Speakers 2021

Ajit Narang works for Small Molecule Pharmaceutical Sciences at Genentech, Inc., in South San Francisco, CA as a Sr. Scientist responsible for the pharmaceutics and biopharmaceutics of small molecules in preclinical and early clinical development of various dosage forms. He also serves as • Scientific Advisor to the Editors of JPharmSci • Chair of the Formulation Design and Delivery (FDD) section of the American Association of Pharmaceutical Scientists (AAPS) • Adjunct Faculty at the Universities of the Pacific and the University of Nebraska Medical Center in Omaha, NE; • Industrial Advisory Board member of Western Michigan University; • A panel member of the Biopharmaceutics Technical Committee (BTC) of the Pharmaceutical Quality Research Institute (PQRI) in Arlington, VA; • Several International Pharmaceutics Excipient Council (IPEC) committees; and • A member of the Systems-based Pharmaceutics (SBP) alliance of the Process Systems Enterprise, Inc. (PSE) in London, UK • Committee member of a Master’s student at Campbell University, North Carolina; • Committee member of a Ph.D. student at University of Nebraska Medical Center, Omaha, NE. • Scientific Advisor to the Editors of JPharmSci Ajit earned his Ph.D. from the University of Tennessee in Memphis, Masters in Pharmaceutics from the Banaras Hindu University in India, and Bachelors in Pharmaceutical Sciences from the University of Delhi in India. He has over 15 years of drug product development experience working for Bristol-Myers Squibb, Co. (BMS) in New Jersey, Wockhardt Pharmaceuticals (ex-Morton Grove Pharmaceuticals) in Illinois, and Ranbaxy Research Labs in India in different capacities. Ajit has contributed to several preclinical, clinical, and commercialized drug products including NDAs, ANDAs, and 505B2s. He is credited with over 74 peer-reviewed articles; 4 books; 9 issued patents/patent applications; 43 invited talks; and 83 presentations at various scientific meetings. His current research interests are translation from preclinical to clinical and commercial drug product design; incorporation of QbD elements in drug product development; and mechanistic understanding of the role of material properties on product performance.

Dr. Ambarish Singh is a regulatory CMC strategist (small molecules) with experience in worldwide filing of regulatory documents to support clinical trials, marketing applications and life-cycle management of medicinal products.   Ambarish has led/participated in many Health Authority interactions on CMC topics, such as, continuous manufacturing, application of process analytical technology (PAT), Quality by Design (QbD) based development and control strategies, regulatory starting materials, genotoxic impurities and other general topics. 

 

Ambarish started his professional career by joining the Chemical Development Division of Bristol Myers Squibb (BMS), where he contributed heavily to the chemical process development of numerous commercial products, such as Fungizone, Pravachol, Taxol, and Baraclude.  In 2007, he transitioned into the Global Regulatory - CMC Division of BMS, where he and his team members worked on the world-wide filing of Eliquis, Daklinza and Sunvepra, in addition to supporting numerous programs in clinical development.  In 2020, Ambarish joined Constellation Pharmaceuticals as the head of Regulatory-CMC department, where he is responsible for providing strategic guidance on the preparation and filing  of regulatory CMC documents.

 

Ambarish holds a PhD in Organic Chemistry from the State University of New York at Stony Brook.  He served as a post-doctoral fellow at the Fox Chase Cancer Center, Philadelphia and Memorial Sloan Kettering Cancer Center, New York.  Ambarish has published several scientific articles, holds patents and has given numerous talks on drug development at Universities, Technical and Regulatory conferences.

