Peter Parsonson
Lampasas (Austin)
Summary
Dynamic regulatory affairs leader with a proven track record at KalVista Pharmaceuticals, achieving NDA approval for a groundbreaking drug and capturing 10% of the market within weeks. Expert in regulatory strategy and eCTD documentation, fostering global collaboration while driving compliance and innovation in clinical trials.
Overview
35
35
years of professional experience
1
1
Certification
Work History
Executive Director and Head, US Regulatory Affairs
KALVISTA PHARMACEUTICALS, INC.
01.2021 - Current
- Provide US inputs and requirements within the Global Regulatory Strategy for development projects in accordance with Company objectives
- Ensure US regulatory goals for each development project are met
- Achieved NDA approval for first oral drug product for acute Hereditary Angioedema attacks and enabling rapid product launch capturing 10% of the total addressable market in the US within 12 weeks of launch
- Provide US regulatory expertise to the product development teams
- Oversee and implement regulatory strategies and solutions for advertising, promotional, and medical affairs materials compliance. Provide accurate reviews of advertising and promotional materials to meet internal timelines and requirements.
- Write/review eCTD Modules 2 and 3
- Prepare, manage and submit IND/NDA applications in accordance with project goals and maintained to ensure regulatory compliance.
- Prepare and manage the submission of Orphan/Fast Track/Breakthrough Designations as required.
- Act as US Agent for IND, NDA, and Orphan Drug applications
- Conduct regulatory reviews of promotional materials for use in marketing related to approved NDA products.
- In conjunction with the Project Regulatory Lead, manage FDA meetings (e.g. Pre-IND, EOP2 meetings) including preparation and submission of Briefing Documents, preparation of the team and follow-up.
- Direct and manage the US Regulatory team to ensure continued professional development and motivation
- Set and manage the annual budget for US/N.America Regulatory Affairs
- Maintain an up-to-date knowledge of all applicable FDA regulations and laws and undertake training and/or information sharing with regulatory and development colleagues to ensure KalVista implements appropriate processes to maintain compliance
- Maintain SOPs for US/N. America regulatory activities and ensure compliance
- Responsible for evaluating and implementing Artificial Intelligence (AI) practices into regulatory affairs operations and strategies
Director, Promoted to Senior Director, Regulatory Affairs
AEGLEA BIOTHERAPEUTICS, INC.
Austin
01.2018 - 01.2021
- Build and manage the regulatory affairs department from the ground up to include regulatory strategy group, regulatory operations group, and a lifecycle management as well as medical/legal/regulatory review function.
- Implement aggressive regulatory strategies for all pipeline products and responsible for execution of strategies across the product portfolio of rare disease and oncology products.
- Act as lead liaison with regulatory agencies and lead all meetings with regulatory agencies in Europe, Japan, and the US.
- Lead, guide and collaborate with other development departments and external partners in writing regulatory documents, briefing packages, TPPs, reports and summaries.
- Manage and lead other functional staff to ensure they meet regulatory requirements in structure, data and presentation as needed.
- Develop staff capabilities in key areas such as CMC and nonclinical RA strategies.
- Participate in cross-functional teams in preparing development plans, while monitoring and tracking activities relevant to regulations.
- Responsible for department budget development and adherence to operational budgets for all programs.
- Key results to date include the following:
- Successful EOP2 meeting with FDA and Scientific Advice meeting with EMA harmonizing the Phase 3 pivotal study designs across sites in Europe and the US
- Lead interactions with all global regulatory agencies including FDA, EMA, MHRA, and PMDA
- Obtained Pediatric Rare Disease Voucher which can be sold to fund future company growth requiring no dilutive financing
- Obtained Breakthrough Designation Therapy in the US thus enhancing the regulatory meeting options available for pivotal rare disease program and permitting an accelerated BLA submission reducing the timeline to BLA submission by 18 months and adding $50 million to the company’s market capitalization
- Initiation of Phase 3 confirmatory trial for rare disease product and IND filings for 2 new pipeline products following pre-IND meetings with FDA and scientific advice meetings with MHRA and EMA
- Establishment of process and procedures for medical, legal, and regulatory (MLR) review of promotional materials
- Deep experience with FDA’s Division of Rare Diseases and Medical Genetics
Senior Director, Regulatory Affairs
ACELITY L.P. INC.
