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Strategic Evidence & Value Communication Symposium

Join us on Wednesday, April 21, 2021, from12:00 PM – 2:00 PM EDT for Certara’s first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.

https://www.certara.com/on-demand-webinar/evidence-value-communication-symposium/

Effectively engaging KOLs & Stakeholders: An interview with Erin Duffy

Healthcare providers (HCPs) expect greater product education and information on the medications that they prescribe to patients. At the same time, data and scientific information relating to therapies continues to become more complex. Thus, the role of the Medical Science Liaison (MSL) has become more and more crucial in the key stakeholder and Key Opinion … Continued

https://www.certara.com/blog/effectively-engaging-kols-stakeholders-an-interview-with-erin-duffy/

Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format

Starting June 24th, 2021, the US FDA will require all your post-marketing submissions of promotional materials and submissions of promotional materials for accelerated approval products be submitted via electronic Common Technical Document (eCTD) format. The 37-page guidance by the FDA titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials … Continued

https://www.certara.com/on-demand-webinar/are-you-prepared-for-june-24th-fda-promotional-materials-submissions-in-ectd-format/

5 points to Consider When Designing an Immuno-oncology Clinical Pharmacology Program

Immunotherapy presents interesting and proximally viable therapeutic options in the growing armamentarium of treatment modalities to combat complex, multifactorial diseases. Indeed, its revolution within oncology is astounding. The field has witnessed rampant and clinically significant advances, with the approval of several checkpoint inhibitors. Clinical trials with these inhibitors suggest that there are more robust and … Continued

https://www.certara.com/blog/5-points-to-consider-when-designing-an-immuno-oncology-clinical-pharmacology-program/

Certara Set to Join Russell 1000® Index

PRINCETON, N.J.—Mar. 11, 2021– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it is set to join the Russell 1000® Index, effective after the U.S. market open on March 22, 2021, according to a preliminary list of quarterly IPO additions posted February 26, 2021. The Russell 1000® Index measures the performance … Continued

https://www.certara.com/pressrelease/certara-set-to-join-russell-1000-index/

Sealing Pharma Commercialization Deals: Creating Optimal Value for Investors

It is crucial for biotech developers to engage in early commercial market assessment to generate value for Regulators, Payers, and Clinicians. This approach should be integrated with a clinical development strategy that will help drive acquisition potential, co-development prospects, and overall return on investment. Speakers: Fran Brown Dr. Fran Brown is currently the SVP of … Continued

https://www.certara.com/on-demand-webinar/sealing-pharma-commercialization-deals-creating-optimal-value-for-investors/

Episode 15 – Entrepreneurship and Consulting in Clinical Pharmacology and Pharmacometrics Part 1 with Patrick Smith and Emily Cicali

Moderated by Early Career Community member Emily Cicali, PharmD (University of Florida), Patrick Smith, PharmD (Certara) discusses the risks and rewards with entrepreneurship in the field of clinical pharmacology and pharmacometrics. Patrick talks honestly about the mistakes made early on and the differing needs of team members who are starting a business in varying stages … Continued

https://www.certara.com/podcast/episode-15-entrepreneurship-and-consulting-in-clinical-pharmacology-and-pharmacometrics-part-1-with-patrick-smith-and-emily-cicali/

Commercial and Regulatory Success in Accelerated Gene Therapy Development

Thanks to regulatory frameworks and driven by high unmet patient needs, the pace for clinical development of gene therapies (GT) is often greatly accelerated. This presents GT innovators with the opportunity to reach their patients faster, but it also raises the bar for critical decision points such as around trial design, endpoint selection and population … Continued

https://www.certara.com/on-demand-webinar/commercial-and-regulatory-success-in-accelerated-gene-therapy-development/
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