Regulatory Strategy/US Agent
Cindy Dinella, R. Ph., Pharm.D.
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, M.S.
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.
Liz Lucini Batson, Pharm.D.
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.
Ketna Patel, Pharm.D.
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.
Heather Knight, Pharm.D.
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.
Candice Teuber, Pharm.D.
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.
Rula Ibrahim-Saker, Pharm.D.
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.
Marissa Fletcher, Ph.D.
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, B.S.
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, B.S., M.S.
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.
Medical Writing and Publications
Jacqueline Sterner, Ph.D.
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, M.Ed.
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, M.S.P.H.
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, B.S.
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, B.A.
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.
Regulatory Operations and Submissions
Theresa Dalla Riva
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, B.S.
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, B.S.
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, B.S.
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, B.S.
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, B.S.
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, M.A.
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, M.A.
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.
Catherine A. Wheeler Consulting, LLC
Catherine Wheeler is a hematologist and oncologist with over 20 years of industry experience in Clinical Development. She has held senior level positions in Pharma and Biotech in early and late clinical development for both small molecule and biologic therapeutics and has particular expertise in new molecule projects going from Discovery into Phase 1. She has been responsible for medical strategy for compounds in clinical development as well as functional and cross-functional team leadership. Most recently she has been a consultant in pharmaceutical development for numerous companies and projects. Catherine was Chief Medical Officer and Senior Vice President for Clinical Development at Acetylon Pharmaceuticals Prior to Acetylon, Catherine was Site Head for Oncology Translational Medicine at Roche Pharmaceuticals. Prior to Roche, Catherine was Vice President for Strategic Planning and Business Development within the Oncology and Infection Therapeutic Area for AstraZeneca. Catherine received her Bachelor of Science Degree from Bennington College and her Medical Degree from the University of Illinois Medical Center. Her Residency in Medicine was at Beth Israel Hospital and she was on the staff of Beth Israel Deaconess, Dana-Farber Cancer Institute, and Harvard Medical School.
Boudicca Dx, LLC
Dr. Gordon has worked in the oncology field for over 20 years and the diagnostics industry for over 10 years developing innovative biomarker and diagnostic testing products. Dr. Gordon has experience working in both diagnostic and therapeutic companies driving the product development and regulatory strategy for high-value companion diagnostic assays, which include the multi-indication PD-L1 immunohistochemistry assays launched by Roche for the cancer immunotherapy TECENTRIQ and the pan-cancer genomics testing strategy for Loxo Oncology’s VITRAKVI. Dr. Gordon runs a consulting firm Boudicca Dx., LLC. supporting clients with their biomarker testing and companion diagnostics strategies. Dr. Gordon received her B.S. in Molecular and Cellular Biology from the University of Arizona, Ph.D. in Pharmacology from Duke University, and completed post-doctoral training in Cancer Biology at the Translational Genomics Research Institute and Arizona Cancer Center. Dr. Gordon has hands-on experience analytically and clinically validating tests spanning genomic, proteomic and transcriptomic technologies. Dr. Gordon knows the regulatory pathways for clinical trial assays and in vitro diagnostics and has direct experience developing tests in accordance with CAP, CLIA, NYS-DOH, EU (IVDR), and US-FDA regulations. Dr. Gordon has led regulatory submissions and interactions to support both the investigational use (in clinical trials) and marketing of tests. https://www.boudiccadx.com
Aaron Bernstein Consulting, LLC
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.
Mary Clark, LLC
Mary Clark has over 30 years of experience in medical and scientific writing focused on pharmaceutical regulatory documents or scientific/medical manuscripts for peer-reviewed journals. Mary has expertise in a number of therapeutic areas including pulmonary, oncology, cardiovascular, gastroenterology, immunology, pain management, CNS, orthopedics, infectious disease, and women’s health. She also has a strong background in scientific research and statistics, having conducted studies in biological oceanography at the Smithsonian Institution while holding a doctoral fellowship. Mary earned her Master’s Degree in Technical and Scientific Communication from Miami University of Ohio and a Bachelor’s Degree in Biology from the University of Delaware.
