The Evolving Role of the CDMO: Integrated First-in-Human Services Symposium

8:30am - 12pm PDT

A significant fraction of the biopharma pipeline is held by small – and even virtual – biopharma companies. These companies often lack the all of the capabilities, expertise and/or bandwidth necessary to advance their molecules to initial clinical studies. In the absence of internal resources, small biopharma often look to contract development and manufacturing organizations (CDMOs) to support their development programs. While it is common to support these activities through consultants and multiple CDMOs, studies indicate that working with a single integrated service provider for API and drug product can reduce complexity, development timelines, and costs.

Please join Biocom California and Lonza for a half day virtual symposium as we discuss capabilities across critical aspects of rapidly advancing today’s molecules.

Key takeaways:
The role of solid form selection services within API development
Particle engineering considerations to improve bioavailability
Phase-appropriate and scalable drug product development for first-in-human studies

Join Quotient on Thursday, April 15th at 9am (Brisbane) for a live webinar entitled:”Challenges and Considerations for Developing A Successful Oral Modified Release Formulation”

9am (Brisbane)
Dr Vanessa Zann , Senior Drug Development Consultant , ,

Seminar overview
Oral modified release (MR) drug products remain highly prevalent in drug development pipelines. These dosage forms tailor the in vivo drug release profile to achieve improved therapeutic outcomes for drugs intended for both local (gastrointestinal) action and also systemic delivery. Patients with chronic and acute conditions benefit from the use of MR dosage forms given that they offer greater compliance and less frequent dosing regimens, coupled with potentially greater efficacy and fewer side effects in comparison to Immediate Release (IR) delivery systems.

A large number of MR technologies are available to drug developers, each designed to fulfill very specific performance requirements, such as gastro-retention or sustained-, pulsatile-, or delayed- release formats. The design and development of an effective MR formulation is however an inherently complex process, presenting many challenges for the development team. Human GI anatomy and physiology strongly influences drug release and performance of MR dosage forms given regional variations in pH, fluid volumes and compositions, surface area, metabolizing enzymes and membrane transporters. Challenges are exacerbated by an over-reliance on in vitro and preclinical test results to inform formulation prototype selection, despite evidence that these data often correlate poorly with pharmacokinetic performance in humans.

In this seminar we will discuss the drivers for MR development and key considerations for rational formulation design and technology selection. Using case studies, we will describe the specialized formulation technologies that are available in the “toolbox” in order to achieve an optimal target product profile, and the use of innovative, adaptive clinical programs where human PK data is used to optimize MR formulation compositions in real-time.

Key Discussion Topics:

Bridging from an Immediate Release (IR) formulation to Modified Release (MR) - What drives the need and what are the benefits?
Key formulation design strategies and technologies – Which approaches to deploy?
The relationships between formulation parameters, in-vitro data and in-vivo performance – Can we establish an IVIVC?
The use of Design Space concepts – How to evaluate and optimize formulation performance “real-time” using clinical data
Featured Case Studies on Modified Release Drug Programs and MR Best Practices

Event Details
Date- Thursday, April 15th
Time- 9:00am Brisbane, AUS
Where- Zoom

About Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.

Clinical Trial Supplies April Webinar Series

8:30am PST / 11:30am EST / 4:30pm London (GMT)
2:30pm EST / 7:30pm London (GMT)
10am London (GMT) / 11am Paris (CET)
Dr Andrew Lewis , Vice President of Pharmaceutical Sciences , , Nick McEntee , , Sr. Director of GMP Operations ,

Join us on April 6th, 7th or 8th for an hour long clinical trial supply focused webinar, entitled: "Flexible strategies for getting drug product to patients – adaptive product manufacturing and customized clinical trial supply"
Seminar Overview:

Your clinical trial supply chain can be a complex network of manufacturers, logistics companies and storage warehouses in multiple countries around the globe. This can cause a real logistical headache that many biotech and virtual pharma companies haven’t considered; How do you coordinate your supply chain? How do you ship to multiple countries with different rules, regulations, and languages? What packaging do you require? How much product do you need to manufacture? It can be common to over manufacture, leading to unnecessary stockpiling, wastage, and product attrition.

This webinar will explore the existing challenges of managing the manufacture and distribution of clinical trial supplies to numerous sites, in multiple countries, and discuss how to streamline your clinical trial supply chain and accelerate your proof-of-concept timeline. Learn how to protect your precious API with a logistics strategy that reduces waste and discover how to manage global supply so that you only distribute product where it’s needed, anywhere in the world, when it’s needed.

