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 * Home
 * About Us
   * Services
   * What Our Clients Are Saying
   * A Few Clients We’ve Worked With
   * Careers
 * Leadership
 * Latest Insights
 * Events & Speaking Engagements
 * 


 * Home
 * About Us
   * Services
   * What Our Clients Are Saying
   * A Few Clients We’ve Worked With
   * Careers
 * Leadership
 * Latest Insights
 * Events & Speaking Engagements




HomeCatalystAdmin2020-03-27T21:58:35+00:00
   
 *  
   
   
   
   Helping clients surf ahead of regulatory trends to help shape the environment
   
 * HELPING TO CREATE PATHWAYS
   
   For Innovative Pathways and Payment
   Approaches for New Technologies
   
 * Video:
   Analyzing Innovation’s Progress in the
   Gottlieb Era; Watch Catalyst’s Nancy
   Myers Highlight Key areas of
   Modernization at FDA
   
   
 * STRATEGIC POSITIONING
   
   Lining up Regulatory, Political,
   Advocacy and Reimbursement Efforts
   
 * CREATING NETWORKS
   
 * REGULATORY INTELLIGENCE
   
   Fostering a Better Understanding of
   FDA and Global Regulators
   
 * Video:
   Big Data, Artificial Intelligence and
   Real World Evidence: Watch Catalyst’s
   Nancy Myers Discuss the Technologies
   of the Future
   









   
 * Helping clients surf ahead of regulatory trends to help shape the environment
   
 * HELPING TO CREATE PATHWAYS
   
   For Innovative Pathways and Payment
   Approaches for New Technologies
   
 * Video:
   Analyzing Innovation’s Progress in the
   Gottlieb Era; Watch Catalyst’s Nancy
   Myers Highlight Key areas of
   Modernization at FDA
   
   
 * STRATEGIC POSITIONING
   
   Lining up Regulatory, Political,
   Advocacy and Reimbursement Efforts
   
 * CREATING NETWORKS
   
 * REGULATORY INTELLIGENCE
   
   Fostering a Better Understanding of
   FDA and Global Regulators
   
 * Video:
   Big Data, Artificial Intelligence and
   Real World Evidence: Watch Catalyst’s
   Nancy Myers Discuss the Technologies
   of the Future
   









 * How is the tidal wave of gene therapy innovation causing CBER to evolve?
   Catalyst President Nancy Bradish Myers offers her perspectives in this
   opinion piece in The Pink Sheet.
 * Join Catalyst's Nancy Bradish Myers and FDA's CBER Director, Dr. Peter Marks
   on June 15, 2020 @ DIA 2020 for their panel entitled: Gene Therapy
   Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?




WELCOME TO CATALYST HEALTHCARE CONSULTING, INC.

Catalyst Healthcare is a dynamic, hands-on regulatory affairs and reimbursement
and coverage strategy partner to global innovators, thought leaders, advocates,
investors, payors, providers states and trade groups, helping to speed
innovative health care solutions to market in order to improve lives; patients
are at the center of our work.

With strategic vision, expertise and energy, we work side-by-side with clients
to generate and advance meaningful policy, engagement, communications and
regulatory strategies in order to create opportunities and solutions, while
side-stepping unnecessary challenges. Serving as a Catalyst is what we do best.

We thrive on surfing and anticipating upcoming trends in science, policy,
reimbursement, coverage and identifying opportunities for clients through
regulatory and market intelligence gathering and working with thought leaders.

We take the time to understand our clients’ current needs and their vision of
the future, working within the bounds of their risk tolerance and the resources
at hand.

We are experts in the fields of translating FDA, CMS, State Medicaid programs,
influencing and interpreting regulatory policy and strategic pathways. In
addition, our service offerings include: strategic business advice, strategic
positioning and counsel, and regulatory intelligence gathering and environmental
scans.

Our team prides itself on being nimble, ahead of the curve and well-networked in
DC healthcare policy circles.

