前臨床医薬品開発プログラムにおいて、情報収集は十分ですか？
新薬臨床試験開始申請（IND）のためのアーリーフェーズ開発ソリューション初期の医薬品開発プロセスは複雑なものですが、経験豊富なチームが強固な薬事戦略を提案することで、より効率的に実施できます。サターラの早期開発支援チームは、ヒットからリード化合物の同定、FIHを可能にする試験、薬事戦略や会議のサポートまで、お客様のプログラムを幅広く支援します。当社の専門家は、低分子化合物から高分子化合物まで、早期開発のあらゆる分野 (ADME、生物分析、毒性学、医薬品安全性、CMC) をサポート可能です。
サターラのサービスは、アドバイス提供やギャップ解析、DMPK、安全性薬理学、毒性学、臨床薬理学、またはプロジェクトチームのCMCリードとしての役割など多岐にわたります。CROの選定や契約交渉から、NDA/BLAや市販後のコミットメントに至るまで、規制当局への提出書類作成や提出に至るまで、幅広い経験を誇ります。
他社となにが違うのでしょうか。私たちは医薬品開発の専門家であり、お客様の最も重要な意思決定においてアドバイスする方法を熟知しています。新薬臨床試験開始申請（IND）を利益相反なく導き、デザインします。私たちはクライアントと同じテーブルに座り、効率的かつ効果的なベストプラクティス戦略を開発・展開するために、1つのチームとしてクライアントとパートナーシップを組んでいます。
- サターラは、何百ものプログラムを初期の臨床開発段階から概念実証まで進めるお手伝いをしてきました。
- 2017年以来、サターラの統合医薬品開発チームは、IPO、医薬品資産の導出、大手製薬企業へのクライアント企業の売却などを通じて、クライアントのバイオベンチャー企業が組織と投資家のために最大$440億ドルの価値を創出するのを支援してきました。
専門家の力を借りて医薬品開発プロジェクトを推し進めませんか。新薬臨床試験開始申請（IND）をサポートするために最適化されたGLP毒性学/安全性薬理学プログラムはもちろん、完全なADMEパッケージが貴社に利益をもたらします。予期せぬ安全性の問題に対処してスケジュールの遅れを防ぎ、独自の試験デザインを適用してPOC（proof-of-concept）臨床試験への移行を早めます。
吸収・分布・代謝・排泄(ADME)
サターラは、専門的な探索および非臨床 DMPK 医薬品開発サポートを提供します。専門家チームは、生物学的分析法の開発およびバリデーション、非臨床 PK および TK、in vitro および in vivo 吸収、分布、代謝・排泄試験 (放射性標識試験を含む)、代謝物プロファイリング (MIST サポートを含む)、酵素表現型、ならびに代謝酵素・トランスポーター相互作用試験の設計と管理を行います。ヒトPKパラメータプロジェクションを実施し、臨床的に関連する薬物間相互作用のリスクを評価することで、候補化合物の選定を支援します。私たちのゴールは、新薬臨床試験開始申請IND/FIHパッケージを最適に設計し、FIH用量選択、臨床PKサンプリングスキーム、適切な併用薬除外（複数可）をサポートすることで、臨床へのシームレスな移行を保証することです。
サターラの DMPK チームは、お客様のニーズに合わせた非臨床開発計画やステージに応じたギャップ分析で、計画立案のお手伝いをすることもできます。
サターラの早期開発グループは、米国外でのFIHおよびFIHを超える医薬品開発活動の要件に精通しています。
毒性学と医薬品の安全性
皆さんご存じのINDSソフトウェアがサターラの一員になりました！新たに拡充された当社の毒性学サービスは、規制戦略への一般的なインプットから、毒性学／安全性試験の計画と実行の全面的なサポートまで多岐にわたります。当社の包括的な毒物・医薬品安全性プログラムサポートは、CRO管理、プロトコール開発、試験監督、結果報告を含んでおり、最終的には重要なデータ結果を規制関連文書に統合します。新薬臨床試験開始申請/FIH段階での毒性学および安全性薬理学の全領域をサポートするのが最も一般的ですが、生殖毒性学、慢性試験、発がん性試験にも対応します。専門家チームは、低分子および複雑な生物学的製剤の毒性学的リソースのネットワークと顧客企業をつなぐ、リーダーまたは貴社チームの助っ人・サポーターとして機能します。
化学・製造・管理（CMC）
サターラは、前臨床開発初期からフェーズ3、製品登録、上市後まで、低分子・高分子、多様な投与経路の CMC サポートを提供しています。CMC戦略には、品質基準、規制会議の準備と文書化、CDMOの推奨と評価分野（早期段階のリスク回避、適切な原薬/製剤開発の維持、潜在的機会のデューデリジェンスなど）が含まれます。具体的な支援内容：
- プログラムが商業化に向けて進行するにつれて修正される、適切なAPI/医薬品リリース仕様の段階的変更
- 非臨床およびFIM GMPサポート
- 放射性標識活性
- 製剤
- BEとIVIVE
- BCS分類
当社のチーム
Nathalie Rioux Vice President of Integrated Drug Development
Christina Riordan Sr. Director, Integrated Drug Development
Deven Shah Sr. Director, Integrated Drug Development
Nathalie Rioux Vice President of Integrated Drug Development
Christina Riordan Sr. Director, Integrated Drug Development
Deven Shah Sr. Director, Integrated Drug Development
Dr. Rioux joined Certara in October 2018 and is now a Vice President of 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.
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 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 also has extensive experience with 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.
Dr. Rioux joined Certara in October 2018 and is now a Vice President of 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.
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 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 also has extensive experience with 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.
