September 18-19, 2023; Boston, MA

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.  He has also completed 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.

Jaymin Shah is a Research Fellow in Pharmaceutical Sciences and heads a topical and advanced drug delivery group in Pfizer R & D. He also holds an adjunct faculty appointment at the University of Houston. He obtained his Ph.D. in Pharmaceutics from University of Houston.  From 1988-1999 he served as Associate Professor (Tenured) of Pharmaceutical Sciences at Medical University of South Carolina, where he led a lab developing sustained release parenteral delivery systems and modeling of skin transport and mentored 7 Ph.D. and 2 MS graduates.  Jaymin joined Pfizer in 1999 where he has led formulation groups and project teams supporting development of various candidates as parenteral/ophthalmic dosage forms, peptide and oligonucleotides development and research initiatives in parenteral and ophthalmic delivery including LAI, depots, sterile suspensions, implants, and nanoparticles.  Jaymin has been recognized with achievement awards for leadership and innovation in Pfizer.  Jaymin has published 63 papers, 10 patents/patent applications, 75 abstracts and made more than 114 presentations at various scientific forums such as Arden House Conference, AAPS symposia, CRS, FDA and academic centers.

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.

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.

Dr. Jahangir is an innovative, entrepreneurial and transdisciplinary team leader with 15 years of experience and knowledge in Combination Product and Digital Health. He is currently the Director of SaMD and Medical Devices LCM at Pfizer’s Global Engineering Team. Previously he led Janssen’s Quality Engineering team in charge of E2E development and flawless execution of Quality Management Systems for complex Biologic-Device Combination Products as well as other emerging technologies. He has championed the development and global launch of safe, effective and functional several combination products and other emerging technologies globally. Armed with a unique and multidisciplinary technical background along with expertise in Quality, R&D, and Regulatory Affair, Alie’s passion lies in enablement of new emerging technologies into practical solutions with direct impact on patients’ current therapeutic journey and their well-being. Dr. Jahangir is also an Adjunct Professor at the Department of Bioengineering at Temple University in Philadelphia.  He holds a Doctorate and Master’s degree in Polymer & Biomedical Engineering from University of Toronto and Dalhousie University and completed a Post-Doctoral Fellowship at Harvard School of Public Health in Boston.

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).

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.

Brett Kopina is a Principal Scientist in Drug Product Design in the Pharmaceutical Sciences Small Molecule organization at Pfizer in Groton, Connecticut. He received his bachelor’s degree in Pharmacology and Toxicology and Ph.D. in Pharmaceutical Sciences from the University of Wisconsin-Madison in 2008 and 2014, respectively. Since graduating, Brett’s 8-year industry career has focused on the development of products spanning sterile injectables, nasal sprays, and oral solids. His current focus is patient-centric, modified-release oral solids

Huw Jones is the Executive Director of Patient Centric Medicines at Quotient Sciences. In his current role, Huw works closely with clients to help them scope their development programs. He also provides ongoing technical support and expertise related to formulation development to the entire Quotient Sciences product development team.

Huw has over 35 years of experience in the pharmaceutical and consumer healthcare industries, where he has worked in product development roles with Parke – Davis, Boots Healthcare International, and Reckitt Benckiser. Huw's experience includes taking products from the concept stage through to scale up and commercial manufacture.

Prior to joining Quotient Sciences, Huw was Co-owner and Director of Co-Formulate Ltd, a contract formulation development organization acquired by Quotient Sciences in 2015. Huw holds a Bachelor of Science degree from the University of London

Pavan Handa is a pharmaceutical business executive with over 25 years of experience in new product development, marketing, and commercialization. He has held senior management positions in business development and commercialization at leading specialty pharmaceutical & drug delivery companies where he was responsible for building product portfolios, entering strategic partnerships, and completing over thirty deals that resulted in generating billions of dollars in value creation. He is currently working as Amneal’s Senior Vice President of Specialty Portfolio Management. Previously, he has served as Chief Business Officer at Kashiv Pharma, Senior Vice President at Antares Pharma, Vice President at Noven Pharmaceuticals, & Business Director at Enzon. Pavan holds a B.A. Honors degree in economics, and an M.B.A. with dual majors in Finance and Marketing. He has also completed advanced programs in drug delivery, intellectual property, and negotiations from MIT, Northwestern, and Harvard, respectively.

