Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORA’s Office of Import Operations. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch.

Matt is a +20 year Trade Compliance and Transportation professional with a passion for all aspects of international trade and problem solving.  He is an US Licensed Customs broker, international tax expert and Logistician with a background in pharmaceuticals, chemicals, biotech, munitions, and cosmetics.  Whether dealing with imports or exports of controlled materials, Matt brings major bench strength to any project or workstream.

Anwar Mahmood has 16+ years of clinical system experience including IRT, CTMS, eCOA, and wearable device experience. He is currently a Director in the Clinical Technology Solutions Group at Exelixis where he oversees the IRT Team.

Aviral has 20 years of experience in Software Engineering field and has worked across Life Sciences, Banking, Utilities and Telecom industries in US, UK, and India. He is currently Senior Director within Digital Transformation group at Exelixis and oversees Business Process Automation and Quality Engineering teams.

Experienced and self-motivated process development scientist and team leader with specialty in process improvement, scale up, technical transfer to bioprocess manufacturing in cGMP environment. Strong subject matter experts in design robust processes for protein purification with monoclonal antibody, antigen and VLP etc, ensuring Critical Quality Attributes are achieved.

Solid trouble shooting and problem solving skills and encouraging innovation technology to achieve high efficiency and avoid repetitive work.

Strong proven track of define, design, manage and deliver projects upon all milestones, goals and cost target.

Build, develop, train and supervise team members and engage and motivate members to ensure the overall success and growth.

Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). He played a pivotal role in the development and commercialization of Veltassa® (USA and EU), a treatment for hyperkalemia, Intermezzo® for MOTN insomnia, Kerydin® for onychomycosis, and Eucrisa® for atopic dermatitis. Dr. Hayat is managing partner of Revive Pharm USA. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He received M.Sc. Chemistry degree from Punjab University, Institute of Chemistry

Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. She holds medical license issued by Serbian Medical Chamber. She is also a Certified Clinical Research Professional, and a trained journalist. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals.

Jennifer Banh is an experienced clinical supply chain professional currently working in the rare disease (sickle cell disease) space. Jennifer has vast experience in end-to-end clinical supply chain from study start up to close out. She also has extensive experience with Interactive Response Systems (IRT), inventory planning and forecasting, and CMO management and oversight.

High performing, excellence-driven, end-to-end Clinical Supply Chain Professional carrying over 20 years of industry experience in pharmaceuticals and biotechnology. Over 10 years of clinical and commercial supply chain experience. Proven success in leading study teams, including external partners, to target milestones on time and on budget. Highly skilled at supply and demand planning, developing distribution strategies, scenario planning and risk mitigation, troubleshooting, streamlining processes, saving on costs, and increasing the speed to clinics and to markets without compromising product quality.

David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations.

Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. NikZ shows promise against other important fungal diseases.

Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents.

Moving to law, in leading law firms he advised major companies on patent matters. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005.

Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever.

Ying Cai is a Director of Supply Chain at Ashvattha Therapeutics with 16 years industrial experience, specializing in clinical supply chain. Ying uses that experience to ensure end to end supply chain efficiency and integrity from raw materials to patients.

Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life sciences innovation ecosystem

Well seasoned Quality Professional with a demonstrated history of working in the biotechnology industry. Strong quality assurance professional skilled in Quality Systems, CMC, QC, Regulatory, and overall GxP (GMP, GCP, GLP) Operations, including supplier oversight, investigations and CAPAs, change management, audits, vendor qualification, and Trial Master Files. Ability to navigate from Phase 1 up to and including commercialization.

Kevin Liao is Associate Director of Supply Chain at Caribou Biosciences where he is responsible for the planning and logistics of raw materials and delivering investigational allogeneic products to patients. He has more than a decade of experience in Supply Chain Planning, Logistics, Procurement, and Systems. Prior to Caribou, he was Head of Supply Chain and Procurement at insitro and Vor Biopharma building the Supply Chain functions and defining processes to support manufacturing and sourcing.

Brittney is currently Senior Director, Technical Operations & Supply Chain at Aligos where she is responsible for the supply chain department and external vendors accountable for packaging, labeling and distribution of clinical trial materials to investigational sites.

