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Regulatory Strategy/US Agent

Cynthia Dinella, R. Ph., Pharm.D.

Chief Executive Officer/President/Founder

Dr. Cindy Dinella is a founding partner and holds the position of President and Managing Partner of Advyzom.  Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry.  She is committed to providing experienced, scientific and proven successful leaders to advise and deliver on regulatory strategy, medical writing and regulatory intelligence. Cindy specializes in leading, guiding, and assisting biopharmaceutical companies with global and US drug development programs to meet and influence health authority requirements.  She has strong leadership, strategic thinking, influence management and cross-functional teamwork skills, gained over many years of experience working across therapeutic areas, throughout phases of development including commercialization, with Senior Corporate Management and Boards, and with the Food & Drug Administration (FDA). She has led numerous FDA meetings across divisions, centers and with FDA senior management.  Read full bio >>

Lisa Maffei Luther, MS

Head of Regulatory and Founder

Lisa Maffei Luther is Head of Regulatory and a founder of Advyzom. Lisa provides regulatory strategic leadership and guidance on global and US development programs to biopharmaceutical companies so they are best positioned to successfully navigate through complex and evolving regulatory requirements. Lisa serves numerous clients where she provides strategic leadership to develop IND filing, development and registration strategies and manages the IND and NDA/BLA submission and approval process. Lisa leads FDA milestone, critical issue and Type A meetings across FDA Centers, Offices and Divisions and has long-standing relationships with senior FDA leadership. She provides many successful clinical and regulatory solutions for Boards, CEOs, Heads of Development and Heads of Regulatory Affairs. Lisa provides high- level strategic guidance across drugs, biologics, drug/device combination products, targeted therapies in a multitude of disease areas. She has a special interest and expertise in the areas of rare diseases and serious and life-threatening illnesses where she leverages her experience in FDA’s expedited development strategies and processes including accelerated approval.  Read full bio >>

Liz Lucini, Pharm.D.

Vice President, Regulatory Strategy

Dr. Liz Lucini is a Vice President of Regulatory Strategy at Advyzom. Liz provides strategic regulatory guidance and acts as a US Agent to FDA for domestic and international biopharmaceutical companies.  Liz’s areas of expertise include infectious disease, virology, rare diseases, women’s health, CNS and recently oncology.  Liz has hands-on experience in obtaining breakthrough, QIDP, orphan, and rare pediatric disease designations from the FDA and has led NDAs to successful approval.  Liz works within Global Research and Development and Commercial teams to lead and support a broad range of regulatory activities from early development to marketing support. Liz manages multiple complex projects simultaneously, including FDA meetings, IND submissions, amendments, responses to FDA requests, promotional materials review, advisory committee preparation and critical issue management.  She brings strong expertise to clients through her role as US Agent and Global Regulatory Leader, providing strategic advice to small and large clients. Liz has over ten years of experience in the pharmaceutical industry.  Read full bio >>

Angela Windt, Pharm.D.

Senior Director, Regulatory Strategy

Dr. Angela Windt is a Senior Director of Regulatory Strategy at Advyzom.  Angela provides strategic regulatory guidance and acts as a US Agent to FDA for domestic and international biopharmaceutical companies. Angela has diverse experience across therapeutic areas including oncology, metabolic/endocrine, cardiovascular, virology, gastrointestinal, liver disease, transplant, and rare diseases. Her oncology experience ranges across solid tumors, such as breast, ovarian, colon and lung, melanoma, multiple myeloma, soft tissue sarcoma, and gene therapies.  Angela has strong leadership, influence management and strategic skills gained while working within global drug development across multiple therapeutic areas, phases of development and FDA divisions.  She has acted as the US and/or Global Regulatory lead on drug development or marketed products team both remotely or on site. Angela can work with other client regulatory team members such as submissions, labeling, CMC and medical writing.   Angela has led FDA  meetings across various therapeutic areas.  She has been successful in obtaining Fast-Track, Breakthrough and Orphan Drug Designations.  Read full bio >>

Candice Teuber, Pharm.D.