DC Writing LLC
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. Dianne is an RN who received her BA in English from Montclair University and her BSN from Fairleigh Dickinson University.
La Puerta Roja, LLC.
Dr. Hilary Sheevers is a toxicology and strategic consultant to the pharmaceutical industry. She provides advice on nonclinical safety and strategic planning for drug development, gap analysis, and due diligence for in/out-licensing assets. She was previously at Janssen, Inc, founder and president of Aclairo pharmaceutical consultants, and a regulator at FDA, CDER. She currently is sole proprietor of La Puerta Roja LLC and continues to provide nonclinical worldwide safety strategy, study planning and monitoring recommendations, and regulatory interactions. She is an acknowledged worldwide expert in regulatory communications with health authorities, including simple regulatory filings to complex position papers with sophisticated scientific and regulatory discussions. Dr. Sheevers’ experience includes virtually all therapeutic areas for biologics and small molecules.
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 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.
LM Drucker Consulting LLC
Dr. Lisa Drucker has over 20 years of experience in Regulatory Affairs with focused expertise in ensuring medical products meet FDA requirements related to Advertising & Promotion and Labeling. She has extensive experience in interacting with the FDA Office of Prescription Drug Promotion (OPDP). She has built and optimized efficient business processes in electronic document management systems, especially for the Promotional and Medical Review Committees and Labeling Review Committee processes. Dr. Drucker has specific industry experience in hematology/oncology, supportive care, rare diseases, endocrinology, neurosciences, cardiovascular, anti-infectives, urology, women’s health and pain management. She has supported over 15 product launches and advised US and Global Marketing teams on the development of strategic messaging that are competitive and compliant with FDA regulations. Dr. Drucker is an expert on FDA’s Consistent with FDA Labeling Guidance and use of data in promotion that is not in FDA-approved labeling. She also has proficient expertise on FDAMA 114 regulations, 21st Century Cures Act, and FDA’s Payer Guidance. Dr. Drucker held various positions in Regulatory Affairs at Celgene, Daiichi Sankyo, Novartis, Sanofi-Aventis and Johnson & Johnson. Dr. Drucker received her Doctor of Pharmacy degree with a Business Minor from University of Rhode Island, College of Pharmacy and her Masters in Business Administration from Rutgers Business School. She completed a Medical Information Post-Doctoral Fellowship with Rutgers University at Ortho-McNeil Pharmaceutical.
The Oberman Group, LLC
Jana Oberman is a Regulatory Affairs Strategic Consultant based in Manhasset, NY. Jana founded The Oberman Group, LLC in August 2022 after having served as Vice President, Global Regulatory Affairs at biotech startups EQRx, Inc. and Ovid Therapeutics Inc. Prior to that, Jana held roles of increasing responsibility at Hoffmann-La Roche, Inc., where she served as a regulatory strategist for drug development teams focused on the Neuroscience, Ophthalmology & Rare Diseases (NORD) therapeutic areas. She considers herself deeply committed to fulfilling areas of high unmet medical need by addressing lack of treatment options, barriers to access, and financial toxicity associated with available therapies. Jana previously served as a member of the Steering Committee for the Women in Bio and Co-Chair of the Young Women in Bio Metro New York Chapter. Currently she is a Life Science Entrepreneur Mentor at the Center for Biotechnology, NYS Center for Advanced Technology and a member of the Board of Directors of Eglevsky Ballet. Jana obtained her Bachelor of Science in Biopsychology and Cognitive Sciences from the University of Michigan at Ann Arbor and a Master of Public Health in Health Promotion and Disease Prevention from Columbia University Mailman School of Public Health. Jana also earned her Regulatory Affairs Certification in 2012 and in 2018 and completed a 200-hour Registered Yoga Teacher Training.
