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

dinella

Dr. Cindy Dinella is a founding partner and holds the position of President of Advyzom, located in Berkeley Heights, New Jersey. 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. Dr. Dinella specializes in leading, guiding, and assisting biopharmaceutical companies with global and US drug development programs to meet and influence health authority requirements in order to successfully deliver the best outcome for each patient and company. She has strong leadership, strategic thinking, influence management and cross-functional teamwork skills, gained over many years of experience working within global drug development across therapeutic areas, throughout phases of development, internally with Senior Corporate Management and Boards, and externally with the Food & Drug Administrations (FDA). Dr. Dinella managed and mentored hundreds of employees over her tenure and believes in people with talent and core values as a critical asset to success. Based on her experience, skills and passion for her work, Dr. Dinella has been partnering with clients to advise on developing products, resolve critical regulatory issues, proactively influence health authorities, develop people and increase confidence with Boards and Investors with their programs and plans. Read full bio

Lisa Maffei Luther, MS
Senior Vice President

maffei-lutherLisa Maffei Luther, M.S. was a Founding Partner of Advyzom, and currently holds the position of Senior Vice President.  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. Advyzom is committed to provide highly qualified and proven successful professional leaders and experts in regulatory strategy, medical writing and regulatory intelligence. Ms. Maffei Luther’s broad global/domestic regulatory development expertise gained in her 30 years in Pharma uniquely suits her to provide the needed strategic leadership and guidance that biopharmaceutical companies need to successfully navigate through complex and evolving Health Authority requirements. Ms. Maffei Luther has been recognized for her leadership and innovation by assuming positions of increasing magnitude and scope and successfully bringing multiple products across a range of therapeutic areas and FDA Divisions to the market and to the patients who need them. Her diligence and drive to deliver on company objectives has been exemplified by directly managing and guiding the approval of >70NMES/line extension and >100 INDs. Read full bio

Angela Windt, Pharm.D., R.Ph
Senior Director, Regulatory Strategy

Angela_WindtDr. Windt is Senior Director of Regulatory Strategy at Advyzom. Prior to Advyzom, Angela worked at Hoffmann-La Roche where she gained diverse regulatory experience in early and late stage development and for marketed products across a broad range of therapeutic areas including virology, oncology, cardiovascular, and metabolism. Dr. Windt served as Global Regulatory Leader (GRL) as well as US Regulatory Lead for various development programs. Dr. Windt has successfully led team preparations for health authority meetings, FDA Advisory Committee meetings, and meetings with various government bodies such as HHS, BARDA, CDC and NIH. As the Regulatory Leader for Tamiflu® during the 2009 influenza pandemic, Dr. Windt also is experienced in pandemic planning and Emergency Use Authorizations (EUAs). Read full bio

Rula Ibrahim-Saker, R.Ph. Pharm.D.
Director, Regulatory Strategy

Rula Ibrahim-SakerPrior to joining Advyzom, Dr. Ibrahim-Saker worked at Hoffmann-La Roche where she held positions in Regulatory Affairs and Regulatory Intelligence. Dr. Ibrahim-Saker is experienced in developing and implementing regulatory strategies for early development programs and marketed products across various therapeutic areas. Dr. Ibrahim-Saker’ s special expertise is in regulatory intelligence services that range from monitoring and analyzing new regulatory trends, creating regulatory databases, preparing presentations and briefing materials for topics of interest to special regulatory requests across different therapeutic areas. Dr. Ibrahim-Saker possesses extensive experience in advisory committee meetings preparations that involve developing FDA briefing packages, creating issue cards and development of advisory committee member profiles. In addition, Dr. Ibrahim-Saker has worked on the development and launch of iPLEDGE, the risk management program (REMS) for Accutane. Read full bio

Jackie Sterner, Ph.D.
Global Head of Medical Writing and Publications

Jackie SternerDr. Sterner joined Advyzom in December 2011. Since joining Advyzom, Dr. Sterner has been involved in the writing of a broad range of clinical and nonclinical documents for IND and CTA filings and for global marketing applications. Dr. Sterner was formerly North American Head, Medical Writing and Editing and at Hoffman-La Roche and Group Director of Labeling. As North American Head of Medical Writing and Editing, Dr. Sterner provided leadership and strategic direction to a staff of 30 medical writers and editors. She personally directed, prepared, and submitted over 70 global marketing applications for NMEs and line extensions and over 100 IND and CTA filings for drugs and biologics in diverse disease areas, including metabolic/cardiovascular, oncology, virology, CNS, dermatology, immunology, pulmonary, and transplant. Read full bio

