Temperature Controlled Logistics in Biopharmaceuticals 2020 - A Virtual Experience

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.

Session Details: Strategy and best practice for injectable biopharmaceuticals logistics 08-04-2020, 12:30 pm View In Agenda

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.

Session Details: Preparing your supply for the new regulatory provisions outlined in Health Canada guide 69 from frozen to CRT 08-04-2020, 1:30 pm View In Agenda

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.

Session Details: Utilization of cargo drones for public health logistics in low resource settings 08-04-2020, 2:00 pm View In Agenda

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.

Session Details: Developments in the Airfreight to support Pharma logistics 08-04-2020, 11:00 am View In Agenda

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.

Session Details: COVID-19 Disease Overview: Impact on Pharma, Industry Responses and Future Implications 08-04-2020, 9:00 am View In Agenda

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.

Session Details: Preparing For The Future – Are Blockchain And Artificial Intelligence Taking Over? 08-04-2020, 10:00 am View In Agenda

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.

Session Details: Mapping the Future: How Effective Data Utilization Will Transform Our Global Supply Chains Abstract 08-04-2020, 9:30 am View In Agenda