Tom Goodin Email & Phone Number

Boston, Ma, Us

Marlborough, Ma, Us

Individual contributor role evolved into a co-lead of the SUN-101 NDA submission for a nebulized bronchodilator to treat COPD. SUN-101 is a glycopyrrolate solution inhaled into the lungs using an innovative electronic nebulizer. The SUN-101 (Lonhala™ Magnair™) NDA was approved in December 2017.• Co-developed presentation strategy for pre-NDA briefing book• Responsible for strategy and authorship of clinical study reports (CSRs), ISE, ISS and Clinical Overview.• Co-authored the CMC Device Performance Overview to support CDER and CDRH reviews. Global Program Leader-Respiratory August 2016. Led cross-functional development team and provided a shift to a vision, mission and success oriented environment through open, transparent communication. Developed and integrated medical strategy to support launch, publication plans and serve as product champion for respiratory portfolio. • Responsible for FDA information requests during NDA review and approval. • Internal and external product champion for 5 respiratory portfolio products (handheld DPI and nebulized); including communication of clinical information to internal and external stakeholders.• Provide strategic support to Medical Affairs.o Co-authored seminal SUN-101 publications.o Co-developed clinical strategy and tactics, including publication plans, to support COPD portfolio.o Provided respiratory disease/product training to the field-based medical team (MSLs) and HCP speaker’s bureau.o Member of Sunovion-Novartis Joint Medical Affairs Team for DPI handheld products• Developed medical strategy to support the launch of three COPD bronchodilators within 12 months.• Member of the Sunovion-PARI JSC for Lonhala Magnair• Partner with Business Development and the Digital Health Search Teams to provide due diligence support for product/technology in-licensing opportunities.• Chairman’s Award recipient (June 2017).

Cambridge, Ma, Us

Led a team of high-performing Directors who integrated scientific and broad operational expertise to develop effective and innovative Clinical Development Plans (CDP) in close collaboration with Medical Research and other functional subject matter experts across the entire development portfolio including CNS and rare diseases (~ 120 studies). The Directors also led matrixed development teams ensuring drug candidates were best positioned for the next phase of development. This team was accountable for the delivery of the CDP results.Established identity and leadership culture with direct reports.Led a joint team of senior operational and CRO leaders to develop a consolidated rationale to clearly define the financial and operational benefits of the sole source CRO model that was presented to senior leaders throughout the organization .Co-led and developed a new operational model with sole source CRO partner to improve organizational interfaces, relationships and allow for a flexible level of trial execution support to be aligned with program and business needs .

Us

Responsible for integrating MCDA (multiple criteria decision analysis) modeling into R&D portfolio, project and in-licensing strategies and investments as an Experimental Medicine and Science department corporate initiative.Expand and develop departmental translational medicine capabilities.Interim Respiratory Therapeutic Area Head (September 2012-June 2013) and Product Development Team Leader - The responsibilities as interim department head included integrating clinical leadership into the development (Phase II-IV) and implementation of commercial, scientific, regulatory and life cycle management strategies for the Respiratory portfolio of bronchodilator and PDE4 inhibitor therapies for the treatment of COPD with ex-US co-development partners.

Us

Served as clinical sub-team leader and PDTL included responsibility and accountability for leadership in a matrix team responsible for the development and implementation of commercial, scientific and regulatory strategies for the clinical development/registration of aclidinium bromide for all indications throughout the product life-cycle with an ex-US co-development partner, The product development team (PDT) includes clinical and non-clinical subject matter experts.Clinical Program Leader (LAMA/LABA project) - The primary responsibilities of this position included providing and integrating clinical leadership into the development and implementation of commercial, scientific and regulatory strategies for the clinical development/registration of a LAMA/LABA fixed-dose combination in COPD.Clinical Program Leader (LABA project) - The primary responsibilities of this position included integrating clinical leadership into the development and implementation of commercial, scientific and regulatory strategies for the clinical development/registration of a novel LABA + ICS in COPD and asthma.CV/Respiratory Study Director - The primary responsibilities of this position included integrating clinical operations leadership into the development and implementation of corporate business, scientific, clinical and regulatory strategies to support ongoing development programs for pre and post-marketed products including COPD and hypertension.