Anand Subramony is Vice President of Novel Product Technologies at AstraZeneca. In this role, Anand heads the function from the CTO office and oversees efforts for creating patient centric products that rely on the principles of digital health, connected devices and other novel technologies including breathomics, sensors, wearables and novel diagnostics towards enabling improved patient outcome. Before his current role, Anand headed the drug delivery and device development at Medimmune and was Principal Fellow and Head of the Novel Delivery Technologies & Therapeutics within Development at the Novartis Institute for BioMedical Research where he established and managed a high performing cross functional team. In prior roles, Anand led the Materials Science function of the Biomedical Engineering group at Alza /J&J, and was Director of Materials Science & Drug delivery at Dr. Reddy’s Laboratories With his broad experience in pharma biotech, Anand brings in innovation and scientific rigor coupled with execution excellence and sense of urgency towards product development. Anand has over 25 refereed publications and several patents in the areas of drug delivery. Anand holds an MS in Materials Sc. Engineering from IIT Bombay and PhD from Purdue University

A high performing, energetic leader, Andrea offers over 25 years’ experience in the life science sector. Having acquired a novel blend of technical and commercial expertise in global healthcare organisations across Pharma, Consumer Health, Medical Device, Biotech and Life Sciences, Andrea is uniquely positioned to lead leon and its clients into the next stage of development.

Andreas Bernkop-Schnürch is serving as the Head of the Department of Pharmaceutical Technology at the University of Innsbruck. He is a leading researcher and inventor in the field of drug delivery, nanotechnology and biomaterials. He is author of >500 research articles and reviews.

Arul Joseph leads the Pharmaceutical Development and Clinical Supply Chain function at Avanir Pharmaceuticals. He has 15 plus years of experience in chemistry, manufacturing, and controls (CMC) development and prior to Avanir has held roles of increasing responsibility at Gilead Sciences, Merck, and Schering Plough. Before joining the pharmaceutical industry, he conducted postdoctoral research at the Scripps Research Institute in La Jolla, CA.  Arul earned his PhD in Organic Chemistry from the University of Maryland in College Park, MD, and an MBA in Strategy and Finance from New York University's Stern School of Business in New York, NY.

Bharathi Vellalore is a Pharmaceutical Scientist with >12 years of cross-functional research experience in discovery and development of cyclic peptides, small-proteins,  antibody-based molecules and cell therapy products for diagnostic and therapeutic applications. Before joining Janssen Drug Product Development, he conducted postdoctoral research in the Saskatoon Translational Cancer Research Cluster and Janssen Biotherapeutics. Bharathi earned his MSc and PhD in Biochemistry from the University of Saskatchewan, Canada (2017) and BTech in Biotechnology from Anna University, India (2008).

Chris joined Quotient Sciences in 2015 as a Research Fellow, bringing over 20 years’ experience across pharmaceutical sciences and biopharmaceutics through a series of previous technical and leadership roles at Sanofi, Pfizer, AstraZeneca and Walgreens Boots Alliance. His expertise ranges from early pre‑formulation and biopharmaceutical assessments ensuring appropriate new chemical entity selection, through development of a wide range of dosage forms including preclinical and early clinical inhalation, topical, oral immediate release and modified release formulations, to maintenance and life-cycle management of existing marketed products. Chris’ role at Quotient involves designing science­-­led, robust, clinical study programs which maximise output for clients, in addition to providing scientific support throughout study delivery. Chris holds a Bachelor of Science degree in Medicinal Chemistry from Newcastle University and Postgraduate Certificate in Education from Nottingham Trent University.

Christian Jones is Chief Commercial Officer at Nanoform. Christian is a chemist by training and a Fellow of the Royal Society of Chemistry. He formerly led global business development for Prosonix Ltd, where his work helped to transform their offering from a crystallisation platform into a particle engineering/drug delivery business, which was later sold for $100 million. Christian’s previous experience also includes senior commercial roles within leading CDMOs, including Dr Reddy’s Laboratories and Johnson Matthey Plc. As Commercial Director, Innovator Pharma Products and Solutions at Johnson Matthey, Christian was a driving force behind the company’s particle engineering strategy

Daniel (Danny) Kuntz has spent 15 years in the pharmaceutical industry including more than 13 years developing formulations, processes, and products in development, clinical, and commercial settings, as well as 2 years as a quality control analyst. Danny completed a bachelor’s degree in chemical engineering at West Virginia University (Morgantown, WV) and a doctorate at Carnegie Mellon University (Pittsburgh, PA). In his current role, Danny works as a research engineer at Lonza (Bend, OR) focusing on multiparticulate dosage form development across early- and late-phase programs.