Senior Director, Regulatory Strategy

Dr. Candice Teuber is a Senior Director of Regulatory Strategy at Advyzom. Candice provides strategic regulatory guidance and serves as a US Agent to the FDA for domestic and international biopharmaceutical companies.  Her primary focus is in US regulatory affairs with experience in other global regions (EU, Canada, Australia).  Candice has worked in all phases of pharmaceutical clinical development within the therapeutic areas of hepatology, neurology, pain/analgesia, nephrology, cardiology, virology and oncology.  She also has recent experience with cellular and gene therapy products through providing strategic guidance and support for companies developing cancer vaccines.  Candice has expertise with innovative regulatory pathways such as Orphan Drug Development, 505(b)(2) based applications and FDA expedited programs for serious conditions including Fast-track designations and accelerated approvals. She provides strategic guidance on rare disease product development with outcomes ranging from orphan product designations and product approvals to successful FDA Orphan Products research grant award.  Read full bio >>

Ketna Patel, Pharm.D.

Senior Director, Regulatory Strategy

Dr. Ketna Patel is a Senior Director of Regulatory Strategy at Advyzom. Ketna works within Global Research and Development and Commercial teams to provide strategic regulatory guidance for domestic and international biopharmaceutical companies. Ketna has recently filed and successfully obtained global approval for an anti-infective product for resistant pathogens and an opioid drug-device analgesic. She also has diverse experience across therapeutic areas including cardiovascular, oncology, virology, anti-infectives, gastrointestinal, dermatology, pain, anesthesiology and urology. Ketna has strong leadership, influence management and strategic skills gained while working within global drug development across multiple therapeutic areas, phases of development from early development to post-approval.  She has acted as the US and/or Global Regulatory lead on products in early development and marketed products on a  range of regulatory activities including Pediatric Study Plans, Qualified Infectious Disease Designations, IND Submissions, NDA submissions including 505(b)2, amendments, and responses to FDA requests  Read full bio >>

Rula Ibrahim-Saker, Pharm.D.

Director, Regulatory Strategy

Dr. Rula Ibrahim-Saker is a Director of Regulatory Strategy at Advyzom.  She provides strategic and tactical regulatory services across all phases of drug development and therapeutic areas for Advyzom clients.  Rula has led successful IND submissions, prepared Fast Track, Qualified Infectious Disease Product (QIDP) Designation requests.  She also leads the development of FDA Briefing Packages for key milestone meetings, labeling, regulatory strategic plans, and risk assessments.  Rula has diverse experience across therapeutic areas including anti-infectives, dermatology, opthamology and virology.  She understands the complex US regulatory environment and is skilled at providing research and regulatory precedent in different therapeutic areas.  Rula brings strong expertise to clients through her role as a US agent and as a liaison to the FDA. Rula has over ten years of drug regulatory affairs experience in the pharmaceutical industry.  Prior to joining Advyzom, Rula was a Regulatory Lead for marketed products at Hoffman La Roche where she was an FDA liaison.  In this capacity, she was involved in Regulatory Strategy, managing programs from a regulatory perspective, leading REMS activities, and preparing teams for advisory committee meetings.  Read full bio >>

Elizabeth Daglish, MS

Director, Regulatory Strategy

Elizabeth Daglish is a Director of Regulatory Strategy at Advyzom and operates out of the Boston area. She is responsible for providing companies with strategic regulatory guidance and acts as a regulatory lead on programs. Elizabeth has recently filed and successfully obtained US and EU approval for an anti-infective product for resistant pathogens. She also has experience across therapeutic areas including immunotherapies, cardiovascular, and anti-infectives.  Elizabeth has in depth global regulatory experience, and provides global regulatory strategy and leadership of US and EU submissions on development programs from early development thru marketing authorizations.   Elizabeth has led global regulatory strategy for NDA/MAA filings and post-approval supplements/variations to successful approvals. She also leads strategic interactions with Health Authorities throughout development and has strong expertise in preparation and submission of regulatory documents to support clinical trial initiation (IND/CTA submissions) and responses to health authority requests. Elizabeth also has experience in the development of global pediatric plans (PSP and PIP), Orphan designation requests in US and EU, and QIDP designation.  Read full bio >>