Dr. Vaka is a Director of Formulation R & D, specialty product division at Amneal Pharmaceuticals. He obtained his Ph.D in Pharmaceutics & Drug Delivery from the University of Mississippi. After graduating, he worked at Kashiv Pharmaceuticals LLC., for about 8 years in R & D, focusing on 505(b)(2) programs. He developed GRANDE® (advanced gastric retention system) and KRONOTEC® (advanced osmotic oral drug delivery system) proprietary technology platforms for controlled drug delivery of challenging compounds that significantly improve efficacy, tolerability and compliance. He has authored 25+ research articles in peer-reviewed international journals, 2 book chapters and is an inventor on over 15 patents.

Tim is a Principal Human Factors Engineer within the User Centered Design team at Cambridge Consultants, UK. He holds a MSc. in Ergonomics & Human Factors and a BEng. in Design Engineering. He has been working in medical product development for over a decade, having lead roles in the development and validation of numerous surgical, drug delivery, and acute care systems. Tim has cultivated a particular interest in the design and risk management of complex systems.

Chen Mao is a Distinguished Scientist in the Synthetic Molecule Pharmaceutics Department at Genentech, Inc.  He received his Ph.D. in Industrial and Physical Pharmacy from Purdue University in 2006.  Prior to joining Genentech, he assumed various scientist positions at XenoPort and Schering-Plough.  Chen is an Adjunct Assistant Professor in the College of Pharmacy at the University of Texas at Austin.  He serves in the editorial board of Drug Development and Industrial Pharmacy and the scientific advisory board of Journal of Pharmaceutical Sciences.  He also serves in the board of ETC consortium and the Drug Product Leadership Group of the IQ consortium.

Chen’s primary focus is solid dosage formulation development and manufacturing.  A main research focus is to investigate the behaviors of pharmaceutical powders involved in drug product manufacturing, such as powder flow, compaction, mixing, and segregation. Additionally, Chen is also interested in applying predictive tools to fundamental processes involved in the drug product performance, such as disintegration, dissolution, and absorption.  The emphasis is to employ mathematical modeling in conjunction with advanced material characterization techniques to enable new insights and prediction of pharmaceutically relevant processes.

Simone Alidori is a Scientific Leader and Associate Fellow in the Global Biopharmaceutics Team within the Drug Product Development Group at GSK, based in Upper Providence (PA) and has over 6 years of experience in drug delivery, formulation development and integrated in vitro, in vivo and in silico approaches to understand and predict performance of novel Long-Acting Injectable Drug Products. In 2022, he organized and co-chaired a AAPS Workshop in ‘Patient-Centric Design of Long-Acting Injectable Drug Products’. Prior to GSK, Simone held a Research Associate position at Memorial Sloan Kettering Cancer Center, focusing on chemical modification of nanoparticles and their use as delivery systems for small molecules and biologics. Simone received a PhD. in Synthetic Chemistry from the University of Camerino in Italy and is co-author of 26 publications and patents.

Mark Howansky is the Vice President of Device Development and Commercialization at Viridian Therapeutics, where he leads a team responsible for the development, launch and commercial supply of the device constituent part of combination products. Mark is a dynamic leader with over 25 years of industry experience including serving as Director of Device Development at Bristol-Myers Squibb and Director of Engineering at Caliber Therapeutics (now Orchestra Biomed). Mark holds a Bachelors degree in Engineering Sciences from Harvard University and a MBA from Stern School of Business, New York University.

