September 18-19, 2023; Boston, MA

Prof. Sailor is Distinguished Professor at the University of California, San Diego, Director of the UC San Diego Materials Research Science and Engineering Center (an NSF MRSEC), and Director of the UC San Diego Institute for Materials Discovery & Design. Trained as a chemist at Harvey Mudd College and Northwestern University, he joined the faculty at UC San Diego in 1990. He holds Affiliate Appointments in the UCSD Bioengineering Department, the Nanoengineering Department, and the Materials Science and Engineering program. He has supervised more than 160 undergraduate, graduate, and post-doctoral students, he is the author of more than 250 peer-reviewed research publications, one book, and 34 issued patents and has an h-index (Google Scholar) of 100. He is an elected Fellow of the American Association for the Advancement of Science, the U.S. National Academy of Inventors, and the Royal Society of Chemistry.

Dr. Shawn (Xiaotian) Yin received his Ph. D. in Solid-State Chemistry from University of Waterloo, Canada. He then completed his Post Doctoral fellowship at Department of Materials Sciences and Engineering, Cornell University.  Currently, Dr. Yin is a scientific director at Bristol-Myers Squibb Company. His research interests include pharmaceutical polymorphic form studies, API form in drug product, physical characterizations of pharmaceutical substances, powder X-ray diffraction applications in pharmaceutical sciences, amorphous and nanomaterials for drug delivery. 

Dr. Yin has (co)-authored over 30 scientific publications and 10 patents.  He serves as a scientific organization committee member for the Pharmaceutical Powder X-ray Diffraction Symposium. He was awarded the title Fellow by International Centre for Diffraction Data. Dr. Yin is also a frequent invited lecturer at international and domestic scientific conferences and workshops.

Dennis Leung received his PhD in Chemistry from the University of California, Berkeley in 2006 working on supramolecular chemistry as a joint student with Prof. Bob Bergman and Ken Raymond. He then pursued a postdoctoral position at the University of California, Irvine working on novel polymerization catalysts before beginning his industrial career at Merck. He moved to Genentech in early 2016 where he is currently a Director and head of the Discovery Pharmaceutics group. This group is integrated in the drug discovery and early drug development phases with a focus on pharmaceutics, materials science, formulation, and drug delivery.

Sheri Shamblin is a Director at Pfizer Worldwide Development and Research and leads a group of formulation scientists that design and develop clinical and commercial oral formulations.  She has over 25 years of experience in the pharmaceutical industry that includes preclinical and late-stage development, with expertise in novel modified release formulations, and strategies for overcoming poor solubility that include salt formation and amorphous solid dispersions.   Sheri has published over 30 research articles, served as an Adjunct Professor at Purdue University School of Pharmacy and lecturer at Connecticut College Department of Chemistry.  In addition, she is a Member of the Advisory Board for the Zeeh Pharmaceutical Station at The University of Wisconsin-Madison Wisconsin and in 2020 was a Nominee for Connecticut Women of Innovation.

Filippos Kesisoglou is a Distinguished Scientist at Merck & Co., Inc., (Rahway, NJ) where he has been leading the Biopharmaceutics efforts in the Pharmaceutical Sciences department. Filippos has more than 18 years of experience in the fields of biopharmaceutics and formulation development, pharmacokinetics, PBPK and IVIVC modeling as related to clinical, drug product development and CMC regulatory applications across modalities. He has been a key contributor to multiple new drug applications. He has authored/co-authored 90 manuscripts/book chapters and more than 90 conference abstracts/podium presentations in several national/international meetings in the fields of biopharmaceutics, PBPK modeling, formulation development and drug delivery. He is currently serving as an Editor for Journal of Pharmaceutical Sciences and on the Editorial Advisory Board for the AAPS Journal and Pharmaceutical Research. In 2017 he was elected a Fellow of the American Association of Pharmaceutical Scientists (AAPS).

Dr. Manuel Sanchez-Felix is a Associate Director with the Chemical and Pharmaceutical Profiling (CPP) group at the Novartis Institutes for BioMedical Research in Cambridge, MA. He is a scientific leader with over 20 years of experience in drug discovery and development where he co-invented and contributed to the successful development and launch of various pharmaceutical products. 

