Strategically solving your critical Global R&D challenges
WHO WE ARE
Pyxa is honored to have a talented and experienced team of consultants.
At Pyxa, our commitment to diversity and inclusion in the workplace starts with the partners. We believe that our high-performing, talent-led organization can be attributed to our values of inclusion and diversity.
We are proud that our organization embraces and exhibits diversity across age, ethnicity, gender and gender orientation.
With over 25+ years of experience in the pharmaceutical industry, Carol’s background as a leader in regulatory strategy, operations and labeling, aided her in the establishment and strategic direction of global regulatory operations functions with a focus in cross-functional R&D and its delivery.
DALIA EL-SHERIF, PHD
With over 20+ years of experience, Dalia’s unique background blends entrepreneurship, management consulting and industry in the pharmaceutical, medical device and healthcare industries, delivering innovative solutions in research, operations, strategy and technology.
Michael has 20 years of experience in regulatory and global submissions management. His attention to detail and expertise in R&D operations has reduced costs and increased value and efficiency cross-functionally in many pharmaceutical companies.
- Carol implemented global regulatory operations functions at J&J, Astra Merck, AstraZeneca and Shire, excelled at cross-functionally R&D delivery and technology implementations.
- Her extensive proven prominence as an industry leader in the development and execution of global strategic initiatives has enabled Carol to develop and manage cross-functional R&D centers of operational excellence. Carol has successfully delivered in every size pharma (small to very large).
- Carol has in-depth knowledge of global regulatory affairs (including, but not limited to, global Health Authority Requirements, cross-functional processes, standards and training requirements) and implementation of content management and publishing systems (including but not limited to Veeva, Documentum, eCTD express, Insight Manger, Insight Publisher, Glemser, etc.).
- Carol co-founded Pyxa Solutions in 2012, with a passion for driving excellence in R&D operations in the pharmaceutical industry, Carol leads Pyxa’s Strategy Practice.
- Carol has led multiple global simultaneous submissions, cross-functional processes (e.g. Promotional Materials Management) and several large scale compliance initiatives (e.g. Global Labeling).
- Dalia was top Strategy/Change consultant at PA Consulting & IBM and a top performer at Shire.
- At PA and IBM, Dalia successfully led 20+ projects over 14 accounts, including, post-merger integrations, process and organizational transformations, risk management and compliance programs, strategic, business and portfolio management initiatives.
- At Shire, Dalia led the Process Optimization group for the Global Regulatory Affairs function, then moved on to lead the Strategic Planning and Portfolio Management function for Shire’s Specialty Pharma division, where she delivered a Presidents Club award winning strategic 2020 roadmap.
- Dalia leads Pyxa’s R&D Consulting and Technology Services. Dalia is also leading the development of Pyxa’s DirectusPro, a strategic Life-Science focused Cloud-Based Global Labeling Solution that streamlines and drives global labeling strategies, processes and compliance (CCDS/Local Label).
- Dalia co-founded Daylan Digital, LLC, which focuses on iTakeControl, a mobile Health Platform. Daylan Digital operates as a SaaS company with a strategic consulting collaboration with Pyxa Solutions.
- Michael has successfully led global submissions teams at Johnson & Johnson, Astra-Merck, AstraZeneca and Shire Pharmaceuticals, his success can be measured by the numerous simultaneous global submissions, with zero refusal to files and no submission delays.
- Michael co-founded Pyxa Solutions in 2012, where he leads Pyxa’s Operations Practice to support clients in development of their global submission needs across R&D (including but not limited to Submission Management, Publishing Support, System Analysis and Implementation).
- Michael’s areas of expertise include: Establishing, globalizing and leading publishing teams, processes and global submissions; Leading businesses through the development and implementation of global registration tracking solutions and R&D document management systems; Creating and document management strategies for mergers/acquisitions and litigations; Partnering with IT organizations for large scale data mappings and migrations.
MEET SOME OF PYXA'S CONSULTANTS
FRANK FAUNCE, PRINCIPAL CONSULTANT
With over 17+ years of experience in Regulatory Operations, Frank’s background in Global Submission Management, Regulatory Information Management, Document Management, and Data Governance provides in-depth comprehension of regulatory requirements to create streamlined processes and systems integration.
- Frank delivered excellent submission support and publishing for countless paper and electronic submissions to various Health Authorities throughout his years at Wyeth, Shire, Takeda, and AbbVie.
- Frank received numerous company awards for submission process streamlining and document management, submission publishing, and regulatory information management systems implementation and harmonization.
- Frank develops trusted working relationships with his colleagues to understand and develop holistic strategies to meet all needs for each client and their projects.
- Frank joined Pyxa Solutions in 2016 to support clients in development of their global regulatory operations needs (including, but not limited to, clinical trial and marketing application submission support and process improvements, data governance development, document management strategies, and regulatory information management and IDMP implementation).