Honolulu, Hi - Hawaii, Us

Key management hire to provide leadership in the development and implementation of corporate business/finance, scientific, clinical and regulatory strategies. Cardax is a small biotech company developing a platform of novel natural product derivatives (i.e. carotenoids) for the treatment of acute and chronic disease states characterized by oxidative stress, inflammation and reactive oxygen species pathophysiology.Provided leadership and experience to transition the company culture from discovery oriented to a focused drug development company.Established key international CMC vendor relationships (i.e. BASF SE, CarboGen, BioDynamics, Patheon) to achieve project timelines and milestones within quality and budget expectations. Actively participated in the audit and due diligence phases of the competitive bidding process for each of the vendor selections. Led CMC effort with BASF to produce 50 kg of a cGMP quality key intermediate for the API synthesis on time and within budget. Led expansion of Cardax- BASF Joint Development and Supply partnership to include specialty synthesis (i.e. zeaxanthin to support a macular degeneration program), R&D chemistry support and cGMP API manufacturing.Managed preclinical pharmacokinetic, toxicology, and proof-of-concept (POC) efficacy extramural programs at CROs (i.e. MPI, Covance, Charles River) and with key thought leaders (KTLs) at academic institutions (i.e. University of Michigan, Wayne State, Cleveland Clinic, Case Western Reserve University).Co-organizer for company Cardiovascular Scientific Advisory Board meeting held on February 1-3, 2007 in Honolulu. Responsible for compliance and scientific review for all of the manuscripts submitted to the American Journal of Cardiology Supplement titled “Oxidative Stress and Heart Disease”. Am J Cardiology 2008; 101 (10, Suppl 1). This supplement was a compilation of papers presented at the company sponsored Cardiovascular Scientific Advisory Board meeting in 2007.

Paris, France, Fr

Responsible for operational oversight and primarily post-marketing support of US Cardiovascular-Thrombosis Therapeutic team including the Plavix®, Lovenox®, Avapro®, Avalide® and Multaq® brands that collectively accounted for approximately $6B in US sales. The primary responsibilities of this position included: local and global brand planning, clinical trial oversight/design, budget and resource planning /management, partner (BMS) management, personnel management and departmental/corporate administrative responsibilities.Key role in the management of the Cardiovascular-Thrombosis (CV-T) team in a post integration (sanofi-aventis merger) setting. Assisted the therapeutic area Vice-President in establishing financial and strategic planning for a team of 85 drug development professionals (e.g. medical directors, medical liaisons, clinical trial/program managers, medical education and publications staff).Received President's Circle Award for role in presenting the MATCH clinical trial results to neurologists. Exceeded execution and enrollment targets for the REACH registry (26,000 Us patients) and INCLUSIVE hypertension study that evaluated difficult to treat sub-populations.Key role in developing a futility analysis to present to senior management and trial steering committee to justify the closure of a peripheral arterial disease trial. Cost savings realized - $8M.

Paris, France, Fr

Responsible for operational oversight and primarily post-marketing support of Uroxatral®, Ambien® and Eloxatin® clinical programs. The primary responsibilities of this position were clinical trial oversight/design, personnel management, and departmental/corporate administrative responsibilities including budget planning/management. Developed preliminary process for managing IST (Investigator Sponsored Trials) program associated with the US launch of Eloxatin®.

Us

The primary responsibilities of this position include strategic development of clinical programs, clinical trial oversight/design, personnel management, and departmental/corporate administrative responsibilities.Developed strategy to stimulate enrollment in a multicenter (40 sites) Phase II prostate cancer trial. Shared corporate award with Oncology team for terminating the prostate program due to efficacy concerns. The cost savings to R&D was $3M. Co-managed program closeout activities.Proposed dose finding strategy for combination of an anti-angiogenic biologic NCE with chemotherapy. Co-developed Phase II protocol in non-small cell lung cancer.