Regulatory Strategy Partners

Aclairo

We have a strategic alliance with a world class regulatory group, Aclairo.   Aclairo consultants are experts in FDA regulations and guidelines and provide insight into current regulatory interpretation at the FDA. http://www.aclairo.com

Tim Kachmar

Tim Kachmar has 24 years of experience in Regulatory Affairs and has held various positions as a Senior Regulatory Affairs professional with significant FDA, EMA, MHRA, MPA, MEB and BfArM liaison experience.  Tim specializes in CMC, global clinical trial initiation and submission project management.  Tim’s therapeutic categories include oncology, cardiovascular, antibiotics and medical imaging.  Tim is Assistant Vice President  in Regulatory Affairs and Quality Assurance for Regenacy Pharmaceuticals.  Tim previously worked at Acetylon Pharmaceuticals as an Associate Vice President of Regulatory Affairs where he led the regulatory affairs team and provided regulatory leadership in the development of novel HDAC compounds. He also served as Senior Director of Regulatory Affairs and Quality Assurance at Verastem, Radius Health, Inc., and Mersana Therapeutics. Tim received his undergraduate degree and M.S. in Biology from the University of Massachusetts at Lowell.

Karen H. Noh, R.Ph., Pharm.D.

Dr. Noh is a regulatory leader with experience in developing and implementing regulatory strategies for both drug and biologic products in all phases of drug development, including marketed products. She has served as the US regulatory lead for various development programs and has been involved in INDs, and NDA/BLA filings including major efficacy supplements. Her experience includes developing global strategic regulatory development plans, labeling analysis, pediatric programs, as well as leading Health Authority meetings. In addition to development programs, Karen has broad expertise with marketed products, including critical issues management, safety related labeling changes, drug shortages, Dear Healthcare Professional letters, and formulation withdrawals and risk management programs. She has also provided regulatory leadership on the development and review of promotional campaigns, including DTC and initial product launch campaigns. She has managed FDA advisory committee meeting preparations by developing and implementing regulatory strategies, assisting in the preparation of briefing packages, as well as identifying key issues and responses. Karen has led development of US and global publication plans for marketed products and has expertise in researching, and interpreting regulatory intelligence information to shape regulatory strategies. Previously, Karen worked for Hoffmann-La Roche where she held positions in regulatory affairs, medical information, and publication management She is currently an employee of MBO Partners and is a sub-contractor for Advyzom. Karen received her Bachelor of Science and Doctor of Pharmacy degrees from the Philadelphia College of Pharmacy and Science and completed a drug information residency at Roche Laboratories Inc.

Rupal Patel

Rupal has 22 years of experience in the pharmaceutical industry overall including more than 10 years of Regulatory Affairs experience. Most recently, Rupal was an Associate Director of Regulatory Affairs at ContraVir Pharmaceuticals.  While at ContraVir, she successfully submitted an initial IND, started a Phase I study for treatment of Chronic Hepatitis B, successfully completed an orphan designation, a 505(b)(2) designation, and multiple FDA meetings while supporting multiple development projects. Previously, Rupal worked at Chugai Pharmaceutical Company as a Senior Manager of Regulatory Affairs wherein she successfully also submitted an initial IND with the FDA’s Division of Cardiovascular and Renal Products and actively managed multiple global projects. Her experience includes early and late phase drug development work for INDs and CTAs as well as supporting marketed products globally with NDA or MAA applications. She is familiar with electronic submissions, IND and NDA regulations, CTAs and MAA submissions to EMEA and Health Canada, labeling supplements, PSURs, annual reports, CMC amendments, IND amendments and IND safety reports.  Rupal received her Bachelor of Science in Chemistry from Rutgers University and her MBA in Finance from Fairleigh Dickinson University.  She has a Regulatory Affairs Dual Certificate in Medical Devices and Pharmaceuticals from Regulatory Affairs Professional Society (RAPS).

