PharmaLex US

10/09/2023

// New! Read the eBook from subject-matter expert Gerardo Gomez, Ph.D. from regulatory consultancy PharmaLex which provides insight into key concepts in aseptic processing and current trends in their application, including special considerations for aseptic processing of ATMPs.

pharmalex.com

In this eBook, Gerardo offers valuable impressions on commissioning, qualification, and validation (CQV) from the 2023 Society for Pharmaceutical Engineers (ISPE) Aseptic Conference in Bethesda, MD. The meeting convened presenters and delegates from the world over to discuss recommendations for aseptic-process simulation (APS), novel isolator and restricted-access barrier (RABS) systems, implications of the 2022 update to Annex 1 of the EU good manufacturing practice (GMP) guideline, and more. Read the eBook now to learn about key concepts in aseptic processing and current trends in their application, including special considerations for the aseptic processing of ATMPs.

https://bioprocessintl.com/multimedia/ebooks/ebook-aseptic-processing-reflections-from-the-2023-ispe-aseptic-conference/

Book a meeting with Gerardo to explore your Quality, Management, and Compliance (QMC) projects today!

[email protected]/bookings/s/MqM7033nQU2C6gFfFCFZ0A2" rel="ugc" target="_blank">https://outlook.office365.com/owa/calendar/[email protected]/bookings/s/MqM7033nQU2C6gFfFCFZ0A2

10/09/2023

This is a must-read!

// New! Read the eBook from subject-matter expert Gerardo Gomez, Ph.D. from regulatory consultancy PharmaLex which provides insight into key concepts in aseptic processing and current trends in their application, including special considerations for aseptic processing of ATMPs.

pharmalex.com

In this eBook, Gerardo offers valuable impressions on commissioning, qualification, and validation (CQV) from the 2023 Society for Pharmaceutical Engineers (ISPE) Aseptic Conference in Bethesda, MD. The meeting convened presenters and delegates from the world over to discuss recommendations for aseptic-process simulation (APS), novel isolator and restricted-access barrier (RABS) systems, implications of the 2022 update to Annex 1 of the EU good manufacturing practice (GMP) guideline, and more. Read the eBook now to learn about key concepts in aseptic processing and current trends in their application, including special considerations for the aseptic processing of ATMPs.

https://bioprocessintl.com/multimedia/ebooks/ebook-aseptic-processing-reflections-from-the-2023-ispe-aseptic-conference/

Book a meeting with Gerardo to explore your Quality, Management, and Compliance (QMC) projects today!

[email protected]/bookings/s/MqM7033nQU2C6gFfFCFZ0A2" rel="ugc" target="_blank">https://outlook.office365.com/owa/calendar/[email protected]/bookings/s/MqM7033nQU2C6gFfFCFZ0A2

09/22/2023

// Update:

Recently, the PharmaLex US Extended Leadership had an enriching session at Cencora's headquarters, our esteemed parent company. This face-to-face collaboration wasn't just about catching up; it was about forging our path forward.

As we gear up for 2024, our mission to provide unparalleled product life cycle solutions for our clients stands strong. The union of PharmaLex US and Cencora is not just a merger – it's a catalyst for a promising tomorrow.

There's a wave of innovation, collaborations, and dynamic projects on the horizon. We’re eager to bring you along on this journey. Watch this space for more!

Your trust fuels our passion. Let’s make 2024 remarkable!

09/22/2023

// Regulatory precedent research plays a crucial role in supporting regulatory science and product development strategies. This webcast highlights the available tools and approaches for conducting regulatory precedent research and describes their utility to inform decision-making in the biotechnology and pharmaceutical industry. Understanding and leveraging regulatory precedents can enhance regulatory intelligence, facilitate informed decision-making, and contribute to the development of innovative and safe therapeutic products.

Register for the RAPS Indiana Chapter’s webcast now for RAC credits on “Utilizing Regulatory Precedence for Decision Making” Monday Monday, 25 Sep 2023 (03:30 PM – 5:00 PM EST) featuring PharmaLexperts Renata Kover and Anusha Kesireddy.

Learn more about Regulatory Affairs and CMC at PharmaLex.

This webcast highlights the available tools and approaches for conducting regulatory precedent research and describes their utility to inform decision-making in the biotechnology and pharmaceutical industry.

09/19/2023

// Exciting News! Our recent "Optimizing Product Development" event in collaboration with PA Biotechnology Center was a resounding success thanks to all of you who attended and contributed to the insightful discussions.

In an ever-evolving landscape, where innovation is key, it's crucial to stay at the forefront of product development strategies.

Our experts shared insights on how to avoid delays, streamline development, and improve the probability of success throughout each phase of the product development value chain.

Keep the conversation going! Let's continue to learn, grow, and optimize product development together.

08/18/2023

Introducing our latest episode of the PharmaLex Talks Podcast: "Avoiding Pitfalls with your Product Development Strategy," featuring special guest Alex Klein, Director of Development Consulting & Scientific Affairs at PharmaLex. Click to listen now: https://pharmalextalks.com/episodes/avoiding-pitfalls-with-your-product-development-strategy/

With over 15 years of hands-on experience in global drug development, Alex Klein is a seasoned expert who has served in prestigious organizations such as Abbott, Abbvie, and Hospira, as well as various biotech startups. Her impressive credentials include extensive work on both biologics and small molecules across multiple therapeutic areas. Alex’s vast understanding of the drug development process is evident in her contributions to several assets, from preclinical stages to commercialization, including key support roles in regulatory agency meetings and submissions.