Us

The primary responsibilities of this position included strategic development of clinical programs, clinical trial oversight/design (Phase I-IV), scientific consultant to the corporate business development group, personnel management, and departmental/corporate administrative responsibilities.Worldwide clinical program leader for the Phase I-III development of an NCE dopamine agonist transdermal patch for the treatment of Parkinson’s disease. Responsible for overall strategic program planning, budget development /forecasting, contract placement with CROs, PI and investigator selection, protocol development and allocation of resources for on and off-site management and monitoring of the clinical trials. The rotigotine transdermal patch (Neupro) was approved by the FDA in May 2007.Participated in the product in-licensing and due diligence. Managed international clinical group of 8 (3 US and 5 EU). Co-directed 30 member development team (e.g. Clinical, Statistics, Regulatory, DMPK, QA, CMC, Marketing) with EU based Project Manager. Led clinical development discussions with FDA. Directed efforts to rapidly resolve a QTc prolongation issue raised by the FDA.Directed the initiation of eight (8) clinical trials in 1999: PK (2), Phase I (4) and Phase II (2). The trials were conducted in the US, Europe and the Baltic states. The Phase II studies were to enroll patients in the US, Europe, Baltic states, South America and South Africa. Managed key relationships with US and EU medical thought leaders in the management of Parkinson’s disease. Worked with Marketing (US & EU) to develop product profiles, focus groups, short and long-term strategies for product recognition and introduction.Directed and managed local (US) Phase II clinical trial development for locally delivered anti-restenosis agents (i.e. antisense oligonucleotide, cytoskeletal inhibitors) immediately following coronary balloon angioplasty (PTCA).

Recruited as an original employee of the company and was responsible for setting-up, equipping and staffing the corporate laboratories.Designed and managed developmental, GLP pre-clinical safety/pharmacology and efficacy evaluations of a synthetic oxygen carrier, Oxyfluor, from product conception through IND approval (IND #5015: Perfluorochemical Emulsions as Gas Transport Agents in the Blood). Interacted directly with FDA while presenting pre-clinical and clinical results from Oxyfluor studies in healthy volunteers, surgical and CPB pateints. Oxyfluor was developed under a joint venture with Baxter Healthcare Corporation.Led and directed small (mouse/rat) and large (primate) pre-clinical POC research programs using perfluorochemical and/or emulsion technology platform for potential oncology (emulsified Taxol), liquid ventilation and diagnostic imaging agents/therapeutics.Directed and conducted a number of toxicological and physiological research studies in several primate species (i.e. cynomolgous, rhesus, baboon). The rhesus monkey was used to specifically evaluate the effects of Oxyfluor on pulmonary function, hematology (bone marrow morphology, platelet count and function) and tissue morphology. In addition to overall safety assessment, the baboon was used to study the effects of perfluorochemical emulsions on the respiratory system (pulmonary function), bone marrow morphology, hemostasis and platelet count.Responsible for small and large animal model development to study hemodynamics, oxygen transport, airway pressure and/or mechanics under the following conditions: normovolemia, normovolemia with anemia (mild and extreme acute normal hemodilution), hypovolemia (hemorrhagic shock) and normovolemia with partial liquid ventilation.

Irvine, Ca, Us

Research efforts focused on the use of a rodent exercise model for evaluating oxygen transport physiology in animals hemodiluted with crystalloid solutions or a stroma-free hemoglobin solution. Preliminary results from these developmental studies suggested that the physiological parameters of exercise may be a useful means to quantitate the oxygen delivery/consumption (i.e efficacy) of candidate red cell substitutes. Consultant for a local start-up venture (Oxygenetics) attempting to raise funds to develop and commercialize a red cell substitute technology using chemically modified bovine hemoglobin.

Cambridge, Massachusetts, Us

The research collaboration with Dr. Robert Geyer resulted in the development of a number of fundamental biological, toxicological and physiological methods for perfluorocarbon emulsion evaluation. These methods were utilized in both rodents and primates to evaluate the safety and efficacy of: 1) Fluosol-DA which was being commercialized by Alpha Therapeutic Corporation, 2) several novel perfluorocarbons provided by industrial suppliers, 3) two perfluorochemicals for an NIH sponsored research contract and 4) a perfluorochemical developed under a research and development contract with Adamantec.

Doctor Of Philosophy (Ph.D.), Physiology

Bgs, Biological Sciences