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

Date
9:00 am PST - 10:30 am PST
Location
Webinar
Speakers:
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

Date
9:00am - 10:30am
Location
Live Webinar
Speakers:
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

PART 1: Biotech Innovation from Concept to IND to Clinical Development

Date
9:00am - 10:30am
Location
Live Webinar
Speakers:
Yinghong Gao , VP & Associate Business Partner, Viva Biotech , Yinghong Gao, VP of BD & Associate Business Partner at Viva Biotech and its Viva BioInnovator investment division, is an experienced drug R&D scientist turned business development and investment professional. She also serves as a board observer of DTx Pharma. Prior to that, she was an integral team member of target selection, licensing & scientific network of MerckMillipore, responsible for lead evaluation and new product introduction. She has over a decade of drug discovery experience as a medicinal chemist with additional expertise in computer aided drug design, working at biotech companies including Cytel Corporation, Neurocrine Biosciences and Arena Pharmaceuticals with increasing responsibilities. Her successful drug discovery track record is evidenced by over 30 publications and patents, and multiple IND clinical candidates in different therapeutic areas and her indelible contributions to the discovery of ORILISSA®, a GnRH antagonist, which gained FDA approval in 2018. She also has broad CRO experience ranging from early drug discovery to pre-clinical and clinical development. She holds a MSc. Degree from Chinese Academy of Sciences in physical chemistry and a MSc. Degree from Tulane University in organic chemistry. , Samuel V. Alworth, MS, MBA , Chief Executive Officer and Co-Founder, AcuraStem , Samuel V. Alworth, MS, MBA, Chief Executive Officer and Co-Founder of AcuraStem, has nearly 20 years’ experience in the life sciences covering research, drug development and business development. Since co-founding AcuraStem, he has been actively involved in advancing the company's innovative drug candidates for ALS / FTD. With a technical background in machine learning and image recognition, Sam has led the implementation of new informatics pipelines at AcuraStem, incorporating both innovative machine learning and traditional image processing algorithms for the iNeuroRx® platform. Prior to co-founding AcuraStem, Mr. Alworth was VP of Sales & Marketing at DRVision Technologies LLC (Bellevue, WA), where he led the development of an artificial intelligence enabled software for automated microscopy (SVCell, now Aivia). Sam holds several U.S. patents and has contributed to numerous scientific journal publications. ,

Part 1- Viva Biotech & AcuraStem: “Turning Your Idea Into a Fundable Business Plan”

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

Do you have a brilliant idea that you believe may lead to transformative innovation? Are you in the process of getting your new company off the ground? Turning an innovative idea into a fundable business plan can be daunting, especially for first time entrepreneurs. Some of the most frequently asked questions by scientists-turned-entrepreneurs are “what is a business plan?” and “what needs to be included in an investment deck?”

In this informative webinar, you will be hearing from Yinghong Gao of Viva, an early stage life-science investor and incubator, about the key ingredients that investors like Viva are looking for in a business plan and the most relevant building blocks that will help make your investment pitch deck stand out from the pack. Sam Alworth, CEO of AcuraStem, will then share his expertise with the audience from a founder’s perspective, outlining his unique journey, which has led to successful funding to enable AcuraStem’s trailblazing research in neurodegenerative disease drug discovery.

Webinar 3: “How and Why” to Commercialise your Hearing Research

Date
8:00 pm PST
Location
Webinar

Agenda for Webinar 3: "How and Why" to Commercialise
your Hearing Research

What’s it about?

To provide an insight into the opportunities to commercialise hearing research, access hearing research capabilities and expertise, and secure investment.

Who should join?

Academics interested in spinning out companies, drug discovery companies interested in investment opportunities in the hearing therapeutic space, investors looking to invest in new emerging fields.

Will I be able to join if I have hearing loss?

Yes, the webinar will be BSL-interpreted and scripted in real-time by a professional typist to enable people with hearing loss to join and interact with the live event.

16:00 Opening Remarks and Welcome
Dr Ralph Holme, RNID and Dr Beverley Isherwood, MDC

16:05 The Commercial Landscape in Hearing Drug Discovery
Prof Rick Cousins, Cinnabar Consulting

16:20 Accessing External Hearing Drug Discovery Expertise and Capabilities
Dr Wahid Awad, CILcare and Dr Helen Blackshaw, ENT Clinical

16:30 Considerations in Seeking Investment for Hearing Medicines Discovery
Dr Erica Whittaker, Head of Corporate Venture Fund at UCB

16:40 Panel Session: Q&A and Discussion
Chair: Dr Ralph Holme

17:00 Close

Webinar 3: “How and Why” to Commercialise your Hearing Research

Date
16.00 GMT | 17:00 CET - 11:00 EST | 8:00 PST

Through this series of webinars, we will explore the emerging hearing medicines landscape by inviting leading clinicians, academics and industry representatives along with people with lived experience of hearing loss, to share their expertise and insight.

