/ internal development through regulatory and launch, with P/L.
- Organization Transformation: Turnaround situations, M&A integration, IPOs, C-Suite retirement, and Executive level termination following FDA enforcement action.
- Thinking Across Borders: Worked for multinational companies, leading cross-cultural teams spanning countries/continents and navigating across functional boundaries, i.e., R&D, regulatory, operations, compliance and commercial.
- Corporate Governance: As a C-level executive in start-up biotech companies, have recruited and chaired Scientific Advisory Boards and have Governance experience as a Board Member in NFPs.
Sharon began her career at Baxter International (BAX:NYSE) as a Research Scientist. She was a founding member of Transcend Therapeutics (TSND:NASDAQ). She was Head of R&D at Apotex Inc., COO at Advanced Life Sciences (ADLS:NASDAQ), Global VP at Hospira (HSP:NYSE), CSO at Pinnacle Biologics Inc., and Global VP at Fresenius Kabi (FRE:DAX).
Donna Kopera, MBA
Senior Healthcare Leader, Point B
Donna is a senior level executive, providing global leadership in marketing, operations, and program management within the medical device and biopharma industries. She currently serves as a Senior Healthcare Leader at Point B Management Consulting, where she is responsible for helping clients develop and execute product launch and commercialization strategies. Prior to this, Donna spent 30 years at healthcare industry leaders, Baxter and Baxalta.
Donna spent most of her career with Baxter, serving in roles of increasing responsibility in Business Development, Marketing, Customer Operations and Commercial Operations. She was asked to serve as the North American PMO lead for Baxter’s separation into two publicly traded $6B companies. Moving to the spin-off organization, Baxalta, she was involved in organizational and governance design. Donna was appointed to the newly formed senior leadership team as Vice President of Marketing Services where she worked to establish streamlined, compliant and operationally efficient processes for the Marketing Operations Center of Excellence. Prior to joining Baxter, Donna worked as a Manufacturing and Distribution Engineer at SC Johnson.
Donna holds an MBA in Marketing and Finance from Northwestern University’s Kellogg Graduate School of Management and a Bachelor of Science degree in Industrial and Systems Engineering from Illinois Institute of Technology. She serves on several non-profit boards in Lake County, IL.
- Members: $20
- Non-Members: $50
Special Pricing for Guests
Members can register guests at member price.
Yes. Cash or check only.