Advyzom was founded by four partners with in-depth regulatory, global drug development and policy experience.
Cynthia Dinella, R.Ph. Pharm.D.
President and Managing Partner
Dr. Cindy Dinella is a founding partner and holds the position of President and Managing Partner of Advyzom, located in New Jersey and Washington, DC. 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
Lisa Maffei Luther, M.S. is a Founding Partner of Advyzom, located in NJ and Washington, D.C. 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
Krishnan Viswanadhan, Pharm.D., MBA
Vice President and Partner
Krishnan Viswanadhan, Pharm.D., MBA is founding partner and Vice-President 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.
Dr. Viswanadhan brings a broad knowledge of drug development and an in-depth understanding of regulatory strategy. This unique combination of experience allows him to provide the needed strategic, tactical and technical advice to our partners in the healthcare industry. Dr. Viswanadhan’s expertise comes from over 13 years of drug development and regulatory experience in early to late stage drug development and life cycle management across broad therapeutic areas including oncology, transplantation, metabolism, and dermatology. Read full bio
Jeff is a founding Partner of Advyzom. He has spent more than 15 years working with life sciences firms, particularly assisting small and mid-sized device and biopharmaceutical companies overcome dynamic regulatory hurdles to achieve U.S. market access.
Mr. Kimbell is also CEO and President of Jeffrey J. Kimbell & Associates, Inc., a Washington, D.C.-based boutique lobbying firm specializing in representing life science companies before the U.S. government. The firm has provided strategic solutions to over 80 hand-selected clients seeking creation, modification, or proper implementation of public law. Clients include: Allergan, Astellas Pharma, Cyberonics, DelCath, Orthovita, Sunovion, Abbott Medical Optics, Covidien, Amylin and many others. Mr. Kimbell established the firm in 1998 and three years later was named to the Presidential Transition Team Advisory Committee for the U.S. Department of Health & Human Services (HHS). He was the only consultant to serve on the Committee. Read full bio
Chief Operating Officer
Donna 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 in both New Jersey and Washington DC. 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
Jackie Sterner, PhD
Global Head of Medical Writing and Publications
Dr. 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
Angela Windt, Pharm.D., R.Ph
Senior Director, Regulatory Strategy
Dr. 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
Joanna Waugh, BSc (Hons)
Executive Director, Regulatory Strategy
Joanna Waugh is Executive Director, Regulatory Strategy at Advzyom. 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
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. Read full bio
Rula Ibrahim-Saker, R.Ph. Pharm.D.
Director, Regulatory Strategy
Prior 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
Jessie Tombalakian, Pharm.D.
Freelance Medical Writer
Prior to becoming a freelance medical writer, Dr. Tombalakian worked at Hoffmann-La Roche for 10 years where she held positions in Medical Affairs, Sales, Market Analytics and Marketing.
In medical affairs, Dr. Tombalakian was responsible for preparing, managing and providing medically accurate verbal and written information in response to inquiries from health care professionals, patients, and key decision makers in all aspects of managed health care and the Compendia. Dr. Tombalakian was also responsible for developing and implementing the Oncology Medical Education programs. Read full bio
Regulatory Operations and Submissions Manager
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
Regulatory Intelligence and Policy Intern
Ms. Brown joined Advyzom, as Regulatory Intelligence and Policy Intern in September 2012. Since joining Advyzom, Ms. Brown has supported and been involved in a wide range of regulatory intelligence and policy activities. Ms. Brown graduated from Carnegie Mellon University with college and university honors in May 2012. Majoring in Ethics, History, and Public Policy and minoring in Hispanic Studies, Ms. Brown wrote a senior honors thesis entitled ‘Health Care Access for Undocumented Hispanic Immigrants in New York City: Analysis and Policy Proposal.’ It won the First Place Johnson and Johnson Undergraduate Research Award at Carnegie Mellon’s Undergraduate Research Symposium.