Events

This webinar will discuss the importance of creating Target Product Profiles (TPPs) early in the product development stage and will provide several example profiles. The presentation will also include clinical trial design considerations at each phase of clinical development and will present examples of common mistakes at each phase, from real-world examples. Mitigation of issues and reduction of development time will also be discussed.

Dr. Mark Levi is a Director of Regulatory Affairs at RTI International with 20 years' experience in medicinal chemistry, pharm/tox, and CMC with a 9-year tenure at the FDA in NCTR and CBER. He has also consulted and worked at a late-stage biotech.

Dr. Elizabeth Mannick is a Director of Regulatory Affairs at RTI international as well as a pediatric gastroenterologist who was a clinical reviewer at FDA/CDER and a safety physician and regulatory affairs specialist for multinational, public, pharmaceutical companies.

What is a pre-IND? Why have a pre-IND? What goes into preparing for a pre-IND? And, what documents are required? All of these questions and more will be answered in this webinar presented by Dr. Carmella Moody, a regulatory affairs specialist at RTI International. Dr. Carmella Moody brings her expertise in regulatory affairs and the development of small molecules to the Catalyze program, where she serves as a technical project lead. In this 1-hour webinar, Dr. Moody will explain the process of preparing and approaching an effective pre-IND meeting, but also what to expect from FDA feedback and how to incorporate it into your project to ultimately save time and money.

Presenter Carmella S. Moody, Ph.D. is a Regulatory Program Director at RTI; she has more than 33 years of experience developing small molecules, large molecules (biologic), and combination products with emphasis in product development and regulatory affairs.

This presentation will focus on developing therapeutics from a Chemistry, Manufacturing, and Controls (CMC) perspective. Information will be provided regarding important considerations to keep in mind during development and an overview of data included in the CMC section (Quality Section) for early phase IND submissions.

Join presenter F. David Rothkopf, President, and Founding Managing Partner of MEDIcept, Inc., who will guide you to a better understanding of feasibility design control in the development and regulatory control of medical devices. Feasibility studies are a critical early step for evaluation of a medical device. This presentation is meant to be accessible to the academic and small business innovator, spanning different stages of device development. David has over 35 years of professional experience in technical and hands-on applications in a variety of regulatory, compliance management, and quality processes. In this webinar, you will gain insights into the FDA's review process, the type of controls the FDA is looking for in the feasibility stage and managing risks in feasibility studies. Time will be allotted for questions and answers.

After 12 years working for the FDA and personally evaluating over 1,000 medical technologies, Mr. Kwame Ulmer is ideally positioned to share insights on the process of approaching the FDA as a MedTech innovator. In this educational webinar, Kwame will provide an introduction to the FDA and regulatory issues, tailored to innovators that have not reached the FDA previously. He will also provide practical tips for digesting, distilling, and understanding guidance documents for engaging the FDA as a MedTech innovator.

Presenter Kwame Ulmer brings nearly twenty years of experience evaluating medical technologies in the government and serving in senior operating roles at medical device companies. He is currently an Entrepreneur-in-Residence at NHLBI and an active MedTech executive, lecturer, and researcher.

Presenter Diane Earp has 25 years of experience working in regulatory affairs and quality assurance with expertise in the U.S. and international regulatory requirements applicable to biologics and medical devices development, testing/validation, manufacturing, and distribution.

This presentation will provide a general overview of the medical device landscape for a sound regulatory plan/strategy and explain how it can provide a competitive edge for product development. Additionally, the speaker will provide a list of reference material and briefly discuss the evolving framework for new devices and combination product clearance/approval by the US FDA.

Catalyze Office Hours are an open opportunity for anyone engaged or interested in translational science to informally connect with several members of the Catalyze technical team.

Come with questions about the Catalyze program or product development, topics for discussion, or simply drop in to listen to the conversation!

Catalyze has a coordinated and comprehensive array of activities and support services which are personalized to meet participants' individual needs. The Catalyze Coordinating Center works with investigators to develop individualized, milestone-driven pathways to success. In addition to funding opportunities, Catalyze has a network of experts who share best practices, provide technical assistance, offer advisory services, and conduct entrepreneurial education and training. The Catalyze network includes experts in regulatory affairs, product development, preclinical study design, pharm/tox, commercialization, and many other areas that help bring products to market.