Joanna Waugh ,BSc (Hons)

Ms. Waugh is an experienced regulatory executive with more than 15 years of global regulatory experience across all phases of drug development and multiple therapeutic areas from positions based in both US and Europe. During her tenure with Advyzom, Joanna has led major projects for clients including assuming the role of an internal US head for Marketed Products and leading a team in successful preparation for a US advisory committee. Prior to joining Advyzom, Joanna was Vice President of Regulatory Affairs and Pharmacovigilance at Noven Pharmaceuticals where she provided oversight of critical filings for Abbreviated NDA, sNDA and 505b(2) NDA submissions and led FDA interactions across all products. She was responsible for evaluation and restructuring of the department after a recent company integration. Joanna has also held the position of Group Director of Marketed Products and Advertising/Promotion Regulatory Affairs at Hoffmann La-Roche Inc. where she was responsible for setting strategic direction and vision for US Marketed Products and Advertising Group and managing a portfolio of products with US annual revenue >$2billion. During her career, she has led precedent setting risk management and REMs programs for a number of products including Opiod REMS, CellCept and Accutane. Previously Joanna has held a number of positions of increasing responsibility at the European, US and global level across multiple therapeutic areas, notably as the global regulatory leader during the filing and approval process for Tamiflu, US regulatory lead for Accutane at the time of intensive risk management program development and the regulatory leader for CellCept approval in renal and cardiac transplant. Joanna has a Bachelor of Science degree with Honors in Genetics from Leeds University in the United Kingdom.

Medical Writing and Publications

Jacqueline Sterner, PhD

Vice President and Head of Medical Writing and Publications

Dr. Jackie Sterner is the Vice President and Head of Medical Writing and Publications at Advyzom.  Jackie was instrumental in creating the global medical writing organization at Advyzom.  Jackie provides a broad range of global medical writing services for clinical, nonclinical, commercial, and regulatory documents.  She brings expertise in the interpretation of clinical trial data and the development of key messages to support regulatory applications and product labeling.  Jackie also provides clinical trial data analysis across a broad range of therapeutic areas. Jackie and her Medical Writing team are experts in authoring Investigator Brochures, protocols, IND Summaries, Clinical Study Reports, NDA/MAA/BLA High Level Summaries, Pediatric Plans, Orphan Drug Applications, Fast Track, Break Through, REMS, and Health Authority Briefing Packages including Advisory Committees. Jackie has over 20 years of experience in medical writing.  Prior to joining Advyzom, Jackie was formerly North American Head of Medical Writing and Editing at Hoffman-La Roche Inc/Genentech of Labeling wherein she provided leadership and strategic.   Read full bio >>

Linda Freed Puertolas

Senior Director, Medical Writing and Publications

Linda Freed Puertolas is a Senior Director, Medical Writing and Publications at Advyzom. Linda has over 30 years of experience in the healthcare industry with 25 years of medical writing and preparation of clinical documentation for regulatory submissions across various therapeutic areas. She is responsible for providing biopharmaceutical clients with a broad range of clinical and nonclinical documents for IND and CTA filings, and for global marketing applications. Prior to joining Advyzom, Linda was President of ClinDoc Associates, wherein she was responsible for providing strategic direction and medical writing services to various large pharmaceutical companies for regulatory submissions, including INDs, CTAs, NDAs, and MAAs. Linda has experience across a range of therapeutic areas, including anti-infectives, cardiovascular, central nervous system, metabolic, oncology, respiratory, rheumatology, and urology. Linda also held positions as Senior Medical Writer for Glaxo Wellcome Inc., R.W. Johnson Pharmaceutical Research Institute and Hoffman-La Roche Inc. Linda earned her Bachelor of Arts. Read full bio >>