Sarah Stevens, Ph.D. is the Vice President, Drug Development Sciences at Quotient Sciences. Sarah is responsible for global leadership of the Drug Development Consulting team, and the design of differentiated, integrated programs of work for pharma and biotech clients.  Sarah qualified as a PhD Pharmacist and then completed post-doctoral research at the University of Strathclyde in Glasgow prior to starting her career in industry. Over the last 15 years, Sarah has held a range of scientific and leadership roles within CDMO organizations, most recently at AMRI where Sarah led development and commercial sites both in the UK and US and was responsible for Drug Product Development.

Dr Forster has worked in medical product development and commercialization for 20 years and has overall responsibility for the research, development and operations of Vaxxas. Since 2012, Angus has established the Vaxxas R&D team that includes more than 70 scientists, engineers and professional staff, and led three Phase I clinical studies. He brings considerable experience in pharmaceutics, formulation development, analytical science, medical device design and development, risk management and quality systems.  Before joining Vaxxas, Angus commenced his career with GlaxoSmithKline in pharmaceutical development and spent 5 years with PA Consulting (UK) working medical product development projects.  Angus has Ph.D. in pharmaceutics and a B.Pharm (Hons) both from Otago University, New Zealand.

Dr Jamie Unwin is the Commercial Insight Officer at Nanoform, an innovative nanoparticle medicine-enabling company.  A passionate advocate for patient centricity as a “North Star” for new drug development, Jamie’s role is to help clients understand the value Nanoform’s services and solutions can bring to their individual drug candidates, and portfolios as a whole.  A twenty-year pharma industry veteran, Jamie and his teams have provided Insights to maximise patient, physician, and payer access to twenty three new drug launches.  Jamie is a recognised opinion leader in the Business Insight world, and has held senior roles at GlaxoSmithKline, GE Healthcare, Janssen (Pharmaceutical Companies of Johnson and Johnson) and most recently was VP Enterprise Insights for Biocon Biologics.  In addition to his role at Nanoform, Jamie is also visiting lecturer at Imperial College Business School (London, UK) where he teaches classes on advanced analytics in healthcare.

Estelle Beguin holds a PhD in Engineering Science from the University of Oxford, U.K. where she worked on developing ultrasound-responsive lipid-based drug delivery systems. With experience working as a formulation and process engineer on drug delivery programs for several biotech companies in Boston, she joined MilliporeSigma as the global Strategic Marketing Manager for synthetic lipids. In her current role, she is responsible for managing MilliporeSigma’s lipids portfolio and custom manufacturing businesses supporting top industry players and young start-ups in the fields of RNA delivery and vaccines.

Dr. Christopher Worrall obtained his PhD in synthetic organic chemistry from the University of Manchester.  After his studies he spent two years developing synthetic processes for GMP syntheses within SAFC before moving to Pharmorphix.  Subsequently, Chris has spent 13 years specializing in the area of crystallization and physicochemical modification, starting as a scientist before being promoted to project leader and rising to become US business development manager, and has been involved in the development of 5 commercial products.  A native of North West England, Chris has spent the last 9 years in BD in San Diego – where the weather is significantly better – and in May this year became the Vice President of US Business Development for Nanoform.

Faraj Atassi is a director of pharmaceutical development at AstraZeneca (AZ). Before joining AZ, Faraj held pharmaceutical development positions at Eli Lilly and Novartis, and was the director of formulation and CMC and analytical development at Sage therapeutics and at Pulmatrix, respectively. He holds a Master’s degree in medicinal chemistry from Philadelphia College of Pharmacy and a PhD in Industrial and Physical Pharmacy from Purdue University. He has numerous peer-reviewed articles and presented at U.S. and international conferences.

Geoff Wise is a medical device engineer and a senior manager in Genentech's Device and Packaging Development group. Geoff has over 15 years of experience in the medical device field and more than 10 years experience in combination products. He has developed and commercialized autoinjectors, prefilled syringes and other various types of combination products throughout his career. Geoff holds a Bachelors of Science from California Polytechnic University, Pomona, is a lean/six sigma black-belt, and holds 9 patents with others pending.

