In 2021, mechanistic modeling demonstrated that physiologically based pharmacokinetics (PBPK) and quantitative systems pharmacology (QSP) have an outsized impact on drug development. Together, we achieved record numbers of drug approvals using the Simcyp Simulator in lieu of clinical studies and industry utilization of our QSP Vaccine Simulator for supporting COVID-19 vaccine development. Add to that, pivotal new global regulatory guidances on MIDD and participation in pivotal FDA workshops on immunogenicity and complex generics. 2022 is here and we can’t wait to work on your toughest challenges!
New Drug Approvals
マーケットリーダーである Simcyp を象徴する Simcyp PBPK Simulator プラットフォームは、開発早期から臨床、承認申請、さらに市販後の全フェーズにわたって様々な意思決定に活用されてきました。The Simcyp Simulator predicts how the drug will move through the body and how a drug is affected by other medications, ethnicity, age, genetics and disease-state. Simcyp is a proven approach for reducing, informing and/or eliminating clinical trials and advising on dosing for new patient cohorts. The Simcyp Simulator has been used in lieu of clinical studies to provide label claims for more than 85 novel drugs. 13 of these new drugs were approved in 2021 alone, as shown in this chart.
Driving Advances in Technology
We are experiencing a rapid expansion in drug development, fueled by our increased understanding of systems biology and underlying pathology; the proliferation of reliable data sources, such as omics, genomics, proteomics and high throughput screening; and an explosion in computing capabilities. Simcyp harnesses these technology advances and combines them with regulatory guidance to innovate our software platforms and apply new learnings via tech-enabled consulting. This year, new product launches have included:
Certara Simcyp QSP Vaccine Simulator Receives R&D 100 Award
Simcyp was recently awarded a R&D 100 award for its QSP Vaccine Simulator, and alongside our sponsor partners, published new findings around dose selection, optimized dose intervals, age-appropriate dosing and special populations.
Technology Networks spoke with Piet van der Graaf, senior vice president and head of quantitative systems pharmacology, to learn more about the vaccine simulator.
Significant Growth in Regulatory Adoption
Several years ago, FDA identified MIDD as an important pathway for lowering drug attrition and dealing with regulatory uncertainty. MIDD has been an integral element in the past several user fee documents (pharmaceuticals and generics), with the agency actively encouraging industry participation and use of these in silico technologies. Global agencies have followed along.
- US FDA final guidance for both in vitro and clinical DDI
- Draft guidance on DDI for therapeutic proteins
- Draft guidance on pediatrics and neonatal studies
- Draft guidance on PK in renally-impaired patients
- Final guidance on PBPK analyses-format and content
- Draft guidance on PBPK for biopharmaceutics use for oral drugs
- FDARA implementation guidance for pediatric studies of molecularly targeted oncology drugs
- Draft guidance of gastric pH dependent drug interactions with acid-reducing agents
- EMA (Europe) guidance on DDI
- PMDA (Japan) guidance on DDI
- NMPA (China) guidance on DDI
Since its inception in 2000, the Simcyp team has committed itself to teaching and education to advance the field. 2021 was another prolific year for the team, with workshops, on-line training, podium speaking, poster presentations, peer reviewed publications, and webinars.
- 21 Webinars
- 40 Publications
- 529 Scientists Trained
- 45 Presentations
In addition to the above, Simcyp was invited to speak by global regulators at 10+ workshops/events focused on advances in PBPK for innovator and generics and QSP, specifically on immunogenicity and immuno-oncology.
Speaking at Regulatory Workshops
Simcyp was invited to speak by global regulators at these recent workshops/events focused on advances in PBPK for innovator and generics and QSP, specifically on immunogenicity and immuno-oncology:
|Regulatory Body||Event||Simcyp Subject Matter
|US FDA||QSP Industry Exchange||Co-chair and organizer|
|US FDA||OCP Strategic Planning||Keynote speaker and panelist|
|PMDA||MIDD Workshop||Invited lecturer|
|US FDA||GDUFA Workshop||Speaker and panelist|
|US FDA||MIDD Pilot Program||Consulting partner to sponsor company|
|EMA||Innovation Task Force||Collaboration partner|
|US FDA||Immunogenicity Workshop||Co-organizer, speaker and panelist|
|US FDA||Regulatory Utility of Mechanistic Modeling||Invited speakers|
|US FDA||2030 New Drug Roadmap||Collaborator and invited speaker|