Brittney has more than 15 years of experience working in both technical development and supply chain organizations in the consumer products and pharmaceutical/biotech industries.  Prior to Aligos, she was at Tricida, Intarcia, and Genentech where she managed all aspects of supplying 40+ clinical trials across the world in over 30 countries for thousands of patients. She also managed the commercial supply chain for the Clorox Disinfecting Wipes business, dealing with un-precedented demand changes through the H1N1 flu outbreak.

Experienced Clinical Supply Chain Professional with holistic understanding of the pharmaceutical industry and GXP requirement for clinical trials, Phase I-IV, with extensive experience in managing and leading the end to end execution of clinical trials ensure effective and efficient supply of Investigational Product (IP) across the globe. Having collaborated with several clinical service providers and cross functional groups, Anu has exhaustive experience and unique insight on managing processes related to setting up and winding down of clinical trials.

Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Isaac Blum has served as Senior Manager of Clinical Supply at ALX Oncology since June 2021. Previously, Isaac served in operational roles of increasing responsibility at BioMarin Pharmaceutical, Sangamo Therapeutics and Puma Biotechnology. Isaac is excited about developing global supply strategies and systems to help advance innovative, life-saving treatments. He has used his expertise to launch multiple global oncology clinical trials, and has shared his expertise at numerous speaking events. Isaac holds a B.A. from the University of Puget Sound.

Marc has 20+ years of Biopharmaceutical experience overseeing global clinical supply chain activities for oncology and rare disease clinical programs. Cold chain logistics experience in managing clinical supply inventory in the US, APAC, EU, US and AU regions.

Thomas started his career at Baxter Biosciences (later Baxalta) where he worked in the External Manufacturing and Supply group managing fill/finish CMO's. Thomas took a role at Vetter Pharma as a Customer Project Manager responsible for early phase clinical tech transfers. Thomas then worked for Kite Pharma's Supply Chain group managing critical raw material suppliers. He then joined ArsenalBio where he is leading the Strategic Supply Chain group responsible for managing clinical supply and production planning.

Ronald Schaefer is Senior Principal, Consulting. He is also the Consulting Head of the Certifications Programs (CEIV Pharma, CEIV Live Animals, CEIV Fresh, CEIV Lithium Battery, CBTA, etc.) at IATA. He was born in Hamburg, Germany, raised in Mexico and educated in the US. After long-term professional assignments in Germany, Spain, Malaysia, Kuwait, Venezuela and Canada, he has been based in Miami for the last 14 years working for IATA. Before joining IATA, Mr. Schaefer accumulated vast experience in the air transport field working as a consultant for Lufthansa Consulting GmbH, Roland Berger Strategy Consultants GmbH and Ferrostaal México. He has worked on corporate restructuring, strategy, post-merger integration, market and competitive analysis, safety, risk management initiatives among others, in the transportation industry on all continents. Throughout his career Ronald has held positions in Mexico, Stuttgart, Kuala Lumpur, Frankfurt, Cologne, New York, Montreal and Miami.

At IATA he developed in conjunction with the IATA Pharma subject matter expert the CEIV Pharma pre-assessment tools and materials to facilitate successful independent validation of organizations. He also led the initial independent assessment Proof-of-Concept for Singapore Air Terminal Services (SATS) and is now managing the program worldwide. Since its start he has managed ~450 certifications, +1000 assessments and +800 validations.

He is also jointly responsible for the development and implementation of new CEIV initiatives such as CEIV Live Animal, officially launched in April 2018 and CEIV Fresh launched in 2019. In conjunction with the IATA Live Animal and Perishable expert, he is also developing the pre-/assessment tools for validations of organizations and jointly managing the on-going pilots.

He holds a Bachelor of Science (B. Sc.) in Business Administration from California State University at Sonoma and Master of Business Administration (MBA) from Georgetown University.

Jenifer Shahan McIntosh counsels clients on privacy, data security, and data governance. She has significant experience with legal, operational, and reputational risk guidance, particularly as it relates to compliance initiatives, EU & UK clinical trial privacy requirements, product design, mergers, acquisitions, and tech transactions. She counsels clients on domestic and international privacy laws and regulations, including cross-border data transfers.

