Technology Transfer: Drug Product Manufacturing Process

Dr. Ajay Babu Pazhayattil, Pharmaceutical Consultant, Toronto, Canada

Dr. Ajay Babu Pazhayattil is a highly experienced pharmaceutical professional with a strong background in industrial pharmacy and executive management. He has a track record of driving innovation for brand, generic, and CDMO pharmaceutical organizations. He is known for his data-driven, regulatory-compliant approach to formulation and is well-respected in the industry. He is actively involved in industry organizations and is recognized as a thought leader in the field, having made significant contributions through published journal articles and textbooks.

Sanjay Sharma, Senior Vice President & Head Manufacturing Science and Technology, Zydus

Sanjay is a seasoned pharmaceutical industry professional with over 23 years of experience in the development, launch, and maintenance of drug supply. He possesses a results-driven approach and a deep understanding of pharmaceutical manufacturing science, which has enabled him to contribute to the success of some of the largest organizations in the industry. Sanjay has held various leadership positions in Indian and multinational pharmaceutical companies such as Cipla, Dr. Reddy's Laboratories, Sandoz, Watson, Torrent, and Lupin.

Joe Paul Philip, Joe Paul Philip, Vice President & Head, Global Process Excellence and New Products, Glenmark Pharmaceuticals

Joe Paul Philip has over 20 years of experience in Technical and Strategic Leadership roles, specifically in Life Cycle Management of Formulations. He has experience leading multicultural teams globally and expertise in Process Development, New Product Launches, Technical Services, R&D Technology Transfers, Global Technology Transfers, Process Validations, Computer System Validations, Equipment Qualifications, Technical Investigation, Root Cause Analysis, and Data Analytics for OSD, Parenteral & Semi-solid technology platforms. He also has experience and knowledge in negotiating development/commercial agreements.

Michelle Gischewski-Silva, Scientific Advisor, Eurofins Alphora, Alphora Research Inc

As a highly experienced and accomplished leader in the pharmaceutical industry, Michelle brings a wealth of knowledge and expertise to her role. With a solid background in critical new product development projects, she possesses deep technical knowledge in R&D formulation development, scale-up, process validation, and technology transfer of solid and liquid dosages. As the head of the formulation, she was responsible for optimizing formulations and streamlining processes to ensure robustness.

Marzena Ingram, Senior Consultant, Validant Inc.

Marzena Ingram is an experienced independent senior pharmaceutical consultant who specializes in quality and technical operations for solid-dose and active pharmaceutical ingredient manufacturing. She helps clients address FDA warning letter scenarios. She has developed a specialized team for continued process verification. She has also implemented programs to meet global regulatory requirements, developed and published statistical tools for pharmaceutical manufacturing processes, and led the implementation of a comprehensive life cycle management software. Marzena is a board member of ISPE Canada.

Dr. Ajay Babu Pazhayattil，藥品顧問，加拿大多倫多

Dr. Ajay Babu Pazhayattil 是一位經驗豐富的藥品專業人士，擁有工業藥學和高層管理的堅實背景。他在品牌、仿製藥和 CDMO 藥品組織的創新推動方面有著卓越的成就。他以數據驅動和符合規範的配方方法而聞名，並在業界享有良好的聲譽。他積極參與行業組織，並被認可為該領域的思想領袖，通過發表的期刊文章和教科書做出了重要貢獻。

Sanjay Sharma，高級副總裁兼製造科學與技術部門負責人，Zydus

Sanjay 是一位經驗豐富的藥品行業專業人士，擁有超過 23 年的藥物供應開發、推出和維護經驗。他擁有以結果為導向的方法和對藥品製造科學的深刻理解，使他能夠為行業內一些最大的組織的成功做出貢獻。Sanjay 曾在印度和跨國藥品公司如 Cipla、Dr. Reddy's Laboratories、Sandoz、Watson、Torrent 和 Lupin 擔任多個領導職位。

Joe Paul Philip，副總裁兼全球流程卓越與新產品負責人，Glenmark Pharmaceuticals

Joe Paul Philip 擁有超過 20 年的技術和戰略領導經驗，專注於配方的生命週期管理。他在全球領導多元文化團隊方面擁有經驗，並在流程開發、新產品推出、技術服務、研發技術轉移、全球技術轉移、流程驗證、計算機系統驗證、設備資格、技術調查、根本原因分析和數據分析等方面擁有專業知識，涵蓋 OSD、注射劑和半固體技術平台。他還在談判開發/商業協議方面擁有經驗和知識。

Michelle Gischewski-Silva，科學顧問，Eurofins Alphora，Alphora Research Inc

作為一位經驗豐富且成就卓越的藥品行業領導者，Michelle 為她的角色帶來了豐富的知識和專業技能。她在關鍵新產品開發項目方面擁有堅實的背景，並在 R&D 配方開發、放大、生產驗證和固體及液體劑型的技術轉移方面擁有深厚的技術知識。作為配方部門的負責人，她負責優化配方和簡化流程，以確保其穩健性。

Marzena Ingram，高級顧問，Validant Inc.

Marzena Ingram 是一位經驗豐富的獨立高級藥品顧問，專注於固體劑型和活性藥物成分製造的質量和技術運營。她幫助客戶應對 FDA 警告信的情況。她建立了一個專門的團隊以進行持續的過程驗證。她還實施了滿足全球監管要求的計劃，開發並發表了藥品製造過程的統計工具，並主導了全面的生命週期管理軟體的實施。Marzena 是 ISPE Canada 的董事會成員。