DUNN REGULATORY ASSOCIATES - Key Persons
Job Titles:
- Director, Regulatory Affairs
Dr. Robinson has 3+ years of experience in medical writing, specifically related to oncology and early phase clinical trial protocols. Prior to joining Dunn Regulatory Associates, Dr. Robinson was a Medical Writer at Technical Resources International, Inc. Before moving to Medica Writing, she was involved in non-clinical academic research in neuroscience. She holds a Ph.D. in Pharmacology and Biomedical Neuroscience with a concentration in neuroanatomy from Boston University and a BS in Chemistry from University of Florida.
Job Titles:
- Member of the Compliance Committee
- Senior Consultant CMC
Mr. Bosco is an experienced pharmaceutical development professional with over 15 years of industry experience collaborating with small and medium sized Pharma and Biotech companies on early and late stage product development activities. Specializing in a broad range of product development support services, his role within the DRA group focuses on the following areas:
Pre-clinical program development and project management
CRO/CMO drug substance and drug product vendor management
CMC gap analysis for IND, IMPD and NDA regulatory submissions
GLP compliance auditing and study monitoring
GCP compliance and early phase clinical trial monitoring
Early phase (Phase I/II) clinical program management
Gap analysis and development of Medical device 510(k) applications
Before joining Dunn Regulatory Associates, Mr. Bosco was the Associate Director of Research at MAP Pharmaceuticals, Inc. He holds a Master's Degree in Pharmacology and Physiology with a concentration in clinical aerosol science and pulmonary drug delivery from McMaster University, and a BSc in Biology and Pharmacology from McMaster University.
Ms. Shrestha is a pharmaceutical regulatory professional with over 10 years of industry experience in pharmaceutical product development, formulation, process development and technology transfer. She also has regulatory consulting experience collaborating with small to mid-sized pharmaceutical companies for early-stage regulatory filings. Prior to joining DRA, Ms. Shrestha worked at Valeant Pharmaceutical International (previously Biovail Technologies), Integrated Pharma Solutions, and ProPharma Group. She holds a Master's Degree in Pharmaceutical Science from Massachusetts College of Pharmacy, Boston and a Master's Degree in Regulatory Affairs from George Washington University, Washington DC.
Dr. Roegge has more than 15 years of industry experience in nonclinical development and safety evaluation of small molecules, biologics, and drug-device combination products. As a DABT-board certified toxicologist, Dr. Roegge has successfully led the nonclinical sections opening a number of IND/CTAs and contributing to NDA/BLA/MAAs in multiple disease areas. She also has strong current expertise in biocompatibility for long-term implanted medical devices including devices with indirect and neural contact. Prior to joining DRA, Dr. Roegge held positions at FDA's National Center for Toxicological Research, GLP Study Director at WIL Research (currently Charles River Ashland Ohio), Project Toxicologist at Upsher Smith Laboratories and later Proximagen LLC, and most recently Senior Principal Scientist and Technical Fellow at Medtronic Neuromodulation. She holds a Ph.D. in Neuroscience from University of Illinois Urbana-Champaign with dissertation research focusing on developmental neurotoxicity of environmental contaminants, and a B.A. in Experimental Psychology and Applied Mathematics from Millikin University.
Job Titles:
- President
- International Regulatory Expert
Ms. Dunn is an international regulatory expert and has over 30 years of consulting experience. Her expertise includes regulatory strategy and implementation and GLP compliance. As a regulatory consultant, Ms. Dunn has reviewed and written numerous IND, NDA/BLA, and CTA/CTR packages, participated in FDA and ex-US regulatory meetings, and provided strategic regulatory advice for global development programs. She has successfully negotiated expedited regulatory packages with the FDA including Breakthrough therapy designations, and has written numerous Orphan Drug Designation packages. Ms. Dunn currently serves as an US Agent across all Division of CBER and CDER, and maintains excellent working relationships with the FDA. In addition, she is an expert in GLP implementation and interpretation, and is an author on the RAPS chapter on GLP compliance. Ms. Dunn has strategic regulatory expertise in OTC and Rx pharmaceuticals, cosmetics, biopharmaceuticals, and devices. She was a founding majority partner at Aclairo Pharmaceutical Development Group, Inc. and a consultant at Milestone Biomedical Associates, SRA Life Sciences, Inc. and an independent consultant prior to the formation of Dunn Regulatory Associates, LLC. Prior to her consulting experience, Ms. Dunn worked at Covance and EPL, Inc. in project management and project coordination roles.
Job Titles:
- Senior Regulatory Publisher
Ms. Bell joins DRA as a Senior Regulatory Publisher with substantial experience in preparing, formatting, reviewing and publishing of eCTD submissions. Prior to joining DRA, Ms. Bell was the Manager of Regulatory Operations at Opko Health and was directly involved in the training of the publishing team, assigning publishing submissions to direct reports, performing QC on published submissions as well as developing promotional materials for submissions.
In addition, Ms. Bell has experience in creating Regulatory Operations SOPs and developing work instruction. She also managed the implementation of new publishing software and User Acceptance Validation Testing. Ms. Bell was the Veeva Vault RIM Manager and point of contact.
Job Titles:
- Vice President, Operations
Ms. Kostadinova has more than fifteen years of combined management and paralegal experience in the pharmaceutical and legal industries. She served as Senior Contracts Administrator and subsequently, as General Manager at Aclairo Pharmaceutical Development Group, Inc. Ms. Kostadinova has successfully negotiated contracts with some of the largest pharmaceutical companies in the US and abroad. In addition, she has extensive experience as a Senior Paralegal providing legal services to organizations and law firms practicing in various fields of law. Ms. Kostadinova holds a Master's Degree in International Economics with a minor in Human Resource Management.