Members of the Catalyze technical team that will be present to engage with you are:

• Mike Pieck, Scientific Director of the Catalyze program at the National Heart, Lung, and Blood Institute (NHLBI).
• Diana Severynse-Stevens (pharmacology/regulatory), Catalyze Coordinating Center Project Director with more than 25 years' experience in product development, including work in drug discovery, preclinical and clinical drug development.
• Sudie Rowshan (CMC/project management), Catalyze Coordinating Center Project Deputy Director with 25 years' experience in product development and program management within the pharmaceutical industry.
• Sharon Daily (toxicology/regulatory), Catalyze technical lead with more than 20 years' experience in the pharmaceutical industry specializing in regulatory strategy of nonclinical safety programs for drugs and biologics.
• Diane Earp (biologics/device regulatory), Catalyze technical lead with 25 years' experience working in regulatory affairs and quality assurance with expertise in U.S. and international regulatory requirements applicable to biologics, and medical device development, testing/validation, manufacturing, and distribution.
• Greg Gatto (pharmacology/regulatory), Catalyze technical lead with more than 14 years' experience in the pharmaceutical industry and extensive experience in project management leading scientific research programs from discovery to IND.
• Mark Levi (CMC/regulatory), Catalyze technical lead with 20 years' experience in medicinal chemistry, pharm/tox, and CMC with a 9-year tenure at the FDA in NCTR and CBER.
• Elizabeth Mannick (clinical/regulatory), Catalyze technical lead with more than 20 years' experience in clinical medicine and pharmaceutical development including a clinical reviewer at FDA/CDER.

Would you benefit from expert tips on identifying which Catalyze funding mechanism is right for the advancement of your technology and how to best showcase its potential in your application? If so, please join us for a webinar focused on helping applicants identify which of the Catalyze funding mechanisms is the best fit for their technology and learning from experts on how to write a compelling grant application.

The webinar will begin with an overview of the grant funding mechanisms available through Catalyze Product Definition presented by Dr. Diana Severynse-Stevens, the Principal Investigator of the Catalyze Coordinating Center. This description will guide investigators to a better understanding of their project's fit and readiness for the program, as well as the most appropriate funding opportunity to support their project's development needs.

Presenters Dr. Kristen Goltry and Dr. Manoj Valiyaveettil are Scientific Review Officers (SROs) within the Office of Scientific Review at the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). As SROs for the Catalyze Product Definition Program, Kristin and Manoj have extensive knowledge of the Catalyze award mechanisms, assessing application completeness, and overseeing the review process. In this webinar, Drs. Goltry and Valiyaveettil will provide attendees with information and tips for submitting their best Catalyze grant application possible, including what reviewers are looking for, how Catalyze grants differ from other NIH grant mechanisms such as R01 research project grants, as well as common mistakes made in Catalyze applications (and how to avoid them).

This presentation is developed for applicants intending to apply or re-apply to Catalyze Product Definition grant funding opportunities. The next receipt date for Catalyze applications is July 21st, 2023.

The February Catalyze Webinar will be held on February 22nd at 12:00 PM ET and will feature Catalyze Scientific Director, Dr. Mike Pieck, announcing and describing a new suite of support services offered by the Catalyze Program. The Catalyze Preclinical Services Program is a new component of the Catalyze program which will support preclinical development activities from end-stage proof-of-concept, through preclinical development and US regulatory approval. In this presentation, Dr. Pieck will explain what the program seeks to accomplish in providing preclinical services, along with details of the application process. Time will be allotted for questions and answers.

This month's live webinar will feature Program Directors from NHLBI's Extramural Divisions and Centers who will provide an overview of their respective divisions and their priority areas for funding:

• Dr. Denny Buxton, Division of Cardiovascular Sciences (DCVS),
• Dr. Patricia Noel, Division of Lung Diseases and the National Center for Sleep Disorders Research (DLD, NCSDR),
• Dr. Asif Rizwan, Division of Blood Diseases and Resources (DBDR),
• Dr. George Mensah, Center for Translational Research and Implementation Science (CTRIS).

There will be a Q&A session following the presentations. We invite you to ask questions to the guest speakers and/or of the Catalyze Scientific Program Director, Dr. Mike Pieck, as you prepare for the November 21st application deadline.

The Catalyze Program is a translational science program that offers a unique set of resources to support you along your innovation journey in moving your projects into practical application. Accepted investigators not only receive clinical, manufacturing, and regulatory expertise from the Catalyze team, but have access to broader resources at RTI International, including market and value proposition assessments from the RTI Innovation Advisors. Interested in learning more?