Feng Zhang is an associate professor at the Division of Molecular Pharmaceutics and Drug Delivery at College of Pharmacy at The University of Texas at Austin. He received his Ph.D. in pharmaceutics from the University of Texas at Austin. He worked in the industry for 14 years prior to joining the department of pharmaceutics at the University of Texas at Austin in 2014. He was the Director of Product Development at PharmaForm from 2007 to 2010 and Senior Scientist in the Formulation and Process development department at Gilead from 2011 to 2013.

His principal research interest at UT Austin includes formulation and process design of implants for long-term drug delivery and amorphous solid dispersions for bioavailability enhancement.  His research also focuses on continuous granulation and powder blending enabled by twin-screw extrusion. He is the editor of 2nd edition of “Pharmaceutical Extrusion Technology”, published in 2018. He has authored four book chapters on twin-screw extrusion process. He has published 90 peer-reviewed papers articles.  He is also inventor on 12 issued patents covering a wide range of drug delivery systems. He serves on the editorial board of AAPS PharmSci Tech and North American editor for Journal of Drug Delivery Science and Technology.

Sreejit Menon, is the Research and Technology Manager for Croda Pharma’s team in North America He joined Croda in 2017 as Technology Specialist, moved to the Team Leader role in 2018 and recently moved to his current role. In his current role, he leads the new product development and applications team to drive design and development of innovative and differentiated high purity excipients and processing aids that provides smart solutions to customers in the pharmaceutical market. Prior to joining Croda, Sreejit has worked in various technical roles with BASF, Mitsui Chemicals and PeroxyChem.  He earned his MS in Organic Chemistry from U.D.C.T in Mumbai, India and Ph.D. in Chemistry from University of Toledo, Ohio.

Katherine McQuillan is a Research Scientist at Nautilus Biosciences, a division of Croda Canada. She has been working with Nautilus for the past 12 years with a focus on mammalian cell culture. She currently works in a high throughput screening lab to conduct bioassays for the identification of new ingredients for a wide range of applications including skin and personal care. She holds a BSc in Biology from the University of Prince Edward Island.

Tom has a diverse background in the development of therapeutic delivery systems including drug products and interventional medical devices. At Celanese, Tom is responsible for developing strategic partnerships and technical collaborations. Prior to Celanese, Tom held positions at DSM Biomedical and W.L. Gore and Associates, where he led key development programs.  Tom has a bachelor’s degree in Mechanical Engineering and a master’s degree in Engineering Management. He completed post-graduate programs through the Oklahoma Heart Institute and Wharton School of Business.

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.

Ajit D’Souza is the Sr. Director of Combination Product Development and Manufacturing at Kiniksa Pharmaceuticals where he directs the development of formulations, devices and manufacturing processes.  Ajit has earned a PhD in Pharmaceutical Chemistry from the University of Kansas, a Professional Certificate in Systems Engineering at MIT xPRO and an MBA.  He has spent majority of his career in functional and program leadership roles, developing drug formulations, medical devices for drug delivery and combination products.

Ryan is the Manager of the Quality Control and Development Laboratories at Singota Solutions. He received his B.S. in Biochemistry degree from Indiana University, Bloomington from the department of chemistry.  He has 16 years of experience in the pharmaceutical industry including roles in product development, quality control, clinical and commercial manufacturing support, and control strategies planning. His past employment includes work at Roche, Eli Lilly, Cook Pharmica, and Catalent holding various analytical and project leadership roles.

Jignesh Patel currently works as a Field Application Scientist for Precision NanoSystems, covering the Eastern United States and Eastern Canada. In his current role, he is serving as a technical expert working with various biopharmaceutical and academic customers for the development of genomic medicine using Precision NanoSystem’s microfluidic technology.