Ms. Nye joins DRA as a Regulatory Associate with more than 18 years of experience in the pharmaceutical industry and in preclinical development. Prior to joining DRA, Ms. Nye was a Research Associate for Lovelace Biomedical focusing on writing protocols and final reports. She also has experience performing hands-on nonclinical research for vaccine development. Ms. Nye holds a Bachelor of Science degree in Biology from Mount Ida College.
Job Titles:
- Regulatory Affairs Consultant
Dr. Erwin joins DRA with 2+ years of experience as a Regulatory Affairs Consultant and excels in developing effective product development strategies that meet all regulatory requirements. Her expertise enables companies to navigate complex regulatory frameworks and achieve successful FDA meetings with ease.
Dr. Erwin's experience includes FDA meeting preparation, pre-IND, IND, and NDA submissions, breakthrough therapy designation, fast track designation, orphan drug designation, and abuse liability assessment plans. Prior to joining DRA, Dr. Erwin was a Regulatory Scientist at Allucent, formerly CATO-SMS. Dr. Erwin holds a doctorate degree in pharmacology from LSU Health Sciences Center and received post-doctoral training from Harvard Medical School and Mclean Hospital. She has presented her work at conferences around the country, published on abuse liability, and discussed Scheduling issues and concerns with Senators and Representatives on Capitol Hill. Her extensive research background in preclinical pharmacology has aided her in assessing, communicating, and managing the risks related to various types of products being developed (e.g., small molecules, biologics, and devices).
Job Titles:
- Senior Director, Regulatory Affairs
Ms. Segar has 14 years of experience in medical writing and consulting, specifically related to project management, orphan drug regulatory and nonclinical expertise. Her experience includes regulatory strategy and participating in FDA meetings and writing of numerous INDs/NDAs/BLAs, FDA meeting requests and briefing packages, orphan drug designations (US and EU), fast track designations, breakthrough therapy designations, and pediatric rare disease designations. Prior to joining DRA, Ms. Segar was an Associate Director of Regulatory Affairs at IQVIA and Cote Orphan, LLC, as well as a Senior Project Manager at Aclairo Pharmaceutical Development Group, LLC. She has a Masters's Degree in Biotechnology with a concentration in Biodefence at Johns Hopkins University, a BA in Biology from Elon University and holds a Regulatory Affairs Certification.
Job Titles:
- Member of the Compliance Committee
- Senior Consultant CMC
Dr. Gehrke has more than 20 years of experience within CMC and bioanalytical from multiple early-stage Pharma companies, various roles within a CRO, and Regulatory CMC oversight of commercial products at a medium size Pharma company. His CMC responsibilities have included discovery through commercialization activities including drug-device combination products. Dr. Gehrke's most recent roles, prior to joining Dunn Regulatory Associates, include Principal Regulatory Affairs CMC specialist at Upsher-Smith Laboratories, LLC and Sr. Director of CMC for Proximagen, LLC. He received a Ph.D. in Analytical Chemistry from Missouri University of Science and Technology.
Job Titles:
- Senior Director, Regulatory Affairs
Dr. Kashyap has 4+ years of experience in medical writing and regulatory consulting, specifically related to orphan drug development and nonclinical/clinical expertise. His regulatory experience includes providing a strategic course for developing drugs, participating in numerous FDA meetings and writing INDs, FDA meeting requests and briefing packages, orphan drug designations (US and EU), fast track designations, breakthrough therapy designations, and pediatric rare disease designations. Prior to joining DRA, Dr. Kashyap was an Associate Director of Regulatory Affairs at IQVIA and a Senior Regulatory Affairs Officer at Cote Orphan, LLC. Before moving to the field of regulatory affairs, he was an immuno-oncology scientist, first at Johnson & Johnson and then at MedImmune/Astrazeneca where he worked to develop anti-cancer drugs. He has a Ph.D. Degree in Microbiology and Immunology with a concentration in the immunology associated with inflammatory diseases from Virginia Commonwealth University and a BS in Biochemistry from University of Wisconsin-Madison.
Job Titles:
- Senior Regulatory Publisher, Team Lead
Saleha Ripa joins Dunn Regulatory Associates, LLC as a senior regulatory publisher. Ms. Ripa is proficient in regulatory submission preparation, eCTD formatting, electronic publishing and quality control review of regulatory submission documents. She has experience in management of clincialtrials.gov protocol registries and regulatory document archival.
Previously, Ms. Ripa worked at RTI International as a regulatory operations specialist where she received President's Award for her contribution to a New Drug Application for extensively drug-resistant, treatment-intolerant or multidrug-resistant pulmonary tuberculosis. In addition, Ms. Ripa has experience in developing work instructions and training team members and clients on the use of eCTD templates and document preparation.
Dr. Kim joins DRA as a Medical Writer with prior medical writing experience in the field of oncology and phase I-III clinical trial support. Dr. Kim is proficient in writing and updating clinical protocols, clinical study reports (CSRs), Investigational New Drug Applications (INDs), and Development Safety Update Reports (DSURs).
Prior to joining DRA, Dr. Kim served as a Medical Writer at Technical Resources International, Inc. He holds a Ph.D. in chemical biology with a concentration in chemical neuroscience from Syracuse University, and a BS in Chemistry from the University of Maryland - College Park.