Medical Writing and Publications Partners

Jill Bartruff

Jill Bartruff has 24 years of experience in the pharmaceutical industry with over 20 years of regulatory submission experience. Jill is responsible for the writing of documents for electronic submissions to health authorities. Documents include Phase 1 through 4 clinical study reports, Phase 1 through 4 protocols and amendments, integrated summaries of safety and efficacy, clinical trial registry summaries, 120-Day Safety Updates, Investigator’s Brochures, safety narratives, informed consent forms, and documents for therapeutic agents in Medical Foods. She has written submission documents in the following diseases/disorders: asthma, bipolar disorder, cancer (breast, colorectal, prostate), COPD, coronary heart disease, Crohn’s disease, diabetes, epilepsy, HIV, liver fibrosis, major depressive disorder, migraine, mood disorders, opioid dependence, osteoarthritis, overactive bladder, painful diabetic neuropathy, Parkinson’s disease, respiratory syncytial virus, restless legs syndrome, rheumatoid arthritis, schizophrenia, sternal wound infections, systemic sclerosis, and therapeutic agents in Medical Foods. She is a graduate of the University of South Florida with a MSPH in Epidemiology and Biostatistics.

Nancy Baxter

Nancy Baxter has 25 years of extensive experience as a medical writer, editor, and publications specialist. She works closely with authors and coauthors in the planning and development of clinical study reports and review articles in a wide range of therapeutic areas. Nancy’s writing and editorial skills ensure accurate and expert presentation of the content in line with both scientific principles and individual journal policies. She also guides articles through the entire submission process and, together with the contributors, implements revisions in response to peer reviews. In concert with the authors, Nancy focuses on producing articles of the highest quality to optimize prospects for acceptance by target journals. She received her Master of Communications from American University, Washington, DC.

Aaron B. Bernstein, Ph.D.

Dr. Aaron Bernstein has over 25 years of experience in the pharmaceutical industry leading the strategic planning of new drug applications to global health authorities. Aaron has played a lead role as the Project Manager of several New Drug Applications, Supplemental New Drug Applications, Investigational New Drug Applications. He has been the lead author on many Clinical Study Reports (Phases 1‑4), Integrated Summaries of Efficacy, Integrated Summaries of Safety, Summaries of Clinical Efficacy, Summaries of Clinical Safety, Protocols, Benefit/Risk Summaries, Investigator Brochures, and Health Authority Briefing Documents. The work of Aaron spans many therapeutic areas, most notably metabolic diseases, Hepatitis C, HIV/AIDS, cardiovascular disorders, infectious diseases, oncology, women’s health, and type II diabetes mellitus. Aaron is a founding member and past president of the European Medical Writers Association. He is an active member of the American Medical Writers Association, where he frequently presents on topics of medical writing standards and processes, as well as, drug regulation and drug development. Aaron is a primary contributor in the development and publication of CORE Reference tool, a detailed companion to the ICH E3 guideline on Clinical Study Reports.  Aaron received his Ph.D. in Human Anatomy and Cell Biology from the University of Maryland, Baltimore, MD.

Dianne Ciccone

Dianne Ciccone is a Regulatory Medical Writer with over 20 years of pharmaceutical industry experience including over 10 years of experience in leading the strategy, planning, and writing of clinical documents for US and International drug application dossiers. As an independent consultant, she is currently providing professional support to Advyzom. Prior to becoming an independent consultant, Dianne worked at Hoffmann-La Roche for 12 years where she was a Clinical Scientist, helping to design and conduct clinical trials from protocol initiation on through the entire study process; and an International Documentation Manager in Medical Writing, monitoring dossier progress and creating dossier strategy. Prior to joining Roche, Dianne was a Drug Safety Specialist at Berlex Laboratories (now Bayer AG), and a Clinical Research Nurse in a private physician’s practice.  Diane received her BA in English from Montclair University.

Chris Jennings

Chris Jennings has more than 20 years of medical writing experience. Chris has experience authoring clinical study reports, protocols, narratives, Investigator’s Brochures, publications, as well as, technological and scientific marketing, sales force and continuing medical education material across a range of therapeutic areas, including metabolic, oncology, cardiovascular, ophthalmology, allergy, immunology, and infectious disease.   He received his BA in Biology from Harvard University.

Deana Kaye

Deana Kaye has over 13 years of medical writing experience.  She was responsible for medical writing services for regulatory submissions, including INDs, NDAs developing protocols, Investigator Brochures, and briefing packages.  Deana has experience across a range of therapeutic areas, including cardiovascular, dermatology, endocrinology, hematology, infectious diseases, musculoskeletal, neurology, ophthalmology, oncology, psychiatry, respiratory and urology.  Deana has received her MS in Biomedical Writing from the University of the Sciences in Philadelphia..