Jignesh obtained his M.S. at the University of Canterbury, New Zealand in Cellular and Molecular Biology. He has extensive academic research experience in developing and validating vaccine candidates in the field of infectious diseases. His research project was focused on developing an mRNA vaccine for human ehrlichiosis. He has a broad technical and educational background in the field of immunology, molecular biology, and virology.

Michael is a Global Product Specialist and New Business development Associate with more than thirty-two years’ experience with W.L. Gore & Associates. Currently, Michael is leading the development of the GORE® IMPROJECT® 0.5 mL Plunger for use in silicone free pre-filled syringes (PFS) for intravitreal injections and ophthalmic applications.  Michael is focused on addressing the emerging customer, product and regulatory needs leveraging Gore’s unique fluoropolymer science and expertise for silicone free drug delivery and packaging.  Michael has had multiple commitments in Product Management & Engineering in multiple markets during his tenure at Gore, including over 13 years developing & establishing  GORE’s Chemical Biological Protective Clothing Business.   Michael has deep-rooted knowledge and understanding of GORE’s Core Technology operations for membrane/film processing.   Prior to his current commitment, Michael last served as Product Specialist in Gore’s exploratory Innovation team, tasked with evaluating new business opportunities creating new business models for growth.  Over the years, Michael has been a member of many Industry Organizations, and served as a Technical Committee Member for several Protective Clothing Standards of the National Fire Protection Association (NFPA).    Michael is currently a member of the Parenteral Drug Association.  Michael has a Bachelor of Science in Chemical Engineering from Lehigh University and a MBA from Villanova University.

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.

Dr. Babaee is an Associate Principal Scientist in the Device and Combination Products Development team at Merck Research Labs, where he focuses on identifying and development of early phase delivery technologies including injectable, implantable, and wearable systems. He leads R&D efforts on developing novel parenteral injection devices with enhanced performance for the delivery of a wide range of therapeutics from large-volume high-viscosity biologics to multiphase suspensions and lyophilized products. He holds a Ph.D. in Materials Science and Mechanical Engineering from Harvard University. Prior to Merck, he was a Research Scientist in the Langer Lab at MIT where he was leading a research team to develop translational therapeutic technologies. While at MIT, Sahab also held an affiliate position at the Department of Gastroenterology, Brigham and Women’s Hospital at Harvard Medical School focused on developing innovative technologies for prolonged oral delivery of large-dose therapeutics via the gastrointestinal tract.

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.

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

Alexandra is a passionate human factors professional who loves everything about combination product usability. At Sanofi, she serves as the HF subject matter expert on several programs and advocates for implementing creative HF strategies, which are rooted in her strong understanding of applying HF principles to developing safe and effective combination products. Before working at Sanofi, Alexandra was a Senior Human Factors Specialist at Emergo by UL, where she was responsible for planning, managing, and conducting usability tests throughout the product development process. She has both a bachelor’s degree and master’s degree in human factors engineering from Tufts University.

Nathan Westcott is the director of LNP discovery at Beam focused on extrahepatic LNP delivery. He received his PhD in 2011 from the University of North Carolina at Chapel Hill in Chemistry while studying self-assembled monolayers of alkanethiolates on gold to model the extracellular matrix. During his postdoc at the Rockefeller University, he studied ADP-ribosylation using alkynylated adenosine. Previously, he worked at Repertoire Immune Medicines and was focused on developing liposomes as an ex vivo drug delivery vehicle for immune agonists.

Deep S Bhattacharya is a senior scientist working with Pfizer since November 2019. He received his Ph.D. from the University of Nebraska Medical Center, College of Pharmacy in Pharmaceutical Sciences with a focus in engineering polymer-protein conjugates and polymeric nanoparticles using computational chemistry, biophysical tools, formulation developments. After joining Pfizer, he has worked with multiple complex gene therapy and protein-like modalities and is technical SME for protein formulation development and high dose high volume subcutaneous delivery technologies. He is experienced in the formulation development of recombinant protein vaccines and high concentration mAbs. His areas of interest include biophysical assessment of proteins, utilizing NMR for structural determination of biologics, subcutaneous assessments of biologics.