Join Dr. Mike Pieck (the Catalyze Scientific Director) and members of RTI Innovation Advisors team ahead of the next application receipt deadline (due: July 21st, 2022) to:

• learn what types of resources you have access to as a member of the Catalyze Program
• receive guidance for developing a competitive Catalyze application

This is the final webinar in a 3-part series dedicated to effective partnerships with external research/manufacturing organizations. The Catalyze team receives many questions around approaching Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMO), or Contract Development and Manufacturing Organizations (CDMO) to perform necessary studies. This webinar focuses on preparing for and managing partnerships to carry out chemistry, manufacturing, and controls (CMC) activities.

This webinar is presented by Dr. Mark Levi, an expert in regulatory affairs with other 20 years of experience. Dr. Levi will answer common questions about required CMC activities by providing real-world examples. This presentation is meant to give academic and small business investigators a better understanding of the regulatory process and tools to set their product up for regulatory success through partnership.

This is the second webinar in a 3-part series dedicated to effective partnerships with external research or manufacturing organizations. Approaching Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMO), or Contract Development and Manufacturing Organizations (CDMO) to perform necessary studies to aid your product's success can be daunting. Many investigators turn to the Catalyze technical team with questions like:

• What does FDA expect from a Contract organization for medical device submissions?
• How do I know what services to request from a CRO/CDMO?
• What can I expect to pay for a CRO/CDMO's services?

Join us for a webinar presented by Diane Earp, an expert in regulatory affairs and quality assurance in the development of medical devices. Diane will answer common questions about how strategic partnering with a CRO/CDMO can benefit your product and what you can expect as you integrate these efforts into your overall product development life cycle. This presentation is meant to give academic and small business investigators a better understanding of the regulatory process and tools to set their medical device up for success.

Approaching Contract Research Organizations (CROs) to perform necessary studies to aid your product's success can be a daunting task. Many investigators turn to the Catalyze technical team with questions like: What studies are needed to approach the FDA? What is a reasonable amount to expect to pay for a CRO's services? How do I know what services to request? Do I need to have a pre-IND meeting before, or after, hiring a CRO?

Join us for a webinar presented by Dr. Sharon Daily, an experienced professional in pharmaceutical development specializing in regulatory strategy of safety programs for drugs and biologics, where she will walk through the questions you need answer before approaching a CRO in order to have an efficient and effective relationship, and to ultimately set your product up for regulatory success. Dr. Daily will present several real-world cases as practical examples demonstrating why adequate preparation before approaching a CRO will save you time and money.

This webinar is the first in a three-part series that will provide practical advice with examples for medtech innovators preparing to hire a Contract Research Organization or Contract Manufacturing Organization (CMO). The next webinar in our series will focus on approaching and partnering with CMOs in January 2024. The series will conclude with a discussion about medical device-specific considerations when partnering with CROs/CMOs.

In this webinar, Diane Earp Vice President, Corporate Regulatory Compliance, at Research Triangle Institute, will discuss the evolving capabilities of Artificial Intelligence (AI) in MedTech development including its impact on clinical trials, new medical devices, drug efficacy, pharmacovigilance, and robotics. This presentation is developed for innovators engaged in product development and seeks to provide considerations and potential implications of the rise of AI on your development, manufacturing, and regulatory process. Time will be allotted for questions and answers.

Presenter Diane Earp has over 25 years of experience working in regulatory affairs and quality assurance with expertise in U.S. and international regulatory requirements applicable to drug, biologics, and medical device development, testing/validation, manufacturing, and distribution.

This webinar will be presented by Greg Gatto and Willie Salminen who have extensive experience sourcing and vetting medical product development contractors. The webinar will provide practical advice for outsourcing medical product development studies at 3rd party laboratories (e.g., Contract Research Organizations [CROs]) and manufacturers (e.g., Contract Development and Manufacturing Organizations [CDMOs]). This will include highlighting the importance of vetting and selecting CROs and CDMOs, oversight of the work, and final reporting and wrapping-up projects. As a case example, the webinar will focus on designing, contracting, monitoring, and reporting Investigational New Drug Application (IND)-enabling Good Laboratory Practice (GLP) nonclinical studies, which encompasses pivotal toxicology studies to support first-in-human clinical trials. However, the general concepts are applicable to all work that is outsourced to 3rd parties such as Clinical Studies and Chemistry, Manufacturing, and Controls (CMC) work and some examples of these activities will also be covered.

Writing focused, effective, and realistic milestones is a critical component of product development and a key element of funding applications. Milestones provide key indicators at defined points during product development to guide the project and its management. In this webinar, you will learn the differences between specific aims and milestones, how to create well-designed and thoughtful milestones, and how appropriate project management keeps your product on schedule saving time and money.

