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Silver Sponsors

Chemic

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Gold Sponsors

abbvie

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Bronze Sponsors

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Element

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ILC Dover

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Selkirk Pharma

Wavelength

Yali Friedman
Yali Friedman, Ph.D., is founder of thinkBiotech and publisher of the Journal of Commercial Biotechnology. His first book, Building Biotechnology, has been used as a course text in dozens of biotechnology programs. His other books include Best Practices in Biotechnology Education and Best Practices in Biotechnology Business Development. Scientific American also named Dr. Friedman as one of the 100 most influential people in biotechnology.Dr. Friedman has strong exposure to leading issues in international biotechnology. He is editor of the Scientific American worldVIEW global biotechnology scorecard, a global biotechnology perspective profiling biotechnology industries and innovation capacity in more than fifty countries, and has been invited to participate in biotechnology industry development forums for US federal agencies, international groups such as APEC and ASEAN, and for individual countries such as Canada, Germany, India, Japan, the Philippines, and Turkey.Dr. Friedman taught biotechnology management at the National Institutes of Health for several years and continues to regularly guest-lecture for other biotechnology education programs. He writes and speaks on diverse topics such as biotechnology entrepreneurship, strategies to cope with a lack of management talent and capital when developing companies outside of established hubs, and new paradigms in technology-based economic development.Dr. Friedman has a long history in biotechnology media. He created the first blog on the business of biotechnology for a NY Times web property which was named to Forbes “Best of the Web” list. His other projects include the Student Guide to DNA Based Computers, sponsored by FUJI Television, BiotechBlog.com, and DrugPatentWatch.com, a pharmaceutical industry competitive intelligence platform based on a business plan that was awarded second place in the Panasci Entrepreneurial Awards Competition.

Dave Windley

David Windley
Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 20-year career in investment research, Mr. Windley has covered a broad range of healthcare product and service sectors, including managed care, healthcare information technology, pharmaceutical services, and specialty pharmaceuticals. Dave is a five-time Wall Street Journal Best on the Street honoree and a 6-time Starmine award recipient. Dave is involved in the Nashville financial and healthcare community, having served as an officer and board member of the CFA Society of Nashville, an Alumni Board Member of the Owen Graduate School of Management, and a member of Leadership Healthcare.

José L. Toro
José L. Toro, Ph.D., is a Director in the Compliance Practice at Lachman Consultants who has extensive R&D Quality, and Quality Operations experience in the pharmaceutical industry. Dr. Toro specializes in the transformation of Quality and Technical Services organizations including Quality Systems, global implementations, corporate auditing, technology transfer and plant operations. He has a broad knowledge of regulatory compliance and quality control. Dr. Toro is well versed in FDA, MHRA, IMB, ANVISA; Japan and Korean inspections. He is highly experienced in manufacturing technologies for multiple dosage forms and associated processes; aseptic operations, complex prefilled syringes, extended-release solids, liquids, semi-solids, parenterals, medical devices, combination products, as well as bulk operations. Dr. Toro co-authored the PDA Technical Report (TR 60-2) on Solid and Semi-Solid Process Validation.

Janet Gould

Janet Gould
Dr. Janet Gould, PhD, DABT, CIH is a Principal Toxicologist at SafeBridge Consultants based in New York, NY. She has over 20 years of experience in occupational toxicology including 14 years at Bristol-Myers Squibb, which also included general EHS support for R&D. In addition, she has experience with chemical industry product safety and regulatory toxicology support. She has numerous presentations, training and publications including on the topics of occupational exposure limits, banding, sensitization, biologics, ADCs, and structure activity relationships. She is a member of the Workplace Environmental Exposure Level (WEEL) Committee, Occupational Toxicology Roundtable, Society of Toxicology, AIHA and the NIOSH Hazardous Drug Alert Committee.

Michael Wilkinson

Michael Wilkinson
Michael Wilkinson has worked for the Sponsored Research program within the Tufts Center for the Study of Drug Development (TCSDD) for more than four years. He is currently a project manager focusing on research requiring knowledge of quantitative analysis, clinical technologies, protocol optimization, and data science. Mr. Wilkinson received a BA from the University of Massachusetts Lowell in the field of quantitative sociology and a master’s in public heath from Tufts University with a concentration in epidemiology and biostatistics.