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. 

Sathya has a PhD in Biochemistry/Biophysics from University of Zurich, Switzerland and postdoc from Stanford University, CA. She has more than 15 years of experience as Project and Group leader in discovery and development of Antibodies, Nanobodies and Nanodiscs, Radio Conjugates, Fusion Proteins, Multi-specifics, RNA Therapeutics from Integrated Biotherapeutics, Boehringer-Ingelheim, Janssen Bio (J&J) and Amgen; She has successfully led numerous projects in multiple therapeutic areas (Ophthalmology, Immunology and Oncology) and has couple of antibody theranostics (therapeutic and diagnostic) in clinical trials and in preclinical development for indications such as Diabetic Retinopathy, Immunology and Prostate Cancer. She owns several publications and patents. Currently she is leading the “Protein Science” team in Biologics Research at AbbVie.

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.  He has also completed 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.

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.  He has also completed 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.

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. James DiNunzio is currently a Director at Merck & Co., Inc. in Rahway, NJ where he leads a team of scientists responsible for oral drug product formulation and process definition.    Since joining Merck in 2013 he has contributed to multiple programs in the disease areas of oncology, virology and CNS disorders.  He has also lead technology development efforts in the areas of amorphous solid dispersions and continuous manufacturing.  Prior to Merck, he served as a Senior Scientist in the Pharmaceutical & Analytical R&D group at Roche where he was responsible for the formulation design of poorly soluble compounds using enabled technologies.  He has also held positions of increasing responsibility at PharmaForm and Forest Laboratories. 

Dr. DiNunzio received his Ph.D. in Pharmacy (Pharmaceutics) from The University of Texas in 2009 specializing in thermal manufacturing of amorphous dispersions.  He also holds M.S. and B.S. degrees in Chemical Engineering from Columbia University and The State University of New York at Buffalo.  He currently serves on the Editorial Advisory Boards of AAPS PharmSciTech and the Journal of Pharmaceutical Sciences.  He has authored over 25 research papers and book chapters in the field of hot-melt extrusion and formulation design for bioavailability enhancement.  His current research interests include: formulation design for bioavailability enhancement, melt extrusion process design for challenging systems and the development of continuous manufacturing technologies.

I am a Scientist in Biologics Drug Product Development& Manufacturing Organization at Sanofi.  I primarily lead and provide oversight to the Drug Product development activities for non-viral gene therapy programs.  I obtained my PhD from Northeastern University in Pharmaceutical Sciences with focus on developing processes and analytics for novel compounds and biologic targets for a diverse subset of indications. Prior to joining Sanofi, I worked at GSK in their vaccine formulation development group in the early days of lipid nanoparticle development as well as traditional vaccine platforms.

Anthony drives the development of ASO combination devices and gene therapy delivery devices at Biogen.  Anthony has over 25 years of medical device experience in the areas of product development, project management, marketing, new business development, and technology scouting.

Prior to his time with Biogen , Anthony was consulting with GSK and other Biotech companies in the Oral Solid Dosage CMC area pertaining to depression, oncology, and other therapeutic drugs.  Anthony was also the Director of CMC Project Management at Alkermes.

Anthony has four issued patents, several pending patents, and six publications.  He has a PhD and a Master’s in Biomedical Engineering from Rutgers University and Penn State University respectively.  His undergraduate degree is in Electrical Engineering from the University of Delaware, and he has an MBA from MIT.

Sergie Letser joined Nanoform in 2020 and is currently the Deputy CCO and SVP of Business Development. Sergie started his career as a process chemist and was involved in scaling operations from kilo through to commercial scale API and drug product before transitioning to a customer facing roles.  He has broad experience in pharmaceutical development and manufacturing and has previously held senior business development positions at Porton Pharma Solutions, Johnson Matthey, and Cambridge Major Laboratories.

