News and Resources

Integrated clinical development and supply: Breaking down the early-development journey of a small molecule.

Check out this replay of a Catalent-sponsored webinar where Mark Krook, Head of Early Drug Development at NGT BioPharma Consultants, presented his thoughts and insights on an integrated drug development approach for small molecules! 

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Effective Due Diligence Assessments Improve Decision-Making

Due diligence is essential for successful biopharmaceutical investment, helping investors evaluate the true potential, risks, and value of drug development assets, projects, or biotech companies before committing their capital. Biopharmaceutical drug development is complex, highly regulated, and costly, with extended timelines for research, clinical trials, and regulatory approvals. Key components of due diligence include evaluating scientific validity, patent protections, competitive landscape, regulatory hurdles, reimbursement potential, management expertise, and financial health. A thorough examination of these factors enables investors to avoid costly mistakes, identify promising opportunities, and make informed decisions that maximize returns while managing risks.

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NGT BioPharma Consultants Pediatric Center Of Excellence

Carsten joined NGT Biopharma Consultants after his retirement from Roche at the end of 2022 and he is an expert on our Pediatric Center of Excellence team.  His research interests include pediatric and geriatric drug development, drug delivery of poorly soluble drugs and early phase drug development topics. Carsten most recently led the pediatric formulation working group at Roche from 2014 until he retired from Roche.

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NGT BioPharma Consultants Pediatric Center Of Excellence

Steven joined NGT Biopharma Consultants after his retirement from Janssen Research and Development (a JNJ company) and he is an expert on our Pediatric Center of Excellence team.

From 2007 until his retirement in 2018, Steven led Janssen Research and Development (a JNJ company) as VP and Head of Established Products, a $7B portfolio of pharmaceutical products sold globally through various JNJ subsidiaries.  In addition to other development projects, Steven led the program to obtain Pediatric Exclusivity for AcipHex (a proton pump inhibitor).  This 10-year program involved multiple trials, some conducted in NICUs, and was ultimately successful.

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NGT BioPharma Consultants Pediatric Center Of Excellence

Fran is a member of the NGT BioPharma Consultants team and is an expert on our Pediatric Center of Excellence team.  He has over 30 years of experience in the pharmaceutical industry, including 21 years at GlaxoSmithKline and 5 years at Incyte Corporation where he led pharmaceutical development teams that successfully commercialized four products and progressed a wide variety of early and mid-stage new chemical entities into clinical studies.

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NGT BioPharma Consultants Pediatric Center Of Excellence

Daniel is head of the newly created Pediatric Center of Excellence at NGT BioPharma Consultants. He is a pharmaceutical executive with over 30 years of experience in pharmaceutical development and he has 10+ years expertise in developing pediatric products. Daniel retired from Janssen R&D LLC (Johnson & Johnson) in 2019 as Sr. Scientific Director, CMC Leader, where he co-chaired the J&J internal pediatric formulation network.

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NGT BioPharma Consultants Welcomes Roger Nosal, Head of Regulatory Strategy

NGT BioPharma Consultants Welcomes Roger Nosal. 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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“Integrated Clinical Development and Supply: Breaking Down the Early-Development Journey of a Small Molecule”

The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.

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Don’t Forget About Quality When Formulating Your Drug Development Plan

It is not uncommon for small biotech and biopharma startup companies to overlook Quality & Compliance when formulating their drug development plans and budgets. However, industry guidance from the International Conference on Harmonization (ICH) recommends that serious consideration be given to Quality Assurance (QA) very early in the process.

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Digital Validation – Why BioPharma is Going Paperless.

The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.

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CMC Expertise: Paving the Road for Product Development

The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.

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