About Us
Consultant Biographies
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Todd Kessler
Todd has over 20 years of experience in the biotechnology industry and has worked on more than 40 biologics/therapeutic proteins/vaccines from early development through commercial approval and sale. Prior to establishing PVLMC, he contributed to the approval of 10 commercial therapeutic protein products in the US, EU, Canada, and Japan. He has experience with upstream and downstream microbial and mammalian processing techniques for the manufacture of bulk drug substance, and liquid and liophilized drug product.
He has helped numerous biotechnology companies design and implement quality systems for all stages of process validation which meet or exceed the ICH and FDA requirements. These include, but are not limited to systems for determining the quality target product profile (QTPP) and critical quality attributes (CQAs), and for process characterization, process qualification, process performance qualification (PPQ), and continued process verification (CPV).
Catherine Kessler
Catherine has over 25 years of experience in the biotechnology/pharmaceutical industry supporting regulatory affairs, regulatory compliance, and quality assurance for early and late-stage product development.
She is well-versed in regulatory research and surveillance across numerous therapeutic areas. She develops nonclinical, CMC, and clinical strategies leading products from clinical development nomination to market approval, and routinely interacts with the FDA (CDER/CBER/CDRH) through various stages of clinical and product development.
Our Regulatory Filings
The table below includes the products which gained regulatory approval with contribution from our CEO. For more information, click the product names below to be forwarded to the corporate website for that product.
PRODUCT NAME
Lusduna™ Nexvue
Iplex™ (mecasermin rinfabate)
Filing Agency
FDA, EMA, HC, PMDA
FDA, EMA
FDA, EMA
FDA, EMA
FDA, EMA
FDA, EMA
FDA
FDA, EMA, HC, PMDA
FDA, EMA, HC
FDA, EMA
Filing Type
Breakthrough Designation/Accelerated Approval/Priority Review - Therapeutic Protein
Breakthrough Designation/Accelerated Approval/Priority Review - Therapeutic Protein
None - Sublingual Immunotherapy
None - Sublingual Immunotherapy
None - Sublingual Immunotherapy
None - Sublingual Immunotherapy
Orphan Drug Designation - Therapeutic Protein
None - Therapeutic Protein
None - Therapeutic Protein
Priority Review - Conjugate Vaccine
*Additionally, the CEO has helped clients gain approval of more than 10 products since beginning PVLMC consulting services in 2016.
Our Impact on our Clientele
After completion of multiple major scope of works (SOW) for two of our clients, they were each subsequently acquired by major biotech companies for greater than 1 billion dollars.
One of our clients received regulatory approval of two biologicals/therapeutic proteins after we helped re-design their process validation quality system and provided global process validation training.
Another of our clients gained regulatory approval for a biological/therapeutic protein after we helped with their CQA determination and updating part of their process validation quality system.
Led process validation initiatives to take a biologic from being phase 3-ready to PPQ-ready in 3 months in support of the FDA Coronavirus Treatment Acceleration Program (CTAP)
We are Proven Leaders in the Protein Therapeutics Industry
Our Successes Include:
Establishment of a PPQ readiness program which led to the approval of 6 biological products within 3 years (including 2 drugs with Breakthrough Therapy Designation and Priority Review).
Gained FDA/EMA approval of at least 10 products (including 2 blockbuster products, 1 product with Orphan Drug Designation, 1 biosimilar, and 2 products with FDA Breakthrough Therapy Designation).
Development of process characterization and/or process validation programs at 3 different companies, all of which led to the approval of commercial products.
Supported multiple PAIs and biennial inspections which resulted in no 483s.
Performed risk analyses on CMO sites and successfully predicted 12 of 13 FDA inquiries during a biennial inspection. The inspection team successfully used pre-drafted responses, resulting in no 483s.
Managed PPQ readiness activities, which led to multiple successful PAIs and subsequent product approvals.
Twice had the FDA request to keep characterization/validation studies (for the extension of chromatography resin expiries) as model examples.
Was commended by the FDA for providing a “very well written and transparent” BLA.
Led process validation initiatives to take a biologic from being phase 3 ready to PPQ ready in 3 months in support of the FDA Coronavirus Treatment Acceleration Program (CTAP).