Paul McGuirk

Paul McGuirk
Paul McGuirk is Director, External Supply, for small molecule drug product at Pfizer. He has broad responsibilities that include managing a global team engaged in Drug Product Manufacturing oversite, vendor management, and sourcing strategy. He has been instrumental in developing Pfizer World Wide R&D’s vendor database, which is utilized to capture relevant information required to support outsourcing activities. Paul has 10+ years of experience in various supply chain roles for both the consumer goods and pharmaceutical industries including SC Quality, Manufacturing/Packaging and Procurement. Paul holds a Bachelor of Science degree in Molecular and Cell Biology from the University of Connecticut as well as an MBA from the University of New Haven.

Melissa Joseph

Melissa Joseph
Melissa Joseph, PhD, has over 20 years of experience in the pharmaceutical industry and is currently owner and principle consultant at Chymesis, LLC.  Dr. Joseph has worked and consulted for small, virtual pharmaceutical development companies that rely on vendor relationships for all of their manufacturing and distribution needs.  Dr. Joseph has been responsible for establishing and overseeing vendor relationships supporting all aspects of the manufacture of clinical trial material from the synthesis of the drug substance, through to the manufacture, packaging, distribution and regulatory activities required to support clinical trial supplies from Phase 1 to NDA.  She has been integral in reformatting Quality Systems in order to ensure compliance with current Good Manufacturing Practices, while at the same time structuring systems and processes in order to optimize vendor relationships.  Given her previous employment at contract as well as sponsor firms, Dr. Joseph has a unique understanding of the importance of the vendor relationship from both parties’ perspectives.

Gautam Ranade

Gautam Ranade
Dr. Gautam Ranade is an active consultant to the pharmaceutical industry in the areas of Pharmaceutical R&D outsourcing, dosage form development, novel drug delivery, due diligence, CMC strategy and external alliance management. Previously, Dr. Ranade was a Senior Director, Strategic Sourcing (Pharmaceutical Sciences) in Pfizer Worldwide R&D. He has a Ph.D. in Chemical Engineering and has many years of R&D, technology transfer and supply chain experience in pharmaceutical R&D at Pfizer. In a prior role, he was a Senior Director of Drug Product Manufacturing. He made major contributions to the development and commercialization of many parenteral/oral/topical dosage forms for several Pfizer drugs. He holds 19 U.S. patents and many international patents in the areas of drug delivery and formulation development. He has 20 publications in various scientific journals in the areas of novel dosage forms and drug delivery systems. He was actively involved in outsourcing activities for drug product development. Based on his broad and extensive experience Gautam is uniquely qualified to advise on how best to navigate the complex challenges of outsourcing drug product development.

Ben Locwin

Ben Locwin, PhD, MBA, MS, MBB, is a Healthcare Futurist and SVP of Quality at Lumicell, as well as a member of several pharma and biotech Boards of Directors and Advisory Boards. He has been featured in The Wall Street Journal, Forbes magazine, USA Today, and other top-tier media outlets. Dr. Locwin is widely published in the healthcare arena, his work extending to improving patient care, hospital practice, and infection reduction. He has participated as a futurist for new treatment modalities and medical devices, and has also been a consult for drug pricing in the current sociopolitical climate. Some of these paradigms have also extended to work with ICH as well as FDA on forward-thinking metrics for the future of the pharmaceutical industry. Ben is also an active board member for the Genetic Literacy Project, an internationally-recognized organization for the critical thinking and publication of clear science on the future of genetics and genomics, and technologies therein to enhance health and well-being for humanity.

Eric Langer

Eric LangerEric Langer, president and managing partner of BioPlan Associates has over 20 years of experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies and is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher. He has published, edited and authored numerous books, reports, and major studies on topics including: Advances in Biopharmaceutical Technology in China, Advances in Large-scale Biopharmaceutical Manufacturing, Biopharmaceuticals in the U.S. Market, and many others. He lectures extensively on marketing, pricing and channel management topics, and teaches at Johns Hopkins University and American University: Biotechnology Marketing, Marketing Management, Services Marketing, Advertising Strategy, and Bioscience Communication. In 1989 he co-founded BioPlan Associates, Inc. He has launched and managed marketing programs for product lines ranging from $500k to $500 million.

 

 

 

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