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Thomas Collet

Principal Collet Consulting LLC

Fort Hunt, United States

$2,250/day

PhD MIT biological chemistry, Scripps, Engagement Manager McKinsey, VP BD Monsanto, Partner Tullis-Dickerson, multiple start-up companies, long-time independent professional.

Domain experience

Relevant Total Experience: 25 years

Seniority Level: Senior

Sector Experience: 

Chemicals Pharmaceuticals, Biotechnology and Life Sciences

Skills

Skilled in: Corporate Strategy, Project Management Office (PMO), Commercial Due Diligence, Technical Due Diligence, Capital Raising, Fundraising strategy, Corporate Development

Technical Skills: Microsoft Excel, PowerPoint, Microsoft Office

Languages: German, English, French

Work Experience

Collet Consulting LLC (CCLLC)

Principal (Life Science Consulting, Strategy to Implementation, Discovery to Commercialization)

1/1/2002

 

- Now

Management consulting practice serving top institutions in their fields • Projects include business unit strategies (animal health); formation of internal start-ups (GMP production, wound debridement); clinical development strategies (diabetes/insulin delivery device, biopharm, ophthalmology, oncology); business creation (strategy and implementation); project management in GMP manufacturing • Clients include Top Ten companies in their respective fields: Pharma, medical devices, animal health, chemicals • Worked with agencies such as Business Talent Group, Genioo, Eden McCallum in US & Europe • US partner for Cepton Strategies, an international consultancy. Responsible for US market entry strategies • Subject Matter Expert for manufacturing at GEP Worldwide, a leading global provider of strategy (consulting), software, and managed services (outsourcing) solutions PROJECT EXPERIENCE – SELECTED PROJECTS 1. As Independent Professional Strategy • Evaluation of market need for a novel diagnostic method to replace HbA1c for the diagnosis and monitoring of glycemic status in diabetes and pre-diabetes as competitor for continuous glucose monitoring CGM (for global specialty chemical company) • Two voice-of-customer projects for a leading, global adhesives/specialty chemicals manufacturer regarding the wearables market for healthcare applications (including continuous glucose monitoring) and an automation market assessment • For Global Marketing of Top 10 pharmaceutical company, assisted in developing an outside-in perspective for their largest vaccine franchise and a defense strategy against competition for their low-end vaccine and for their high-end, “performance” vaccine • Completed an interview-based technology evaluation covering a new approach to epitranscriptomics • Conducted a strategy and market research project for a US-based materials company on how to best grow its long-acting delivery business into the animal health and rare disease markets • Conducted a strategy and market research project for a European, family-owned company on best practices in setting up a new rare disease business • Advised a top ten biotechnology company regarding its commercialization strategy in Precision Medicine • Counseled the CEO of a newly formed biotechnology company on his interactions with his board of directors and his first big board meeting post-company formation • Advised leading in vitro diagnostics (IVD) company on strategic options in the molecular diagnostics (MDx) market • Advised US-based rare disease drug developer on commercialization options for novel orphan drug in Europe • Advised European manufacturer and developer of hyaluronic acid on entry options into the US market for raw and finished products • Completed a project in the medical wearables space for an adhesives and coatings company • For a large Private Equity firm, advised investing team on pharma industry trends ranging from drug pricing to commercialization of rare diseases • For Midwest-based, university-affiliated venture fund, conducted due diligence project for portfolio company in rare disease space • Advised German developer of Artificial Intelligence (AI)-based companion diagnostics with regard to commercialization approaches in the US market • Led strategy study for branded generics business unit of global animal health company (client: GM of BU & corporate Sr. VP Strategy). Successfully delivered business plan, which was accepted by Corporate Strategy • Strategic advisor for Global Marketing department at Top Ten Pharma company for global launch of rare disease product (endocrinology) – developed launch strategy and operating budgets (US, Japan, EU5) • Developed business strategy/business plan project for a development-stage medical device company with a male health medical device and an androgen diagnostic device concept, both under 510k (US-based) • Developed product strategy for