San Antonio
01.2017 - 01.2018
- Led 11 regulatory professionals and five contract consultants in developing and implementing regulatory strategies and processes while also implementing strategies and processes to maximize and optimize global Acelity RA performance.
- Provided regulatory guidance to core project teams, resulting in the rapid and successful approvals necessary for global product launches.
- Optimized global regulatory affairs goals and teams.
- Updated technical files and CERs for EU MDR compliance, preparing CERs in accordance with MEDDEV 2.7.1 Rev 4.
- Developed and implemented regulatory strategies to obtain the necessary regulatory approvals to market products globally.
- Maintained current knowledge of applicable regulatory affairs requirements and trends for submitting 510(k) and notified body documentation for new and marketed products.
- Participated in FDA and notified body audits of technical files, 510(k) submissions, QMS, and MDR readiness and compliance.
Senior Director, Regulatory Affairs, Advanced Surgical Devices Division
SMITH & NEPHEW
Fort Worth
01.2015 - 01.2017
- Led staff of 30 regulatory professionals in developing and implementing regulatory strategies and processes for pharmaceuticals, biologics, and medical devices, ensuring timely global commercialization of products while maintaining compliance with applicable regulations and standards.
- Prepared CMC and clinical NDA/BLA/MAA sections in eCTD format to support ten different drug and biologic products sold in the U.S., Europe, Canada, and across the world.
- Reviewed the work of staff and contracted medical writers.
- Supervised multisite RA staff of 30 professionals across four U.S. sites and one U.K. site, covering products with sales in excess of $2,000,000,000.
- Established regular communication and priorities for key markets.
- Consolidated multiple divisions into one harmonized process.
- Built new RA group to support international registrations in emerging markets, reducing work backlog from 200 dossiers to zero within five months and resulting in over $100,000,000 in company sales growth.
- Partnered with company directors from Latin America (LATAM), China, India, Russia, Asia, the Middle East, Africa (IRAMEA), Japan, and Australia and New Zealand (ANZ) in establishing harmonized processes to improve the efficiency of international registrations.
- Translated organizational regulatory intelligence by market and region to ensure work processes reflected changing regulatory requirements.
- Managed complex international manufacturing site transfer projects and developed the attendant regulatory strategies.
- Provided new product development teams with regulatory strategies and requirements for emerging markets, such as China and Brazil.
Director
Advanced Wound Management Division
Fort Worth
01.2013 - 01.2015
- Developed and implemented regulatory strategies to ensure timely global commercialization of products while meeting regulations.
- Interpreted regulations and conveyed information to management and project teams, advising on compliance impacts.
- Coordinated documentation for submissions across departments, ensuring adherence to compliance timelines.
- Partnered with clinical affairs to establish strategies for compliance with local, state, and federal regulations in clinical trials.
- Managed document production for regulatory submissions, securing approvals for product marketing.
- Prepared comprehensive regulatory documents, including clinical study reports and CMC summaries.
- Designed approval processes for labeling and reviewed all advertising and promotional materials for compliance.
- Conducted negotiations with regulatory agencies to ensure timely submission approvals.
Associate Director, Regulatory Affairs
ALCON LABORATORIES, INC. (DIVISION OF Novartis INTERNATIONAL AG)
Fort Worth
01.2009 - 01.2013
- Proposed and implemented global regulatory strategies for development and approval of new drug and combination products.
- Prepared and submitted INDs, CTAs, NDAs, MAAs, NDSs, and other equivalent international applications for new drug and combination products in CTD and eCTD formats.
