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BioArbor May 2018 at MGCS
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A very special BioArbor hosted at the 2018 Michigan Growth Capital Symposium

5/16/2018
When: Wednesday, May 16, 2018
11:30am - 12:30pm
Where: Ann Arbor Marriott Ypsilanti at Eagle Crest
1275 S Huron
Auditorium II
Ypsilanti, Michigan  48197
United States
Contact: Kate Oesterle
734-527-9147


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BioArbor May 16, 2018 at the
2018 Michigan Growth Capital Symposium

 

Building Product Value: Clinical, Regulatory and Reimbursement Strategies to Impact Commercial Success

 

Today’s product pipelines increasingly face barriers within a complex healthcare economics landscape. From new financial drivers to varying reimbursement models to detailed regulations, the ever-changing environment can greatly impact a product’s market potential and viability. Learn from the experts as they discuss how to evaluate and design the most effective clinical, regulatory and reimbursement strategies early in the product development process that will be essential for downstream commercial success. 

 

Moderator:

 

Mona Patel
VP Clinical Training & Fellowship Education
Boston Scientific

Mona Patel is the vice president for clinical training and fellowship education for the Neuromodulation Division of Boston Scientific. In her role, she is responsible for the training and education of clinicians in the use of Boston Scientific spinal cord stimulator products. She previously served as the division’s vice president of marketing where she launched the first rechargeable spinal cord stimulator. Prior to joining Boston Scientific, Mona spent eight years in Guidant’s Cardiac Surgery Division. She was a key member of the team that introduced a novel procedure, endoscopic vessel harvesting, which now has become standard of care in cardiac surgery. She earned a BS in Mechanical Engineering from the University of Michigan and an MBA from the University of Pennsylvania, Wharton School of Business.

 

 

 

Confirmed Panelists:

 

Kay Fuller, RAC

President, Medical Device Regulatory Solutions
VP, Regulatory & Clinical Affairs / Rindex Medical, Inc.


Ms. Fuller has more than 39 years experience developing and commercializing complex cardiovascular and neurosurgical medical devices. She has led successful global clinical studies and regulatory marketing authorization submissions for more than 38 Class II & Class III medical devices and combination products, via the U.S. FDA IDE, IND, 510(k), PMA and E.U. CE mark processes, which have enabled over $5B in global medical product sales. She founded MDRS, LLC, a national regulatory consulting firm that specializes in providing strategic FDA and global regulatory, quality and clinical research support to biotechnology companies. A seasoned regulatory executive, advisor and author, Kay has guided many organizations toward gaining FDA enforcement action resolutions, including those associated with FDA 483 Observations, Warning Letters and Consent Decrees. A frequent Regulatory Sciences guest speaker at UM and nationally, Kay was a member of the UM Coulter Translational Partnership Program Technical Oversight Committee and a founding member of the National NIH CTSA Regulatory Working Group IND/IDE Support Taskforce during her tenure at UM’s Medical School. Kay has held regulatory, quality, clinical and R&D positions of increasing responsibility with global medical device companies, including W. L. Gore & Associates, P-S Medical (acquired by Medtronic), C. R. Bard, Terumo Corporation, Cohera Medical, Tangent Medical and Rindex Medical. Kay is the primary inventor on two patents and received her undergraduate degree in Veterinary Technology from Texas State Technical College and is board certified in medical device and pharmaceutical regulatory affairs.

 

 

Jennifer Mischke
Global Vice President of Consulting Services
NAMSA

Jennifer Mischke has been supporting medical device, combination product, IVD, and drug development for almost 20 years. Trained as a biostatistician, her focus has been on efficient and effective study design and interpretation of data. At NAMSA, Jennifer serves as Global Vice President of Consulting Services, leading a global organization which includes the departments of regulatory consulting, quality systems and compliance, biological safety, sterilization and validation consulting, medical writing, project and program management, and a high-level, cross-functional team of scientists that focus on product development and translational research.