Hagar Labouta is an Assistant Professor at the College of Pharmacy, University of Manitoba (Canda) with research experience in nanomedicine, drug delivery, and biomedical engineering. She got her Ph.D. in pharmaceutical nanotechnology from Saarland University (Germany). She completed several Postdoctoral fellowships at Helmholtz institute (Germany), and Departments of Chemistry and Biomedical Engineering, University of Calgary (Canada). At University of Manitoba, her team is using microfluidic lab-on-a-chip models for designing and evaluating nanoparticles for the aim of breaching biological barriers such as the placenta and the extracellular matrix of a tumour. Her lab is well-funded by national (New Frontiers in Research Fund, NSERC) and international funds (New York Academy of Sciences, and Japan Agency for Medical Research and Development). Dr. Labouta has a strong publication record and is a co-inventor on an international patent for the development of nanosystems for intracellular targeting. She has also worked with the World Health Organization on two health-related projects. She has won several awards and fellowships including Innovation and Career Development Award by the Biomedical Engineering Society (USA), Apotheker Jacob Prize for the best PhD thesis (Germany), and DAAD Scholarship (Germany), and curriculum award for the Nanoscience Minor Program (Canada). She is a Young Associate Editor of Drug Delivery and Translational Research (DDTR), and an executive YSC committee member in the Controlled Release Society.

Hannah Mann has over 20 years’ experience as a market insight expert, working with big pharma clients to bring the voice of the customer to the heart of decision making.   In March 2019 Hannah decided to co-found Day One Strategy with the ambition of partnering with forward thinking clients to help develop modern healthcare brands that truly meet the needs of today’s customer. Hannah has also served as a judge for the annual EphMRA awards, presented at MRS and EphMRA conferences and written a number of successful blogs on women in leadership.  In 2021 Hannah also launched The Day One Room 101 podcast that brings together leaders in the field of market research to discuss their pet hates and future predictions for our industry. Her passion projects have included working with the Princes Trust to help provide opportunities for underprivileged young adults and mentoring young female execs looking to grow in their careers whilst balancing work with family life.

Jeffrey T. Blue has been with Merck more than 26 years.  Through his career, Jeff has led the Vaccine Drug Product Development and New Technologies Department.   Jeff’s department is responsible for the development of both in‑line and pipeline programs and spans both early and late stage vaccine development.  Jeff has supported live virus, oncolytic, subunit, conjugate, and mRNA vaccines.  His department is responsible for technology transfer of the drug product formulation and process to the final commercial sites.   In addition to pipeline support, his department is also responsible for supporting novel innovative technologies for drug product development including new drying technologies, novel adjuvants, and alternative delivery for vaccines and biologics (i.e., Patch technology, ID and oral delivery, pulsatile and controlled release formulations, Lyospheres etc.).  

Through his leadership, the innovative technologies are being advanced to clinical development and recently gained manufacturing support for implementation into Merck’s vaccine pipeline.   He has published multiple book chapters and various articles on vaccine drug product development and lyophilization.  Over the course of his career within Merck, he has championed the development and successful launch of Varivax®, Zostavax®, and ProQuad® vaccines.   He has also played an integral role in the development of the Ebola Zaire Vaccine that Merck has recently licensed (Ervebo®).  Jeff has been a key leader on multiple cross-functional teams, engaged in key integration teams for vaccine strategy, is involved in multiple due diligence activities and continues to champion external collaborations to advance Merck’s vaccine pipeline.

Luis is a Lecturer at the Department of Chemical Sciences at the University of Limerick (Ireland), Course Director in the BSc in Industrial Biochemistry programme and a Principle Investigator at the Bernal Institute. He is a Funded Investigator at SSPC (the SFI Research Centre for Pharmaceuticals), Principle Investigator at PMTC (Pharmaceutical Technology Centre) and has been awarded grants as PI/Co-PI from various funding agencies (EU H2020, Science Foundation Ireland, Enterprise Ireland). Luis studied Biochemistry at undergraduate level before obtaining his PhD in Chemical Engineering at the University of Lisbon (Portugal). Following his PhD, Luis worked in the pharmaceutical industry for almost 2 years (Hovione FarmaCiência, Portugal) before joining SSPC in UL as a Postdoctoral Researcher and as a Senior Research Fellow later on. Luis worked in different institutions (academia and industry) and countries (Ireland, Portugal and Sweden) focusing his research on Particle Engineering Technologies, Continuous Nanocrystallization and (Bio)Pharmaceutical Processing.