Amanda is a scientist in Lonza’s internal research and development team in Bend, Oregon. She has a particular interest in designing and developing creative laboratory-scale experimental set-ups for studying unusual problem statements. Over her near-decade-long career in the industry, she has worked on a wide range of pharmaceutical dosage forms and intermediates, spanning oral, respiratory, and subcutaneous delivery.

Dave Seghers is a seasoned professional with 20 years of experience in the pharmaceutical industry, supporting many new drugs in their path to clinical trials. As a bio-engineer and after completing his PhD in Applied Biological Sciences from Ghent University, he joined Pharmavize (now Ardena) in 2004. He has extensive knowledge in CMC writing, drug product formulation and analytical development, GMP production for early an late phase clinical trials, and CMC development. Dave currently serves as the Head of Sales of the Pharmaceutical Division at Ardena.

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. 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.

Twinkle Christian is a Principal Scientist and team lead in Process Development at Amgen. Prior to joining Amgen, Twinkle worked at VaxGen and ALZA where she focused on vaccine product development and alternate drug delivery of biologics, respectively. Twinkle has 20 years of experience in drug product development across diverse modalities and has led the advancement of multiple programs from early discovery to clinical trials and commercialization. She has worked on approved Amgen products including Repatha and Evenity. Twinkle’s expertise encompasses high concentration and ultra-high concentration product development, alternate drug delivery of biologics, investigating protein-protein interactions, and macromolecular crystallography for structure and formulation. Twinkle is a recognized SME in biologics formulation and drug delivery with peer reviewed publications, 6 granted US patents, 35+ patent applications and invited speaker at national and international conferences. Twinkle is an active member of scientific societies and currently serves as a reviewer for J. Pharm. Sci, Chair of AAPS Pharmaceutical Discovery and Preclinical Development community, Co-chair of IQ consortium High Concentration Product Development working group, past co-chair of the IQ consortium Closed System Transfer Devices working group. Twinkle is an adjunct faculty at California State University, Channel Islands, and a guest lecturer at UCSB.

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.

Dr. Kannan Rangaramanujam is the Arnall Patz Distinguished Professor of ophthalmology and co-director of Center for Nanomedicine at Johns Hopkins Medicine. His research interests are in the field of translational nanomedicine centered on unique ‘cell-targeted dendrimer nanomedicines’. His team has developed approaches to target and manipulate injured glia/macrophages specifically, without a need for ligands, from systemic administration. Targeted therapies for neuroinflammation and angiogenesis are being developed with this approach, with significant implications for addressing unmet needs in many CNS, systemic and ocular disorders, and cancer (e.g., pediatric brain disorders, age-related macular degeneration, diabetic retinopathy, cerebral palsy, immunotherapy, neuroimaging).  He is an author of >110 patents (issued and pending, licensed), >140 peer-reviewed publications, and is supported by significant NIH and federal funding. He is the co-founder of Ashvattha Therapeutics Inc., a clinical-stage spinoff that is translating his team’s inventions to the clinic for wet AMD, CNS disorders and neuroimaging.

Chemical engineer with 15 years of experience in the Pharmaceutical Industry, in the fields of Solubility Enhancement, Dry Powder Inhalation, Controlled Release, and Drug Product Development.

Twelve years of experience in R&D, from which the last 2 years were heading Hovione’s team in Portugal, Reporting to Hovione's Chief Technology Officer, with responsibilities over Process Chemistry Development, Drug Product Development, Analytical Development, Process Safety, Modelling, and PAT.

In the last 2.5 years, Senior Director and Strategic Business Management Products, Reporting to Hovione's CEO, with responsibilities for the P&L and Development of the Portfolio of Products at Hovione.

