Development
Development Experience
Alita's senior management team is composed of industry leaders with extensive and demonstrated experience in clinical, regulatory and commercial execution along with therapeutic expertise in urology and female healthcare.
Carole Ben-Maimon, M.D., President & CEO and Wayne Mulcahy, Ph.D., Alita's VP of Research and Development have worked together closely for more than 15 years. Together they have successfully developed and commercialized many notable products including the specific female healthcare products SEASONALE®, SEASONIQUE™, Enjuvia®, and Cenestin® along with products in other therapeutic areas such as COPAXONE®¹. Dr. Ben-Maimon and Dr. Mulcahy are complemented by Debra Gayda, Ph.D., VP of Regulatory and Quality, who has managed the submission of numerous INDs, NDAs, sNDAs and regulatory development programs for projects within several therapeutic areas and throughout FDA's Divisions. Together, this team understands the urology and female healthcare businesses and has experience in developing clinical programs, managing regulatory filings and launching drugs and biologics.
Collectively, the Senior Management team has achieved the following:
- > 10 clinical programs completed
- > 25 clinical programs designed and implemented
- 30 IND and NDA filings successfully completed in both drugs and biologics
- > 15 branded approvals attained
- Interaction with EMEA and FDA groups
- Regulatory management of hundreds of marketed products
- Participation in multiple advisory panels
¹SEASONALE®, SEASONIQUE™, Enjuvia®, and Cenestin® are trademarks of Duramed Pharmaceuticals, Inc.; COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.