Lynne Isopi is a Principal Scientist in Vaccine Drug Product Development in Merck. She heads a group that develops stabilizing formulations and drug product manufacturing processes for vaccine programs. She is responsible for projects from pre-clinical development through technical transfer to the commercial site. She has also developed process improvements for inline vaccines. She is an expert in stabilization of labile live viruses and viral vectors. Her accomplishments include development of a universal formulation for adenovirus-vectored vaccines has been implemented widely across the field. Prior to her 22 years at Merck, she developed stable reagent formulations for diagnostic assays at the Roche Diagnostics Group.

Manish is an enthusiastic scientific leader who is passionate about connecting biology and drug product design to create the best medicine for the patient. He has demonstrated learning agility across roles of increasing line and matrix leadership responsibility with courage and collaboration as key personal areas of focus.  Manish has championed science and risk-based product development for multiple oral and parenteral commercial drug products and has successfully led interactions across regulatory agencies.  Manish has 20 plus years of industrial experience and is currently leading the department for Pharmaceutical Development of Sterile products at GlaxoSmithKline.

Matthias G. Wacker is an Associate Professor in the Department of Pharmacy of the National University of Singapore (NUS). Initially, he studied Pharmacy at Goethe University in Frankfurt (Germany) where he obtained his doctoral degree in pharmaceutical technology. As a principal investigator, he has joined Jennifer Dressman and Jörg Kreuter in the Institute of Pharmaceutical Technology, Goethe University. There he accomplished his habilitation exploring the rational design of nanocarriers and was awarded the Venia legendi in pharmaceutical technology. Before joining NUS, he headed the Department of Pharmaceutical Technology and Nanosciences of the Fraunhofer Institute for Molecular Biology and Applied Ecology in Frankfurt. Currently, he serves the European Journal of Pharmaceutics and Biopharmaceutics and the Journal of Pharmacy and Pharmacology of the Royal Pharmaceutical Society as an editorial board member. Further, he is a scientific advisor to the Journal of Pharmaceutical Sciences editors and was guest editor for the Beilstein Journal of Nanotechnology and Frontiers in Chemistry. He was honored with the Eudragit® Best Paper Award (2014) and the Phoenix Pharmaceutics Science Award (2017) in recognition of his research excellence. From 2020-2025, he is a member of the General Chapters – Dosage Forms Expert Committee and the Expert Panel on New Advancements in In-Vitro Product Performance Testing of the United States Pharmacopeial Convention. His research focuses on the development and characterization of various types of formulations following a quality-by-design approach. His group develops biopredictive performance assays and physicochemical characterization methods for oral dispersions and injectables such as long-acting depot formulations or nanomedicines.

Michael Roe is the Senior Director of Device Development & Industrialization at kaléo Inc.  A seasoned expert in combination products, he had a 27-year career at Eli Lilly and Company, where he helped launch their first prefilled injector in 1998. Mike had subsequently led Lilly’s reusable device programs and develop cartridge/device specifications and compatibility testing before joining kaléo in 2017.

Mick has more than 17 years of pharmaceutical and device development experience within large multi-national biotechs to small innovative start-ups. His projects have ranged from solid oral dosage forms to computer controlled parenteral combination products across antiviral, oncology, and cardiopulmonary indications. Prior to joining InCarda, he served as the Senior Director of Pharmaceutical Development at SteadyMed Therapeutics working to launch a drug/device combination therapy for pulmonary arterial hypertension. Prior to SteadyMed, Mick worked at both Gilead Sciences and Vertex Pharmaceuticals helping to launch Harvoni®, Kalydeco®, and Incivek.

