About Saira Sultan, JD
PRESIDENT & CEO, CONNECT 4 STRATEGIES
Run successful consulting company serving a wide range of clients from patient and provider groups to life science, device, and diagnostic companies
Established and led a coalition of ultra rare patient organizations
Led reimbursement efforts for over a decade at Pfizer and Sanofi, working collaboratively with commercial, medical and market access teams.
Former Director of Patient Advocacy and Provider Organization Partnerships
Strengthened and led Government Affairs, Policy, and Reimbursement function at ACCC, and served as Association spokesperson
Chief Counsel for Senate subcommittee with jurisdiction over healthcare issues
Represented Medtronic during significant Medicare reimbursement overhaul
Biography
Saira Sultan has represented corporate, nonprofit, and government interests in the legislative and regulatory health policy arena for more than 20 years in Washington, D.C. She has had repeated success in designing business solutions by identifying and creating advocacy opportunities and translating them into strategic legislative and regulatory results.
Saira brings a decade of experience working with market access, health outcomes, and commercial teams in pharmaceutical companies, including Pfizer and Sanofi. Saira is an experienced project management lead for large cross-functional efforts at Medtronic, Pfizer, Sanofi, and more.
Focusing in areas such as oncology, rare and extremely rare therapies, vaccines, and specialty products in sickle cell, pain, addiction, cell and gene therapy and more, Saira has worked extensively with CMS, FDA and Capitol Hill. Her insight and skill in working cross-functionally in a corporate environment, as well as with advocacy organizations and key trade associations serves her clients well. Saira's leadership at the Association of Community Cancer Centers (ACCC) allowed her to build strong relationships with the oncology community and gain insights into the evolution of oncology care. She continues to work closely with many oncology organizations, identifying emerging trends that have led to repeated success in tackling coverage, coding and payment of marketed and pipeline Part B and D products. The Government Affairs and Policy team at ACCC, under Saira's direction, raised significant revenue, improved the Association's profile, as she became a sought after speaker on oncology policy issues.
Complementing her 10 years in pharmaceuticals, Saira's time at Medtronic gives her an in-depth understanding of the unique needs of the device industry. Representing Medtronic at a time when CMS was completely revamping device reimbursement in hospital outpatient departments, gave her the opportunity to work closely with CMS and key stakeholders. Saira built a successful coalition of varied stakeholders that ensured reimbursement for Class III devices reflecting their value to patients.
Additionally, Saira brings House and Senate experience, including work on the Ways and Means Committee, and roles as senior legislative counsel for Senator Mike DeWine (R-OH) and Chief Counsel to one of the Senate Healthcare Subcommittees. She handled all healthcare issues under the Senate HELP Committee's jurisdiction, including extensive negotiations with FDA and industry on the Balanced Budget Act of 1997 and the first reauthorization of the Prescription Drug User Fee Act. She spearheaded passage of the first Better Pharmaceuticals for Children.
Saira holds a JD from the University of Virginia in Charlottesville, VA.
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M Kay Scanlan, JD
Senior advisor
M Kay Scanlan has 20 years of health policy and reimbursement experience. As an HHS Office of General Counsel attorney representing CMS (then, HCFA), Kay has worked on a wide array of regulatory issues and policy initiatives, earning the Administrator’s Award for Excellence in connection with her leadership on the Agency's clinical laboratory test negotiated rulemaking team. Following her work in the Office of General Counsel, Kay joined Arnold & Porter, where she was instrumental in delivering the creative strategies and high rates of success necessary to build a strong reputation for the Firm’s new Healthcare Group.
Kay's expertise extends from preclinical stage landscape analyses, through launch planning, regulatory impact analyses, strategy development, and Agency communications. Her understanding of CMS’ processes, interests and goals fits Connect 4's vision of ensuring clients not only get strategies that resolve their concerns, but are designed to be win for both client and agency. Clients appreciate this qualitative edge in a competitive market.
Kay received her J.D. from the University of Maryland where she subsequently served as an Adjunct Professor of Law, teaching healthcare law and Medicare and Medicaid policy.