Jenifer has an extensive and diverse background in commercial litigation, including complex contract and licensing disputes, patent litigation, business torts and regulatory investigations defense—all of which she brings to her privacy and data security work. Her cybersecurity experience includes working with clients to stand-up security programs, helping clients establish robust privacy-by-design in product development, advising and guiding clients in the conduct of cyber and data governance due diligence during M&A transactions, and advising on vendor and licensing agreements regarding the transfer and security of data. She has advised leading pharmaceutical trials companies, private equity firms, SaaS service providers, health-tech, ad-tech, and e-commerce clients on privacy and data security issues in technology-driven transactions.

Jenifer is a Certified Information Privacy Professional for for the United States (CIPP/U) and licensed in New York, Colorado and Texas. Prior to her relocation to Dallas, she served as in-house counsel for a clinical trials company and web-based educational technology company. Jenifer has been quoted in the Law360 on legislation regarding privacy and big-tech tracking, and is a prolific writer on international and domestic privacy and data security law developments.

Chris Driver is currently Director, IT Architecture at IQVIA, with over 21 years of experience in the IRT and Biotechnology space, and across a number of R&D and Information Technology functions. Chris’s experience and background in infrastructure architecture, global health platforms and more recently, decentralized trial adoption through real-time integrations, drives his enthusiasm for the future state of patient-centered health care.  In his “downtime”, Chris enjoys spending time with his growing family, advocating for adoption, especially for those blessed with an extra chromosome!

Edo Madussi is the Managing Director, of Euromed Pharma US and Business Unit head of the Clinical Trial Division at the Petrone Group.

His business experience combined with his academic background and four spoken languages - English, German, French, and Italian - brought him to develop an extensive network within the global clinical supply chain space.  He is currently developing one of the latest ventures of the Petrone Group: a US-based integrated platform to support Clinical Trial Sponsors and other industry players around the world with a wide range of services in the R&D space.

Melanie has worked in Quality since starting her career in 2007 and spent six years with a pre-clinical CRO before making a switch to software and the clinical trial industry. Started working for endpoint Clinical in 2013 and has worked with the Quality leadership team in building up the quality management system. She has helped endpoint establish a robust remote client audit and inspection support program that allows the company to respond to requests and questions efficiently and in a timely manner.

Jennifer is part of World Courier's team leading the cell and gene therapy and direct-to-patient service lines, focusing on defining strategy, driving growth, and solving operational and process challenges arising from these shipments' complexity. With experience in roles on both the sponsor and vendor side for clinical and commercial pharmaceutical logistics, Jennifer has served in many leadership roles in the clinical trial supply chain, project management, vendor and alliance management before joining World Courier in 2022. Jennifer is helping the health tech sector integrate and grow within the continuously shifting landscape.

Tracy is an RTSM Solutions Specialist at Medidata with 26+ years of experience in the Life Sciences Industry including 25 years specializing in Interactive Response Technology (IRT)/Randomization and Trial Supply Management (RTSM) for large and small study systems for both US based and global projects in multiple trial phases and indications. Prior to joining Medidata, Tracy was a Client Oversight Manager at PPD whose responsibilities included ensuring project/study activities were in compliance with company and sponsor requirements; meeting with internal teams to coordinate efforts, providing recommendations and risks, and serving as an escalation contact with clinical project management teams and sponsors for PPD’s proprietary IRT platform as well as Medidata Rave RTSM at PPD (as an accredited Medidata partner). With her years of experience and knowledge in the pharmaceutical industry and the clinical trial space, she has a great understanding of what it takes to work with CROs and Sponsors and to help them navigate and troubleshoot their varying system needs.

Brandy Porter is the Assistant Center Director for Enforcement, of CBP’s Pharmaceutical, Health, and Chemicals Center of Excellence and Expertise (PHC CEE). PHC CEE oversees imports of pharmaceuticals, healthcare, medical equipment, and chemicals into the United States. Prior to her work at PHC CEE, Ms. Porter was the Deputy Assistant Director for the Center for Intelligence, Targeting, and Enforcement, located in the New York Field Office.  She began her career with CBP in 2009, as an analyst.

Gina Reneau is a Biological Threat Exclusion Coordinator (BTEC) for U.S. Customs and Border Protection (CBP) in the Office of Field Operations

Agriculture Programs and Trade Liaison/ Biological Threat Exclusion.  As a BTEC, Ms. Reneau is charged with supporting and developing CBP operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.  Ms. Reneau has more than 27 years of public service with CBP, and has worked in a variety of environments, including in air passenger, cargo, maritime, and express consignment locations.