Past Meetup

Regulatory monsters like to eat new biotech companies

This Meetup is past

90 people went

CoMotion Incubator, Fluke Hall,Suite 300

4000 Mason Road · Seattle, WA

How to find us

Fluke Hall is on the University of Washington Seattle campus. See details below.

Location image of event venue

Details

Health startups increasingly combine digital health, wearable/implantable biotech devices, and pharmaceutical-relevant data. Having a regulatory strategy is no longer just a “nice-to-have” for people working to transform healthcare. Join University of Washington CoMotion (formerly known as the Center for Commercialization, or C4C) and UW Professional & Continuing Education on April 16 for a panel discussion about what entrepreneurs wish they had known about the regulatory monsters hiding in their closets when starting their new companies.

This is a great opportunity for Seattle-based health startups and others interested in health innovation to meet and connect with startups and other resources at the UW. We're all trying to break down the silos, so please join us.

Panelists will include executives from 3 companies that recently spun out of UW’s CoMotion Incubator: Deurion, Stasys Medical, and M3 Biotechnology. It will also include regulatory experts who will provide insight and context for companies starting down that pathway. Panelists include:

Daniel R. Baker, Ph.D., Kinetic Research & Design, Inc. Dan has spent the past 15 years consulting for early-phase development companies and starting several medical product companies with roles in research planning, patent and IP strategy, product design, development, and testing. He runs a small consulting firm (Kinetic Research & Design, Inc.) and a small product development firm (Gary-Dan Industries, LLC). He earned a Ph.D. in mechanical engineering at the University of Utah and a post-doctoral position in Orthopaedic Surgery and Mechanical Engineering at the University of Pittsburgh where he was instrumental in establishing their Spine Mechanics Laboratory. He accepted a position at the University of Washington investigating workplace accidents and injuries and subsequent consulting work led to a significant role at a startup spine implant company. He has an Affiliate Faculty appointment in the UW Bioengineering Department where he taught a medical product design course focusing on designing for humans. He is a Certified Professional Ergonomist and regularly reviews for several organizations including the NIH SBIR program and The Spine Journal. Dan’s primary focus remains designing, developing and testing new medical technologies.

Jill Herendeen, PharmD, Senior Director of Regulatory at Pharmacyclics with 15 years of regulatory and clinical experience in oncology/hematology drug and in vitro diagnostics (IVD) development spanning all development phases. Jill joined Pharmacyclics in March 2014 and prior to that worked at ZymoGenetics, a subsidiary of BMS, where she worked as a regulatory lead on a number of oncology immunotherapeutics in early stages of development. Prior to joining ZymoGenetics, Jill worked at Amgen, Inc. in both regulatory and clinical development roles on several oncology therapeutics and hematologic supportive care products covering phase 1 to 4 regulatory development stages and GlaxoSmithKline as a drug development fellow where she worked on a number of clinical pharmacology studies for lapatinib, a small molecule tyrosine kinase inhibitor being developed in metastatic breast cancer. Jill received her PharmD at University of Washington and did her residency and clinical research fellowship training at University of North Carolina at Chapel Hill.

Leen Kawas, Ph.D, is CEO of M3 Biotechnology Inc., a biotech startup that is targeting growth-factor systems with a drug that could reverse the course of neurodegenerative diseases like Parkinson and Alzheimer’s. Leen originally trained as a molecular pharmacologist who started her career as a clinical and retail pharmacist in Amman, Jordan, subsequently trained in the Neuroventure Executive Training program at the Foster Business School which gave her a broad perspective on the drug-development process. While growing the company’s science and licensing the technology out of Washington State University, she was also able to raise more than $2 million from both dilutive and non-dilutive sources, including grants from the National Institute of Health (NIH), Alzheimer’s Drug Discovery and Michael J Fox Foundations, to support development of the therapeutics being advanced in M3, especially MM-201. Her unique scientific and medical knowledge give her the credibility to lead the company in this next research-intensive phase. Jill's goal and passion is entrepreneurship that leads to disease modifying pharmaceuticals that address critical unmet medical needs. As a female entrepreneur with a scientific background, she is committed to mentoring women in science and business and has been selected for programs to inspire women to go into those fields, and was featured a role model for women in a profile recently in a Spokane business magazine.

Erik Nilsson serves as CEO of Deurion, a biotech company developing diagnostic technology. Erik's technical background is in software, concentrating in machine learning applications. His entrepreneurial career spans two decades. His first CEO position was GraphiCode, a Washington company he sold in 1999. Prior to Deurion, he was CEO of Insilicos. Erik is a member of the board of the Washington Biotech and Biomedical Association. He sits on the Executive Committee, and chairs the Government Affairs Council.
Deurion is a biotech company applying mass spectrometry to disease diagnosis and similar research applications. Deurion has commercialized a novel mass spectrometry ionization stage, and is developing new diagnostic tests.

Ari Karchin is the Program Director of Stasys Medical Corp. In this role he is responsible for bringing the team together to align technical and business development goals. Previous to this role, Ari worked at the UW Center for Commercialization evaluating innovations for commercial potential, and assisting with commercialization efforts of UW start-ups. Ari earned a PhD in Bioengineering from the UW, and MS and BS in Biomedical Engineering and Mechanical Engineering, respectively, from UC Davis. He also earned a certificate in Medical Devices & Commercialization from UW Extension. Stasys Medical’s mission is to save lives and reduce healthcare costs by rapidly assessing a patient’s coagulation status. This information will help emergency physicians deliver the proper blood products/drugs and avoid unnecessary transfusions. To accomplish this mission, Stasys Medical is developing a quick and accurate point-of-care device capable of diagnosing coagulopathy in trauma and surgical patients in under 5 minutes.

Venue and Parking

The "CoMotion Incubator" (formerly the Center for Commercialization) is in Fluke Hall, 3rd Floor on the University of Washington Seattle campus.

We have arranged to allow visitors to park at the Padelford Garage, near Fluke Hall. Cost to park is $5.00 after 5:00 p.m.At the Guard House, indicate arranged parking under “Innovators”

Assigned Garage: Padelford Garage (http://www.washington.edu/facilities/transportation/parkinglots) (near Fluke Hall) – Park on Levels N18-N21 only.

Here is a link to the campus map: (http://www.washington.edu/maps/#!/flk)

http://www.washington.edu/maps/#!/flk

Fluke Hall is located on the south end of parking lot N21 and has a large purple banner that says “Idea->Impact” out front. Enter the building and take the elevator or stairs to the third floor where the incubator reception area is located.