We love to with firms of all sizes and stages, from start-ups to the largest
global biopharma companies.

Our US-based and global clients include:

 * Biopharma companies
 * Medical device firms
 * Combination product developers (whose products cross regulatory silos)
 * Digital health companies
 * Cell and gene therapy companies
 * Genomics companies
 * Patient advocacy organizations
 * Nonprofits
 * Trade associations
 * Payors
 * Venture capitalists launching and investing in new companies

We specialize in helping innovators advance important agendas in the most
effective way, with an eye to the future and a goal of building long-term trust.

Click here to learn more about our leadership team.


It is all about the PATIENT. We help clients build both strategies and
relationships with the most influential advocacy groups who are driving policy
and understanding of their diseases.
Data, deep analysis, and carefully curated insights successfully drive strategic
planning and tactical execution: we have the high-level pertinent relationships
and subject matter experience to conduct due diligence and analyze critical
information quickly to inform business decisions.
Market access strategies are critical for both innovative companies and all
types of payors/providers. These strategies can inform regulatory strategies, so
it is vital to consider the shifting reimbursement environment and payor
perspectives. There is a clear nexus between regulatory and reimbursement
pathways; we leverage members of our Team and Expert Advisor Network to help
clients develop holistic strategies that integrate and optimize their
reimbursement and regulatory opportunities.
Engaging optimally with trade associations and like-minded engaged interest
groups allows a company to leverage outside resources and expand its influence
and policy footprint. We help clients prioritize policy objectives, identify
allies and ultimately fully leverage outside groups to accomplish strategic
objectives.
The current regulatory environment is constantly shifting, especially for
innovative technologies. Frequently, pathways through the FDA are not clear—or
no appropriate pathway exists at all. We help clients navigate the FDA; we
leverage our experience with the agency and our understanding of regulators’
needs to create solutions that help both our clients and the agency. We provide
strategic thinking and lay the groundwork to help pave the way for FDA
engagement.
Understanding the legislative landscape is critical when developing regulatory
strategies. Although we are not registered lobbyists, we help clients think
through the legislative environment in which regulators operate—in addition to
analyzing new regulatory mandates that may be coming down the pike from
Congress.
Identifying allies and working effectively with thought leaders in policy,
academia, think tanks, and in political circles is key to maximizing
opportunities, given the many players converging to form emerging health policy.
We facilitate collaboration and networking opportunities across the healthcare
spectrum: between and among industry, patient and consumer advocacy groups,
professional organizations and academics.
Effective engagement in the regulatory policy environment depends on having the
right messages to deliver at the right time to the right audience. We develop
communications strategies, including specific message development, to help
advance our clients’ objectives.
With the vast array of stakeholder voices involved in health policy, we are here
to ensure your voice is heard. We create policy options that support our
clients’ objectives, and try to help identify and align common interests with
those of FDA or other federal agencies.





CATALYST NEWS

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CatalystAdmin2020-03-26T22:33:07+00:00

GENE THERAPY OPINION PIECE – THE PINK SHEET: SCIENTIFIC WAVE PUSHES CBER INTO
BRIGHTER LIGHT

CatalystAdmin2020-03-26T22:33:07+00:00March 26th, 2020|Comments Off on Gene
Therapy opinion piece – The Pink Sheet: Scientific Wave Pushes CBER Into
Brighter Light

The Pink Sheet Scientific leaps forward have opened the floodgates of interest
and investment in gene therapy. As the tidal wave of gene therapy innovations
approaches, the time is right to take a look at [...]

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CatalystAdmin2020-02-20T21:25:12+00:00

ORIGINAL MEDICAID FAVORS BRAND INSULIN; MANAGED CARE FAVORS GENERICS

CatalystAdmin2020-02-20T21:25:12+00:00February 20th, 2020|Comments Off on
Original Medicaid Favors Brand Insulin; Managed Care Favors Generics

Inside Heath Policy highlights new study showing how states continue to use
branded insulin despite cheaper and equally effective options. Jeff Myers,
Catalyst Senior VP of Market Access and Reimbursement Strategies, explains how
the Medicaid [...]

