USER CONTRIBUTIONS - Key Persons
Job Titles:
- Head of Pediatric Center of Excellence
Job Titles:
- Chemistry, Manufacturing & Controls
Job Titles:
- Head of Business Development
Jim is a high-performing R&D leader with significant experience developing biologics and small molecules into successful drug candidates. As an accomplished scientific leader and functional manager in areas of Analytical and Pharmaceutical Development, Jim has led teams in the development of several new biologic and chemical entities that are now marketed drugs. He has a proven track record of building and optimizing organizations, managing cross-functional projects, and applying essential technologies and data strategies to achieve business objectives while minimizing risk.
Throughout his career, Jim has been responsible for working with multi-disciplinary teams creating pharmaceutical development and regulatory strategies, including leading the development & execution of data & dossier sciences system strategies, for biologics (monoclonal antibodies, vaccines, bispecifics) and small molecules and he has been a team leader for key initiatives across R&D and Commercial organizations (Lean Early Development, Criticality Analysis, and Data Sciences projects).
Job Titles:
- Head of Early Drug Development
Mark is a pharmaceutical executive with more than 35 years of experience, covering all aspects of CMC (Chemistry, Manufacturing & Controls) research and development, from early drug development through commercial manufacturing.
Mark began his pharmaceutical career at The Upjohn Company (finally becoming Pfizer) as a process chemist working on API process development for clinical and commercial needs, eventually moving into the leadership of global, multi-site, chemical process R&D organizations with responsibilities for both laboratory and pilot plant facilities. From there he transitioned to portfolio management, providing broad technical, strategic and governance oversight for cross-functional CMC activities within a highly diversified portfolio of development projects.
Upon joining Johnson & Johnson (Janssen), he had responsibility for the API development group in the US and took over leadership of the global CMC Portfolio Management function with accountability for CMC activities across the entire small molecule development spectrum (pre-clinical to life cycle management; all therapeutic areas). His most recent role was in Janssen Supply Chain, leading End-to-End Strategy, where he helped orchestrate the end-to-end lifecycle management of commercial products, via improved strategies, oversight, and governance, with attention on delivering the best product possible.
Expertise:
Cross-functional CMC strategy and development, from early development through commercial manufacturing
Organizational design, leadership and governance, with an emphasis on operational effectiveness
Job Titles:
- Head of Digital
- Pharma Life Sciences Leader
Mark Buswell is an experienced pharma life sciences leader with a unique blend of experience in pharma late-phase development and manufacturing, and digital transformation strategy and system delivery. He is noted for his blend of deep life sciences knowledge and strategic business thinking.
Mark worked at GSK from 2002 to 2023 where he held senior roles in R&D, manufacturing and IT. He has experience across a range of modalities including small molecules, large molecule biologics, oligo's, cell and gene therapies and vaccines. He has a PhD in Chemical Engineering from University of Cambridge and an MBA from Cranfield University. His interests include information technologies, synthesis of APIs using novel methods, novel formulation technologies, fermentation technologies, advanced analytical technologies and automation. He is a chartered Chemical Engineer, a Fellow of the Institute of Chemical Engineering and a Fellow of the Royal Academy of Engineering.
Mark has proven skills delivering technology-driven business transformation. His functional expertise includes:
Late-phase development and manufacturing strategy
Advanced manufacturing technologies
Digital life sciences transformation
IT transformation to a product-centric agile philosophy
Creative and inspirational leadership
Job Titles:
- CEO
- President
- President & CEO of NGT BioPharma Consultants
President & CEO of NGT BioPharma Consultants, Dr. O'Brien is recognized as a forward-thinking, technology-savvy business executive with over 25 years of biopharmaceutical industry research and development experience.
From 2001 through 2010, Michael served as the AVP of Wyeth's Synthesis Research & Development (SR&D) group and as the acting head of Chemical Development, overseeing the cGMP Kg-laboratories, Pilot Plant, SR&D, EH&S, and the API External Supply departments. After the 2010 acquisition of Wyeth, Michael transitioned to become Pfizer's Pharmaceutical Sciences Vice President of Technology & Innovation, where his diverse group of scientific leaders and technology experts developed and managed the Pharmaceutical Sciences technology strategy. The teams' activities included creating and leveraging innovative funding approaches to address Pfizer's future-state API, drug product, analytical, and digital technology capabilities. The creation and management of multi-party external alliances directed towards the design, development, and implementation of high-value technology platforms reinforced the teams' efforts, resulting in several very successful platform implementations. Notably, Michael championed the design, fabrication, and implementation of a portable, continuous, miniature, and modular (PCMM) solid oral dose manufacturing facility. The first of its kind facility was fabricated off-site, assembled in a Pfizer warehouse, and ultimately commissioned to provide launch and commercial supplies of the 2019 FDA approved oncology drug Daurismo.
After leaving Pfizer in early 2018, Michael decided to leverage his decades of scientific expertise, leadership experience, and entrepreneurial endeavors to establish an innovative and transformative consulting firm, NGT BioPharma Consultants, founded in late 2018, was created to partner with life sciences companies of all sizes, offering strategic advice, ‘boots on the ground' assistance, and outsourcing solutions. The company's leaders, experts, and professionals are strategically focused on biopharmaceutical drug development and the advanced technologies foundational to the industry's development & manufacturing of medicines.