 

 

Seth Reno
Chief Commercial Officer
Gemphire Therapeutics

Mr. Reno serves as our Chief Commercial Officer and has over 25 years of experience in the Bio-Pharmaceutical industry. He has extensive experience in building commercial capabilities to successfully commercialize both small and large molecules across a range of therapeutic areas including the cardiovascular market. Prior to joining Gemphire, he spent five years at Medimmune building commercial teams and capabilities that focused on launching complex biologics such as Mylept and Lynparza with orphan designation status into rare disease markets. As Medimmune’s Head of Commercial Operations he was responsible for leading core business functions across: Sales Operations, Marketing Operations, Market Research, Fleet Services, Sales Training, Commercial Insight, Advanced Analytics and Forecasting. Mr. Reno spent ten years at AstraZenca across a number of roles in Sales, Commercial Operations, Managed Markets and Brand Team. He led the Commercial Insight’s team for the dyslipidemia franchise, most notably the successful launch of Crestor’s atherosclerosis indication. He also led the insight work for several mixed dyslipidemia fixed dose combinations in development with industry partners. Prior to Joining AstraZeneca in 2001, Mr. Reno Spent eleven years at Wyeth in commercial operations and sales account management successfully building B2B relationships across Federal, Trade, Military and Commercial accounts. Mr. Reno holds a B.S. in Human Resources from University of Delaware and a MBA from Strayer University.

 

 

 

Randel E. Richner, BSN, MPH
Senior Advisor, Boston Biomedical Associates

Richner Consultants, Inc.

Randel has over 30 years’ experience working in health policy, reimbursement, economics, and data analytics for health service, technology and pharmaceutical companies. She presently serves as a Senior Advisor to Boston Biomedical Associates, a leading regulatory and clinical consulting firm in Marlborough, MA. She recently completed a Senior Advisory role at Avalere, a prominent health policy consulting firm in Washington DC. From 2006 to 2013, she successfully founded and sold The Neocure Group, a company providing data analytics, health economics, reimbursement strategic services for biotech, technology, pharmaceutical industry to Intralign, LLC, a company focusing on orthopedic episodic service delivery models for hospitals in the US. Previously, for 9 years she was Vice President, Global Government Affairs, Reimbursement, Boston Scientific Corporation (BSC), establishing the global reimbursement and economics function, expanding to national/international medical device legislative and regulatory, tax, and trade issues.

Richner has been actively engaged in policy initiatives with US Congress and CMS for many years, serving a four-year term as the first industry representative, Executive Committee (EC) Medicare Coverage Advisory Committee (MCAC), developing national coverage guidelines, reappointed 2007. She currently serves on Executive Dean's Advisory Board, University of Michigan’s School of Public Health, Board of MassMedic, founder of MassMedic Women in Medtech, and was recently appointed to the Medical Device Industry Consortium (MDIC), serving on the committee for commercial payer/FDA parallel review processes. She served as a Board Member of International Society of Pharmacoeconomics and Research (ISPOR), was founder of the US Medical Device Council of ISPOR, and Asia-Pacific Medical Device Council. She has served on Institute of Medicine (IOM) special committee on cost-effectiveness/post-market surveillance; American Institute of Medical and Biological Engineers (AIMBE); National Institute of Health Commercialization  Program (NIH-CAP) Advisor; Executive Advisory Board, Center for Evaluation Value, Risk in Health (CEVRH) Tufts New England Medical Center. She is an invited executive lecturer at Dartmouth, Tuck School of Business, University of Michigan School of Engineering and Pharmacy and was recently appointed as a Griffith Leadership Fellow at the University of Michigan School of Public Health.

Richner is active in national and regional forums concerning mental health issues in children and adolescents.

Randel has a Master’s degree in Public Health Policy and Administration from the University of Michigan, and was a practicing dialysis and transplant nurse for 12 years at the University of Michigan Hospital and Northern Michigan Hospital.

 

 

The panel is open to the public and for a fee of $30 attendees may also register and immediately after the panel attend the closing MGCS networking lunch!


STEP 1: Click the green 'Register' button to attend the May BioArbor (Free!)

 

STEP 2: Register and pay online for the MGCS networking lunch: $30:
Click the 'Register' tab, On the form under 'Registration Type', please select 'Coulter Foundation Member / Guest' for $30.00.

 

 *Please note: BioArbor attendees who wish to attend the MGCS networking lunch must register/pre-pay online. On-site payments the day of the event can not be accepted.

BioArbor registration/name badges will be available outside of Auditorium II

 

 

 

 

Creating Value
by delivering business-critical resources & bottom line savings
Building Networks
by connecting Michigan's bio-industry one member at a time
Growing Talent
by creating opportunities that develop people & build organizations
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