Key considerations and topics covered:

Flexible product presentations and logistics – getting your product delivered as bulk, Brite Stock in primary package, or as patient kits
Global “on demand” supply – ensuring distribution where it’s needed, anywhere in the world, when it’s needed.
How to avoid stockpiling and product attrition at clinical sites through Brite Stock Inventory Management and Just-in-time labelling and distribution
Lean logistics strategies to speed development and reduce waste of API and drug product
Understanding of local rules, regulations and managing import and export licensing to avoid hold ups
How to exploit efficiencies across protocols and minimize waste through drug pooling

About Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.

Working with CROs – From selection to managing relationships

9:00 AM - 11:00AM PST
Tiina Kähkönen, Ph.D. , Chief Scientific Officer , , Joe Flynn , Chief Commercial Officer, Inotiv , ,

How to choose the right preclinical CRO

There is an increasing trend in pharma/biotech industry to outsource studies to contract research organizations (CROs). There are over 3000 CROs globally that have a variable selection of models and services, which can make it difficult to decide who to partner with. This event discusses advantages and risks in using CROs and gives you tools for evaluating, selecting and managing CRO relationships.

Featured Speaker: Tiina Kähkönen, Chief Scientific Officer, OncoBone Ltd

Presentation Topic: How to chose the right CRO

Tiina Kähkönen did her MSc in a Drug Development and Pharmacology program, and her PhD focusing on drug research for breast cancer and especially for cancer-induced bone metastasis. She worked previously in a preclinical CRO offering efficacy models for oncology and skeletal diseases, first as a Research Director and later as Chief Scientific Officer. At OncoBone she serves clients as scientific advisor, where one of her duties includes assisting pharma and biotech clients in finding suitable vendors, such as CROs, for outsourcing preclinical studies.

Featured Speaker: Joe Flynn, Chief Commercial Officer, Inotiv

Presentation Topic: How to create value for clients above the value of the project

Joe Flynn joined Inotiv in July 2018, having served as chief commercial officer and executive vice president of Seventh Wave Laboratories. Appointed to his current role as chief commercial officer in February 2019, he is responsible for leading sales, marketing, client experience and program management efforts across Inotiv’s five sites.

Flynn has had an esteemed career as a senior executive in contract research, with over 25 years of strategic and operational experience focusing on pharmaceutical research and development. Prior to his tenure at Seventh Wave, Flynn was a global vice president of sales and client services for multiple divisions of Covance Laboratories. Prior to Covance, he held operational roles at PPD Inc. and ABC Laboratories (now Eurofins). Flynn is also a board member of the Missouri Biotechnology Association.

Understanding the B6 mouse

12:00 PM - 1:00 PM
Dr. Fred Beasley , Field Application Scientist , About the speaker: Dr. Fred Beasley is a Field Application Scientist with Taconic Biosciences, covering the western regions of the United States and Canada. He obtained his doctorate degree from the University of Western Ontario characterizing mechanisms of bacterial pathogenesis. Dr. Beasley moved to San Diego to pursue postdoctoral projects at the University of California and at the Calibr Institute, developing in vivo models of infection and therapy for validation of novel small drug immune boosters and antimicrobials. Prior to joining Taconic, Dr. Beasley served as the In Vivo Biologist for NASH startup Jecure Therapeutics, and as the Director of Scientific Engagement for cardiovascular and metabolic disease at Crown Bioscience. ,

The C57BL/6 mouse is the most widely used animal model in the world, and provides the background for most genetically engineered mice. But what do you really know about it? This seminar will discuss the origins, characteristics, and utilities of this mouse strain; the key differences between substrains; and recent findings that are critical for anyone who uses C57BL/6 mice for research.

From this presentation, you will better understand:
• What makes an inbred mouse and the origins of C57BL/6 mice
• Unique characteristics of the C57BL/6 mouse
• Variation between different C57BL/6 sub-strains and how these affect your research
• How microbial differences can affect performance of C57BL/6 models
• Influences of background strain contamination in genetically engineered mice

First 50 registrants will receive a $20 GrubHub voucher to enjoy lunch on Taconic!

8am - 4pm

Engaging Business Minds to Achieve Success
Join us for the 2nd Annual San Diego Business Summit to be held virtually on Thursday, January 28, 2021, from 8 am - 4 pm.

Can't make a session? Don’t worry - an unedited recording of the panel discussion will be made available for 3 months so you can watch on your own time.

The 2021 San Diego Business Summit offers a wealth of insight from some of San Diego's most successful business leaders.

This all-day interactive Summit will bring together business owners, entrepreneurs, managers, and leaders for a day of workshops, keynote speakers, exhibitors, and networking.


Michael Levin
Custom Solutions Inc.

Creating an Entrepreneurial Workplace®

Michael’s talk on “Creating an Entrepreneurial Workplace®” is about his powerful philosophy that creates ownership and empowerment throughout an organization. Your people will not only embrace change they will actually lead and drive that change.

After the opening keynotes, attendees will have the opportunity to attend a variety of breakout sessions throughout the day.

