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Pharmaceutical companies, ingredient suppliers, and contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) need to continually evaluate their strategies, technologies, and capabilities. Formulation and drug delivery innovations are critical in managing product lifecycles and creating new market opportunities. What are the criteria for a successful drug delivery strategy and how are limitations overcome?
Pharmaceutical and industry experts share their vision for next-generation formulations and drug-delivery technologies and the impact they have on growth rates, commercial product applications, and R&D dosage form pipelines. The program highlights next-generation technologies, partnerships, and regulatory platforms to strategically advance drug development and delivery.
Market Overview What were the most significant business, product and technology trends of 2016 and what is on the horizon for 2017 and beyond? Using a trends analysis covering a 10-year history of drug delivery and formulation approvals, this presentation will provide an in-depth market overview of pipeline developments and commercial activities by dosage form and highlight the key partnerships driving formulation development, drug development, and commercialization.
Josef Bossart, PhD, Executive Editor, PharmaCircle LLC
Next-Generation Technologies: Strategies, Smart Pills and Advanced Drug Delivery for Small Molecules Learn from leading executives of key strategic considerations used in evaluating advanced formulation and drug-delivery technologies, including whether to build internal capabilities or use external partners.
Keith Horspool, PhD, Vice President of Material and Analytical Sciences, Boehringer-Ingelheim
Ronald L. Smith, PhD, Scientific Associate Vice President, Pharmaceutical Sciences, Merck Research Laboratories
How can conventional formulation and drug delivery be transformed to allow for more accurate dosing and potentially greater patient compliance? Learn about an emerging category of new drugs, digital medicines, and how smart pills may factor into the strategies of pharmaceutical companies in the future.
Jeremy Frank, Vice President, Digital Medicine Platform Development, Proteus Digital Health
Advanced Drug Delivery for Small Molecules Finding cost-effective and innovative approaches in delivering drugs to improve patient compliance and health outcomes is an ongoing challenge, but it is particularly so for drugs targeted for the developing world, where drugs need to be stable for longer periods with limited cold chain, be easily adoptable by users with limited training and equipment, and convenient enough to promote patient adherence. Learn of the advances in small-molecule drug delivery that the Bill & Melinda Gates Foundation is making to overcome these issues by engaging a broad set of partners, including academics, start-ups, and multinational pharmaceutical companies, and the key learnings that can be applied across the business of drug development.
Susan Hershenson, PhD, Deputy Director, Chemistry, Manufacturing and Controls, Bill & Melinda Gates Foundation
The 505 (b)(2) Regulatory Pathway: Market Opportunities The 505 (b)(2) pathway is a regulatory route for a new drug application that potentially enables a lower cost, lower risk, and faster path to regulatory approval and market. It may be used to create a new dosage form, alternate route of administration, or new mechanism of drug delivery. This presentation will explain the key elements of 505 (b)(2) development requirements, including CMC (chemistry, manufacturing and control) requirements, and the typical interactions required between CDMOs/CMOs and sponsor companies, including the experience of a pharmaceutical company using this pathway leveraging external partners.
Kenneth V. Phelps, President and CEO, Camargo Pharmaceutical Services
Gemma Casadevall, PhD, Chief Scientific Officer, Medichem, S.A.
Attendees should pre-register and pre-pay for DCAT Week programs and events before March 15, 2017 (5pm ET). Confirmations and receipts will be emailed to registrants when payment is received.
Member Badges: On or about Thursday, March 16, 2017, DCAT members will receive an email with an e-ticket attachment confirming all of their pre-registrations for DCAT Week. Attendees should print the e-ticket (or store it on their phone) and bring it with them to DCAT Week. The QR code on the ticket can be used to quickly print a member badge or to scan attendees into all of the programs and events they have pre-registered for throughout the week. A separate badge system will be used for non-member registrants.
Badge Pickup Locations during DCAT Week:
Walk-ins are welcome if space permits. All walk-ins must pay with a credit card or check. Walk-ins cannot be invoiced.
Speaker bios have been requested from presenters and will be posted here as they are received.
Gemma Casadevall, Ms. Pharm Sciences and PhD., is Chief Scientific Officer at Medichem, overseeing all corporate scientific research operations (Spain, Malta, and China) for both active pharmaceutical Ingredients and finished dosage forms. With more than 20 years of experience in the pharmaceutical industry, her career has been focused in: formulation, drug delivery, development, and technology transfer. Her special fields of interest have been implementing Quality by Design under ICH Q8 and process analytical technology (PAT) systems for pharmaceutical dosage forms, mostly oral controlled released products, for the US market. Also, she has led several technology platforms focused on drug delivery and bioavailability enhancement as well as site specific delivery with polymeric chemistry with applicability for oral, nasal, ophthalmic and otic products. She has held several senior management and director positions at Salvat (Spain), Esteve (Spain), Lacer (Spain), Johnson and Johnson (USA), and Ferrer (Spain).
Jeremy Frank is Vice President of Digital Medicine Platform Development at Proteus Digital Health, Inc. and leads the company's design, development and manufacturing of ingestible sensors, wearable sensors and digital medicines. His prior responsibilities at Proteus included leadership positions in operations where he developed and scaled the manufacturing processes for Proteus core ingestible technology, as well as program management for the company’s first beta product offering, called Helius. Prior to joining Proteus, Jeremy designed tools for cardiac surgery at Vascular Innovations, Inc. (now Cardica, Inc.) and neural stents at Guidant, Inc. His Master’s and PhD research at the University of California, Berkeley focused on developing microfluidic systems for low-power wearable sensing platforms and he holds a Bachelor’s of Science degree in Mechanical Engineering from Stanford University.