Mick earned his B.S. in Chemistry from the University of Central Florida and a Ph.D. in Analytical Chemistry from the University of North Carolina – Chapel Hill. Over his career, Mick has earned numerous awards for outstanding contributions both at his employer and for external organizations such as the ACS and IUPAC.

Mike is CEO and Founder of IDEA Pharma and Protodigm. He is a pharma innovation protagonist, antagonist, and geek. Mike is the author of “Positioning Pharmaceuticals” and a contributor to Fortune, STAT, and Endpoints. He is recognized as an industry influencer — Global Power List: 20 in 2020 and 2021, the Top 20 inspirational medicine makers in biopharmaceuticals (The Medicine Maker); Top 10 Innovators in Pharma (PharmaPhorum); PharmaVOICE Red Jacket: 100 Most Inspiring People in Healthcare (2011, '13, '15 and '16, + lifetime Red Jacket winner); and Global Power List 100 (Medicine Maker, the 100 most influential people in healthcare, 2017, 2018, 2019). Mike is also a Senior Fellow at the Milken Institute, and an advisor to BioEthics International.

 

Dr. Mohamed ElSayed is an accomplished leader with +25 years of experience spanning academia, biotechnology, and pharmaceutical organizations. He is a recognized expert in the development of small molecules, biologics, nucleic acids, and regenerative cell therapy.

Currently, he is the Oral Peptide Delivery Platform Leader at Eli Lilly & Company where he leads a cross-functional team of talented scientists that delivers the oral peptides portfolio. Prior to joining Lilly, Dr. ElSayed advised numerous pharmaceutical and biotechnology companies on challenging drug development programs while pursuing an academic career in parallel. He was a tenured professor at the University of Michigan where he established and led the Cellular Engineering and Nano-Therapeutics Laboratory. His research spanned multiple disciplines including biopharmaceutics, drug delivery, and material sciences with special emphasis on development of novel formulations for multiple therapeutic modalities. He constantly integrated technologies from disparate fields to develop innovative, robust, and scalable drug delivery platforms.

Dr. ElSayed received his B.Sc. and Ph.D. in Pharmaceutical Sciences from Cairo University, Egypt and the University of Maryland, Baltimore, respectively. He received +25 awards, contributed to 6 patents, co-authored +170 research articles and conference proceedings, and delivered +60 invited talks. Dr. ElSayed serves as chair of AAPS Pre-Formulation & Formulation Design/Development Community, a member of the Scientific Advisory Board of Boulder Peptide Society, and a member of the Editorial Office of Precision Nanomedicines and Journal of Pharmaceutical Sciences.

Puneet Tyagi is currently a senior scientist at AstraZeneca, based in Maryland, USA.  Puneet  received his Bachelors and Masters in pharmaceutical sciences  from India and his Doctorate in Pharmaceutical Sciences from the University of Colorado.  His area of research is biologics formulation development, with a focus on sustained delivery systems and oral delivery of biologics. Puneet Tyagi is co-inventor of several U.S. and international patents and has published extensively in the field of drug delivery.

Puneet is a member of various professional organizations including the American Association of Pharmaceutical Scientists (AAPS), and the Controlled Release Society (CRS). He is serving as a steering committee member of the AAPS Nanotechnology Community since August 2015.   

As an ETH Zurich, Switzerland, Master of Pharmaceutical Sciences, Robert started his industrial journey at a Swiss subsidiary of J&J where he directed Formulations Development during several years. After being appointed as a director at a local CDMO, Robert joined Selectchemie, a renowned Swiss distributor of Active Pharmaceutical Ingredients and Excipients. He established several service functions and gained growing management responsibilities. After several years as Project and Product Manager within the Life Sciences Division of Merck KGaA, he joined Sensile Medical, a subsidiary of Gerresheimer where Robert brings in Sales and Product Management expertise.