At Novartis, Dr. Sanchez-Felix leads a cross-functional group from Discovery and Development that is responsible for the evaluation and implementation of external Novel Delivery Technologies. His previous position at Novartis involved heading a group of scientists at the interface between Research and Development, establishing physicochemical and biopharmaceutical properties, and combining this information to initiate development strategy and formulation design. Prior to joining Novartis, Manuel was at Eli Lilly & Company for 20 years. His area of expertise includes Biopharmaceutics, drug delivery and patient-centered formulation design. Areas of drug discovery where he has developed products include CNS, infectious diseases (specifically TB, Malaria and Rheumatic fever), oncology, bone regeneration, and diabetes.

Dr. Sanchez-Felix received his B.Sc. Honors degree and Ph.D in Chemistry from the University of Surrey, UK. He is also an Adjunct Professor in the Department of Industrial and Physical Pharmacy at Purdue University (West Lafayette, IN) and a Fellow of the Royal Society of Chemistry. Recently, he has joined the Advisory Board of both the Biomedical Programs at Middlesex Community College and Northeastern University who have a program supporting students from minority communities.

Harshal is part of our global medical division based out of Boston, with more than a decade of experience in medical device development, product life cycle strategy, and innovation management. He has significant expertise in oncology patient journey, economics of cancer care and innovations in oncology. He has a Bachelor of Mechanical Engineering degree from Nirma Institute of Technology in India, an MBA from Syracuse University, New York, and he recently completed a post graduate program in cancer biology and therapeutics development from Harvard Medical School.

Al Berchielli works in Pfizer Drug Product Design for the last twenty-eight years as a formulator and group leader.  He previously worked in the formulation department at Wyeth/ Lederle Labs for 5 years.  Al’s areas of expertise include design and scale-up of immediate release and extended-release oral drug delivery systems (e.g., osmotic pump and matrix tablets).  His research interests include IR/ER combinations, spray application of active ingredients in tablet coatings, extended-release functional coatings, and coating process modelling. 

Al received his M.S. in Industrial Pharmacy from the Arnold and Marie Schwartz School of Pharmacy at Long Island University, New York, and his B.S. in Chemistry from the State University of New York College at Cortland.  Al has several published patents, papers, and book chapters covering formulation design and tablet coating process modelling.

Keith Faucher, MBA, PHD is a Sr. Director of Device Development and Innovation at Aura Biosciences, a clinical stage oncology therapeutic company.  He has worked in the medical device and biotechnology industries for the last 20 years focused on the development of combination products to treat vascular, soft tissue, and oncologic diseases.  His recent work has included developing drug and light delivery devices for the treatment of ocular and bladder cancers using virus-like drug conjugates.  Keith received his BS in Chemistry and MBA from the University of New Hampshire, his PhD in Analytical Chemistry from the University of Georgia, and his post-doctoral training at Emory University Medical School.

Dr. Leung is a Physicist/ Material Scientist by training and completed his degree at Northwestern University.

With more than 10 years of experience in the pharmaceutical industry, Dr Leung has extensive experience in small molecule formulation design and process development including pediatric, bioavailability enhancement, control release and continuous manufacturing. In his current role in Agios, Dr Leung supports multiple programs to help patients in the rare genetic disease area.

Anthony is a Technical Development Principal Scientist in the Pharmaceutical Development department at Genentech. During his time at Genentech, he has been involved in the formulation of biopharmaceuticals and, particularly, in the area of surfactant degradation and characterization. Prior to working at Genentech, Anthony held a variety of positions in other pharma companies and research institutions. He has a BS in Microbiology from UC Davis.

Maya Lipert a Principal Scientist in the Molecular Profiling and Drug Delivery within Small Molecule CMC Development at AbbVie, Inc., in North Chicago, IL, where she leads a group responsible for high throughput physicochemical profiling assays to support discovery projects.  Previously, she conducted  API solid form evaluation, selection, and derisking activities on discovery and early development teams across modalities and routes of administration. Prior to joining AbbVie, she worked for 5 years at Merck & Co., Inc. (West Point, PA), in Pharmaceutical Sciences where she focused on improving the quality of drug candidates based on a sound understanding of physiochemical properties as they relate to clinical developability and development of clinical oral formulations. She earned her Ph.D. from the University of Michigan in 2015, where she studied the influence of drug-solubilizing agents on pharmaceutical cocrystals.

