Adare Pharma Solutions

Articles

A discussion of the FDA's guidance on nitrosamine impurities, various approaches for reducing the presence of impurities, and how Adare's unique nitrosamine mitigation process can help products achieve compliance.

Nitrosamine Impurities Deadline: Are You Compliant?

In this article, gain insights into how early-stage pharmaceutical product development is foundational for successful clinical trials and regulatory approvals, and why collaboration with experienced partners like CDMOs is essential.

Streamline Early-Stage Development to Reach the Clinic Faster

To help improve adherence in children, drug developers need to consider innovative new dosage forms that can deliver flexible and convenient medications for young patients.


Overcoming The Challenges Of Pediatric Formulation

Pediatric formulations have become increasingly important as the healthcare field recognizes the huge impact that strict patient adherence can have on a treatment’s efficacy. But to overcome the challenges of adherence in children, drug developers need to consider innovative new dosage forms that can deliver flexible and convenient medications for young patients.

Overcoming The Challenges of Pediatric Formulation

Join the webinar to help prepare for QMM. Learn how corporate culture incentives, confidential assessments, rating systems, and quality issues relate to C Suite decisions. Hear if results be published, or will it be discretionary to companies themselves? What was “value added” for the companies the participated in the pilot program.

https://globalmeet.webcasts.com/starthere.jsp?ei=1587812&tp_key=75697412c7

FDA has begun championing Quality Management Maturity (QMM), a new quality surveillance initiative intended to raise awareness at all levels of management in the pharmaceutical industry as to how to best achieve quality objectives and improve manufacturing site quality and supply chain reliability in drug manufacturing processes. QMM follows a maturity modeling paradigm. According to FDA, QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance

Join the webinar to learn what QMM is, and how far beyond GMP functions QMM will drill into.


Compliance management: ability to consistently meet and/or exceed compliance with applicable laws, regulations, and industry best practices

Risk management: ability to identify and manage organizational risks and build resilience

Quality culture: ability to develop and maintain an organizational mindset and behaviors that value continuous learning and improvement, and customer satisfaction

Sustainability: ability to successfully secure and manage appropriate technology, infrastructure, human capital, suppliers, customers, institutional knowledge, and other resources to sustain the operations.

 President at Shabas Solutions LLC, is a management consultant with 30+ years’ experience in academic research institute and global consulting firms, providing CIO and CFO advisory services to academic, state, federal government organizations, and Fortune 100 firms. Currently he oversees multiple public health related engagements with federal organizations at Shabas including those related to drug discovery and development, medical logistics, and COVID-19 Vaccine/Therapeutics Development. He led the FDA QMM Foreign API Manufacturer Pilot project including the design, development, and administration of the draft QMM Assessment tool.


 is currently a Senior Associate with Shabas Solutions LLC providing consulting services to government and private sector life science organizations. He has over 19 years’ experience in the pharmaceutical/biotech industries serving in various roles in manufacturing, quality control, and quality assurance for both large and small sized companies. He has a broad and diverse background, with a focus on Quality Management System development, Risk Management, and Continual Improvement. 


 Microbiology, University of Maryland, currently a Senior Associate with Shabas Solutions LLC. More than 40 years working in the Government, Academia, and Industry. Patent holder with 100 publications.


, is a Senior Consultant for Shabas Solutions LLC, specializing in data analytics and pharmaceutical logistics. He is an advocate for using data-driven solutions to improve operational sustainability and quality culture. He is excited to help usher in a new chapter of global quality excellence with Quality Management Maturity (QMM).


Advisor, Quality & Corporate
Compliance
Shabas Solutions LLC

 is an Advisor (Quality and Corporate Compliance) at Shabas Solutions LLC. He is a seasoned regulatory professional offering scientific, regulatory, quality, and legal consulting services to FDA-regulated companies. He has more than 30 years of experience in the biopharmaceutical, cell & gene therapy, and medical device industries, including 10 years’ experience in biotechnology as a R&D protein chemist. For the past 20 years, he has been focused exclusively in areas of biopharmaceutical & medical device product development, regulatory project management and pre- & post marketing compliance.