Judy Kinberg, Ph.D.

Dr. Judy Kinberg has over 25 years of experience in regulatory documentation within the pharmaceutical industry. She has worked closely with Regulatory Affairs personnel, Clinicians, Statisticians, and Pharmacologists on multiple projects to support the drug development process from preclinical research and clinical trials to FDA and European Union approval. She was responsible for the preparation and finalization of clinical documents required for NDAs, sNDAs, and MAAs. These documents included clinical study reports (Phase I, II, and III), high-level summaries (ISS, ISE, CTD Clinical Summaries, and CTD Clinical Overviews), Investigator Brochures, and other Health Authority-related documents. Major therapeutic areas include, but are not limited to, oncology, osteoporosis, virology, and endocrinology and metabolism.  Judy received her Ph.D. in Microbiology from Mt. Sinai School of Medicine, NYC.

Janet Merritt, Ph.D.

Dr. Janet Merritt has 30 years of experience in the pharmaceutical industry, with over 15 years of medical writing experience. Janet is based in the UK, near London, and works with clients in the UK, US and Europe. Janet offers a broad range of writing services to support drug development and approval. She has extensive experience in writing nonclinical and clinical documents, including (but not limited to) Investigational New Drug applications, New Drug Applications, Briefing Documents, Investigator’s Brochures, protocols, study reports, and publications. Janet has experience in many disease areas, including (but not limited to) oncology, metabolic diseases, viral diseases, inflammation and auto-immune diseases, respiratory, cardiovascular, and gastrointestinal diseases. She has experience with new chemical entities, biologics and literature-based submissions. Janet has a broad area of scientific knowledge and the ability to make balanced scientific judgments, enabling a flexible approach and the ability to acquire rapid understanding of new areas. Janet is the author of over 50 full papers in peer-reviewed journals; she has completed a 5-year term on the Editorial Board of the Biochemical Journal; and has completed the Professional Development program of the European Medical Writers Association. She has a MA in biochemistry from Oxford University, UK; a PhD in cellular pharmacology from Sheffield University, UK; and postdoctoral experience in cellular pharmacology at the Medical College of Virginia, USA. This was followed by experience leading research groups in cellular pharmacology at two large pharmaceutical companies in the UK. client standards.

Terry Paul, Ph.D.

Dr. Terry Paul has over 17 years of experience as a medical writer. He was a medical writer at GlaxoSmithKline for 3 years where he was responsible for preparing clinical study reports and integrated summaries for regulatory submissions. As a freelance medical writer since 2002, Terry has worked closely with clinical teams, clinical pharmacology teams, contributing authors, and stakeholders to prepare documents for regulatory submissions. Terry has experience preparing clinical study reports; integrated summaries of efficacy and safety; common technical document modules 2.5, 2.7.1, and 2.7.4; protocols; narratives; INDs; investigator’s brochures; safety updates; and annotated product inserts. Terry has experience in several therapeutic areas, including HIV, herpes, asthma, diabetes, osteoporosis, neurology, urology, and oncology. Terry has been a member of the American Medical Writers Association since 1999.  He received his Ph.D. in Microbiology from the University of Aston, Birmington, England.

Karen Rittweger

Karen Rittweger has over 40 years of experience in the pharmaceutical industry, with more than 30 years in clinical development. Karen is primarily responsible for writing study protocols and other clinical documents, and works closely with stakeholders in document preparation and finalization. Karen is experienced in oncology, virology, infectious disease, rheumatology and gastroenterology. She has had extensive experience with Protocol Amendments, Informed Consents, Investigator Brochures, Clinical Study Reports, Abstracts, Posters, Manuscripts, Annual Reports, Briefing Packages, and developing training materials, SOPs and best practices. Karen held positions at Hoffmann La Roche in laboratory research, clinical operations, project coordination, clinical science, and was team leader for a successful oncology product.  Karen received her Master of Science in Physiology from Fairleigh Dickson University, Teaneck, NJ.