VANESSA ARBOGAST, SENIOR ASSOCIATE CONSULTANT
Vanessa has 8 years of experience in Pharmaceuticals. Her background has been in regulatory affairs. Her focuses include time management, maintaining compliance, hard work, and new challenges.
- Prior to working as a consultant at Pyxa Solutions, she worked alongside the Submissions Management team at Shire Pharmaceuticals.
- Provides publishing services, including Clinical, Nonclinical, CMC and Regulatory documents including the expansive knowledge of bookmarking, hyperlinking, and PDF formatting/vertification.
- Specializes in the global standards/process development of generating, submitting and obtaining approval of variation applications for MRP and nationally registered products in the EU/ROW.
- Additional skills including creating and maintain work instructions, a guide on proper documentum standards, and performing maintenance cleanup of existing labeling document properties.
JUSTINE HAN, SENIOR ASSOCIATE CONSULTANT
With a background rooted in leading cross-functional teams in research & development, Justine is dedicated to driving innovative solutions to solve complex problems In industry.
- Prior to joining Pyxa, Justine was the Lead R&D Engineer for a technology start-up where her technical contributions resulted in 2 patents, 5 publications, and 4 conference proceedings. She was a key player in mapping the path for commercialization, synthesizing complex findings to form strategic intents.
- She is the recipient of numerous awards for her innovative work from prestigious institutions such as the National Science Foundation, the Association for Research in Vision & Ophthalmology, and Jefferson Health Systems
- Justine earned her Bachelor of Science in Chemical Engineering in 2014 at Drexel University where she was a Dean’s Scholarship recipient.
VIEW A SAMPLE OF PYXA’s WORK
Successful Delivery of 100+ Engagements, Driving Value Across 40+ Organizations
We have effectively worked at all levels of the organization from senior leadership through to management.
Collectively the team has worked across small, mid and large Pharma, Biotech, Med Device and Healthcare companies.
The team has successfully delivered cross-functionally in Regulatory, Clinical, Medical Affairs, Legal, Safety, Program Management, Strategy, Program Management, IT, Compliance and Commercial.
SAMPLE CASE STUDY: COMPLIANCE WITH TIME-SENSITIVE SUBMISSIONS
CHALLENGE: The Client, a large global Pharmaceutical Company, was anticipating an audit by the FDA for several of its time-sensitive submissions. They did not have visibility in the end-to-end process, were not able to track or report on the status of these submissions and were at risk of receiving a warning letter for non-compliance. The company required an assessment and optimization of the processes and supporting procedural documentation to ensure compliance with regulated submission timelines and a mechanism for tracking and reporting against those timelines. Some of the identified processes were cross-functional in nature and spanned multiple systems; alignment of functions and streamlining the fragmented systems was a key measure for successful delivery.
- Identified what works well, areas or risks/gaps and activities that required optimization. Established requirements for TO-BE state with cross-functional alignment on the identified needs.
- Developed optimized processes to address gaps, risks and areas of process improvement need.
- Developed a process and mechanism to track and report compliance of the time sensitive submissions quarterly to all relevant senior management stakeholders.
- Developed a training, communication and implementation plan for roll-out. Developed e-learning materials for efficient and streamlined implementation.
VALUE: Within 6 months of implementing the optimized processes the companies compliance rate was significantly improved; they were happy to report exact figures (e.g. the 1572/CV submission process was IMPROVED FROM A BASELINE OF 30% TO 96%).
SAMPLE CASE STUDY: END-TO-END RIM
A large pharma company embarked on an initiative to replace all core regulatory systems, specifically document management, registration planning and tracking, query/commitment management and change control.
CHALLENGE: A lack of cross-functional processes and scalable systems reduced the firm’s ability to improve submission cycle times resulting in an inability for the firm to effectively keep up with increased submission volume due to geographic expansion of their products.
DELIVERABLE & VALUE: End-to-end cross-functional processes, enabled by systems that ensured compliance and value.
- Established disciplined data accountability and governance.
- Established consistent document management processes across all functions responsible for regulatory submissions.
- Created a simultaneous submission strategy for submission in the US, EU and Japan on the same day.
- Developed a Core submission package and associated processes to reduce multiple builds as result of growth market expansion.
- Recommended and helped implement systems that enabled the strategies above.
EXPLORE PYXA’S CORE VALUES
COLLABORATE & LISTEN
We listen to our clients needs and collaborate to ensure alignment throughout the engagement.
PROBLEM SOLVE & PLAN
We solve complex problems with actionable plans. We deliver QUALITY projects ON TIME and ON BUDGET.
We innovate and provide a framework for integrating and bridging knowledge across multiple technologies and thought leaders.
Our flexible approach and experience in identifying and implementing solutions allows us to respond to a client’s changing needs.