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.

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.

Dr. Liz Lucini Batson is a Senior 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 oncology, rare diseases, virology, infectious disease, women’s health, and CNS. Liz has hands-on experience in obtaining breakthrough, Fast Track, QIDP, orphan, and rare pediatric disease designations from the FDA and has led NDAs to successful approval. Liz works within global teams to lead and support a broad range of regulatory activities from early development to marketed product support. Liz manages multiple complex projects simultaneously, including FDA meetings, IND submissions, amendments, responses to FDA requests, 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.

Dr. Ketna Patel is a Vice President 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.

Dr. Heather Knight is a Vice President of Regulatory Strategy at Advyzom. Heather provides strategic regulatory guidance and acts as a US Agent to FDA for domestic and international biopharmaceutical companies. Heather’s areas of expertise include oncology/hematology, virology, immunology, diabetes, CNS, obesity, urology, radiation medicine and pulmonary drugs, biologics, generics, imaging and medical countermeasures. Heather has hands-on experience in successfully obtaining BLA, NDA and sNDA approvals.  Heather manages multiple complex projects simultaneously, including FDA meetings, IND submissions, amendments, responses to FDA requests, 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.

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 and products for rare inherited conditions. 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 RMAT and 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.

Dr. Ibrahim-Saker is a Senior Director of Regulatory Strategy at Advyzom. She provides strategic and tactical regulatory services across all phases of drug development for Advyzom clients. Rula has led IND submissions, prepared Fast Track, Qualified Infectious Disease Product (QIDP) Designation requests, IND annual reports, developed briefing packages for key development milestone meetings, labeling, regulatory strategic plans, regulatory risk assessments and worked with global and US development teams and personnel to assess regulatory plans. She understands the complex US regulatory environment and is skilled at providing research and regulatory precedent in different therapeutic areas to obtain the desired outcomes. Rula brings strong expertise to clients through her role as a US agent and as a liaison to the FDA.

Dr. Marissa Fletcher is a Senior Director of Regulatory Strategy at Advyzom.  Marissa provides strategic regulatory guidance and serves as a US Agent to FDA for domestic and international biopharmaceutical companies.  Marissa has a strong and comprehensive understanding of product development providing strategic direction for projects ranging from early to late stage development.  Her therapeutic product experience includes Oncology, Gene Therapy, Immunology, Neurology, Vasomotor, Pain, and GI. Marissa has over 15 years of Regulatory Affairs experience working in big Pharma, small biotech and OTC companies.  Prior to Advyzom, Marissa has led the development and implementation of innovative regulatory strategies for early and late-stage development programs. She prepared teams for FDA meetings and acted as primary interface to FDA. Marissa has acted as a US Lead and a Global Regulatory Lead focused on developing regulatory strategies to support successful filings to INDs, BLAs and NDAs. In her previous roles, she successfully led FDA milestone meetings, applications for Fast Track designation, Orphan Drug designation and Pediatric Study Plan, and worked with biomarker/companion diagnostic strategies.

Nicole Segalini is an Associate of Regulatory Strategy at Advyzom. Nicole is responsible for providing companies regulatory US Agent support and has worked on drugs and biologics across therapeutic areas including oncology, cardiovascular, neurology, anti-infective and rare diseases. Nicole is also responsible for the compilation and publishing of Health Authority submissions, conversion of Word documents to eCTD compliant PDF’s, bookmarking, and hyperlinking within a document or across a submission.

Esha Gajjar is an Associate of Regulatory Strategy at Advyzom. Esha acts as a regulatory US Agent and/or on large projects supports the Global Regulatory Leads. She has played a role on filing NDAs, INDs, CTAs, Fast Track Designations, and Orphan Designation applications. She supports the development of global regulatory strategic plans with the conduct of precedent research and assessment of the regulatory landscape.

Dr. Jackie Sterner is the Senior 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.

Linda Sreshta is a Senior Director, Medical Writing and Publications at Advyzom. Linda has over 30 years of experience in the healthcare industry with 30 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. Linda is skilled in her abilities to communicate effectively, critically review, analyze, and interpret clinical trial data, and present scientific information in a clear and concise manner with particular attention to detail.