Regulatory Operations and Submissions

Theresa Dalla Riva

Vice President and Head of Regulatory Operations and Submissions

Theresa Dalla Riva is Vice President and Head of Regulatory Operations and Submissions at Advyzom.  Theresa was instrumental in implementing the electronic publishing services at Advyzom.  In addition to managing the Regulatory Operations staff, Theresa spends a significant amount of her time on day to day project work for Advyzom clients.  Theresa also serves as a project manager for IND and NDA/MAA applications. Theresa and her team have the capability, flexibility and customer service spirit to meet our client’s diverse set of needs.  Advyzom has an approved FDA gateway and uses validated software to perform on behalf of clients IND, NDA/BLA, and pharmacovigilance for submissions to FDA, as well as submitting advertisement and promotional materials to the Office of Prescription and Drug Promotion (OPDP).  Additionally, the Operations and Submissions team is experienced in publishing documents and submissions to EMA and Canada.  She is knowledgeable in eSubmitter  for Center for Veterinary Medicine(CVM).  Theresa ensures compliance with FDA e-CTD requirements and client archiving  Read full bio >>

Renee Norton

Senior Director,  Regulatory Operations and Submissions

Renee Norton is a Senior Director of Regulatory Operations and Submissions at Advyzom. Renee provides leadership and support by directly handling submissions to the FDA. She has a proven track record in delivering projects with strict deadlines on time. Additionally, she can provide pre-submission document publishing, including working with clients and their submission vendors. Renee is highly focused on client’s services in meeting their needs and timelines, offering frequent communication and close collaboration, including on-site publishing support. Renee has over 26 years of experience in Regulatory Operations and Submissions. Prior to joining Advyzom, Renee held positions within Global Regulatory Operations Groups at Celgene Inc., Elusys Therapeutics Inc. and Hoffmann-LaRoche Inc./Genentech. Renee offers a wealth of knowledge in eCTD global submissions. She also has extensive experience developing training materials, SOPs and best practices to ensure the use of templates processes and tools critical to compiling electronic submissions, as well as submitting advertisement.  Read full bio >>

David Perez

Senior Director,  Regulatory Operations and Submissions

David Perez is a Senior Director of Regulatory Operations and Submissions at Advyzom. David provides leadership and support by directly handling submissions to the FDA. He has a proven track record in delivering projects with strict deadlines on time. Additionally, he can provide pre-submission document publishing while working with clients and their submission vendors. David has the skill set to efficiently manage multiple projects in a matrix Global environment and interacts effectively with executives, regulatory agencies, vendors and staff. He is responsible for the planning and preparation of regulatory submissions and support formatting, organization and structuring of major submissions in eCTD  format and submitting advertisement and promotional materials to the Office of Prescription and Drug Promotion (OPDP). He is knowledgeable in eSubmitter for Center for Veterinary Medicine(CVM). David has 23 years of experience in the pharmaceutical industry with 16 years in Regulatory Operations and Submissions. His career began as a Clinical Laboratory
Scientist at Roche Laboratories.  Read full bio >>

Regulatory Operations and Submissions Partners

Shalini Aneja

Shalini Aneja has over 5 years of experience in the Pharmaceutical industry, with a strong understanding of Regulatory publishing operations, Clinical TMF (Trail Master File) document management and business processes. Shalini has worked as a Clinical and Regulatory Specialist at Daiichi Sankyo Pharmaceuticals. She has been responsible for preparing Safety Submissions (for INDs) and compiling INDs for Investigators. Shalini is proficient in records management, indexing and archiving of the Health Authorities Correspondence(s) activities. She is also proficient in the use of Documentum based Electronic Data Management System (EDMS) FirstDocs, Veeva Vault; Publishing Tools : Insight Publisher (IP), and DocuBridge.   Shalini graduated  with a Bachelor of Arts from Delhi College and  has a post graduate diploma in Computer Education. Shalini is also a certified EMT.

