Allison Kotas, Pharmd Email & Phone Number

Cambridge, Ma, Us

Cambridge, Massachusetts, United States

US Regulatory Strategy: Early Development, Late Development, Marketed Productso Serve as the US Regulatory Strategy Lead for an Early Development program by participating cross-functionally in core program, study, and co-development program teams to define the clinical development plan and provide strategic regulatory inputo Lead the preparation, review, and submission of Investigational New Drug (IND) Applications and Fast Track Designation Requests, along with subsequent activities, including responses to FDA Information Requestso Manage preparation, timelines, and development for regulatory submissions to FDA, including successful lifting of a full clinical hold, Module 1 documents for a supplementary New Drug Application (sNDA), Annual Reports, New Investigators, Meeting Briefing Documents, Protocol Amendments, and a United States Adopted Names (USAN) Council submissionGlobal Regulatory Strategy: Late Development, Marketed Productso Chair and facilitate Global Regulatory Team meetings to ensure effective communication of regulatory updates and program strategies across international marketso Direct and coordinate the preparation and timely submission of comprehensive responses to Agency queries, including Health Canada, MHRA, and EMA, for Clinical Trial Applications (CTAs), fostering cross-functional collaboration across teams and senior management, as well as co-development sponsor partnerso Manage the preparation of an indirect treatment comparison involving cross-functional collaboration with value evidence and strategy, biostatistics, and clinical research teams, ensuring robust regulatory support for product development strategieso Conduct comprehensive regulatory intelligence searches including compiling nonclinical advice across CNS programs, orphan maintenance, endpoints, filing pathways, and competitive drug labeling, to inform and optimize EU and global regulatory strategies

o Collaborated as an interprofessional health care team member to ensure the accurate preparation, selection, dosage, and distribution of patient medicationso Educated patients on discharged medications, promote vaccinations to patients, as well as communicate with patients to gather updated medication history listso Conducted adverse drug reports periodically to determine if proper indication of diphenhydramine, epinephrine, and racepinephrine are being utilizedo Assisted with the largest COVID-19 vaccination site in WNY at the Niagara Falls Convention Center, which gave over 1700 doses/day, by preparing the dosages to be given and ensuring optimal work flow in the pharmacy area

o Assimilated and gained exposure to the various roles and regulations FDA executes, including the applications for new drug products and medical devices, the patient labeling process, and prescription drug advertising and promotional activitieso Examined and researched the multifaceted approach for which drug, device, and promotional labeling are each carried througho Reviewed and dissected public comments from the Code of Federal Regulations pertaining to FDA draft guidance and ruleso Acquired a solid comprehension of the regulatory interplay between pharmaceutical companies and FDA across multiple offices

o Gained and enriched medical writing skills, research, and communication abilities, from both clinical and marketing perspectiveso Collaborated with a cross functional team, who drew from extensive managed care, clinical, and marketing experience, to produce content and strategic tactics for pharmaceutical clients supporting the clinical and economic value of productso Devised an understanding of the various internal and external stakeholders within the pharmaceutical industry and managed care landscape, including exposure to medical, regulatory, and legal teamso Exhibited proficiency across multiple medical writing platforms including Social Bridge, Veeva, and Adobe Acrobat

I worked alongside, as well as precepted interns on IPhO-focused projects. My main role was helping to shape and evolve the process of ReCAP, which evaluates and ranks student IPhO chapters in order to constantly evolve their participation and acknowledge their achievements.

As an off-cycle intern, I helped to coordinate national recruitment of student faculty for the first ever Regional Breakout Session during the IPhO National Meeting held in September 2021. I also was able to present in the meeting and facilitated a breakout session focusing on student IPhO chapters.

Lancaster, Ny

In this role, I was responsible for directly communicating with customers and ensuring customer satisfaction. I was able to gain immense interpersonal and verbal skills, as well as efficiently learned how to balance responding to customers on top of completing daily, required paperwork.

Doctor Of Pharmacy - Pharmd, Cumulative Gpa As Of November 2022: 3.98/4.00

Activities and Societies: Industry Pharmacists Organization (IPhO) - Director of Professional Programming, P1 Liaison; American.

Pre-Pharmacy, Cumulative Gpa 4.00/4.00

Activities and Societies: Early Assurance PharmD Candidate, Honor's College, Teaching Assistant for Evolutionary Biology 201

Doctor Of Pharmacy - Pharmd, Pharmacy