Whether you're an established professional in the field or just setting out on your product development journey, this podcast is crafted to provide you with actionable tips and expert insights that can significantly benefit your efforts.

Stay up-to-date with future episodes of PharmaLex Talks by subscribing here: https://pharmalextalks.com/

For more information on Strategic Product Development at PharmaLex here: https://www.pharmalex.com/pharmalex-solutions/integrated-product-development/

08/18/2023

// Are you losing sleep over product development challenges? Join us for a game-changing event, proudly sponsored by PharmaLex and hosted at the PA Biotechnology Center that will put your mind at ease!

Date: September 13, 2023

Time: 4:00 PM – 6:00 PM

Location: PA Biotechnology Center, Doylestown, PA

Register here: https://go.pharmalex.com/optimizing-product-development

The vast majority of drugs that enter development fail, most often during the clinical stages. Even at the earliest stages, successful product developers have an understanding of what it takes to progress their assets through development to regulatory approval and commercial success. Importantly this includes a keen awareness of the risks and challenges that can occur throughout the development lifecycle. Understanding those challenges and proactively planning for how to address them will reduce costs, save significant development time and improve the probability of regulatory and commercial success.

Join us to learn more about how to efficiently navigate the product development landscape.

This event is brought to you by PharmaLex, a leading consultancy in the life sciences industry, in partnership with the PA Biotechnology Center, a hub for innovation and research.

Learn more about PharmaLex: https://www.pharmalex.com/pharmalex-solutions/

08/16/2023

// Exciting News! Check out this insightful article in the August issue of Pharmaphorum published by Michelle Anastasi at PharmaLex: "4 Questions to Determine the Health of Your Company's QMS (Quality Management System)."

Michelle Anastasi, https://www.linkedin.com/in/anastasim/ a seasoned expert in Quality and Compliance dives deep into these questions, providing invaluable insights and actionable strategies to boost the health of your QMS.

Is your Quality Management System (QMS) in tip-top shape? Get ready to enhance your understanding of QMS with these 4 essential questions:

1. Do you have a Quality Policy and/or Quality Manual, approved by senior/executive management, and issued within the past three years?
2. Are all controlled documents (SOPs, policies, work instructions, etc.) reviewed every two to three years by document owners in collaboration with quality assurance personnel?
3. Does the CAPA and/or investigation procedure give a step-by-step description of how to conduct root-cause analysis while identifying effective CAPAs, and assessing the impact on products and processes consistently in every investigation?
4. Is a Quality Management Review conducted periodically, involving senior management, and does that review result in continuous improvement?

Read the full article here: https://pharmaphorum.com/market-access/4-questions-determine-health-your-companys-qms

Don't miss out on this opportunity to elevate your QMS game! Learn more about Quality and Compliance at PharmaLex: https://www.pharmalex.com/pharmalex-departments/quality-management-and-compliance/

08/15/2023

// Omics Data Science - an interdisciplinary approach

PharmaLex has been supporting clients in analyzing Omics data since the beginning of genome-wide association studies (GWAS) in the early 2000s. Since then, our team has been keeping pace with the fast development of Omics technologies, integrating Omics data with phenotype data (clinical trials and real-world evidence) and building apps and dashboards to visualize the results and make data more accessible to the medical researcher.

Learn more about Omics Data Science at PharmaLex here: https://www.pharmalex.com/pharmalex-services/omics-data-science/

08/03/2023

// We're proud to highlight the contributions of our very own Lin Li, Ph.D., who will be chairing the "Methods and Applications of Statistical Genomics in Basic and Biopharmaceutical Research" session on Sunday, August 6 from 2:00 PM - 3:50 PM at the Metro Toronto Convention Centre, Room: CC-715B.

Brad Carlin, Ph.D. will chair a session on "New Methodological and Practical Approaches for Facilitating Drug Approvals in Rare Disease." Find his session on Thursday, August 10 from 10:30 AM - 12:20 PM at the Metro Toronto Convention Centre, Room: CC-714B.

For detailed conference information, please visit: https://ww2.amstat.org/meetings/jsm/2023/conferenceinfo.cfm

07/21/2023

// Unlocking Success in Regulatory Meetings: Check out Mark Lane, Ph.D.'s latest article on the "Top 10 Considerations when Meeting with Regulators."

Proper preparation is crucial for regulatory meetings, as it clarifies the necessary requirements and helps regulators grasp the development program and potential challenges.

These meetings go beyond gathering feedback; they foster strong relationships that streamline the drug development process. By understanding regulators' needs and timelines, you can achieve alignment, maximizing the chances of success.

Read the article here: https://www.pharmtech.com/view/top-10-considerations-when-meeting-with-regulators

Learn more about Integrated Product Development at PharmaLex: https://www.pharmalex.com/pharmalex-solutions/integrated-product-development/