Dr. Xiaofeng Lu is a principal scientist in the Drug Product Development, CMC Biologics group at AbbVie in South San Francisco, CA. Her primary work involves end-to-end pharmaceutical development, including liquid and lyophilized formulation development, drug product process development, and technology transfer for manufacturing biologics. In the recent years, her research interests include complex multi-specific antibodies and antibody drug conjugates (ADCs) stability studies and characterization, formulation and process optimization, drug product configuration development, as well as clinical in-use studies to guide drug dose preparation and administration instructions for clinical trials.

Steve Persak is a Director of Device Development at Merck Research Labs. He is responsible for Device Innovation, Device Program Leadership, as well as other technical functions.

Mr. Persak has more than 10 years of experience in the medical device and combination product sector, developing delivery devices for a variety of formulation types and delivery modalities. During his time at Merck, he has supported several programs, including Keytruda®, NuvaRing® and NuvaRing® Applicator, Nasonex®, Asmanex®, Simponi®, Nexplanon®, Implanon®, PegIntron®, and Lusduna®.

By training, he is a Mechanical Engineer and holds bachelor’s and master’s degrees The Cooper Union in NY as well as an MBA from the NYU Stern School of Business.

Will Forrest is a Principal Scientist at Merck Research Labs in the Sterile & Specialty Products division where he is responsible for the formulation and process development of biologic parenteral products, pipeline program leadership and Pharmaceutical Sciences IP lead.

Dr. Forrest has more than 8 years of experience in the drug product formulation/process development and analytical method development fields for a variety of parenteral modalities.

By training, he is a Chemist and holds a B.S. from Furman University, Ph.D. from Purdue University and Post-doctorate from the Massachusetts Institute of Technology.

Gaauri Naik, currently director at Relay Therapeutics, joined Relay for more than 5 years ago and has led R&D formulation efforts which focused on profiling and formulating early preclinical stage small molecules and then advancing solid oral dosage forms into early clinical development. Prior to Relay, Gaauri has worked at various pharmaceutical/biotech companies. There, she managed and contributed to formulation development and commercial manufacturing that covered early to late-stage development along with technical transfer to commercial manufacturing facilities which included solid oral and parenteral dosage forms. Gaauri developed extensive expertise in technologies for delivering poorly soluble drugs, injectable formulations including novel drug delivery approaches. She has held roles of increasing responsibility at Cubist, Merck, Keryx and Relay Therapeutics., culminating in her role to lead clinical formulation development including pediatric formulation development and commercial drug product manufacturing across North America, Europe and Asia

My Name is Shwetha Iyer, and I work as a Principal Scientist I in Novartis. My organization in Novartis is called Novartis Biologics Center (NBC) which is a part of NIBR here in Cambridge, MA. Within NBC, I am leading the formulation team for large biotherapeutics and other modalities such as gene therapy, Adeno-associated virus (AAV), Lentivirus (LV) etc. My group’s core responsibility includes but not limited to establishing developability assessments focusing on preformulation studies for large biotherapeutics in order to successfully lock down clinical service formulation for Phase I studies and in some cases, beyond Phase I. We work with high throughput, state of the art automation systems that enable us to determine the degradation mechanisms of the protein during stability and mitigate the risk to enable a successful liquid in a vial (LiVi) for clinical applications

Dr. Varsha Dhamankar is the Director and Head of Formulation at Ribon Therapeutics. She leads drug product development and preformulation for Ribon’s clinical and preclinical candidates. Varsha has over 10 years of experience in small molecules oral and parenteral formulation development, with a focus on solubility and bioavailability improvement for oral solids. Previously, Varsha has worked at Vertex Pharmaceuticals, Cyclerion Therapeutics, and Sage Therapeutics. In these roles, she managed formulation development and drug product strategy for multiple programs with internal and outsourced teams in various stages of clinical development. Varsha holds a Bachelor of Pharmaceutical Sciences degree from the Institute of Chemical Technology, India, and a Ph. D. in Pharmaceutics from the University of Iowa.

