Michael Guth - Director, Research Advisor Consultant (Obesity) at Transforming Growth Factor-Beta (TGF-ÃƒÅ¸) LLC

Disclaimer: This information was obtained from publicly available sources online and is believed to be accurate at the time of publication. Valimates collects this information with proprietary technology and cannot guarantee the accuracy or completeness of the data. The purpose of the data is to inform the reader about the expertise of the individual and should not be used for any other purpose. Valimates does not have any affiliation with the individual.

Michael Guth Director, Research Advisor Consultant (Obesity) at Transforming Growth Factor-Beta (TGF-ÃƒÅ¸) LLC

Claim Profile Update Profile Delete Profile

Michael Guth boasts an illustrious career spanning over 15 years as a medical writer and publication specialist, with a robust LinkedIn network reflecting a high degree of connectivity in the professional sphere with 9973 connections. They hold a distinctive competence in health outcomes research, the evolving reimbursement ecosystem, real-world evidence (RWE), and regulatory writing, laying a strong foundation for their current focus on advertising and promotional material regulatory compliance within pharmaceutical firms.

Michael's expertise is broad, covering a variety of therapeutic areas including ophthalmology, diabetes, endocrinology, cardiovascular disease, and oncology, to name a few. Notably, they are the sole author of clinical evaluation reports required for medical devices in the EU and possess a comprehensive understanding of the drug development and approval process. Michael is a thought leader who has had their work indexed by PubMed, and they play a crucial role in developing medical communication materials that comply with regulatory standards.

Holding the title of Director, Research Advisor Consultant at Transforming Growth Factor-Beta LLC in Oak Ridge, Tennessee, Michael demonstrates a deep dive into medical research, particularly in fields such as obesity and neuromuscular disorders. They have also worked on medical communications and regulatory medical writing at Risk Management Consulting, showing versatility in drafting clinical documentation across various health conditions and treatments. Their educational background from Caltech and Rice University in social science (quantitative modeling) and economics underpins their analytical acumen and contributes to their comprehensive skill set. Michael Guth is a powerhouse of knowledge and an invaluable asset in the realms of pharmaceutical and medical research and communication.

More about this expert

Full name: Michael Guth
Location: Oak Ridge, Tennessee, United States
Title: Director, Research Advisor Consultant (Obesity)
Company: Transforming Growth Factor-Beta (TGF-ÃƒÅ¸) LLC
LinkedIn profile: https://www.linkedin.com/in/populationhealthmanagement/
LinkedIn Connections: 9973
Summary: LION Open Networker (9954+ first degree connections) Michael A. S. Guth has over 15 years medical writing and medical publication experience. Most recently, he has focused on advertising & promotional material regulatory compliance for pharmaceutical firms. Core expertise in health outcomes research, changing reimbursement landscape, real-world evidence (RWE), and regulatory writing. Write and/or assist in the development of medical communications materials such as slide presentations and accompanying notes, poster presentations, new offerings developed by the company, content for internet sites, videos vignettes, other enduring materials, and meeting agendas-all consistent with promotional material regulations. Sole author of clinical evaluation reports (CERs) as robust assessments required for all medical devices being sold/marketed in the EU. These evaluations are very thorough and are meant to act as an overall summary and assessment of the safety and performance of a device. They require thesis-level research for each and every device regardless of classification. Diverse therapeutic research experience including ophthalmology, diabetes, endocrinology, cardiovascular disease, osteoporosis, microwave ablation of solid tumors, and oncology. Thorough understanding of the pharmaceutical drug development and approval process. Sole author of medical journal articles indexed by PubMed. Assist in the development of scientific platforms, including research and compiling all relevant data for generation of a comprehensive data gap analysis. Oversee work of scientific associates as needed, and provide mentoring/training to new or more junior team members. Meet with clients and/or other external parties, as necessary, during the development and review of clinical evidence materials. Cultivate existing relationships with key opinion leaders and initiate new relationships to drive appropriate communication strategies and content. Responsible for providing strategic insight and medical direction based on thorough knowledge of clients products and therapeutic areas. Research, write, develop, and deliver, within budget and on time, strategic and scientifically accurate materials for a variety of healthcare audiences.
Skills: Identifying Issues Document Preparation

