Navigating the Small Molecule CMC Pathway: Strategies for Avoiding Regulatory Hurdles and Early Drug Development Pitfalls

Life Sciences, Pharmaceutical Regulation, Drug Discovery & Development, Preclinical,
  • Thursday, January 19, 2023

Navigating the small molecule CMC pathway from discovery to the clinic comes with its own set of challenges and regulatory hurdles. Once the lead candidate has been selected to move into development, what’s next? Bridging discovery and clinical development can present many questions and unknown challenges for drug developers:

  • What are some of the drug substance, drug product and clinical supply considerations in advancing a drug candidate towards a First-in-Human study?
  • Would an integrated drug substance and drug development approach be best for a clinical program?
  • How long does each critical step take before reaching the clinic?
  • What regulatory considerations does one need to be aware of?

With the stakes high, having trusted and experienced guidance at this stage can help streamline the pathway from discovery towards IND, reduce risk and improve the likelihood of clinical success.

Consulting group NGT BioPharm Consultants and Quotient Sciences have helped hundreds of customers achieve their IND milestones and beyond. By offering strategic guidance and integrated services spanning the entire development pathway, both have supported programs with lead candidate selection, drug substance, drug development, biopharmaceutics, clinical and regulatory services, all focused on accelerating development and expediting strategies to address regulatory expectations toward clinical development.

Join the featured speakers as they share their expertise around the challenges and considerations that drug developers may face in early development. Mapping out key early development milestones, they will share strategies on how they’ve helped customers remove obstacles off the critical path, reduce development risks and shorten the small molecule CMC pathway to the clinic.

Speakers

http://Eleanor%20Row,%20Quotient%20Sciences

Eleanor Row, Executive Director, Quotient Sciences

Eleanor Row has over 15 years’ experience in the pharmaceutical and contract research environment working with multinational companies such as Sanofi-Aventis and Covance.

Eleanor holds a PhD in chemistry/pharmacology from The University of Sheffield. Her subsequent postdoctoral studies were carried out at the University of Liverpool under the supervision of Dr. A. Stachulski and Professor P. M. O’Neill developing anti-parasitic and anti-malarial compounds.

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In 2006, Eleanor moved to Sanofi–Aventis focusing on the synthesis of radio/stable labelled compounds and has a proven track record for delivering high quality materials to sponsors. Eleanor has held a variety of Senior Leadership roles and as an APM accredited Project Manager has first-hand experience leading early candidate development programs.

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http://Mark%20A.%20Krook,%20NGT%20BioPharma%20Consultants

Mark A. Krook, Head, Early Development, NGT BioPharma Consultants

Mark A. Krook is a pharmaceutical executive with more than 35 years of experience, covering all aspects of small molecule CMC 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.

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Upon joining Johnson & Johnson (Janssen), he was responsibile 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 (preclinical to lifecycle management). His most recent role was in Janssen Supply Chain, leading End-to-End Strategy, where he helped orchestrate the lifecycle management of commercial products, via improved strategies, oversight and governance, with attention on delivering the best product possible.

Since retiring from J&J, Mark has joined the leadership team of NGT BioPharma Consultants and is also an independent consultant.

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http://Roger%20Nosal,%20NGT%20BioPharma%20Consultants

Roger Nosal, Head of Regulatory Strategy, NGT BioPharma Consultants

Roger Nosal is currently Principal Consultant with Roger Nosal PharmaCMC Regulatory Consultants and serves as Head of Regulatory Strategy for NGT BioPharma 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).

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Roger is currently Rapporteur for the ICH QDG and has served as PhRMA representative to several ICH EWG & IWGs. Roger was instrumental in the 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). Roger’s 41 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 28 years in regulatory CMC & 13 as a medicinal & process chemist & author of 24 patents.

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Who Should Attend?

  • Chief Scientific Officers
  • Medicinal Chemists
  • Process R&D Chemists
  • Preclinical Formulations Scientists
  • Research Fellows/ R&D Scientists
  • CMC Management
  • Technical Operations
  • Outsourcing Managers
  • Drug Substance Process Development Engineers
  • Project Managers
  • Manufacturing Director
  • CMC Consultants

What You Will Learn

Attendees will gain insights into:

  • Drug substance and formulation considerations for improving downstream clinical outcomes
  • A timeline overview for each stage of the development process
  • Benefits on an integrated approach to accelerate from candidate selection and onwards into the clinic
  • Regulatory challenges to be aware of when bridging from candidate selection to IND and beyond
  • Case studies that demonstrate the benefits of an integrated drug substance and drug product approach

Xtalks Partner

Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated services across the entire development pathway for small molecules & peptide drug programs. We cut through silos across a range of drug development capabilities, saving precious time and money in getting drugs to patients.

We work with customers in a flexible way by either designing and delivering fully integrated programs at each stage of the development lifecycle, or by providing them support through tailored individual services in Drug Substance Synthesis & Manufacturing, Formulation Development, Clinical Trial Manufacturing, Commercial Manufacturing, Clinical Pharmacology, Data Sciences, Bioanalysis and Drug Development Consulting.

Quotient Sciences has over 30 years of experience developing a breadth of formulations across a range of indications and across an array of drug product formats including oral, inhaled, parenteral & topical. We also have a depth of expertise in modified release, oral peptides, ADME studies, Radiolabelling, Scintigraphy, Pediatrics, and we have the ability to handle highly potent compounds. Our innovative approach to formulation development is based on our proven track record in early clinical evaluation delivering phase-appropriate formulations across the product development pathway from candidate selection thru commercial product launch.

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