Temperature Controlled Logistics in Biopharmaceuticals - A Virtual Experience

Biography: Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman,

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Biography: Experienced Technical Operations Lead with a demonstrated history of advancing clinical development programs in the biotechnology industry. Strong operations professional skilled in Manufacturing, Development, Supply Chain and Quality Operations for both large pharma and small biotech.

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Biography: Ben is the CEO of LedgerDomain, founded in 2016 to bring blockchain solutions to enterprise ecosystems, unlocking a world of communal computing and real-time performance. After doing undergraduate and graduate work at MIT, Ben spent a quarter of a century incubating and investing in early-stage technology companies. In partnership with the Clinical Supply Blockchain Working Group (CSBWG), the world's largest pharmaceutical blockchain consortium, LedgerDomain developed the world's first iOS blockchain app for the clinical supply chain. In 2019, LedgerDomain also partnered with UCLA on a pilot for the US Food & Drug Administration (FDA) on a last-mile application that helps deliver lifesaving medications to babies.

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Biography: Currently Vice President of Regulatory Affairs of Almatica. Previously, was Head of Regulatory Affairs with responsibilities in building and leading global regulatory organizations. Early and late stage Regulatory experience in Diabetes, Oncology, Neurology, Infectious disease as well as experience in Combination Products , Generics and Diagnostic Imaging with U.S. Food and Drug Administration (FDA) and other leading Health Authorities in Life Sciences. Research and Development (R&D) industry experience in development of products from test tube to market . Degree in Chemistry and post-doctoral research in Oncology, strong R&D, business development and management experience in industry.

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Biography: A real project/program manager with a wide experience in general management (incl strategic thinking), data/process analyze, purchasing/sales and coaching. This expertise allows me to act in a broad variety of functions within the Supply Chain Management and be a motivator/coach for others. In the past years, I’ve developed a lot of interest and expertise in Supply Chain within pharmaceutical environments. Especially interested in the IoT, seamless monitoring development and the way this can be used within the inductry. Also a in-depth knowledge of all regulations, like GxP / Gamp 5 and all modes of Transport.

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Biography: Derrick L. Kearney – Supervisory Import Specialist - Pharmaceuticals, Health and Chemicals Center of Excellence and Expertise, Partnership Division, U.S. Customs and Border Protection (CBP). Mr. Kearney joined CBP in 2007, and is currently assigned to the Port of Philadelphia, PA. Previous positions within CBP include Import Specialist and Trade Operations Program Manager at the Port of JFK, New York. Prior to joining CBP, Mr. Kearney worked for the New York City Office of the Comptroller. Mr. Kearney is an Air Force veteran. Educational accomplishments include numerous classes, seminars and workshops as a member of CBP, and a Master’s of Public Administration (MPA) Degree from Baruch College, City University of New York.

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Biography: Biopharmaceutical professional of over 20 years with demonstrated capability across broad areas of CMC functions, specialized in cGMP analytical methods, technology transfer and CRO/CSP management. Over 15+ years of QC and technical operations management including compliant labs, quality systems, robust stability program, global reference standard and critical reagent program. Expertise in bioanalysis of small molecule, protein, mAb, vaccine products and biomarker for PK/PD, release, stability and product characterization studies. CMC support for IND, NDA and BLA submissions. Expertise in cGMP method validation for product/process/equipment/facility and systems. Contributed to success of commercial programs of anthrax vaccine and Erbitux; multiple oncology mAb products including cancer immunotherapy product Keytruda®. Depth in diverse areas of structure-function and applied studies on proteins. Enterprise focused leader of high quality results and project deliverables with team work and collaboration. Strategic and motivational leader committed to build high-performance teams with mentoring and coaching. Thorough understanding of regulatory guidelines, operational excellence, continuous process and performance improvements. Detail oriented, adept in written, verbal and interpersonal communication, and business savvy public speaking. Creation and setting-up of new functional biophysical and immunochemistry labs. GOALS: Work for companies and organization engaged in innovation and problem solving in vast areas of pharmaceutical development for human needs.

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Biography: Mr. Antonetti holds a Masters of Science degree (M.Sc.) in Biophysics with a Specialization in Neuropharmacology. With more than 20 years of experience in the Regulatory Agency (Health Canada), Pharmaceutical and Medical Device industry, he has acquired extensive experience and understanding of the GMPs including sterile manufacturing, GCP and Medical Device Regulations. While at Health Canada, he worked in the Drug Investigation Unit, the Medical Device Unit and the GMP Inspection Unit where he was a member of the GMP Committee and contributed to the development and enhancement of Regulations, Policies and Guidelines, including Health Canada Guide-00069 on Temperature control. He currently holds the position of Executive Director, Regulatory Affairs & Quality Management – Safety, Health and Environment at Roche Diagnostics where he is responsible for all aspects of Licensing, Compliance, Quality and Safety. He is actively involved with MEDEC representing the Medical Device industry during meetings held with Health Canada and other stakeholders.

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Biography: Contributes Warehousing and Distribution assistance to Country Programs work through short-term technical assistance trips, report development, and project implementation. Experienced in international project management, including contract and subcontract administration, budget development and tracking, recruitment, and operations oversight.

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Biography: My goal now is to create and awareness in our supply chain min requirements how to transport Temperature sensitive goods especially on the Pharma Sector in the aircargo supply chain. Worked very close with Dupont to develop the cargo thermoblanket. Giving the shipper an understanding the difference between pax operation and cargoperation. Ensuring that forwarder and shipper of the pharma community have an understanding what the requirements are. Involved in various projects to ensure pharmaceutical companies switch to our company following the requirements set by the various authorities.

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Biography: Biopharmaceutical market research analyst with experience across a host of therapeutic areas, including dermatology, ophthalmology, genitourinary, oncology, anti-infectives, and niche and rare diseases specifically in the hepatitis C, HIV, vaccine, NASH, and cystic fibrosis spaces. I specialize in corporate financial analysis, market forecasting, primary and secondary market research, and drug pipeline and portfolio analysis. I have been featured in multiple peer-reviewed scientific publications and have presented data at scientific conferences.

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Biography: Dave is recognized for the creative development of standardized systems and business processes, and for developing enabling technology throughout the entire supply chain. During his career, Dave has implemented over 30 different computer systems – WMS, ERP, Finite Scheduling, Product Launch, and Order Entry, among others. Dave is past Chairman of the Supply Chain Council and past member of the Executive Committee of NASSTRAC. Dave is currently Executive Vice President of Industry Liaison and Talent Development for the BSMA (Biotech Supply Management Alliance). In 1993, Dave joined Alcon Laboratories where he steadily advanced through leadership roles such as Purchasing Manager, Materials Operation Manager, and Global Supply Chain Director before becoming the Vice President of Global Supply Chain in 2005. In this role, Dave provided strategic direction for the company’s Global Supply Chain initiatives and created global centers of excellence for Purchasing, Distribution, Transportation, Customer Service, Sales and Operations Management, Data Management, Graphic Design and Artwork Development, and Product Launches. Dave retired from Alcon in 2014.

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Biography: Mr. Herjolfsson co-founded Controlant, a global company that offers next-generation Cold Chain solutions as a Service (CHaaS). He has driven the vision, culture, and growth of the company for the last 10 years.

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