Each hour offers different workshops that focus on Strategy & Planning, The Customer Experience, Marketing & Communications, Human Resources, Professional Development, and Technology. Attendees will gain valuable knowledge that they can take back to the (home) office and implement the very next day.

Space is limited at each live session and is on a first come basis. All sessions will be recorded to view at a later time.

2021 Workshops Include:

Strategy & Planning

Adjusting Your Business Plan to Survive During a Crisis
Staying Strategic and Pivoting During Challenging Times
Inclusion: Creating a Lasting Impact in the Workplace
The Customer Experience

Client Retention & Growth Strategies During a Crisis
How to Build Relationships with New Customers and Colleagues Virtually
Selling Yourself and Your Organization Virtually
Marketing & Communications

Digital Marketing Trends
Using Social Media Efficiently to Tell Your Story
Crisis Management - Communicating an Honest Message with Customers
Is Your Brand Working For You or Against You?
Human Resources

Strengthen Employee Morale While Being Remote
Top New Employment Laws in 2021
Managing Employee Burnout and Building Resiliency
Professional Development

Overcoming the New Workday Challenge: Work, School, and Health at Home
Working Virtually – What is okay and not okay?
Virtual Presentation Skills
Looking for Work in A Remote World

Leveraging Technology & Thinking Outside the Zoom Box
Cyber-Security and Remote Workers

Part 3- Stiris Research: “Operationalizing your Clinical Program”

9:00 am PST - 10:30 am PST
Carrie Hamilton , Director of Clinical Science, Stiris Research , Carrie Hamilton is the Director of Clinical Science at Stiris Research, which is a Clinical Trial Management company providing Phase I through IIIb full-service support and insights to biotechnology and biopharmaceutical companies. Her 30+ year career in clinical development has allowed her to be involved in the early stages of drug development of clinical programs, to launching products, and being involved in post-market studies and patient access programs. Working directly in large Pharmaceutical companies, her therapeutic experience is very extensive, as she has been part of the development of over 65 new molecular entities, involving over 200 Phase I to IV clinical trials. Carrie has been instrumental with the success of small first-in-human studies to large clinical programs, representing all Country Operations on Global Study Management teams, while being hands-on with the operations in North America. Now, at Stiris, she is an integral part of a team who work with sponsors on the development of their Clinical Development Plan for new entities and taking their pharmaceutical candidate into the clinical trial environment. ,

With record breaking biotech investment this year, emerging companies are flourishing and forging new strategic partnerships despite the pandemic. This 3-part webinar will guide you through the exciting journeys of Biotech Startups From Concept to IND and Clinical Development

Part 3- Stiris Research: “Operationalizing your Clinical Program”

You have spent years developing your New Molecular Entity and have the necessary pre-clinical data to move into the clinic. What do you need to know about operationalizing your Clinical Development Plan? Who are the experts you need to help you with the development and implementation of your studies?

In this final leg of our 3-part webinar, “Biotech Innovation from Concept to IND to Clinical Development”, Carrie Hamilton, will go through common questions many sponsors have, when they are moving their potential product into the clinic. She will also discuss the capabilities and skills, you should be looking for, when selecting a company to collaborate with, to help run your studies.

PART 2: Biotech Innovation from Concept to IND to Clinical Development

9:00am - 10:30am
Live Webinar
Matthew D. Durman, Ph.D. , , Dr. Surman is a medicinal chemist with approximately 19 years of experience working on drug discovery projects at Albany Molecular Research, Inc. (AMRI). Dr. Surman received his Ph.D. in synthetic organic chemistry from the University of Notre Dame under the direction of Prof. Marvin J. Miller. He joined the AMRI Medicinal Chemistry department in 2002 and worked on contract research projects spanning a variety of therapeutic areas including oncology (tubulin inhibitors, HSP-90), anti-infectives (FabI, DXP-R) and CNS (D2/5HT2A antagonists). From 2005 to 2011, Dr. Surman was part of the AMRI internal Discovery Research and Development department. His efforts were focused in the area of metabolic disorders, particularly in obesity. He served as the project leader for the AMRI MCH-1 antagonist program from 2008 until returning to the contract Medicinal Chemistry department in late 2011. During that time, the project culminated in the discovery and development of a successful Phase I clinical candidate. Since returning to the Medicinal Chemistry department, he has led the discovery efforts on a number of programs including projects involved in oncology, neurological disease, and pain. Dr. Surman is the co-inventor / co-author on approximately 30 patent applications and publications. ,

Part 2- AMRI: “Early discovery from Concept through IND”

With record breaking biotech investment this year, emerging companies are flourishing and forging new strategic partnerships despite the pandemic. This 3-part webinar will guide you through the exciting journeys of Biotech Startups From Concept to IND and Clinical Development