Rosario has 25+ years’ experience as an inspiring, patient-centric leader in the industry driving R&D with a strong focus on regulatory strategy, commercial, and operational excellence in development, scale-up and launch preparation of generic/branded products at Merck, Novartis, TEVA and Sandoz. This includes development of APIs/drug products containing small molecules, synthetic polypeptides and proteins and drug-device combination products. Currently at Sandoz he is Head of Scientific Affairs responsible for external partnership product development and oversees due diligence evaluating CMC/bio-analytical aspects of new product opportunities amenable to co-development, in-licensing or acquisition.  Moreover, he advances pipeline strategy and pioneering access for patients leading team in the identification, evaluation and prioritization of internal/external assets.

Russ Hornung is a Business Development representative for Drug Delivery and Packaging for W.L. Gore & Associates.  Russ began his career at with a BSEE (Electrical Engineering) from The Pennsylvania State University and went to work at Westinghouse as a design & new product development engineer.  He later transitioned into new business development representative while studying MSEE at Johns Hopkins University.  Russ returned full-time to receive his MBA from the Katz Graduate School of Business, University of Pittsburgh.  Since 1996, Russ has held various Product Management and Business Development positions at Gore focused on providing unique and valued material based solutions to difficult market needs in various industries.

Currently, Soroush is a manager at Pacira Biosciences Inc., a leader in providing non-opioid pain management and regenerative health solutions. At Pacira, he’s part of the formulations development team where he’s responsible for new product development and involved in projects from conception to clinical evaluation. Soroush received his B.S. in Chemical and Biomolecular Engineering from the University of Illinois Urbana-Champaign. He then earned his Ph.D. in Bioengineering from the University of California-Riverside in 2016. His thesis work primarily focused on the development of therapeutic polymer/lipid-based drug delivery systems. Upon graduation, he completed a brief postdoctoral assignment before entering the pharmaceutical industry.

Srinivas currently is the Head of Engineering Technologies at Bristol Myers Squibb company where he leads a cross-functional team of engineers and scientists that integrates deep scientific expertise with process and technology innovation to enable drug product  development across BMS’ small and large molecule portfolio. He brings over 20 years of experience in pharmaceutical industry including leadership roles in Drug Substance, Drug Product and CMC project leadership. Srinivas had been an active member of the IQ consortium Leadership Group and is a founding member of the Enabling Technologies Consortium. He is the recipient of the 2013 AIChe Institute Award, for industry contributions to Quality by Design process development of small-molecule pharmaceutical compounds.

Srinivas has a Bachelors degree in Chemical Engineering from the Indian Institute of Technology, Kharagpur, India, and received his Ph.D. in Chemical Engineering from the University of Minnesota and a MBA from NYU, Stern School of Business.

Dr. Shanmugam has more than 20 years of experience in designing and development of conventional, NDDS/alternate, advanced/modified drug delivery systems, and pharmaceutical platform technologies for oral and other routes of administration. His expertise includes stability, solubility/dissolution, permeability, and bioavailability enhancement techniques/technologies for challenging drugs. Additionally, Dr. Shanmugam has published numerous research articles, holds multiple patents, and is a reviewer/editorial member of various prestigious journals. In his current position, Dr. Shanmugam is involved in the development and expansion of Adare's pharmaceutical technology portfolio and facilitates product development and co-development opportunities.

Steve Rumbelow is the Life Sciences Research Fellow for Croda Inc and has been in this position since early 2020, with responsibilities that include developing partnerships and collaborations between the R&D team and external organizations, both in academia, research institutes and customers.  Prior to that he developed and managed the US Health Care R&D team for several years, generating new high purity excipients and supporting performance claims data, specifically for the pharmaceutical and animal care industries.  This includes products for all major delivery routes and applications, ranging from emulsifiers and dispersants through to solvents and permeation enhancers.  The team also generates accompanying application and claims data, with an emphasis on the impact of excipient purity on drug delivery and performance.  

Steve graduated from Leeds University with a PhD in 1982 and started his career in the food and fine chemical industries, developing his skills in analytical chemistry (primarily chromatography and mass spectrometry) covering areas ranging from trace analysis through to polymer characterization, during which he has worked with a combination of conventional and novel separation techniques to resolve complex problems.  Starting his career with Cadbury Schweppes in the UK, Steve joined ICI in 1995 before moving to the US division of Uniqema (an ICI business) 1999 before finally joining the R&D team in Croda in 2007.  During his career he has authored more than 40 scientific presentations, posters and articles and has been involved on several industry specific and technique-based groups and expert panels (including most recently, the USP).  Current memberships include the AAPS, American Society of Mass Spectrometry and the Controlled Release Society.