Dr. Susan Hershenson is Deputy Director of Chemistry, Manufacturing and Controls at the Bill and Melinda Gates Foundation. With close to 30 years of drug development experience, she works closely with the Foundation’s strategy teams and partners to provide technical expertise and strategic guidance for the therapeutics projects. Prior to joining the Foundation she founded Pharmaceutical Transformations LLC, a consulting service for the pharmaceutical, biotechnology, drug delivery and related industries. Her clients included a wide range of biotechnology, pharmaceutical and drug delivery companies, VC’s, university labs and non-profit organizations. Before starting her own practice she served in a variety of roles in the biopharmaceutical industry, including most recently Vice President of Pharmaceutical and Device Development at Genentech and Vice President of Pharmaceutics at Amgen. During her career, Dr. Hershenson has made significant contributions to the development and commercialization of numerous therapeutic products including Betaseron®, Stemgen®, Kepivance®, Aranesp®, Neulasta®, Sensipar®, Nplate®, Vectibix®, Prolea®, Xgeva® and Nutropin NuSpin®. She earned a B.A. in Chemistry from University of Chicago; received her Ph.D. in Biochemistry from Yale University; and held a postdoctoral fellowship in the laboratory of Dr. Robert Stroud at UCSF. Dr. Hershenson publishes and teaches actively and serves on Scientific Advisory Boards.
Keith Horspool, PhD, is Vice President of Material and Analytical Sciences at Boehringer-Ingelheim (BI), Ridgefield, Connecticut. His department develops and applies physical/material sciences-based approaches to deliver integrated drug substance and drug product material attributes to enhance product and process understanding, and robustness, supporting the implementation of effective, cost efficient processes for design and manufacture of drug product and drug substance. Prior to joining BI, Keith worked at Pfizer and Astra Zeneca. He has 30 years experience during which he has managed preformulation, product development, drug delivery and materials science. He has a B.Sc. in pharmacy and a PhD in pharmaceutical chemistry.
Kenneth V. Phelps is co-founder and Chief Executive Officer of Camargo Pharmaceutical Services. He has more than 40 years of industry experience, including a number of executive-level positions in areas such as quality control, project management and regulatory, clinical and medical affairs. He applied more than three decades of industry experience to found Camargo Pharmaceutical Services in 2003. As an expert in drug development and development via the 505(b)(2) regulatory approval pathway, Phelps leads the team that has guided hundreds of FDA approvals and Camargo now has the largest percentage of 505(b)(2) submissions of any team submitting to the US Food and Drug Administration. Before founding Camargo, Phelps’ diverse background in drug development had led to a number of executive-level assignments in the areas of quality control, project management and regulatory, clinical and medical affairs at Duramed Pharmaceuticals. Phelps also held a number of positions at Merrell-National Labs (which merged to become Merrell Dow and later evolved into Aventis), where he was responsible for global quality assurance, quality control and processing technology with an assignment based in Milan, Italy.
Ronald L. Smith, PhD, is Scientific Associate Vice President of Pharmaceutical Sciences at Merck Research Laboratories leading the Exploratory Products & Technologies group. Dr. Smith joined Merck in 2008 as Executive Director of Pharmaceutical Research in West Point, PA and was most recently Executive Director of Product Value Enhancement. Prior to Merck, Dr. Smith led Exploratory Biopharmaceutics & Drug Delivery at Bristol-Myers Squibb Company where he also had responsibility for drug substance and drug product stability for small molecules and biologics. He began his career with the Procter & Gamble Company leading the research and product development of several patented technologies for intranasal, buccal, mucoadhesive and transdermal drug delivery. Dr. Smith is a Fellow of the American Association of Pharmaceutical Scientists and past-Chair of the Pharmaceutics & Drug Delivery Section of AAPS and the Board of Scientific Advisors for the Controlled Release Society. He has held Adjunct faculty appointments at the University of Cincinnati College of Pharmacy and the School of Pharmacy at West Virginia University and received his degrees in Chemistry from West Chester University (BS) and the University of Iowa (PhD).
Marriott East Side (Stuyvesant Room)
525 Lexington Avenue at 49th Street
New York, New York 10017
Map & Directions
To cancel your program registration and receive a refund, you must call the DCAT office by March 15, 2017 (5pm ET) at +1-800-640-3228.
Refunds with receptions may be subject to a processing fee due to hotel guarantees.
The DCAT organization regrets that no refunds can be given after March 15, 2017 (5pm ET).
Registration payments made by credit card will be refunded within two to three business days from the date of cancellation.
Registration payments made by check will be refunded within 20 days of the program date.
Education program topics for DCAT Week are selected and developed by members of DCAT's Education Committee and other volunteer task forces of the organization. Speakers are selected based on their expertise and/or experience related to these topics, their ability to impart important information and concepts, and their willingness to do so without promoting specific business interests. By advance meetings with speakers, reviewing materials and slide presentations, DCAT volunteers make every effort to ensure that each program is a relevant, value-added experience for our members.