- Prepared clinical study reports, investigator’s brochures, and CMC sections for MAAs and NDAs submitted in eCTD format.
- Obtained timely approvals for new products and supplemental changes through proactive interactions with regulatory authorities and cooperation with internal R&D, manufacturing, and QA functions.
- Reviewed protocols and clinical study reports for regulatory content and reviewed labeling and promotional material for regulatory compliance.
- Served as primary contact and spokesperson to the FDA for assigned products and coordinated with local regulatory personnel to ensure effective interaction with regulatory bodies.
- Monitored and evaluated changes in regulatory requirements and trends, assessed the impact of changes, and advised appropriate individuals within the company of changes through training opportunities.
- Ensured proper representation on regulatory affairs project teams, interdepartmental project teams, and global development teams.
- Acted as RA representative to global project development teams and allocated staff for regulatory affairs project teams according to skill level, project scope, and workload.
- Served as company RA representative to the Cambridge location of the Novartis Institutes for BioMedical Research.
Senior Manager, Regulatory Operations
SIRION THERAPEUTICS, INC.
San Diego
01.2007 - 01.2009
- Supervised eight employees and three contractors, including medical writers, eCTD publishers, and operations staffers.
- Coached, mentored, and supervised department managers and staff in both San Diego and Tampa.
- Prepared advisory committee briefing packages, slide sets, notes, and talking points for medical staff.
- Managed vendors and budgets, supervised project timelines, and led interdepartmental project staff.
- Prepared regulatory documents in eCTD format, such as clinical study reports, Module 2 summaries, investigator’s brochures, and integrated summaries.
- Developed regulatory strategies for combination and prescription ophthalmic drug products, decreasing drug development times, enhancing market penetration, and facilitating meetings with the FDA.
- Supervised validation projects for software implementation, including OpenText Livelink, ISI eCTDXPress, Toolbox, and ISIWriter.
- Directed day-to-day regulatory operations by preparing clinical study reports, statistical analysis plans, pre-IND briefing packages, IND and NDA submissions, annual reports, NDA supplements, and CMC documents.
- Managed biostatistical data from biostatistics groups for clinical study reports, statistical analysis plans, and publications.
- Led interdepartmental projects involving medical affairs, scientific communications, clinical operations, and manufacturing.
- Wrote documents for all eCTD modules, with particular emphasis on CTD Modules 2, 3, and 5.
- Prepared clinical study reports, investigator’s brochures, advisory committee briefing packages, and CMC documentation for IND and NDA submissions.
Chief Operating Officer and Executive Coordinator
THE ROSKAMP INSTITUTE
Sarasota
01.2004 - 01.2007
- Directed administrative operations for 50 researchers, clinicians, and operations support professionals focused on developing new treatments for Alzheimer’s disease.
- Oversaw $6,000,000 annual budget.
- Evaluated and negotiated contracts for clinical and preclinical research with CROs and pharmaceutical companies.
- Served as point of contact for all FDA inquiries regarding both pre-IND and IND submissions.
- Managed all administrative support operations, including HR, finance and accounting, information technology, clinical operations, facilities engineering, vivarium, regulatory, and research support functions for six laboratories and two clinics.
Director, Regulatory Affairs and Quality Assurance
ROMARK LABORATORIES, LC
Tampa
01.2002 - 01.2004
- Prepared, coordinated, and compiled NDA and ANDA submissions in hybrid CTD (electronic and paper) format.
- Oversaw quarterly and annual reports to the FDA for approved products and negotiated with FDA personnel to achieve favorable regulatory outcomes for NDA submissions.
- Prepared regulatory strategy on project teams for all NDAs and INDs.
- Participated in pre-IND FDA meetings.
- Managed multiple manufacturing suppliers to ensure the timely manufacture and delivery of marketed products.
- Selected and audited API and drug product manufacturers.
Manager, Information Technology, Chemical Engineering Department
WASHINGTON STATE UNIVERSITY
Pullman
01.1999 - 01.2000
- Oversaw management of all information technology systems supporting multiple sites with over 150 chemical engineers, chemists, students, and vendors across 15 analytical chemistry research laboratories.