Nélio Drumond is a PharmD by training with a PhD in Patient Centric Drug Product Design. He shares several years of experience in the Pharmaceutical Industry, providing scientific leadership to govern formulation and manufacturing strategies for drug product development programs during clinical stages, including their scalability and validation for commercial use. Nélio has spent the last 2 years overseeing Takeda’s external commercial manufacturing portfolio within the EMEA region and has recently joined the Global Manufacturing Sciences group in Cambridge, MA to support launch and commercialization of promising NCE’s from clinical programs. Dr. Drumond is a strong advocate for patient centric drug product design and is regularly invited to speak at various international conferences. 


 

I am an Associate Director in Biologics Drug Product Development& Manufacturing Organization at Sanofi.  I primarily lead and provide oversight to the Drug Product development activities for viral and non-viral gene therapy programs.  I obtained my Ph.D from New York University in Chemical Engineering with focus on developing lipid-based drug delivery nanocarriers for cancer therapy. Prior to joining Sanofi, I worked at Shire (Takeda) on early and late-stage protein therapeutic programs along with their mRNA/LNP platform.

Dr. Nitin Joshi is an Assistant Professor at Harvard Medical School and an Associate Bioengineer in the Department of Anesthesiology, Perioperative and Pain Medicine at the Brigham and Women’s Hospital. After obtaining his PhD degree in Biomedical Engineering from Indian Institute of Technology Bombay, India, he did his postdoctoral fellowship at the Brigham and Women’s Hospital. His lab works at the interface of chemistry, material science, biology, and medicine, to develop translatable technologies for solving medical problems across a wide range of diseases. Technologies developed by him have resulted in several granted and pending patents and technology disclosures, with most licensed to biotech companies and one already advancing through clinical trials. Dr. Joshi’s research work has been published in top tier journals, including Nature Communications, Science Advances, Nanotoday, Biomaterials, and Journal of Controlled Release, and has been highlighted by multiple media outlets and scientific journals around the world. He has received multiple awards for his work, including MIT’s Technology Review Magazine (TR35) India Award, Lockheed Martin Innovation Award, and Boston Patent Law Association (BPLA) 2020 Invented Here! Featured Honoree Award. He is also a co-founder of Akita Biosciences, a biotech company that aims to advance a nasal spray technology developed in Dr. Joshi’s lab. He also serves as a consultant for multiple biotech companies.

Yan He is the Head of Formulation Development for Early Development US at Sanofi.  She started her career as a pharmaceutical scientist after receiving her Ph.D. at Dr. Samual H. Yalkowsy's lab from the University of Arizona in 2005.  She has over seventeen years of industry working experience since then.  She has published twelve research papers in the peer reviewed journals and the Handbook of aqueous solubility data.  She has served as a Scientific Advisor to the Journal of Pharmaceutical Sciences during 2013-2017 and is a member of JPharmSci® Editorial Advisory Board (EAB) since 2017.

Dr. Zhi Chen is an Associate Scientific Director in the department of Sterile Product Development in Bristol Myers Squibb. He and his team are responsible for developing analytical methods and strategies to support formulation development, drug product process development and CQA assessment. Dr. Chen has been a key contributor to many IND and BLA filings. Prior to joining BMS, Dr. Chen’s career spanned in Merck, Novartis, and legacy Schering-Plough. He has been a significant contributor to the commercialization of many marketed products including Keytruda®, Opdivo®, and Opdualag™.