Education

Caltech: M.S.
Field of study: Social Science (Quantitative Modeling)
Rice University: B.A.
Field of study: Economics (major)

Positions

Transforming Growth Factor-Beta (TGF-ß) LLC Oak Ridge, Tennessee - Eastern time zone · Remote: Director, Research Advisor Consultant (Obesity)
Nov 2023 - Present

Investigating selective activin receptor ligand trap being developed for both the treatment of obesity and neuromuscular disorders. This ligand trap can inhibit the biological effects of myostatin and activin A to increase skeletal muscle and bone mass, increase fat metabolism, and reduce fibrosis. Collaborate with project teams to support clinical studies from protocol development through study execution and completion of study reports. Perform a deep dive into the scientific landscape (medical journal articles, pipeline drugs, proprietary research) on both acquired and genetic obesity. Combine scientific expertise, clinical development experience, and a comprehensive understanding of regulatory requirements with research on Acquired and/or Genetic Obesity. Prepare and deliver detailed reports and presentations to convey findings and recommendations to diverse stakeholders.
Principal Investigator of "A Study of Compounded Terzepatide + L-Carnitine in Overwight but Non-Obese Vegans." Injectible GLP1 analogs now face significant excess demand. Human GLP-1, an incretin secreted by entero-endocrine cells in response to food intake, enhances insulin secretion by the pancreatic ß-cell and improves insulin sensitivity. It reduces appetite through a reduction of gastric emptying and central effects on satiety signaling. These mechanisms allow improvements in both glucose metabolism and body weight. GIP induces weight loss by stimulating satiety in the hypothalamus. The leptin-melanocortin pathway leads the hormone leptin, synthesized by the leptin gene (LEP) in adipocytes, to activate its receptor (LEPR) inducing, in anorexigenic neurons, prohormone subtilisin/kexin 1 convertase (PCSK1) activity which converts proopiomelanocortin (POMC) to alpha-melanocyte stimulating hormone (α-MSH). The latter is the natural ligand of the melanocortin receptor type 4 (MC4R) which induces a satiety signal upon activation.
Risk Management Consulting Remote: Oak Ridge, TN · Remote: Head, Medical Communications, Regulatory Medical Writing
Feb 2002 - Present

Reporting to the Chief Medical Officer, medical writer to draft RadioPharmacy Manuals, Informed Consent Forms for clinical trials, Investigator Brochures, Clinical Trial Protocols, Drug Safety Update Reports, Clinical Study Reports, Fast Track Request, and related documents. The three main first-line therapies include BRAF/ mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors (dabrafenib/trametinib, vemurafenib/cobimetinib, encorafenib/ binimetinib), PD-1 antibody monotherapy (nivolumab, pembrolizumab), and a combination programmed cell death protein 1 PD-1/ cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody therapy (nivolumab/ipilimumab). Advanced melanoma is characterized through its depth of invasion (> 4 mm) known as Breslow thickness or the presence of in-transit or lymph node metastases. Utilizing the isotope lead-212 (212Pb) to bombard cancer cells with powerful alpha radiation (protons) and effectively "nuke" the cancer cells via specialized targeting peptides. This approach of internal bombardment of cancer cells is being studied in Phase 1/2a clinical trials of advanced and metastatic melanoma and neuroendocrine tumors (pancreatic cancer, colon cancer, G-I cancer). Precision oncology combining a portfolio of targeted radioligand assets and a secured supply for medical isotopes including actinium-225 and lutetium-177. for a pan-cancer program targeting fibroblast activation protein-α (FAP-α).
Oncology/Rare Disease Indication
• Prelaunch
• Lead the group responsible for data dissemination, education, regulatory document drafting
o Publications
o Medical Education
o Medical Training
o Content Development