Theresa Dalla Riva
Vice President, Regulatory Operations and Submissions

Theresa Dalla Riva is the 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.  Additionally, the Operations and Submissions team is experienced in publishing documents and submissions to EMA and Canada.  Theresa ensures compliance with FDA e-CTD requirements and client archiving.
Theresa has over 28 years of experience in Regulatory Operations and Submissions.  Prior to joining Advyzom, Theresa held management positions within Global Regulatory Operations at Daiichi-Sankyo Inc. and Hoffmann-LaRoche Inc./Genentech.
Theresa’s technical capabilities include state of the art publishing tools such as, Accenture Quantum/ViewPoint, Liquent InSight Publisher/Viewer, eCTD Reviewer, Lorenz docuBridge, Global Submit, Documentum/First Doc, Adobe Acrobat 7, 9, 10 Pro, ISI ToolBox, Compose for PDF, Lifecycle Management, Word Templates, Microsoft Office Suite 2007/2010/2013, IpSwitch/Filezilla FTP Transfer, and  Electronic Submissions Gateway (ESG).

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.
Renee’s extensive technical capabilities include state of the art publishing tools such as, Accenture Quantum/ViewPoint, Liquent InSight Publisher/Viewer, eCTD Reviewer, Lorenz docuBridge, Global Submit, Documentum/First Doc, Adobe Acrobat 7, 9, 10 Pro, ISI ToolBox, Compose for PDF, Lifecycle Management, Word Templates, Microsoft Office Suite 2007/2010/2013, IpSwitch/Filezilla FTP Transfer, and  Electronic Submissions Gateway (ESG).

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.
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.  He held positions within the Regulatory Submissions Group and Regulatory Program Management at Hoffmann La Roche Inc/Genentech Inc.  Subsequent to Roche, David held leadership positions with Regulatory Operations at Mitsubishi Pharma and Chugai.
David has a BS in Biology from the University of Puerto Rico.  David has outstanding working knowledge of document management systems, publishing software, and technical capabilities which include Liquent InSight Publisher/Viewer, ISI toolbox, Adobe Acrobat, SharePoint, Lorenz docuBridge, Documentum/First Doc, Adobe Acrobat Pro 7, 9, 10 and 11, Compose for PDF, Lifecycle Management, Word Templates, Liquent/Accenture templates, Microsoft Office Suite 2007/2010/2013, Filezilla FTP Transfer, and Electronic Submissions Gateway (ESG).

Donna Sobol
Chief Operating Officer

Donna SobolDonna Sobol is the Chief Operating Officer for Advyzom, a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry. Donna runs all financial and operational aspects of the business. Donna prides herself in developing positive relationships with all clients, vendors and subcontractors as they are an integral part of her business success. Donna spent ten years of her career working for Chase Manhattan Bank in New York City in various departments. As Second 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 City comprising total business of $41 million. She motivated and trained staff to manage high net worth clients who in turn produced an increase in deposits of $15 million annually. Read full bio

 

CONSULTANTS

Joanna Waugh, BSc (Hons)
Executive Director, Regulatory Strategy

Rula Ibrahim-SakerJoanna Waugh is Executive Director, Regulatory Strategy at Advyzom. 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, Ms Waugh 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, Ms. Waugh 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. Read full bio

Karen H. Noh, R.Ph., Pharm.D.
Director, Regulatory Strategy

Rula Ibrahim-SakerDr. 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. Read full bio

Sathya Viswanadhan
Regulatory Operations and Submissions Manager

Sathya_Viswanadhan Sathya Viswanadhan is Regulatory Operations and Submissions Manager at Advyzom. At Advyzom, Sathya assists the regulatory team in the compilation of regulatory documents by supporting the authoring (document editing, formatting/working with templates) and the regulatory publishing (i.e. building document bookmarks and hyperlinks, performing document level quality checks) in preparation for submission to global Health Authorities. Sathya has extensive experience preparing regulatory submissions, including IND/NDA filings, Annual Reports, Labeling Supplements, Protocol Amendments, Briefing Packages and Information Amendments. Read full bio

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