Jill Bartruff is a Senior Director of Medical Writing and Publications at Advyzom. Jill has over 25 years of experience in the pharmaceutical industry with over 20 years of medical writing and preparation of clinical documentation for regulatory submissions across various therapeutic areas. Jill is responsible for leading team members in authoring and providing high quality documents for electronic submissions to health authorities. Prior to joining Advyzom, Jill was President of Bartruff Medical Writers, Inc. where she managed and wrote documents for NDA and MAA submissions for 15 years for the pharmaceutical industry. Documents included 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, and informed consent forms.

Erin Bolger is a Director of Medical Writing and Publications at Advyzom. Erin is responsible for leading team members in authoring and providing high quality documents for electronic submissions to health authorities. These documents include Clinical Study Reports, Clinical Protocols, Non-Clinical Summaries, Briefing Packages, Clinical Data Memos, Orphan Drug Designation, Investigator’s Brochures, Fast Track Designation, and General Investigational Plan. She has a proven track record in delivering projects with strict deadlines. Additionally, she can work with document templates and provide pre-submission document publishing, which includes, but is not limited to, information amendments, protocol amendments, IND safety reports, annual reports, and NDA/MAA, summary documents. 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.

Dawn Bracy is a Director of Project Management, Editing and Quality Control at Advyzom. Dawn is responsible for supporting various projects within the Medical Writing, Regulatory and Operations areas. Dawn has over 25 years of professional experience in project management, quality control, submission publishing, and marketing in the pharmaceutical and nutraceutical industries. As a member of Advyzom’s Medical Writing and Operations teams, she provides project management, editing, quality control, formatting, submission publishing, and data set management of clinical and non-clinical documents for NDAs and INDs.

Theresa Dalla Riva is Vice President and Head of Regulatory Operations and Submission 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).

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.

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).

Kathy Paul is a Director of Submissions and Operations at Advyzom. Kathy provides leadership and support by directly handling submissions to the FDA and meeting tight timelines. Kathy has strong experience in publishing all documents for IND/NDA/BLA and NDS applications. For Kathy, communication is the KEY to a successful submission. Kathy has over 25 years of experience in Regulatory Submissions. Prior to joining Advyzom, Kathy held positions as a Regulatory Operations Specialist at Bristol-Myers Squibb/Celgene and Senior Document Publisher for Quintiles, Hoechst Marion Roussel and Marion Merrell Dow. Kathy has been a Global Lead Publisher for Submissions for EU, Swiss, Australia, New Zealand, Saudi Arabia and Bosnia/Herzegovina

Melissa Benedict is a Director of Regulatory Operations and Submissions at Advyzom. Melissa 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. Melissa is highly focused on client’s services in meeting their needs and timelines, offering frequent communication and close collaboration, including on-site publishing support.

Alyssa Zacchia is an Associate of Regulatory Operations and Submissions at Advyzom. Alyssa is responsible for the compilation and publishing of Health Authority submissions, conversion of Word documents to eCTD compliant PDF’s, bookmarking, and hyperlinking within a document or across a submission. Alyssa has strong working knowledge and technical capabilities which includes Microsoft SharePoint, ISI Toolbox, Adobe Acrobat, Lorenz DocuBridge, Microsoft Office Suite, Word Templates, and Electronic Submissions Gateway (ESG).

Donna Sobol is Vice President 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.

Theresa DeRojas is a Director of Business Operations at Advyzom. Theresa supports managing Advyzom’s Financial Operations and Financial Reporting which includes facilities management, expense oversight, processing payroll, preparation of client invoices and reconciliation of financial records. Additionally, Theresa directly supports the CEO with day to day administration. Theresa has over 20 years of experience working within business and financial operations. Prior to joining Advyzom, Theresa spent 12 years of her career working in New York and New Jersey financial institutions including Castle Harlan, KPMG and Ernst & Young. Theresa brings a broad array of expertise in managing budgets, forecasting and expense management. She has supported Executive management to coordinate meetings, budgets, and expenses as well as the Annual Investor’s Meeting.

Christine Mazzarisi is the Senior 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.