Over 4 webinars we will provide a 360-view of the field covering the patient need, the key challenges faced by innovators, how to commercialise your hearing research and why regenerative approaches could be a game-changer for hearing medicines discovery.

Agenda for Webinar 3: "How and Why" to Commercialise
your Hearing Research

What’s it about?

To provide an insight into the opportunities to commercialise hearing research, access hearing research capabilities and expertise, and secure investment.

Who should join?

Academics interested in spinning out companies, drug discovery companies interested in investment opportunities in the hearing therapeutic space, investors looking to invest in new emerging fields.

Will I be able to join if I have hearing loss?

Yes, the webinar will be BSL-interpreted and scripted in real-time by a professional typist to enable people with hearing loss to join and interact with the live event.

16:00 Opening Remarks and Welcome
Dr Ralph Holme, RNID and Dr Beverley Isherwood, MDC

16:05 The Commercial Landscape in Hearing Drug Discovery
Prof Rick Cousins, Cinnabar Consulting

16:20 Accessing External Hearing Drug Discovery Expertise and Capabilities
Dr Wahid Awad, CILcare and Dr Helen Blackshaw, ENT Clinical

16:30 Considerations in Seeking Investment for Hearing Medicines Discovery
Dr Erica Whittaker, Head of Corporate Venture Fund at UCB

16:40 Panel Session: Q&A and Discussion
Chair: Dr Ralph Holme

17:00 Close

Introduction to elluminate® Clinical Analytics

Date
8:00am PST - 8:30am PST
Location
Webinar
Speakers:
Achilleas Zaras , Sales Engineer, eClinical Solutions , Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions. ,

In a 2019 Tufts CSDD survey, 90% of respondents from over 140 life sciences companies rated self-service analytics as important for managing multiple data sources and growing volume of data. However, just 46% of respondents had analytics dashboards currently available. To effectively manage trials, resources, timelines and oversee vendors according to regulatory requirements, clinical teams need on-demand access to their clinical and operational data for decision making. The elluminate clinical data platform was designed to provide an end to end comprehensive platform that delivers access to governed clinical data to clinical teams. elluminate Analytics includes more than 50 out of the box visualizations designed to support data review objectives and provide new insights to medical monitors, data managers, clinical operations and biostatisticians.

elluminate Analytics helps clinical teams visualize data to see outliers and trends that are not possible to detect in line listings and supports cross study analyses for deeper insights.

More than 50 Life Sciences companies rely on Clinical Analytics from elluminate to improve the clinical data review process and enhance operational oversight.

COVID-19 Preclinical Disease Modeling and Vaccine Development

Date
8:00am
Location
Webinar
Speakers:
Dr. Terina Martinez , Field Application Scientist , ,

Taconic Biosciences' webinar presented by Dr. Terina Martinez, Field Application Scientist, will present a high-level overview of the animal models suitable for COVID-19 research along with a deeper dive into specific mouse models for studies of SARS-CoV-2 disease pathogenesis and screening of therapeutics and vaccines.

OC LIFe (Lifesciences Innovators Forum) – featuring Vivek Mutalik & Chang Liu

Date
3:00 PM - 4:30 PM PST
Location
Webinar
Speakers:
Vivek Mutalik , Research Scientist, Berkley Lab / Innovative Genomics Institute , Vivek Mutalik is a staff scientist at the Environmental Genomics and Systems Biology Division and Biological Systems and Engineering Division at the Lawrence Berkeley National Laboratory. Previously Dr. Mutalik was a team leader at the BIOFAB, the first biological design-build-test facility, which focuses on developing extensively tested standard biological parts to facilitate easier engineering of biology. Currently, his work focuses on developing standardized genetic tools for industrially important microorganisms, a robust functional genomics platform and study of regulatory design principles in microbial stress responses. Vivek’s recent research is based on exploring how to engineer bacteriophages to precisely control microorganisms important to human and environmental health. , Chang Liu , Associate Professor, Liu Lab UCI , Professor Liu’s research is in the fields of synthetic biology, chemical biology, and directed evolution. He is particularly interested in engineering specialized genetic systems for rapid evolution and creating synthetic organisms that use new building blocks for their informational and functional macromolecules. For example, his group is known for their construction of an orthogonal DNA replication (OrthoRep) system capable of driving the rapid, scalable, and deep evolution of desired genes in vivo. These systems can be widely applied for the engineering, discovery, and understanding of biological function. ,

OC LIFe aims to connect industry with entrepreneurs and strengthen the life sciences and medical technology communities.

Create connections that could last a lifetime.
The OC LIFe (Life Science Innovators Forum) is a monthly free event series focused on creating a collaborative environment that fosters connections between innovators in the life sciences and medtech industry.

Exploring emerging technologies and innovative methods to advance genomic research.
Searching beyond the core set of genomic editing tools and next-generation sequencing to design therapeutics and solve environmental problems.

1. What emerging technologies and methods can improve genomic research
outcomes for developing therapeutics?
2. What are the challenges of synthetic biology and how can we move closer
to solving these problems?