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Laleh Bighash

Laleh Bighash is a distinguished figure in the pharmaceutical industry, boasting over three decades of expertise and leadership. Her journey began as an R&D scientist, where she honed her skills in research and development. Over the years, she transitioned seamlessly into roles in quality assurance, compliance, and regulatory affairs, showcasing her versatility and depth of knowledge. Laleh’s commitment to excellence and her visionary approach have been instrumental in her founding and leading two prominent training institutes, AAPS and NAI, where she has trained over 5000 skilled professionals, shaping the future of the pharmaceutical workforce.

As a respected speaker, lecturer, and thought leader, Laleh has contributed significantly to the field of pharmaceutical regulatory compliance. Her extensive network and active involvement in conferences have established her as a sought-after advisor and mentor, guiding individuals and organizations towards success. Laleh’s impact extends beyond training and education; she has collaborated with esteemed institutions and regulatory bodies, including Health Canada, leveraging her expertise to drive industry standards and advancements.

Recognized for her outstanding contributions, Laleh Bighash was awarded the prestigious University of Toronto Alumni of Influence Award in 2019, a testament to her profound influence and achievements in the pharmaceutical arena. With her unparalleled experience, dedication to excellence, and unwavering commitment to advancing the industry, Laleh continues to inspire and shape the future of pharmaceuticals, leaving an indelible mark on the field and the lives of those she touches.

Arthur Kawasaki

Arthur Kawasaki leads the Medical Technology Regulatory Consulting group for AAPS Pharma focusing on client success and satisfaction as they obtain market authorization for their medical devices and in vitro diagnostic devices (IVDs) globally.  Under his leadership and guidance, the Medical Technology Regulatory Consulting group supports, guides and helps clients navigate the Regulatory requirements and considerations required to obtain approval (e.g., Health Canada medical device licensing, US FDA 510(k) clearance and EU IVDR CE marking) for their health technology products.

Arthur has over 29 years of global medical device, IVD and pharmaceutical industry experience in Regulatory Affairs, Quality and Clinical.  Mr. Kawasaki has held several senior and leadership positions in Regulatory Affairs, Quality and Clinical with a number of organizations including:

  • Eli Lilly Canada, Inc.
  • Becton Dickinson Canada Inc.
  • Nippon Becton Dickinson Ltd.
  • Becton Dickinson and Company
  • Canon BioMedical, Inc.
  • DiaSorin Molecular
  • Exact Sciences Corp. 

 

Most recently, Arthur was the Vice President, Regulatory Affairs for Exact Sciences Corp., an US based cancer (molecular) diagnostic IVD manufacturer and clinical lab.  During his industry time, Mr. Kawasaki played critical strategic, guiding and hands-on roles in securing Health Canada licensing, US FDA 510(k) clearance, De Novo classification and PMA approval as well EU IVDR CE marking for medical devices, including IVDs on budget and within targeted Regulatory review lead-times for submissions.  Additionally, he played pivotal roles in securing market authorization for IVDs in Japan (PMDA), Australia (TGA), and other markets in Asia-Pacific and Latin America.  

Arthur has significant experience in engaging regulatory authorities (e.g., US FDA, Health Canada and Competent Authorities/Notified Bodies) in pre-submission, review and remediation meetings.  Examples of successes include successfully influencing Health Canada to reverse a prior decision and grant priority review for a then novel biologic for late-stage osteoporosis, negotiating with Health Canada to grant expedited review for a Class III IVD that resulted in device licensing within 14-days, and negotiating FDA authorization for product design changes to an Emergency Use Authorization (EUA) authorized COVID-19 test without having to submit an EUA amendment.

Mr. Kawasaki obtained a B.Sc. and research thesis-based M.Sc. in Physiology from the University of Toronto and an MBA from the Schulich School of Business at York University.  In his spare-time, Arthur enjoys working-out, the great outdoors and an active lifestyle with his wife.

Kay Gaynor

A seasoned regulatory affairs executive with over 35 years of industrial experience, span in biologics, pharmaceuticals, consumer health and natural health product, and chemicals. Her broad background encompasses all aspects of product development, global regulatory affairs and quality along with extensive expertise in due diligence, critical operational activities, work planning and workflow analysis, third party oversight and management, learning and knowledge development, team building and remediations, both domestically and internationally. She has a deep understanding of physical product delivery for regulated markets and delivers thought leadership on client projects. She maintains current industry / leading practices knowledge and understanding to further broaden her comprehensive knowledge of the regulated industry, including the ability to understand and interpret current / envisioned regulatory and compliance processes and procedures.

As a recognized industry expert, Ms. Gaynor has distinguished herself as an accomplished Product Quality professional with extensive progressive experience and achievements in quality management, QbD tech transfer, project management, and leadership of diverse, global and cross-functional teams. Her experience and insights guide clients in quality management systems, regulatory inspection preparation, and global GxP audits and compliance. She specializes in end-to-end product development and lifecycle product management of pharmaceuticals (biopharmaceuticals, aseptic, oral solid dose, liquids, gels / creams / ointments, combination products) and medical device.

An accomplished expert opinion leader, Ms. Gaynor is a thoughtful and skilled speaker, most often sought by organizations on the topics of Managing Global Quality, Quality Risk Management, and Preparing for FDA inspections. She represented global clients in domestic and foreign agency inspections (Canada, China, Mexico, Germany, Hong Kong, India, Italy, Switzerland, Taiwan, and the U.S.A). She participated in the first FDA pilot “joint FDA-Italian PAI” of an injectable plant.

Ms. Gaynor holds professional membership with the Regulatory Affairs Professionals Society (RAPS). She is also a part-time instructor of post-graduate program in Regulatory Affairs, Product Development, Quality & Compliance.

Tigran Uzunyan

Tigran Uzunyan stands as a distinguished leader and expert in medical writing with a proven track record of excellence. His illustrious career path, spanning over two decades, showcases a remarkable evolution from a medical doctor to a clinical pharmacologist and ultimately to a seasoned research scientist. Throughout his journey, Tigran has demonstrated an unwavering commitment to advancing healthcare through his expertise in drug development and clinical research.

Tigran’s contributions to the scientific community are profound, characterized by his adeptness in designing, implementing, and monitoring clinical studies across various regulatory jurisdictions. His ability to translate complex scientific data into meticulously crafted, accessible documents, including regulatory submissions and research findings, has earned him widespread acclaim.

At AAPS, Tigran has assumed leadership roles in Clinical Research and Drug Safety training programs, enriching his contribution to the field by nurturing the next generation of scientists in drug development and safety practices.

Within the medical writing department, Tigran’s leadership is marked by a harmonious blend of his medical background, research acumen, and educational insights. He spearheads initiatives that support and propel healthcare innovation, playing a pivotal role in the development of medical treatments and therapies that transform lives. Tigran Uzunyan’s expertise and leadership are indispensable assets in our pursuit of excellence in healthcare.

Terry Pilkey

Ms. Pilkey has been involved in the pharmaceutical industry at both the government and private level for 44 years.  She was involved in performing GMP and Medical Device inspections with the Health Products Food Branch Inspectorate of Health Canada.  She has also performed chemical analyses both with Health Canada and Industry.

She has recently retired from her position as the Regulatory Affairs Director at Eurofins Biopharma Product Testing Toronto, Inc. where she served as a Regulatory/Quality Control consultant and auditor to clients who are involved in fabrication, packaging, testing, importation, distribution, and wholesaling Drug Products, Natural Health Products, Medical Devices, and Medicinal Cannabis.