Over the years, Dr. O'Brien has received many awards and recognitions, including Case Western Reserve University's prestigious 2017 Department of Chemistry Outstanding Alumnus Award and being named an Industry Influencer on The Medicine Maker 2019 Power List. His contributions to the public domain include more than 60 publications, presentations, and patents.
Expertise
CMC drug development from late discovery through commercial tech transfer
Ground-breaking technology conceptualization, development and commercialization
Job Titles:
- DABT - Head of Nonclinical Sciences
A seasoned pharmaceutical drug development executive, Dr. Placke's expertise includes drug safety and metabolism (DSM), exploratory research and discovery biology, chemical product development (CPD) and contract research organizations (CROs). He recently concluded a position as Head of Drug Discovery for Shire Pharmaceuticals (prior to Takeda's acquisition of Shire), a role that included Global Head of Nonclinical Development and Head of U.S. Discovery Research. In that position, he was responsible for a Research portfolio comprising 35-40 programs and nonclinical development of more than 45 development stage programs, including discovery biology, modality development, pharmacology, toxicology, pathology, pharmacokinetics and drug metabolism, bio-analytical and biomarker support, in vitro diagnostics, nonclinical regulatory submissions, and as an executive member of R&D.
Recognized as a drug safety expert, Dr. Placke's experience includes building and leading a multi-discipline, non-clinical drug development group while senior vice president at Alnylam Pharmaceuticals, where he recruited more than 50 subject experts across multiple disciplines to create the Drug Safety and Metabolism Department. He has a solid record of accomplishments in research and development, including advancing drugs from discovery through market registration, as well as executive leadership skills and expertise in scientific assessment of new pharmaceutical therapies and technologies.
Expertise
R&D of small molecules, biologics, gene therapy, siRNA therapies, vaccines and specialty drug products
Job Titles:
- Head of Non - CMC Regulatory Strategy
As an accomplished pharmaceutical leader, Ms. McGuinness has earned a reputation for crafting successful regulatory strategies, obtaining regulatory approvals, driving principles-based compliance initiatives, and providing advice that empowers the business to better understand risk and ensure that smart, informed decisions are made. Ms. McGuinness has broad experience across all the regulatory science disciplines, and is passionate about drug development, especially for rare diseases and unmet medical needs.
Prior to joining NGT, Ms. McGuinness held various positions of increasing responsibility at AstraZeneca Janssen, Veloxis Pharmaceuticals, Mylan, PA Consulting, Octagon Research Solutions (now part of Accenture), Sanofi, Liquent (now part of Parexel) and Ranbaxy Pharmaceuticals Inc. Ms. Mc Guinness has participated in several joint industry-agency initiatives. She was awarded the FDA Commissioner's Special Citation for her contribution to the HL7 Structured Product Labeling standard & FDA guidance.
Expertise
Regulatory strategies, including expedited pathways and orphan drugs
Driving digital transformation within the regulatory, quality, and compliance space
Fast track, breakthrough, accelerated approval, rare pediatric disease designation, orphan drug designation, and priority review
Managing health authority meetings and negotiations
Creating and enhancing commercial compliance frameworks
Job Titles:
- Chemistry, Manufacturing & Controls
Job Titles:
- Administrator
- Head of Administration
- Senior Executive
- NGT BioPharma Consultants' Senior Director of Administration
As NGT BioPharma Consultants' Senior Director of Administration, Ms. Franckowiak opens the line of communication between clients and consultants to get projects done. With over a decade of Executive-Level experience, Rachel is highly skilled in office management, bookkeeping, website content development, strategic implementation, and company communications. Rachel's background includes working with executives in corporate finance, investment banking, and M&A consulting.
Expertise
Executive/C-suite Office Management
Research and Reporting
Content Development, Website, Social Media
CRM/Database Development and Maintenance
Job Titles:
- Head of Global Regulatory Strategy and Submissions
- Principal Consultant With Roger Nosal PharmaCMC Regulatory Consultants
Roger Nosal is Principal Consultant with Roger Nosal PharmaCMC Regulatory Consultants. Prior to September 2022 he was Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer where he was accountable for development, preparation & prosecution of global regulatory CMC applications for new commercial products & investigational applications (small & large molecules, combination products, vaccines including the COVID-19 mRNA vaccines and gene/cell therapies).
Roger is currently Rapporteur for the ICH QDG and has served as PhRMA representative to several ICH EWG & IWGs. Roger was instrumental in development & implementation of Quality by Design & was awarded the Pharmaceutical Discovery, Development and Manufacturing Forum Award from AIChE for outstanding contributions to advancing QbD in 2013. He has been an invited speaker/expert panelist (>230) on a myriad of CMC development/regulatory topics including technical innovations (continuous manufacturing, PAT & adaptive controls).
Expertise:
Contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees.
Roger's 41 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 27 years in regulatory affairs & 13 as a Medicinal & Process Chemist and author of 24 patents.
Job Titles:
- Head of Quality & Compliance
Job Titles:
- Process Analytics and PAT Innovator