US-based, VC-backed engineering products company with focus on developing cavitation-based products for pharma production • Co-authored business plan for German medical device company with focus on shape memory materials • Advised Top Pharma company’s branded commercial team on key issues regarding the generics business ranging from product launch/discontinuation to pricing, brand defense strategies, generics attack strategies and generics industry trends including orphan and generic drug pricing • For Top 10 pharma company, evaluated several long-term collaboration models for bio-electronics with governmental research sponsors in the form of public-private partnerships (DARPA, NIH, Common Fund, Foundation for NIH) – UK company with strong US presence • For a large Private Equity firm, prepared a landscape analysis for the Contract Development and Manufacturing Organization (CDMO) market to inform their thinking for new investments and to support their due diligence efforts • For a large Private Equity firm, completed an assessment of two potential targets in the contract development and manufacturing (CDMO) space • For a large Japanese industrials company, completed long-range market research study into new technologies used in Ag Biotech. Focus was on both new types of foods and new ways of growing, harvesting and distributing foods with a perspective towards 2050 • Supported business review for Top Ten pharma company as outside strategy advisor and communications specialist (three pre-Proof-of-Concept therapeutics areas: ophthalmology, cancer, biopharm) • Supported Phase 3 product development review for Top Ten pharma company as outside strategy advisor and communications specialist • Assisted a pharma client in understanding the impact of companion diagnostics in the development and commercialization of PARP inhibitors in oncology (competitive intelligence project) • Conducted workshop review of Top Ten pharma company’s women’s health portfolio. Review was conducted in the context of a competitive intelligence program that generated a new finding regarding the client’s key drug-device combination product • Developed market entry strategy for European orthobiologics company with focus on spinal fusions. Responsible for all aspects of value chain from market access / reimbursement to practice guidelines. Includes secondary and primary research, interviews with KOLs, experts, practicing physicians, reimbursement specialists and industry consultants • Served as expert consultant on a competitive intelligence team for regulatory and clinical development questions on orphan drug development and commercialization effort for a Top Five US pharmaceutical company • Assisted company that is commercializing micro-fermentation instrument platform with entry in US market • Completed due diligence project for US-based hedge fund in the personal genetics / genomics space comprised of companies such as 23andme, Ancestry, Counsyl, Helix, Human Longevity, Pathway Genomics and others • Completed due diligence project for European PE firm in the Point of Care (POC) space with focus on Prothrombin Time and International Normalized Ratio (PT/INT) testing for Vitamin K antagonists (VKA) / warfarin testing. Included market access and re-imbursement considerations for the US market • Developed business plan for NewCo focused on delivery of small molecules, biologics, gene therapies, liposomes & cells for the development of novel therapies and life cycle management of existing therapies (drug-device combination products) • For a leading global medical device company, completed a market research project into interventional oncology and interventional cardiology products in APAC • For leading US industrial and consumer products company, completed due diligence project focused on genomic sample prep subsidiary of European, AgBio-focused life science tools company • For leading US industrial and consumer products company, completed due diligence project focused on global genomic sample prep market and on one small, fast-growing competitor in this market • Advised silicones manufacturer regarding approach to commercialization of new medical device product Implementation • For leading life science materials company, led process to establish cross-functional Advisory Board for their growing Medicals/drug delivery business • For leading global Pharma/generics company, operated global, cross-platform and cross-divisional PMO responsible for bringing aseptic and low bioburden manufacturing efforts into compliance with FDA warning letter requirements (Switzerland/USA and Global) • For leading German immuno-oncology company, stood up Project Management Office (PMO) for CMC-related product development efforts • Led PMO for largest oral solids site of generics subsidiary of Top 10 pharmaceutical company to