- Implemented and supported multiple laboratory data acquisition systems and chemical process simulation software packages.
- Managed multiple chemical research support projects, help desk work orders, contractors, and IT systems, including UNIX, Linux, Windows NT, and Windows 2000 servers and desktops.
System Administrator, Information Services Department
SOLVAY PHARMACEUTICALS
Marietta
01.1999 - 07.1999
- Oversaw implementation and validation of new computer networking system for entire research and development division in compliance with FDA regulatory requirements.
- Led and managed team of validation engineers, consultants, users, and department managers.
- Managed multidisciplinary project teams tasked with software systems implementation and developed training procedures for chemists and QA auditors.
- Conducted experiments on biological samples using chromatographic methodologies (GC, HPLC, GC-MS, HPLC-MS) for pharmaceutical compounds and metabolites.
Analytical Chemist
SMITHKLINE BEECHAM CLINICAL LABORATORIES, INC.
Atlanta
01.1992 - 01.1996
- Conducted clinical toxicology and analytical chemistry experiments on bodily fluids for hospitals, doctors, pharmaceutical clinical trials, and state crime laboratories.
- Gained experience working with thin-layer chromatography, HPLC, GC, GFAAS, GC-MS, and UV-Vis analytical instrumentation.
Analytical Chemist, GC-MS Laboratory
LAW ENVIRONMENTAL NATIONAL LABORATORIES
Atlanta
01.1991 - 01.1992
- Analyzed water and soil samples for volatile organic compounds using GC-MS instrumentation.
Education
M.S. - Chemistry
Georgia Institute of Technology
Atlanta, Georgia01.1996
B.S. - Chemistry
UNIVERSITY OF North Georgia
Dahlonega, Georgia01.1991
Skills
- Regulatory strategy
- NDA submission and approval
- FDA compliance
- eCTD documentation
- Clinical trials
- Global collaboration
Certification
Medical Writer Certified (MWC), American Medical Writers Association (AMWA)
Patents
9,186,363, Pharmaceutical composition and method for treating age-related macular degeneration
Timeline
Executive Director and Head, US Regulatory Affairs
KALVISTA PHARMACEUTICALS, INC.
01.2021 - Current
Director, Promoted to Senior Director, Regulatory Affairs
AEGLEA BIOTHERAPEUTICS, INC.
01.2018 - 01.2021
Senior Director, Regulatory Affairs
ACELITY L.P. INC.
01.2017 - 01.2018
Senior Director, Regulatory Affairs, Advanced Surgical Devices Division
SMITH & NEPHEW
01.2015 - 01.2017
Director
Advanced Wound Management Division
01.2013 - 01.2015
Associate Director, Regulatory Affairs
ALCON LABORATORIES, INC. (DIVISION OF Novartis INTERNATIONAL AG)
01.2009 - 01.2013
Senior Manager, Regulatory Operations
SIRION THERAPEUTICS, INC.
01.2007 - 01.2009
Chief Operating Officer and Executive Coordinator
THE ROSKAMP INSTITUTE
01.2004 - 01.2007
Director, Regulatory Affairs and Quality Assurance
ROMARK LABORATORIES, LC
01.2002 - 01.2004
Manager, Information Technology, Chemical Engineering Department
WASHINGTON STATE UNIVERSITY
01.1999 - 01.2000
System Administrator, Information Services Department
SOLVAY PHARMACEUTICALS
01.1999 - 07.1999
Analytical Chemist
SMITHKLINE BEECHAM CLINICAL LABORATORIES, INC.
01.1992 - 01.1996
Analytical Chemist, GC-MS Laboratory
LAW ENVIRONMENTAL NATIONAL LABORATORIES
01.1991 - 01.1992
M.S. - Chemistry
Georgia Institute of Technology
B.S. - Chemistry
UNIVERSITY OF North Georgia