How well informed is your pre-clinical drug development program? Early phase development solutions

The early drug development process can be a complex space that becomes more efficient when driven by an experienced team delivering a more robust regulatory strategy. The Certara Early Development group can provide support for your programs from hit to lead identification and into first-in human (FIH)-enabling studies to include regulatory strategy and meeting support. Our experts can support the full range of early development disciplines (ADME, bioanalytical, toxicology and drug safety, and CMC) for both small and large molecules.

With a dynamic support model, Certara’s support spans from advice and gap analyses to acting as your FTE in DMPK, safety pharmacology, toxicology, clinical pharmacology and/or CMC leads on project teams.  We have extensive experience ranging from CRO selection and contract negotiations to regulatory writing and submissions all the way through NDA/BLA and post-marketing commitments.

How are we different? We’re expert drug developers that know how to advise on your most critical decisions.  Our success is your success – we guide and design IND-enabling programs without conflicts of interest. We sit on the same side of the table as our client and partner with them to develop and deploy efficient and effective best practice strategies.

  • Each year, for the last 6 years, Certara’s Technologies and Consulting Services supported > 90% of all FDA novel approvals and advised on hundreds of programs from early clinical development stages through proof of concept.
  • Since 2017, Certara Strategic Consulting has helped its biotech clients create up to $44 Billion in value for their organizations and investors, through IPO’s, Out-licensing of drug assets and the sale of client companies to big pharma.

Get peace of mind now. Our clients benefit from complete ADME packages as well as optimized GLP toxicology/safety pharmacology program to support an IND.  We can address unexpected safety issues to prevent timeline delays and apply unique study designs to move faster into the proof-of-concept (POC) clinical studies.

ADME

Certara can provide expert discovery and nonclinical DMPK drug development support.  Our team can design and manage bioanalytical method development and validation, nonclinical PK and TK, in vitro and in vivo absorption, metabolism, distribution and excretion studies (including radiolabeled studies), metabolite profiling (including MIST support), enzyme phenotyping, as well as metabolic enzymes and transporter interaction studies.  We will assist you in candidate selection by performing human PK parameter projection and assess the risk of clinically relevant drug-drug interactions.  Our goal is to design the optimal IND/FIH package for your drug and assure a seamless transition to the clinic by supporting FIH dose selection, clinical PK sampling scheme, and appropriate co-medication exclusion(s).

Certara’s DMPK team can also help you plan ahead with tailored nonclinical development plans and stage appropriate gap analysis.

Certara’s Early Development Group is experienced with the requirements for ex-US FIH and drug development activities beyond FIH.

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Toxicology and Drug /Safety

Toxicology services range from general input into regulatory strategy to full support of tox/safety study planning and execution.  Comprehensive toxicology and drug safety program support includes CRO management, protocol development, study oversight and result reporting, culminating into integration of key data results into regulatory documents. We support all areas of toxicology and safety pharmacology, most commonly in the IND enabling/FIH phase of development; however, this also extends to reproductive toxicology, chronic studies, and carcinogenicity testing.  The Certara Team serves as the lead or as an extension of internal capacity, connecting the client company with a network of toxicology resources for small molecule and complex biologics.

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Chemistry, Manufacturing, and Controls (CMC)

Certara can provide CMC support spanning from early preclinical development through Phase 3, Product Registration & post-launch activities for both small & large molecules & diverse routes of administration. The CMC strategy  covers quality standards, regulatory meeting preparation & documentation, CDMO recommendation & evaluation areas such as early phase de-risking, phase appropriate drug substance/drug product development while maintaining, and due diligence of potential opportunities to name a few.

Specific areas of support:

  • Phase appropriate API/drug release specifications with modifications as the program progresses towards commercialization.
  • Nonclinical and FIM GMP support
  • Radiolabeling activities
  • Formulation support
  • BE and IVIVE
  • BCS classification
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Our Team
Nathalie Rioux Sr. Director, Integrated Drug Development

Dr. Rioux joined Certara in October 2018 as Sr. Director, Integrated Drug Development. Nathalie obtained her Ph.D. in Pharmacy at Laval University, Quebec, Canada, where she studied lung cancer chemoprevention by non-steroidal anti-inflammatory drugs and lipoxygenase inhibitors.  Following graduate school, Nathalie completed an industrial post-doctoral fellowship in drug metabolism, sponsored by NSERC Canada/Biochem Pharma. 

Nathalie has more than 15 years of experience in the pharmaceutical industry, in biotech, pharma, and CRO service.  After being a DMPK lab head & project leader for multiple antiviral drug development projects at Boehringher Ingelheim Canada, she moved to a principal scientist role at Epizyme, where she represented DMPK on multidisciplinary oncology discovery and nonclinical programs including alliances with GSK, Eisai, and Celgene.  Most recently, she built the DMPK, bioanalytical and clinical pharmacology group at H3 Biomedicine in Cambridge, MA, where she drove the strategic and tactical activities around ADME, PK/TK, bioanalysis, and modeling across the discovery and development space.  At H3, she acted as a member of the development leadership team, where she contributed to regular review of project strategy, selection of development candidate, and multiple due-diligence activities.  Nathalie has co-authored multiple regulatory documents and contributed to several development compounds in H3’s Phase 1/1b oncology program. 

Christina Riordan Senior Director of Integrated Drug Development

Dr. Christina Riordan is currently a Senior Director of Integrated Drug Development at Certara. Christina has almost 19 years of industry experience in toxicology working at a CRO and at small and large companies with both biologics and small molecules serving as the toxicology/safety lead on several multidisciplinary drug development teams.   Christina has been involved in toxicology and safety pharmacology studies from early to late development including general toxicology and pharmacokinetic studies, genetic toxicology, reproductive toxicology, drug abuse liability studies, cardiovascular studies and more and has extensive regulatory writing experience.  She has worked in many therapeutic areas and most recently with a focus on immuno-oncology and inflammation.  Dr. Riordan holds a doctorate in molecular genetics from the University of Albany.

Deven Shah Sr. Director

Deven Shah is Certara’s  Chemistry, Manufacturing & Controls (CMC) lead helping clients with their drug development CMC needs.  Deven also supports the Certara Global Health practice area spending a significant amount of time attending to the Bill & Melinda Gates Foundation work.

Before joining Certara, Deven held positions of increasing responsibility and most recently as the Head of Pharmaceutical Development at Noven Pharmaceuticals and CMC/Preclinical Development Leader at GSK.  Deven’s impressive background includes extensive experience leading cross-functional matrixed teams comprising of senior leads and hands on experience of CMC development across all phases in formulation development & drug delivery for diverse routes of administration & therapy areas.  He has also extensive experience of conducting due diligences, managing biotech alliances, & identifying potential CROs for robust product development.  Deven has contributed to regulatory filings spanning from pre-IND to NDA filing stage as well as represented organizations in the regulatory interactions with global agencies.

Deven received his B.Pharm from Jadavpur University in Calcutta, India and Ph.D. (Pharmaceutics & Drug Delivery) from the University of Southern California.  He was the recipient of the Procter & Gamble award for excellence in graduate research in Pharmaceutics and Drug Delivery for his Ph.D. work.

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