Erin Bolger

Erin worked as a Regulatory Operations Specialist/Project Coordinator at Radius Health Inc.  with responsibilities in identification and tracking of submission components, preparing, organizing, and publishing submissions to Health Authorities for multiple drug applications, prioritizing workload, and quality and timely filing of documents.  She was the key point of contact for Veeva Submissions Vault Users to support the full use of the Regulatory Information Management (RIM) system.  She created and maintained regulated documents and data in the RIM system.  Erin was responsible for assembling and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP) utilizing Veeva PromoMats.  Erin graduated from James Madison University with a BS in Biology.

Sharon Nazimek

Sharon Nazimek has over 25 years experience in combined Regulatory Report/Submission Publishing in the pharmaceutical industry.  Sharon worked for Daiichi Sankyo as a Lead Dossier Specialist in Regulatory Operations wherein she performed and oversaw preparation of submissions to the FDA in both electronic and paper formats and submitted Daiichi’s first cross-referenced initial IND.  Sharon is proficient in publishing eCTD submissions using Lorenz DocuBridge, MS Word, Adobe Acrobat Professional with ISI Toolbox and Veeva Vault. Previous to Daiichi, Sharon worked for Hoffmann-LaRoche as a Senior Submission Publishing Specialist.

Lana Rutitsky

Lana Rutitskaya has over 10 years of experience in Regulatory Submissions in the Pharmaceutical area.  Lana worked at DSI Pharmaceuticals as a Lead Dossier Specialist in Regulatory Operations.   Lana was responsible for preparing and publishing a variety of submissions for IND’s/NDA’s, Annual Reports, Briefing Packages, CMC supplements, Protocol and Information Amendments and CSR’s.  She is proficient in publishing eCTD submissions using Lorenz DocuBridge, Octagon Viewpoint, MS Office Suite, Adobe Orifessional and ISI Toolbox, as well as preparing paper submissions.  Lana has a BS in Electrical Engineering and a Certificate in Computer Programming and Design Technique.

Drea Wilkerson

Andrea “Drea” Wilkerson has over 27 years of experience in the pharmaceutical industry with over 17 years in report publishing and preparing submissions, including IND amendments, global NDA’s, BLA’s, SAE’s and Labeling Supplements, Protocol Amendments, Briefing Packages and Information Amendments to the FDA. Drea worked as a Submission Publisher Specialist for Regulatory Affairs at Roche and at Parexel.    She was responsible for formatting and electronic publishing of complex clinical and regulatory documents such as CSRs, IBs, Protocols, Safety Documents, Briefing Packages, FDA Responses, RMPs using RCAM, Word, Adobe Professional, ISI Toolbox and Insight Publisher.

Business Operations

Donna Sobol

Senior Director,  Business Operations

Donna Sobol is Senior Director of Business Operations at Advyzom. Donna works with the CEO and Business Partners to manage Financial Operations for Advyzom which includes managing expenses, payroll and financial records. Additionally, Donna manages the invoicing and contracts process and is the primary interface to clients. Donna has over 14 years of experience supporting business and financial operations. Prior to joining Advyzom, Donna   spent 10 years of her career working for Chase Manhattan Bank in New York in various departments.  As Vice President in the Personal and Private Banking Divisions, Donna was responsible for the sales and client services for the Upper West Side of New York comprising a total business of $41million. Donna brings a broad array of expertise in financial and operational leadership experience.  Read full bio >>

Christine Mazzarisi

Director, Human Resources and Relations

Christine Mazzarisi is the Director of Human Resources and Relations at Advyzom.  Christine provides support for human resource processes, including recruitment, new hire orientations, employee relations, benefit administration, as well as, development of job descriptions and Advyzom’s employee manual.  Christine creates strategies to encourage and support Advyzom’s strong team culture.

Christine has over 20 years of experience in Fortune 500 companies with 12 years in the pharmaceutical industry. Prior to joining Advyzom, Christine was a Human Resource Director for IMSHealth and provided HR strategy in resource planning, employee relations, executive coaching, performance development and training. She received the STAR Award from IMSHealth for developing and implementing a rotational training program across the organization for decreasing new hires’ learning curves and increasing productivity. Read full bio >>

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