PILOT Rx LLC
Dr. Jeffrey Murray is an internal medicine and infectious diseases physician who is currently an independent consultant for issues related to antiviral drug development through his consulting company, Pilot Rx LLC (launched 2021). He previously worked at the Division of Antiviral Drugs at the Food and Drug Administration (FDA) for 29 years, where he served as the Deputy Director for 20 years. During his service at FDA, he oversaw drug development and approval of numerous antivirals agents and was lead author or co-author on FDA guidance documents for the development of therapeutics for HIV, HCV, HBV, HDV, herpes simplex, influenza, RSV, and antiretroviral combinations intended for use under the PEPFAR (President’s Plan for AIDS Relief) program. He spearheaded numerous initiatives to facilitate HIV drug development including: pathways for expedited development and approval of new versions of HIV drugs for use under PEPFAR, ways to streamline trials for multi-drug resistant patients living with HIV, and innovation of trial designs for HIV prevention. He also served as FDA’s scientific lead for validating surrogate markers in HIV, HCV, and HBV drug development. Dr. Murray received his medical degree from The Ohio State University, and his MPH from George Washington University. He completed his infectious diseases fellowship at the University of Cincinnati.
Roth PharmaReg LLC
Dr. John Roth is a regulatory strategic leader with more than 25 years of experience in the development and implementation of US and Global regulatory strategies for small molecule and biologic products across all phases of drug development. He has direct experience in gaining approvals for BLAs, NDAs and sNDAs, as well as IND submissions, FDA and Global Health Authority Meetings, Formal Dispute Resolution procedures, Orphan Drug development and expedited approval pathways including Breakthrough Therapy, Fast Track and Priority Review designations. His therapeutic areas of expertise include Endocrine and Metabolic, Infectious Disease, Immunology and Inflammation, and Rare Disease and Rare Blood Disorders.
Therainnova AG, Switzerland
Dr. Stephanie Krumholz is Founder and CEO of therainnova AG, Switzerland. Dr. Krumholz is an entrepreneur and a regulatory leader with about 20 years of experience in developing and implementing regulatory strategies focusing on EU, Switzerland and certain ROW countries. She supports companies in shaping the regulatory environment across therapeutic areas from early development through filing submissions and up to providing post-marketing support in those markets. Dr. Krumholz has served as EU regulatory lead, US regulatory lead, and Global Regulatory Leader in various NDA /BLA / MAA submissions across several jurisdictions. Her experience includes providing international strategic development plans, labelling analysis, paediatric programs, as well as leading Health Authority meetings with EU, Swiss, US and certain ROW Health Authorities including managing two FDA Advisory Committees and several EU Scientific Advise meetings. In addition, Dr. Krumholz has successfully managed critical issues and safety related changes across a variety of projects. She supports companies in Switzerland to gain marketing approvals through identifying the most optimal filing pathway while within Switzerland, in parallel, advising the clients in the local requirement (QMS) when acting as Swiss Marketing Authorisation Holder.
YRS Consulting, LLC
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.
ZASADDYM V SAJ, LLC
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.
Sharon Nazimek, LLC
Sharon has over 25 years of combined Regulatory Document and Submission Publishing in the pharmaceutical industry. Sharon has worked as a Lead Dossier Specialist in Regulatory Operations/Submissions where she performed and oversaw preparation of submissions to the FDA in both electronic and paper format for IND’s/NDA’s such as initial INDs, Annual Reports, Briefing Packages, CMC supplements, Protocol and Information Amendments, CSRs and OPDP. She is proficient in publishing eCTD submissions using Lorenz docuBridge, MS Word, and Adobe Acrobat Professional with ISI Toolbox. Sharon is highly focused on the client and can provide pre-submission document publishing and submission support offering frequent communication and close collaboration to meet needs and timelines.
Prior to joining Advyzom as a consultant in Regulatory Operations and submissions, Sharon held positions within Regulatory Operations at Mallinckrodt Pharmaceuticals, Daiichi Sankyo, Inc., and Hoffmann-La Roche Inc. /Genentech.