improve manufacturing quality. Site successfully exited remediation status and was the only site globally to meet project-specific quality metrics (Germany and Global) • Supported leading global procurement and supply chain consulting company as Subject Matter Expert for Direct Materials • Assisted leading global generics company in decentralizing its North American third-party sourced products business into the regional functions • Led sub-team for drug product and API manufacturing as part of Top Five pharma company generics strategy (global manufacturing, including locations in India, with commercial focus on Europe) • For leading global generics company, led internal reorganization to improve global product development engine (from sourcing of new molecules to filing of dossier) – Swiss client with strong US presence • Supported global launch for diabetes product(s) with initial focus on major five EU countries from clinical development, medical affairs, market positioning and market access perspectives (Top Five pharma company) • For leading global business service provider focused on modular space & secure storage solutions, developed case studies and playbooks to support product launch strategy to promote local best practice throughout global organization – global company with headquarters in the US and strong European presence Other • Consulted on a preclinical/early clinical program to employ 505(b)(2) approach for accelerated approval of a pro-drug whose drug moiety is approved as a generic human therapeutic • Protocol development for 10 patient proof of concept study in an orphan disease: Included input from KOLs, CMC and regulatory input, input from parent organizations and agreement of protocol with trial site, a top-rated children’s hospital and academic medical center (AMC) • Advised Japanese femto-second laser company (IMRA) with US R&D organization with regard to commercialization of colloidal gold nanoparticle technology in point of care diagnostics and research reagents • Evaluated several incubator concepts to boost bioscience innovation in large metropolitan area (working with McKinsey team) 2. As Entrepreneur • Started MIT spin-off company with focus on treatment of constipation, metabolic disorder (e.g., diabetes, obesity) & raised seed funding • Started specialty pharmaceutical/branded generics company in Women’s Health that employs method-of-use IP and 505(b)(2) to create exclusivity and simplified clinical development plan (all three active ingredients are generic). Included sourcing of API and drug product manufacturing in Germany; establishing product development path and building commercial/pricing model • Started specialty pharmaceutical company with orphan drug focus on Duchenne muscular dystrophy. Approach employs orphan drug exclusivity and method-of-use IP to protect generic active ingredient (505(b)(1) pathway for NCE). Included sourcing of API and drug product in US; establishing product development path, regulatory activities, building commercial/pricing model and relationships with patient and parent organizations • Started medical device company with product candidate for the treatment of hemorrhagic stroke (Neural Intervention Technologies). Company sold to WL Gore in 2007 • Started genomic sample prep company with focus on unbiased whole genome amplification (Rubicon Genomics). Company sold to Takara Bio in January 2017 for $75 million • Started oncology company with focus on transcriptional inhibition of bcl2 (ProNAi Therapeutics. Company went public in July 2015 with a market capitalization of >$800 million (DNAI), subsequently renamed Sierra Oncology and sold to GSK for $1.9B 3. With McKinsey • Led strategy development for chemical company’s entry into drug delivery business • Changed strategic course of major Chicago area academic medical center facing managed care threat to focus on local market dominance rather than network alliance • Developed detailed sales and marketing program for a global top-five pharmaceutical company (focus on EU, Germany) • Assisted mid-size US pharmaceutical company in search for partner for its European business • Changed strategy of chemical specialties maker (silicones) from conservative parochial approach focused on US and Germany to global approach targeting alliance with partner in China – multi-year effort • Developed business unit strategy and proposal for investment for global engineering resin manufacturer (ultra-high molecular weight polyethylene) – multi-year effort in US and EU • Induced chemical company client to enter Indian market via $10 million investment in fine chemicals business • Developed new global strategy for VC-backed, US-based steel waste product recycler • Participated in product development change process to reduce manufacturing costs for gas turbine manufacturer