Presenter Erin McKenna is the Deputy Director and Senior Project Manager in the Boston Biomedical Innovation Center (B-BIC), a life science accelerator program. She has extensive expertise in medical device product development and commercialization, from Research and Development to company-wide process improvement.

The January Catalyze Webinar, "Concept to Company: An investigator's guide to starting a business", was presented by Steve Flaim, Senior Special Advisor and Investor-in-Residence with the Office of Innovation and Commercialization at the National Heart, Lung & Blood Institute and Entrepreneur-in-Residence in the SEED Office on January 25th at 12:00 ET. While there are several paths to market that are available to innovators, startup companies are one of the most popular. Steve has a wealth of knowledge and experience in pharmaceutical research & development, management, and investing potential. Specific topics that Steve will discuss include:

• When and how to form a startup company
• Key features of investable startup companies
• Important considerations in developing a pitch deck

Join presenter Dr. Renée Arnold as she walks through Reimbursement and Health Economics and Outcomes Research as evidence development. This webinar aims to provide a basic understanding of the structure of the US Healthcare System and components of reimbursement and to convey how evidence development support reimbursement. Attendees will gain a deeper understanding of why and how reimbursement guides product development and ultimately which products eventually reach market.

Dr. Renée JG Arnold is currently the President & CEO of Arnold Consultancy & Technology, LLC, where she develops and oversees outcomes research and affiliated software for pharmaceutical companies and the federal government. She is also an Entrepreneur-in-Residence in the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. Her special interest in evidence-based health derives from her research that deals with the use of technology to collect and/or model real-world data for use in rational healthcare decision-making by healthcare practitioners and policymakers.

This presentation will provide an overview of the different types of investors interested in early-stage companies, their preferred investment strategies, and what they are looking for in an investment deal. We will also discuss some of the key features of a successful investor pitch, what to include and what to avoid. Finally, we'll discuss the typical process that the entrepreneur needs to understand to navigate their way through to a successful early-stage investment round.

Presenter Dr. Flaim holds a doctorate in Human Physiology and Pharmacology from the University of California at Davis. He is a Technology and Business advisor to the Institute for the Global Entrepreneur at the University of California, San Diego, Senior Special Advisor & Investor-in-Residence with the Innovation Office of the Division of Extramural Research Activities at the National Heart, Lung, and Blood Institute of the National Institutes of Health and an Entrepreneur-in-Residence with the Small Business Education and Entrepreneurial Development (SEED) Office in the Office of the Director at the NIH.

Delivering a successful pitch for your project can often depend on a practiced approach. It's strongly encouraged that you join Steve Flaim as he breakdowns real-life pitches and outlines what changes a pitch from good to great! The webinar "Make it Matter - Preparing and Delivering Effective Pitches" is specifically designed for Catalyze Investigators to prepare for a pitch contest, an exciting module in the upcoming Catalyze Annual Meeting.

As a medical product innovator engaged in technology development, you are likely dedicated to seeing your product reach the market and impact both patients and the broader healthcare system. Navigating this journey necessitates a comprehensive understanding of your technology's potential to be adopted, which includes defining your technology's opportunity through market sizing. This webinar will explain the importance of market sizing, when to perform it during development, and will consider different methods as well as resources available for conducting market sizing.

This webinar is presented by Emily Vernon and Brailey Faris of RTI Innovation Advisors. Emily readily supports early MedTech and life science innovators by advising on commercialization strategy and providing critical market research insights to improve the likelihood of successful launch and adoption. In addition to Brailey's work with NIH-funded small businesses, she facilitates design thinking workshops across different industries to help translate products to the market.

In our webinar series, you have already heard from many team members of NHLBI's Office of Translational Alliances and Coordination (OTAC), including Dr. Steve Flaim and Dr. Renée Arnold. In April's webinar, OTAC's Director, Dr. Kathleen Rousche, will be joined by NHLBI's Small Business Program Coordinator, Dr. Stephanie Davis, to connect the information you have learned about in previous webinars to the resources and services available to MedTech innovators through OTAC. The presenters will cover in detail who makes up OTAC and what they aim to do, the professional advisory services OTAC offers, tailored support available to small businesses, additional funding opportunities, and networking capabilities.

Presenter Moline Pandiyan is an RTI Innovation Advisor with more than 12 years of experience guiding, supporting, and empowering innovators along their innovation journeys, enabling them to bring their research, inventions, and capabilities into practice.

This presentation will emphasize the importance of desirability in a successful innovation, highlight techniques to engage the market and incorporate critical stakeholder insights early, and introduce a framework tool — ICANVAS for Medical Applications — that can help guide your innovation journey from concept to impact.