• Reviewing publications from vendors to determine if in good enough shape for internal review team, facilitate the review process, liaise with vendor, meet with teams, cross functional team meetings, etc.
• 30-40% Cross functional team meetings
• 30-40% Reviewing publications
• 20% Vendor management
• 10% Administration
Risk Management Consulting Oak Ridge, Tennessee, United States · Remote: Senior Director, Medicine Capability Processes Clinical Development and Medical Affairs
Aug 2018 - Present

Senior Director to design and manage a learning & development (L&D) program that provides medical leadership across the whole product lifecycle — from advising on research & development investment decisions, to leading pre-launch scientific efforts, to accelerating evidence-based healthcare changes in the real world. Specialized qualifications in human resources, learning, and staff development. Over 20 years’ experience in L&D, delivering in-house training seminars, preparing scientific and medical content of payer and symposium presentations, organizational development, talent management, and professional education and/or human resources business partner experience. Knows effective L&D initiatives and environments, identifies gaps and opportunities for capabilities development, and designs tailor-made interventions. Executive presence with the ability to influence, negotiate, and drive change across an organization. Strong curriculum and L&D design skills including visual learning and emerging trends in L&D. Defines the cross-functional vision and strategy for medicine capability processes including standards and performance metrics. Evaluates current process performance and develops the strategic roadmap to realize the vision and business value. Examples of processes: Early and Strategic Engagement (EASE), early Asset Teams, Integrated Brand Planning (IBP), Integrated Customer Plan (ICP), Medical Affairs Planning (MAP), Launch Readiness, Segmentation, Customer Engagement, etc.
• Operate within the L&D environment as a thought leader, consultant, and subject matter expert on medical capability training strategy, business planning, and solution design.
• Partner with colleagues across Human Resources, Commercial Excellence, Market Access and Evidence to adopt best practices, leverage learning assets, and enhance implementation of company-wide initiatives.
• Maximize value from existing vendors and continually evaluate the learning marketplace for new opportunities
Risk Management Consulting Oak Ridge, Tennessee, United States: Medical Communications (Journal & Conference Publications)
Jul 2021 - Present

Draft medical journal article for treatment of Myelofibrosis (MF) using fedratinib, an oral, selective inhibitor of Janus kinase 2 (JAK2) approved in the United States for treatment (Tx) of Intermediate (INT)-2 and High-risk primary or secondary (post-polycythemia vera [PV], post-essential thrombocythemia [ET]) MF. MF is also treated with Ruxolitinib (RUX), a JAK1/2 inhibitor approved in the US and European Union for Tx of INT- or High-risk MF. RUX Tx often leads to patients experiencing substantial weight gain (mean increase from baseline was ~4 kg in the pivotal COMFORT-I and COMFORT-II studies). Additional JAK2 inhibitors (eg, pacritinib and momelotinib) are currently in late-phase clinical trials for MF. Separately, prepared five technical abstracts reporting retrospective study and matching adjusted indirect comparison (MAIC) models (methods, results, conclusions) for the American Society of Hematology (2021) congress. Topics included (1) Economic Burden of Hospitalizations for Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) in Remission in the United States, (2) MAIC of Oral Azacitidine (AZA) versus Injectable AZA in Patients with AML in First Remission after Intensive Induction Chemotherapy, (3) The Impact of COVID-19 on Treatment Patterns for Patients with AML, (4) Real-World Evidence Comparing Venetoclax Plus AZA (VEN-AZA) vs. Intensive Chemotherapy as Induction for Patients with AML, (5) Impact of Post-Remission Maintenance Therapy on Outcomes in Patients with Newly Diagnosed AML in real-world practice.