Sylvestre Grizot is a Principal Investigator at MedinCell (Jacou, France), where he is leading a research team around the formulation of peptides and therapeutic proteins with the aim of designing long acting injectables for better treatments and improved patient compliance. Prior to this position, he worked for several companies in the field of protein engineering. He holds a Master in Bioengineering from Ecole Centrale Paris, a Master of Science in Molecular Biophysics from University Paris VI and a PhD in protein biochemistry and crystallography from Grenoble University, France.

Tony Listro is Vice President, Technology of Foster Delivery Science, Inc., a CDMO focused on novel drug delivery dosage forms based on polymer processing technologies. He is responsible for the continued research and development of new melt extrusion technologies as well as guiding Foster’s team of engineers and scientists in the contract development and manufacturing of specific formulations and dosage forms for clients in the pharmaceutical industry. Tony is an expert in the areas of polymer materials and polymer processing. He has worked on blending active pharmaceutical ingredients with polymers for various drug delivery applications including oral and implantable dosage forms for more than 15 years. Tony holds both a BS and MS in Plastics Engineering from the University of Massachusetts in Lowell, MA, and an MBA from the University of Massachusetts in Amherst, MA. He holds two issued US patents and has authored and/or co-authored 20 publications. Tony is a member of the Society of Plastics Engineers, Controlled Release Society, and AAPS.

Twinkle Christian is a Process Development Scientist at Amgen. She has 15+ years of industry experience in formulation development across diverse modalities and has led the advancement of multiple programs from early discovery to clinical trials and commercialization. Twinkle’s expertise encompasses high concentration formulation and drug delivery of biologics, investigating protein-protein interactions, and macromolecular crystallography. She is an adjunct instructor at California State University, Channel Islands & University of California, Santa Barbara. Twinkle holds a Master’s in Biochemistry and Molecular Biology and was employed at Alza (Johnson & Johnson) and VaxGen prior to Amgen.

Vijay Sethuraman is a Senior Scientific Manager at Genentech with over 13 years of experience. Before moving to Genentech, he was a group leader at Novartis Pharmaceuticals. His area of focus is preclinical formulations with specialization in intravenous, lung and liposomal delivery. He has worked in oncology, Infection, immunology and other disease areas. He has a Bachelor of Engineering in Polymer Sciences and Technology and a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. In his leisure time he like reading and biking with his son.

Yasmine Gomaa is a Senior Research Scientist and the Associate Director of the Laboratory of Drug Delivery at Georgia Institute of Technology, Atlanta, Georgia since April 2021. She earned a BA, MD and Ph D degrees in Pharmaceutical Sciences from Faculty of Pharmacy, Alexandria University, Egypt. Her research experience over the past 20 years has been in the delivery of drugs, vaccines and cosmeceuticals, especially via the transdermal and topical route. Early in her research career, she utilized drug delivery systems for skin delivery and recently microneedle based systems for skin and transdermal delivery of drugs and vaccines. She has a strong publication record, is a co-inventor for two pending patents and co-wrote several successful grants. She has worked in collaboration with industry, academic institutions, and several governmental, private and regulatory agencies as well as organizations such as CDC, WHO, UNICEF and Bill and Melinda Gates Foundation.

Zoe Zhang is a formulation scientist at REGEXBIO, an adeno-associated virus gene therapy company based in Maryland. Before REGENXBIO, Zoe has worked at Novavax and Fresenius Kabi on formulation and process development for vaccines, peptides, and small molecules. She has published 18 research articles, 19 meeting presentations, and contributed to 3 patents. Zoe received her Ph.D. in Biopharmaceutical Sciences from the University of Illinois at Chicago and worked on microRNA delivery with polymeric nanoparticles for her Ph.D. thesis.