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CatalystAdmin2019-11-11T21:55:42+00:00

STEPHEN HAHN FOR US FDA COMMISSIONER: WILL ACADEMIC EXPERIENCE SUFFICE FOR
CONFIRMATION?

CatalystAdmin2019-11-11T21:55:42+00:00November 11th, 2019|Comments Off on
Stephen Hahn for US FDA Commissioner: Will Academic Experience Suffice for
Confirmation?

The Pink Sheet Commenting in an article on the recent nomination of MD Anderson
Cancer Center’s Stephen Hahn as FDA Commissioner, Catalyst President Nancy
Bradish Myers says that the wide depth and breadth of the [...]

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CatalystAdmin2019-05-24T19:00:47+00:00

FDA AFTER GOTTLIEB –CATALYST PRESENTATION ON THE FUTURE OF FDA

CatalystAdmin2019-05-24T19:00:47+00:00May 24th, 2019|Comments Off on FDA After
Gottlieb –Catalyst Presentation on the Future of FDA

Healio and MM&M May 22, 2019 What lies ahead for FDA under Acting Commissioner
Ned Sharpless? This article in Healio covers a presentation by Catalyst
President Nancy Bradish Myers at the May 22 Coalition for [...]




EVENTS


CatalystAdmin2018-04-11T19:05:13+00:00

CATALYST TO SPEAK ON FDA & INNOVATION, MARKET TRENDS AFFECTING THE FUTURE OF
HEALTH CARE, AND RWE IN DRUG DEVELOPMENT

CatalystAdmin2018-04-11T19:05:13+00:00Comments Off on Catalyst to Speak on FDA &
Innovation, Market Trends Affecting the Future of Health Care, and RWE in Drug
Development

Catalyst Healthcare Consulting will be speaking at a number of events this
spring and summer. Come join us as we explore some of the key issues [...]

CatalystAdmin2018-05-24T23:23:32+00:00

THE IMPACT OF NEW FDA LEADERSHIP: CATALYST TO SPEAK AT BIOTECH SHOWCASE
CONFERENCE

CatalystAdmin2018-05-24T23:23:32+00:00Comments Off on The Impact of New FDA
Leadership: Catalyst to Speak at Biotech Showcase Conference

Come and join us on Jan. 8 as Catalyst President Nancy Bradish Myers speaks as
part of a panel on “The impact of new leadership and [...]

CatalystAdmin2018-02-13T21:39:33+00:00

DIGITAL MEDICINE: CATALYST TO SPEAK AT DIGITAL MEDICINE & MEDTECH SHOWCASE

CatalystAdmin2018-02-13T21:39:33+00:00Comments Off on Digital Medicine: Catalyst
to Speak at Digital Medicine & MedTech Showcase

Join us on Jan. 9 as Catalyst President Nancy Bradish Myers speaks as part of a
panel entitled “Once the train has left the station, is [...]




BLOG POSTS

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CatalystAdmin2018-05-24T18:28:04+00:00

RWE AT THE TIPPING POINT: FROM REGISTRIES TO ARTIFICIAL INTELLIGENCE, RWE IS
POISED TO ACCELERATE MEDICAL PRODUCT DEVELOPMENT

CatalystAdmin2018-05-24T18:28:04+00:00May 24th, 2018|Comments Off on RWE at the
Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to
Accelerate Medical Product Development

By Anne McNickle This is an exciting time for those of us interested in RWE
development. Digital technologies and advanced computing capabilities are
enabling the generation of RWE continuously, and from sources that have
traditionally [...]