𝐌𝐞𝐫𝐠𝐞𝐫𝐬 & 𝐀𝐜𝐪𝐮𝐢𝐬𝐢𝐭𝐢𝐨𝐧𝐬: Advised start-up pharmaceutical firm with a very expensive radionuclide drug to test in clinical trials and only $30 million in the bank, that its cash position will not get the firm very far. That means this firm could be a takeover opportunity, if an acquiring firm believed the target firm's alpha-particle emitting drug technology vastly improves cancer survival/remission rates.
Risk Management Consulting -- PCSK9 and ANGPTL3 Inhibitors, Fibrinolytic Enzymes Thousand Oaks, California, United States · Remote: Sr Director, Cardiovascular Medical Communications
Feb 2005 - Present

𝐂𝐚𝐫𝐝𝐢𝐨𝐯𝐚𝐬𝐜𝐮𝐥𝐚𝐫
• Treatment by statins and the newer class of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. The enzyme PCSK9 causes liver cells to remove more LDL (the “bad” cholesterol) from the bloodstream. PCSK9 inhibitors stop the protein from working so that patients have more LDL receptors on their liver cells and less cholesterol in their blood. Whereas statin drugs induce a mild blood clot inhibiting effect, the PCSK9i class does not. The anti-clotting effect could lead to higher risk of bleeding (hemorrhaging) in the brain. Two monoclonal antibodies (mAbs) targeting PCSK9, evolocumab and alirocumab, significantly reduce LDL-C levels in Heterozygous FH patients.
• Likelihood of FDA regulatory approval and feasibility of developing fixed-dose combo therapy for PCSK9i and Angiopoietin-like protein 3 (ANGPTL3) inhibitor drugs intended to lower LDL. ANGPTL3 is a secreted protein that regulates plasma lipid levels via affecting lipoprotein lipase- and endothelial lipase-mediated hydrolysis of triglycerides and phospholipids upstream of LDL production.
• ANGPTL3 PPlays a major role in the trafficking of energy substrates to either storage or oxidative tissues in response to food intake. Evinacumab, the mAb targeting ANGPTL3, is highly effective in reducing LDL-C levels even in Homozygous FH patients thanks to its LDLR-independent mechanism of action.
• The Metabolic Syndrome, which often results in insulin resistance, lower high density lipoprotein (HDL) levels, and fatty liver disease (hepatic steatosis).
• Drafted and prepared Clinical Evaluation Reports and related documents on the safety and efficacy of catheters, ports, and retrievers to administer medicines and treat medical conditions in the cardiovascular system – including microcatheters and retrievers used in neurovascular surgery.
• Four-time peer reviewer for the prestigious Journal of the American College of Cardiology.
Real-World Evidence Master Class Company Remote: DIRECTOR, REAL-WORLD EVIDENCE (RWE), GLOBAL EVIDENCE & VALUE DEVELOPMENT
Feb 2005 - May 2012

Direct real-world evidence (RWE) collection and analysis function to inform regulatory decision-making across the continuum from discovery, translational, clinical, pre-market review, and post-marketing surveillance. Maximize the value of RWE investments, including secondary data and analytic tools, through training and awareness programs, appropriate governance, and collaboration with procurement, IT, R&D, Value & Access/Health Economics & Outcomes Research (HEOR) and other key functions. Communicate detailed observational study results in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings.
• Support real world data (RWD) and analytic operations to enable evidence generation activities, providing the company with structure and operational capabilities-related RWD.
• Maximize the value of RWE investments, inclusive of secondary data and analytic tools, through training and awareness programs, appropriate governance, and collaboration with procurement, IT, R&D, Market Access/HEOR and other key functions.
• Understand the “big picture” and pull out meaningful insights and actions for RWE data sets: commercial data sources, including Truven and Optum; electronic health records and registry data; phase IV and post-market clinical trial data.
• Design and conduct relevant process, data and tool trainings; facilitate dynamic sharing of knowledge and establishment of best practice; ensure and develop effective and consistent communication within the user communities, both global and local.
• Maintain awareness of new developments in RWE analytics, data, and technology which may be applied to the design and execution of observational research and/or the management and reporting of data used in observational research.