Webcasts

Webinar Date/Time: Thursday January 19, 2023 at 11am EST | 10am CST | 8am PST


FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

https://globalmeet.webcasts.com/starthere.jsp?ei=1579812&tp_key=9ecaa2e743

Pediatric populations represent the most diverse patient groups in all of medicine. Factors such as individual preferences, physiology, and dosage considerations all serve to complicate drug formulation aimed at pediatric care. Drug formulation for children has become increasingly important as the healthcare field recognizes the huge impact that strict patient adherence can have on a treatment’s efficacy as well as how off-label administration of a therapy, more common among younger and older patients, can both decrease efficacy and create the potential for medication-related toxicities.


In this webcast, three panel speakers will discuss the unmet needs within the pediatric population and related clinical recommendations for pediatric dosage forms. Swallowability challenges and the impact to children’s medication, and strategies to optimize pediatric formulation development resulting in improved patient outcomes within the pediatric population will be discussed. Join the webinar to learn how you can apply these strategies for your products today.

Learn about the unmet needs facing pediatric populations:

Dose Volume and Liquid Dose Measuring Challenges

Challenges Specific to Pediatric Formulation Development

Strategies and Solutions to Improve Patient Outcomes

Swallowability and Determining the Right Dosage Form

Swallowing Challenges Unique to Pediatrics

Strategies for Improving Medication Acceptability

Rachel Meyers, PharmD, BCPS, BCPPS, FPPA


Clinical Professor
Ernest Mario School of Pharmacy,
Rutgers University

 is a Clinical Professor at the Ernest Mario School of Pharmacy at Rutgers University, and the Pediatric Clinical Pharmacist at Cooperman Barnabas Medical Center in Livingston, New Jersey. Dr. Meyers completed her undergraduate degree at the University of Mary Washington and her Doctor of Pharmacy degree at the University of Connecticut. After graduation she completed a PGY-1 residency at the University of Wisconsin Hospital and Clinics in Madison, Wisconsin, and a PGY-2 residency in Pediatric Pharmacotherapy at the University of North Carolina Children’s Hospital in Chapel Hill, North Carolina. In her current position, Dr. Meyers provides both didactic and experiential education in pediatric pharmacotherapy for pharmacy students and residents. She practices in both the Pediatric Intensive Care Unit and General Pediatric Unit at Cooperman Barnabas Medical Center.


Senior Director, Pharmaceutical
Sciences, Business Support, and
New Technologies
Adare Pharma Solutions

 has more than 20 years of experience in designing and development of conventional, NDDS/alternate, advanced/modified drug delivery systems, and pharmaceutical platform technologies for oral and other routes of administration. His expertise includes stability, solubility/dissolution, permeability, and bioavailability enhancement techniques/technologies for challenging drugs. Additionally, Dr. Shanmugam has published numerous research articles, holds multiple patents, and is a reviewer/editorial member of various prestigious journals. In his current position, Dr. Shanmugam is involved in the development and expansion of Adare’s pharmaceutical technology portfolio and facilitates product development and co-development opportunities.



Senior Director, Pharmaceutical
Sciences
Adare Pharma Solutions

i is a pharmaceutical chemist by training and completed his degree at the University of Turin.
With more than 30 years of experience in the Pharmaceutical Industry, Dr Boltri has held leading positions as Department Head and Director. Dr. Boltri has extensive experience in formulation development for various dosage forms, with a focus on oral delivery and bioavailability enhancement.


In the current role, Dr. Boltri supports Company processes leading to identify new and innovative technologies as well as valuable opportunities for product development and co-development.

Thursday, November 17, 2022 at 10 am EDT | 9 am PDT | 6 am CDT

Thursday, November 17, 2022 at 10 am EDT | 9 am PDT | 6 am CDT
In this webcast, panel speakers will discuss the unmet needs within the pediatric population, swallowability challenges related to children’s medications and strategies to optimize pediatric formulation development resulting in improved acceptability and patient treatment plans.