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CatalystAdmin2018-05-24T15:14:57+00:00

ARTIFICIAL INTELLIGENCE (AI): COMING TO A POLICYMAKER NEAR YOU

CatalystAdmin2018-05-24T15:14:57+00:00April 2nd, 2018|Comments Off on Artificial
Intelligence (AI): Coming to a Policymaker Near You

By Nancy Bradish Myers It’s as if Artificial Intelligence just reached the DC
area and policy makers need to think about it. Software companies, academic
institutions and innovative companies hoping to develop and harness the [...]

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CatalystAdmin2018-05-24T19:38:33+00:00

DIGITAL HEALTH: NEW LAW ENCOURAGES TELEHEALTH SERVICES FOR MEDICARE PATIENTS

CatalystAdmin2018-05-24T19:38:33+00:00February 9th, 2018|Comments Off on Digital
Health: New Law Encourages Telehealth Services For Medicare Patients

By Nancy Bradish Myers As Congress moved to keep the doors open for the federal
government, it also swept in changes to advance the use of telemedicine for
Medicare patients. These are exciting changes that [...]

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CatalystAdmin2018-05-24T19:41:26+00:00

DIGITAL MEDICINE IS HERE: WHY THE COMBINATION OF ABILIFY AND PROTEUS’ INGESTIBLE
SENSOR IS “SWEET”!

CatalystAdmin2018-05-24T19:41:26+00:00November 14th, 2017|Comments Off on
Digital Medicine is Here: Why the Combination of Abilify and Proteus’ Ingestible
Sensor is “Sweet”!

By Nancy Bradish Myers Yahooooo! What a thrill it is to finally have the first
digital medicine approved by the FDA: Abilify Mycite (aripiprazole + Ingestible
Event Marker). When I visualize it, it’s like the [...]





RECENT TWEETS

Nancy Bradish MyersFollow


Nancy Bradish Myers@FDAinsightguru·
6 Apr


We need leadership from every corner --but it is critical to ensure FDA &
reviews do not become a tool of Politics! FDA must maintain its credibility so
people trust the treatments recommended by their MDs. #FDA #COVID @SteveFDA
@realDonaldTrump @scottgottiebMD


Retweet on TwitterNancy Bradish Myers Retweeted
Dan Diamond@ddiamond·
2 Apr


Alternate explanation for why Fauci needs a security detail
https://twitter.com/nypost/status/1245782619075330050


Nancy Bradish Myers@FDAinsightguru·
26 Mar


Can #CBER #FDA surf ahead of the wave of gene therapies barreling its way? Read
my op-ed for insights. #genetherapy
https://pink.pharmaintelligence.informa.com/PS141927/Scientific-Wave-Pushes-CBER-Into-Brighter-Light


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RECENT TWEETS

CatalystHCConsultingFollow

Catalyst Healthcare Consulting, Inc.: a strategic policy ®. affairs advisory
firm helping cutting-edge companies chart the best paths fwd. #HHS #FDA experts.


CatalystHCConsulting@Catalyst_HC_C·
27 Mar


Surf’s up! 😎☀️ Catalyst Healthcare Consulting's @FDAinsightguru weighs in on
how the FDA is preparing to ride the gene and cell therapy wave 🌊 in a
@PharmaPinkSheet op-ed:
https://pink.pharmaintelligence.informa.com/PS141927/Scientific-Wave-Pushes-CBER-Into-Brighter-Light
#FDA #CBER #GeneTherapy


CatalystHCConsulting@Catalyst_HC_C·
3 May


Congratulations to @realrickpazdur for winning the 2019 Dr. Harvey Wiley Lecture
Award for his visionary leadership in oncology! Nancy Myers presented the award
on behalf of the FDA Alumni Association. FDLI#annual19


CatalystHCConsulting@Catalyst_HC_C·
29 Apr


Although digital medicines http://ow.ly/T0Wq30ozJlE may not be the right
solution for everyone, in some cases, it may be very important to patients'
health to make sure they are taking their medicines as prescribed.


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MEDIA INQUIRIES:

Phone: 323-868-5827
Email: Anne McNickle



CAREERS

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Inc.


© 2020 Catalyst Healthcare Consulting
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