Michael Halstead Email & Phone Number

Sydney, Nsw, Au

Sydney, New South Wales, Australia

Working in the newly established Australian affiliate of the German company focusing on digestive and metabolic diseases. Dr Falk Pharma is a German Company with its headquarters in Freiberg. The company is focused on the research & development & delivery of transformative products to patients with digestive and metabolic diseases. Established fully compliant pharmacovigilance, medical information and product complaint oversight and the internal disease/product training program for the Australian company from scratch. Also actively involved in registration and market access applications. Member of senior management team and work closely with the cross-functional team, providing medical/scientific input. Member of the global Falk scientific innovation team and global publication team.

Sydney, Australia

Alexion is a US company with its headquarters in Boston which is focused on the research and development and delivery of transformative products to address an unmet medical need in patients with a rare or ultra-rare disease.Roles & Responsibilities:1. Preparation & execution of ANZ medical plan to support pre- & post-launch activities, aligning with commercial plans (local & global).2. Thought-Leader (TL)-engagement through multiple activities, including medical education initiatives, advisory boards and PBAC hearing meetings3. Reviewed & approved scientific & promotional materials in compliance with MA Code of Conduct. 4. Product & disease state training for internal colleagues5. Supported Medical Information group, including authoring medical letters6. Supported Market Access colleagues including authoring clinical sections for PBAC/LSDP submissions7. Supported Regulatory Team with review & approval of PI and risk management protocols for TGA submissions8. Managed Compassionate Access Program for metabolics products for ANZ9. Managed investigator-initiated study program for ANZ; Region10. Managed MSL11. Member of Cross Functional Teams (ANZ & Asia Pacific)

Sydney, Australia

Sydney, Australia

Sydney, Australia

Roles & Responsibilities:1. Reviewed & approved scientific & promotional materials, in compliance with MA Code of Conduct or MTAA Code of Practice.2. Product & disease state training for internal colleagues3. Thought-Leader (TL)-engagement through medical education initiatives & through conduct & publication/presentations of results at scientific congresses of Phase IV studies supporting the lifecycle of Allergan's products. 4. Managed Regional Investigator-initiated Study Program5. Authored technical manual for external use by HCPs to support utilization of a medical device requiring a invasive procedure & pre- & post-procedural oversight 6. Supported Market Access Team through multiple activities including authoring clinical sections for PBAC submissions; conduct of a pivotal study to generate randomised, controlled data to underpin an MSAC submission7. Authored or co-authored multiple SOPs & work instructions to support fully compliant activities overseen by medical affairs, PV and medical information8. Managed clinical operations team (x6 colleagues) across ANZ; Asia-Pacific9. Successfully passed a subsidiary & financial audit with no major findings10. Member of Cross Functional Team

South San Francisco, Usa; Sydney, Australia

Actelion (now a division of J&J) is focused on the development of therapies to address an unmet medical need, including in patients with rare diseases, with a specific focus on pulmonary arterial hypertension. Roles & Responsibilities:1. As part of a seminal pre-launch activity in the US, addressed a significant knowledge gap amongst treating physicians; other HCPs in disease pathophysiology & differential diagnosis of a ultra rare disease & of company’s first-in-class therapeutic agent through: →Establishing a fully functional medical information department from scratch, incl. drafting > 200 medical letters (authored most) which were continually updated & used globally by Actelion to ensure scientifically accurate, balanced, fully referenced commentaries, provided reproducibly→Establishing interactive web-based training program for sales team/MSLs/marketing team from scratch; used globally →Conducting face-to-face training for internal colleagues in US, Canada, Australia/Asia-Pacific on first-in-class Actelion product in this ultra-rare disease using materials I drafted from scratch; used globally2. Reviewed & approved promotional materials in compliance with FDA guidelines (in US) and MA Code of Conduct (In Australia)3. Reviewed & approved external communiqués; press releases on company products4.Thought-Leader (TL)-engagement through multiple activities incl. medical education initiatives, advisory boards, peer-review publications/presentations of results from sponsored clinical studies at scientific congresses5. Designed agenda & authored slide decks for key launch activity for Actelion product in China, focused on medical education for HCPs managing relevant patients 6. Supported Market Access team through series of initiatives7. Provided medical review of all SAS applications8. Managed Medical Information Senior Managers (US)9. Member of Cross Functional Team10. Industry Representative on series of MA Code of Conduct Complaints & Appeals Meetings

Palo Alto, California, United States; Sydney, Australia.

Roles & Responsibilities:1. As Global Clinical Lead for an new investigational product in inflammatory bowel disease (IBD) oversaw multiple activities, including: →conducting series of advisory boards with US TLs to obtain support for entry into man→ co-authoring US IND submission to the FDA facilitating the initiation of the Phase I program (authored both single dose and multiple dose protocols and CRFs)- no major safety issues identified from studies; important PK data generated→ Initiated Phase II program at multiple US sites (authored 2 protocols: (a) Crohn's disease & (b) ulcerative colitis)2. Established closed collaborate relationship with US TLs, based on above activities

Sydney Australia

Roles & Responsibilities:Medical Affairs & Clinical Lead in lifecycle management of the company's portfolio of products in areas of infectious disease, cystic fibrosis, dermatology & rheumatology. Key roles:1. training of the sales team on the products and related diseases 2. Review & approval of promotional materials3. Support for the medical information group on HCP enquiries 4. Design of clinical trial protocols and CRFs, the subsequent study management & support for the publication of the results from these studies (peer-review & abstracts/presentations at scientific congresses) as an important vehicle to generate data to support product lifecycle; TL engagement activity5. Supporting Health Economics Group in PBAC submission.6. Industry Representative on Australian Cystic Fibrosis Research Group

Sydney, Australia

Sydney, Australia

Short term contract focused on preclinical pharmacokinetic studies of an investigational product (growth hormone).

Master Of Science (Medicine), Endocrinology, Diabetes And Metabolism Residency Program

Studied at Garvan Institute of Medical Research, St. Vincent's Hospital, Sydney; Awarded the Garbutt Scholarship for Post-Graduate.

Bsc (Hons), Biochemistry

Honours degree obtained through study at the Human Nutrition Unit, Uni. of Sydney