Loading…
Attending this event?
12: Value-Access [clear filter]
Monday, June 17
 

11:00am PDT

#114: Breaking Boundaries: Overcoming Policy Crosstalk and Globalization Barriers to Foster Innovation
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-528-L04-P; CME 1.00; RN 1.00

We all want to see innovation in treatments and prevention that meets the many unmet needs of patients globally. And yet, despite this compelling goal, the complexity and uncertainty involved in delivering innovation has baffled policy makers, regulators, healthcare systems and companies at every step of the process. The response has been to establish policies and requirements to “direct” innovation to best effect. The result has been a confused environment where crosstalk of policy measures and requirements collectively and often constrain, rather than enable, innovation.

In this forum, we are going to aim to take a more holistic framing of the drive for innovation and explore three recent cases where policy crosstalk risks frustrating innovation.

Learning Objectives

Explore how various legislative and other policy-related initiatives, including some not directly targeting the industry, are threatening the climate for development of innovative products.

Chair

Virginia Acha, PhD, MSc

Speaker

Policy Cross-Talk Case Study: Clinical Research
Karen A Noonan, MA

Policy Cross-Talk Case Study: Supply Chains and Resilience
Christopher Colwell, MPA

Policy Cross-Talk Case Study: Pricing and Access Policies
Duane Schulthess, MBA



Speakers
avatar for Virginia Acha

Virginia Acha

AVP, Global Regulatory Policy, Merck Sharpe & Dohme LLC , United States
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better... Read More →
CC

Christopher Colwell

Vice President, International Government and Regulatory Affairs, US Pharmacopeia, United States
Chris Colwell is Vice President, International Government & Regulatory Affairs at the United States Pharmacopeia (USP). He leads a team that develops USP’s position on public policy and regulatory affairs issues related to its mission to improve global health through public standards.Chris... Read More →
avatar for Karen Noonan

Karen Noonan

Senior Vice President, Global Regulatory Policy, Association of Clinical Research Organizations (ACRO), United States
Karen joined the Association of Clinical Research Organizations (ACRO) in 2014. Founded in 2002, ACRO represents the world’s leading clinical research and technology organizations. In her role as Senior Vice President of Global Regulatory Policy, she leads ACRO’s global regulatory... Read More →
avatar for Duane Schulthess

Duane Schulthess

Chief Executive Officer, Vital Transformation LLC, United States
Duane Schulthess is the CEO of Vital Transformation, an economics consultancy in Brussels, Belgium and Washington, DC. He is a member of the U.S. Congressional Health Care Task Force, and the Executive Producer of the Vital Health Podcast, ranked in the top 30 healthcare podcasts... Read More →


Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  12: Value-Access, Forum
 
Tuesday, June 18
 

10:00am PDT

#229: Clinical Trial Enrollment Diversity: Why and How to Engage Community Health Centers
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-580-L04-P; CME 1.00; RN 1.00

Minority access to clinical trials is an ongoing challenge. Community Health Centers (CHCs) can support linking these populations to studies. This session shares results from a national CHC survey that informs about needs and perceptions that can help increase participation.

Learning Objectives

Describe how to distinguish Community Health Centers (CHCs) from other types of healthcare organizations; Discuss results from a grant that surveyed 40 CHCs nationwide about their perceptions and needs related to clinical trials; Evaluate options for CHCs to be involved with supporting clinical trial and diverse enrollment.

Chair

Pete Fronte, MBA

Speaker

Industry Update
Karen Correa, PhD

Community Health Care Update
James Schultz, MD, MBA, FAAFP

Patient Update
Mario DuCre



Speakers
avatar for Pete Fronte

Pete Fronte

President and Chief Executive Officer, Altura, United States
Pete Fronte, MBA is President/CEO of Altura. During the past 30 years Mr. Fronte has been a leader in developing technology and services to expand clinical study participation for patients and building quality-based research centers within health systems and community health centers... Read More →
avatar for Karen Correa

Karen Correa

Vice President, Head of Global Clinical Operations, Takeda, United States
Dr. Karen Correa is the Vice President, Head of Global Clinical Operations at Takeda; where she is responsible for the advancement of the portfolio and execution of global clinical trials. Her 30 years of clinical research experience cover a large range of settings and venues including... Read More →
avatar for James Schultz

James Schultz

Chief Medical Officer, Neighborhood Healthcare, United States
MD

Mario DuCre

Patient, United States


Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  12: Value-Access, Forum
 
Wednesday, June 19
 

8:00am PDT

#313: The Future of Women’s Health: Do We Really Want Innovation? Policy Ideas To Advance Innovation, Access, and Novel Approaches
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-634-L04-P; CME 1.00; RN 1.00

There is a critical need for innovation in women’s health, particularly maternal health. What will it take to improve care in this area? How can innovative regulatory, reimbursement and access policies encourage novel approaches to women’s health?

Learning Objectives

Identify areas of women’s health which face barriers preventing innovation; Describe disparities in women’s/maternal health and existing regulatory, payment and access policies intended to improve outcomes; Evaluate the types of policy changes needed to encourage innovation

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Panelist
Lynne Yao, MD

Panelist
Tara Croft, MBA

Panelist
Sandy Milligan, JD, MD



Speakers
avatar for Nancy Myers

Nancy Myers

CEO and Founder, Catalyst Healthcare Consulting, Inc, United States
Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 19 years and has been active in the DC policy arena for three... Read More →
avatar for Tara Croft

Tara Croft

Chief Executive Officer, Baymatob, Australia
Tara is a passionate advocate for womens health and technology. A MedTech expert with 20 years industry experience, Tara is the CEO of Baymatob, a female-founded, female-led, early-stage business aiming to improve and save the lives of mothers and their babies, by developing an AI-enabled... Read More →
avatar for Sandy Milligan

Sandy Milligan

Board of Director Member, Gossamer Bio; Principal, Innovex Strategies, United States
Sandy Milligan is President of Aspira Women's Health, working to transform women’s gynecological health through the development and commercialization of innovative testing options. Previously, Sandy was the head of Research and Development at Organon, focused on improving the everyday... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →


Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  12: Value-Access, Forum
 

Filter sessions
Apply filters to sessions.