Dr. Wei Zhang received his Ph.D. degree in Pharmaceutical Sciences program from the University of Wisconsin-Madison in 2016. Since then, Dr. Zhang has been working in the Small Molecule Pharmaceutical Sciences Department at Genentech Inc. as a research scientist. Dr. Zhang’s research interest focuses on development of amorphous solid dispersion formulation to deliver poorly water soluble drugs especially with its application in industrial drug development. Dr. Zhang’s work in this area covers the investigation of amorphous solubility enhancement prediction, amorphous formulation stability evaluation, downstream processing of amorphous solid dispersion tablet etc. From his research work, Dr. Zhang has published 20 research papers and given several presentations at conferences and university. Dr. Zhang also serves as a peer reviewer for major pharmaceutical journals including Molecular Pharmaceutics, International Journal of Pharmaceutics, Pharmaceutical Research, AAPS PharmSciTech etc. He has reviewed approximately 100 manuscripts since 2016.

Kausik Nanda has more than 23 years of experience in the pharmaceutical industry. In his early career as a medicinal chemist, Kausik had worked on discovery programs in the neuroscience, cardiovascular and infectious disease areas, where his team successfully developed lead identification, lead optimization and pre-clinical candidates. In his later career, Kausik’s work focused on solving multitude of problems in the development area, arising from chemical interaction in the drug product. The range of activities encompasses early development through commercial launch. His current research interest is in the field of novel drug degradation mechanism operating on drug product.

Principal formulator, within combination product development group. Emphasize on development of semi-solid, liquid, and transdermal dosage forms. I have developed numerous products on variety of dosage forms including topical, transdermal, ophthalmic, long acting injectable, sublingual, and oral liquids. I received my undergraduate degree in Pharmacy from Gujarat University, India in 2011 and a master’s in Pharmaceutical Science from Long Island University, Brooklyn, NY in 2014.

Tina Xiong is an associate principal scientist at Merck in Boston, Massachusetts. Her work is centered around developing tools to inform preclinical formulation development and FIH formulation strategy across therapeutic areas, including neuroscience, oncology, and immunology. Her formulation experience spans across various modalities: small molecules, biologics, and peptides.

Cesar Calero, Ph.D., is a member of the Biologics Drug Product Development & Manufacturing group at Sanofi. He has more than 7 years of experience developing formulations and manufacturing processes for biologic modalities including polypeptides, enzymes, monoclonal antibodies, multi-specifics, fusion proteins, and viral gene therapy programs; for early- and late-stage clinical programs. He is an active contributor to the scientific literature involving protein physical stability, drug product development, AI/ML and computational modelling, and in-use clinical administration considerations and compatibility studies.

Hitesh Purohit is currently a Senior Scientist in Drug Product Development organization at AbbVie. He received his PhD in Pharmaceutics from Purdue University in 2017 where his research focused on understanding the hydration and dissolution behavior of amorphous solid dispersions. At AbbVie, his job responsibilities and experience include leading drug product technical teams toward developing conventional and enabling solid oral formulations, characterizing intermediates and finished drug products, and manufacturing process development. His research interests include understanding the phase behavior of amorphous dispersions, utilizing high-resolution analytical techniques to study drug product microstructure, bioavailability enhancement approaches and modified drug delivery strategies. He has authored 15+ publications in peer-reviewed journals.

Over the past 25+ years, Rosario LoBrutto has held progressive global leadership positions in R&D and strategy while accelerating growth in fast-paced Fortune 200/500 organizations (including Merck, Novartis, TEVA and Sandoz). Currently he is Head of Pharmaceutical Sciences and Global Expansion at Radius Health, contributing toward the mission of delivering patient-centric innovative medicines.  His experience includes successfully developing and launching both innovative and generic medicines.  His expertise spans API and Drug Product Development (small molecules, peptides and proteins), with a strong focus on innovation, portfolio strategy, and operational excellence. His most recent prior role at Sandoz was Head of Scientific Affairs where he advanced pipeline strategy, with responsibility for due diligence evaluations (CMC) of new opportunities for co-development, in-licensing or M&A.  He oversaw external partner product development and implementation of effective regulatory and development strategies leading to timely submissions, approvals and launches.

Rosario completed his undergraduate degree in Chemistry from Drexel University and PhD in Analytical Chemistry from Seton Hall University.  Currently he is completing his MBA from the Cornell Johnson Graduate School of Management and his MS in Health Care Policy and Leadership from the Weill Cornell Graduate School of Medical Sciences.