The Wyss Institute at Harvard University

Visiting Scholar

1/10/2019

 

- 1/12/2019

Supporting start-up project for ultra-long delivery of parenteral drugs.

Phrixus Pharmaceuticals, Inc.

President & CEO & Co-Founder (rare disease/orphan drug, discovery to Phase 2, Duchenne MD)

1/1/2010

 

- 1/11/2018

Co-founded company based on publication in Science and license from University of Michigan and developed two programs to clinical stage, one for Duchenne muscular dystrophy (DMD), an orphan disease, and one for heart failure • Set scientific strategy and with CSO managed pre-clinical studies to deliver proof-of-feasibility • Raised $4 million in private and $2.1 million in NIH funding, (plus further off-balance sheet support from NIH) • Opened two INDs, one for DMD and one for acute decompensated heart failure • Company started first Phase 2 trial to develop poloxamer 188, a medium-sized polymer, for DMD in 2018

Meditrina Pharmaceuticals, Inc.

President & CEO & Co-Founder (Women's Health/endometriosis/uterine fibroids, repurposing)

1/1/2006

 

- 1/12/2010

Co-founded clinical-stage specialty pharmaceutical company focused on women’s health • Negotiated licenses with Wayne State University and AstraZeneca for Phase 2 products for endometrial ablation and endometriosis • Further indications: uterine fibroids, menorrhagia, ectopic pregnancy • Product candidates based on estrogen/progestin/aromatase inhibitors • Raised $5 million in capital • Together with VP Clinical Development and co-founder, managed CROs and engaged medical collaborators (Ob/Gyns) to develop therapeutic to IND stage and beyond • Company opened two INDs and completed one phase 2 trial for endometrial ablation

ProNAi Therapeutics, Inc.

President & CEO & Co-Founder (oncology, NHL, DNAi)

1/1/2003

 

- 1/1/2005

Co-led launch of early stage DNA Interference (DNAi)-based biopharmaceutical company with focus on oncology therapeutics (internally created intellectual property, bcl2/NHL as first target) • Responsible for raising initial $4.5 million, assembling key team, preparing business plan, and executing key product development agreement for DNAi delivery vehicle • Prepared company for next stage (additional $11 million follow-on funding & IND within next two years) Company went public in July 2015 with a market capitalization of >$800 million (DNAI), then renamed to Sierra Oncology and later sold to GSK for $1.9B (2022).

Neural Intervention Technologies, Inc.

President & CEO & Co-Founder (neurovascular med device, hemorrhagic stoke, aneurisym, AVM, alginate)

1/1/2003

 

- 1/1/2005

Simultaneously to ProNAi, co-founded and led early stage medical device company for the treatment of hemorrhaging stroke, a spin-off company from the University of Michigan • Set and executed product development strategy together with two co-founders • Company raised $6.3 million and opened one IDE • Engaged external partners during product development, one of which then acquired the company in 2007 (WL Gore)

Tullis-Dickerson & Co., Inc.

Vice President (VC, early stage and life science investor)

1/1/1999

 

- 1/1/2001

In charge of opening and growing new office for the Midwest • Responsible for investments from $38 million sub-fund with focus on early- to mid-stage opportunities in life sciences, drug discovery, and drug development • Invested in six companies including TransMolecular, ViaCell (acquired by Perkin Elmer in 2007), Synageva BioPharma (formerly Avigenics, acquired by Alexion in 2015)

Bilayer Therapeutics

President & CEO

1/8/2020

 

- Now

Developing first-in-class therapeutics for GI disease and metabolic disorder such as obesity and Type 2 diabetes based on proprietary bilayer tablets and bile acids Email me if you need a drug delivered to the colon or if you are interested in GLP-1 mediated therapy for obesity and diabetes: thomas.collet@bilayer-therapeutics.com

Rubicon Genomics, Inc.

President & CEO (genomics tools, unbiased whole genome amplification, DNA sequencing, SNP scoring)

1/1/2001

 

- 1/1/2002

Re-started university spin off into commercialization-stage life sciences and genomics tools company • Recruited three outside directors including CEOs from two publicly held companies and recruited high caliber management team in order to balance out academic founders • Redirected strategy toward high value, fundable products and market opportunities, and instituted professional management practices • Raised $6 million Series B in spite of genomics implosion Company sold to Takara Bio in January 2017 for $75 million

Monsanto Company (Integrated Protein Technologies)

VP Business Development (production of therapeutic proteins and antibodies in green plants)

1/1/1997

 

- 1/1/1999

Started new internal business for the production of therapeutic antibodies, biogenerics/biosimilars in green plants • Led BD efforts with five contracts executed over 18 months and six more contracts under negotiation • Responsible for first contracts of ~$2 - $3.5 million for Phase 1 production of first parenteral protein ever produced in plants (included involvement in development of IND) • Wrote key elements of business plan and assisted in generating internal funding of several million dollars per year (equivalent of about 20 internal FTEs)

Education

Massachusetts Institute of Technology

1/1/1985

 

- 1/1/1991

RWTH Aachen University

1/1/1983

 

- 1/1/1985

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