Kathleen Shoemaker, PharmD, MBA, CPHIMS
senior Advisor
Dr. Kathleen Shoemaker has over 20 years of experience working on payer strategies, outcomes research, quality measures, registries and Health IT. Health care delivery across pharmacy and Medicare Advantage have been a particular focus. Most recently, Kathleen led Strategic Alliances for Premier, where she provided business development and sales support for professional medical societies, associations, and medical schools using Premier's technology solutions for registry, reporting, learning management, and other services to meet strategic quality, research, and education goals. Kathleen managed top-tier Premier clients while successfully meeting an annual multi-million dollar sales target.
Before Premier, Kathleen was at the American Heart Association, where she was responsible for the strategic Health IT, quality measures (including PROMs), data, and registry development direction for AHA's quality and credentialing programs suite. In addition, Kathleen supported the association’s grant writing and funding efforts.
Kathleen came to AHA from Eli Lilly, where she engaged national quality organizations, payers, and employers. She developed government payer strategies for Medicaid and Medicare Parts C and D. She also led projects focused on Medicare Part B, quality measures, HIT strategy, and payment models.
Kathleen is a past Managed Care Pharmacy director and clinical manager at regional health plans, where she set up specialty drug benefits, managed formularies, negotiated drug rebates, set up and supported physician detailing, actuarial group ranking, MACs, and ran RFPs for PBM services. She also supported the HEDIS process for the plan. As a pharmacist, Kathleen has practiced extensively in both hospital and retail pharmacy as a pharmacist and immunizer.
Kathleen Shoemaker has a Doctor of Pharmacy from the University of Illinois, a master's degree in Business Administration from Eastern Illinois University, and a bachelor's degree in pharmacy from North Dakota State University. She is certified in Comparative Effectiveness Research and is a Certified Professional in Health Information Management (CPHIMS). She has published and presented in state and national venues.
Jami S. Earnest, PharmD, MS, BCPP
Scientific Strategy for Patient Access and Healthcare Quality Expertise
Jami Earnest has over 25 years of commercial experience creating and leading scientific strategies that ensure patient access to new medications and novel treatments. As a senior leader for the United States Pharmacopeia (USP), Jami led the teams that created healthcare quality standards used in federal and state regulations for pharmaceutical manufacturers, healthcare settings, healthcare providers and payers. Her extensive interagency work with FDA, CMS, FDA, NIH, and other federal agencies earned her the FDA Commissioner’s Award for Sustained Contributions. Prior to USP, Jami served as a Scientific Director for Johnson & Johnson, where she launched over twelve pharmaceutical products and supported four blockbuster franchises through her role on brand teams and leadership of field-based medical and outcomes support services.
Jami’s expertise spans from pre-clinical landscape analyses through launch and lifecycle management, bringing the medical and scientific perspective to optimize market access and product marketing. Bridging science-to-policy from the medical perspective, Jami’s experience has led to successful market access for novel drugs, innovative dosage forms, new technologies, and first-to-market specialty pharmacy products—all with unique patient access challenges.
Jami holds a PharmD from the University of Maryland, MS in Healthcare Quality and Safety from the Thomas Jefferson School of Population Health, and board certification as an advanced practice pharmacist.
Cara Tenenbaum, MBA, JD
Regulatory/Advocacy Advisor
Cara Tennenbaum brings almost two decades of advocacy as well as regulatory and health policy experience to Connect 4 Strategies. Cara recently spent six years at the FDA, working in both the Office of External Affairs in the Commissioner’s Office and the Office of the Center Director in the Center for Devices and Radiological Health. There, Cara worked on issues at the intersection of policy, legislation, and advocacy, helping further the Agency’s agenda with patient and provider groups.
Prior to that, she headed up policy and government affairs for a small but active non-profit focusing on women’s health. This included both authorizing and appropriations work, drafting and presenting testimony, preparing regulatory comment letters, and working with all operating divisions of HHS. She also served as spokesperson for the organization, appearing on national and international TV as well as in print.
She holds a JD and MBA from Case Western Reserve University and a BA in Economics from the University of Maryland, College Park.
“The most difficult thing is the decision to act, the rest is merely tenacity. The fears are paper tigers. You can do anything you decide to do. You can act to change and control [the laws or regulations that impact your patients or govern your business]; and the procedure, the process is its own reward.” ”