The Industry’s Only Scientific & Regulatory-Focused Event For Uncovering Novel Bioequivalence Approaches To Ensure A Safer, Regulatory-Compliant & Faster Time-To-Market On Future Branded & Generic Drug Products
In order for generic drugs to be approved, the FDA requires bioequivalence studies to make sure the generic drug, when administered will have the same effect as the branded drug. However, ensuring the safety of a drug can be a very complex and costly process with a high failure rate. A challenge that often creates a bottleneck between the scientific community and regulatory agencies.
What can be done to bridge the gap between the scientific community and the regulatory agencies in safely bringing a new drug to market? The must-attend Bioequivalence: Intersection between Science and Regulatory Conference will share and address specific case studies and take-home examples on how we can clarify, simplify and unify the bioequivalence testing process, and ensure a faster time to market on future drug products.
Over the course of 2 days, you will hear from a number of the drug development industry’s leading bioequivalence innovators who will share multiple unique, take-home strategies, examples and best practices from scientific, practical and regulatory standpoints.
This must-attend event is co-located with Curtis & Coulter’s Oral Drug Formulation Innovations Summit. Conveniently hosted in San Diego, attendees have access to both events in the same location.
Agenda at a Glance
Conference Topics include:
- Emerging Bioequivalence Studies
- Bioanalytical Methodology
- Contemporary Challenges of Drug Design, Discovery and Development
- Managing BA/BE Studies
- Drug Design, Discovery, and Development
- PK/PD Models, Biowaivers, and Biosimilars
- Advances in Assessment of Bioequivalence
- Bioequivalence and Drug Product Selection
- Relevance of Genetics to BA/BE in Drug Development
- Regulatory Policies, Procedures and Prerequisites
- IVIVC Correlation
- Quality Guidance for Amorphous Drugs and Crystalline Measurement Systems
Benefits of Attending:
- 45+ industry-led speaker faculty over 2 full days sharing innovative drug development take-home strategies
- 120+ senior participants spanning pharma, biotech, and specialty technology companies
- 5+ hours of networking and breakout sessions, including evening cocktail reception
- Exhibit hall with multiple leading formulation and bioequivalence providers
- Jan Neuhauser, PhD, Medical Assessor, Department for Medical Assessment, AGES, Austria
- Wenlei Jiang, PhD, Reviewer, Officer of Generic Drugs, FDA
- Alexander Pontius, PhD, Lab Head Dissolution Testing, Bayer Pharma AG
- Arijit Chakravarty, PhD, Director, Modeling & Simulation (DMPK), Takeda
- Anthony Lucas, PhD, Vice President, R&D, Putney, Inc.
- Han Chao, PhD, Scientific Director, Janssen, Johnson & Johnson
- Shefali Kakar, PhD, Senior Director, Clinical Pharmacology, Novartis
- Ding Ding, PhD, Director, Regulatory Affairs, Zhejiang Hisun Pharmaceuticals
- Vit Perlik, PhD, Senior Clinical Development Manager,, Zentiva
- Anthony Lucas, PhD, Vice President, R&D, Putney, Inc
- Adnan Sabir, M.S., RPh, QA-CMC , Kowa Pharmaceuticals, America, Inc.
- SImmanuel Freedman, PhD, Manager, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline
- Anjali Joshi, PhD, Scientist I, Forest Laboratories Inc
- Oksana Olkhovyk, PhD, Senior Scientest, Gateway Analytical
- Marta Bellini, PhD, Senior Analytical and Formulation Scientist, Chiesi Group
- Piyush Jain, PhD, Formulation Scientist, GlaxoSmithKline
- Elizabeth Hewitt, PhD, Senior Scientist, Analytical Development, Small Molecules, Takeda
- Pavel Farkas, Pharm.Dr., Senior Director, Biopharmaceutics R&D Zagreb, Teva
- Binfeng Xia, PhD, Senior Scientist, Preclinical Dev. Biopharmaceutics, Merck & Co.
Interested in presenting at this focused event? Our speaker programs are carefully researched each year to ensure that delegates are exposed to the highest level of expertise. However, delegates not only benefit from the experience of our speakers, but also gain an insight into the experiences of other attendees.
Q&A sessions and panel discussions are utilized to enable sharing of knowledge and facilitate idea exchange.
If you have a cutting edge case study or relevant presentation and are interested in joining the speaker faculty at one of our events, please email email@example.com. Q&A sessions and panel discussions are also utilized to enable sharing of knowledge and facilitate idea exchange.
Please note that due to the high volume of submissions we receive, places on the speaking faculty are extremely limited and subject to approval via our conference advisory committee. Solution providers submissions should contact Mark Coulter at firstname.lastname@example.org.
Who Should Attend
Pharmaceutical, biotech, CRO, diagnostic and academic professionals specializing in:
- Pharmaceutical R & D
- Clinical Develpoment
- PK / PD
- Drug Delivery
- Regulatory Affairs
- Product Development
- Medical Affairs
- Project Management
- Life-cycle Management
Quest Life Sciences is a decade old CRO pioneering in the conduct of BA/BE studies and clinical trials. We are a 5 time USFDA approved center and have submitted over 500 studies including regulated and ROW markets. We are fully operational in Thailand and Russia etc, markets which mandate BE studies on local population. Handling regulated markets like US, UK, EU, TGA etc has been our prime focus including para IV submissions, patient based onco/derma studies as well.
1. Topical – Ointment, creams, gels, lotions, foams, solutions
2. Transdermal patches – Matrix-type, reservoir, active delivery systems
3. Ophthalmic solutions, semi-solids, suspensions
4. Solid orals – IR, MR, tablets, capsules
5. Liquid orals – solutions, suspensions
Both Quest and Chemech offer other independent services like bio-analytical services, regulatory support and selected clinical trial services based on client’s requirements.
Curtis & Coulter have limited sponsorship opportunities available to help showcase your solutions and services in front of the event delegation. Whether it is showing industry leadership through a speaking engagement, promoting your brand in creative ways throughout the event, hosting a networking reception, or exhibiting your products / services, please feel free to contact Mark Coulter at email@example.com or call +1 (781) 499-2685 to arrange a needs assessment.*
* Please note that sponsorship opportunities are limited due to the educational-led focus of this event. Please enquire for availability.
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