NGT BIOPHARMA CONSULTANTS - Key Persons

Job Titles:

• Head of Business Development
• Global Business Leader
• Head of Strategy, Marketing, and Business Development

Angie is an experienced strategic global business leader who has 25+ years of experience in the Life Sciences, Pharma/Biotech and CRO industries with broad market knowledge and significant strategy, corporate development, marketing, market research/competitive intelligence, sales/business development, products, services and portfolio management, mergers & acquisitions, strategic partnerships, licensing, operations, and consulting experience. Angie leverages both a science and business background to help global companies develop and commercialize their products & services, achieve their business goals and objectives, and consistently deliver successful results in complex high-tech markets. She has held leadership positions at a variety of industry leading companies in life sciences, genomics, drug discovery, and preclinical drug development such as: Science and Medicine Group, Eurofins Pharma Discovery Services, Promega, Covance Discovery/Early Development/PreClinical, Merck KGaA/EMD Biosciences, Invitrogen Drug Discovery Solutions, Sigma, Whitehead Institute/MIT Center for Genome Research, and Amersham Life Sciences. Angie has also previously founded her own consulting company, BioToBiz, to help companies capitalize on bringing scientific business opportunities to their full commercial potential.

Job Titles:

• Head of Pediatric Center of Excellence

Job Titles:

• Chemistry, Manufacturing & Controls

Job Titles:

• Head of Business Effectiveness

Job Titles:

• Head of CMC Biologics

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:

• Principal Consultant

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:

• Head of Discovery & Investigative Research

Mike is a pharmaceutical industry veteran with 22 years of experience in research, alliance and program management, business development, scientific diligence, contract management and business projects. Mike began his career in medicinal chemistry at SmithKline Beecham (now GSK), delivering multiple candidate and pre-candidate molecules as a team and matrix leader. He then transitioned to its innovative Center of Excellence for External Drug Discovery where he helped to set strategy leading to the creation of complex alliances in the biotech space. Mike variably also served as the alliance leader or joint steering committee member for established alliances and focused his efforts primarily at the interface of discovery and development. Subsequently, he held a similar role in GSK's ophthalmology research unit before joining Johnson & Johnson Diabetes, leading multi-disciplinary teams in the evaluation and execution of business relationships. Mike is a strategic and scientific thinker, highly skilled at drug discovery, preclinical development, and managing teams and business relationships, and has led programs across therapy areas including in oncology, cardiovascular disease, inflammatory disorders, infectious diseases and ophthalmology. Expertise: Leading teams in Drug Discovery and Preclinical Development

Job Titles:

• CEO
• President

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