Ian is one of the founders of Ripple Therapeutics (RIPL) following its spin out from Interface Biologics (IBI) in 2020. Ian has a PhD in Chemical and Biomedical Engineering from the University of Toronto and a BASc in Biomedical Engineering (Engineering Science) from the University of Toronto.

Ian joined IBI in 2010 and is responsible for leading the R&D Team in the discovery of novel prodrugs for drug delivery and in managing the nonclinical development (Preclinical evaluation and Chemistry, Manufacturing, and Controls (CMC)) for controlled drug delivery product concepts through to clinical readiness. As lead inventor for the Epidel technology, Ian is also responsible for managing and strategically developing Ripple’s platform and patent portfolio. Ian has 7 granted US patents, 11 pending US patent applications, 3 pending PCT patent application and 24 pending international patent applications along with a robust pipeline of provisional patent applications in process. Ian is an author of 7 peer-reviewed journal articles and recipient of a Natural Sciences and Engineering Research Council of Canada Industrial R&D Fellowship.

Reza is currently working as Senior Medical Affairs Manager with Gerresheimer companies. He specializes in medical affairs and clinical research, supporting value-based product development with strong focus on patient centricity. He holds a PhD in musculoskeletal biomechanics and tissue engineering from Hannover Medical School, Laboratory for biomechanics and biomaterials. He has supported several product development/launches and market authorization of medical devices under FDA, MDD/MDR and other global market requirements, during the past 10 years while having worked in multiple sectors of the medical device and pharma industry

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.

Huyen Tran is currently a Director in Formulation and Delivery and Platform Lead of Oral Peptide Delivery in Biotherapeutics Discovery Research at Eli Lilly and Company. She holds PhD, MSc and BS in Pharmaceutics focusing on the development of controlled release formulations and nanoparticle-based delivery systems for improving oral drug bioavailability. Huyen had 5+ years of Postdoctoral experiences in formulation development of nanoparticle-based delivery systems for small molecules, DNA and RNA for cancer therapies and treatment of inflammatory diseases. Since joining Lilly in 2015, she has been leading formulation development in Discovery phase including identification and implementation of new formulations and drug delivery technologies to overcome challenges of oral peptide delivery. Huyen is an author of >30 publications and co-inventor of 3 patents and 2 patent applications on formulation development, nanoparticles for drug delivery and oral peptide delivery.

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. 

Nick DiFranco, MEM, is the Global Market Manager for Oral Drug Delivery at Lubrizol Life Science Health (LLS Health). In his role, Nick coordinates a multi-disciplinary team offering excipients and services for controlled release and solubility enhancement in oral solids and liquids, including Carbopol® and Apinovex™ polymers. Prior to this role, Nick held positions as an Applications Scientist and Market Manager at Lubrizol supporting long-acting drug delivery and CDMO services. Nick holds a B.S. in Biomedical Engineering (Biomaterials focus) and a Master of Engineering and Management degree from Case Western Reserve University.

Sudhakar Voruganti received his doctorate in Biochemistry and Molecular Biology from OSU, Stillwater. Dr. Voruganti has over 15 years of experience in bio-pharmaceutical industry and worked for Bristol-Myers Squibb before joining Pfanstiehl. Since May 2022 Dr. Voruganti is working as Director of Business Development for US East Coast at Pfanstiehl, the world’s leading manufacturer of low endotoxin and high purity GMP parenteral grade carbohydrate based excipients, providing commercial and technical support to customer base in the territory.

Christian is heading a process development team in Schaffhausen, Switzerland at MilliporeSigma. Before joining MilliporeSigma in 2019, he was working at Dottikon in Switzerland, where he worked on process chemistry. Christian studied chemistry and holds a Ph.D. from ETH, Zürich in Switzerland in the field of total synthesis and medicinal chemistry (Epothilones). His subsequent postdoctoral work at UC Berkeley, CA is centered around chiral gold-catalysts.

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.  He has also completed 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.

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.  He has also completed 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.